[Elective, 20 points]
B19: PREPARATION OF PHARMACEUTICAL
PRODUCTS
Domain 5: Prepare pharmaceutical products
Standard 5.1: Consider product requirements
Standard 5.2: Prepare non-sterile drug products
LEARNING OUTCOMES
On completion of the activity, students should be able to:
1. Safely, accurately and efficiently prepare an extemporaneous product under
supervision utilising appropriately the work space and equipment available in the
pharmacy.
2. Complete a record of the process in sufficient detail so that another pharmacist
could use this record to prepare the same product in a safe and efficacious manner.
3. Reflect on their compounding knowledge and skills
BACKGROUND
In carrying out this task, you should prepare a pharmaceutical product that is effective and
safe for use by the client. To achieve an acceptable standard of product, you will need to
complete the following steps:
1. Identify the required product from the prescription
2. Record any calculations on the batch sheet
3. Record the proposed method for this product on the batch sheet. Discuss the
method with your preceptor. Remember to record the type of the final container
used
4. Present your batch sheet to your preceptor for checking before proceeding to the
next step
5. Select the correct ingredients. Ensure the ingredients are in date ie check the expiry
date
6. Prepare the label according to the prescription directions.
7. Prepare your product. This requires you to complete the batch sheet. Ensure that all
weighings and measurements are checked and that the signature of the checking
pharmacist appears alongside each relevant step in the compounding process. You
must write neatly as another person must be able to read your notes. The
preparation of this product should be completed in a timely manner.
8. A copy of the dispensed label including any additional labels used should also be
affixed to your batch sheet.
9. Present you completed product and batch sheet to your preceptor for final checking
There is an example of a completed extemporaneous worksheet on the following page.
It is the student's responsibility to ensure:

they are prepared to undertake the task

the batch sheet, including calculations and proposed method, is presented to the
preceptor for checking prior to commencement of compounding (safety)

they are familiar with the weighing apparatus

this task should be undertaken without interruption (efficient)

equipment must be cleaned immediately before and after manufacturing the product
(efficient)

the self assessment form is completed, discuss the effort with your preceptor and
construct a skills development plan.
Preceptor role and responsibilities
The amount of extemporaneous dispensing and manufacturing varies widely from pharmacy
to pharmacy. Please expose the student to the range of compounding undertaken in your
pharmacy.
If you perform in-house quality control on finished products it would be appreciated if the
students can be exposed to this practice element.
Page 2 of 15
Preceptors are asked to check and sign the student's work prior to starting the product. This
includes a brief discussion of the method and assessing the product after completion, and
signing the relevant sections of the batch sheet.
Remember confidentiality requirements
Page 3 of 15
Task(a): Prepare Pharmaceutical Products
You are asked to prepare products as directed by your preceptor. Below is an example of
how to complete the Compounding template for a product, Resorcinol and Sulphur
Ointment Compound, that you have been asked to prepare.
Name of product:
Resorcinol and Sulphur Ointment Compound
Date prepared:
19 March 2009
Source of Formula:
APF 17th edition
Prescription Number: 692462
Product Expiry Date: 19 April 20091
Ingredient
Quantity in
formula
Quantity
used
Resorcinol
2
Sulphur
Precip.
Student To
sign when
measured
or weighed
Pharmacist
to sign
when
checked
Batch Number
Expiry date
4grams
SI26RA
3/2013
3
6grams
AJ30947
4/2011
Salicylic Acid
1
2grams
FHF278DG6
10/2011
White
Simple
Ointment
94
188grams
FHF7828364R
4/2012
Method:
As per APF 17th edition page 430
The resorcinol was finally powdered on a slab using a heavy spatula. Each powder was
triturated separately with a small amount of white simple ointment until smooth. They
1
Not all extemporaneous prescriptions are given an expiry date but it is reasonable practice to date a product
to discourage hoarding of medications for many years after intended use.
Page 4 of 15
were then mixed together and doubling up incorporated into the remainder of the base.
The finally mixed ointment was transferred to an opaque 200gram plastic ointment pot.
Label:
Caution Not To be Taken
For External Use Only
Resorcinol and Sulphur Ointment Compound
Apply to the affected skin twice daily
Patient Name
Prepared 19/3/01
Batch 692462
Store below 25OC
Expiry date 19/03/02
Page 5 of 15
Compounding template
Product number ........
Name of product:
Date Prepared:
Source of Formula:
Prescription/order Number:
Product Expiry Date:
Ingredient
Quantity
in
formula
Quantity
used
Student to
sign when
measured or
weighed
Pharmacist
to sign when
checked
Batch
Number
Expiry
date
Page 6 of 15
Method:
Attach Label:
Preceptor FEEDBACK:
This form should be submitted in your portfolio.
Page 7 of 15
Student self assessment form
You are asked to reflect on your skill for each product you compound. This self- assessment form
contains a number of process criteria that relate to the task. Use this self assessment form to reflect
on your effort and consider how you could improve next time.
Place a tick in the left hand column if you satisfied the criterion and a cross if you did not. Again, be
honest with yourself. Then ask your tutor to do the same. Where there are areas of difference, or
where you have identified areas where you need to improve, discuss with your tutor an action plan
that will address those areas. Complete one of these forms for each product and use it as a feedback
tool when you discuss your effort with your pharmacist
Process criteria
Completed/not completed
Student review Tutor review
Research stage
Correctly identified the required product from the
prescription/order
Proposed formulation identified from texts/references or
formulation devised
Preparation Stage
Batch sheet used
All ingredients correctly recorded on batch sheet
Expiry dates of ingredients checked and recorded on
batch sheet
Batch number of ingredients recorded on batch sheet
Calculations recorded on batch sheet
Method recorded on batch sheet
Final container details recorded on batch sheet
Calculations, selection of ingredients and method
checked by supervising pharmacist prior to moving to the
production stage
Production stage
Weighings and measurements for each ingredient
checked and initialled on batch sheet by supervising
pharmacist
Finishing stage
Ensure label is correct
A copy of the dispensed label (including additional labels
if required) affixed to batch sheet
Completed batch sheet and product checked and signed
off by the supervising pharmacist
You do not need to submit this self-assessment form in your portfolio. These are
designed to assist you to reflect on your skills around compounding in preparation
for tasks (b) and (c) and to use as a tool in discussing your effort with the
preceptor.
Page 8 of 15
Preceptor Assessment of Student - Compounding skills
This assessment to be completed at end of placement
Skills assessed at end of placement; good manufacturing procedures; understanding of
quality assurance; ability to complete documentation accurately and appropriately;
compounding skills, correct labelling, acceptable product, product completed in a timely
manner
Evaluation (Mark) Key:
1= Very poor: Needs extensive prompting. Sometimes the preceptor must complete the
task. Knowledge/skills base is lacking.
2= Poor:
Needs consistent prompting. Preceptor must provide directed questioning in
a problem-solving manner. Knowledge base is poor.
3=Average:
Requires occasional prompting. Performs within expectations with some
input by tutor. Knowledge base is average – able to askewer many questions
4= Good:
Requires little prompting to meet expectations. Performs in a manner that
would require minimal supervision if not a student. Knowledge base is good
– able to answer most questions.
5= Very Good: Requires no prompting. Performs above expectations in a manner that would
not require supervision if not a student. Demonstrates confidence,
efficiency, and proficiency.
N/A = not applicable
------------------------------------------------------------------------
Score:
Preceptor comments:
Strengths
Areas for improvement
Preceptor signature: ……………………………………. Date /
/
This form needs to be submitted in your portfolio
Page 9 of 15
Reflecting on your level of competency in Compounding Skills c
Background
Any skill takes time to learn and to master. At your stage, you are becoming an “advanced
beginner”. You have had the opportunity to develop basic compounding skills at university.
Now you have had the opportunity to test your skill in the real life environment in a public
situation (even though you are still under supervision) and take the opportunity to further
develop and refine your skills.
Preparation
Read the criteria, reflect on your current level of knowledge and skills around compounding
and complete the table on the following page. This will help you identify areas of strength
and areas where you need to further develop your knowledge and skills. As you move from
left to right, this signifies improvement in the criteria being assessed. Use your reflections to
assist your develop your CPD.
Criteria
Increasing degree of development
A
B
Competent
C
D
Level of
support
Significant
assistance or
direction needed
Minimal
assistance or
direction
Guidance
(prompting, cues)
Able to
complete task
independently
Time taken
for preparing
for the task *
Significant time
needed to
prepare/research
Some
additional
time needed
to prepare/
minimal
research
needed
Little additional
time needed for
preparation/any
research
completed
efficiently
Undertakes
preparation
effectively and is
time efficient
Time taken
for doing the
task **
Significant time
needed to
complete task
Some
additional
time needed
Little additional
time needed
Prioritises
effectively and is
time efficient
Problem
solving
Has some
knowledge, little
application ability
Has knowledge
and recognises
some aspects
of problem
solving
Knowledge
mostly integrated
and applies some
aspects of
problem solving
Identifies all
problem aspects
and integrates
Page 10 of 15
Notes
*”Prepare’ means undertaking mental rehearsal of the upcoming task; “Research” means
preparation of materials necessary for the task
** Time (and efficiency) of undertaking the task, appropriateness of the chosen structure
used in completing the task,
“A, B, C and D” relate to the descriptors for each of the phases you go through as you move
from beginner to competent. For example, for the criteria “Level of Support, say you needed
significant direction and support for your first effort at patient counselling, you then would
put A under FIRST in the following table. However by the end of the placement you had
improved such that you now only needed minimal assistance or direction. Thus, you would
place B under LAST for the criteria “Level of support”. Do this for each of the other criteria.
Performance
Criteria
Evidence Guide
Level of
support
first last
Selects a standard
formulation to
correspond to a
specified product
where one exists
Ability to use standard
reference sources
Ability to select the
correct standard
formulation for a
specific product
Time
taken to
prepare
Time
taken
for task
First last
First last
Problem
solving
first last
A
B
A
C
A
C
C
C
C
D
B
D A
C
A
C
In the following table, the information in the two left hand columns is taken directly from
the competency standards. Carefully read and consider each performance criteria and
evidence guide.
Task (b) complete the following reflective table
Complete the table using the above criteria that you believed you achieved firstly following
your first attempt (or as near as possible to), and then following your last attempt at your
placement site.
Submit the completed table below in your portfolio.
Page 11 of 15
Domain 5: Prepare pharmaceutical products
Performance Criteria
Evidence examples
Level of
support
first last
Standard 5.1: Consider product requirements; Element 4 – determine if production requirements are met
1
Understands the formulation
instructions, including preparation
methods.

Ability to interpret and explain the terminology, abbreviations and
instructions for preparing specific products.
2
Understands issues impacting on
stability that are likely to influence
preparation technique and selection
of final storage container.

Ability to describe the effects of moisture, oxygen, light, heat and
microbiological contamination on product stability, efficacy and
shelf-life.
Ability to identify or promptly access information on any issues
impacting on the stability/shelf-life of particular products.
Confirms the active ingredients and
excipients required for preparing the
product and their suitability for use.

3



Ability to accurately identify ingredients by trade, generic or
common name.
Ability to differentiate active ingredients from excipients and to
explain the purpose of each ingredient present in the formulation
(e.g. therapeutic agent, vehicle, flavouring and suspending agent,
buffer, antioxidant, preservative).
Ensures storage conditions for ingredients and materials are optimal
for protecting their integrity and quality.
Standard 5.1: Consider product requirements; Element 5 – prepare and product documentation
1
Understands the value of using a
worksheet, logbook or register for
recording details of prepared
products.

Ability to describe the reasons for completing a product
worksheet/logbook/register (e.g. tracking batches of ingredients in
the event of a recall, checking of involved personnel, quantities and
ingredients in the event of consumer complaint or misadventure).
2
Calculates the required quantities for
each of the ingredients in the final
product.

Ability to accurately calculate (e.g. weight, volumes, percentages,
displacement values and aliquots, dilutions) requirements for the
final product.
3
Ensures product worksheet, logbook
or register is legible, accurate and
complete.

Ability to demonstrate the use of a worksheet, logbook or register
as appropriate to document the details of prepared products,
including ingredients and their batch number and expiry dates,
compounding process, and expiry date and labelling of the final
product.
Ability to recognise calculation errors and/or inconsistencies
between the worksheet/logbook/register and master manufacturing

Time taken to
prepare
First
last
Time taken
for task
problem
solving
first last
first last
sheet or product order/prescription.
4
Seeks additional information or
guidance about any issue of concern
or uncertainty before proceeding to
preparation of the product.

Ability to describe or demonstrate ways in which additional
guidance or enhanced certainty can be achieved (e.g. double
checking of calculations by another individual, reviewing
preparation methods described in master worksheet, use of
reference texts to confirm strengths, doses or dilutions).
Standard 5.2: prepare non-sterile drug products; Element 1 – assemble ingredients and materials
1
Selects ingredients of appropriate
quality.

Ability to select ingredients of appropriate quality/standard for
inclusion in products intended for human therapeutic use (e.g.
pharmaceutical grade, in date, stored according to storage advice on
label, visually free of contamination and/or signs of degradation
such as colour change, crystallisation or deliquescence).
2
Selects ingredients and equipment
accurately.

Ability to select ingredients (form and strength) and final container
that exactly match the descriptions on the worksheet.
3
Reduces the potential for other
activities and/or materials to
impede, cross contaminate or cause
error in the preparation process.

Ability to organise an area of suitable size in the workplace in which
production can proceed in an unimpeded manner.
Standard 5.2: prepare non-sterile drug products; Element 2 – Apply compounding principles and techniques
1
Measures quantities required
according to the worksheet.

Ability to accurately weigh and measure ingredients.
2
Adopts a systematic process for
combining ingredients that is
consistent with sound
pharmaceutical compounding
practice.

Ability to demonstrate preparation techniques and use of
equipment (e.g. grinding, mixing, blending, balances and calibrated
measures).
Ability to demonstrate a systematic technique for making a variety
of pharmaceutical products (e.g. creams, emulsions, solutions).
Uses techniques that avoid
contamination of the product.

3

Ability to demonstrate technique and personal hygiene measures
that limit the opportunities for contamination of the product.
Page 13 of 15
Task (c) Your reflections on your developing compounding skills
Write a 400 word critical reflection to explain changes in your self-assessment rating between the
first and last patient counselling activities.
Read the information about reflection available on the learnonline site. In it is a series of
questions that will also help you develop your reflective skills.
In your reflections;
(1) explain what the most significant changes are,
(2) explain why changes in competency skill development are occurring,
(3) describe the evidence for this change,
(4) describe the change you have observed in terms of the links to pre-placement and during
placement support/learning materials and
(5) summarise your action for the future to further develop your proficiency in this skill.
In formulating your response, refer to the following areas of written responses in your handbook
and support/learning materials that you have re or utilised in your reflective thoughts:
 Performance Criteria and Evidence Guide on the self-assessment rating grid on the previous
page
 ‘Identification of Student’s Strengths and Areas for Improvement’ (Preceptor/Student) & the
CPD Plan
 Patient Counselling Information –‘Reflect on and Critique your Counselling Sessions’
(early/late)
 Student Counselling Skill - Preceptor Assessment Feedback sheet
 Academic Assessment graduate qualities marking grid criteria below (see GQ1, GQ2, GQ6)
Submit your report in your portfolio. You do not need to print the assessment template found on
the next page.
Page 14 of 15
Reflecting on your level of Competency
in Compounding Skills cou
Academic Assessment
Assessing your compounding competency
Key components of this assignment
Performance on this component
Excellent
Good
Fair
Poor
Comment
Very
Poor
Understanding of role and function of
competencies (GQ1)


Uses competency developmental
criteria language (for criteria see
top of table previous page, and see
under Assessment and Appraisal
section for further explanation)
Refers to relevant Performance
Criteria
Clear, thoughtful analysis based on
evidence from competencies (GQ2)


Uses Performance Criteria &
related evidence in analysing
competency
Makes connections between
experiences, course material &
other relevant events
Written communication skills (GQ6)
 Uses accurate sentences,
paragraphing, grammar, punctuation,
vocabulary
Page 15 of 15