Pharmacy Leve III Skill Gap Training Materials Based On Version

SKILL GAP TRAINNING MATERIALS FOR
PHARMACY LEVEL BASED ON OCCUPATIONAL

STANDARD, 2018
By T3(Pharmacist)
Nekemte, Ethiopia
SKILL GAP TRAINNING MATERIALS FOR PHARMACY LEVEL BASED ON OCCUPATIONAL STANDARD, 2018
Occupation: Pharmacy Pharmacy Level: III
Unit of Competence
HLT PHS3 01 0218 Use Pharmaceutical Calculation Techniques and Terminologies
HLT PHS3 02 0218 Assist Extemporaneous Preparations
HLT PHS3 03 0218 Provide Information on Nutritional Supplement
HLT PHS3 04 0218 Provide Compassionate, Respectful and Caring Service
HLT PHS3 05 0218 Comply with Infection Prevention and Control Procedures
HLT PHS3 06 0218 Detect Pharmaceutical Health Hazards and Act
HLT PHS3 07 0218 Apply First Aid and Emergency Response
HLT PHS3 08 0218 Use New Technology and Software Application
HLT PHS3 09 0218 Monitor Implementation of Work Plan/Activities
HLT PHS3 10 0218 Apply Quality Control
HLT PHS3 11 0218 Lead Workplace Communication
HLT PHS3 12 0218 Lead Small Teams
HLT PHS3 13 0218 Improve Business Practice
HLT PHS3 14 0218 Prevent and Eliminate MUDA
Pharmacy Level III By T3(Pharmacist) Page 1

1. ASSIST EXTEMPORANEOUS PREPARATIONS

1.1. Introduction to Compounding
Brainstorming
What is compounding?
Definition: The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device,
or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the
practitioner/patient/pharmacist/compounder relationship in the course of professional practice.
Compounding includes the following:
 Preparation of drug dosage forms for both human and animal patients
 Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly
observed prescribing patterns
 Reconstitution or manipulation of commercial products that may require the addition of one or more
ingredients
 Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic),
teaching, or chemical analysis
 Preparation of drugs and devices for prescriber’s office use where permitted by federal and state law.
1.2. Reasons and benefits of compounding (Why do we need to compound?)
Pair Discussion
Why do we need to compound?
Compounding is done when certain medical needs of individual patients cannot be met by the use of an
approved commercial drug product. Main reasons for compounding include:-
 Unavailable dosages, strengths and routes of commercial products

 Dilution of adult doses of medications to Pediatric/Geriatric strengths if a patient needs a reduced
strength of medication or a special dosage that is currently unavailable commercially
 For children who have difficulty taking prescriptions that have an unpleasant taste
 Conversion of solid dosage forms to solutions or suspensions if a child or adult has trouble swallowing
pills
 Combination of topical dermatological products not available by the manufacturer
 Changing inactive ingredients of commercial products which may cause allergic reactions in individuals
 Preparing certain pharmaceuticals from raw materials (topical preparations, antiseptics, disinfectants,
etc.)
The ultimate goal in preparing compounding medications is to help the healthcare provider and the patient achieve a
more positive therapeutic outcome.

1.3. Distinguishing Compounding from Manufacturing

Pair Discussion
What is the difference between compounding and
manufacturing?
It is important to differentiate between compounding and manufacturing.
Compounding involves the preparation, mixing, packaging, and labeling of a small quantity of a drug based on a
practitioner’s prescription or medication order for a specific patient. This is different than Manufacturing, which is the
production, preparation, propagation, conversion, and processing of a drug or device, either directly or indirectly, through
extraction from substances of natural origin or independently through means of chemical or biological synthesis; the term
includes any packaging or repackaging of the substance(s) or labeling or relabeling of its container and the promotion and
marketing of such drugs or devices. Manufacturing also includes the preparation and promotion of commercially available
products from bulk compounds for resale by pharmacies, practitioners, or other persons.
In other words, compounding a preparation for a specific patient usually takes place in a pharmacy, whereas
manufacturing products in bulk typically occurs in licensed manufacturing facilities.
Compounded versus manufactured medications
Compounded medications Manufactured medications
Governed by the state board of pharmacy regulated by the federal government and FDA
Must be prescribed by a licensed prescriber for Is commercially marketed to drug wholesalers

a specific patient and is made to cover a large population with a
specific condition
May not duplicate a commercially available
product
1.4. Nonsterile and Sterile Pharmaceuticals compounding

Brainstorming
What is the difference between sterile and non-sterile
pharmaceuticals compounding?
Nonsterile Pharmaceuticals compounding (NSPC)
 Nonsterile compounding refers to creating compounded medications outside of a laminar hood or a

sterile environment.
 This includes ointments, creams, suppositories, capsules, and other oral or topical products.
 This does not mean that the environment used to create these drugs and mixtures does not need to be
clean; this type of compounding is just required to adhere to a different set of regulations and methods.
Sterile Pharmaceuticals compounding (SPC)
 Sterile compounding is the process of compounding medications using aseptic technique in a sterile
environment.
 Sterile compounding is necessary when patients are unable to take a medication orally, require a rapid
delivery of drug, or if a medication is unavailable in oral form.
 Most medications produced through sterile compounding techniques are for parenteral administration.
 Examples: Injections, Eye preparations, Total Parenteral nutrition’s
1.5. Good Compounding Practice (GCP)
It is a system for ensuring that products are consistently produced and controlled according to quality
standards.
General compounding principles
 Personnel are appropriately trained and qualified to perform their assigned duties.
 Compounding raw materials of appropriate identity, purity, and quality should be used, properly stored
and labeled according to manufacturer recommendations.
 All equipment used in compounding should be cleaned, status labeled, properly handled, and used
appropriately.
 Compounding environment should be clean and suitable for its intended purpose.
 System must be in place to reduce any risk of contamination and cross-contamination.
 Quality control (QC) and assurance system must be in place.
 All aspects of compounding must be appropriately documented.

Standards/ Requirements for Good Compounding/Manufacturing Practice
Brain storming
Do you think special knowledge and skill is required to
practice compounding?
What are basic requirements for compounding practice?
The basic requirements that GCP encompasses include mainly:

Personnel
Premises
Sanitation and hygiene
Equipment
Materials
Documentation
1.6. General Steps in the Compounding Process
The steps to be followed before, during, and after compounding shall be grouped into five categories
A) Preparatory
Designated pharmacist or pharmaceutical technician shall:
 Judge the suitability of the prescription in terms of its safety and intended use and the dose for the
patient.
 Wear the proper attire and washing hands according to the respective written procedures.
 Clean the compounding area and the equipment if necessary.
 Perform the calculations to determine the quantities of the ingredients needed.
 Select the proper equipment and making sure it is clean.
 Assemble all the necessary materials and ingredients to compound and pack the preparation.
B) Compounding
 Compound the prescription according to the formulary record or the prescription using techniques
according to the art and science of pharmacy, strictly observing GCP procedures.
 Proper compounding record should be maintained.

C) Final Check
 Check and ensure adequacy of mixing, clarity, odor, color, consistency, and/or pH.
 Register the information in the compounding log and documented.
 Pack the compounded product in suitable container appropriately; check weight variation; and label it.
D) Sign-Off
 Sign and date the prescription, affirming that all of the indicated procedures were carried out to ensure
uniformity, identity, strength, quantity, and purity
E) Cleanup
 Cleaning and storing all equipment.
 Cleaning the compounding area
1.7. Hand Hygiene/Hand Washing

Introduction
Hand hygiene is the most important health procedure that can be performed to prevent the spread of microbes
of all types. It requires washing the hands by vigorous rubbing of all surfaces of the hands while lathered with
an appropriate antimicrobial soap (from a dispenser, and not in bar form), followed by rinsing under running,
warm water. Cold water does not provide enough lather from the soap and hot water may damage the skin.
The hands can usually be washed effectively in 15 to 20 seconds unless they are visibly dirty or soiled.
Procedure: Hand Washing
Objective: To use proper technique during hand hygiene procedures to reduce the spread of infection.
Equipment Needed: sink, running water, antimicrobial liquid soap, a nail brush (or orange stick), paper
towels within a dispenser, water-based antimicrobial lotion, and a properly labeled biohazard waste container
Steps/Procedures:
1. Remove all jewelry.
2. Turn on the water faucets with a paper towel if they are not foot-operated.
3. Make sure that the water is lukewarm.
4. Wet your hands.
5. Apply soap and lather with a circular motion and friction, holding the fingertips downward.
6. Make sure to rub well between the fingers.
7. If this is the first time of the day you are washing your hands, use a nail brush (or orange stick) to clean
under every fingernail.
8. Rinse well while holding the hands with the fingertips still pointed downward.

9. Repeat the scrubbing procedure a second time, for 1 to 2 minutes.

10. Rinse again.
11. Dry hands with paper towels, avoiding touching the paper towel dispenser.
12. Turn off the water faucets with a paper towel if they are not foot-operated.
13. Place used towels in the biohazard waste container.
14. Apply the water-based antibacterial hand lotion to prevent chapping or drying of the skin.
Practice: Hand hygiene/Hand washing procedures

Objective: To reinforce the importance of hand hygiene.
Practice the procedure of hand washing.
1.8. Donning Gloves

The use of gloves prevents the spread of disease. Usually, pharmacy technicians will wear nonsterile latex or
vinyl disposable gloves for nonsterile compounding, and sterile gloves when sterile compounding procedures
are required.
Procedure: Donning Gloves
Objective:
 To demonstrate the proper method of donning gloves to practice infection control
techniques.
Equipment Needed: gloves
Steps/procedures:
1. Select a pair of sterile gloves.
2. Remove the first glove from the packaging, keeping your fingers within the cuff of the gown.
3. Place the glove on the palm of your hand with the thumb side of the glove toward your palm.
4. Pull the glove’s cuff over the cuff of the gown.
5. Unfold the glove’s cuff so that it completely covers the cuff of the gown.
6. Grasp both the glove and gown at the level of the wrist.
7. As you pull the glove into position, work your fingers into the glove.
8. Repeat the above steps for the second glove

Procedure: Proper Removal and Disposal of Gloves

Objective:
 To demonstrate proper removal of gloves to prevent contamination and infection of hazardous
materials.
Equipment Needed: gloves, gown, biohazard container
1. Use your dominant hand to grasp the glove of the opposite hand near the palm. Your arms
should be extended from your body, with your hands pointed down.
2. Pull the glove inside out until you reach your fingers, holding the glove inside your dominant,
gloved hand.
3. Insert the thumb of your non-gloved hand inside the cuff of the remaining glove.
4. Pull the glove down, inside out, over the first removed glove. This leaves the contaminated side
of both gloves on the inside.
5. Dispose of the gloves together in a biohazard waste container.
6. Wash your hands.
1.9. Donning of Face Masks

Face masks should be worn when exposure to droplet secretions may occur. These masks should cover the
pharmacy technician’s nose and mouth. The mask should be tied to fit snugly, using either the elastic band or
strings that are attached to the mask. If the mask has strings, make sure that they do not cross each other
when they are tied behind the head.
Procedure: Proper Donning of Face Masks
Objective:
 To demonstrate the proper procedure for donning a mask to
prevent contamination from hazardous substances.
Equipment Needed: mask
Steps/Procedures:
1. Wash your hands.
2. Place the mask so that it covers your nose, mouth, and chin.
3. Fit the flexible nose piece over the bridge of your nose.
4. Secure around your head (whether it has ties or elastic).
5. Adjust so that it fits comfortably

Practice/Demonstrate
Objective:
 To become familiar with the proper order and procedures for donning PPE.
Practice:
 Donning gown, gloves, and face mask in the proper order and manner.
1.10. Cleaning and Disinfection

Cleaning is the physical removal of soil, debris, blood, and body fluids from instruments, furniture, and other
items. Cleaning is necessary before disinfection because organic debris decreases the effectiveness of
disinfectants. Cleaning is an ongoing part of the environmental routing of the clean room environment.
Disinfection is destruction of pathogenic microorganisms by direct exposure to chemical or physical agents.
This process is done by using specific detergents that are selected according to the type of instrument to be
cleaned. Manufacturer instructions must always be followed for correct dilution, temperature, and use.
Procedure: Cleaning and Disinfecting
Objective: To properly clean and disinfect work areas and equipment to prevent the spread of
infection.
Equipment Needed: disinfectant, cloth.
1. Thoroughly rinse and/or clean items before a disinfectant is used. The foundation of manual
cleaning is friction, which loosens the organic materials and allows their removal during the rinsing
process.
2. When cleaning stainless steel instruments, use a back-and-forth motion to follow the grain of the
instrument, rather than a circular motion, which can scratch the surface of the item.
3. To avoid spotting on the instruments, dry the items immediately after rinsing.
General Cleaning of Compounding Premises and Equipment
Compounding premises and Storage facilities should be clean and free from liter and dust. Cleaning equipment
should be chosen and used in order not to be a source of contamination.
Objective:
 To ensure that the Compounding premise is maintained clean, tidy at the highest level of cleanliness.
Equipment and Material:
 Sponge mop, Rubber mop, Broom, dust bin, Detergents, Disinfectant and Detergents (different
types), Protective equipment
Cleaning principles
 All areas of Compounding premises such as Compounding areas, weighing area, storage area should be
cleaned on programmed basis.
 The compounding unit should execute a cleaning regimen as required (i.e. on a daily, weekly, monthly
and annual basis)
 Cleaning should performed using protective equipment like gloves, aprons, boots, face mask etc., as
necessary during cleaning procedures
 All cleaning chemicals and materials should be properly labeled and stored separately from medical
warehouse / kept in utility room/
 Disinfectants that are used to disinfect compounding area and equipment should be applied rotationally,
in order not to produce resistant strain to ward s specific detergent.
Cleaning of Equipment and Accessories
Objective:
 To prevent contamination of health supplement products by ensuring that proper cleaning procedure
for equipment and accessories in the manufacturing area is in place.
Procedure:
Cleaning of Major Manufacturing/Compounding Equipment
1. Dismantle all the removable parts of the equipment to be cleaned.
2. Adhere “To be cleaned” sticker on the equipment and transfer the removable parts to the designated
washing area.
3. Clean the immobile part of the equipment according to the manufacturer’s suggested cleaning procedure
then fill-out the Equipment Log Book after completion.
4. Reassemble all the cleaned removable parts to the cleaned equipment after assuring that every part is
dried.
5. Affix the signed and dated “Cleaned” sticker on the reassembled cleaned equipment. The “Cleaned”
sticker must identify previous batch being processed by the equipment.
6. Use the cleaned equipment within 72 hours from the date of cleaning. Wipe all product contact parts
with clean lint-free cloth prior to next use.
7. If the equipment is not used within 72 hours after the date of cleaning, adhere “To be cleaned” sticker
on the equipment and perform cleaning procedure again before use.
Cleaning of Accessories and Utensils
1. Transfer the accessories and utensils to the designated washing area.
2. Wash with sufficient potable water.

3. Clean with nylon brush or cleaning pad using potable water and disinfectant solution.
4. Wash off clean with potable water until no bubbles are present.
5. Final rinse with purified water.
6. Rinse or wipe with 70% v/v solution of Alcohol
7. Dried accessories and utensils
8. Affix signed and dated “Cleaned” sticker, with identification of previous product, on the bag.
9. Store the cleaned accessories and utensils in designated equipment storage area until next use
Practice/Demonstrate:
Cleaning and disinfection of different types of reusable Compounding equipment.
1.11. Weighing and Measuring Process/Techniques/Procedures in compounding

Brainstorming (Weighing and measuring process)
What are the processes that should be followed during measuring
and weighing?
During weighing and measuring process, appropriate instrument selection is one of the critical steps. It depends
on different parameters such as nature of material to weigh or measure, amount and accuracy needed.
1.11.1. Weighing process/Techniques

Weight is measured by means of a balance. Prescription balance is most commonly used for weighing of ingredients during
pharmaceutical compounding.
For compounding purpose, usually we use the following two types of prescription balances.
Beam balance
Digital balance
Cares that should be taken in weighing:
o Keep the balance in a place where there is no environmental disturbance (Vibration, dust, moisture,
wind, etc.)
o Keep the balance cover down except when the balance is in use.
o Never weigh pharmaceutical materials directly on the balance pan. Use a piece of paper for solids,
waxed paper or watch glass for semisolids, and an appropriate vessel for liquids.
o Use a suitable spatula for the transfer of materials to the balance pan. Take care not to spill any material.

Weighing Procedures/Techniques
1. Select a balance with appropriate capacity and sensitivity.
2. If weighing a solid material which requires being size reduced (ground) or sieved, always ensure
that this is carried out before weighing.
3. Ensure that the balance is clean, dry and working properly
4. Put the balance on a level, non-vibrating and clean table
5. Adjust the balance, put the container for the material to be weighed and weigh it (to deduct
from the final total weight) or use auto zero to cancel its weight. Grease-proof papers should be
used for weighing of semisolids.
6. Read carefully the label of the material to be weighed (check name, strength, expiry date)
7. Check the appearance and any sign of stability problems.
8. Add the material to be weighed on to the container using spatula until the correct weight is
obtained, close the container and return to the original place
9. Carefully remove the weighed material and transfer to the suitable container
10. Clean the balance and its accessories.
11. Return the balance and its accessories to the original place
12. Clean the working table
Using an Electronic Balance
Electronic balances have digital displays and may have internal calibration capabilities. These may either be
top-loading or encased to protect the balance from dust and drafts.
To use an electronic balance, follow these guidelines:
Tarring
1. Open the slide door, or level the balance away from vibration area
2. Place a container/ watch glass/weighing bottle/butter paper on weighing pan
3. Press the O/T key. The display changes to zero, 0.000g

Operation procedure
1. To switch the balance ON briefly touch the ‘’ ON/OFF’’ key after the main power supply of the balance
has been switched on.
2. Check the level of the weighing balance; Centre the position of the air bubble.
3. When the display indicates 0.0000g, place the sample on the weighing pan and close the sliding doors.
4. To switch the balance off briefly touch the ‘’ ON/OFF’’ key.
PRACTICE: Weighing Techniques

1. Weigh accurately 0.3 g of sodium chloride/Zinc oxide powder
2. Weigh accurately 10 g of white soft paraffin
Resources (equipment tools and materials)

Chemicals/Ingredients Equipment/Tools
 Sodium Chloride  Beam balance/digital balance
 Zinc oxide  spoon spatula
 Liquid paraffin  weighing paper/watch glass/greasy proof paper
Procedure/Observation Check List

Performance
Satisfactory Not
Steps
Procedures/steps/Observation checklist satisfactory

1 Wear gown and glove
2 Clean the working area and lab bench
3 Select the appropriate balance
4 Check that the balance is clean and dry
5 Put the balance on a level, non-vibrating and clean table and adjust
the balance to zero
6 Put the container/paper for the material to be weighed and weigh
it (to deduct from the final total weight) or use auto-zero to cancel
its weight
7 Using a spatula, transfer, 0.3 g sodium chloride to the paper/ watch
glass. Check the weight, check the ingredient. Repeat the same

procedure for 10g of white soft paraffin by using watch glass/greasy

proof paper
8 Transfer the weighed Sodium chloride and a to its
respective packages and label it(repeat the same procedure for
white soft paraffin )
9 Return the stock pot to the shelf
10 Clean the working equipment and environment
11 Complete recordings and documentation
12 Store the weighed sodium chloride to an appropriate place
Overall Performance: Competent/not yet competent
1.11.2. Measuring Techniques/Volume Measurement/
The measuring of all liquid starting materials should be undertaken in appropriate and validated measuring
vessels wherever possible.
Equipment used for measuring:
Cylindrical graduates, conical graduates, burettes, graduated pipettes, droppers and volumetric flasks
can be used.
Guidelines for selecting liquid measurement devices:

 Always select the smallest device (graduate, pipette, and syringe) that will accommodate the desired volume of
liquid. It will minimize the potential for errors of measurement associated with misreading the scale.
o Use a graduated pipette, syringe, or calibrated dropper to measure/deliver volumes <1 ml.
 Where possible, glass measures should be avoided to minimize the risk of undetected contamination with broken
glass. When glass is used, it should be regularly inspected for chips and cracks and replaced as necessary.
 When you read the final volume on the side of a container with a meniscus, it should be determined by aligning
the bottom of the meniscus with the desired graduation mark. If the liquid is densely colored or opaque, such as
a suspension, the top of the meniscus should be read.
Figure: Meniscus reading

Procedures/Techniques for Measuring Liquids

1. Make sure the availability of appropriate graduated measure (cylindrical graduate, conical graduate,
pipette, syringe, and dropper) depending on the viscosity and quantity of the liquid to be weighed.
2. Select a clean and dry graduated measure of appropriate size.
3. Read the label of the liquid carefully (check name, strength, expiry date)
4. Check the appearance and any sign of stability problems.
5. Pour the liquid into the measure until the desired volume is obtained.
6. In case of measuring more than one liquid, hold the cap of the container in your hand, preferably
between the fourth finger and the palm of the hand, so that the possibility of exchange of closures
ending up with cross-contamination is minimized.
7. Transfer the liquid from the measure.
8. Allow to drain for sufficient time. Viscous liquids need more time as compared to aqueous,
alcoholic and hydrochloric liquids which can drain within 30 seconds. Approximately 60 seconds
(or more) are required for more viscous liquids such as syrups, glycerin, propylene glycol, and
mineral oil to drain.
9. Clean the measure and replace to its original place.
10. Clean the working table.
PRACTICE: Measuring Techniques using Measuring cylinders and droppers

1. Measure appropriately 5 ml of water.
2. Measure appropriately 10 ml of liquid paraffin.
3. Measure 0.25 mL, 0.75 mL, and 1 mL Purified water with droppers.

Chemicals/Ingredients:
 Purified water
 liquid paraffin
Equipment/Tools:
 Measuring cylinder
 Final container(bottle/conical flasks)
Performance
Steps
Satisfactory Not
Procedures/steps/Observation checklist satisfactory
1 Wear glove
2 Clean the working area and lab bench
3 Select the appropriate measuring cylinder
4 Check that the cylinder is clean and dry
5 Measure the specified amount of purified water for water
measuring practice and liquid paraffin for its practice

6 Transfer the measured amount of purified water and liquid paraffin
to the dispensing bottles
7 Label the measured liquids
8 Return the stock pot to the shelf
9 Clean the working equipment and environment
10 Complete recordings and documentation
11 Store the measured purified water and liquid paraffin to an
appropriate place
Overall Performance: Competent/not yet competent
1.12. Beyond-use date and dating methods

 The Beyond-use Date (BUD) is the date after which a non-sterile compounded preparation should no
longer be used and is determined from the date when the preparation is compounded.
 Compounded preparations are intended for administration immediately or following short-term
storage, therefore their BUD may be assigned based on certain criteria.
 When assigning a BUD, compounders should refer literature and document with regard to stability.
 When a manufactured drug is used as the raw material, information provided by the manufacturer may
be used as a reference. The manufacturer’s expiry date for the drug should not be used as the BUD for
the final preparation.
 Generally, BUD should be assigned conservatively by considering the following points:
 Nature of the ingredient to be used,
 Compounding methods,
 Degradation mechanisms,
 Compatibility,
 Dosage form,
 Potential for microbial proliferation in the preparation,
 Container in which the preparation is packaged,
 Storage conditions, and Intended use.
Maximum BUDs recommended for non-sterile compounded preparations that are packaged in air-tight, light-
resistant containers and stored at controlled room temperature are indicated in the table below:
Table: Beyond-use date by type of formulation
Formulation Type Beyond use date(BUD)

Non-aqueous No longer than 6 months or the earliest expiration date of any ingredient
Formulations used, whichever is shorter, and stored at controlled room temperatures.
Water Containing Oral No longer than 14 days or the earliest expiration date of any ingredient
Formulations used, whichever is shorter and stored at controlled cold temperatures.
Water Containing No longer than 30 days or the earliest expiration date of any ingredient
Topical/Dermal and used, whichever is shorter, and stored at controlled room temperatures.
Mucosal Liquid and This includes water being added as an ingredient or water is a component
Semisolid Formulations: of any ingredient used
NB: Drugs or chemicals known to be labile to decomposition will require shorter BUDs

1.13. Packaging, Storage and labelling of extemporaneous Preparations
Packaging, labeling and storing activities are an integral part of compounding practices. Thus, the compounder
is responsible for compounding preparation of acceptable strength, quality, and purity with appropriate
packaging, labeling and storing in accordance with good compounding practices.
The package and label are the first points of interaction between health product and a healthcare professional
or patient. They communicate key information about the safe and proper use of health products, and are
important aids in product identification, selection, and administration.
Packaging
Brainstorming
 Define pharmaceutical packaging?
 What is the importance of proper packaging of compounded preparations?
Pharmaceutical packaging means the combination of components necessary to contain, preserve, protect
and deliver a safe, efficacious drug product, such that at any point of time before expiration date of the drug
product, a safe and efficacious dosage form is available.
Purposes/Functions of Packaging:
The packaging and package labelling have the following objectives:
1) Physical Protection
2) Barrier Protection
3) Containment or Agglomeration
4) Information Transmission
5) Marketing/Promotion
6) Security
7) Convenience
8) Portion Control
Packaging Materials
 Packaging materials and closures can be made from: glass, plastic, metals, paper and board.
Storage
 Materials used for compounding (raw, packaging and labeling materials) should be stored in clean and
dry area, and protected from contamination.
 Ingredients that require special precautions when stored should be identified.
 Raw materials and compounded products must be stored and kept safely under conditions that will
preserve their quality and purity.
 Products that have been stored should be inspected before use to detect any signs of deterioration.
 Storage should not be on the floor, windowsills, under sinks, or near heating or cooling vents.
 The temperature of the premises (pharmacy, warehouse, etc.) should be controlled and should remain
within the recommended limits as per the following table:

Table: Storage conditions with temperature range
 All products dispensed extemporaneously require some form of additional storage instructions to be
detailed on the label. This information can be the addition of just a product expiry date through to a
number of important additional auxiliary labels.
Labelling
General principles of labelling and requirements
Every extemporaneously prepared preparation will require a label to be produced before the product can be
dispensed or sold to the patient.
Various materials are used for labelling such as paper and readymade sticker type and it will be done in form
of written, printed, or graphic matter.
The accuracy of the label is paramount as it conveys essential information to the patient on the use of the
preparation.
The label of a pharmaceutical product has many functions:
 To indicate clearly the contents of the container
 To indicate clearly to patients how and when the medicinal product should be taken or used
 To indicate clearly to patients how the product should be stored and for how long
 To indicate clearly to patients any warnings or cautions of which they need to be made aware.
Remember, the label of a pharmaceutical product must be in the right place and contain the right information.
The following need to be taken into consideration:
Appearance
 Correct position
 Clean
 Secure
Information

 Legible
 Concise
 Adequate
 Accurate
Labelling Materials and equipment:
 Different size self-adhesive labels
 Blank Paper or Printed type labeling materials
 Inedible ink Pen
 Adhesives with brush
 Cutting materials
Contents (Components) of Label
Labeling should be done according to Ethiopian Food and Drug Authority (EFDA) regulations. The
recommended labeling preparations for compounded product in response to a prescription for a specific patient
may include the following information:
a) Name of patient;
b) the name and strength of the pharmaceutical product;
c) Complete name of active ingredients (generic name should be used wherever possible );
d) Dosage form;
e) Amount of active of ingredient(s) in a specified quantity of suitable base or vehicle, and the quantity of
preparation in the container
f) Batch (lot) number;
g) Preparation date;
h) Beyond-use date (BUD);
i) Directions for use, warnings, and precautions that may be necessary; Any special Storage condition or
handling precautions that may be necessary; and
j) Name and address of the institution
Procedure of Labelling:
1. Clean the packing materials before filling the prepared materials
2. Select the appropriate packing materials
3. Select the appropriate labeling materials

4. Read the prescription information and prepare labeling
5. Check the prepared labeling information with ordered prescription/form
6. Finally stick the labeling materials to the dispensing package
7. Record to the final dispensing logo
Note: Write the necessary information on the Labeling materials if you are using printed type of labeling
materials. But, if it is ready made self-adhesive labeling materials, stick to the dispensing materials.
Sample Labeling Format
Generic Name, Strength, Dosage Form, and quantity of the preparation:_________________________
Ingredient:_________________________________________________________________________
Action and use:_____________________________________________________________________
Dose and administration:______________________________________________________________
Preparation date:____________________________________________________________________
Beyond use date:___________________________________________________________________
Batch number:_____________________________________________________________________
Storage:__________________________________________________________________________
Precaution/Auxiliary labels:___________________________________________________________
Place of preparation:_________________________________________________________________
 Remember, the label of a pharmaceutical product will need to indicate the contents.
 For official preparations, it will be sufficient to put the official title (as this
indicates the contents).
 For unofficial products, the formula will need to be detailed on the label.
 For internal products this information is given per dose; for external products,
per container.

Table: Guide to containers, auxiliary labels and discard dates for extemporaneous preparations
Preparation/ Suggested
Dosage Forms Container Important auxiliary labels discard date
Capsules Amber tablet bottle with CRC Swallow with a draught of water 3 months
Creams and gels Amber glass jar or collapsible For external use only 3 Weeks
metal tube Store in a cool place
Dusting Plastic jar, preferably with a For external use only 3 months
powders perforated, reclosable lid Not to be applied to open wounds or raw
weeping surfaces
Store in a dry place
Ear drops Hexagonal amber fluted glass For external use only 4 weeks
bottle with a rubber teat and
dropper closure
Elixirs Plain amber medicine bottle 4 weeks
with CRC
Emulsions Plain amber medicine bottle Shake the bottle before use 4 weeks
with CRC
Enemas Amber fluted bottle with CRC For rectal use only 4 weeks
Warm to body temperature before use
Gargles and Amber fluted bottle with CRC Not to be taken 4 weeks
mouthwashes Do not swallow in large amounts
Inhalations Amber fluted bottle with CRC Not to be taken 4 weeks
Shake the bottle
Linctuses Plain amber medicine bottle 4 weeks
with CRC
Liniments and Amber fluted bottle with CRC For external use only 4 weeks
lotions Shake the bottle
Avoid broken skin
Mixtures and Plain amber medicine bottle Shake the bottle 4 weeks
suspensions with CRC
Nasal drops Hexagonal amber fluted glass Not to be taken 4 weeks
bottle with a rubber teat and
dropper closure
Ointments Amber glass jar For external use only 3 months
Pastes Amber glass jar For external use only 3 months
Pessaries Wrapped in foil and packed in For Vaginal use only 3 months
an amber glass jar
Powders Wrapped in powder papers and Store in a dry place 3 months
(individual) packed in a cardboard carton Dissolve or mix with water before taking
See BNF for advisory labels
recommended for active ingredient
Suppositories Wrapped in foil and packed in For rectal use only 3 months
an amber glass jar See BNF for advisory labels
recommended for active ingredient
For soluble or dispersible tablets Dissolve or dispensed in water before taking 3 months
For chewable tablets Chew before swallowing 3 months
For sustain release, Enteric coated or unpleasant Do not crush or chew 3 months
tasting tablets
BNF, British National Formulary; CRC, child-resistant closure.

1.13. Compounding of Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms:
 The manner in which drug substance are presented in the market.
 Drugs are rarely administered in their original pure state.
 They are converted into suitable formulation which are called dosage forms.
 Every dosage form is a combination of the drug and other non-drug components.
 The non-dug components are known as “additives”.
 The additives are used to give a particular shape to the formulation, to increase its stability and also to
increase its palatability as well as to give more elegance to the preparation.
The Need for Pharmaceutical Dosage Forms

A drug is converted into a dosage form for the following reasons:
 To protect the drug substance from the destructive influences of atmospheric oxygen or humidity
(coated tablets, sealed ampules)
 To protect the drug substance from the destructive influence of gastric acid after oral administration
(enteric-coated tablets)
 To conceal the bitter, salty, or offensive taste or odor of a drug substance (capsules, coated tablets,
flavored syrups)
 To provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle
(suspensions)
 To provide clear liquid dosage forms of substances (syrups, solutions)
 To provide rate-controlled drug action (various controlled-release tablets, capsules, and suspensions)
 To provide optimal drug action from topical administration sites (ointments, creams, transdermal
patches, and ophthalmic, ear, and nasal preparations)
 To provide for insertion of a drug into one of the body’s orifices (rectal or vaginal suppositories)
 To provide for placement of drugs directly in the bloodstream or body tissues (injections)
 To provide for optimal drug action through inhalation therapy (inhalants and inhalation aerosols)
COMPONENTS OF DOSAGE FORMS/ TYPES PHARMACEUTICAL INGREDIENT
There are two components:
 Active Pharmaceutical Ingredients (API)/drug component and
 Excipients or additives/non-drug component
1) Active Pharmaceutical Ingredients (API)
 Chemical compound with pharmacological (or other direct effect) intended for use in diagnosis,
treatment or prophylaxis of diseases or.
 Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
 Any substance or mixture of substances intended to be used in the manufacture/compounding of a
pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical
dosage form.
Direct Clinical Use of the Active Drug Substances „as they are“ is Rare Due to a number of good
Reasons:
 API handling can be difficult or impossible (e.g., low mg and µg doses).
 Accurate drug dosing can be difficult or impossible.
 API administration can be impractical, unfeasible or not according to the therapeutic aims.
 Some API can benefit from reducing the exposure to the environmental factors (light, moisture…), or
they need to be chemically stabilized due to the inherent chemical instability
 API can be degraded at the site of administration (e.g., low pH in stomach)

 API may cause local irritations or injury when they are present at high concentrations at the site of
administration
 API can have unpleasant organoleptic qualities (taste, smell – compliance!)
 Administration of active substance would mean to have no chance for modification (improvement) of
its PK profile
2) Pharmaceutical Excipients/ Additives/ Necessities
 Pharmaceutical necessities or excipients are non-drug ingredients added to the dosage form to build
these properties into a delivery system.
 Any substance other than the active drug or prodrug that is included in the manufacturing process or
is contained in a finished pharmaceutical dosage form.
 They act as a carrier by which drug molecules are delivered to sites of action within the body.
 Excipients give shape to the formulation; increase its efficacy, stability, and palatability; and impart
elegance to the preparation.
Roles of Excipients in Pharmaceuticals:
 Modulating solubility & bioavailability of the drug
 Enhancing stability of the drug in its dosage forms
 Helping drug to maintain a suitable polymorphic form
 Maintaining pH and osmolality of liquid products
 Acting as antioxidants, suspending agents, emulsifier, aerosol propellants, base, tablet diluents
 Preventing aggregation or dissociation
 Modulating the immunogenic response of drug
Ideal Properties of Excipients:

Feasible
Pharmacologically inert
Cost effective
No Interaction with drug
Stable for handling
Classification of Excipients Based on Objective of Addition in Dosage Forms:

Excipients/Additives
Organic Stablizers Dose Accuracy Process aids Drug release
Compliance
Colors Preservatives Diluents Binder Disintegrant
Flavours Antioxidants Bulking agent Lubricants Penetration
Sweetners Emulsifier Filler Glidant enhancers
Suspending agent Antiadherant Coating agents

Classification of Pharmaceutical Dosage Forms

Based on:
I. Physical States/Properties
Types Examples
Liquid dosage Forms Syrups, Elixirs, Spirits, Linctuses, Mixtures ,Emulsions, Suspensions,
Collodion, Drops, Enemas ,Gargles, Gels ,Injections, Irrigations, Liniments,
Lotions, Mouthwashes, Sprays ,Tinctures, Paints
Solid dosage Forms Tablets,Capsules,Powders,Cachets,Granules,Lozenges,Pessaries,Suppositories
Semisolid dosage forms Creams, Jellies, Ointments, Pastes
Gaseous Dosage Forms Aerosols, Inhalation
Miscellaneous Transdermal drug delivery systems
Sustained release drug delivery system
Ophthalmic drug delivery systems
Implants
II) Route of administration
Route of Administration Dosage Forms

Oral Tablets, Capsule, powder, Syrups, Elixirs, Linctuses, gargles etc
Parenteral Sterile Solution, Sterile Suspension, Sterile emulsion
Topical Ointments, pastes, creams, jellies, lotion
Rectal and Vaginal Suppositories, Pessaries, douches, enemas
Pulmonary Inhalations, aerosols

Practice: Indicate the appropriate route of administration for the given dosage forms
Emulsion, tablet, creams, infusion fluids, elixir, spirit, sterile solution, aerosols, suppository, enema, pessaries,
douches, capsule, tincture, linctuses, vaginal inserts, conventional suspension, ointments, liniments, sterile
suspensions, pastes, colloids, inhalations, syrups, jells and gargles.
S.N Oral Route of Parenteral Route of Topical Rectal &vaginal Pulmonary
administration administration(IV,IM,SC) Route(skin, Route Route
mucous)
1
2
3
4
5
6
7
8
9
10
1.14. Compounding of liquid pharmaceutical dosage forms dosage forms

Dilution and Concentration of Pharmaceutical Preparations
 Stock solutions are concentrated solutions of active (e.g., drug) or inactive (e.g., colorant) substances
and are used by pharmacists as a convenience to prepare solutions of lesser concentration.
 Stock medication- Medication kept on hand for use in preparing prescriptions; medication of a higher
percentage of active ingredient that is used to prepare a medication of a lower percentage.
The strength of a pharmaceutical preparation may be increased or decreased by changing the proportion of
active ingredient to the whole.
Concentration:

The concentration of a liquid preparation, as through the evaporation of a portion of its solvent or vehicle,
rarely is performed nowadays.
 However, the fortification of a liquid, solid, or semisolid dosage form, by the addition of a calculated
quantity of additional therapeutic agent, remains a viable practice in pharmacy compounding
A preparation may be strengthened or made more concentrated by:
 the addition of active ingredient,
 admixture with a like preparation of greater strength, or
 through the evaporation of its vehicle, if liquid.

Dilution:
 The dilution of a liquid dosage form, as a solution or suspension, may be desired to provide a product
strength more suitable for use by a particular patient (e.g., pediatric, elderly, those in disease states).
 The diluent is selected based on its compatibility with the vehicle of the original product; that is,
aqueous, alcoholic, hydroalcoholic, or other.
 The dilution of a solid dosage form (as a powder or the contents of a capsule) or a semisolid dosage
form (as an ointment or cream) also may be performed to alter the dose or strength of a product.
The strength of a preparation may be decreased or diluted by:
 the addition of diluent or admixture with a like preparation of lesser strength
In order for these formulas to work:

a) Volumes and weights must be expressed in the same units.
b) Concentrations must be expressed in the same units.
c) Formula: V1 C1 = V2 C2
Where, V1 = Volume of stock preparation
C1 = Concentration of stock preparation
V2 = Volume of desired preparation
C2 = Concentration of desired preparation
d) Formula: W1 C1 = W2 C2
Where, W1 = Weight of stock preparation
C 1= Concentration of stock preparation
W2 = Weight of desired preparation
C2 = Concentration of desired preparation

Dilution of Alcohol
 Colorless and volatile liquid which is flammable

 Soluble in water
 Ensure the area where solution preparation occurs is well ventilated.
 Use appropriate personal protective equipment (as it irritates mucous membranes, the skin and the
airway)
 Used as antiseptic, preservative, mild counter irritant and as a solvent.
 Germicidal action occurs with concentration of 60-90%
 Metabolized in human body by series of oxidation
Practice:
Prepare 50ml and 100 mL of 70% ethanol from 96% stock solutions and label it
 98% ethanol stock solutions  Measuring cylinder
 Purified water  Bottle/Flask
 Paper
PROCEDURES:
1) Check the initial concentration of stock solution of ethanol you are using.
2) Determine the volume of the ethanol solution that needs to be prepared
3) Calculate the total volume of ethanol from stock solution required to make a dilute ethanol solution
by applying the following formula:
 Where, C1 and V1 are concentration and volume of stock solution respectively

 C2 and V2 are concentration and volume of dilute preparation (70%), respectively
4) Tare the bottle
5) Measure ethanol 96% stock solution
6) Add the calculated amount of Alcohol to the tarred dispensing bottle
7) Add the purified water to the bottle and adjust to the final volume
8) Clean the working equipments and environment.
9) Prepare Label and attach to the container
10) Complete recordings and documentation
11) Store the preparation to an appropriate storage place
Uses: Antiseptics and disinfectants
Direction for use: Apply to the affected area
Auxiliary Labels:
For external use only
Protect from light
Keep out of reach of children
Storage:
 Store in a closed container to protect from heat and light
PRACTICE: Dilution of Hydrogen Peroxide
 H2O2 It is clear, colorless liquid and water miscible.
 The chemical is odourless at low concentration, at high concentrations is slightly pungent
 H2O2 is a powerful oxidant
Practice:
Prepare 50ml of 3% and 6% H2O2 from 30% stock solutions
 Hydrogen peroxide 30%  Measuring cylinder
 Purified water  Bottle/Flask
Procedure:
1) Develop your working formula
2) Tare the bottle
3) Measure hydrogen peroxide
4) Add the calculated amount of hydrogen peroxide to the tarred dispensing bottle
5) Add the purified water to the bottle and adjust to the final volume
6) Clean the working equipments and environment
7) Prepare Label and attach it
8) Complete recordings and documentation
9) Store the preparation to an appropriate place
Indications/Uses: Antiseptics
 Mild oxidising Antiseptic
 As Cleanesing agent on cuts and wounds, In deodorants, Gargles and Mouth wash
Direction for use: Apply to the affected area
Auxiliary Labels:
For external use only
Protect from light
Keep out of reach of children
Storage: Store in a closed container to protect from heat and light

General Procedures for preparation of Solution

The following general method should be used in the preparation of a solution:
1) Write out the working formula either from the prescription (unofficial) or from an official text (official).
2) Calculate the quantities required for each ingredient in the formula to produce the required final
volume. Additionally, as far as is practically possible, the product will be assembled in the final measure,
thus reducing any transference losses.
3) Complete all sections of the product worksheet.
4) Prepare a suitable label.
5) Weigh all solids.
6) Identify the soluble solids and calculate the quantity of vehicle required to dissolve the solids fully. If
more than one solid is to be dissolved, they are dissolved one by one, in order of solubility (i.e. the least
soluble first). In almost all cases, dissolution will take place in a glass (or occasionally plastic) beaker, not
a conical measure. Remember that the solubility of the soluble solids will be dependent on the vehicle
used.
7) Transfer the appropriate amount of vehicle to a glass beaker.
8) If necessary, transfer the solid to a glass mortar and use the glass pestle to reduce particle size to aid
dissolution.
9) Transfer the solid to the beaker and stir to aid dissolution. If a mortar and pestle have been used to
reduce particle size, ensure that the mortar is rinsed with a little vehicle to ensure complete transfer
of the powders.
10) When all the solid(s) has/have dissolved, transfer the solution to the conical measure that will be used
to hold the final solution.
11) Rinse out the beaker in which the solution was made with a portion of the vehicle, and transfer the
rinsing’s to the conical measure.
12) Add any remaining liquid ingredients to the conical measure and stir.
13) Make up to final volume with remaining vehicle.
14) Transfer to a suitable container, label and dispense to the patient
PREPARATION OF IODINE TINCTURE (B.P, 1988)
Tinctures are alcoholic or hydro-alcoholic solutions of medicinally active ingredients obtained from vegetable
materials or from chemical substances.
Ingredients Send:30 mL 50 mL
Iodine ----------------------------------------- 25g
Potassium iodide -----------------------------25g
Purified Water -------------------------------25ml
Ethanol 90% q.s to------------------------1000ml
Prepare 30 mL 90% ethanol from a given stock solution.

Equipment/Tools
 Beam/digital balance
 Spoon spatula
 Watch glass
 Amber colored medicinal bottle
 Glass mortar and pestle/Erlenmeyer flask/ conical graduates
 Measuring cylinder
 Pipettes/droppers
 White paper
PROCEDURE:
2) Tare the bottle to the desired volume by using purified water
3) Weigh potassium iodide, and iodine
4) Measure Alcohol(90%) and purified Water
5) Dissolve potassium iodide in purified water by continuous stirring and adding small amount each time
6) Add iodine and shake it well
7) Transfer to the final tarred bottle
8) Then make the volume up to 1000ml with 90% ethanol
9) Shake well and then store in a closed wall container
10) Label it properly
11) Clean the working equipments and environment
12) Complete the Recordings and documentation
13) Store the preparation at appropriate place
ROLE OF INGREDIENTS
 Iodine------------------------------anti-septic and disinfectant/Active ingredient
 Potassium iodide---------------to enhance solubility of iodine
 Purified water------------------as drug carrier/solvent
 90% Ethanol---------------------as an anti-septic/solvent/co-solvent
USES: Act as anti-septic and disinfectant for minor cuts, wounds and abrasions
DOSE: Topically as prescribed by the physician
DIRECTION FOR USE: Apply to the affected part with cotton wool or a small brush
AUXILIARY LABELS
 For external use only
 Avoid prolonged use
 Do not cover
 Do not use on open wounds
 Protect from light
 Keep out of reach of children

STORAGE
Store in a closed container to protect from heat and light
PRECAUTIONS
 Iodine will stain plastic surface, take appropriate precautions.
 Care must be taken to avoid spillage during weighing and transfer
 The equipment and container must be spotlessly clean because this solution may stain the working
benches
Label for iodine tincture
Iodine Tincture B.P.
50 mL
Ingredients: Iodine---------------------5 g
Potassium Iodide-----------------------5 g
Use: As antiseptics for minor cuts
Dose: Topically as prescribed by physician. Avoid prolonged use
Directions: Apply to the affected part with cotton wool or a small brush
Preparation Date: Expiry Date:
Store in a closed container to protect from heat and light
For Externally use only
Do not use on open wounds
Keep out of the reach of children
Place of preparation: ------------------

Compounding of Semisolid Pharmaceutical Dosage Forms

Compounding of Topical Dosage Forms
The topical delivery system refers to a method in which the formulation is applied to the superficial areas such
as the skin, eyes, nose and vagina for the treatment of local diseases.
Classification of topical dosage forms
Topical dosage forms are classified into three major categories. These are solid topical dosage form (dusting
powder), liquid topical dosage forms (lotions, liniments), and semi-solid topical dosage forms (ointments, pastes,
creams and gels).
Ointments
Ointment is a homogeneous, viscous, semi-solid preparation, most commonly greasy, thick oil (oil 80% - water
20%) with a high viscosity that is intended for external application to the skin or mucous membranes. They are
used as emollients or for the application of active ingredients to the skin for protective, therapeutic, or
prophylactic purposes and where a degree of occlusion is desired.
Characteristics of ointments include:
o Viscous but Spreadable
o Greasy
o Occlusive
o Non-gritty
o staining
Pastes
Pastes are homogeneous, semi-solid preparations containing high concentrations of insoluble powdered
substances (usually not less than 20%) dispersed in a suitable base.
The pastes are usually:-

 less greasy, more absorptive, Stiffer in consistency than ointments because of the large quantity of
powdered ingredients present, and
 Pastes are well adsorbed on the skin.
Pastes can absorb watery solutions so that they can be used around oozing lesions.
Common excipients/additives for dermatological preparations
Excipients are commonly added to ensure stability over a given shelf life, to improve palatability, to facilitate
solubility, to bulk up formulations that contain highly potent active ingredients and to preserve from
microbiological contamination.
The common excipients that are added to dermatological preparations include:
o Ointment bases
o Solvents
o Preservatives
o Antioxidant
o Emulsifying waxes
o Buffering agents
o Gelling agents
Ointment bases
Activity: Individual reflection
What are ointment bases?
Mention ointment bases you know
Ointment bases are usually fatty, waxy or synthetic in nature. They are intended to soften but not melt when
applied to the skin.
There are two distinct purposes for an ointment base:
 As a vehicle from which drugs may be absorbed by the skin
 As a protective or emollient for the skin.
Ointment bases are generally classified by the USP into four groups:
a) Oleaginous (hydrocarbon) bases,
b) Absorption bases,
c) Water-removable bases, and
d) Water-soluble bases.

Oleaginous (Hydrocarbon) bases

 Oleaginous bases are also termed hydrocarbon bases.
 On application to the skin, they have an emollient effect, protect against the escape of moisture, are
effective as occlusive dressings, can remain on the skin for long periods without drying out, and because
of their immiscibility with water, are difficult to wash off.
Common hydrocarbon bases in use include:
o Yellow/White Soft Paraffin BP
o White Soft Paraffin BP
o Hard Paraffin BP
o Liquid Paraffin BP
Absorption (Emulsifiable) ointment bases
These bases are capable of absorbing water and aqueous solutions to form water-in-oil (w/o) emulsions. They
consist of one or more of the paraffins combined with a sterol type of emulsifying agent such as:
 Wool fat (Anhydrous lanolin)
 Hydrous wool fat (Lanolin)
 Wool alcohol
 Beeswax
 Cholesterol
Absorption bases are of two types: Non-emulsified and Water-in-oil emulsions
 Non-emulsified bases
- permit the incorporation of aqueous solutions resulting in the formation of water-in-oil (w/o)
emulsions (e.g., hydrophilic petrolatum) and
 Water-in-oil emulsions (also called emulsion bases)
- permit the incorporation of additional quantities of aqueous solutions (e.g., lanolin).
Water-Removable (Water-Washable) Bases
 These bases are miscible with large amounts of water. Ointments made from such bases are easily
removable after use.
 Water-removable bases are o/w emulsion bases, commonly referred to as creams, and represent the
most commonly used type of ointment base.
 The three anhydrous water-miscible ointment bases are as follows:
o Emulsifying ointment B.P. (contains anionic emulsifier).
o Cetrimide emulsifying ointment B.P. (contains cationic emulsifier)
o Cetomacrogol emulsifying ointment B.P. (contains nonionic emulsifier)

 An example of an ointment containing water-miscible base is compound benzoic acid ointment

(Whitfield’s ointment), which is an antifungal ointment.
 Hydrophilic Ointment, USP, is an example of this type of base.
Water-Soluble (Greaseless Ointment) Bases
 Water-soluble bases do not contain oleaginous components.
 They are completely water washable and often referred to as greaseless. Because they soften greatly
with the addition of water, large amounts of aqueous solutions are not effectively incorporated into
these bases.
 They mostly are used for incorporation of solid substances.
 Major components, and in some instances the only components, of water-soluble bases are the
polyethylene glycols (PEGs). In the BP PEGs are named „macrogols.
 PEGs are relatively inert, nonvolatile, water-soluble or water-miscible liquids or waxy solids identified
by numbers that are an approximate indication of molecular weight.
Preparation method for ointment, paste and cream
Ointments and paste can be prepared by two general methods depending primarily on the nature of the
ingredients;
A) Incorporation
B) Fusion
Incorporation (Trituration/ Levigation)
 The components (active drug and base) are mixed using a mortar and pestle (trituration), or a spatula
and ointment slab (levigation) until a uniform preparation is attained.
 In this method, finely divided drug substances are evenly distributed through small quantity of the base
by grinding (if necessary) followed by dilution with gradually increasing amount of the base (geometric
dilution).
Procedure:
a) Particle size of a powder or crystalline material should be reduced to make a smooth dispersion
- may be done by levigating or mixing the solid material in a vehicle (levigating agent in which it is
insoluble)
b) The base is placed on one side of the working surface and the powdered components on other side
c) A small portion of the powder is mixed with a portion of the base until uniform.
- Add soluble solids to the molten fatty bases (pre-prepared base) at the lowest possible temperature
and the mixture stirred until cold
- incorporate insoluble solids using a glass tile and spatula

Figure: Geometric dilution in levigation by spatula on ointment slab
Figure: Geometric dilution in trituration using mortar and pestle

Fusion method
 Fusion method is used when the melting the starting material is needed for appropriate mixing the
components.
General tips about compounding ointment, paste and cream
 Between 2 and 4 grams of product may be lost by adhering to beakers, ointment tiles, or ointment pads
in the compounding process. To compensate for this loss, make an excess of the product. Some general
rules might be to add 10% excess to the prescribed amount.
 When heat is used to melt ingredients, use a water bath or special low temperature hotplate.
 Most ingredients used in ointment bases will liquefy around 70°C.

Compounding of Ointments
Compounding of Emulsifying Ointment, BP using the following master formula(MF)
Master Formula
Emulsifying Wax……………………………..30 %
Liquid paraffin………………………………..20 %
White soft paraffin……………………………50 %
Send 25g
Procedure:
1. Add the emulsifying wax to an evaporator basin over water bath and melt at 70°c
2. Add the white soft paraffin and stir until melted
3. Add the liquid paraffin to the melted ingredients
4. Stir until congeal
Uses:
 As emollient to moisturize and soften dry skin in eczema, dry cases of psoriasis and other dry skin
conditions.
 As a base/vehicle.
Role of the ingredients
 All are components of ointment base
Packaging
 Pack in a well-closed container.
Storage
o Store at room temperature and protect from moisture.
Dose and administration
Apply to the affected area as often as required.
Smooth gently into the skin in the direction of the hair growth.
Compound Benzoic Acid Ointment BP (Whitfield's Ointment) (BP, 1988)
Master Formula(ingredients) Send:25g 50g
Benzoic acid………………………….60 g
Salicylic acid…………………………30 g
Emulsifying ointment……………….910g

Equipment/Tools
o Beam/digital balance
o Flexible spatula
o Ointment slab/tile
o Waxed papers /watch glass
o Weighing paper
o Glass rods
o Water bath/hotplate
o Spoon spatula
o 180µm sieves
o Ointment Jars
o Label –white paper
PROCEDURE:
2) Sift the medicaments through separate 180µm sieves
3) Weigh Benzoic acid and Salicylic acid powder after sifting and mix them
4) Place the mixed Benzoic acid and Salicylic acid on one side of the tile
5) Weigh the required amount of Emulsifying Ointment (using a piece of waxed paper), and place it on
one side of the tile
6) Take a portion of the base (about two to three times the weight of the power) and levigate it with the
powder mixture until there is no sign of any gritty particles (This can be checked for by spreading a thin
layer on the tile).
7) Gradually incorporate the remaining base in portions geometrically and continue levigation until
uniformly mixed
8) Finally, collect the ointment together to the center of the tile using the spatula and pack into an ointment
jar Clean the working equipments and the surroundings
9) Label and Write short report/complete the Recordings and documentation
10) Store the preparation to an appropriate place
Note:
salicylic acid very irritant to the respiratory tract and precautions should be taking to avoid inhalation.
levigate with two or three times their weight of the base until homogenous.
Gradually incorporate the reaming base.

Dose: Apply twice a day.

Use:
 Benzoic Acid BP has antifungal and antibacterial properties and this ointment was commonly used to
treat fungal infections of the skin.
Container: Wide-mouthed amber jars with a greaseproof paper disc
Advice for patients when dispensed:
The ointment should be applied sparingly to the affected area. It should not be applied to the broken
or inflamed skin
Role of the ingredients
Benzoic acid: active ingredient
Salicylic acid: active ingredient
Emulsifying ointment: ointment base
Compounding of Solid Dosage Forms
Compounding of Powders
Powders are intimate mixtures of dry, finely divided drugs and or chemical that may be intended for internal
or external use (e.g. external applications to the skin).
The classification of powders is as follows:
1) Bulk powders:
 Medication in bulk powder forms is limited to non-potent substances.
 Examples of powders taken in the bulk forms are medicated topical anti-infectives such as polymyxin
B sulfate, tolnaftate, etc., douche powders for vaginal use such as Massengill powder, reconstituted
antacid preparation such as sodium bicarbonate, laxative such as psyllium, etc.
2) Divided powders:
 These are properly blended by using geometric dilution method and then based on the amount to
be taken at a single time are divided as single dosing units.
 The divided powders are packed in small piece of paper folded to enclose the medication.
 Examples: Powdered laxatives, douche powder and analgesic powders.
3) Dusting powders:
 Dusting powders are used externally for local application, not intended for systemic action.
 It should contain a label as “FOR EXTERNAL USE ONLY.” The categories of drugs dispensed are
lubricants, protectives, adsorbents, antiseptics, antipruritics, astringents and antiperspirants.
 Dusting powders can be classified into the following two types:
a) Medicated dusting powders: These are the bulk SDFs, which are intended to be applied on the
intact skin for local action.

b) Surgical dusting powders: These are the bulk SDF, which are intended to be applied into the deep
layers of the skin. These preparations need to be sterile as it comes in contact with open wounds and
deep layers of the skin.
Preparation of Oral Rehydrating Salts (ORS)
ORS is a simple, cheap and effective treatment for diarrhea-related dehydration, e.g. cholera or rotavirus. It
consists of a solution of salts and other substances such as glucose, sucrose, citrates or molasses, which is
administered orally. It is used around the world, but is most important in the Third World, where it saves
millions of children from diarrhea, still their leading cause of death.
ORS are oral powders, containing either anhydrous glucose, sodium chloride and potassium chloride and
sodium citrate or sodium bicarbonate. After being dissolved in the required volume of water, they are intended
for the treatment of dehydration due to diarrhea including maintenance therapy. It is recommended by diarrheal
disease control, program of WHO and UNICEF.
Practice:
Prepare and dispense one dose of oral rehydration powder for 1000 ml of oral rehydration
solution (ORS)
Ingredients Mitt:100 mL doses Mitt: 500 mL doses
Sodium Chloride………………………….5.0 g
Potassium chloride……………………….7.50 g
Sodium Bicarbonate……………………..7.50 g
Anhydrous Glucose……………………....182 g
Send:1000 ml doses
Equipment/Tools
o 250µm sieve
o Beam/digital balance
o Weighing paper
o Mortar and pestle
o Spoon spatula
o Powder papers
o Label –white paper

Compounding Procedures
1. Wash your hands
2. Wear personal Protective Equipment(Gown, Glove, Goggle)
3. Clean the working lab bench
4. Develop your working formula
5. Weigh All ingredients, make a small excess to allow for losses in the mortar
6. Mix the powders in a mortar in order of increasing bulk
7. Pass the resulting mix through a 250µm sieve, lightly remix and pack
8. Label
9. Clean the working equipment’s and the surroundings
10. Complete the recordings and documentation
11. Store the preparation to an appropriate place.
Develop working Formula:
Wrap each dose (4.04 g) in powder papers, or supply each dose in an individual amber glass screw capped jar
or plastic pot
ORS 40.4g
Sodium Chloride………………………….1.0 g
Potassium chloride……………………….1.50 g
Sodium Bicarbonate……………………..1.50 g
Anhydrous Glucose……………………....36.4g
Each dose of 8.08 g is usually packed separately in an individual amber glass jar or plastic pot. Each dose of this
powder is dissolved in 200 mL of recently boiled and cooled water to make a solution used for rehydration
and electrolyte replacement in the treatment of diarrhea.
USES: Prevention and treatment of dehydration
DOSE: Depending upon the age and severity of dehydration
Infants and children: 1-2 litres (5-10 glasses) over a period of 24 hours
Adults: 2-4 litres (10-20 glasses) over a period of 24 hours
DIRECTIONS FOR USE: Dissolve in one litre of water to be taken orally and continue treatment until
diarrhea stops. Solutions to be used within 24 hours.
STORAGE: Store in a cool and dry place
PRECAUTIONS
 Use with caution in impaired renal function or intestinal obstruction
 Close tightly after every use and keep away from moisture
 Hot water should not be used as it may lead to breakdown of bicarbonate and alteration in flavor
 Do not use if the solution is coloured.
 Always use freshly prepared solution.
 The solution made should not be used 24 hours after its preparation.
 Use clean utensils to make solution.
Pharmacological Actions:
Sodium chloride
 As you know, sodium is the main ion involved in various processes in the body, e.g. action potential
generation. It helps to maintain muscle tone.

Anhydrase Glucose
 Glucose is the source of energy.
 Apart from that it helps in absorption of sodium.
 Molar ratio of glucose is more than sodium in ORS. Sodium is absorbed through facilitated diffusion or
cotransport with the help of glucose.
Sodium Bicarbonate
 Other contents provide sufficient amount of potassium, chloride and bicarbonate lost in diarrhea.
Sodium citrate is the source of HCO3-and also provides stability to the solution.
Potassium chloride
 Influences the muscle action and ameliorates the cramps.
 Chloride helps to maintain the fluid balance and production of gastric acid.

2. PROVIDE COMPASSIONATE, RESPECTFUL AND CARE TO GIVE INFORMATION ON

NUTRITIONAL SUPPLEMENTS
Instruction: under this project the candidate is expected to perform the task based on the information provided.
Task 1: Information:
The age of the baby is 10month, and the mother was giving only her breast milk and she need additional formula
feed from the pharmacy. The assessment center will assign one person to act as mother character.
Task 2: Information:
A mother, who is HIV Positive, come to ART Pharmacy. When she comes to pharmacy, she was with her baby
both her baby who age is 2 month. The mother told to pharmacist as she has been feeding her baby both her
breast milk and formula feed.
Task 1: Provide information on nutritional supplement and CRC Service.
Task or activity Yes No
The provider greets the client respectfully
The provider introduces him/herself to the client
The provider called the name the client by name
The provider properly address patients considering their social status and age of the
baby
Asking the customer if the baby used formula feed before
Engage himself/herself with the client (Making conversation)
Actively listening what the client is saying
Understand the client’s need
Actively understand patients emotions
Show relational communication
Use supportive words
Respond promptly and professionally when the client ask a questions
Address the varies needs of the client
Involve the client in treatment options
Allocates adequate time to the client to discuss issues
Respects patient’s view on treatment and care
Ensures confidentiality of patient information
Maintains privacy in providing clinical care

Verbally abuse patients
Treat patients equally without discrimination
Use of the formula feed
How to use formula feed
Storage condition
Frequency and Shelf life
3.USE DAGU OR HEALTH COMMODITIES MANAGEMENT AND INFORMATION

SYSTEMS(HCMIS) SOFTWARE TO ENTER TRANSACTIONS IN PHARMACY STORE
HCMIS Exercise
Receiving the following Items:
1. Bole 17/20 Health Center receives 100 boxes of Cotrimoxazole 120mg (Sulphamethoxazole 100mg +
Trimethoprim 20mg) tablet of 10x10 with two batches from XYZ Pharmaceutical company for OI
Program information provided with the receipt is:
a. Cotrimoxazole 120mg tablet 60 boxes with batch number 154620 and 40 boxes with batch
154622 and with expiry date of October, 2020 price per pack is 125 birr. The receiving model 19
number is 002345 as of today.
2. PFSA supplies Bole 17/20 Health center with the following products(see the attached PFSA STV)
Please receive to program store with model 19 no. 002356 as of today.
Issuing the Following Items
3. Bole 17/20 Health center has opened new DU called Feeding Center for malnutrition in children and
mother. Sr.Ayinalem the assigned for this DU requested store for supply of Sulphamethoxazole 100mg +
Trimethoprim 20mg tablet and Nevirapine (NVP) 200mg Tablet with IFRR. The store keeper issued the
items using his model 22(25913) please issue to feeding center as of today. The DU has bi-weekly
schedule.
4. Please issue the items in the IFRR to the reporting DU (see copy of IFRR) with model 22 no 25914 as of
today.
Record losses and adjustments
5. Bole 17/20 Health center, store manager found 2 boxes of Nevirapine (NVP) 200mg of 60 tablet with
the same batch what he had in the Program store. Adjust the found Nevirapine.
6. Bole 17/20 Health Center has overstock of Lamivudine (3TC) + Zidovudine (AZT) (150mg + 300mg)
and wants to transfer 2 boxes of 60 tablets to shire HC. Do the transaction Ref No is 192021.

Stock Transfer Voucher Form (STV)
Bole 17/18 Health Center
Internal Facility Report and Resupply Form (IFRR)

PART II: THEORETICAL/KNOWLEDGE
KNOWLEDGE ASSESSMENT
1. ------------ Is the kind of care, in any setting, which supports and promotes, and does not
undermine a person’s self-respect, regardless of any differences.
A. Sympathy
B. Respect
C. Stigma
D. Equity
2. In the provision of first aid care critical/emergency case, identify the one which is less important to check?
A. Breathing
B. Body temperature
C. Circulation
D. Airway
3. Identify the storage condition which is best describes “refrigerator temperature”?
A. 8-150c
B. 15-250c
C. 2-80c
D. Below 00c
4. Identify the role of amaranth solution in the preparation described below
Alkaline phenol
Phenol---------------------------30ml
Potassium hydroxide 5%------30Ml
Amaranth solution---------------1Ml
Water to--------------------------1000Ml
Mitt: 50ml
A. Active ingredient
B. Cleansing agent
C. Solvent
D. Coloring agent
5. Identify the excipient with the primary role of promoting adhesion of active and inactive ingredients in
tablets?
A. Diluents
B. Binders
C. Preservatives
D. Disintegrating agent
6. Among the following communication practices, identify the one is the most appropriate/acceptable?
A. Maintaining optimal proximity during communication with the second party.
B. Facing our heads down during communication with the second party.
C. Crossing our legs over knee during communication with the second party.
D. Putting hands in our pocket during communication with the second party.
7. A business breaks even at the level of output where
A. Total revenue = total costs
B. Variable costs=fixed costs
C. Fixed costs=total revenue
D. Total profits=total costs

8. ----------------is defined is being sensitive to the pain or suffering of others and a deep desire to alleviate
the suffering.
A. Impartiality
B. Respect
C. Care
D. Compassion
9. Identify the dosage form which requires shaking prior to usage?
A. Syrup
B. Elixir
C. Tincture
D. Emulsion
10. Monitoring implementation of work plan --------- can be solved through provision of on job training or
formal training for staffs.
A. Equipment failure
B. Delays and time difficult
C. Competence
D. Customer dissatisfaction
11. A solid dosage form designed mainly for insertion into the rectum to exert local or systemic effect?
A. Tablets
B. Capsules
C. Suppositories
D. powders
12. Solid dosage forms in which the medication is contained within hard or soft gelatin shell?
A. Tablets
B. Capsules
C. granules
D. Powder
13. All systems which ensures activities involving planning, quality control, quality assessment, reporting and
quality improvement is known as
A. Quality management
B. Quality assurance
C. Quality control
D. Quality assessment
14. The patient was under IV infusion of malarial treatment with the drops of medicine that pours at the rate
of 10drops/ml of 1L volume and finished within 4hrs.What was the rate of the IV infusion
A. 4.2 drops/min
B. 84 drops/min
C. 42 drops/min
D. 22 drops/min
15. What are the parts involved in the dilution of 95% and50% of alcohol to get 70% alcohol.
A. 25:20
B. 4:5
C. 30:5
D. 15:20
16. _______ are biphasic liquid dosage form of medicament in which the finely powdered solid particles
are suspended or dispersed in a liquid
A. Emulsions
B. Suspensions
C. Solutions
D. All of the above
17. One of the following is not Barrier for effective communication?

A. Language
B. Educational level
C. Value and beliefs
D. None of the above
18. The preparation, mixing, assembling, packaging, and labeling of a drug is referred to as:
A. Dispensing
B. Compounding
C. Sorting
D. Selecting
19. The process of sampling, specification, testing and release of procedures to ensure the quality of the
product is
A. Quality assurance
B. Good manufacturing practice
C. Quality control
D. None of the above
20. If we say expiration date for commercial drugs, we can say---------for extemporaneous.
A. Stability C. Shelf-life
B. Beyond use date D. Expiration date
21. Are non-medicinal agents that are used stabilize, dilute, suspend, preserve, color, flavor medicinal agents
into efficacious and appealing dosage forms.
A. Excipient C. Active ingredient
B. Gargles D. Spirits
22. Is the substance in dosage form which has activity desired for medicinal purpose?
A. Excipient C. Active ingredient
B. Gargles D. Spirits
23. A prescription called for procaine penicillin 400,000 IU BID for 07 days. How many vials of 4,000,000 IU
should be dispensed?
A. 1 vial C. 3 vials
B. 2 vials D. 4 vials
24. Which one of the following is water soluble vitamin_______
A. Vitamine A C. Vitamine E
B. Vitamine C D. Vitamine D.
25. If 2ml of a drug is 48drops. How many drops for 0.08ml?
A. 1ml B.2ml C.4ml D.3ml
26. In which stages of team develop conflict in the previous stages are addressed?
A. forming B. storming C. norming D. performing
27. Which one of the following is male contraceptive?
A. COC B. POP C. Tubaligation D. Vasectomy
28. Which one is mismatched matched?
A. PRN –as necessary C. PO- by mouth
B. PC- before meals D. OU- right
29. How many milliters of 1: 400 (W/V) stock solutions should be used to 1:2000 make 4liters?
A . 600 B . 80 C. 800 D.60
30. _____is understanding and how one perceives one’s feelings and thoughts
A. Empathy B. Motivation C. sensitive D. Sympathetic
31. ___is generally conducted with the person’s line manager and the focus is generally on day to day work
activities and job performance improvement
A. Mentoring B. Coaching C. supervising D. management
32. . _____ study about structure of the body?

A. Physiology B. Cytology C. Anatomy D. pathology
33. Which one of the following is fat soluble vitamin?
A. B B.C C.A D. None
34. Tablespoonful is equal to
A . 5ml B .30ml C. 15ml D. 20ml
35. .____is a source or situation with the potential for harm in terms of human injury or ill-health, damage to
property, the environment, or a combination of these
A. Safety B. Welfare C. Hazard D. Occupational health
36. Druggist is ‘just too busy’ in a high volume drug store OPD pharmacy.
A. Environmental barrier B.Work place barrier
C. Time barrier D. Personal barrier
For PCP adjuctive treatment prodnisolone 40mg BID for 5days than 40mg QOD for 5days then 20mg QD FOR
11days if the available dose of predenisolone is long calcluatilotel dispensed for 21 days?
A.62 B.84 C.82 D.92
1. Qid________________Every day
2. Qod________________Every other day
3. Noct_______________Ati night
4. Ou_________________Both eye
5. Os_________________Left eye
6. Od________________Right eye
7. Rx________________Take
8. Human body ________Anatomy
9. Human funaction_____Physiology
10. Vaginal_____________Pissarie
11. Commincate_________TB
12. Vitamine C-_________Scarve
13. Vitamine D_________Rwckets
14. Vitamine E_________Oxidation
15. Leader_____________Which person
16. Manager____________Dose right things
17. Shaking____________Syrup
18. 20mg______________0.02gm
19. FMACA___________Ethiopia
20. 2-8co___________________Refrezeter(Cold)
21. Gtt___________________________drop
22. Teaspoonful____________________5ml
23. Tebles spoonful_________________15ml
24. AC___________________________befor meal
25. PC___________________________after meal
26. Vitamine B deficiency___________pellagra
27. Vitamine C deficiency___________scurve
28. Potential for harm_______________hazards
29. Asubstance which cause harm______toxin
30. W/O__________________________oily cream
31. All food contain ________________nutrients
32. West fully activity_______________muda,mura,muri

33. O/W__________________________aqueos cream

34. Compassionate__________________feeling of deep sympathy
35. Sympathy_______________________ability to feelings or concernsof others
Matching
A B
1. Respect E A. W/O emulsion
2. before meal C B. Kind of care
3. Oily creams A C. a.c
4. Nutrients D D. Content of food
5. Care E E. It is coupled with effective interventions to
6. Drops F alleviate that suffering
7. Toxin J F. gtt
8. After meal N G. Substance which cause harm
9. Compassionate H H. Is a feeling of deep sympathy
10. Muda I I. Wasteful Activity
11. Muri O J. Potential to harm
12. Scurvy K K. Vitamin C deficiency
13. Hazard G L. Teaspoonful
14. Teaspoonful(tsp) P M. Vitamin B3 deficiency
15. tablespoonful(Tbsp) R N. P.c
16. Non greasy Q O. Overburden
P. 5ml
Q. Jelly
R. 15ml
Matching
A B
1. Study of the functions of body organs P A. Every other day
2. Ethiopian drug regulatory body L B. at bed time
3. Study of human body K C. at night
4. QOD A D. Norming
5. h.s B E.to be applied on inanimate object
6. noct C F.left eye
7. o.s G. Right eye
8. o.d H. to be applied on ananimate surface
9. Rx I I.You take
10. QD M J. Transforming
11. Q4D R K. Anatomy
12. Antiseptics E L.FMHACA
13. Disinfectants H M. Every day
14. Playful interactions N.a person who does thing right
15. reflect the truly synergistic result of highly performing team J
a peson who does right thing
P. Phsiology
Q.Tuberculosis
R.Every four hour

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SKILL GAP TRAINNING MATERIALS FOR

PHARMACY LEVEL BASED ON OCCUPATIONAL

Occupation: Pharmacy Pharmacy Level: III

HLT PHS3 01 0218 Use Pharmaceutical Calculation Techniques and Terminologies

HLT PHS3 02 0218 Assist Extemporaneous Preparations

HLT PHS3 03 0218 Provide Information on Nutritional Supplement

HLT PHS3 04 0218 Provide Compassionate, Respectful and Caring Service

HLT PHS3 06 0218 Detect Pharmaceutical Health Hazards and Act

HLT PHS3 07 0218 Apply First Aid and Emergency Response

HLT PHS3 08 0218 Use New Technology and Software Application

HLT PHS3 09 0218 Monitor Implementation of Work Plan/Activities

HLT PHS3 10 0218 Apply Quality Control

HLT PHS3 11 0218 Lead Workplace Communication

HLT PHS3 12 0218 Lead Small Teams

HLT PHS3 13 0218 Improve Business Practice

HLT PHS3 14 0218 Prevent and Eliminate MUDA

Pharmacy Level III By T3(Pharmacist) Page 1

1. ASSIST EXTEMPORANEOUS PREPARATIONS

Compounding includes the following:

 Unavailable dosages, strengths and routes of commercial products

Pharmacy Level III By T3(Pharmacist) Page 2

1.3. Distinguishing Compounding from Manufacturing

Compounded versus manufactured medications

Compounded medications Manufactured medications

Must be prescribed by a licensed prescriber for Is commercially marketed to drug wholesalers

1.4. Nonsterile and Sterile Pharmaceuticals compounding

Nonsterile Pharmaceuticals compounding (NSPC)

 Nonsterile compounding refers to creating compounded medications outside of a laminar hood or a

Sterile Pharmaceuticals compounding (SPC)

 Examples: Injections, Eye preparations, Total Parenteral nutrition’s

1.5. Good Compounding Practice (GCP)

General compounding principles

 System must be in place to reduce any risk of contamination and cross-contamination.

 Quality control (QC) and assurance system must be in place.

 All aspects of compounding must be appropriately documented.

Pharmacy Level III By T3(Pharmacist) Page 4

Standards/ Requirements for Good Compounding/Manufacturing Practice

The basic requirements that GCP encompasses include mainly:

Designated pharmacist or pharmaceutical technician shall:

 Clean the compounding area and the equipment if necessary.

 Perform the calculations to determine the quantities of the ingredients needed.

 Select the proper equipment and making sure it is clean.

 Proper compounding record should be maintained.

Pharmacy Level III By T3(Pharmacist) Page 5

 Register the information in the compounding log and documented.

 Cleaning and storing all equipment.

 Cleaning the compounding area

1.7. Hand Hygiene/Hand Washing

Pharmacy Level III By T3(Pharmacist) Page 6

9. Repeat the scrubbing procedure a second time, for 1 to 2 minutes.

Practice: Hand hygiene/Hand washing procedures

1.8. Donning Gloves

Pharmacy Level III By T3(Pharmacist) Page 7

Procedure: Proper Removal and Disposal of Gloves

1.9. Donning of Face Masks

Pharmacy Level III By T3(Pharmacist) Page 8

1.10. Cleaning and Disinfection

General Cleaning of Compounding Premises and Equipment

Pharmacy Level III By T3(Pharmacist) Page 10