SolRx Notes

NAPRA
Competencies are set forth by NAPRA.
NAPRA – National Association of Pharmacy Regulatory Authority
• It is an umbrella organization of Canada’s provincial pharmacy regulatory bodies
(eg. OCP, etc.)
• NAPRA outlines schedules
• In addition to the Provincial and Territorial Pharmacy Regulatory, the Canadian
Armed forces are part of NAPRA
• Their mission is to make sure that the public interest is always upheld, which is
accomplished by
o Representing the interests of the members organizations
o Serving as national resource center
 Ex: This is where you can find the standards of practice for
pharmacy technicians
o Promoting the harmonization of legislation and standards
 Ex: each state has its own needs and wants, how do you make it all
the same? NAPRA. If you go to one province, you should receive
same care as another. Your Rx should apply to different provinces.
In Canada you can transfer prescriptions across provinces (for
most drugs)
 People in Canada are vastly distributed, different wants and needs.
NAPRA helps to harmonize all that
o NAPRA developed a set of national competencies
 Standards for entrance into profession
 Provincial regulatory bodies such as the OCP
 Provide a guidelines for practice for pharmacists
• Who regulates the practice of pharmacy in Canada? In
Ontario, it is the OCP. It is the provincial regulatory
colleges. Regulate means control – license is control.
• NAPRA does not regulate! It provides guidelines.
o There are 7 main competencies set out by NAPRA
 Patient Care
 Professional collaboration and team work
 Ethical, legal and professional responsibilities
 Drug, therapeutic and practice information
 Communication and education
 Drug distribution
 Understanding management principles

Pharmacists
What does a Pharmacist actually do?
• The pharmacist’s practice is based on these competencies, and all the NAPRA
definition of a registered/license pharmacists is who:
 o Practices in accordance with professional registration and licensure, and
professional standards within his/her jurisdiction
o Possess broad-based and pharmacy specific knowledge.
o Uses critical thinking, problem solving, and decision making skills
appropriate to the pharmacist’s role
o Mentors pharmacists, students, interns, and pharmacy technicians or
others
o Takes responsibility for his/her own continuing professional development,
and commits to life long learning
 Learning portfolio – we have to show evidence/proof that we are
always studying. Every province has its own template to keep track
of the CEs and lessons that you’ve done
• The pharmacist is the one who runs, manages the pharmacy and is allowed to
carry out any act involved in the Drug Distribution process!
o Eg: counseling, dispensing, putting through prescriptions, drug info, MD
interactions, etc.
o This doesn’t mean only the pharmacist can do these things. Especially
important in the last couple of years, because there has been a new
profession introduced – Pharmacy Technicians R.Ph.T. (it is a protected
title).

Pharmacy Technicians
• Why do we have Regulated Pharmacy Technicians?
o Need a standardized approach in this profession (regulation)
o Pharmacists have a greater ability to deal with patients with regulated
technicians. They can deal with the technical aspects of the distribution
process while pharmacists counsels.
o Pharmacy assistant vs Pharmacy technician
 Assistant is not a protected title
 Implication of protected title? It is a legal offense to call someone
who is not a technician one.
o Are there differences between registered technicians between provinces in
context to regulation of pharmacy techs?
 There are some small differences, just like there is differences
between pharmacy roles in provinces.
 But this is a national exam, so you worry about national things
o There are national standards for techs created by NAPRA – Model
Standards of Practice for Technicians
o On exam, if it’s a question about scope of practice, are they talking about
assistant or tech? Since almost every province has some legislation in
place for registered pharmacy techs, and the PEBC is testing for
CURRENT understanding of the profession, if mentioned pharmacy
technician, assume it is to be registered.
• Before and after regulation, what are the things a tech can do now?
o Receive new or repeat prescriptions from prescribers (techs couldn’t do
this before, now they can take verbal rx)
 o Transfer prescriptions or receive prescriptions from other pharmacies (If
you go out of town, and need to transfer your med. Pharmacist used to
always have to do this, now registered tech can)
o Copy prescriptions for authorized recipients (can copy rx for doctors, for
transfer, etc.)
o Check pharmaceutical products prepared by another regulated pharmacy
technician or on their own (they can check the bottle, rx, etc, and then the
pharmacists sign off on it. Must be signed off before dispensed)
o Refer all inquiries and/or issues that require therapeutic decision to the
pharmacists (pharmacist has say on anything that has to do therapeutics)
o http://napra.ca/Content_Files/Files/Model_Standards_of_Prac_for_Cdn_P
harmTechs_Nov11.pdf  Models of Practice for Techs (Look at Page 9)
• Why do we have R.Ph.T.? There is a need for educators (for diabetic educators, or
other topics). With a pharmacy technician available, pharmacists have more time
to do this.
• INSERT CHART OF PRE AND POST REGULATION
o Accepts new Rx for processing? Pre - Yes Post – Yes
o Accept verbal rx? Pre - No Post – Yes
o Release final product after completing final check to pt? Pre - No Post –
Yes.
 (Every Rx whether new or repeat, must always be checked for
therapeutics by pharmacists. Pharm wont be worried about right
pill or right directions. Ex: Rx for Rampiril. When is it
cardioprotective? After MI, because remodeling of heart. This is
going to be a chronic med – longterm. If patient comes in and says
he changed his own dose to every other day – the pharmacists will
recognize therapeutics of this, not tech.)
o Complete transfer? Pre - No Post – Yes
o Need professional liability insurance? Pre - No Post – Yes
o Etc.
• After completing the final check in the rx process, within the scope of practice of
the new regulations, what must the regulated pharmacy tech do BEFORE giving
out the rx?
o Consult with the pharmacist to confirm that the prescription is
therapeutically sound. (doesn’t have to be at the end, pharmacist can
accept the rx, and talk to patient, screens therapeutic soundness of rx, then
can get it filled. Just as long it is checked by pharmacist at one point)
• Are registered techs allowed to check ALL prescriptions, including narcotics?
Yes! They can check all rx technically.
• What is an important condition with the verbal rx which registered pharmacy tech
can accept from a prescriber? They can only accept non-narcotic/controlled rx.
• Transfer – through fax. Can transfer verbally. Where can we transfer to?
Anywhere in Canada, not out of country.
• Are there any differences in the capacity or what kind of rx a registered pharmacy
tech can transfer v a pharmacist? Can not transfer narcotics regardless of your
role! The capacity and kind of rx that a tech and pharm transfer is the same.
 • What can a pharmacy tech do?
o Assisting the pharmacist in the prep of rx
 Can receive written rx, or request for a rx refill from patient or rep
 Ensuring completeness of info on rx
 Preparation of rx labels
 Retrieving, counting, pouring, weighing, measuring and mixing
meds
 Reconstituting medications (this is with water!)
 Selecting type of prescription container
 Affixing prescription and auxiliary labels to prescription containers
• Tech does not have therapeutic knowledge to know which
auxiliary
 Pricing rx
 Filing rx
o Clerical activities
 Preparing and reconciling third party billings (drug plans from
employer or wtv, may have a premium, etc.)
 Preparing receipts, invoices, letters, and memos, and general filing
 Billing appropriate department for medication
 Receiving and sending electronic communications
o Communication activities
o Inventory management
 Monitoring stock levels to ensure sufficient quantities for optimal
operation (may want to increase stock at different times,
anticipatory increase in need)
 Preparing and placing orders from specified sources
 Maintaining inventory records, including those for narcotics and
controlled drugs
 Rotating stock and monitoring expiry dates
 Identifying expired products for disposal, destruction or return to
manufacturer
 Prepackaging of medications (including unit dose packaging)
o Controlled acts only a registered pharm tech can do

Background: Community Pharmacy Workflow

• Community pharmacy team = pharmacist + registered pharmacy technicians,
assistants students, interns or cashiers
o Intern vs Student. Intern is registered with college. Students are still in
school
• General processing of a rx:
o Entry
o Filling
o Checking (only R.Ph., R.Ph.T.)
o Therapeutics
o Counseling and intervention (Only pharmacist)
o Pickup
Background: Hospital Pharmacy Workflow
• Hospital pharmacy team = dispensary pharmacist, clinical pharmacist + pharmacy
technicians, students, interns
• Hospital can be centralized (one inpatient pharmacy where all the drugs and doses
are made up, physicans send rx there, pharmacy chcks it there), or decentralized
• General processing of a rx (order):
o Physican’s order (sent to the dispensary)
 Clinical pharmacist’s orders (medical directive). A clinical
pharmacists may have the medical directive (rule or agreement
with the physician) that states that you have the necessary skills to
make changes by yourself (ex. Can change warfarin dose based on
INR)
o Filled
o Checked
o Delivered
o Administration (by nurses, physicians, etc. NOT PHARMACISTS)
• Is there any difference in the requirements of registration in hospitals vs
community pharmacies for pharmacy technicians in Ontario? Hospitals – every
technician must be registered. Community – can be assistant or registered tech

Scenarios to Keep in Mind

• Pharmacy tech counseling a patient (or answering a drug info question)
o What is wrong? Tech cannot counsel on therapeutic drug information
o How do you deal with this? Intervene. Let the tech know that the
pharmacist is trained in counseling and has the therapeutic knowledge.
Ask them to come get you next time
• Pharmacy assistant taking a verbal rx?
o What is wrong? Assistant cannot take verbal
o How would you deal with it? Politely try to interrupt them
• Pharmacy assistant check the dispensing accuracy of a rx and giving it to the pt?
o No – intervene
• Pharmacy tech check the dispensing accuracy of a rx and giving it to the pt?
o No – intervene
• Pharmacy assistant/tech compounding – it’s fine
• Tech giving an OTC recommendation – pharmacist should intervene
o Would you let the tech continue, ie, finish up? No – try to intervene
o Would you let the tech give out recommendations in the future? No – tell
them why
• Tech talking to pt to process a refill? They can
• Tech talking to 3rd party insurance company for reimbursement – they can
• How to approach these situations
o Determine if the act being conducted is illegal
o Talk to the patient – even if it was wrong or right information
o So now that the inappropriate act was done by the tech, does it mean you
fire the tech? Educate the patient! Set expectations
 Ethics

Ethics
• A pharmacist has to deal with many ethical issues in his/her day to day practice
• There is a very fine line between ethics, morals and laws

Ethics vs Morals vs Laws

• Ethics
o Focus on behavior
o Not about what you think but about what you do
 Even if you don’t agree with what you’re doing you have to do it –
it’s not about what you think it’s about what you do
 Ex: pt who is obese and eats McDonalds every day and is getting
insulin funded by government, pharmacist may not agree, but has
to dispense it regardless of their feelings.
o Ethics are based on individuals behaviors towards others
o Every day examples:
 Friends with a married couple, one of them confides in you that
they are having an affair. Do you tell the other? No, confidentiality
 You are a researcher at a drug company, and you are developing an
untested cancer drug. Your mother is dying of cancer, what do you
do? Don’t give it to her.
• Morals
o Principles of “right”
o Right vs. wrong
o Based on set of values (eg. Religious, cultural, spiritual, etc.)
 Everyone has their own set of values – cannot let it get in the way
o May have beliefs, but cant act on these beliefs
o Can you refuse giving out a medication?
 Yes – Plan B, if med doing more harm to pt
 No – receiving med on religious beliefs (unless im harming
myself, cant go to sleep about it, then can refuse it?), therapeutics
(if MD prescribes something you feel uncomfortable dispensing)
o Everyday examples:
 You’re travelling home on the subway after a busy day studying
for class, you get the last seat in a packed subway car. A heavily
pregnant woman walks in at the next stop. You stare down at the
floor…Right thing to do is to get up!
 You are studying for an exam and get a call from your friend
saying they have the answers… right thing to do is not to look
• Laws
o Rules and regulations that govern behavior (not feelings, thoughts, or
opinions)
o If you break these, there are consequences
o Laws are created by society
 o Laws are the “said/written” rules, ethics are the “unsaid/unwritten”
o Everyday examples:
 You are having a party to celebrate your birthday at home, serving
alcohol, your guests enter the vehicles without proper intervention
… it is your legal responsibility to stop them
 You know a pretty girl or boy at store, but are too shy to talk to
the. So you follow the, where every they go, hide around corners,
etc… illegal, stalking
 You accept a rx even with bells ringing in in the back of your mind
…don’t dispense, illegal

What is true and false about ethics?

• What it is …
o Comprehensive, dynamic (changing)
o Multiple stakeholders
o Rational and logical
o Objective
• What it isn’t …
o Subjective
o Feelings, emotions, beliefs
o Religious influence
o Legality

Ethics vs Morals vs Law: Case

• Should a pharmacist, based on his/her clinical judgment at the time of an
emergency, give a patient a life saving drug, not authorized by a physician’s
prescription, when technically, he/she is breaking the law but is arguably acting
ethically.
o Asthma attack – give the salbutamol or not? Ethically – yes; legally – no
 Ethics here trumps the law – patient could’ve died, pt is number 1
o Ask yourself – if 9/10 pharmacists would agree with you, then you
probably acted justifiably

Example situation
• 16 yo girl presents asking for Plan B, she seems anxious and makes sure no one is
watching or listening. Upon Questioning her, it was not forced upon on her, there
was consent (not a rape or sexual assult).
• What is Plan B?
o An emergency contraception.
o Is it an abortificient? No (pregnancy – is fertilization and implantation.
Plan B stops implantation, stops pregnancy from even occurring)
• Mechanism of action of Plan B?
o Active ingredient – levongesterol (progestin)
o MOA: thickens cervical mucous, changes motility of fallopian tubes -
which will effect the movement of ova sperm, and does not allow uterine
lining appropriate for implantation
 • What counseling would you have for plan B?
o Are you pregnant? When was your last period? Can be used within 5 days,
best within 72 hours. Two tablets, taken 12 hours apart (not taken together
because of nausea)
o Does not require Rx

Case: Ethics vs. Morals vs. Law

Ethics Morals Law
We have to respect the You, as a person, may not Legally, we can sell Plan B
persons choice and believe in Plan B, and that without a prescription and
decisions (autonomy) one should not interfere without it being kept behind
with pregnancy of the counter.
Have to act in the best conception.
interest of the patient Legal age of consent (for
(beneficience) You may believe someone sexual activity) is 16 in
son young and unmarried Canada
We cannot let our morals should not engage in sexual
and beliefs stand in the activity
way of healthcare and
drug access

What is a code of ethics?

• Set of principles that forms the basis of ethical conduct for pharmacists
o Must be tailored to the profession
• Gives a guideline for how to exercise professional judgment

Why do pharmacists need to practice ethically?

• To engender the trust of the public
• To maintain the reputation of the profession
• To deliver excellent care
• To protect the public interest
• To retain the ability to self govern

Guiding principles of the code of ethics

• Act in the best interest of the patient
• Observe the law
• …

Main Ethical Principles

1. Autonomy – what does the patient want
2. Paternalism – how am I affecting the patient
3. Beneficence – what good can be done for the patient
4. Non-maleficence – is harm for patient being avoided
5. Justice – is patient receiving what is fair
 6. Veracity – is patient being told the truth
7. Confidentiality – is the patients privacy being protected

Autonomy
• This is the main principle of ethics
• Patient’s right to choose what is done to them
o When is a child too young to make choice for themselves? Person that is
mentally handicapped? Etc. You have to gauge the capacity to consent.
• Informed Consent
o Have to gauge the capacity to consent
o Competent minor (18 yr old is technically the age, but if the young pt
seems competent, then you don’t have to talk to the parent)
o Parental involvement
o Three things: pt must understand issues, treatment, and consequences.
• Example:
o Pt does not what to take new cholesterol medication. Pharmacist tries to
coerce her by telling her she can get a heart attack if she does not take her
meds. What ethical principle are you breaking? Autonomy (what you
should do: discuss disease state, warn them that it can lead to heart attack
by explaining it, explain the risk vs benefit)
Beneficence
• Care for the patient
• Acting in the best interest of the patient
• The well-being of the patient is at the center of professional practice
• There is risk of paternalism (telling the patient what to do, avoid this. Even if you
think you are doing it for the best of the patient. Educate, explain and make sure
they are aware and then the decision is theirs)
• Example
o Pt comes into pharmacy asking for an advance (extra pills once his is
finished).
 His BP meds, doesn’t have any refills, and seeing the doctor in 4
days. What would you do? Yes you can, you would be illegally
giving it patient. What are you trying to uphold? Beneficence –
trying to make sure the patient is okay. Make sure you document
what you did and tell the doctor.

Non-maleficence
• Do no harm to the patient
• Balancing risks and benefits (if you know side effects are not worth it and you
give it, you are acting maleficently)
• We don’t use patients as guinea pigs! (don’t dispense medications that have not
been tested/approved)
• Only use treatment if medically necessary (ex: in surgery, you are removing one
organ, ex one ovary, and see it could effect another so you remove the other one
too, if there is no reason to you are violating non-maleficence
 • Example:
o Patient, 27 years old, comes into the pharmacy to ask you for an advance
for: Cipro 500 mg as she is having similar symptoms as her previous UTI
when she successfully used cipro. She is seeing the doctor tomorrow
evening. What would you do? Not dispense. What ethical principle are
you trying to uphold? Non-maleficence (Explain: I understand your
situation, explain it could be due to a different cause, could do harm by
taking wrong medication, must see doctor)
 Why does non-maleficence come before beneficence in this case?
This is not life threatening situation – more harm would be done
than good. If we did give the antibiotic it would be only one day,
wont make much different in the infection. Here it is more
important to do no harm.
o Working in a community pharmacy, you get a rx for morphine for a
broken arm. Based on calculated dose, it is very high, almost excessive.
You call the prescriber, explaining your concern, but she says that’s fine,
fill it as is. Thinking of the patient first, so you fill it, doing no harm
• Important to know which principles come first, because all may apply to a given
case. Look at the specific case!!

Veracity
• Patients have the right to the truth
• Honesty is the basis for trust
• There can be conflict of interests where one may be hesitant in being honest
o Business interests
 Dispensing wrong med to someone you have a good relationship
with, still have to tell them. Or business benefit – ordering brand
name drug for your own benefit, and dispensing higher price brand
name instead of generic to patient and not giving them cheaper
option, not being honest.
o Pharmaceutical industry
• Example:
o Pt tells you that he has heard that Lipitor can be bad for your liver, is this
true. He also mentions that if it is true he will not take the drug. Must tell
him truth

Confidentiality
• Important in many professions
• Patient information is protected
o This is fortified by law – can be penalized (sued) for violating this
• Only shared in “circle of care” (can include nurses, pharmacists, caregiver,
physicians, family directly taking care of patient, other health care professionals,
etc.)
• Legal and ethical right of the patient
• Example:
 o Police officer comes to you during evening shift and tells you he wants to
know if a pt of yours has valid rx for oxycontin. Do not tell him. Unless he
has a warrant you can deny telling him
Justice
• Fairness, equitable, consistent treatment of patients
• Consistent use of rules/laws with everyone
• Fair allocation of resources to all (this is what Canada is all about!)
• Example:
o John is well known pt at your pharmacy, where he gets expensive meds
and OTC products. Boss listed him as VIP pt and so he is not to wait for
prescriptions and bumped up to first. NOT right.

Systematic approach to solving ethical dilemmas:

1. Describe the ethical problem and gather the facts (clinical, legal, ethical, who is
involved, stake holders, etc.)
a. At this step it is the patient, the caregiver, the pharmacists
2. Work with the patient or other stakeholder (patient should be aware of dilemma)
a. Talk to patient and find out what they want to do
3. Recognize the ethical principles at play in this situation
a. Find out which of the 7 is the most important (could be multiple)
4. Generate all reasonable alternatives to solve the issue, which reults in the least
harm, keeping in mind the patient’s preferences, and the practicality of the option
a. Could do several things, but plan A should be one that works best for the
patient
5. Select the resolution that you and the patient will implement, and plan it
6. Critically examine the decision that has been made and justify it
7. Implement your alternative, and communicate it comprehensively
8. Follow up with the patient

Components of ethical practice

• Knowledge competence – subject matter knowledge
• Communication competence – able to communication with each …
• Sensitivity to difficult issues that people bring to people
• Therapeutic relationship with patient
• Professional relationship with colleagues

Key concepts in ethical decision making

• Do not make assumptions in regard to behaviors, values or morals
• Avoid forcing your views or values on a situations (again, your actions, not what
you think or feel)

Practice Case Examples

• Grace has a son, Isaac, 6 yo, who has a rare genetic disorder, where his lung
function is severely affected, and unable to attain enough oxygen. There is a new
drug therapy for the condition, having received “NOC” (notice of compliance)
from health Canada earlier that year. She was pressured to see a respirologist, and
 was prescribed the new drug for her son. Even though she has the financial means
to pay for the medications, she intends not to fill it nor administer it. She belongs
to a religious group, which does not believe in taking medication in this situation.
She believes that this is an act of a higher being and should not be meddled with.
This consequently may lead to the eventual death of her son.
o Factors: autonomy, beneficence, and can say paternalism
o If pharmacist does nothing about it – don’t do that.
o If pharmacist does take action, force the medication – he is breaking
autonomy, don’t do this.
o Can educate the mom – cannot force her, child is 6, working with the
mother not patient. Education is big! Explain to her why it is good, accept
her beliefs, not insult them.
o We can also contact the physician – explain the situation, have an entire
team looking at it. Physician can actually override mother’s autonomy
because beneficence is more important. If a physician feels that the child
is at harm, it is legal for them to override mother.
• In ER, a team is working on unconscious teenage boy. You, the ER pharmacist,
goes through his belongings to find any medication he may be taking, and in his
bag you find lip stick, make u and a blond wig and dress. Patient expires, and
could not be revived. He leaves behind a mother and sister who are expecting to
collect his belongings.
o If your patient died, their confidentiality doesn’t end. We wrap it up and
put it back where it is, do not go out of our way to tell the mother or
daughter anything. Main thing is confidentiality; care does not care even
after death.
• 17 yo girl comes to get her oral birth control filled regularly at your pharmacy.
She has one odd request of not including anything with the name of the
medication or her name on medication, because she’s afraid of her parents finding
out she’s taking medication. Next week, you see a middle-aged woman storm up
to the counter with a pack of yasmin. She angrily demands to know who
dispensed this to her daughter and threatens to transfer her family’s prescription to
your competitor.
o Could potentially breach confidentiality – even if mother is threatening
you, you do not breach patient confidentiality.
o Communication is key here – de-escalate the situation, try to calm her
down. Introduce yourself, ask her if she’d like to speak in a private area.
Explain that you can imagine how she feels, reassure the mom. If the mom
says that her daughter is too young for boys and OC, then explain that
there are multiple indications with this drug. If she asks for the direct
indication the patient is using it for, you cannot tell her that.
• You hail from a small town in north eastern Ontario, with a population of 6000,
and the first resident to become a pharmacist. You’re a clinical pharmacist
working at princess Margaret hospital in Toronto, the main cancer ward. You get
a call from your close school friend you grew up with one day for a favor. Her
mother has been diagnosed with breast cancer 6 months ago, but she hasn’t had a
 chance to see an oncologist yet, as there is a long waiting list. Your friend asks if
you can move her up in the waiting list
o Factors: Justice, (beneficence maybe? Not enough info)
o All we can talk about is justice here.
o How do you explain it? “I know this may be tough to understand but in
my profession, I have to treat everyone the same. What I could do, if there
is a cancellation, I could give the doctor your number, or give you their
number to contact them”
o Always give them something – don’t leave the patient empty handed
• You’re a pharmacist working at a community hospital in a small town in northern
Alberta. There is only 1 hospital for the entire local population. The most
important industry is oil refinery, and the company CEO is a former patient at
your hospital. He is a very generous benefactor of the hospital, especially to the
pharm department. He approaches your team asking for no wait times for him and
his family from now on for exchange of donating one million dollars.
o NO

Case: Sexual Abuse and Dating

• You cannot date a patient from your pharmacy and fill their prescriptions – this
constitutes sexual abuse
• The RHPA outlines that sexual contact between a pharmacist or pharmacy
technician and a patient is prohibited

Practice Case Examples

• You get a rx for clinda, for a 11 year old child. Based on the dose you calculated,
per kg, you found that the dose is below the therapeutic dosing range. The patient
is experiencing a skin infection, secondary to an in-grown toenail, which is not
severe, and a small area. The mother seems a little overbearing too, who wants to
give her sons drugs for every single ailment
o Therapeutic problem: dose is in low therapeutic range
o What makes you feel like it’s not a big problem? Site, severity of infection
o Mother is overbearing – something to consider
o Must specify to mother that dose is too low, may lead to resistance. If not,
would be violating non-malifence. And if mother asks you if rx is fine and
you say yes, you lied – violating veracity
o Must call doctor
• In wanting to do good for a patient of yours, Mr. Smith, you – the pharmacist
forces Mr. Smith to get use saline nasal spray for sinus congestion as opposed to
oral decongestant medications such as pseudoephedrine. Earlier, Mr. Smith, who
has HTN, had come into pharmacy asking for oral med for his nasal congestion.
o Is the pharmacist’s action justified? No, violating autonomy. Must educate
first, then respect their decision. Also, paternalism (telling patient want to
do)
 Communication
Case
• A middle aged woman, who’s first language s not English, came to the pharmacy
with a rx. She didn’t understand a single word of English. What do you do?
o Check if anyone in your pharmacy that speaks that language
o Draw or use some other form of communication. Or use your actions
o Ask for phone number – call their house and speak to family member and
explain how to use the medication. If there is crucial information in the
counseling, make sure you try to say it, otherwise can hold on till later

What’s the big deal with communication?

• Pharmacists are front-line health care professionals
• Patients!
• Management! (to be effective managers we need effective communication skills)
• There are no MIND READERS! (don’t assume anything with the patient – ask
and probe)
o Communicating vs communicating effectively
• Does talking = communicating? NO

Scenario
• You are the pharmacist in a Family Health Team (FHT), and you have prepared
heparin injectables for anti-coagulation. Your clinic has a strict policy on
parenteral (anything that passes the GI tract) anti-coagulants, in light of a
medication error which costs the life of a patient. You find expired syringes in the
drawer. You talk to the RN (registered nurse) responsible for administration
o FHT – consists of doctors, nurses, pharmacists, etc. work together to make
best choice for patient
o She says: “I don’t have time for this! I have so much on my plate, so many
patients to take care of. What do you want from me ?!” The next thing you
say will determine if this goes in the right or wrong direction. Don’t
command her to do something, see if you can lessen the load and explain
the situation.
Patient-Centered Care
• Pharmacists have become more patient focused
• Pharmaceutical care is about the patient
• In order to do this, pharmacist needs to establish a trusting relationship
o Open exchange of information
o Patient can participate in their care (patient is master of their care)
o Reach therapeutic goals (what we want to reach with our drug therapy, ex.
Reduction in BP, cholesterol, blood glucose, etc.)
Scenario
• You’re working at a community pharmacy and you have a withdrawn patient
come up to you, not saying much, answering in one word answers, with a new rx.
 o How would you approach this? Ask open ended questions (Ex: why did
you see the doctor? Or Tell me what’s going on.) Ask if theyd like to talk
in private counseling area

Communication – the key!

• Communication between ehatlh professionals and patients helps in 2 ways
o Ongoing relationship
o Exchange of information
• Communication channel
o Crucial
• Medication experience and use from the patient’s perspective – they are in
ultimate control
o Some people are okay with drug therapy, some are not. Understand their
medication experience – you could talk as much as you want but must
understand how pt will respond. Ex: New rx for hctz – could counsel pt on
HTN, but if patient does not have a good attitude towards medication they
wil not take the medication or understand it. Patient is in control of what
happens
• 2 important concepts to understand
o Empathy
o Interpersonal relationships (between you and someone else)
Interpersonal Communication
• Basically, a form of communication between two people
Empathy
• Putting yourself in their shoes
• Identification of feelings of others
• Consideration and compassion
• Is sincere understanding and responding to other feelings
• Puts others needs above his/her own
• Takes necessary time to explain information
• Identify underlying feelings of self and other person
• Identify with patient’s feelings and ask to follow up.
Case
• “I just can’t take it!!! My baby wont stop crying, and I have tried so much. I must
be a bad father”
o Empathize with the patient (tell them you know what they’re going
through).
o Duration of crying? Age of baby? Gas? How often is it crying?
o Could be infant cholic (baby cries for no particular reason)
• Anita comes in to pharmacy and asks to speak to pharmacist. Upon approaching
her you notice she is looking down, avoiding eye contact, and has her arms
crossed. You remember she is often ate for her prescriptions. She gives you a rx
for Nidagel (metronidazole) vaginal gel. She says quietly, “can this be filled, and
my refill for my thyroid meds?”
o She could be embarrassed because of drug she’s picking up
The Sender
• Patient
• Pharmacists
The Message
• Element that is transmitted (sent)
• Can be thoughts, ideas, emotions, information or other factors
• Both verbal (talking) and nonverbal (gesture, facial expression, body language)
• Can be consciously or subconsciously transmitted
o Why is it important to pick up? Patients often lie – need to learn to pick up
on nonverbal because that is hard to fake
The Receiver
• ?
The Feedback
• Process by which the receiver communicates back to the sender their
understanding of the message
• Receivers respond with their own verbal and nonverbal messages (therefore then
the receiver then becomes the “sender” at the instance!)
• Feedback loop
• Important to allow 2-way communication
Barriers
• Affect the accuracy of the exchange of information
• There are several different types of barriers
o Environmental barriers (lighting, cleanliness, etc.)
Model of Interpersonal Communication
• Image shown. Remove barriers for proper communication

Non-Verbal Communication in Pharmacy

• Nonverbal expressions include
o Body language
o Proximity to another person
o Your physical environment
Proximity (distance)
• Distance between 2 interacting people (structure and space between)
• Be in a comfortable zone – don’t get too close
Physical Barriers
Personal Barriers
• Lack of confidence in ability to communicate effectively
• Shyness, anxiety, cultural differences, lack of objectivity, etc.
HIV/AIDS – subject to reporting requirement procedures, set up by public health laws. If
there is imminent harm to patient you have a legal obligation to tell the patient. Contact
the public health authorities to notify them. Partner needs to be aware! Can break
confidentiality.
 Canadian Health Care System and Health Canada
Federalism in Canada
• Canada is a federal nation
o National (federal) government and provincial/territorial governments
• There is independent authority amongst the provincial governments
o National government does not necessarily have direct say in provincial
government. Provincial government has autonomy in how their own
province is run. Why is that a good thing? Every province has its own
needs and wants and the provincial government can address that.
• Basically, division of legislation and power between 2 main levels of government

Pharmaceutical Jurisdiction: Federal

• Does not purchase drugs for general public (except for specific groups – you
should know which ones)
o The federal governments purchase or negotiate a federal rate from drug
companies
• Control over intellectual rights
o What doe this refer to in regard to drugs? Patents for medications in
Canada, NOC (notice of compliance)
• Approval and labeling of pharmaceutical products
• Overall competitiveness of the pharmaceutical market
o Price! They control the price – they tell companies how much they’re
allowed to charge in Canada
• Upholds the Canada Health Act

Pharmaceutical Jurisdiction: Provincial

• Buys medications for drug plans
o In Ontario: ODB (Ontario drug benefit – for seniors, pts on trillium
programs or catastrophic drug coverage, or social assistant)
• Sets prices and decides on what drugs will be included on the formulary
o What’s a formulary? List of drugs that are covered by a drug plan
 A drug formulary in Canada does two things: tells you what is
covered by drug plan (benefit, or not benefit), and will tell you
what is interchangeable.
• Provinces have to address issue of rising drug expenditures and limited health
budgets
o Ontario government are targeting different health professions and cutting
down their money – did that to pharmacists (Bill 102, 179 – removed
generic allowances).

Question
• Based on what the Provincial and Federal government’s roles are, why is there
tension between the levels of government?
o There is tension because of conflict between the two – misunderstanding
Canadian Health Care
• Defining characteristic of Canadian identity (fair, equitable, should be universal)
o Which ethical principle doe this follow? Justice

Canadian Health Act

• Defines the principles that govern our health care system
• Criteria and conditions provinces and territories must meet to get funding from
the federal government  Canada Health and Social Transfer (mechanism)
o Provincial have to comply with the Canada Health Act to get federal
money
• To make sure all Canadians have access to insured health services without direct
charges
o We want to make sure that there is good health care through out provinces
– if you move from one province to another you want to receive the same
health care

5 Main Principles of Canada Health Act (VERY IMPORTANT – MEMORIZE!)

1. Universality: 100% of insured populations covered on uniform terms and
conditions
a. Everyone gets the same treatment country wide!
2. Comprehensiveness: insure all medically necessary services given by hospitals
and physicians
a. We don’t pay when we go to hospital, or see doctor. Government has list
of what is medically necessary. Government covers those necessary things
3. Accessibility: provide access to insured hospital and physician services without
barriers (no economic barriers to medically necessary services)
a. Everyone, regardless of how much you make will have care
4. Portability: residents are entitled to coverage when they move to another
provinces, abroad, etc.
a. Province to province (within Canada)
5. Public administration: health insurance plan operated on non-profit basis by
public authority
Can be memorized as PUPAC!

What are “insured health care services” under the act?

• Medically necessary hospital, physician, and surgical-dental services
o All medically necessary in-patient and out-patient services provided in a
hospital
o Standard or public ward accommodation: nursing services, laboratory,
radiological tests, etc.
o Drugs administered in hospital
 Each hospital has the right to create its own formulary based on its
needs. (Ex: Princess Margaret has big oncology section, so it has a
lot of cancer drugs)
Which groups are covered by the Federal government, not provincial? KNOW THIS
• Canadian forces (military)
• Veterans (via Veterans Affairs)
• First Nations and Inuit
• Officers of the Royal Canadian Mounted Police RCMP
• Inmates of federal penitentiaries (prisoners)

Canada’s Health Care System

• Public funding and private delivery (compared to US which is private funding and
private delivery)
o In Canada: Every doctor has a billing number – bills the province for their
services. Private services, public billing
• 13 different provincial …

Health Canada (www.hc-sc.gc.ca  explore site)

• Federal department for helping Canadians maintain and improve their health,
while respecting individual circumstances and choices
• Divided into 12 branches, 6 agencies (nte – always restricting)
• Federal Minister of Health is responsible for administering the laws/regulations
that run Health Canada

Health Products and Food Branch (HPFB)

• Integrated approach to manage risks/benefits of health products and food
• Regulatory system
• Promoting Canadian make healthy choices and giving info
• Has the Therapeutic Products Directorate (TPD), Natural Health Products
Directorate
o What does the TPD do? regulate pharm drugs and medical devices for
human use
• Special Access Program (SAP)

Therapeutics Products Directorate (TPD)

• Part of Health Canada (HPFB)
• Regulation of pharmaceutical drugs, medical devices, other therapeutic products
in Canada
o Prescription and non prescription products
o Not all drugs available in other countries does not mean it is available in
Canada – must be approved for use here. (US – shoot first, ask questions
later. Canada – ask first!)
• Before anything comes onto the market, there must be evidence and testing
• Post-marketing surveillance
o After drug is on market, they monitor it and ask doctors and patients what
kind of response they are getting
Special Access Program
• Access to drugs not approved on the Canadian market yet
o Ex: Chemotherapy agents, biologics, etc.
• Emergency/other therapies have failed (SAP is last line)
• Allows manufacturers to release a drug that cannot be sold in Canada
• How do we get these drugs?
o Physician fills out form (found in back of CPS, in appendix), send it. Once
it is sent, drug goes to the doctors office or inpatient hospital!
• Is there a charge?
o Company rarely charges, they just give it. But if the company does not
cover it, then patient has to pay out of pocket. It makes sense for them to
give it for free because they want it on the Canadian market.
• What is unique about the operation of SAP?
o They are available 24/7!

Patent
• Exclusive rights to manufacture an innovative product
• Patents have an expiry date in Canada
• Currently, drug patents have an active life of 20 years from the date of filing in
Canada
o This is the minimum patent cycle allowed under our international trade
obligations
o A lot of these drugs are coming from the US. We have NAFTA (bilateral
trade between Canada and US – streamlines trade), pharmaceutical trade is
one of them but demanded 20 years.
• A 20-year patent cycle does not necessarily mean 20 years of market exclusivity
o It may take as many as 8 to 12 years for a new drug product to reach the
market in Canada

Case
• You have a pt who is retired patent lawyer, and he says to you while picking up
his “BRAND” medications that there should be no limit to patents, and that
generic companies are “thieves”. What would your response be?
o Not everyone will be able to afford third medication if not – cost!
o Company had their chance to make their money
o If companies wanted to charge whatever the wanted our country would go
broke.

Patented Medicines Prices Review Board (PMPRB)

• Created in 1987
• 2 roles
o To ensure that prices charged by manufacturers are not excessive
o Report annually on trends of all medicines, and R&D spending
 R&D – research & development
 How do they determine price? Look at how much that drug costs in
other countries and take average price (do something like that)
  If manufacturer comes and says that they want to charge $200 per
pill, because they say there was a lot of money put in. Government
takes a look at all of that
• Reports to federal government
• Have pricing regulations over Rx and OTC
• Having a patented medicine price index

MISSING DRUG LEGISLATION + BEGINNING OF THE NEXT PART

Narcotic Drug Prescriptions: Details

• Written or faxed prescriptions (NO verbals!)
o Good practice to check faxed prescriptions
• Only a physician, veterinarian, or dentist can prescribe
• NO refills!
• Part fills are permitted
• NO transfers to other pharmacies!
• Purchase record – YES
o Purchases must be recorded in Narcotics and Controlled Drugs register or
invoices in chronological order (available in the pharmacy)
• Sales record – YES
o Print out every month or so and keep it in binder
• Ordering narcotic drugs
o Must be written or electronically ordered, NOT verbal, by an “authorized”
pharmacist to a licensed dealer
o What is a narcotic signer?
 Can you be a narcotic signer at more than one location? Yes, but
have to submit paper work for each separate location
 If you are a narcotic signer at one location, are you allowed to be at
other locations as well? Must be signed up for the specific
pharmacy, cant order anywhere. You have to separately apply for
the other location
o What is a licensed dealer? Can only buy drugs from licensed dealers.
Wholesaler where you can order drugs from
• Once narcotic order is received, pharmacist must return signed and dated receipt
within five days to the licensed dealer.
o If you don’t send it in time they can cut you off, and you cant order
anymore
• Purchases must be kept in a safe – a secure safe (lock and key)
Question
• You realize that one of your trusted employees is stealing codeine exempted
product for the last 3 months. You address the issue and terminate the employee.
Apart from administrative duties, what other step must be taken?
o Must contact Office of Controlled Substance
o If there is every a theft, loss, or damage of any controlled substance you
must contact the Office of Controlled Substances in Ottawa within 10 days
of discovery
Part-fills vs. Refill/Repeat
• Very different from each other
• Refills/Repeats
o When a prescriber authorizes additional “repeat” fills on the quantity
prescribed
o Finite number of times
o Not allowed on narcotics
o Refills/repeats as not the same as reauthorizations on depleted prescription
• Part Fills
o Total quantity is prescribed and must be mentioned
o Smaller quantity per fill is specified
o Intervals are not required, but may not be a bad idea!
• Example: Tylenol No 3. Total: 400 tablets. Dispense 100 at a time. Take 1-2 tabs
Q4-6H PRN.
o This is a part fill. Interval is how much time between refills – he can state
refill (ex: 30 days, dispense every 30 days only). You do not have to have
an interval for part fills! But it is good to have. This Rx is fine without an
interval.
o Who controls this interval if MD does not state it? The pharmacist can
control – they have professional judgment. They can calculate maximum
number of tablets, and use that as the interval

Narcotic Preparations – “Verbal Narcotics”

• 1 narcotic (excluding the “special 5”) + 2 or more active non-narcotic ingredients
o Ex: Tylenol No. 2, 3, Fiorinal with codeine, Robitussin AC
• Non parenteral formulations
o ONLY for oral formulations. The other formulations are considered
Straight Narcotics
• Can be taken over phone, does not have to be just written or faxed
• Also includes “Exempted Codeine Products”
o Medications kept behind the counter that you do not need a prescription to
get
• Legislation is the same as narcotics EXCEPT verbal Rx is ok
• Verbal RX to be received by pharmacist, registered intern, or registered student
under the supervision of the pharmacist
o NOT pharmacy technicians (even if registered)
• Need a purchase record still (same as straight narcotics)
• No record of sale needs to be maintained
• Can be ordered verbally also

Controlled Drugs: Part I

• Schedule G drugs (CDSA)
• 1 controlled drug (stimulants)
o What are these “stimulants”? Methylphenidate, Amphetamines
o Pentobarbital
 • All straight controlled drugs (nothing else)
• All preps containing more than oe controlled drug

Aside: stimulants - categories

• What drugs are indicated for ADHD?
o Methylphenidate (Ritalin, Ritalin SR, Concerta, Biphentin)
 CR – can be sprinkled on foods
o Amphetamine mixed salts (Adderall XR)
 Can be sprinkled on foods
o Dextroamphetamine (Dexedrine, Dexedrine spansule)
 SR – can be sprinkled on foods
o Atomoxetine (Stratterra)
o Lisdexamefetamine (vyvanse)
 Can be sprinkled on foods
• Categorized based on duration of action (stimulants)
o Long acting – Adderall XR, Biphentin, Concerta, Stratterra, Vyvanse
 Why are long acting better? Better compliance, does not have peak
effect (less chance of rebound hyperactivity and less addiction)
o Intermediate acting – Dexedrine Spansules, Ritalin SR
o Immediate acting – Ritalin, dexedrine
• Concerta – unique formulation, pharmaceutically
o Zero order release – concentration independent release (there will always
be a steady release)
o What happens if you crush Concerta? Very hard to crush – when you
crush it, it turns into gel, cannot snort it. Less abused

Controlled Drugs: Part I

• Written, faxed or verbal rx
• Refills are ONLY on written or faxed prescription, and ONLY with intervals or
dates when to be refilled
o If pt comes in for refill earlier than interval stated, cannot fill it. Tell
patient specific dates.
• Refills are not permitted on verbal prescriptions
o What can you offer? Can have part fills. Or tell him to fax it.
• Need BOTH sales and purchase recrods (same as straight narcotics)

Controlled Drugs: Part II

• Most barbituates and others
• Butorphanol
• Fiorinal (batalbital, ASA, caffeine) (preparation)
o What about Fiorinal with codeine? Narcotic
o Basically 1 controlled drug part II drug plus 1 or more non-controlled
active ingredient
• Written, faxed, verbal with refills allowed (only with intervals or date to be
refilled!)
o With these you can get a refill on a verbal prescription
Controlled Drugs: Part III

• Anabolic steroids, and derivatives – andriol (testosterone), Depo testosterone,

Androderm, Androgel, etc.
o Different formulations of testosterone
• LEGAL REQUIREMENTS ARE SAME as controlled drugs Part II

So far, what is common with controlled substances?

• NO transfers what so ever
o Includes all narcotics and controlled drugs
• All require purchase records
o Includes all narcotics and controlled drugs
o Sales – only required for Straight Narcotic + Controlled Part I
• Written = faxed prescription (basically)
• Repeats or refills are NOT allowed in straight or verbal narcotics, but part fills are
allowed in ANY prescription any drug
• Note – for all controlled substances, how long must you keep all records and
documents for auditing purpose:
o On hand – 2 years. Electronically – 10 years.

Benzodiazepines and Targeted Substances

• Refills permitted without intervals!
o Just because you don’t need an interval, doesn’t mean the doctor wont do
it.
• RX valid only for 1 year from the date of the rx
o What if rx is filled after the date written? One year from the date that it
was written!
• Transfer permitted only once
• Purchase record – YES
• Sales record – NOT required

Controversy Point
• If there is loss, damage/expiry, or theft of a narcotic who dwe contact
o Office of Controlled Substances (Health Canada)
o Have a form, you fill out, gives them details on matter
o Within 10 days of discovery
• For expired drugs, do we go ahead and destroy them after contacting the Office?
o NO
o Why not? Have to have permission, send letter to Office, then when it is
acknowledged, and get a letter back from office
• Same for controlled drugs as narcotic drugs.
• For benzodiazepines, you have to send letter out, but don’t have to wait for the
letter, can go ahead and destroy them.
Marihuana Medical Access Regulations
• Marijuana is not a therapeutic product in Canada or anywhere else in the world
• There is a program, where Health Canada implemented the Marijuana Medical
Access Regulations
• Define the circumstances and the manner in which to access marijuana
• Who is eligible to possess marijuana?
o Palliative care, spinal injury, cancer, spinal cord disease, HIV/AIDS
infection, severe forms of arthritis, seizures from epilepsy
• Applicants must provide a declaration from a medical practitioner to support their
application
How do you get medical Marijuana
• Health Canada gets dried marijuana and seeds from Prairie Plant Systems Inc.
• Patients have to fill out an application form, specific to the type of access they
need
• Health Canada website has a toll number

Summary
• Narcotics
o Written rx – yes; faxed rx – yes
o Verbal rx – no
o Refills – no
o Part fills – yes
o Transfers – no
o Needs a SALES REPORT
• Narcotics prep (verbal)
o Written rx – yes; faxed rx – yes
o Verbal rx – yes
o Refills – no
o Part fills – yes
o Transfers – no
o Note: exempted codeine products (OTC – 8 ng of codeine per tablet or
20mg/30 ml of liquids, with 2 non-narcotic ingredients)
• Controlled drugs: Part I
o Written rx – yes; faxed rx – yes
o Verbal rx – yes
o Refills – yes for written rx, only with # of refills
o Part fills – yes
o Transfers – no
• Controlled drugs: Part II, III
o Written rx – yes; faxed rx – yes
o Verbal rx – yes
o Refills – tes
o Part fills – yes
o Transfers – no
• Benzodiazepines
o Written rx – yes; faxed rx – yes
o Verbal rx – yes
o Refills – yes (for 1 year only)
o Part fills – yes
o Transfers – yes (once)
 Drug Distribution
Drug distribution
• System designed to facilitate the safe transfer of a drug or medical device from
the manfucarere to the patient
• The integrity of the drug or medical devise is maintained
• The safety to the patient is maintained
• Steps include:
o Manufacturing, storage, procurement, dispensing, administration and
returns
• In response to the order of a prescriber

Important:
• Provide the right drug, in the right dosage form, in the right strength, to the right
patient, at the right time
• FIVE RIGHTS must be achieved for a complete and accurate drug distribution to
be carried out

Drug Distribution Systems

• There are 3 major types
1. Community
 Independent pharmacies
 Chain pharmacies
 Outpatient pharmacies in Hospital (drugs not covered by hospital,
just a convenience thing)
 Home health care pharmacies
2. Hospital
3. Long term care facilities

Long-term Care
• What is it? Senior citizen home, retirement home. Different levels of care that
someone needs.
• What kind of patients would this apply to? Elderly, those that need assistance in
daily living, mental incapacitated patients, etc.
• Why do we have this setting? People want to maintain their lives but need help,
this is medium ground
• Pharmacist’s role? Home visits, med-checks, contracts with one pharmacy for all
prescriptions. Long term care facilities do not have in patient pharmacies.
• Accommodations for residents
• Have supported care and treatment
• Professional services
o Physicians, nurses, etc
• Different levels (independent living, etc.)
Recognizing parts of the Prescription
• Prescription heading (has MD name, address, number, etc)
• Name of patient
• Date written
• RX – superscription
• Inscription (name of drug)
• Sig
• Mitte (subscription)
• Prescribers signature
• Refills

Translating Rx onto a Prescription Label – the verb

• Tells the patient how to administer the medication
• Can also give indication as to where to administer
• Examples: apply, inhale, instill, etc.
Missing some info here (translating rx onto prescription) …

Translating Rx onto a Prescription  the auxiliary label

• Additional info to patient not included on prescription label
• Ex: for external use only, take on an empty stomach, avoid dairy products, etc.
• Usually not more than 2-3 per vial. Want them to remember the important things
• ***Warning: do not exceed the dose prescribed by your physician. If difficulty in
breathing persists, contact your physician immediately” (obligated legally with
these meds)
1. Ephedrine and its salts
2. Epinephrine and its salts
3. Ethylnorepinepine and its salts
4. Fenoterol and its salts
5. Ipratropium and its salts
6. Isoetharine and its salts
7. Isopreterenol (Isoprenaline) and its salts
8. Metaproterenol (Orciprenaline) and its salts
9. Salbutamol (Abuterol) and its salts
10. Terbutaline and its salts

Example auxiliary labels

• Tetracycline – take on empty stomach, avoid use with dairy, iron products,
photosensitivity, take with plenty of after
• Acutane (isotretinoin) – photosensitivity, avoid in pregnancy, take with food
• Yasmine (Oral contraceptive) – do not smoke, antiepileptic drugs antibiotics may
decrease effectiveness
• Clarithromycin suspension – shake well, take with food, do not refrigerate
• Aldara cream (imiquimod) – external use only, photosensitivity
• Amoxicillin suspension – shake well, refrigerate
• Norfloxacin tablets (only indication – upper UTI) – take on empty stomach
• Percocet (oxycodone/acetaminophen) – avoid alcohol, may cause dizziness
• Actonel (riserdronate) – do not lie down 30 min after taking it, empty stomach,
with water, avoid dications and diary products
• Metformin – take with food (renally cleared! Lactic acidosis(
• Glyburide – avoid alcohol (hyperglycemic effect because it blocks effect of drug,
rare disulfram like reaction??)
• Atorvastatin (substrate of 3A4) – avoid grapefruit juice and pulp (inhibitor of
3A4)
• Biaxin XL (clarithromycin) – do not chew (any extended release med!)
• Indapamide – increase intake of bananas, orange juice – can lead to hypokalemia
(oranges and banans rich in potassium)
• Tri-cycline (combo OC) – avoid smoking, med decreased efficacy by antibiotics,
anti-epileptics
• Didrocal (riserdronate)– do not lie down after taking this medication ** (don’t
have to lay down!?)
 Drug Discovery Process in Canada
Why does drug discovery continue?
1. Market need
 Dissatisfaction with current products (ie. Efficacy, safety, etc.) or medical
need
2. Viable business
 High risk but high returns (shareholder value – for about 8-10 years of
patent)

3. Intellectual curiosity (requisite knowledge/skills)
 All drugs have benefits/drawbacks
i. Ex: Parkinson’s disease – dopamine agonists, can cause
schizophrenia and other psychoses
 Research to improve molecules; betterment of mankind/goodwill

Ideas for new drugs

• Internal research (R&D)
• exclusive partenerships with start up companies; collaboratoi with universities, etc
• 4 major sources of a New Drug:
1. Synthetic novel chemical or new biotechnology product
2. natural substances found in humans, that has activity as a drug
3. natural substance ot found in humans, as a drug
4. old drug found to have new uses

Preclincial Testing/Trials: animals

• safety pharmacology:
o studies that investigate potential undesirable effects on physiological
function, in relation to exposure
• ….
• What to know about preclinical – done on animals not humans, and test:
o Primary pharmacodynamics
o Secondary pharmacodynamics
o Safety pharmacology
o PK/Toxicokinetics (blood concentration knowledge of the toxic effects of
drugs; LD50 in animals)
o Toxicology
o Mutagenicity (any mutations; genomic damage; heritable effects)
o Carcinogenicity (risk of cancer, for short term or chronic use)
o Reproduction effects (teratogenicity)

Clinical Testing: Humans

• Safe guards
• All studies involving humans reviewed by health Canada: all must follow Good
Clinical Practices (GCP)
o This is done federally
 • Reviewed by Institutional Review Board (IRB), Independent Ethics Committee
(IEC); get patient consent
• Also Data Monitoring Committee

Phases of Clinical testing

• Phase I (tolerance, pharmacodynamics, pharmacokinetics)
o Kinetics – what the body does to the drug
o Dynamics – what the drug does to the body
• Phase II (dose finding)
o Finding proper dose
• Phase III (establishing effectiveness and safety)

Phase I
• Human volunteers
o ADME
o System that may be effecte
o Doses tested
o Single Ascending Dose (SAD) or Multiple Ascending Dose (MAD)
• Bioavailability and bioequivalence
o Rate, equivalence

Phase II
• …

Phase III
• Large scales trials with doses from Phase II; any patients
• Why do we want to do this? We want a large sample because it removes bias,
more powerful to say drug works in many
• Large sample size
• Could be against historical controls
• Placebo, or comparator “Gold Standard” Clinical trial
o Randomized, double blind, comparative phase III study
o Compare your drug to the first line drug being used

Phase IV
• Post-marketing surveillence – after it has been approved for marketing

After approval recommendations / rejecting (NDC, NDNC, DIN). Then final processing
• Get your DIN at the end –

Gaining Market Access

• Regulatory framework
• Approval to market a drug based on assessment of benefit/risk ratio (Health
Canada)
 o We want greater benefit than risk! Health Canada will not approve a drug
that will cause a bigger risk
o What part of Health Canada? TPD (Therapeutic Product Directoria)
• Approval of prices
o Federal legislation (controls competitiveness of market)
o Patented Medicine Prices Review Board (PMPRB)
 Look at other countries, the drug and their pricing and helps
determines hours

Governing Bodies
• Prior to market authorization
o Health Canada
….?

Advertising Agencies
• Agencies that provide advisory opinions on messages directed to consumers for rx
drugs an don educational materials discussing a medical condition or disease
• Advertising standards Canada
• Pharmaceutical advertising advisory board
• In Canada: they can show the drug and say speak to your doctor, cannot say more
• Advertising Standards Canada
• PAAB – Pharmaceutical Advertising Advisory Board
 Pharmacoeconomics
Pharmacoeconomics
• What is the need?
o Limited resources and unlimited wants
• What does that mean? In hospital drugs are covered, ODB, etc. Unlimited wants,
we need to be resourceful with our sources.
• Examples:
o Is it worthwhile for a provincial Ministry of Heath to reimburse
pharmacists at a rate of $300 per patient for disease management program
in congestive HF?

Definition:
• Description and analysis of cost ad consequences (risks/benefits) of
pharmaceutical …

Pharmacoecnomic Methods
• Cost-minimization Analysis
o When alternatives are equal, which is least expensive
o Useful for different new drug dosages
• Cost-benefit analysis
o Costs and benefits in monetary terms
o Ratio of benefits and cost
• Cost effectiveness analysis
o Health consequences measured in natural units of health (eg. Life saved,
life year gained, case cured, disability day avoided)
• Cost-utility analysis
o Variation of CEA in which ALL health outcomes are valued using a
metric called a quality-adjusted life year (QALY)
o Each year of life is weighed by its quality of life using a “utility” weight
(scale of 0 (dead) to 1 (excellent health)] and these weighted life years are
summed over all years of life.

Cost Benefit Analysis

• Cost of providing a program/treatment and comparing those costs with the
benefits that result
• Expressed as:
o Benefit to cost ratio = Benefit ($$)/ Costs ($)
o We want it to be at least 1.0 to be considered worthy. And higher the
better!
• Example:
o Benefit of pharmacist intervention is estimated at $3750 and the cost of
intervention is estimated at $1000. Determine the cost to benefit ratio.
  Cost of benefit intervention, how do they figure it out? They see
the cost of the pharmacist not being there (the adverse reaction
cost, the toxicities, overdose, problems, etc.)
 We want the benefit to be greater. By doing this one thing then we
avoid all the costs of not doing it
 Benefit = 3750
 Cost = 1000
 Divide

Cost Effectiveness Analysis

• Used to compare different treatment options with cost measured in $ and outcome
measured in cost per unit
• Example:
o Treatment A costs $500 and BP lowered
o …
o C/E ratio (A) = $500 / 9 = $55 per mm of Hg
o C/E ratio (B) = $...
o Compare ratios

Important Concepts
• Cost consideration of drug and drug product selection
o Cost differential between therapeutic agents
o Cost differential between brand and generic
o Cost differential between dosage forms and routes of administration
 Why is this important? If it’s IV or parenteral it will cost more –
have to pay for nurse to admin, pump, etc important to look at too
• Economic considerations in therapeutically equivalent treatment
 Pharmacy Management Principles
Management Expectations for Pharmacists: General
• Apply knowledge, skills, principles of management with the intention of
improving patient care and inter-professional collaboration

Management Expectations for Pharmacists: the details

• Supervise personnel, delegate functions, meet standards
• Manage workflow
o Know where to distribute your resources. If it is peak times, make sure
you have someone ready to receive rx.
• Management principles
o Team work, decision making, opportunities for growth

Regulations of Pharmacy Management

• NAPRA
o Created guideline document to state what managers should be responsible
for
• Ontario
o OCP – standards of Practice for Pharmacy Managers
 Why does the college encourage pharmacy managers, or want to
know who the manager is? To facilitate communication! If there is
an audit, college will come in and regulate, come observe the
pharmacy – contact the manager.
o Drug and Pharmacies Regulation Act (community only)
 In law, talks about what a manager should be doing.

Who regulates the profession of Pharmacy?

• Provincial colleges – not NAPRA

How do you manage a pharmacy?

• What is unique about managing a pharmacy? Dealing with drugs – can do great
harm and good.

Pharmacy Management: community and hospital

• Professional services
o Counseling, Med-Checks (when a person is taking three or more chronic
meds and you go through it all with them, etc.)
• Advancement of the profession
• Dispensing functions
o Drug distribution! We have to manage everything about drug
distribution!!
• Financial management
o Inventory is biggest asset
• Human resource management
 o Employees, the team, scheduling, etc.
• Security
• Customer service (hospital?)
o Show services available to nurses, physicians, etc. Board of directors
decides on budget each year, in order to get funding, have to show that
you are providing good service
• Planning
• Marketing
• Legal and Ethical Obligations
• Teaching and Research

Planning: Pharmacy
• The first step
• Involves vision, goals, and objectives
• Strategic planning
o Operations of pharmacy
 Are we going to have a niche? Going to focus on compounding,
chemotherapy, etc.
o Organizations of pharmacy
 Where to place your products, compounding area, etc.
• Marketing Pharmacy services
o Want to show your services so that people will come to you.
o Ex: wants to promote compliance packaging, so you make a package of
info for doctors to show the service you offer.

Vision and Mission Statement

• What is the difference between the two?
o Need vision – sets the mood, ground of the organization. Gives a sense of
purpose
o Mission – why organization exists, their service

SWOT Analysis (IMPORTANT)

• To get an idea what position we’re in for future strategic planning
• Method to incorporate different factors in an organized process
• …
• Strengths: what are we good at ,what do we want to do well
• Weaknesses: Have to find and define these areas
• Opportunities:
o Assess the environment on a local, geographic, national level
o Current economic climate, legislation changes
• Threat

• Ex: David the pharmacists and owner of ABC Pharmacy, which ash been open for
2 years wants to cater to local nursing homes in area. There has been a steady
growth in number of senior patients in his area, as there are new developments for
 retirement and nursing homes. David is a certified geriatric drug therapy
specialist, and already serves many seniors… New home is 20 km away. Rexall
pharmacy available
o S: serves seniors
o W: only been open for 2 years, 20 km away
o O: senior homes, steady growth
o T: Rexall (other pharmacy)

Organizing: pharmacy
• Who are the members of the pharmacy team?
o Pharmacy Manager, Pharmacist
o Pharmacy intern, technician, assistant
• When is it good to have a triangle structure (levels, manager on top)?
o In times of crisis, or high stress, if you need to disseminate info very
quickly, leader steps up and delegates roles.
• When is it good to have a flat structure (everyone is equal)?
o Good for times of steady work, equilibrium, not a lot of change

Prescription Label Requirements

 DPRA outlines what label should have
o The container in which drug is dispensed must be marked with:
identification number that is on prescription, name, address and telephone
of pharmacy, drug info, prescriber, quantity, form, name of owner of
pharmacy (often a cooperation), date, directions, patient.

Case
 Patient who has been filling his rx or over 10 years. He’s elderly, and has several
comorbidities and now, several chronic meds. There have been several phone
calls he’s made because he forgets which medication to take, what each mediation
is for, and how to take them.
o What to do? Blister pack!

Compliance packaging: a patient aid

 Purpose is to help patients with their adherence of meds
 Especially important when have several meds with complicated regimen
 A tool to help reach therapeutic goals for special patient populations
o Elderly (often forget, spouse probably cant help at that point)
o Cognitive impairment
o Large number of chronic conditions
 Increases efficiency f administration (we don’t want to waste anything in health
care)
 Available in various formats
o Eg: single and multi-medication blister cards, strip packaging, hard packs,
etc.
o Includes all the medication per day, drug names, how to take them, etc.
  Generally, the package has little compartments or “blisters” representing each day
of the week and the time of administration.
o This allows us to separate medications from each other, gives the
pharmacist reign on when the patient should be taking the medication

Requirements for Compliance packing

 Must meet the minimum labeling requirements (just like a vial!)
 Should have documentation from the most responsible prescriber, patient, other
family members, etc
 Also to acknowledge that the medications dispensed are not child proof!

Note: Take with lots of water – ciprofloxacin, levofloxacin, norfloxacin (mainly used for
UTI, concentrates in the urinary tract, renally cleared, to flush med our and relieve
infection we need lots of fluid). Fluoroquinolones are mostly excreted unchanged.
Moxifoxacin is hepatically cleared so you don’t need lots of water (moxi is used for chest
infections, not UTIs)

Name of Medication on a Rx
 Brand Name: is the name for which the innovator company holds a patent
o Eg: Teva-hctz, Lipitor, etc.
 Generic Name: non-patented name, usually includes drug chemical names
o Eg: hctz, atorovastatin, etc.
o This is the chemical name ONLY, everything else is considered brand
name
Trade Names
 Both the brand names and generic names such as Avandia, Norvasc, Apo-Hydro,
etc. are TRADE NAMES
 Note: there’s a difference in actual name and??

What is a Generic Drug?

 Products that contain the same medicinal ingredients as the brand name drug
 Generally much cheaper
 “Comparative bioavailability” studies:
o Compare the generic drug to the original brand name drug
o The level of a medicinal ingredients I the blood of a healthy human
volunteers is measured
o Ex: IV – 100% bioavailability; PO – less than 100%

Bioavailability Studies
 Each volunteer receives the original brand name drug and the new generic drug
on two separate occasions
 The generic drug must show that it can deliver the same amount of medicinal
ingredient at the same rate as the original drug
Drug Interchangeability (DIDFA)
 “Interchangeable product” =
o Drug or combo of drugs in a particular dosage form and strength identified
by a special product name or manufacturer
o Designated with one or ore other such as products (products which are
interchangeable)
 Where do you find if a drug is interchangeable? Formulary
 Wont ask us about DIDFA because it is provincial

Drug Interchangeability, must meet the following requirements:

 Same amount of same active ingredient
 Comparable pharmacokinetics
 Same clinical significant formulation characteristics
 To be administered in the same way as the drug prescribed

Drug interchangeable in pharmacy practice

 Get a prescription with an interchangeable product
 The dispenser (pharmacist) may dispense in its place another product that is
“designated” as being interchangeable with it
 Without contacting the prescriber
 How do you explain this to a patient? Tell them it is the same ACTIVE
ingredient; it may look different because of the excipients. The government
regulates it and deemed it to be interchangeable after studies

“No Sub”
 Stands for No Substitution
 Principles of interchangeability no longer apply
 We have to give the brand that the doctor requested! Cannot give generic
 For a written rx: “no sub” or “no substitution” must be in doctor’s own
handwriting
 If it is verbal rx: you can write it for doctor

Why would a prescriber write “No Sub”?

 Patient has severe intolerance or allergy to a generic product
o Perhaps patient has tried generic and patient experienced adverse reaction
or allergy and doctor wants to try brand
 Patient is enrolled in a study where a specific drug is part of the treatment
regimen
 Abuse this?
o Pharmaceutical company may have influence on doctor’s prescribing
habits
o Patient may want the brand medication
 There is a disconnect between doctors and medication – doctors
don’t know how much medications cost. They’ll give patient what
they want, but most insurance companies will not cover it.
Drug Administration – clinical situations
 Sublingual tablets
 Effervescent tablets
o For taste, gimmicks,
 Chewable tablets
o For those that cannot swallow
 Extended release tablets
o For convenience, compliance
 Film coated tablets
o You’re allowed to cut this because in this case it has to do more with the
ease of swallowing, or keep powder together. Ex: film coated metoprolol,
can be split.

Topical medications
 Cream, gel, ointment, lotion
o What’s the difference? Water content (greatest is lotion, then cream then
ointment, ointment is mostly oil)
o When do you use lotion vs ointment? Hair, face
o What makes a gel use? Drying effect (key!), acne preps are often gel
o What is a paste? Has more powder/solids, stays in place
 Usually applied on the skin
 Main purposes
o Protect area from environment, helps skin recover
o Hydration
o Deliver medication ‘
 Advantages of topical agents
o Avoidance of GI tract
o Avoid first pass effect
 First pass: Metabolized through liver before being full distributed
to the body. (Any kind of reaction can occur here – reduction,
hydrolysis, etc. this modifies the drug and effects availability)
• Which drug is
 Topical agents bypass the portal vein
o Control of absorption
 Disadvantages of topical agent
o Potential for localized irritation
o Time needed for diffusion through skin
o Dosage limitations (cant put too much of the drug)
 Lotions and creams have a saturation point
o Lack of standardized administration amongst patients
o Change in skin physiology caused by
 Age (as we age water content decreases), disease (psiorisis, or
eczema, cuts or wounds could cause excessive absorption), diet,
genetics, etc.
Parenteral Administration
 Parenteral = avoid the intestine (therefore injection)
 Subcutaneous (SC) Route
o Beneath the skin (under cutaneous or fatty tissue; above muscles, BVs)
o Sites include upper arm, lower ab, anterior surface of thigh
o Used for intermittent injection (SC)
 Intradermal
o Into the dermis (vascular layer of skin, under the epidermis, above SC)
o Site is anterior …
 IM
o Injection into muscle
o Site include deltoid (upper arm), gluteal (butt), vastus lateralis (thigh)
o Depot medications
o Onset of action is slower than IV but more rapid than subcutaneous
(muscle is richly vascularized, have lots of blood vessels! so onset is
slower, but more rapid than SC)
o Less risk and easier than IV, but more painful because you need longer
needles.
 IV use
o Maintain access to CV system
o Administer drugs
o Maintain fluid requirements (restore and replace)
o Administer nutrition (TPN)
o Advantages:
 Rapid onset (right into blood), immediate access to CV system
 For drugs too difficult or irritating to administer via IM or SC
• Not everything can be administered IM – may get
crystallization of the medication, causes irritation and pain
 Can give drugs and fluids which you cant give any other way
o Disadvantages
 Have rapid onset, therefore rapid onset of adverse reactions
 Irreversible admin
 Risk of infusion of air, microorganisms, pyrogens, particular
matter
 Risk of sepsis (infection), phlebitis, extravasation/infiltration
(leaking outside vein)
 Comparison
o Fastest to slowet onset …..
o Get this from nada

IV Admin Sites
 Peripheral sites (vein in hand or forearm; scalp or foot vein in infants, which is
possible but a central IV site is preferred in neonates) ie. Heparin/saline lock
 Central IV sites (inserted into chest, tunneled under skin)
Bolus IV Injection
 Large dose, starting dose, STAT dose, etc.
 IV push, IV bolus
 One time dose
 Can be used as loading dose
o If you have an infection and need IV antibiotics, means it is an aggressive
infection, so need aggressive treatment

Intermittent IV Admin
 Medication given from time to time
 Iv bolus at Y-site or heparin/saline lock
o Heparin/saline lock: Y-connector on IV. There is a heparin lock to make
sure when you are done infusing heparin (because you have to mix it with
saline), you lock it, so if you give a bolus later, you unlock. Prevents you
from keeping going back in the patient if heparin is needed.
 Medication given by piggyback minibag (medications run side by side, why?
Cant mix the medications until they are in the patient)

Continuous infusion
 Constant therapeutic drug levels
 Typically for drugs with short half life
 Slow onset of action without a loading dose

Epidural
 Into the spine specifically into the epidural space in the central cavity between the
dura matter ad the vertebral column

Intrathecal
 Into the brain, specifically into the subarachnoid space underneath the arachnoid
matter in the brain where there is CSF (cerebrospinal fluid)
o This is sterile space, not in contact with blood.
o BBB is extremely lipophilic (can be helpful when designing drugs. Drugs
have to be uncharged)
 Used for pain control

Storage Conditions
 Some drugs require special storage conditions
 Important as a pharmacist to: …
 Temperature
o Room Temp – 15-30 C; Fridge – 2-8 C; Freezing – -20 C
 Ex: Fridge (Clindoxyl gel, Xalatan, Nuvaring, fludricortisone)
 Light
o Some medications are photosensitive
o Have to store them in light protective containers or vials
 Which should you keep in original containers? Antiretroviral, Aggrenox
Precursor Control Regulations
 Precursor Control Regulations under the Controlled Drugs and Substance Act
(Regulation)
 Provides a regulatory framework
 That enables Canada to address domestic concerns …
 Helps keep certain drugs out of reach
 Two classes:
o Class A precursor are essential components of illicit substances, such as
methamphetamine, MDMA, cocaine, etc.
o Class B precursors are mostly solvents, diluents, acetone, etc.
 Impact on pharmacies
o Pharmacies are closed as general retailers, whose commerce is not
 Pseudoephedrine-containing products that will be limited to 3g per package size
 Pharmacies will be required to have a license if they sell oversized products with
more than 3 g pseudoephedrine per package
 Furthermore, selling or transferring quantities of product to another pharmacy or
retailer is considered wholesaling and will require a license
 Importing/exporting of any precursors requires a license

Drugs of abuse
 Pseudoephedrine – precursor to crystal meth
 Dimephydrinate – large quantities can result in the patient getting a “high”
because crosses the BBB.
 Laxatives – weight loss (specifically stimulant)
 Anabolic steroids – eg. Testosterone for bodybuilding (SE: testicle atrophy,
gynecomastia, acne
 Narcotics – eg oxycontin (oxycodone controlled released), oxycodone, etc.
 Controlled substances – eg. methylphenidate, nabilone

How to monitor trends of abuse

 Early refills
 Pt comes to the pharmacy within 2-3 days to buy a second bottle of a 100s T-1s
o You have the right to deny a sale!
 Buying large quantities of pseudoephedrine
 Large quantities of syringes? Could be diabetic
 Monitor inventory
 Security videos

Drug disposal
 Ontario has a service with community pharmacies, where patients bring in their
expired medications. The pharmacist can send it out to get destroyed, or destroy it
themselves.
 Responsible drug disposal
o Medications should never be disposed in a way that would risk harm to
health of public or environment
o Often pharmacies…
  Can destroy narcotics and controlled substances the same way as other drugs. But
need permission to destroy these drugs (need it for narcotics and controlled
drugs). Once you receive the letter you can proceed
o If you destroy it yourself you need witness

Hospital Drug Distribution

 Five rights
 The P&T committee is responsible for drug distribution in the hospital setting

Detailed Hospital drug Distribution Process – from the Physicians Order

 Physician writes the order (aka prescription)
 Transcribed to MAR (either by computer or by hand)
o Medication Admin Record
 The order is interpreted
 Order is sent to the pharmacy (centralized)
o Entered by pharmacists usually on the particular floor or ward
 Medication is filled
 Checked (R.Ph.T or R.Ph.)
 Medication is then delivered to that unit
 Medication is administered

Hospital Drug Distribution

 All drug distribution systems used in hospitals include
o Procurement (unit dosing, reconstitution, quality assurance to safe guard
patient)
o Preparation
o Administration of drug
 Hospital pharmacy can be
o Centralized: occupies one large area in the hospital and carries out all of
the hospital pharmacy’s activities
o Decentralized: has satellites which are mini-pharmacies in several areas
 Serving several nursing units or more floors
o Advantages/Disadvantages?
 Centralized – advantage: everything is in one area, control flow,
less staff, standardization and greater deficiency
 Decentralized – advantage: pharmacist and physician have closer
relationship, direct care
 Common drug distribution systems utilized in Canada:
o Floor or ward sock
 Drugs are found on the floor/ward (basically the nursing unit)
 Advantage: quick access, less wasted (know exacty what patient
need
 Disadvantage: not as safe – less intervention by pharmacist
 Most common?
o Individual Prescription Order
  Multiple day supply (like a normal prescription you get in the
community) for that patient
 To get another supply, the MD has to create another prescription
 Advantage: more accurate than floor stock (doctor looking at it
daily), more convenient than unit dose (unit dose is labor
intensive)
 Disadvantage: dosages wasted (if there is a dose change, you don’t
take dose back – here you give for example a five day supply), less
safety than unit dose, more people involved (nurses, physicians)
o Traditional System
 Medications are distributed as a combination of
• Floor stock (may include analgesics, laxatives, lotions, etc.)
• Individual Prescription order – Packaged into vials with a
supply for a fixed amount of period (eg.30 day supply)
o Makes up majority of stock (ie. Less stock as floor
stock)
o Unit-dose
 Safest!
 Medications are dispensed for a 24-hour period
 All drugs are compounded and dispensed by pharmacy in a
1. Patient-specific
2. Individually labeled and
3. Ready to administer form
 Advantages: less error (everything is checked all the time), less
waste
 Disadvantage: most costly system (machine, staff, but less errors
so you save money)
 Details:
• Pharmacy packages and dispense the dose (don’t need
anything else in prep or manipulation, easiest to administer
form)
• Almost all drugs and formulations can be dispensed this
way
• Usually the unit dose is delivered from pharmacy once a
day, placed in drawers, which are sent in a card, in what is
needed for 24 hours.
 What happens for PRN? Give a small amount in the bin at the
back, can use it if they need it
 Compounding
What is manufacturing?
 Bulk production
 GMP and FDA
o FDA – Food and Drug Act
o GMP – Good Manufacturing practice
 Health Canada Inspection (Federal)
 Commercially available
o Sold for profit – manufacturer sells to the pharmacist, gets money for that
before a prescription exists

What is compounding?
 Professional pharmacy activity
 Based on a professional relationship
 Pursuant to a prescription
o You cannot make a compound before a prescription
 Customized service (Tailored for the patient)
 Not for commercial sale
 Regulated by OCP (provincial), provincial guidelines
o REGULATED PROVINCIALLY!!
 Pharmacists responsible for prices

Why compound?
 Product is not commercially available
 Allergic to current drug products available
 Discontinued product
o Ex: phenazopyridine
 Improve palatability
 Veterinarian use
 Research needs

What is a compound?
 Compounds = preparations = extemporaneous
mixtures = extemporaneous mixture
 3 main ingredients:
o Solvents or liquids
o Bases
o Powders or chemicals
 What are other ingredients
o Suspending agents, preservatives, buffering agent, chelating agents
o Hydroquinone – reducing agent, for skin

Labeling Requirements
 Ingredients
 Expiry
 o Use shortest expiry out of the ingredients or compounded products
 Storage info
 Period of stability and safety
 Avoid abbreviations
 Include lot numbers (on prescription itself, don’t have to on label)
o Want to do this just incase problems come up about original ingredients (a
withdrawal) we can warn patient.

Pharmacists role in Compounding

 Prepare, check, document, supervise
 Need to sterile conditions/procedure
 Be knowledgeable
 Remington is book for compounding!!! Or Martindale!
 Recognize the potential incompatibilities

Pharmacy Technician’s Role in Compounding

 Maintain inventory and proper storage
 Document and maintain accurate records
 Pharm calculations
 Confirm the phsyiochemicals properties of ingredient
 Techniques – levigation, etc.

Consideration Before Compounding

 Is the product commercially available?
o If yes – do not compound!!
 Able to safely prepare, by modifying a commercially available product due to a
specific patient factors such as an allergy?
o If yes, then consider doing so

Key Elements of Compounding

 …

Preparation of Compounds: Practical approach

 Fill the rx in a manner which limits physical contact
 Calculate the amount of each ingredient needed for the prep
 Count/weigh the correct quantity
 Place in an appropriate container, secure lid

Common sources of compounding error

 Inaccuracy in weighing procedure
 Calculation error
 Failure to completely dissolve the solute
 Inaccuracy in the final volume

Common Techniques in Compounding

 Titration – reduction in particle size of solid, by rubbing/grinding
 o Mortar and pestle, spatula and ointment pad
 Levigation – particle size reduction of a solid to affine state by titration, after
moistening it (Eg. Water, glycerin, mineral oil)
o Decrease in particle size, increase surface area
 Pulverization by intervention – reducing solid particle size by combining with a
solvent (eg alcohol, propylene glycol) which easily evaporates after pulverization
o Used when the solid resists grinding
o Eg. Menthol crystals and alcohol
 Geometric dilution – incorporating equal, increasing amounts of 2 ingredients
o Do this for even distribution

Sterile Preparations
Read on your own

Laminar Air Flow Hood

 Dual filtering system
o Dual filtering – air for particles and HEPA

Types of Laminar Air Flow Hood (LAFH)

 Horizontal Hood
o Air flows from back to front
o This helps to make sure product is not contaminated, and if it is not
dangerous to person making it it’s okay
 Vertical
o Air flows from top to down
o For hazardous compounds/cytotoxic (eg. Chemo drugs)
 If you’re dealing with a toxic drug use vertical. With horizontal air comes to you

Professional Collaboration
Collaborative Care
• Advantages
o Improves access to care
o Enhance the quantity and safety of care
o Enhance the coordination and efficiency of care
o Enhance provider morale and reduce burnout within health professions

Important factors recognized for collaborative care

• Patient centered care
• Mutual trust and respect
o Collaborative and respectful interaction among health care professionals
o Members understand and respect the professional responsibility, knowledge
and skills that come with their scope of practice
 • Clear communication
• Effective and efficient communication
• Should be supported by clear documentation that identifies the author
o Every professional has to identify name and profession, so that the other
health care professionals know what they all did. Only way to work together is
to know what’s going on with the other aspects of the health care.
• Common accessible, …
• Classification of roles and scope of practice
o Roles and responsibilities of each health care professional on the team must be
clearly defined
• Clarification of accountability and responsibility
o Providers must be accountable and responsible for the outcome of their
individual practice
• Examples: Family Health Teams

List of common health care professionals

• Audiologists and speech-language pathologists
• Chiropodists and podiatrists
• Chiropractors
• Dental hygienists
• Dentists
• Dental
• … over 20

Definitions:
• Practitioners: a person registered and entitled under the laws of a province to
practice medicine, dentistry, or veterinary medicine
o Can dispense medication to their own patients
o Practitioner (limited to just doctor, dentist, vet) vs prescriber (midwives,
ophthalmologist, etc.)

Brief description of other health professions

• Audiologists – can prescribe only hearing aids (+physicians)
o These are not medical doctors, do not need a referral
o Collaborate with speech therapists
• Chiropractors – cannot prescribe anything
o Do not need a referral, not medical doctors
• Speech-language Pathologist – cannot prescribe
o Very important for communication, work with children and youths in schools
• Podiatrist – can prescribe (limited things)
o Focus on foot and ankle
o Podiatry vs Chiropody – no clear distinction, slight difference in what they
can prescribe. One can prescribe injectable, one cant (don’t know, doesn’t
matter)
• Dental hygienists - cannot prescribe
 o Work with dentists
• Dietician – cannot prescribe (some can make changes to TPN in the MAR)
o Play a big role with lifestyle, focus on food, diet and nutrition
o Play a role in TPN – work with physician, nurses, pharmacists
o Nutritionist is not a dietician! Dietician is protected title, Nutritionist is not!
• Medical Radiation Technologists (MRTs)
o Work with radiation, diagnostic therapy, etc.
o Pharmacist does not deal with MRT
• Medical Laboratory Technologists (MLTs)
o Perform sophisticated medical tests on blood, body fluids and tissues
• Midwives – can prescribe (small list of things – antibiotics, insulin)
o Help with pregnancy, labor and postpartum period
o Help with complete range of care for baby and woman before and after birth
• Nurses
o Registered Nurses, Registered Practical Nurses, Registered Nurses Extended
Class or Nurse Practitioners
o RNEC or Nurse Practitioners – Can prescribe anything but controlled
substances
• Occupational Therapist
o Enable individuals, families, groups, etc. enable people to participate in
activities of daily life
o Ex: if you’ve had an accident and you cant stand after, they can make
something for you to help you stand
o Often work in collaboration with physiotherapist
• Optician
o Optician like a technician. Optometrist like a pharmacist
• Optometrist – can prescribe
o Help with eye disorders, treatment, prevention of disease (first point of
contact for these things)
o These prescribe eye glasses, contact lenses etc.
o Refer and consult with ophthalmologist
• Physiotherapist
o AKA Physical therapist
o Goal is to restore, maintain and maximize your strength, function, movement
and overall well being
o Prescribe personalized therapeutic exercises, and provide essential education
about the body
• Social worker
o Helping individuals, families, groups and communities to enhance their
individual and collective well being
o Work especially in psychiatric hospitals, poor areas of the city
o Ex: elderly pt who cannot feed themselves, social worker will connect that
patient with someone that can come into patient’s home and feed them. Death
counseling
• Pharmacist
 • Who regulates prescribing of health care professionals? Individual colleges of
province

Math
The Basic Process
• Identify the KNOWNS
 o Identify the things you know that are important to you
• Identify the UNKNOWNS
o What does the question want you to solve?
• Identify the EQUATIONS, or processes that you can be applied
• Identify the TYPE OF ANSWER
o What units do you need?
o
• SOLVE: using the equations and knowns to get you to your unknowns and
answer

Formulae sheet is given to you on the exam

Systems of Measurement
• SI System (International System of Units)
o Metric system – base unit are the meter and the kg
o This is what we use in Canada
• Apothecary Measure
o Predominantly pharmacists’’ system, measures volume – uses ounce,
fluidounce, etc.
• Avoirdupois System
o Widely used in the US for measuring weight – uses ounce or pounds

***ALWAYS CONVERT TO SI UNITS FIRST***

Aliquot Method
• This is a method of weighting by which small quantities of a substance are
measured within the desired degree of accuracy
• Used when precision of measuring device is not sensitive enough to measure
required small amount of drug
• Dilution of drug by a multiple and then taking a small portion out to get desired
quantity of drug which …
• Weight –
o Most scales have a max capacity of 120 mg, rule of thumb we want to avoi
errors of greater than 5%
o Smallest quantity = 100% x sensitivity requirement (mg)
Acceptable error (%)
• Formally, sensitivity requirement is the load that will cause a change of one
division on the index plate of the balance
• Ex: assume you want to measure 10 mg of drug on a scale, which has sensitivity
requirements of 6 mg on a scale which has a sensitivity requirements of 6 mg and
provides of +/- 5% accuracy. How much diluent needs to be added?
o Answer: 120 mg. Therefore 120 mg is least weighable quantity but you need
10 mg, so how much diluent?
o Dilution factor = least measurable qty / drug required
 Factor = 120 / 10 = 12
 Final weight = least measurable qt x factor
 = 120 x 12 = 1440 mg
 Diluent required = 1440 – 120 mg
= 1320 mg of diluent
 What this is saying now that if we pull out 120 mg of mix we have 10
mg of drug (120 mg Drug in 1440 total mass = 10 mg of drug in 120
mg total mass)
• Example: assume you want to measure 10 mg of drug on a scale which has
sensitivity requirement of 10 mg and provides accuracy of +/- 5%?
o Answer: Smallest quantity = 100 x 10 / 5. Smallest quantity = 200 mg.
Therefore 200 mg is least weighable quantity
o But you need 10 mg, so how much diluent?
o Dilution factor = least measurable qty / drug required
 Factor = 200 / 10 = 20
 Final weight = least measurable qt x factor
= 200 x 20 = 4000 mg
 Diluent required = 4000 – 200 mg
= 3800 mg of diluent

Aliquot Method for Volume

• Stick to the same principles, as weight, may be used when relatively small volumes
must be measured with great precision
• Ex: Assume you want to measure 0.1 ml of drug. The container has the least
measurement of 1 ml. Using a diluent as alcohol, how can you measure the exact
quantity of drug?
o Least measurable quality is 1 ml. (did first step for us – add diluent so that 1
ml contains 0.1 ml of drug)
 Factor = 1 / 0.1 = 10
 Final weight = least measurable qt x factor
= 1 x 10= 10 ml final weight
 Diluent required = 10 ml – 1 ml
= 9 ml of alcohol
 Each 10 ml contains 1 ml of drug. 1 ml contains 0.1 ml of drug
• Ex: Assume you want to measure 0.25 ml of drug. The container hast he least
measurement of 5 ml. Using a diluent of alcohol, how can you measure the exact
quantity of drug.
o Least measurable quality is 5 ml
 Factor = 5 / 0.25 = 20
 Final weight = least measurable qt x factor
= 5 x 20= 100 ml final weight
 Diluent required = 100 ml – 5 ml
= 95 ml of alcohol
Interpretation of Prescription and Medication Orders
Interpretation of Rx and Medication Orders
• General info – read later
Use of Abbreviations and Symbols
• Mostly derived from Latin short forms used in medicine and pharmacy
• Take time to learn most important ones *get from Nada

Some examples
• Prednisone 50 mg daily for 1 week, then 45 mg for one dose week, then decrease
by 5 mg Q3D, until finished. Dispense 5 mg tablets
o Answer: 241 tablets
• A physician wants to switch a terminally ill patient from slow release pain
medication tablets, 15 mg twice daily, to a liquid dosage form of same medication
because the patient has difficulty-swallowing tablets. If liquid contains 5 mg per
ml is prescribed every 4 hours, what volume should be dispensed for a 20 day
supply to provide the same pain relief as the tablet regimen.
o Very important question
o Answer: 120 ml

Density and Specific Gravity

Density vs Specific Gravity
• Density = mass per unit volume in a substance, expressed in grams per cubic
centimeter (cc), assume 1 cc = 1 ml
• Density = mass / volume
Whereas,
• Specific gravity, is a ratio (no units), expressed decimally of the weight of a
substance to the weight of and equal volume of a substance chose as a standard
(water)
• Specific gravity = Weight of a substance
Weight of an equal volume of water
• Substances that have a specific gravity < 1 are lighter than water
• Substances that have a specific gravity > 1 are greater than water

Using Specific Gravity

• If we had 20 ml of a liquid with specific gravity of 1.5, it would weight 1.5 times
as much as an equivalent volume of water
• However, an equivalent volume of water, 20 ml, would weigh 1.5 times that or 30
g.
• Therefore, grams = milliliters x specific gravity
Milliliters = grams / specific gravity

Percentage, Ratio Strength and Other Expressions of

Concentration
Percentage preparations
 • Percent weight in volume (w/v) expresses the number in grams of a constituent in
100 ml of solution or liquid
o Eg. Solutions (ophthalmic, otic, topical), lotions, spray
• Percentage volume in volume (v/v) expresses the number in milliliters of a
constituent in 100 ml of solution or liquid
• Percent weight in weight (w/w) expresses the number in grams of a constituent in
100 g of product

Example:
• How many grams of hydrochloric acid should be used to in preparing 8
fluidounces of a 5% solution in 70% alcohol?
o Answer: 12 ml
o 8 fl oz = 240 ml
o 240 ml x (5g /100 ml) = 12 ml
• Rosewater solution contains 10% v/v of concentrated peppermint oil. What volume
of concentrate will be contained in 85 ml of peppermint oil?
o Answer: 850 ml
o (10 ml / 100 ml) = ( 85 ml / x)  x = 850 ml
• How many grams of a drug substance are required to make 120 ml of 20% (w/w)
solution having specific gravity of 1.15?
o Answer: 27.6 g
o SG = 1.15 = x / 120  x = 138g
o (x / 138 g) = (20g/100g)  x = 27.6 g

Ratio Strength
• Usually weak concentration will be expressed in terms of ratio strength – do no tbe
thrown off! This is simply another way of expressing percentage
• Example: how many milligrams of Drug A should be used to prepare the following
solution: Drug A 1:10 000 500 ml sig: as directed
o Answer: 50 mg
o 1 / 10 000 = x / 500 ml  x = 0.05 g = 50 mg

Dosing Considerations: Patient Parameters

Dosing for Individual
• Patient parameters: weight, age, sex, pre-existing medical conditions, etc.
• Usual dose and usual dose range is not always appropriate for your patient
 o Read the question!! If you see a drug that is teratogenic and its asking for a
dose for a pregnant woman, dose is zero!! Don’t give the drug
• Type of patients
o Pediatric patients
o Elderly and geriatric patients
o Compromised renal function
o Obese and under weight
• Important resources: product monograph, Sick Kids Pediatric Handbook,
Therapeutic Choices, Renal Dosing Guidelines
o TIP: if they give you guidelines you probably need to use it

Dosing for the Individual – Pediatric Patients

• Pediatric Patients (don’t have to memorize these?)
o Young’s Rule (age > 2 yrs)
Dose for child = (Age / Age + 12) x adult dose
o Fried’s rule
Dose for infant = Age (months) x Adult Dose
150
o Clark’s rule (2-17)
Dose for child = Weight (lb) x Adult dose
150
• Examples
o Adult dose of a cephalexin is 250 mg. What would be the approximate dose
for a 6 yo child weighing 60 lbs based on wt and age?
 Clark’s Rule: 100 mg
 Young’s Rule: 83.33 mg
o The dose of prednisone is 500 mcg/kg of body wt. How many mg should be
given to child weighing 55 lb?
 Answer: 12.5 mg
 55 lb / 2.2 = 25 kg
 500 mcg x 25 kg = 12 500 mcg = 12.5 mg

Dosing for the Individual – Elderly Patients

• Often have co-morbidities that compromise that way that drugs are absorbed,
metabolized and excreted from the body
• Eg: Chronic Kidney Disease
o Implication: drugs metabolized and excreted by the kidneys may show altered
kinetics
 More often you need lower drug doses because drug isn’t leaving body
as quick.
o Clinic Consequences: risk of overdosing patients
• Often the dosing regimen is altered to account for a decreased renal function
• What about patients with chronic liver disease (eg: hepatitis?)

Dosage calculations based on creatinine clearance (MEMORIZE!)

• By Jelliffe equation
 o For Males
CrCl = 98-0.8 x (Patient’s age in years – 20)
Serum Creatinine in mg/dl
o For females
CrCl = 0.9 x CrCl determined using formula for males
• By the Crockcroft-Gault Equation
o For Males
CrC = (140 – patient’s age in years) x body wt (kg)
72 x Serum Creatinine in mg/dl
o For females
CrCl = 0.85 x CrCl determined using formula for males
• Ex: What is the creatinine clearance for a 78-year old male weighing 185 lbs and
having serum creatinine concentration of 0.9mg/dl?
o Answer: 80.46

Dosing for the Individual: Nomograms

• Use 2 patient parameters to determine another parameters that affects dosing
o A nomogram is like a dosing guideline, for example, if you have weight and
height you can get body surface area.
• Eg. Pediatrics
o Use weight and height
o Extrapolate the percentage of the normal dose that should be given to a patient

Chemotherapy Dosing
• Verification of dose is critical step in chemotherapy admin
• BSA determination is essential for chemotherapy dosage calculations
o We think about site, but also BSA gives you an idea of how big the person is
and distribution of drug. Weight and BSA are essential.
o Often physicians will calculate with BSA and weight and try to go somewhere
in between to make sure they are giving the right one
• The use of a standardized format for determining BSA is needed to ensure optimal
treatment, and can reduce the potential for medication error.

Body Surface Area

• The BSA is the calculated skin surface of a human body
• BSA (m2) = [ height (cm) x weight (kg) 1/3600)]½
o Eg. BSA = SQRT [(cm x kg) / 3600]
• Or in inches and pounds
o BSA (m2) = [ ( height(in) x weight (lbs) ) 1/3131 ] ½
• In addition to chemotherapeutic drugs, even more pediatric drugs are dosed
according to the BSA of the child
• Example:
o The doctor has ordered an antibiotic on 11 yo Ian. The average adult dose is
250 mg. in order to calculate the pediatric doses you must first determine Ian’s
body surface area. Ian is 157.5 cm in height and weighs 45 kg.
 BSA = SQRT [(157.5 cm x 45 kg) / 3600]
  BSA = 1.40 m2
o Child dose formula: (BSA/1.73) x adult dose = approx. child dose
 For Ian: 202.3 mg

Formulae
(ONLY ONE YOU NEED TO KNOW IS BMI – THEYD GIVE YOU THE REST)
• Lean body weight
o LBW (men) = (1.10 x Weight (kg) ) – 128 [ Weight2/ (100 x Height (m) ) ]
o LBW (women) = (1.07 x Weight (kg) ) – 148 [ Weight2/ (100 x Height (m) ) ]
• Ideal body weight
o IBW (men) = 50 + 2.3 ( height (in) – 60) [Devine formula]
o IBW (men) = 45.5 + 2.3 ( height (in) – 60) [Robinson Formula]
• BMI = weight (kg) / height (m2)

• Creatinine comes from the muscle – someone who is very obese, their muscle does
not change, they have more fat rather than muscle. For someone that is obese, we
don’t want their actual body weight, we take their ideal body weight. Actual body
weight would incorporate all their fat
• When do you dose on actual weight?
o Drugs that are absorbed and get into fat (more lipophilic drugs).

Calculations Using Units

• Cost differential between Therapeutic agents
• Ex: How many mls of U-100 insulin should be used to obtain 40 units of Insulin
(U-100 insulin contains 100 units/ml)?
o 0.4 ml (just use 100 units/ml – ratio)
• A biologic contains 50 Lf units of diphtheria toxin in each 2.5 ml of product. If a
pediatric patient is to receive 10 Lf units, how many mls of product should me
administered?
o 0.5 ml

IV Infusions
• Common Examples include
o 0.9% NaCl (NS)
o 0.45% NaCl (1/2 NS)
o 5% Dextrose in water (D5W)
o 10% Dextrose in water (D10W)
o 5% Dextrose in Saline (D5NS)
• Ex: How many grams of Dextrose and NaCl are required to prepare 500 ml of
D5NS for IV infusion?
o Dextrose: ( 5 g / 100 ml ) = ( x / 500 ml )  x = 25 g
o NaCl: ( 0.9 g / 100 ml ) = ( x / 500 ml )  x = 4.5 g

IV Push/Bolus
 • Ex: MD orders 3 mg of IVP of a Drug A. Pharmacists has Drug A as IV in 1.5 ml
vial having 0.75 mg/ml of Drug A. Calculate ml of injection required? Calculate
vials he needs to open.
o (3 mg / x ) = ( 0.75 mg / 1 ml)  x = 4 ml (needs 4 ml)
o 4 ml / 1.5 ml = 2.67  3 vials
• Ex: In a treatment of a condition X, a drug A is indicated as a bolus dose in range
of 0.2 – 0.4 mg/kg IVP. Assuming patient weighs 150 lbs, calculate the bolus dose
range for patient?
o 150 lbs = 68.2 kg
o Dose range: 13.6 mg– 27.3 mg

Important Infusion Concepts

• [Volume (ml) / Minutes] x Drop factor (gtt/ml) = Flow Rate (gtt/min)
o Drop factor (gtt/ml) – IV infusion devices are calibrated to deliver so many
Drops per ml
o Flow rate (gtt/min) – a nurse will set the device to dispense so many drops per
minute in order to achieve the proper ml/min
o Variation of questions can be asked, for example, can ask you how many
drops are administered by the machine per min.

Important distinction
• IV infusions sets are pre-calibrated – cannot change the number of drops that make
a ml!! But you can change the drops per minute (the rate)!
• Ex: there are 250 ml of D5W infusing at 33 drops/min on IV tubing calibrated at
10 drops/ml. Calculate the infusion time
o 250 ml x (10 drops/ml) = 2 500 drops
o 2 500 drops / ( 33 drops/ min) = 75.75 min (=1.26 hr)
• Ex: Using an IV pump calculate the duration of 1000 ml of normal saline infusing
at 125 ml/ hour
o Answer: 1000 ml / 125 ml/hr = 8 hours

IV Infusions and Drip Rates

• If the drip is set to deliver 15 drops per ml and it is set at a rate of 30 drops/min,
how long will it take to deliver the 500 ml IV?
o (15 drops / 1 ml) = ( x / 500 ml)  x = 7 500 drops
o 7 500 drops / (30 drops/min) = 250 min = 4.17 hr

Calculations involved in Hospital

• A baby weighs about 3 lbs and 8 oz. MD decides to provide D10W on basis of 60
ml/kg/day. The drip provides 60 drops per ml and nurse wants to end the infusion
before her shift ends which means she has 4 hours. What rate of drops/min should
be set to ensure that infusion ends in 4 hours?
o 3 lbs 8 oz = (16 oz per pound) = 3.5 lbs = 1.59 kg
o 1.59 kg x 60 ml/kg = 95.45 ml
o 95.45 ml x (60 drops/ml) = 5,727 drops
o 5,727 drops / (60 min x 4) = 23.86 drops / min ~ 24 drops/min
 • Ex: If drip set was changed to different one which gave 15 drops/ml but the
drops/min remained unchanged in previous case, how long will it take for the
infusion to be over?
o 24 drops/min; 95 ml
o 95 ml (15 drops / ml) = 1425 drops
o 1425 drops / (24 drops/min) = 59.4 min

Dilution, Concentration and Alligation

• Concentration: component of a pharmaceutical preparation, based on its quantity
relative to the total quantity of the preparation. Always in 2 sets of units (eg.
Mg/ml, g/L/, etc)
• The most useful calculation you will come across is
o C1 x V1 = C2 x V2
• Ex: How many mls of a 1: 10 000 w/v solution can be made from 125 ml of a
0.2% solution
o (0.002)(125 ml) = (0.0001) V2
o V2 = 2 500 ml
• Ex: How many mls of a 1% stock solution of a certified green dye should be used
in preparing 4000 ml of a mouthwash that is to contain 1:20 000 w/v of the
certified green dye as a coloring agent?
o V1 (0.01) = (4000 ml) (0.00005)
o V1 = 20 ml
• Ex: How many grams of NaCl should be used in preparing 250 ml of a stock
solution such that 50 ml diluted to 1000 ml will yield a 1/3 normal saline for
irrigation?
o 250 ml  using 50 ml to get 1000 ml of 0.3% NaCl Solution
o C1V1 = C2V2
o C1(50ml) = (0.003 mg/ml)(1000 ml)
o C1 = 0.06 mg/ml
o 250 ml (0.06 mg / ml) = 15 mg NaCl

Alligatoin Method
• Ex: How many grams of hydrocortisone powder should be added to 32 g of 5%
hydrocortisone ointment to prepare an ointment containing 20% of
hydrocortisone?
o 32 g (5 g/100g) = 1.6 g HC
o 1.6 g HC + x = 20g Solve for x. Get x = 6g HC
32 g total + x 100 g
 Logic: we know we have 1.6g pure HC in the 5%. We are going to add
X amount of HC to get 20% (20g/100g). The x we add is going to
affect the pure HC, and the total. Solve for x to get 6g
o Other way to do it: the tic-tack-toe method

100% 15 Put  your  final  concentration  in  center.  The  

20 % concentrations  of  product  go  on  the  left.  If  product  
5% 80 you  are  adding  is  pure  place  100%  in  top  left  corner.  
In  this  case,  we  are  adding  100%  HC.  The  bottom  left  
is  the  concentration  we  have  (5%  HC  ointment).  
Cross  subtract.    
 o We now have a ratio of 15:80 = 3:16 (reduced)
o Meaning: 3 parts of powder for every 16 parts of 5% cream
o ? Mg of powder for 32 g of 5% cream
o 16 = 32 Solve for x, x = 6 g
3 x
o
• Ex: a pharmacist wants to use three lots of betamethasone ointment containing,
respectively, 50%, 20%, and 5% betamethasone. In what proportions should they
be mixed to prepare a 10% betamethasone ointment?
o Tic-tac-toe Method
Since  this  is  three  parts  it’s  almost  like  two  
50 5 separate  boxes  in  one.    We  cannot  make  a  10%  
with  50%  +  20%.  So  we  use  50%  +  5%  part  (so  
20 10 5 5  parts  and  40  parts).  (In  blue)  
Then  have  to  do  it  as  if  it’s  20%  +  5%.  So  the  
10%  in  middle  of  those  two.  So  it’s  10  parts  5%  
5 40 + 10
and  5  parts  20%.    (in  red)  
 
Then  add  everything  up!    
5:5:50  à  1:1:10    
o
• From next question. What would the case if final conc. required was 25%?
o Tic-tac-toe Method

50 5 + 20

20 25 25

5 25

o 25:25:25  1:1:1

Isotonicity and NaCl Equivalent

Isotonicity and NaCl Equivalent
• Many solutions to be mixed with body fluids are designed to have the same
osmotic pressure for comfort, efficacy and safety
• Solutions can be
o Hypotonic: lower osmotic pressure than body fluid
o Hypertonic: higher osmotic pressure than body fluid
 o Isotonic: solutions with same osmotic pressure as body fluid
• When solutions are isotonic, homeostasis with the body’s intracellular fluids – thus
preventing movement of water between intracellular membranes
• Thus, in most instances, preparations are made isotonic
• Principles of isotonicity
o When a non-electrolyte in weight equal to its mol weight in gram is
dissolved in 1000g of water: the freezing point of solution depresses by
- 1.86 C
o The freezing point of body fluids is – 0.52 C
• This can be used to calculate the amount required to make any solution isotonic
o That is: any non electrolyte solution that has a freezing point of -0.52 C it will
be isotonic to body fluid
o Use the decrease in temperature to calculate the proportion of moles of a
substance that makes a solution isotonic
• Ex: given 100 ml of a 0.5% w/v solution of NaCl, we can easily calculate how
much NaCl needs to be added to make it isotonic
o In a solution of 100 ml, 0.9 g of NaCl would make the solution isotonic
o Current strength 0.5% = 0.5 g already represented
 0.9 g – 0.5 g = 0.4 g
o Therefore, 0.4 g of NaCl need to be added

Examples:
• Non-electrolyte eg. Boric acid has Mol Wt of 61.8 g/mol. How much boric acid is
required to make 1000 g of water solution isotonic?
o Mole of anything in 1000 g of water get a freezing point of – 1.86 C
o 1 mole of this is = 61.8 g
o Freezing point will change proportionally. If we put less than 1 mole, freezing
point will rise. Use proportions!
o Isotonic = - 0.52
o – 0. 52 / - 1.86 = 0.279 (Always for non-electrolytes! )
 Simplified formula: Grams of substance = MW x 0.28
o 0.279 x 61.8 g = 17.28 g of Boric Acid
• Non-electrolyte substance B has Mol Wt of 90.3 g. How much substance B is
required to make 100g of water solution isotonic?
o MW X 0.28 = 90.3 x 0.28 g = 25.28 g (but this is for 1000g of water)
o So for 100g of water (divide by 10) = 2.53

• In electrolytes like NaCl, the dissociation factor comes into play

o Non-electrolytes have a dissociation factor of 1 because they do not separate
into electrolytes when dissolved into water
o Substances that dissolve into 2 ions (NaCl) have a dissociation factor of 1.8
 Don’t have to memorize this
• Ex: How much NaCl is required to make solution isotonic? All we know it is
0.9%?
 • Formulae:
o Non-Electrolytes
Grams of substance = 0.52 degrees C
Molecular weight of drugs 1.86 degrees C

o Electrolytes
Grams of substance x (i) = 0.52 degrees C
Molecular weight of drugs 1.86 degrees C

(i) – Dissociation factor

Simplified: Grams of substance = (MW x 0.28) / (i)

• Ex: NaCl dissociation factor is 1.8

o Qty of NaCl required for isotonoicity = 585g x (-0.52 / - 1.86) / 1.8
= 9.09 in 1000 ml

NaCl Equivalent
• Compounds may involve multiple ingredients and therefore a standard reference
point is required to express isotonicity across ingredients
• This is called NaCl equivalent calculated as
o (NaCl M.W) / ivalue of NaCl
(X M.W) / ivalue of x
• Amount of NaCl that is equivalent to 1 g of solute/drug
• What does this mean? If we are calculating isotonicity of a certain solution and the
amount that we need to use of a drug is toxic, then we can just use the amount of
drug we want, and then make the solution isotonic with NaCl.

Calculations based on Tonicity

• Simple isotonicity solutions may be calculated:
0.52 degrees C = grams of solute per 1000g of water
1.86 degrees C
o
• Sodium chloride equivalent of a substance may be calculated
Molecular weight of NaCl x i factor of substance = NaCl equivalent
i factor for NaCl MW of substance
• Using isotonic NaCl to make other isotonic solution:
g of drug x E value = ml of water needed to make an isotonic solution of
0.009 the drug
E Value
• Also known as sodium equivalent, is the amount of sodium chloride that is
equivalent to (i.e., has the same osmotic effect as) 1 gram, or other weight unit, of
the drug
• Quantities of two substances that are tonicic equivalent are proportional to the
molecular weights of each multiplied by i value
• Eg: How much sodium chloride is in effect represented by atropine sulfafe
o MW NaCl = 58.5 ; i = 1.8
 o MW atropine sulfate = 695 ; i = 2.6
o MW of NaCl x i factor of atropine = NaCl Equivalent
i factor for NaCl MW of atropine SO4
o 58.5 x 2.6 = 0.12 g
695 x 1.8
o x = 0.12 g of NaCl represented by 1g of atropine sulfate

NaCl Equivalent
• General procedure to calculate tonicity:
1. Calculate the amount of NaCl (in g) represented by the ingredients in the
prescription. Multiple amount of each substance by its NaCl equivalent (E).
2. Calculate amount of NaCl (if used alone) that would be contained in an
isotonic solution of the specified volume in the formula given, ie, amount
of NaCl to make a solution isotonic is 0.9% w/v (0.009 g/ml)
3. Subtract the amount of NaCl in STEP 1 from STEP 2. This amount
represents the amount of NaCl that would need dto be added to the solution
to make it isotonic
4. If an agent other than sodium chloride is to be used to make the solution
isotonic, divide the amount of sodium chloride by the NaCl equivalent of
the other substance.
• Ex: How many grams of NaCl should be used in compounding the following
prescription? (NaCl equivalent of ciprofloxacin = 0.23)
Rx Ciprofloxacin HCl 0.5 g
NaCl q.s
Purified water ad 30 ml
Make isotonic solution Sig: for the eye
o Question is asking how much more nacl do you need to make the entire
solution isotonic. We need 0.5 g of cipro (0.5g/30 ml – therapeutic
concentration)
o Qs – it’s telling you to add in some amount of NaCl to make solution isotonic
o E-value = 0.23  this means 1 g cipro = 0.23 g NaCl
o Convert the drug to an equivalent amount of NaCl
0.23 g NaCl = x x = 0.115 g NaCl equivalent
1 g cipro 0.5 cipro
o Total volume to make whole solution isotonic
 30 ml x (0.9 g / 100 ml NaCl) = 0.27 g NaCl
o Difference is how much NaCl you need to add
 0.27 g – 0.115 g = 0.155 g NaCl
o Therefore you need to add 0.155 g of NaCl.
• Determine the volume of purified water and 0.9% w/v of NaCl solution needed to
prepare 30 ml of a 1% w/v solution of hydromorphone hydrochloride (E= 0.22)
o Hydromorphone 1% w/v in 30 mls  0.3 mg of Hydromorphone
o 0.3 mg x 0.22 (evalue) = 0.066 g NaCl Equivalent
o 30 ml total – must be 0.9% NaCl
 therefore, 0.9g / 100ml = x / 30 ml ; x = 0.27 g NaCl
o 0.27 g – 0.066 g = 0.204 g NaCl needed
  NaCl is provided in NS (0.9% NaCl solution so have to convert to mls
of solution). 0.204 g / (0.9 g/100ml) = 22.67 ml NS
o Total volume we need is 30 ml
 30 ml – 22.67 ml = 7.33 ml
o Answer: 22.67 ml of NS ; 7.33 ml Water

Milliequivalents (mEq)
• A chemical unit, the mEq, is used to express the concentration of electrolytes in
solution
• This unit of measure is related to the total number of ionic charges

What is an “Equivalent”
• Equivalent: an equivalent is an amount of material that will release or react with
Avagadro’s number of electrical changes on particles like OH1-, H1+ of electrons
• This means that an equivalent of HCl will react with a mol of hydroxide ion
change

“Equivalent”: Example
• 1 mol Ca(OH)2 = 2 equivalents Ca(OH)2
• there are TWO OH1- released when the hydroxide dissolves
• the calcium hydroxide releases Ca2+ and two OH1- ions
• the equivalent weight of calcium hydroxide is ½ the mass of a mol of calcium
hydroxide
• 1 mol Ca(OH)2 = 74 grams Ca(OH)2; 1 equivalent Ca(OH)2 = 37 grams Ca(OH)2

“Equivalent”: Example 2
• 1 mol H3PO4 = 3 equivalents H3PO4
• there are THREE H1+ released when the hydroxide dissolves

Milliequivalents
• a milliequvalent is 1/1000 of an equivalent
• This means an equivalent is 1000 mEq, in terms of g the equivalent weight is equal
to 1000 mEq weights
• Example:
o 1 Eq H3PO4 = 1000 mEq H3PO4
o 1 Eq mol H3PO4 = 32 g H3PO4
o 1 mEq mol H3PO4 = 32 mg H3PO4

Electrolyte Solutions
• Milliequivalents
o mEq = mg x valence / (atomic or MW)
o mg = mEq x atomic or MW / valence
• Millimoles
o A mole is a molecular wt of a substance
o Mmol is 1/1000 of MW in grams
• Milliosomes
o Key difference is no of species
o Looking at what it dissociates into
 NaCl: 2 species – Na and Cl
o mOsmol/ L = wt of substance (g/L) x species x 1000 / MW
o Ex: Calculate mOsmol of 0.9% NaCl if the MW is 58.5g?
 mOsm/L = 9g/l x 2 x 1000 / 58.5
 mOsm/L = 308
 How many mmols do I have? Divide by 2, only thing that changes is
species.
o Ex: Calculate mOsmol of 10% anyhydrous if the MW is 180g?
 mOsm/L = 100 g/l x 1 x 1000 / 180
 mOsm/L = 556
o Ex: what is the concentration in mg/ml of a solution containing 3 mEq of KCl
per ml (MW of KCl = 74.5). what is weight in %w/v?
 Use – mEq = (mg/MW) x valence
 223.5 mg/ml
 22.32%
o Ex: what is the concentration in g/ml of a solution containing 5 mEq of
CaCl2. 2H2O per ml (formula wt = 147). What would it be in %q/v?
 36.75%
 Pharmacokinetics and Dynamics
Important Concepts
• Pharmacokinetics
o Study of drug ADME - absorption, distribution, metabolism, and elimination
• Bio-availability
o Relative amount of drug from a given dosage form entering systemic
circulation
OR
o Measurement of rate and extent (amount) to which the drug is available at the
site of action
o Relative bioavailability
 Systemic availability of the drug from a dosage form as compared to a
reference standard given by the same route of administration
o Absolute bioavailability
 (F) is the absolute fraction of drug systemically absorbed from the
dosage form
 F = AUC (oral) / AUC (IV adjusted for dose)
o Bio-equivalence
 The rate and extend of drug absorption between two different mfg or
different dosage form. If it falls within limit, it is considered bio-
equivalent.
 If 2 products (generic vs. RLD- referene listed drug product) are
pharmaceutical equivalents and rate and extent of systemic drug
absorption do not show statistically significant difference …
o Area under the curve
 The blood drug conc. Vs time curve …
o Volume of distribution (Vd):
 Is only hypothetical and not real
 It is the volume required to distribute drug so that the same conc as
found in the blood can be achieved
 It is important indicator of drug’s extend of distribution in body fluids
and tissues.
 Low Vd indicates drug is confined to blood, high indicates vast
distribution in peripheral compartment, and stored in body fats, bound
to tissues.
 Vd = D/ Cp. D = Drug in body; Cp = Drug’s plasma concentration
o Elimination half life
 Time taken by drug plasma conc (as well as the amount of drug in the
body) to fall by one half
 T1/2 = 0.693 / k, where k is elimination rate constant
 T90% = 0.105 /k
 This is for a drug that follows first order kinetics! (Meaning that for
every amount of time that elapses you lose a certain amount of drug by
the body).
  In first order, drug cleared from body is dependent on the amount of
drug at that time.
o Important formulas – you are given these, just have to know what they mean!
 D = Vd x Cp
 DL = Css x Vd
• DL – loading dose
 Css = R / (Vd x k)
• Css = concentration at steady state
 R = rate of infusion; k = elimination constant

Rate and Order of Rxn:

• Zero Order
o The drug conc changes with respect to time at a constant rate
o It is independent of conc of reactants
• First order
o Rate depends on first power of conc of a single reactant
o Drug conc reduces exponentially with time
o Formulas:
 T1/2 = 0.693 / k
 T90% = 0.105 /k = 0.152 x t1/2
o Insert Image of formulas (pharmacokinetics calculations)

Questions
• A specific dose of drug X is given q6h until steady state levels are reached. At
steady state, the AUC for one dosing interval is 72 mg/L/hr. what is the average
concentrations over that interval?
o Every 6 hours they give 72 mg/L/hour. So if (72 mg/l/hr) / 6 hr = 12 mg/l
 With this we are assuming that 72 mg is given every 6 hours. And that
the 72 mg dose elapses over 6 hours equally. So 12 mg/l concentration
is released each hour.
 Css = AUC / T
Css = 72 / 6 = 12
• If the bioavailability factor (F) for a drug substance in a dosage form is 0.50, how
many milligrams of drug would be available for absorption from a 100 mg tablet
of a drug.
o F = 0.5 – meaning 50% is cleared, 50% absorbed
o 100 mg tablet  50 mg available for absorption PO
• If the bioavailability of Drug A in a 0.5 mg tablet is 0.60 compared to the
bioavailability of 0.75 in a liquid form (0.05 mg/ml), calculate the dose of the
elixir equivalent to the tablet.
o Tablet 0.5 mg – bioavailability 0.6  get 0.3 mg with every dose
o Elixir 0.05 mg/ml – bioavailability 0.75  0.0375 mg/ml
o We need to take 0.3 mg of drug, therefore
 0.3 mg / (0.0375 mg/ml) = 8 ml
o We need to take 8 ml of the elixir
• If the AUC for an oral dose of a drug administrated by the tablet is 5 ug/ml/hr, and
the IV dose is 12 ug/ml/hr, calculate the bioavailability of the oral dose of the drug
o 5 / 12 = 0.416
• A patient received a single IV Dose of 400 mg of drug x that produced an
immediate blood concentration of 8.0 ug of drug per milliliter. Calculate the
apparent volume of distribution
o IV dose = 400 mg, blood concentration = 8.0 ug/ml
o C0 = D /Vd
8 = 400 / Vd
Vd = 400 / 8
Vd = 150 L
o Should convert mg to ug. And then ug/ml to ug/L but end up crossing out in
this case
• 12 hours following the IV administration of a drug, a patient weighing 80 kg was
found to have a drug blood level concentration of 10 ug/ml. assuming the apparent
volume of distribution is 10% of body weight, calculate the total amount of drug
present in body fluids 12 hours after the drug was administered.
o Pt wt = 80 kg; C = 10 ug/ml ; Vd = 10% of 80 kg = 8 L
o C0 = D /Vd
10 = D / 8
D = 80 g
o Should convert ug/ml to g/L.
• Drug A has been administered to a patient weighing 80 kg. determine the half life
of a Drug A whose volume of distribution of 0.5 L/kg and gives a clearance of 5.1
L/h
o Wt = 80 kg; t1/2 = ?; Vd = 0.5L/kg *80 = 40L; Cl = 5.1 L/h
o K = Cl/ Vd
K = 5.1 / 40
K = 0.1275
o T1/2 = 0.693 / k
T1/2 = 0.693 / 0.1275
T1/2 = 5.43
• Determine rate constant for drug A following first order kinetics, when
administered initial concentration was 50 mg/dL and after 5 hours the
concentration was determined to be 35 mg/dL
o Get answer from Nada
 Management
Why do we open up a pharmacy?
• Patients
• Money!
• Self-fulfillment (satisfaction in what you do)
• Greater “control”
• Innovative pharmacy systems development
o A lot of pharmacists have great ideas to move away from technical duties to
better save the patient in new ways. They are playing a bigger consultative
role.

Type of Community Pharmacies

• Clinic Pharmacies
o Smaller in size, focus on pharmacy aspect not on front store.
o What you’d find in a walk-in clinic
• Independent Pharmacy
o Sole proprietorship (only one or few honors)
• Retail Pharmacies
o Part of a retail outlet (ex: Loblaws, metro, etc.)
o Banner/Franchise Pharmacies (Ex: IDA, Shoppers Drug Mart, Guardian)
o Co-operative (Ex: Pharmasave)
• Chain (corporate) Pharmacies
o Corporately owned, not franchised
o Have individual managers
o Eg: Rexall, Pharma Plus

Starting the business – the building blocks of a pharmacy

• Marketing
• Operating
• Financing
• Staffing
• Managing
• Organizing

Why are we spending time to talk abut this?

• Have to operate organizations to provide drug therapy and patient care to pubic
• As pharmacists, we need to know how everything works
• This is our aim in management discussions
• Pharmacy is dynamic

How can we make our pharmacy grow?

• Good management
• Good people
• Good marketing
 • In both community and hospital? YES!

Managerial Mistakes
• These are things that a pharmacy manager should not do
o Failure to delegate
o Failure to keep learning
o Lack of accountability
o Lack of knowledge of the business
o Lack of vision
o Can’t build teams
o Failure to make decisions

What makes a bad manager?

• Bias
• Secrecy
• Oversensitive
• Stuck on procedure (not allowing for dynamic change)
• Stuck on trivia (stuck on one specific thing, don’t look at big picture)
• Selects weaker candidates
• Misses deadlines
• Delays decisions
• Hesitant in hiring former employees
• Works long hours

Business Structures
• Is there a better form out there?
o Every structure has pros and cons – depends on situation
• What about for a community pharmacy?
• How do you determine what structure is best for you?
o Owner’s Needs
o Legislature
o Etc.

Forms of Business Organization

• Sole Proprietorship  one person owns it and usually manages it
• Partnership  when 2 or more people involved as co-owners
• Corporation (private/public)  a legal entity separate from the owners

Sole Proprietorship
• Legally, the owner (proprietor) is the same as the business (one in the same)
o Therefore, there’s UNLIMITED liability
• Responsible for all debts and obligations
o Therefore a creditor can make a claim against your assets (personal or
business)
• Pros
 o Easy and inexpensive to start
 Only need to register the business name provincially
o Dicrect control – autonomy
 Deciions
o Less working captal needed
 You need less money to start because it is easier to start
• Cons
o Unlimited liability
 You and the business are one
 Have to use personal assets to pay off business debts, if needed
o The profit from business, if goes towards personal income, taxed at a higher
rate
 If you are taxed as a cooperation you pay less than income
o Lack of continuity
 Succession plan – if you are the sole proprietor you will have to find
someone to pass it onto, sometimes difficult.

Partnerships
• Good option if you want a partner, and you do not want to incorporate yourself
• Easier to raise funds
o Combined financial resources
• Partnership agreement
o Can stipulate whatever you want
• Get a share of the profits
• 2 types of partners: general and limited
• Limited liability partnerships (LLP)
o Don’t have the same control and privileges as a general partner, but only
liable to the amount they invested
o They also don’t have as much say – cant tell anyone what to do
• Pros
o Easy to start, relatively
o Can distribute or share the costs with your partner
o Profits go to owners
o Can have equal share in profits/assets
o Better tax rate
o Easier to manage
• Cons
o Unlimited liability (just like in sole-proprietorship)
o Hard to find the perfect partner!
o Financially you’re labile
o More complex to dissolve

Corporations
• To “incorporate” yourself
• Done on federal or provincial level
• The business (or corporation) is a separate legal entity
 o Separate from the owners/shareholders
• As a shareholder, you are not liable personally
o Don’t have to use personal assets
• Can be public or private
o Crown? A corporation owned by the government
• Can be the big or small scale
• Pros:
o Limited liability!
o Can transfer ownership
 Shares
o Easier to continue the lie of the business
o Separate legal entity
o Ease of raising capital
o Tax advantage
o Attract specialized skills and management (because they are established
people come to them)
• Cons
o More regulations
o More expensive to incorporate
o Complicated to start and regulated
o Conflicts between shareholders and board of directors
 Have to please the shareholders
 How can this affect community pharmacy?
• If the decisions are made by non-pharmacists it may not be for
the best interest for the pharmacist

Cooperatives
• The business is owned by its members
o An association
• Least common form
• Appropriate when you want to pull all your resources in the same “pot”
o Common needs are fulfilled, like delivery, sale and employment
o Happens a lot in agricultures
• Managed by a board elected by the members
o Example in pharmacy? Pharmasave
• Pros:
o Owned and controlled by its members
o Voting system (one member = one vote)
o Limited liability
o Profits are distributed amongst members
• Cons
o Conflict between members
o Decision-making process can be longer
o Need the members to participate
o Profits are distributed
o May feel less incentive to reinvest back into the cooperative
Franchise
• The company gives you the right or a license, to run a business under their name
(brand)
• These are established operating rules and methods
• There’s a fee (royalties)
• It’s a style, not a form of ownership (you don’t own the company)
• Pros
o Provides resources (the company does the work for you)
 Site, lease negotiation, design, pricing, policies and procedures, buying
power (bulk), monitors inventory as well
o Can rely on an established name and reputation
o Customer recognition
o Access to consumer data and research
• Cons
o The fees!
o Lack of proper support from the franchisor
o May be forced to pay for promotional material or activity
o Forced to take on reputation of other locations
o Intrusion

Financial Statement Analysis

• Crucial!
• Need to assess the performance of the business periodically
• Monitoring the cash flow into and out of the business
• Monitor the progress/growth of the business by coparing data from current year to
previous years and industry averages (benchmarks)
• We’re all working towards a profit

Importance of records
• Provides information
o Progress, ups or downs
o Catch and fix the problem before it gets worse
• Banks and lenders want information
o To help decide whether to lend or not
o If you’ll be viable enough to pay back the debt
• Tax purposes
• Auditing
• Valuation of practice
o Value of the pharmacy (need it if you’re selling)

Financial Statements
2 important ones:
Balance Sheet
Income Statement
Balance Sheet
• Basically picture of the financial position of a business in a point in time
o At a particular date
• Snapshot of the assets, liabilities and owner’s equity accounts
• Fundamental equation:
o Assets (A) = Liabilities (L) + Owner’s Equity (OE)
• Owner’s Equity – the personal …
Balance Sheet: The low down
• Assets: Cash, accounts receivable, inventory, etc.
• Liabilities: accounts payable ,loans, notes payable,
Fixed/ Current Assets and Liabilities
• Fixed assets
o Hard assets, eg equipment, furniture, etc.
• Current assets
o What you own and expect to own in 12 months
• Long term liabilities
o Debt which take > 12 months to pay
• Short term liabilities
o Must be paid within 12 months
Working Capital
• = current assets – Current liabilities

Income statement
• shows the change in retained earnings from one balance sheet to the next
• shows profit earned and contribution to owner’s equity.

Basic Income statement

Sales
- Cost of Goods Sold (COGS)
Gross Margin
- Expenses
Profit (before tax aka Net Income)
• How do we increase profit? Increase sales, decrease costs

Basic Income Statement: Components

• Sales = represents the base  100%
• COGS = approx. 65% of retail
• Gross Margin (GM) = Sales – GOCS ie. 35%
• Expenses  30% (ex)
• Profit (before tax)  5% (35-30%)

Price, Sales and Profit:

• Profit and loss statement
• Major components include:
o Gross sales
 o Net sales
o Cost of goods
o Cross margin
o Profit
o Expenses
o Net Earnings

Ordering Opening Inventory

• What are some things that will help you decide what to order?
o New or established practice – difference?
o Types of pharmacy (compounding pharmacy, is it in a derm clinic, etc.)
o Demographics
o Location (strip mall, neighborhood, etc.)
o Health institutions or clinics surrounding you
o Specialization of your pharmacy
o Shelf space
o Investment available
o Availability of drug

Where do we order our inventory from?

• Wholesaler (buy drugs from inventory for a certain price, raise it and sell it to us)
• Manufacturers
• Internal warehouse (if a company is big itll have its own warehouse)
• Group buying (like cooperatives)
• How do we order?
o By phone
o By computer
o By order entry device
• Why is it important to keep right inventory? Keep Patients!!

Inventory Management
• Involves systems and management in place to control, regulate, adjust and protect
inventory
• Have to maintain all levels of merchandise and goods
o Pharmacy, front stores, beauty, food, etc.
• Purchasing, receiving, stock, tracking protocols
• Returns
• Destruction and disposal
• Forecasting (Ex: long weekend, know you cant order for longer so order more to
be prepared – drugs people will NEED)
• Inventory control and audit

Taking Inventory
• PHYSICAL inventory is done on a scheduled basis (at least once a year)
• Pre-printed stock lists with price per unit are used record the actual counts
 • The value of inventory is determined by multiplying the price x count per unit.
• Process is audited by accounting firm

Inventory Turnover
• A quantitative measure, to see how well you are managing yur pharmacy inventory
• Basically, how many times, in a specified time, frame is yur total inventory (all the
drugs in your pharmacy, on your shelves) is replaced (so a rate)
o Often over the course of a year
• Turnover = relationship between cost of drugs (goods) sold and inventory)
• TO = Cost (of goods sold) / Avg. Inventory (at cost)
o Cost – found on income statement
o Avg Inventory– find average of the beginning inventory and ending inventory
of the time period (ie. Past year)
• What is the ideal TO rate?
o Is it good to have a high TO rate, like (10-12)per year? NO! Means you keep
having to order
o Is it good to have a low TO rate, like (2)per year? NO, means stays on your
shelf too long
o Ideal is 4 (can go a bit higher 4-6)
 Hospital Management
Important to know what hospital pharmacists do:
• Medication experts within the multidisciplinary health care learn
• Have access to patient-specific information, such as laboratory test result and
diagnosis
• Have access to colleagues to share info/expertise
• Document their activities and findings in the patient’s health record (progress
notes)

Hospital pharmacists
• Provide care in a variety of settings and specialties
• Long-term care services
o Complex continuing care
o Geriatrics
o Palliative care (end of life)
o Rehabilitation (post-surgery)
• Outpatient services
o Asthma management clinic
o Cancer care
o Home care
o Renal dialysis
o Diabetes clinic
• Preventative and health promotion services
o Immunization, etc.
• Other services
o Drug use evaluation (DUE)
 Evaluates benefits, risks, cost, research behind drug on a global level.
o Medication reconciliation
 “Best Possible Medication History” (BPMH)
o Provision of drug info
 Doctors can call in and speak to these pharmacists for dosing, etc.
o Research

Hospital vs. Community

• Hospitals are considered by some people to be very bureaucratic and complex,
competing for resources with nurses and physicians
• “Clinical” practice more established in hospital
o Meaning, pharmacist can do more “clinical” work with complex patients, you
have the time to use your clinical knowledge
• In General the depth and realm of concerns is different:
o For ex: safety – C. Diff, MRSA, death rates must be documented and
accounted for
The Challenge for a Hospital Pharmacist
• Finding niche and role in the department, ward. Or service assigned to …
• Each of the aforementioned areas are distinct, and requires a different variation of
clinical skills
• Challenge: understand and learn about your patients, and know what common
DRPs to look for and what interventions to employ

Role of Hospital
1. Patient Care: involves the diagnosis and treatment of illness and injury,
preventative medicine, rehab, etc.
2. Education: educating staff to provide better care, patients to are for their ailments
and educating HCP’s in order to train them to be competent professionals
3. Research
4. Public Health Promotion: assisting the community in reducing the incidence of
sickness and to increase the wellness of the population

Pharmacoeconomics
• Use this to make decisions

Role of the Technician to Providing Pharmaceutical Care

• Help the pharmacist in drug distribution duties
• First doses are usually checked by the pharmacists
• Pharmacists also check IV and chemo drugs
• Tech check Tech-all refill orders
• Technicians helps with filling of incident reports for mistakes outside the
pharmacy, discrepancy reports discovered in pharmacy and audits
• Dispensing and certified to double check unit dose and some I.V.s – delegated
• Certified to prepare injectable in a sterile environment including Chemo/TPN
• Packaging in unit dose
• Purchasing and inventory control
• Narcotic distribution

Hospital Pharmacy: Policies and Procedures

• Policy tells you what needs to be done, procedure says how to get it done
• These are important especially for new staff

Hospital Organization
• Complex organization structure similar to business corporation
• Board of trustees, comparable to Board of Directors, governs the hospital
• The broad is the executive body of the hospital and is responsible for the
establishment of the hospital’s by laws and policies
• Medical Advisory Committee (MAC)
o Appoints various medical staff to other standing or special committeees which
report directly to the MAC
o Eg. P&T committee, Quality Assurance committee, etc.
 • Pharmacy and Therapeutics Committee (P&T)
o Formal line of communication between the medical staff and the pharmacy
department of hospital
o Usually composed of at least 3 physicians, a pharmacists and a rep of nursing
staffs
o Role of committee
1. Evaluates and standardizes medication use within the hospital
2. Sets standards for drug use
3. Evaluates the ongoing use of drugs for effectiveness
4. Maintains the hospital formulary
• Recommend drugs to be added to the formulary
• DOESN’T decide – MAC does this!

Common Drug Policies in Hospitals

• Medication order
o Important requirements or components which make up a complete order:
 Patient info
 Medication information (name of drug, strength directions, etc.)
• Therapeutic substitution
o Also known as automatic substitution
o P&T committee develops policies. MAC has to approve them
o To avoid duplication of medications
o Is a medical approved policy that provides for automatic dispensing of a
particular drug in place of a therapeutically different but similar drug product
o Have a list of drugs and substitutions which can be made
• Automatic stop policy
o AKA automatic stop order
o Therapy of certain drug classes are automatically stopped after a fixed
duration (so unless doctor says continue, stop the drug)
o Some examples: for antibiotics, narcotics (other controlled substances),
anticoagulants, antipsychotics, sedatives, hypnotics, anti-diarrheal, ketorolac
(used for short time frame – max 5-7 days, usually 10 mg qid  fear of
kidney failure),
o IV  PO
 Called “step down”
 Why do we have this? Cost savings, PO high availability, ease of use,
less administration time
 Clinical situation? Infectious diseases, anticoagulants (heparin to
warfarin). Pantoprazole is available as IV, use for 72 hours for severe
cases then drop down to PO
 Some markers to look for:
• At 2 days of IV antibiotics
• Afebrile for last 24 hours
• Able to take oral medication
• Negative blood cultures
 • Not being treated for endocarditis, CNS infections, abscess,
febrile neutropenia (cancer patients)
 The same thing applies for IM Drugs
• Formulary
o Purpose: improve the quality of care and to restrain health care costs
o Lists of drugs patients in hospital are eligible to receive
 Up to date in that hospital, based on clinical judgment of P&T
committee and medical staff
o Informs physicians, pharmacists and other health care professionals as to
policies and procedures associated within the availability of drugs in the
hospitals
o Benefits
 Therapeutic: most effective and efficient products are listed and
therefore available
 Economic: eliminates duplication, reducing inventory duplication and
increasing the opportunity for volume purchasing
 Educational: contains info for prescribing and drug use
o Exceptional cases
 Patients may require medications not readily available in hospital –
and often hospital pharmacists are responsible for securing these
medications after reviewing their need
• Eg: Emergency release drugs – via Special Access Program
Medications (drug then goes to inpatient pharm or hospital)
o Non-Formulary Drugs
 Drugs that are commercially available but not included in hospital
pharmacy
 Will not be dispensed unless the physician orders the non-formulary
drug for a specific patient by use of a special non-formulary drug
request form
• If the request is accepted then it is covered
• If pharmacist gets the form, first check the substitutions and try
to give the option to physician
 Physician must provide info to pharmacists regarding the pt receiving
these drug(s) and the reason for use
 Alternatively, the patient’s family might buy the med for patient and
bring it to hospital
o Adding to the Formulary
 P&T committee will have large part in this (provide suggestions,
recommendations)
• Medical directives
o Allowed for implementation of orders as well as method to delegate a
controlled act from health professional to another
o Common in hospitals, but can now be outside of hospitals as well
o In order to delegate or to accept delegation, pharmacists must ensure that the
following principles are met, that is, in summary:
  The procedure being directed or delegated is clinically appropriate and
in the patient’s best interest
o The delegator (authorizer) and the delegate (implementer) have the
competency (knowledge, skills and judgment) to perform the acts or tasks
 If something goes wrong, they both are accountable!!
o In assessing performance readiness, the authorizer and implementer need to
ensure that the procedure will be performed competently and that the
outcomes will also be managed appropriately

Important Because
• Increasing costs of providing the service as well as the cost of drugs
• Increasing demands for accountability including risk management and patient
safety

Statistics
• ADR rate – many preventable, main causes of ADR’s
• Drug costs
• Health care expenditures
• Total health expenditure by use of Funds, in Canada
o 1. Hospitals
o 2. Drugs
o important!

Definitions
• Adverse Drug Reaction (ADR)
o Any noxious, unintended and undesired effect of a drug which occurs at doses
used in humans for prophylaxis , diagnosis or therapy
o Excludes: therapeutic failure, intentional/accidental poisonings, drug abuse,
medication errors in administration (too much/little drug), drug interaction,
noncompliance
• Adverse Drug Event (ADE)
o ADR in addition to medication errors (errors in prescribing, dispensing,
patient adherence, and monitoring)

How Do You Prevent ADE

• Important to understand the different stages at which ADE’s can occur:
1. Prescribe (collaborate with MD)
2. Transcribe (make sure writing is legible)
3. Dispense
4. Administer
5. Monitor
• Importance of:
1. Communication
2. Policies and procedure
3. High alert drugs
4. Recognize patient populations most at risk
Reducing ADEs
• Medication reconciliation: A formal process of obtaining a complete and accurate
list of each patient’s current home medications – including name, dosage,
frequency and route = Best Possible Medication History (BPMH)
o Very important in the emergency room!!
• Comparing the physician’s admission, transfer, and/or discharge orders to that
BPMH list
o This is an extremely valuable way to avoid ADEs at all points!!! (Admission,
transfer and discharge)

Reporting Med Errors

• Hospital Pharmacy Department
• ISMP Canada (Institution for Safe Medical Practices)
o Voluntary, don’t have to report.
o Non-punitive
o Also applies for community pharmacies as well
• Canadian Society for Hospital Pharmacists (CSHP)

Purchasing and Inventory Control

• Contract administration
• Purchasing procedures
• Receiving product …

Workload Measurements
• Drug Distribution
o Raw counts – number of drugs dispensed
o Standard time measurements
• Clinical Activities
o Raw counts – med recs, pt counseled
o Actual time counts
o Management tool around resource allocation
• Should provide the following information
o The workload demands placed on the pharmacy department
o The amount of time (input) spent on various department activities
o The index of pharmacy productivity
o The optimum number of employees that are needed in the department
 Pharmaceutical Calculations:
rd
3 Part Reimbursement and Claims
How do people pay for their drug?
• Out of pocket (cash)
• Insurance plans or 3rd party plans
o Is the government plan also a kind of insurance plan? Yes
o Private vs public

Important Concepts
• Plan sponsor
o A group that is covering the cost of the insurance or health plan
o Ex: a company or employer
• Plan member
o The patient or individual who gets these benefits
• Plan administrator
o The insurance companies which are chosen by the employer, eg. Manulife,
Sunlife
o Companies contract out to these administrators for insurance
• 3rdParty Reimbursement
o Copay
o Deductible
o Professional fee cap
o Total yearly cap
• What is a “claim”?
o What the member sends for reimbursement to insurance plan (ex: prescription,
receipt from dental care, etc.)
o Usually done electronically or manual submission via mail
• Co-pay or co-payments
o A portion/percentage of amount that the cardholder needs to pay along with
third party
o Usually a fixed amount
o Co-pays are there to make people more cautious. If prescriptions were
completely free, people would be more likely to be wasteful with the
prescriptions they get
• Deductible
o An amount that needs to be paid by cardholder before benefits get
activated/kick in
• Professional fee cap
o Third party puts a cap on max. professional fee it will pay. Beyond that
cardholder needs to pay
• Total yearly cap
o The maximum dollar value per year that third party will cover. When
exceeded, cardholder needs to pay the exceeding amount
Other information about insurance plans
• Usually cover the generic drug
o May cover the brand, if the prescriber does what? Only will cover the brand if
the doctor demands no sub
o Most cases however, the patient pays the difference between generic price and
brand price, if they want the brand drug
• Most plans do not cover “life style drugs” (weight management, erectile
dysfunction, smoking cessation, etc.), NHPs, vitamins, OTCs, herbals
• Usually, the max supply a person can get at a time is 100 days worth of a
medication

Calculations
• Mr. XY brings in a new prescription to Pharmacy. The cost of the Rx is $150. It’s
a first Rx of the year for patient. The plan benefits kicks in after payment of $100
deductible. The plan pays 90% of the cost of Rx. What would be the amount
payable by XY on this prescription?
o Cost of Rx: $150. Deductible (paid by patient) = $50: amount for which
coverage applies
o 90% coverage: 50 x 0.90 = $45
o Copay = $50 – $45 = 5$
o Total payable: $100 + $5 = $105
• If there is no deductible to be paid, how much is XY paying for his rx?
o Paying 10% of $150. $150 x 0.10 = $15
• After a month, Mr. XY comes to pick up the refill and the cost is the same, $150.
How much does he pay?
o $15! (Same as question before)
• There is a change in 3rd party plan. Now, they introduce $5 professional fee cap. If
the new Rx is $150 which includes $10 professional fee, how much would Mr. XY
be paying for his Rx?
o $10 professional fee: $150 - $10 = $140 (Patient has to pay $5, because
insurance will only cover $5)
o 90% coverage, so patient pays 10%: $140 x 0.10 = $14
o Total payable: $14 + 5 = $19
• By December, Mr. XY bought drugs worth $4800 the plan has cap of $5000 per
year. The next Rx he brings costs $800 including cost of professional fee of $10.
At 90% coverage, how much money he has to pay for this coverage?
o $800 - $10 (professional fee) = $790 (cost of Rx)
 Patient pays $5 of professional fee (of the $10 fee)
o Plan will cover 90% of $200 (to reach $5000 cap), patient pays 10%:
 $200 x 0.1 = $20
 $790 - $200 = $590 (amount untouched by insurance)
o Total payable: $590 + $20 + $5 = $615
 Medication Safety
Adverse Reaction (AR)
• What is it?
o Unintended and undesirable effects secondary to health products (drugs,
medical devices, natural health products)
• Could cause hospitalization, malformations, disability, or death
• Post-market surveillance is required based on Food and Drug Act and Regulations
• How are ARs detected?
o Patients, health care professionals, manufacturers, regulatory bodies
o Reporting
 Voluntary reporting
 Post-marketing surveillance by manufacturers
o MedEffect Canada  for reporting ARs (IMPORTANT! KNOW IT!)
 By consumers, industry, professionals
 Via fax, online, telephone
 More information found in the CPS (appendix)
 Sole purpose is for dealing with ARs
• What if...
o A mistake happens, even if nothing happens should address it.
o A mistake happens but no one notices?

Institute for Safe Medication Practices (ISMP)

• Independent, not-for-profit
o Not collaborated with any government or provincial agency
• Collaborates with health are community. Regulatory agencies/policy makers,
industry and the public
• Error prevention
• Systems-approach instead of individual fault
o Finding problems in the system rather than blaming an individual at fault.
Firing one person for the fault will not fix it. They are moving away from
punitive consequences (firing pharmacist)
• Voluntary practitioner reporting system

How can we analyze this incident effectively?

• Errors occur at all levels of healthcare
• All staff, even the most experienced and dedicated professionals can be involved in
preventable adverse events

A Team-Based Process
• Multi-disciplinary process
• Those with direct knowledge of the event processes
• Those responsible for change
o Meaning, those that can impose a change or have an impact on the way we do
things (the manager/owner)
Multi-disciplinary Approac: key benefits
• Detailed exam by team often discovers new info not previously known

Medication Safety Example:

• Insulin dependent diabetic. Rx for Novolin ge 30/70 Penfill twice daily via insulin
pen. Patient obtained insulin Rx refill. Next morning, inserted new cartridge into
his pen. A short time later, patient found diaphoretic, pupils dilated, decreased
level of consciousness, glucose reading of 2.5 mm/L (normal 4-7).
o When insulin supply was checked, found 4 boxes of Novolin ge 30/70 and one
box of NovoRapid insulin.
o In this case, patient didn’t know that he was using rapid so took it without
food, and was hypoglycemic
Why did it happen?
• Reasons for incidents are multi-factorial
• Consider: system/process design, workflow, individual accountability (work
around)

Work-Arounds – “At Risk” Behaviors

• Natural tendency to take short cuts to make completion of tasks easier or increase
efficiency
• Workarounds occur when a procedure or action does not fit the workflow

Why did it happen?

• What other info do we need?
o Look alike medication (can I see where it is scored, is there a high chance of
wrong one picked it). Staffing (are there enough staff around when
• Who should we talk to? Manager
• Who should participate in root cause analysis? Those directly involved, managers
• What can you do to prevent it?
o Tagging it, bright stickers to alert person picking it, separate products

Steps to Identify/Avoid Errors

Step 1: Identify the Problem
Step 2: Develop causes (Ex: look-alike packaging, bar coding scanning did not detect
error)
Step 3: Complete the diagram (Ex: identify possible problems)
Step 4: identify the root causes (These are the reasons that contributed in a multi-factorial
way to the error)

Is this a root cause?

• Bottom line question: if this factor was eliminated, would this problem happen
again or avoided

Safety Strategies
• Eliminate  Remove the hazard
 • Control  Provide safeguards
• Accept
o Not an option! If a serious hazard is identified, the minimum strategy is a
controlled measure

How can we reduce the likelihood of a recurrence?

1. Forcing functions and constraints
2. Automation/computerization
3. Simplification/standardization
4. Reminders, checklists, double checks
5. Rules and policies
6. Education and information
Lower leverage strategies:
• Educate staff about high-alert medications and the need for additional safeguards
with these items
Higher leverage strategies:
• Use technology
• Implement barcode scanning of every item dispensed
• Enhance differentiation
o Review storage options – segregate short, intermediate and long acting
insulin’s in fridge
o Consider warning labels

• RCA: is a retrospective technique

• FMEA: is a prospective technique!

Failure Mode and Effects Analysis (FMEA)

• FMEA is a team-based systematic and proactive approach for identifying:
o Ways that a process or design can fail
o Why it might fail, and
o How it can be made safe

FMEA Steps
1. Select process and assemble team
2. Diagram the process
3. Brainstorm potential failure modes and determine their effects
4. Identify the cause of failure modes
5. Prioritize failure modes
6. Redesign the processes
7. Analyze and test the changes
8. Implement and monitor redesigned processes
 Evidence Based Medicine
Evidence Based Medicine (EBM)
• What is it?
o Interaction of best research evidence with clinical expertise and patient values
• Why is it important?
o We have a daily need for valid information
o Traditional forms of information has limitations
 Traditional forms – books. Information is not updated quickly enough.
Practice changes constantly
o With experience, we rely on judgment so we need the most up to date
information

How do we practice EBM: 5 Steps

1. Define the question
2. Collect the evidence to answer the question
3. Critical appraisal = formal evaluation of the evidence gathered
o Just because you read something doesn’t not mean its valid
4. Integration of info in daily practice
5. Evaluation of process an improvement for the future

Defining the question: PICO

• 4 steps: PICO
o P = patient/population (your patient)
o I = intervention (Drug A)
o C = comparison intervention (Drug B)
o O = clinical outcome (consequence or outcome)

Structuring a PICO Question

• If not sure of the comparator then the comparator could either be the current
standard of care or could even be nothing

Sources of Evidence
• Evidence Pyramid (in increasing importance of clinical decision making)
o Case Reports
o Case studies
o Cross-sectional surveys
o Case control studies
o Cohort studies
o RCTs
o Meta-analysis, systematic Review
• As we go down confidence, robustness, power of study increase

Important Definitions and Term

• Baseline characteristics:
 o A set of characteristics or variables collected or measured before the trial
intervention is started
o Ex: age, co-morbidity, etc.
• Controls:
o If a trial is “controlled” = the treatment group is compared to another group
 There to avoid or reduce bias, treatment group is compared to control.
o Placebo-controlled: the treatment group is compared to group receiving
“inactive” treatment
o Active-controlled: the treatment group is compared to the treatment already in
practice
• “Arms of the trial”
o The study groups are split into 2 different groups or “arms”

Sources of Evidence
• Systematic Review
o Formal method to review articles in literature on a particular topic
o Published and unpublished trials
 Unpublished trials may have shown drug in a negative light, important
to include. We don’t care about companies, we want to be thorough.
 Pubmed is based in North America. M-base has studies outside North
America. We want studies outside of the country we are talking about.
 Consider interviews with the publisher of study, they’ll mention things
they did or did not do in the trial
o Reproducible, summaries
o This is the most robust and powerful analysis you can get!!
• Meta-analysis
o Combines several randomized control trials (RCTs) to derive a single
numerical estimate of the result)
 Different journals will do different studies, we want to make sure
baseline characteristics are the same. If you have 10 different RCTs
that had the same control, trial, etc. we can combine them
 Why would we do that?
• Increase sample size. When we do that it lowers variability. It
also increases representation of population.
• More robust and more powerful. In the end we have a single,
numerical estimate. This is a quantitative estimate
• Practical reason: instead of going through ten separate RCTs,
we go through one meta-analysis.
• Randomized Control Trials
o Gold standard
o Ideal for assessing relative effects of drugs
 Very simple – 1 drug, 1 group, 1 control, outcome and measure it.
Tells us if it works or not.
o Have control and treatment groups
 Randomized! Decreases bias! Not just by chance that this drug is safe
 • Cohort studies (cohort – group with similar characteristics)
o Observational, over long periods of time
o To detect complications, new events
o Follow 2 groups and observe
 One with drug, one without drug
o PROSPECTIVE (looking into future!)
 This is a good way to assess risk factors! If one group has higher
incidence of a disease, side effect, etc. then we can look at what was
different with that group
• Case Control Studies (not randomized – subject to bias)
o Selecting patients with a specific disease
o Looking at past data to determine causation
o Takes shorter time period to complete
o RETROSPECTIVE studies
 Ex: hospital admin looking at everyone that died of sepsis. Look at
records, chose patients based on cause of death, and see what is going
on.
• Case series and Case Reports
o Case series – group of people. Case report – one person
o Case report – detailed report (diagnosis, sign symptoms, disease, treatment,
etc.) on one single patient.
 Only used for rare diseases, things that happen one in a million

Sources of Error
• Selection of study participants
• Classification and measurements
• Comparison and interpretation

Important to keep in mind!

• Accuracy: lack of error – getting the correct result
o If you are accurate, there is no discrepancy between theoretical result and
observed result
• Bias: systemic error – independent of study size
o Bias is tendency to do something. Occurs even if you increase sample size
• Error: discrepancy between the observed result and the true value
• Precision: absence of random error
• Reliability: repeatability of a measure
o Can count on it occurring over and over again
• Validity: absence of bias (or absence of all error)

Bias
• Bias = a prejudice or preconceived notion about what should happen
• Different sources of bias
o Selection bias
o Publication bias (most difficult to overcome)
 • Systemic reviews: publication bias is the most difficult type of bias to overcome in
this study design

What is selection bias?

• In assessments of the validity of studies of healthcare interventions, selection bias
refers to systemic differences between comparison groups in prognosis or
responsiveness to treatment
• Random allocation with adequate concealment of allocation protects against
selection bias
• Should be no difference when you select people!!

What is publication bias?

• Systematic reviews aim to find and assess for inclusion all high quality studies
addressing the question of the review
• But finding all studies is not always possible and we have no way of knowing what
we have missed
• Many researchers have shown that those studies with significant, positive, results
are easier to find than those with non-significant or ‘negative’ results
• The subsequent over-representation of positive studies in systematic review may
mean that our reviews are biased toward a positive result

Results
• P-Value
• Confidence Interval (CI)
• Absolute Risk Reduction (ARR)
• Relative Risk (RR)
Relative Risk Reduction (RRR)
• Number Needed to Treat (NNT)

P-value
• P-value = statistical significance
• P < 0.05 – indicates a true difference between the 2 arms: indicates a statistically
significant result
• The smaller the P-value the more likely the result is not due to chance
• P > 0.05 = no difference between the 2 arms; any difference may be due to chance

Confidence Interval
• Validity
• CI = the precision of the results
o Used with ARR, RR, RRR, and NNT
• The wider the CIs, the less precision there is in the results
• Practitioner must decide if it is clinically significant

Results (THESE ARE IMPORTANT!!)

• A = risk without treatment
 • B = risk with treatment
o BOTH EXPRESSED AS PROPORTIONS
• Absolute Risk Reduction (ARR) = A – B
• Relative Risk (RR) = B / A
• Relative Risk Reduction (RRR) = (1 – RR) x 100%
• Number Needed to Treat (NNT) = 1 / ARR

Null Hypothesis
• To test whether a pattern exists in a set of data, you propose a NULL
HYPOTHESIS that the pattern does not exist
• (1) Assumption where an observed difference between two samples of a statistical
population is purely accidental and not due to the treatment
• (2) The hypothesis to be investigated through statistical hypothesis testing so that
when argued against, it indicates that the alternative hypothesis is true
• Meaning:
o We accept the null when the P-value is >0.05. If null is accepted, results is not
statistically significant, meaning drug does not do that, it is by chance
o if we reject the null hypothesis, we accept the alternative, meaning drug
works!

Statistical Errors (IMPORTANT!! – there will be questions!) To Remember:

Type I –RN (Reject Null) à FP
• A Type I Error (alpha) Type II – AN (Accept Null) à FN
o Also known as a ‘false positive’ Doing the opposite creates the error
o Incorrectly rejecting the null hypothesis in favor of the
alternative
 So in reality, drug does not have effect, but company said it worked.
This is a FALSE POSITIVE.
• A Type II Error (beta)
o Type II error, also known as a false negative
o Opposite of a Type I error
o False acceptance of the null hypothesis
 In this case, they should have stated that the drug does work, they
shouldn’t have rejected the alternative hypothesis (accepted the null).
 This may happen when we’re investigating side effects. Ex: found out
drug that causes liver failure, but we accept the null saying it doesn’t.
that is a FALSE NEGATIVE!
Statistical Errors
Statistical True state of the Null Hypothesis
Decision
H0 True H0 False
Reject H0 Type I Error Correct

Do not Reject H0 Correct Type II Error

 Drug and Practice Information
Type of References
• Primary
o Latest information, in scientific journals
o Trials, new studies.
o This is the NEWEST INFORMATION!
• Secondary
o Database of primary literature
 Basically gateways to primary literature!
o Eg. Medline, PubMed, EMBASE
• Tertiary
o Text books, physically you can open

Process of looking up information

• Determine the type of info required
• Start with tertiary source
• If needed, use secondary sources to identify primary sources for specified
questions
• Select primary sources for specific questions
• Select primary sources studies/articles, and critique

Examples of Secondary Sources

• Medline
• PubMed
• EMBASE
• The Cochrane Library
• Clinical Evidence

Medline
• U.S. National Library of Medicine (NLM)
• Database of citations and abstracts in various fields
• Major source of biomedicine information going back to 1950s
• Broad subject coverage
o Biomedicine and health
o Life sciences for biomedical practitioners
• North American emphasis; majority English language publications
• Available in 2 interfaces
o PubMed (more up to date and free!)
o Medline Ovid (easier to search, subscription)
• Are PubMed and Medline separate?
o NO! Medline is part of PubMed

PubMed
• Gives free access to Medline
 • National Library of Medicines (NLM) interface to Medline
• Links to full-text articles
• Search filters for Clinical Queries and Special Queries
• Free service maintained by the National Center for Biotechnology Information
(NCBI)

EMBASE
• Comprehensive online database
• Provides data from outside of North America
• Provides articles not found on Medline
• Biomedical and pharmaceutical information (excellent for drug literature)
• Product by Elsevier (science and health information publisher)

The Cochrane Library

• Collection of 6 databases
o Cochrane Database of Systemic Reviews
o Cochrane Central Register of Controlled Trials
o Cochrane Methodology Register
o Database of Abstracts of Reviews of Effects
o Health Technology Assessment Database
o NHS Economic Evaluation Database
• Independent evidence and review
• Evidence-based medicine databases
o Important for healthcare decision making
• Available in 2 interfaces
o Ovid
o Wiley (more up to date)

Clinical Evidence
• International source of data for decision making
• Under the British Medical Journal
• Summarizes current knowledge and uncertainty about prevention and treatment
• Based on searches and appraisals of systematic reviews, RCTs, observational
studies

Micromedex 2.0
• By Thomson Reuters
• Evidence based clinical reference
• Comprehensive information (concise and detailed information)
• Good information on pharmacology, mechanisms of action
• Drug, disease, toxicology, patient information
• Mobile application
• Easy to search database
• Not a secondary database per say, but is great database
Examples of Tertiary Sources
• CPS
• Martindale
• USPDI
• Therapeutic Choices
• Patient Self-Care

Compendium of Pharmaceuticals and Specialties (CPS)

• Information about drugs in Canada
• Approved indications (on-label uses)
• Drug monographs
o Prescribing considerations
• Product identification (Brand Name)
• Excipient information (eg. Lactose, gluten)
• e-CPS has patient information
o For counseling aid, info for patient
• When to use CPS?
o Can also remember it as Common Pharmacy Stuff!
• What does it contain?
o Glossaries (abbreviated terms, etc.)
o Discontinued products
o Brand and Generic Products (Index is the GREEN section)
o Therapeutic Guide (PINK section – disease or meds grouped together)
o Product identification Section (IVORY section)
o Directory (Poison control, Manufacturer info, Health Organizations, etc.)
 YELLOW section
o Clinical information
o Monographs
o Appendices (Narcotic drugs, ADR forms, special access programme, etc.)
• Other important things it has:
o Lilac pages: Drug and Food interactions, Drug and Grapefruit interactions,
Drugs containing lactose, Drugs containing sulphites
o Immunization information
o Lab reference values
o Drugs in Pregnancy and Lactation
o Drugs in Dentistry

• e-Therapeutics+
o Electronic data based on CPhA
o Based on information published in the Therapeutic Choices (tertiary)
o Main resources
 Therapeutics
 e-CPS
 Drug interactions
 Information for patients
What is e-CPS?
• Web access to CPhA’s CPS
• Current, up-to-date information
o CPS physical book is published once a year
• Health Canada health advisories
• User-friendly search (faster!)
• Information for patients
o Printable sheets
o Supplements counseling
• Also maintained by the CPhA
• Becoming a more important guideline, and increased ease of use (electronic)
• Contents
o Drug monographs
o CPhA Drug Monographs
 Complied by the editorial staff of CPhA and reviewed by the CPS
Editorial Advisory Panel (contain information different from that
found in Health-Canada-approved product Monographs)
o Drug Updates
 Highlights information on new and revised products available in
Canada
• Clinical Info (Clin-Info)
o Calculations and dosing tools
o Monitoring tools
o Drug use guides (dentistry, pregnancy, breastfeeding, etc.)
o Drug Interactions with foods
o Ingredients
 Ethanol, gluten, lactose, peanut oil, soybean, tartrazine
• Directories (similar to physical CPS)
• Product Identification Tool
o Can choose from drop down options
o Eg. Dosage form, shape, color, imprint, scored, etc.
• Glossaries
o Latin Prescription Terms
o Medical Abbreviations

Martindale (Published every 3 years – info not very up to date)

• International reference by Pharmaceutical Press
• Brand names from other countries (foreign product inquiry!)
• Drug monographs
• When to use Martindale. It is unique because
1. It contains pharmaceutical data (eg. Chemical formula, stability, solubility,
etc.)
2. Most chapters begin with a disease treatment review
3. International drug proprietary names
Therapeutic Choices (TC)
• Basically gives information on “how to handle certain diseases/conditions”
• Comparison of different drugs (drug A vs. drug B)
o Often compare drug classes rather than specific drugs
• Useful when the indication is known
• Gives treatment recommendations
• Primarily MD authored
• When to use TC?
o When you know the disease state and a particular recommendation is to be
given
o For example: if the physician wants to know what is the best choice for otitis
media in a 3 year old if the patient has an allergy to penicillin

e-Therapeutics
• Easy and fast!
• Up dated information
o Highlighted in different color (green) and font
• Divided in topics
• Provides easy to browse information
• Based on tertiary TC source

Patient Self-Care (PSC)

• Used to help patients on selecting OTC products, non-drug measures
• Pharmacist-authored
• Addresses everyday issues community pharmacists are challenged with
• Has patient information which can be photocopied
• When to use PSC?
o When need to look up more information on issues handled by pharmacists
o It essentially guides the pharmacists as to the assessment questions (“red
flags”) to be asked to the patient, in order to narrow down the patients
condition and hence and accordingly recommend an appropriate
treatment/referral

USPDI
• United States Pharmacopoeia Dispensing Information
• Two volumes
o Volume I  drug information for health care professionals clinical
information (similar to the CPS): American information!
 They have on and off label use (for American and Canda)
o Volume II  “Advice for the patient”, not intended for health care
professionals, helpful for counseling on prescription drugs
• When to use USPDI Vol. II
o When you want to look up lay language terms and lay languge counseling
points for drugs
o “EASY TO understand” language
Guidelines
• Why do we have them?
o We’re striving for “quality healthcare”
o Effective, efficient, accessible, patient centered, fair, safe health care
o There are clinical gaps we have to fill
o Eg: suboptimal treatment of dyslipidemia, rheumatoid arthritis; improper
control of diabetes; overuse of benzodiazepines

CPG – Clinical Practice Guidelines

• Definition
o Systematically developed statements to assist practitioner and patient
decisions about appropriate healthcare for specific clinical circumstances
(handbook on clinical practice guidelines – Canadian Medical Association)
• Important to understand that they are still guidelines
o Don’t have to do exactly as they say but they are important!
• Important for pharmacists – especially for important chronic conditions

Canadian Hypertension Society

• www.hypertension.ca
• CHEP – Canadian Hypertensive Education Program
o Knowledge translation program that targets various healthcare professionals in
clinic and community settings
o Annually updated standardized recommendations and clinical practice
guidelines to detect, treat, and control hypertension
o 2012 marks the 13th consecutive year that CHEP has updated
recommendations for the management of hypertension

Canadian Diabetes Association

• www.diabetes.ca
• Canadian Diabetes Association
• Comprehensive information
• Published every 5 years
• Most current, evidence-based information (for prediabetes, Type 1, 2, gestational)

Practical use for guidelines: for preparation

• Warning: these guidelines present extensive info
• From diagnosis to follow up
• Focus on the drug therapy, places of therapy, first line, second line, risk
factors, special patient groups
• Use as a supplement to “traditional” study material
• For more associations and societies, see yellow section in CPS

Other references
• Drugs in Pregnancy and Lactation
o Briggs, Freeman, Yaffe
 • Pediatric Dosage Handbook
o Taketomo, Hodding, Kraus
• Drug Interaction Facts
o David S. Tatro
• Stedman’s Medical Dictionary for the Health Professions and Nursing

Drugs in Pregnancy and Lactation

• Briggs?? :
• Gives practical information about the use of drugs in pregnancy and breastfeeding
• Known/possible effects on the fetus
• Known/possible movements of drugs into breast milk
• Uses FDA Risk Factor scale
• Drugs, herbals, nutritional supplement
• KNOW the different pregnancy categories

Pediatric Dosage Handbook

• Detailed information about pharmacotherapy in pediatric population
• Dosing and dosage regimen information
• Updates on drug monographs
• Information on neonatal drug management/dosing
• Another good source for pediatrics: Sick Kids Guide (comes out every year)

Drug Interaction Facts

• Detailed information
• Explains the mechanism of the drug interaction
• Rating scale of the clinical significance/ severity of the interaction
• Documented effects and management options

Stedman’s Medical Dictionary for the Health Professions and Nursing

• Good source for general information on medical terms
• Definitions of diseases, symptoms, anatomical and biomedical terms
• Diagrams on select terms
• 54 000 entries

AHFS (very important in the states!)

• AHFS = American Hospital Formulary Service
• Published by the American Society of Health-System Pharmacists (ASHP)
• Evidence-based, peer-reviewed
• No bias from industry, drug insurers, etc
• Contains monographs (detailed information) – of drugs from the US!)
o Drug interactions, adverse reactions, cautions, toxicity, pharmacology, etc.

Motherisk (The Hospital of Sick Children)

• www.motherrisk.org
• Excellent resource of patients and health care professionals for
 o Drugs and pregnancy
o Drugs and breast feeding
• Public helplines
• Publication also (tertiary and primary)
• Dr. Gideon Karen

Rx Files
• Academic detailing for heath care professionals
o Academic detailing – a look at all medications by topic!
• Based in Saskatoon, Saskatchewan
• Evidence-based and clinically relevant drug comparison charts
• Good, concise, practical information
• Supplement to learning from TC

Next few don’t have to worry about and know as well as previously stated …
They are not REFERENCES!

DIRC
• = Drug Information and Research Center
• Pharmacist operated (run by the OPA)
• Annual subscription
• Call in drug information questions, where you have a live agent looking up the
answer for you
• Also access to online databases, resources, etc.

Other References
• Health Canada (website)
• “Manufacturer’s leaflet” vs. Drug Monograph
• Canadian Pharmacist’s Letter
• Canadian Pharmacists Journal (CPJ)
• Pharmacy Practice
• The Merck Manual
• Remington
• Natural Medicines Comprehensives Database
• Compendium of Self-Care Products

Health Canada (website)

• Lots if information!
• Drugs and Health Products
o Advisories, warnings, recalls
o Biologics
o Compliance and Enforcement
o MedEffect Canada (adverse effects)
o Medical Devices
o Natural Health Products
 o Vet Drugs
o Special Access to Drugs

“Manufacturer’s Leaflet”
• Often, the information included in boxes or bottles of medication
o Often meant for pharmacists to give to patients
o Eg. Yasmin, Crestor, Xalatan, Lipitor, Nasonex, etc.
• Not really considered a resource or reference
• Often a supplement to pharmacist counseling and intervention
o Eg. Directions of use ,common side effects, etc.
• Manufacturer’s leaflet vs. Drug Monograph (by manufacturer)

Drug Monograph (manufacturer)

• As per Health Canada regulations
o Guidance document
• What is a product (drug) monograph
o Factual, scientific document on the drug product submitted by the
manufacturer
o No promotional material
o Describes: properties, claims, indications, conditions of use, etc.
o Basically, everything needed for the safe and effective use of the drug
• Uses and limitations

Main components of a Drug Monograph: 3 Parts: I, II, III

• Part I – Health Professional Informational
o Pharmacology, indication and clinical use, contraindications, warnings and
precautions, adverse reactions, drug interactions, dosage and administration,
overdose, storage and stability, dosage forms, composition, packaging
• Part II – Scientific Information
o Pharmaceutical information such as structure, molecular weight
o Clinical trials, efficacy and safety study, pivotal comparative bioavailability
studies, detailed pharmacology (animal testing, teratogenicity, etc)
o Microbiology, toxicology, references
• Part III – Consumer Information
o No copyright laws for this part (therefore can copy)
o General disclaimer about this medication
o Warnings and precautions, interactions, proper use, side effects and what to do
with them, storage, reporting suspected side effects

Canadian Pharmacist’s Letter

• Subscription service for pharmacists
o Access with Ontario Pharmacists’ Association membership or other provincial
professional bodies
• Covers new developments in drug therapy
• Highlights new trends in pharmacy practice
• Concise updates and advice
 • Independent publishing
• More for continuing education, rather a reference for drug information question

Canadian Pharmacists Journal (CPJ) (not a reference)

• Established in 1868
• Professional development
• Peer-reviewed research
• Published 6x/year with additional supplemental topic articles and information
• Subscription through Canadian Pharmacists Association (CPhA) membership
• More for continuing education, rather than a reference

Pharmacy Practice
• Publication through Pharmacy Gateway (online source of pharmacy publications)
• Rogers Publishing product
• Information on diverse clinical, business, management topics for bot h community,
hospital and industry
• Offers CE lessons
• More for continuing education, rather than a reference

The Merck Manuals (this one is important)

• Created by Merck & Co. Inc (American pharmaceutical Company)
• Meant as an aid physicians and pharmacists
• There are several books
o The Merck Manual of Diagnosis and Therapy
 This is good for learning about pathophysiology of the disease and
diagnosis. Very comprehensive.
o Lots of others

Remington (this one is important)

• Compounding!! (+ Martindale!)
• Science and practice of pharmacy
• Information on
o Pharmacochemical properties of drugs
o Manufacturing considerations and formulas for certain drug products
o Measurement units
o Capsule size (unique)
• Can be helpful when trying to determine compatibilities and compounding
considerations

Natural Medicines Comprehensive Database

• Unbiased information on complementary, alternative and integrative therapies
• From the makers of the Canadian’s Pharmacists Letter
• Excellent information on herbal products
o Names (scientific and common)
o Mechanism of action
 o Uses and its evidence
o Drug interactions

Compendium of Self-Care Products

• The “CPS” of Schedule II, II products on the Canadian market
• Companion reference to patient self-care
• Don’t worry too much about it
• Product monographs on several items (only in past versions)

Health Promotion and Presentations

Didn’t take notes

Documentation
Why Document?
• To meet documentation standards that exists for all patient care practitioners
• To be effective and efficient at caring for the patients
• Limit legal liability
• Obtain reimbursement
• Communicate with the patient and the patient’s other care providers
• Present patient cases for learning purposes and to have clinical experience on
which to reflect and convert to clinical knowledge
• Manage a practice

How Do We Document?
• There are two forms by which we document
o Paper documentation
 Advantage: efficient
 Disadvantage: time consuming to maintain, difficult to retrieve the
information, access
o Electronic documentation
 Advantages: more effective and efficient, retrieval is easy, access
 Disadvantages: takes time to learn the system
• Unstructured
• Structured
o SOAP
o FARM

Guides for Documentation

• Accurate, true
• Date, pharmacists involved, other staff members
• Name of patient, DOB
• Condition, concerns, situation, incident
• Done promptly!
 • Legible
• Retrievable
• Confidential

What should we document?

1. Assessment
2. Drug therapy problems
3. The care plan
4. Follow-up evaluations

Documentations
• Regardless of where and what you are documenting the skills required are the
same
o Be timely
o Be precise
o Be concise
o Be complete
 Study Tips
TC
• Goals of therapy – important (understanding it will help you understand tx)
• Clinical investigation – not important (just understand some of the main markers
or clinical signs/measures for specific disease. Ex: HIV – CD4+, viral load)
• Non-pharm – important to understand, should recall 1-2
• Pharm – most important part!! Understand different options in detail!! Know the
pros and cons of each drug, when will you use which, drugs place in therapy,
MOA, major side effects and a few rare
• Read tips – will help you with how drugs are used
• Understand risk factors

Patient Self Care

• Good to know red flags
• Don’t have to go into excessive detail

CPS
• Know big sections
• Read monographs of important drugs

Rx Files
• Good supplement to learning (use at the end!!)
• Talks about unique and important SEs