Unit 3

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Department of Pharmacy

Department of Pharmacy
Topics:
1. PCNE Classification for Drug-Related Problems (DRPs) V9.00
• Problems
• Causes
• Planned Interventions
• Intervention Acceptance
• Status of the DRPs
2. Adverse Drug Reactions and its corresponding interventions
3. Side Effects and Toxicities of medication and its corresponding
interventions
4. Medication Adherence
Department of Pharmacy

• During the working conference of the


Pharmaceutical Care Network Europe in
January 1999, a classification scheme was
constructed for drug related problems (DRPs).
• The classification system is validated and
adapted regularly.
• The current version is V9.1, which has been
developed during an expert workshop in
February 2020.
Department of Pharmacy

• The classification is for use in research into the


nature, prevalence, and incidence of DRPs and
also as a process indicator in experimental
studies of Pharmaceutical Care outcomes. It is
also meant to help health care professionals to
document DRP-information in the
pharmaceutical care process.
• Throughout the classification the word ‘drug’
is used, where others might use the term
‘medicine’.
Department of Pharmacy

The following official PCNE-DRP definition is


the basis for the classification:

A Drug-Related Problem is an
event or circumstance involving
drug therapy that actually or
potentially interferes with
desired health outcomes.
Department of Pharmacy Structure of the PCNE Classification for
Drug Related Problems
Problems

Problems
3 primary domains, 7 subdomains
Causes
9 primary domains, (*43) 38 subdomains
Planned Interventions
5 primary domains, 17 subdomains
Intervention Acceptance
3 primary domains, 10 subdomains
Status of the DRP
4 primary domains, 7 subdomains
Department of Pharmacy
Problem Domains in the PCNE Classification
The problem is defined as—
• the expected or unexpected event or circumstance that is, or
might be wrong, in therapy with drugs (the P-codes)
Code Primary Domain Description
P1 Treatment effectiveness The clinical effect of the drug treatment is not as
There is a (potential) problem with expected or there is no treatment
the (lack of) effect of
the pharmacotherapy
P2 Treatment safety The patient suffers from an ADR at normal dose or
Patient suffers, or could suffer, from from a toxic reaction
an adverse drug event
P3 Other Nothing seems wrong in the treatment, but there
is another problem related to the
medicines in use
Department of Pharmacy
Problem Subdomains in the
PCNE Classification
Primary Domain CODE Problem
P1. Treatment effectiveness P1.1 No effect of drug treatment despite
There is a (potential) problem correct use
with the (lack of) effect of P1.2 Effect of drug treatment not optimal
the pharmacotherapy
P1.3 Untreated symptoms or indication
P2. Treatment safety P2.1 Adverse drug event (possibly) occurring
Patient suffers, or could suffer, from an
adverse drug event.
P3. Other P3.1 Problem with cost-effectiveness of the
treatment
P3.2 Unnecessary drug-treatment
P3.3 Unclear problem/complaint. Further
clarification necessary (please use as
escape only)
Causes Domains in the PCNE Classification
Department of Pharmacy

The cause is—


• the action (or lack of action) that leads up to the occurrence of a potential
or real problem. There may be more (potential) causes for a problem.
(The C-code)
Code Primary Domain Description
C1 1. Drug selection The cause of the DRP is related to the
Prescribing & drug selection

The cause of the (potential) DRP selection of the drug


is related to the selection of the
drug (by patient or health
professional)
C2 2. Drug form The cause of the DRP is related to the
The cause of the DRP is related selection of the drug form
to the selection of the drug form
C3 3. Dose selection The cause of the DRP is related to the
The cause of the DRP is related selection of a dose or dosage schedule
to the selection of the dose or
dosage
Department of Pharmacy Code Primary Domain Description
C4 4. Treatment duration The cause of the DRP is related to the

Prescribing

selection
The cause of the DRP is related duration of the therapy

& drug
to the duration of treatment

C5 5. Dispensing The cause of the DRP is related to the


Dispensing

The cause of the DRP is related logistics of the prescribing or dispensing


to the logistics of the prescribing process
and dispensing process

C6 6. Drug use process The cause of the DRP is related to the way
The cause of the DRP is related the patient gets the drug administered by
to the way the patient gets the a health professional or carer, despite proper
Use

drug administered by a health dosage instructions (on the label).


professional or other carer, (principally used for hospital or home-care by
despite proper dosage caregivers)
instructions (on label/list)
Department of Pharmacy
Code Primary Domain Description
C7 7. Patient related The cause of the DRP is related to the
The cause of the DRP is related to personality or the behaviour of the patient
Use the patient and his behaviour
(intentional or non- intentional)
C8 8. Patient transfer related The cause of the DRP is related to the transfer
The cause of the DRP can be of a patient between settings or departments
Seamless

related to the transfer of patients (seamless care issues)


between primary, secondary and
tertiary care, or transfer within
one care institution.
C9 Other There is another cause for the problems, not
mentioned before.
Department of Pharmacy
Causes Subdomains in the PCNE Classification
Primary Domain CODE Problem
C1.1 Inappropriate drug according to
guidelines/formulary
C1.2 No indication for drug
Prescribing & drug selection

C1.3 Inappropriate combination of drugs, or


drugs and herbal medications, or drugs
1. Drug selection and dietary supplements
The cause of the (potential) DRP is C1.4 Inappropriate duplication of therapeutic
related to the selection of the drug group or active ingredient
(by patient or health professional) C1.5 No or incomplete drug treatment in spite
of existing indication
C1.6 Too many drugs/ active ingredients
prescribed for indication
*C1.2 Inappropriate drug (within guidelines but
otherwise contraindicated)*
Department of Pharmacy
Causes Subdomains in the PCNE Classification
Primary Domain CODE Problem
2. Drug form
The cause of the DRP is related to the C2.1 Inappropriate drug form (for this patient)
selection of the drug form
Prescribing & drug selection

C3.1 Drug dose too low


C3.2 Drug dose too high
3. Dose selection C3.3 Dosage regimen not frequent enough
The cause of the DRP is related to the
selection of the dose or dosage C3.4 Dosage regimen too frequent
C3.5 Dose timing instructions wrong, unclear
or missing

4. Treatment duration C4.1 Duration of treatment too short


The cause of the DRP is related to the C4.2 Duration of treatment too long
duration of treatment
Department of Pharmacy
Causes Subdomains in the PCNE Classification
Primary Domain CODE Problem

Dispensing C5.1 Prescribed drug not available


5. Dispensing
The cause of the DRP is related to the C5.2 Necessary information not provided
logistics of the prescribing and
dispensing process C5.3 Wrong drug, strength or dosage advised (OTC)

C5.4 Wrong drug or strength dispensed


C6.1 Inappropriate timing of administration or dosing
intervals by a health professional
6. Drug use process
C6.2 Drug under-administered by a health professional
The cause of the DRP is related to the
way the patient gets the drug C6.3 Drug over-administered by a health professional
Use

administered by a health professional or C6.4 Drug not administered at all by a health


other carer, despite proper dosage professional
instructions (on label/list)
C6.5 Wrong drug administered by a health professional
C6.6 Drug administered via wrong route by a health
professional
Department of Pharmacy
Causes Subdomains in the PCNE Classification
Primary Domain CODE Problem
Patient intentionally uses/takes less drug than
C7.1 prescribed or does not take the drug at all for
whatever reason
C7.2 Patient uses/takes more drug than prescribed

C7.3 Patient abuses drug (unregulated overuse)


7. Patient related C7.4 Patient uses unnecessary drug
The cause of the DRP is related to the
Use

patient and his behaviour (intentional C7.5 Patient takes food that interacts
or non- intentional) C7.6 Patient stores drug inappropriately
C7.7 Inappropriate timing or dosing intervals
C7.8 Patient unintentionally administers/uses the drug in
a wrong way
C7.9 Patient physically unable to use drug/form as
directed
C7.10 Patient unable to understand instructions properly
Department of Pharmacy
Causes Subdomains in the PCNE Classification
Primary Domain CODE Problem

C8.1 Medication reconciliation problem

8. Patient transfer related *C8.2 No updated medication list available. *


Seamless

The cause of the DRP can be related to Discharge/transfer information about medication
the transfer of patients between primary, *C8.3
incomplete or missing *
secondary and tertiary care, or transfer
within one care institution. Insufficient clinical information about the
*C8.4
patient.*
Patient has not received necessary medication at
*C8.5
discharge from hospital or clinic.*
C9.1 No or inappropriate outcome monitoring (incl.
Therapeutic Drug Monitoring)
9. Other
C9.2 Other cause; specify
C9.3 No obvious cause
Department of Pharmacy
Planned interventions domains in the
PCNE Classification

• The problem will usually lead to one or more in interventions to correct the
cause of the problem. (The I-code)

Code Primary Domain Description


I0 No intervention There is or can be no intervention
I1 At prescriber level Intervention through the prescriber
I2 At patient level Intervention through the patient, his carers
or relatives
I3 At drug level Intervention by pharmacist (dispenser)
directly by changing drug or indicating
change in drug use
I4 Other Other intervention
9. Other C9.1 No or inappropriate outcome monitoring (incl. TDM)
C9.2 Other cause; specify

Planned interventions subdomains in


Department of Pharmacy C9.3 No obvious cause

the PCNE Classification


The Planned Interventions
N.B. One problem can lead to more interventions
Primary Domain Code Intervention
V9.0
No intervention I0.1 No Intervention
1. At prescriber level I1.1 Prescriber informed only
I1.2 Prescriber asked for information
I1.3 Intervention proposed to prescriber
I1.4 Intervention discussed with prescriber
2. At patient level I2.1 Patient (drug) counselling
I2.2 Written information provided (only)
I2.3 Patient referred to prescriber
I2.4 Spoken to family member/caregiver
3. At drug level I3.1 Drug changed to …
I3.2 Dosage changed to …
I3.3 Formulation changed to …
I3.4 Instructions for use changed to …
I3.5 Drug paused or stopped
I3.6 Drug started
4. Other intervention or I4.1 Other intervention (specify)
activity I4.2 Side effect reported to authorities
Department of Pharmacy
Level of Acceptance domains in the
PCNE Classification

• In this section you can indicate if the suggestion for the intervention to
patient or prescriber has been accepted. (A-Code)

Code Primary Domain Description


A1 Intervention accepted Intervention accepted (by prescriber or
(by prescriber or patient) patient)
A2 Intervention not accepted Intervention not accepted (by prescriber or
(by prescriber or patient) patient)
A3 Other (no information on No intervention proposed or acceptance
acceptance) unknown (no information)
Level of Acceptance subdomains in the
Department of Pharmacy
PCNE Classification
PCNE Classification for Drug-Related Problems V9.00 - Page 7

Acceptance of the Intervention proposals


N.B. One status of acceptance per intervention proposal

Primary domain Code Implementation


9.0
1. Intervention accepted A1.1 Intervention accepted and fully implemented
(by prescriber or patient) A1.2 Intervention accepted, partially implemented
A1.3 Intervention accepted but not implemented
A1.4 Intervention accepted, implementation unknown
2. Intervention not A2.1 Intervention not accepted: not feasible
accepted A2.2 Intervention not accepted: no agreement
(by prescriber or patient) A2.3 Intervention not accepted: other reason (specify)
A2.4 Intervention not accepted: unknown reason
3. Other (no information on A3.1 Intervention proposed, acceptance unknown
acceptance) A3.2 Intervention not proposed

Status of the DRP


Department of Pharmacy
Status of the DRP domains in the
PCNE Classification

• Previously called ‘Outcome’, this section can be used to document if a


problem has been solved.
• For evaluation purposes it is desirable to indicate if the problem has been
solved by a specific intervention (the I-code), that has been not, partially
or fully accepted by the prescriber and patient (the A code).

Code Primary Domain Description


O0 Not known Unknown
O1 Solved Problem totally solved
O2 Partially solved Problem partially solved
O3 Not solved Problem not solved
A2.4 Intervention not accepted: unknown reason
3. Other (no information on A3.1 Intervention proposed, acceptance unknown
Status of the DRP subdomains
Department of Pharmacy acceptance) A3.2 Intervention not proposed in the
PCNE Classification
Status of the DRP
N.B. This domain depicts the outcome of the intervention. One problem (or the combination of
interventions) can only lead to one level of solving the problem
Primary Domain Code Outcome of intervention
V9.0
0. Not known O0.1 Problem status unknown
1. Solved O1.1 Problem totally solved
2. Partially solved O2.1 Problem partially solved
3. Not solved O3.1 Problem not solved, lack of cooperation of patient
O3.2 Problem not solved, lack of cooperation of prescriber
O3.3 Problem not solved, intervention not effective
O3.4 No need or possibility to solve problem
Department of Pharmacy
Adverse Drug Reactions (ADRs)
“one which is noxious and unintended, and which occurs at
doses normally used in man for the prophylaxis, diagnosis, or
therapy of disease, or for the modification of physiological
function.”
-WHO
Department of Pharmacy
The terminology surrounding ADRs is
often confusing…
Department of Pharmacy
ADRs vs. ADEs
vs. Adverse Drug Events (ADEs)
“one which is noxious and “Any untoward medical
unintended, and which occurs at occurrence in a patient or
clinical investigation subject
doses normally used (*vs. toxicity)
administered a pharmaceutical
in man for the prophylaxis,
product, but which does not
diagnosis, or therapy of disease, or
necessarily have a causal
the modification of physiological relationship with this
function.” treatment.”
-WHO -FDA
Department of Pharmacy
ADR vs ADE
Example:
• Antihistamine (H1) – 1st generation
❖ADR - expected/ establish → Sedation
❖ADE - isolated cases → Stevens-Johnson syndrome
Department of Pharmacy
Risk Factors for ADRs
AGE
• neonates, lack fully developed organs for drug metabolism and
elimination
• as children grow, drug dosing can be affected by changes in
body weight, drug distribution, and drug elimination
• ADRs increases with increasing age, being the highest in the
very elderly
• decreased liver and kidney function
• increased sensitivity to medications
• elder population tends to use more drugs and have more
illnesses than younger age groups
Department of Pharmacy
Risk Factors for ADRs
CONCURRENT MEDICINES
(POLYPHARMACY)
• The number and severity of adverse reactions increase
disproportionately with the number of drugs taken
• The best predictor of ADRs is the number of concurrent
medicines
• The potential for drug-drug interactions increases as
the number of medical products used rises
Department of Pharmacy
Risk Factors for ADRs

DURATION OF THERAPY
• The greater the degree of drug exposure, the
greater the likelihood an ADR will occur.
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Risk Factors for ADRs
GENDER
• Females have a 1.5- to 1.7-fold greater risk of developing an
ADR compared to males: (Rationale:  fat deposits)
• Overdosing
• gender-based differences in pharmacokinetics and
pharmacodynamics
• differences in immunological and hormonal makeup
• women are more likely to report adverse events than men
• women take more medications than men.
Department of Pharmacy
Risk Factors for ADRs

COMORBID CONDITIONS
• Illnesses such as congestive heart failure, malnutrition,
obesity, hepatitis, cirrhosis, or diabetes can alter the
pharmacokinetics and pharmacodynamics of drugs,
leading to drug accumulation and toxicity.
Department of Pharmacy
Risk Factors for ADRs
NARROW THERAPEUTIC INDEX DRUG
• majority of ADRs are dose-related, those drugs with
little separation between therapeutic and toxic
concentrations are highly associated with adverse
reactions
• Examples of Drugs with narrow TI
• aminoglycosides,
• anticonvulsants,
• digoxin,
• heparin,
• theophylline
• warfarin
Department of Pharmacy
Risk Factors for ADRs
ETHNICITY AND GENETICS
Pharmacogenetics: the study of the differences in
genes encoding for drug-metabolizing enzymes, drug
transporters, or drug targets
Ex. . For example, 5–10% of the population carries two
decreased activity alleles for the drug-metabolizing
enzyme CYP2D6
Department of Pharmacy
Risk Factors for ADRs
Pharmacogenetics can influence drug therapy in one of three
ways:
1. Genetic polymorphisms that are associated with altered
drug metabolism
ex. N-acetyltransferase polymorphism
• Fast acetylators: Asians, Eskimos
• Slow acetylators: Caucasians
• Drug-induced lupus: HIPSQ: hydralazine, isoniazid,
procainamide, sulfonamide, quinidine
Department of Pharmacy
Risk Factors for ADRs
Pharmacogenetics can influence drug therapy in one of three
ways:
2. Genetic variations can produce unexpected or idiosyncratic
reactions
• hemolytic anemia in persons with a deficiency in glucose-6- phosphate
dehydrogenase (example)

G6PD deficiency – Pentose Phosphate Path. (NADPH)


• Prone to hemolytic anemia from oxidative drugs
• Antibiotics (sulfonamides, chloramphenicol), antimalarials,
large dose vit. C, naphthalene, methylene blue
Department of Pharmacy
Department of Pharmacy
Risk Factors for ADRs
Pharmacogenetics can influence drug therapy in one
of three ways:
3. Genetic variation in a drug target or transporter can alter the clinical
response and frequency of toxicity

• 1–2% of the population may have mutations in the genes


encoding for cardiac ion channels predisposing them to sudden
cardiac death due to long-QT syndrome after exposure to
antiarrhythmics or certain drugs such as terfenadine.
Department of Pharmacy ADR Types and Subtypes
Department of Pharmacy
Classification of ADRs
Type A (Augmented):
• Common;
• Related to the pharmacologic action of the drug –
exaggerated pharmacologic response;
• Predictable;
• Low mortality;
• dose-related/dose-dependent
Department of Pharmacy
Subtype (Type A)
1. Extension Effects - aka “Excessive Action”;
• related/associated to MOA or pharmacological activity of the drug
• unwanted effects of drug overdose
✓Corrective Measures: Decrease the dose/frequency
• EXAMPLES:
• Oral sulfonylureas - Excessive hypoglycemia
• Cardiac glycoside - Arrhythmia
• Albuterol - Tachycardia
2. Side Effects
• unwanted effects w/c occurs in normal doses & usually related or
unrelated to the MOA;
• harmful (usually) or beneficial
• EXAMPLES:
• Antihistamine (1st gen): Sedation | insomnia; anti-anxiety
• Minoxidil (arteriolar vasodilator): for alopecia/ Male Pattern Baldness
:hair growth (hypertrichosis)
Department of Pharmacy
Classification of ADRs
Type B (Bizarre)
• uncommon
• unpredictable
• not dose-related/ dose-dependent
• is not related to the pharmacological action of the drug
Department of Pharmacy
Subtype (Type B)
1. Idiosyncratic Reactions: genetically-determined reactions
✓Corrective Measures:
✓ Withdraw the medication

✓ Treat symptomatically

✓ Avoid future exposure

• EXAMPLES:
• Chloramphenicol - Induce Aplastic Anemia
• G6PD + Antimalarials/ Sulfonamides - Hemolytic Anemia

• Carbamazepine, Phenytoin, Sulfonamides -Steven-Johnson Syndrome


Department of Pharmacy
Subtype (Type B)
2. Hypersensitivity Reactions
• unusual susceptibility
• immune response to environmental antigens resulting in
symptomatic reactions upon secondary exposure to the same
antigen, more commonly referred to as allergen
✓ Corrective Measures:
✓ Withdraw the medication
✓ Institute supportive measure
✓ Avoid future exposure
EXAMPLES:
• Herxheimer reaction (Beta-lactam antibiotic)
• Acute intermittent porphyrra (Barbiturates)
Department of Pharmacy
TYPES OF HYPERSENSITIVITY REACTIONS:
Type I (Immediate or Anaphylactic Immune Response)
• most common category of allergic reaction
• occurs after antigen (e.g. pollen) binds onto IgE found on the surfaces
of mast cells
• re-exposure to the same allergen → cross linking of the cell-bound
IgE → degranulation (release of histamines, leukotrienes &
prostaglandins)
• EXAMPLES:
• Anaphylaxis (Penicillin)
• Hay fever
Department of Pharmacy
TYPES OF HYPERSENSITIVITY REACTIONS:
Type II (Cytotoxic Reactions)
• initiated by antibody (IgG/ IgM) directed against antigens found
on the cell membrane of a given target cell (e.g. leukocytes,
erythrocytes) → complement mediated lysis
• EXAMPLES:
• Hemolytic Anemia (Methyldopa)

• Aplastic Anemia (Chloramphenicol)


Department of Pharmacy
TYPES OF HYPERSENSITIVITY REACTIONS:
Type III (Immune Complex Hypersensitivity)
• tissue deposition of antigen-antibody complexes w/ complement
activation & tissue damage

• EXAMPLES:

• Blood dyscrasias or serum sickness

• Arthus Reaction: an acute, localized inflammatory response that


typically occurs after vaccination.
Department of Pharmacy
TYPES OF HYPERSENSITIVITY REACTIONS:
Type IV (Cell-mediated or Delayed Type)
• T-lymphocytes sensitized by an antigen release lymphokines after
subsequent contact with the same antigen

• lymphokines induce inflammation & activate macrophages

• EXAMPLE: Tuberculin Skin Test


Department of Pharmacy
Department of Pharmacy
Classification of ADRs

Type C (Continuous)
• uncommon
• dose- related & time- related
• associated with the cumulative dose of the drug
Department of Pharmacy
Subtype (Type C)
1. Drug Addiction- condition where a person takes a drug
compulsively, despite potential harm to themselves,
or their desire to stop.
• Example:
• Marijuana
• Opiates
Department of Pharmacy
Subtype (Type C)
2. Drug Dependence-
• unwanted condition resulting to tolerance & physical
dependence;
• compulsion to take the drug repeatedly & experiences
unpleasant symptoms if discontinued
✓Corrective Measures:
✓Withdraw the medication under medical supervision
✓Psychotherapy
• EXAMPLE
Nicotine
Codeine
Caffeine
Department of Pharmacy
Subtype (Type C)
• Physical Dependence: occurs when a drug has been used
habitually & the body has become accustomed to its effects.
The person must then continue to use the drug in order to feel
normal, or its absence will trigger the symptoms of withdrawal.

• Psychological Dependence: occurs when a drug has been used


habitually & the mind has become emotionally reliant on its
effects either to elicit pleasure or relive pain, & dose not feel
capable of functioning without it.
Department of Pharmacy
Subtype (Type C)
3. Drug Tolerance-
• reduce pharmacologic response due to “desensitization” of
receptors
• reduced effect w/ repeated use of drug; need for higher doses to
produce the same effect.
✓Corrective Measures:
✓ Increase the dose/ frequency
✓Change the medication
• EXAMPLES
• Atropine
• Histamine
• Alcohol
Department of Pharmacy
Classification of ADRs

Type D (Delayed)
• Uncommon
• Usually dose related
• Occurs or becomes apparent sometime after use of
the drug
Department of Pharmacy
Subtype (Type D)
1. Carcinogenicity: ability of any substance to cause or
induce cancer
✓Corrective Measures:
✓Monitor the patient
✓Inform the physician/ medical team
• EXAMPLES:
• Polycyclic/Aromatic Hydrocarbons
• Nitrosamines
• Azo dyes
Department of Pharmacy
Subtype (Type D)
2. Teratogenicity: ability of any substance to cause
congenital malformations or birth defects
✓Corrective Measures:
✓ Avoid exposure during first trimester of pregnancy

✓ Avoid exposure to women in child- bearing age


• EXAMPLES:
• Thalidomide (phocomelia)

• Retinol & derivatives- Isotretinoin (powerful teratogen)


Department of Pharmacy
Subtype (Type D)
3. Mutagenesis: permanent change of Germ cell
✓Corrective Measures:

✓ Avoid exposure to children & adults of child-bearing age

• EXAMPLES:
• Aflatoxin

• Cyclamates
Department of Pharmacy Classification of ADRs
Type E (End-of-Use)
Uncommon;
generally occur shortly after stopping the drug
Withdrawal Symptoms:
• Anxiety
• Rhinorrhea
• Irritability
• Nausea & vomiting
• Insomnia
• GI cramping
• Chills
• Diarrhea
• Diaphoresis
• Piloerection
• Salivation
Department of Pharmacy
Subtype (Type E)
• Withdrawal: noxious or unintended response occurring
when a drug is discontinued

• EXAMPLES:
• Opiate withdrawal
• Rebound insomnia & excitation (Benzodiazepine)
Department of Pharmacy Classification of ADRs
Type F (Failure of Therapy)
unexpected failure of efficacy
Common, dose-related
may result from:
a. Use of Counterfeit drugs
b. Use of substandard drugs
c. Use of placebo
d. Antimicrobial resistance (drug resistance): insensitivity of the
pathogen to an antimicrobial agent
Department of Pharmacy Classification of ADRs
Type F (Failure of Therapy)
✓ Corrective Measures:

✓Test the sensibility of the pathogen to a certain antibiotic


✓Avoid combination (Bactericidal + Bacteriostatic = antagonism)
e. Patient’s non-compliance
f. Wrong route of administration
g. Drug instability
h. Drug-drug interactions
Department of Pharmacy
Department of Pharmacy
Side Effects and Toxicities of medication
• unwanted effects w/c occurs in normal doses & usually related
or unrelated to the MOA; harmful (usually) or beneficial

• most common set of side effects


• (for drugs that work inside your body) involves the gastrointestinal
system— nausea or an upset stomach
• (for drugs used on the outside) skin irritation is a common
complaint.
Department of Pharmacy
Examples of Side Effects
Diphenhydramine: eases allergy symptoms, it also blocks

the chemical acetylcholine, and that leads to drowsiness and a

host of other side effects, including dry mouth

Warfarin: used to prevent blood clots, but serious internal

bleeding can happen in the wrong dose (monitoring of therapy

is required for dosage adjustments)


Department of Pharmacy
Examples of Side Effects
Drug Interactions
drinking alcohol while you're taking narcotic painkillers can
cause an accidental overdose
grapefruit juice, which can affect the blood levels of
several drugs, including some blood pressure and cholesterol
medicines
Department of Pharmacy
Examples of Side Effects

Finasteride: treat noncancerous enlargement of


the prostate gland
• SE: regrow hair— millions of men use a low dose of
finasteride to treat male pattern baldness
Department of Pharmacy
Medication Adherence

defined as the patient's ability and willingness to take a


therapeutic regimen that the practitioner has clinically judged
to be appropriately indicated, adequately efficacious, and,
based on all available evidence, can produce the desired
outcomes without any harmful effects
Department of Pharmacy
Reasons for Non-Adherence
The patient does not understand the instructions
The patient, for whatever reason, prefers not to take the
medication
The patient forgets to take the medication
The medication costs too much for the patient to purchase
The patient cannot appropriately swallow or self-administer
the product
The drug is not available for consumption
Patients take the medication for the wrong reason
Department of Pharmacy
Reasons for Non-Adherence
Patients with comorbidities, on many medications, often become
confused and indecisive, thus “put off” taking them

Patients all too frequently have a poor understanding of the


science involved in goals of therapy and the expectations of healthy
outcomes

Patients can be “pharmacologically” illiterate or do not understand


the particular language used by clinician and others
Department of Pharmacy
Reasons for Non-Adherence
Mathematics and measurement involved in dosages and the
patient does not always understand frequencies of
administration; hence, dose and duration are often problematic
as is safety and efficacy

Patients frequently have a poor understanding of their health


problems
Department of Pharmacy
Reasons for Non-Adherence
Patients frequently hold beliefs contrary to any empirically based
allopathic paradigm
Cultural beliefs and practices can, and do, impact the patient's
decision to take or not take medicines
Religious beliefs and practices can inhibit adherence
Complex therapeutic regimens can be confusing and frightening
Cognitive factors (especially in older patients) can lead to poor or
nonadherence
Department of Pharmacy
Achieving Adherence
The practitioner has to positively influence the patient's
decisions to create a positive medication experience. This
requires a good therapeutic relationship.
Patient-centered adherence is achieved once the
pharmaceutical care practitioner ensures that only those
medications which are determined to be appropriate, effective
and safe for the individual patient are being used and that the
individualized care plan developed with the patient takes into
account the unique medication experience of that patient.
Department of Pharmacy
Achieving Adherence
Perhaps more than anything, pharmaceutical care practice
brings the patient who has a certain set of beliefs, expectations,
and concerns together with a practitioner who may have a
completely different set of values and level of knowledge about
drug therapy, and provides the two of them with a common
way to think about medications and a common way to talk
about medications.
This should lead to the best decisions possible, which will
bring about a significantly higher level of patient-centered
adherence.

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