DISPENSING II

M E D I C AT I O N - R E L AT E D P R O B L E M S , M E D I C AT I O N S A F E T Y,
M E D I C AT I O N C O U N S E L L I N G A N D O T H E R P H A R M A C Y
S E RV I C E S
PRESCRIPTION AND MEDICATION ORDERS
OUTLINE:

• Describe prescription and identify its parts.

• Name the different types of prescriptions
• Describe the type of prescription errors
• How is prescription process
• Describe medication orders and other types of orders
 PRESCRIPTION

Origin comes from Latin praescriptio, meaning a written order

Prescription: the action of writing [that takes place] before [a

drug is dispensed]pre- (before)script/o- (write)-ion (action)

A prescription is a written order (handwritten or electronic) by a

registered physician directing the pharmacist to prepare or
dispense pharmacological agents/medications for the diagnosis,
prevention or treatment of a disease.
PARTS OF PRESCRIPTION
 PARTS OF PRESCRIPTION

✓ Prescriber’s Information. The name of the physician or dentist,

his specialty, clinic address, contact number and clinic hours.
✓ Patient information. The full name and address of the patient are
necessary for identification purposes.
✓ Date. Prescriptions are dated at the time they are written. The date
is important in establishing the medication record of the patient
especially in filling prescriptions for controlled substances
✓ Rx Symbol or Superscription. The Rx symbol is a Latin verb
“recipe” meaning take thou or you take
 PARTS OF THE PRESCRIPTION

✓Medication Prescribed or Inscription. Body or main part of the

of the Rx order. It contains the names and quantities of the
prescribed ingredients or drugs, dosage form and potency.

• The name of the product must be written both in: Nonproprietary

(generic name) Proprietary (brand)
• Chemical
• Dosage form- the physical entity of medication (tablet, capsule)
• Strength – potency of drug (250 mg, 100IU)
• Quantity to be dispensed – this includes the amount and the unit
measure (grams, milligrams, tablets)
 PARTS OF THE PRESCRIPTION

✓ Dispensing Directions to Pharmacist or Subscription.

Directions to the pharmacist for preparing the prescription. These can
be used for:
• Preparations (compounding)
• Labeling ( information to be put on the label )

✓ Directions for the Patient or Transcription. Instructions

on the number of dosage units per dose (one tablet), route of
administration, frequency of dosing (every 4 hours), duration of
dosing (one week, for one month) and use of the drug
(optional)
 PARTS OF THE PRESCRIPTION

✓ Refill Information. If refill information is not supplied, it is

generally assumed that no refills are authorized

✓ Prescriber’s Signature. The name and signature of the physician,

veterinary or dentist who wrote the prescription order. Below the
signature of the physician are the licensed number to practice his
profession, PTR ( Privilege Tax Receipt) no. and TIN (optional)
EXERCISE

• Try to identify the parts of the prescription:

 TYPES OF PRESCRIPTION

A. Based on ingredient:

1. Simple Prescription or Pre

compounding prescription:
-it contains 1 active ingredient.
-Prescription for already prepared drug
(by pharmaceutical
companies)

2. Cpmpounded or Extemporaneous
prescription:
- It contains more than one ingredient.
-The pharmacists prepare the
medication according to the drugs and
dosages directed by the physician.
 TYPES OF PRESCRIPTION
EXAMPLE:

Pre compounding prescription: Extemporaneous prescription

 TYPES OF PRESCRIPTION

Based on ingredient:

3. Polypharmacy Prescription
- With more than 2 prepared pharmaceutical
HERA GO 08-01-21

Example:
Losartan 50mg #30
Take 1 tab OD for a month
Atorvastatin 10mg #30
Take 1 tab once a day before
bedtime
Clopidogrel 75mg #30
Take 2x a day
Omeprazole 20mg
Take once a day 30 mins before
breakfast

JDoe
 TYPES OF PRESCRIPTION

B. Based on mode of prescribing

1. Written prescription
• handwritten on a single preprinted form from a prescription pad
• must be written in ink
• must be recorded in the patient’s medical record
• traditional way in which prescriptions have been written for centuries

2. Computerized prescription
• typed into the medical office’s software system
• copy of prescription is printed outsigned by the physician and given to the patient
• may be faxed directly to the pharmacist
 TYPES OF PRESCRIPTION

B. Based on mode of prescribing

3. Verbal prescription
• given over the telephone
• if not for a controlled substance, the pharmacist can fill the prescription
• without having a printed-out prescription
• without having the physician’s signature
 TYPES OF PRESCRIPTION

C. Magistral Prescription – prescribed very often by the same

doctor, same ingredient and compounded by the same
pharmacist.

D. Coded Prescription – is also called “blinded prescription”

and consist of words, symbols, to represent the name of the
drugs. This is unethical practice of doctors and pharmacist

E. Yellow Prescription – It is used for regulated and controlled

drugs with special license. It is made in triplicate copy.
 HOW TO PROCESS PRESCRIPTION

R
Prescription written Prescription is checked for
Patient presents
by authorized completeness; prescriber Correct patient info is
prescription to the
prescriber info, drug name, strength, entered into computer
pharmacy
dose, and directions system

LABEL

Prescription is prepared.
Pharmacy label is generated.
Correct amount of med Prescription is interpreted and
Make sure all the legal items
prescribed is measured and confirmed by pharmacy system. Third
are identified
placed into container party is billed online (optional)

Pharmacist provides counseling on

Prescription is prepared by Patient receives script, pharmacy
the medication prescribed and all
pharmacy technician, and assistant must offer counseling to the
 DISPENSING
FILLING AND RECORDING PROCEDURES
1. Dispensing should be done by Pharmacist
2. Partial Filling is allowed and must be reflected in the prescription
3. The prescription once filled must be retained by the pharmacist for a
period of two years
4. The prescription must be recorded in Rx book and ready for
inspection by FDA/DOHwhen the outlet is open for operation
anytime
TYPES OF ERROR IN PRESCRIPTION

• Erroneous Prescription
• Impossible Prescription
• Violative Prescription
 ERRONEOUS PRESCRIPTIONS

• Where the brand name precedes the generic name

• Where the generic name is the one in parenthesis
• Where the brand name is not in parentheses
• Where more than one drug product is prescribed on one prescription
form.

What to do with erroneous prescriptions

Erroneous prescriptions shall be filed. Such prescription shall also be
kept and reported by the pharmacist of the drug outlet or any other
interested party to the nearest DOH office for appropriate action.
 VIOLATIVE PRESCRIPTIONS
• Where generic name is not written
• Where the generic name is not legible and a brand name which is legible is
written
• When the brand name is indicated and instructions added (such as the
phrase " no substitution") which tend to obstruct, hinder or prevent proper
generic dispensing.

What to do with violative prescriptions

Violative prescriptions shall not be filed. They are kept and reported by the
pharmacist of drug outlet or any other interested party to the nearest DOH
office for appropriate action. The pharmacist shall advise the prescriber of
the problem and/or instruct the customer to get the proper prescription.
 IMPOSSIBLE PRESCRIPTIONS

When only the generic name is written but it is not legible.

• When the generic name does not correspond to the brand name
• When both the generic name and the brand name are not legible
• When the drug product prescribed is not registered with FDA

What to do with impossible prescriptions

Impossible prescription shall not be filed. They shall be and reported
by the pharmacist of drug outlet or any other interested party to the
nearest DOH office for appropriate action. The pharmacist shall
advise the prescriber of the problem and/or instruct the customer to get
the proper prescription.
MEDICATION ORDERS AND OTHER
TYPES OF ORDERS
 MEDICATION ORDERS

• Order for a drug written on the agency’s (hospital, nursing

center) physician’s order form for a patient or resident.
 PARTS OF A DRUG ORDER ALL DRUG ORDERS AND
PRESCRIPTIONS MUST CONTAIN:

• Person’s full name

• Date
• Drug name
• Route of Administration
• Dose
• Frequency
• Duration of order
 4 TYPES OF DRUG ORDERS:

• STAT Order Drug- A single does of a medication is

administered immediately
• Single Order Drug - is to be given at a certain time & only
one time
• Standing Order Drug - is to be given for a certain number of
doses or for a certain number of days
• PRN Order Drug - is to be administered when necessary or as
needed based on the patient’s needs
• Only to be administered by nurse or physician
• Cannot be administered by Medication Assistant
ORDERING METHODS DOCTORS CAN GIVE DRUG
ORDERS IN SEVERAL WAYS:

1. Physician’s order sheet - is used to write medication orders for a patient in the
2. Verbal Order (Telephone Orders)- when a patient is in the hospital, physician
may give a verbal order over the phone to a licensed nurse. The nurse writes the
order on the physician’s order sheet. It is marked as a verbal order (V.O.)the
nurse signs her name. Physician must personally sign the order within a specific
amount of time.
3. Standing Orders - group of specific orders, preprinted on the facility’s
physician’s order sheet. Often pertain to protocol of treatment to a specific
disease or surgical procedure. In addition, a physician would also write more
specific medication orders to address a particular patient’s medical needs.
4. Automatic Stop Orders- originates with the hospital pharmacy and not the
physicianfor certain types of drugs (controlled substances)only valid for a
certain number of days. Determined by hospital's Pharmacy Committee policy
 Medication
Orders and
Labeling
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DISPENSING II
medication-related problems, medication safety, medication counselling and other pharmacy
services
 Learning Objectives:

Understand common medical and

pharmacy terminology, abbreviations,
acronyms, and symbols.

Identify pharmacy directions written in

signa language.

Recognize physician instructions and

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other pertinent information on a

medication order.
.
 Introduction
 The origin of medical
terminology is as old as
medicine itself
 approximately 75% of
medical terminology has its
roots in the Greek language
 the remainder can be traced
to Latin
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 Medical Abbreviations,
Acronyms and Symbols
 Approximately 35,000 abbreviations,
acronyms, and symbols are used in
medicine and pharmacy
 Collectively, they are referred to as
medical abbreviations, or simply
abbreviations
 most abbreviations are developed to
shorten the length of words and word
combinations related to health,
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medicine, laboratory procedures or

tests, and pharmacy
 Medical Abbreviations,
Acronyms, and Symbols

Common Medical Abbreviations

 Indicate specific patient care facilities,

units, or departments or the titles of
individual team members
 Refer to specific medical diagnoses and
conditions, procedures, treatments,
patient directives/activities,
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equipment/supplies, and tests

 Medical Abbreviations, Acronyms, and Symbols

Common Pharmacy Abbreviations Common Pharmacy Symbols

 Typically seen on medication  In addition to knowing pharmacy
orders or other written abbreviations, you need to recognize
communications between providers and understand a number of symbols
and pharmacies specific to pharmacy practice
 provide important information  symbols such as ↑ and ↓ are
 might also include frequently placed on medication
abbreviations to communicate orders to indicate “increase” and
specific compounding “decrease,” respectively
directives  another common symbol is the
 common for indicating the route Greek delta symbol (Δ),
of administration and the which is used to indicate a desired
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change
dosing intervals for prescribed
medications
 Medical Abbreviations, Acronyms, and
Symbols

The Official “Do Not Use” List of Abbreviations

In 2004, the Joint Commission was driven to create The Official “Do Not
Use” List of Abbreviations in response to a number of sentinel events that
had been noted across the United States
list integrated into the Performance Standards for Healthcare
Accreditation
the non-standard and potentially dangerous abbreviations
should not be used in any healthcare application
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 SIGNA INTERPRETATION

 The signa component is a specialized language that physicians or other

prescribers place on a medication order
 provides the pharmacy with specific directions for
administering the medication order
 may include dosage information, the route of administration, the
amount to be dispensed, the time schedule or dosing interval, and
any special instructions
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 SIGNA INTERPRETATION
SIGNA INTERPRETATION
i packet in 2 oz. OJ PO q.i.d. ut Mix one packet in two ounces
dict of orange juice and give by
mouth four times daily as
directed.
aaa b.i.d. prn itching Apply to affected area twice
daily as needed for itching.
SSI Sub-Q p.c. and h.s. Sliding scale insulin, inject
subcutaneously after meals
and at bedtime.
iii gtts au q8h Instill three drops into both
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ears every eight hours.

 SIGNA INTERPRETATION
Transcribing or interpreting a signa requires you to seek the
portions of the directive that address the following questions:

What is the What special

How much of the
route of instructions need to
medication is the be followed when
administration
of the patient supposed taking the
medication? to take and how medication?
often?
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 MEDICATION
ORDERS
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 MEDICATION
ORDERS
 Medication orders are similar to prescriptions
 exclusive to the institutional or hospital setting
 Medication orders entered directly into a computer
by the physician are often called eMARs (electronic
medication administration records)
 Just like other types of prescriptions, medication orders
are legal documents that must be filed, usually based
on the date the order was written, and kept on hand
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for up to two years

 MEDICATION
ORDERS
 Upon receipt of the medication order, the
pharmacy determines what medications and
dosages have been ordered and then
interprets the signa directions
 it is then transcribed, or interpreted, and
then entered into the pharmacy’s computer
system through a process called order entry
 the pharmacist usually performs order entry,
but specially trained pharmacy technicians
may also complete this task
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 A label is then prepared for each of the

medications
 Lets review some
important facts
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 Question 1
a. 350
b. 3,500
c. 35,000
Approximately how many
d. 350,000
abbreviations, acronyms,
and symbols are used in
medicine and pharmacy?
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 Question 2
a. delta
b. signa This component is a specialized
c. alpha language that physicians or other
d. omega prescribers place on a medication
order.
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 Types of Medication Order
 During hospital treatment, a physician
examines a patient and then writes the first
medication order on the patient’s medical
chart
 the medical chart is commonly called the
medication administration record, the
patient’s chart or, simply, the chart
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 Types of Medication Order

 The physician’s initial

order is called the
admission order and is
often written while the
patient is in the
emergency department or
has just been admitted to
a hospital room
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 Types of Medication Order

 If applicable, the admission order includes a list

of the medications, including dosages and
dosing intervals, that the patient has been
taking at home
 These medications are commonly referred to as
● home medications or home meds
 in many instances, the physician orders the pharmacy to
continue home meds so that the patient will receive
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these same medications while he or she is hospitalized

 Types of Medication
Order
 Every time a physician
examines a patient, new
orders, or changes to
existing medication orders,
are written
 may be referred to as daily
orders
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 Types of Medication Order

 Some physicians whose

specialties involve commonly
prescribed medical treatments
take advantage of preprinted
order forms called standing
orders, or routine orders
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 Medication Order Contents and
Processing
 The medical chart contains both patient identification
information and copies of all treatment orders
prescribed during the patient’s stay
 Standard patient identification information is either
handwritten on the order, provided on a computer-
generated patient ID label affixed to the order, or
preprinted at the top of each medication order by
using an addressograph
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 Medication Order Contents and
Processing

 Access to protected health information (PHI), such

as that found on a medication order or in a patient
chart, is restricted and the information may be
viewed only by those departments that must see
the data in order to correctly treat the patient
 pharmacy
 laboratory
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 nursing
 Medication Order Contents and
Processing
 The treatment orders kept in the medical chart are carbon
copies of all medication, diagnostic, laboratory, dietary, and
other orders prescribed
 the original copy remains in the chart, while the other
carbon copies are hand-delivered, faxed, scanned
electronically, or sent via pneumatic tube system to the
pharmacy or other relevant hospital departments
 may be kept at the nursing station or maintained on a
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computer record
 Medication Order Contents and
Processing
 Orders are most often written by hand, using a combination
of medical terminology and signa instructions, but they
may also be entered directly into a hospital computer
 facilities that depend on an eMAR system provide
computer terminals at the nursing station or near the
patient’s room
 physicians use these terminals for direct order entry,
commonly referred to as computerized physician order
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entry (CPOE)
 Medication Order Contents and
Processing
 A pharmacist or technician based in either the central
pharmacy or a satellite pharmacy enters the order into the
pharmacy’s computer system
 specialized pharmacy software assists with the
identification of patient medication allergies and
cross- sensitivities, drug–drug or drug–food
interactions, appropriate medication dosage,
duplicate therapy, contraindications, and other
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information
 COMPOUNDING
STERILE
PRODUCTS
(CSP)
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 CSP LABELING
 Upon completion of sterile compounding and
checking procedures, personnel must appropriately
label the sterile compound in its final container
 Labels will most often be affixed by the IV technician
but may also be affixed by the pharmacist
 Federal laws require that pharmacy labels accurately
identify the ingredients and the amount of each
ingredient in the final sterile compound
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 STERILE COMPOUND LABEL COMPONENTS

 The CSP label provides general information

 must also contain very specific information
about the product, its administration and
storage requirements, expiration date, and
preparer
 Product information on the CSP label specifies the
name, concentration, and amount of each base
solution used to prepare the compound
 The label must also clearly identify each additive, or
medication or ingredient that has been added to the
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base solution
 STERILE COMPOUND LABEL
COMPONENTS
 In general, only IV push and
IVPB medications require an
administration time, which is
the length of time over which
the drug is to be given
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 STERILE COMPOUND LABEL
COMPONENTS
 If the medication’s administration is not ordered by the
physician and the package insert is unavailable, the
pharmacist may find this information by consulting one
of the pharmacy reference manuals, such as the
Handbook on Injectable Drugs, or a computerized
pharmacy reference source, such as Micromedex
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 STERILE COMPOUND LABEL
COMPONENTS
 In contrast to an administration
time, an infusion rate is
specified for large-volume
parenteral (LVP) products, such
as IV bags and TPN solutions
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 STERILE COMPOUND LABEL
COMPONENTS

 The CSP label must also

provide the physician’s
directions for the medication’s
dosing interval
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 STERILE COMPOUND
LABEL COMPONENTS

 Personnel also add auxiliary

labels to clarify special
instructions or highlight
physician directions for the
nursing staff
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 STERILE COMPOUND
LABEL COMPONENTS

 Another required component on the

CSP label is the expiration date of the
sterile compound, sometimes
referred to as the beyond-use date
(BUD)
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 STERILE COMPOUND LABEL
COMPONENTS

 Several factors determine the expiration date,

including the stability of the drug in its compounded
form
 storage requirements must also be included on the label
 Every CSP label must also identify the pharmacy
personnel who prepared the compound
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 STERILE COMPOUND
LABEL COMPONENTS
 Verifying the accuracy of the
medication order and the CSP label is
one of the most important
components of ensuring the Five
Patient Rights
 Sterile product labels must be legible,
pharmaceutically elegant, and
complete
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 Question 3
a. start order
b. begin order
The physician’s c. check-in
initial order is order
d. admission
called order
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 Question 4
a. storage
requirements of
medication
b. administration rate The CSP label
c. medication patient
diagnosis provides all of the
d. patient
identification number
following information
except
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DOSING REGIMEN
❑ Dosage regimen design is the selection of drug dosage, route,
and frequency of administration in an informed manner to
achieve therapeutic objectives

❑ Deliberate planning of drug therapy is necessary because the

administration of drugs usually involves risk of untoward effects

❑ Specific drugs have inherently different risks associated with

their use and a dosage regimen should be selected which will
maximize safety

❑ At the same time, the variability among patients in

pharmacodynamic response demands individualized dosing to
assure maximum efficacy
Factors to consider in Design of Drug Dosage Regimens
I. Route of Administration:
1. Drug absorption characteristics

2. Presence of presystemic elimination

3. Accumulation of drug at absorption site, e.g. intramuscular

depots

4. Need for immediate onset of action

5. Ease of administration

6.Half-life: infusion may be necessary for drugs with short t1/2

or sustained release formulation

7. Patient acceptance of route and dosage form

Factors to consider in Design of Drug Dosage Regimens…
II. Dose:
1. Therapeutic index: if high, consider benefits of loading dose

2. Volume of distribution: to estimate peak plasma

concentration

3. Documented nonlinearity of pharmacokinetics

4. Cost of medication

5.Half-life: tapering of dose may not be necessary for some

drugs with long t1/2
6. Availability of treatment for overdose

7. Existence of a therapeutic or toxic concentration range

Factors to consider in Design of Drug Dosage Regimens…
III. Dosage interval:
1. Half-life: dosage interval can generally be extended in
relation to half-life

2. Therapeutic index: the higher the TI, the longer an interval

can be spaced with higher doses

3. Body clearance: to evaluate accumulation

4. Side effects which may require special administration times,

e.g. bedtime to avoid sedation
Factors to consider in Design of Drug Dosage Regimens…
IV. Complications:
1. Analytical methodology and reliability in monitoring Cp
2. Active metabolites

3. Changing pathophysiology

4. Drug interactions

5. Auto or exogenous enzyme induction

6. Development of pharmacodynamic tolerance

7. Side effects not dose or concentration related

8. Need for baseline con. data with recent history of drug use
❑ Several methods may be used to design a dosage regimen
❑ Individualized dosage regimen

❑ Dosage regimen based on population average

❑ Dosage regimen based on partial pharmacokinetic

parameters

❑ Empirical dosage regimen

Individualized Dosage Regimen:
❑ Most accurate approach
❑ Dose calculated based on the pharmacokinetics of the drug in
the individual patient derived from measurement of serum /
plasma drug levels
❑ Not feasible for calculation of the initial dose, however,
readjustment of the dose is quite possible
❑ Most dosing program record the patient’s age and weight and
calculate the individual dose based on creatinine clearance and
lean body mass

Dosage Regimens based on Population Averages:

❑ Dosage regimen is calculated based on average
pharmacokinetic parameters obtained from clinical studies
published in the drug literature
Dosage Regimens based on Population Averages…
❑ There are two approaches followed
❑ Fixed model
❑ Adaptive model

Fixed Model:
❑ Assumes that population average pharmacokinetic parameters
may be used directly to calculate a dosage regimen for the
patient, without any alteration

❑ The practitioner may use the usual dosage suggested by the

literature and then make a small adjustment of the dosage based
on the patient’s weight and / or age
Fixed Model…
❑ Usually, pharmacokinetic parameters such as Ka, F, Vd, k are
assumed remain constant and most often drug is assumed to
follow one compartment open model

❑ When a multiple dose regimen is designed, multiple dosage

equations based on the principle of superposition are used to
evaluate the dose

Adaptive Model:
❑ This approach attempts to adapt or modify dosage regimen
according to the need of the patient

❑ Uses patient variable such as weight, age, sex, body surface

area, and known patient’s pathophysiology such as, renal
disease, as well as known population average pharmacokinetic
parameters of the drug
Adaptive model…
❑ This model generally assumes that pharmacokinetic parameters
such as drug clearance do not change from one dose to the next

❑ However, some adaptive models allow for continuously adaptive

change with time in order to simulate more closely the changing
process of drug disposition in the patient, especially during a
disease state

Dosage Regimen based on Partial Pharmacokinetic Parameters:

❑ For many drugs, the entire pharmacokinetic profile for the drug is
unknown or unavailable

❑ Therefore, the pharmacokineticist needs to make some

assumptions in order to calculate the dosage regimen

❑ These assumptions will depend on the safety, efficacy, and

therapeutic range of the drug
Dosage Regimen based on Partial Pharmacokinetic Parameters…
❑ The use of population pharmacokinetics uses average patient
population characteristics and only a few serum / plasma
concentration from the patient

❑ Population pharmacokinetic approaches to therapeutic drug

monitoring have increased with the increased availability of
computerized data bases and development of statistical tools for
the analysis of observational data

Empirical Dosage Regimens:

❑ In many cases, physician selects a dosage regimen of the
patient without using any pharmacokinetic variables

❑ The physician makes the decision based on empirical clinical

data, personal experience and clinical observations
❑A nomogram typically has three scales: two scales represent
known values and one scale is the scale where the result is read
off

❑ The known scales are placed on the outside; i.e. the result scale
is in the center

❑ Each known value of the calculation is marked on the outer

scales and a line is drawn between each mark

❑ Where the line and the inside scale intersects is the result

❑ Examples include, height – BMI – weight, total clearance –

❑ For ease of calculation of dosage regimens, many clinicians rely
on nomograms to calculate the proper dosage regimen for their
patients

❑ The use of nomogram may give a quick dosage regimen

adjustment for patients with characteristics requiring adjustments
such as age, body weight, and physiologic state

❑ In general, nomogram of a drug is based on population

pharmacokinetic data collected and analyzed using a specific
pharmacokinetic model
❑ In order to keep the dosage regimen calculation simple,
complicated equations are often solved and their results
displayed diagrammatically on special scaled axes to produce a
simple dose recommendation based on patient information

❑ Some nomograms make use of certain physiologic parameters,

such as serum creatinine concentration, to help modify the
dosage regimen according to renal function

❑ For many marketed drugs, the manufacturer provides tabulated

general guidelines for use in establishing a dosage regimen for
patients, including loading and maintenance doses
❑ Examples of drugs for which nomograms are being used for
designing dosage regimen:
❑ Digoxin
❑ Warfarin
❑ Heparin
❑ Vancomycin
❑ Tacrolimus
❑ Phenytoin
❑ Clozapine
EXTEMPORANEOUS
COMPOUNDING
 LEARNING OBJECTIVES
• Define the term extemporaneous compounding, and describe
common situations in which compounding is required.
• Identify and describe the equipment used for the weighing,
measuring, and compounding of pharmaceuticals.
• Use the proper technique for weighing pharmaceutical
ingredients.
• Use the proper technique for measuring liquid volumes.
 LEARNING OBJECTIVES
• Define the term percentage of error.
• Explain the process by which solutions, suspensions,
ointments, creams, powders, suppositories, and capsules
are prepared.
PRESCRIPTION SAMPLE
 COMPOUNDING

Is 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.

(USP 795)
 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
 EXTEMPORANEOUS COMPOUNDING

• Is the preparation of a therapeutic product for

an individual patient in response to an
identified needed
• Is defined as they timely preparation of good
drug product according to another physician's
prescription, in which the amounts of
ingredients are calculated to meet the needs of
a particular patient or a group of patients
according to “Good Manufacturing Practice”
 COMPOUNDING
Extemporaneous compounding
 On-demand preparation of a drug product.

 According to a physician’s prescription.

 Meets the unique needs of an individual

patient.
Manufacturing
 The production or processing of a drug in a
LARGE quantity by various mechanisms.
 WHY COMPOUND?
1. Pediatric patients requiring diluted adult strengths of drugs.
2. Patients needing an oral solution or suspension of a product
that is only available in another form.
3. Patients with sensitivity to dyes, preservatives, or flavoring
agents found in commercial formulations.
4. Dermatological formulations with fortified (strengthened) or
diluted concentrations of commercially available products.
5. Specialized dosages for therapeutic drug monitoring.
6. Care for hospice patients in pain management.
Compounding for animals.
 Compounding Issues

Disclaimer:

• Products compounded for veterinary use cannot

be used in humans.
 COMMON PROBLEM WITH SPECIAL
PRESCRIPTIONS
1. If short dated-will patient use up quantity prescribed within that
time
2. Cost if using special company-very important if private
prescription
3. Lack of detail on prescription especially creams and ointments
where no base is indicated
4. Computer generated prescriptions where inlicensed
preparations are not in the standard menus.
5. Finding a formula.
6. National differences with non-compedial formula.
 PRESCRIPTION ANALYSIS:
COMPOUNDING CONSIDERATIONS
 Always consider the use of commercially available products as far
as possible.
 If no suitable commercial product exists, consider a therapeutic
alternative that is available in a suitable dosage form. This must
be discussed with the physician.
 Extemporaneous preparations should be done based on
evidence-based references.
 Always check for the suitability of the product/brand for
extemporaneous preparations.
 Preparations should be done according to what is stated as far as
possible unless stated otherwisein the product leaflet.
 PRESCRIPTION ANALYSIS:
COMPOUNDING CONSIDERATIONS
 When no information is available, compound an oral medication
by dispensing a tablet and/or capsule and directing the caregiver
to mix just prior to administration.
 Stability for shelf storage in the pharmacy is applicable without
opening. Once opened, the stability of the preparation should be
no longer than 30 days. Maximum quantity of the
extemporaneous preparations to be dispensed should mot exceed
one month.
 Refrain assumptions on the therapeutic equivalence in the case of
suggesting alternative agents as the possibilities and supporting
data may be limited
 PRESCRIPTION ANALYSIS:
COMPOUNDING CONSIDERATIONS
 Techniques in compounding preparations and manipulations
should always be in line with the standard Good Preparation
Practice as delivering an accurate dose is paramount.
 Staff and facilities are challenged to undertake intermittent
competency assessments in order to achieve the standards
requirement.
 Documentation after each preparation should include details on
the materials used, processes involved and the responsible
personnel in-charge.
 CONSIDERATIONS FOR PREPARING
EXTEMPORANEOUS COMPOUNDS
 Pharmacy personnel are reminded not to empirically change flavourings or
suspending agents because they can affect the pH and stability of the product
and result in an unstable product.
 Please consider ingredients in the formulations that require special
precautions in neonates.
 Mixing of a compounded formulation should always be in line with the
following principles:
a) Ensure that all ingredients used are within the expiry date.
b) Ensure that all utensils are clean; including mortar and pestle, graduates, pill cutters
and stirring rods.
c) Product should be labelled clearly and stored as recommended within the formula.
d) For solution or suspension products, emphasise on the importance of thorough
shaking before administration.
 CONSIDERATIONS FOR PREPARING
EXTEMPORANEOUS COMPOUNDS
 If compounding a preparation using contents from an ampoule, remember to
withdraw the solution (medication) from the ampoule using a filter needle to
ensure no glass particles are incorporated into the compound.
 Place tablet(s) within mortar and pestle to grind tablets to a fine powder. For
film-coated tablets, it may be necessary to add a small amount of diluents
such as water, to soften the coating prior to grinding the tablets. This will
ensure that the compound will not have an eggshell appearance from the film
coating floating throughout the suspension. If you are using capsules, open the
capsule and empty the powder into the mortar and discard the capsule shell.
 Solutions will have a clearer appearance versus a compounded suspension.
 CONSIDERATIONS FOR PREPARING
EXTEMPORANEOUS COMPOUNDS
 Manipulations of the available dosage forms in order to fulfil the
unusual practitioner’s request may impose risks such as
preparation and administration errors as well as unpredictable
bioavailability, compatibility and stability profile.
 Understand the roles of excipients in certain formulations and
consider their risks over benefits limitation.
 If distilled water is not available, water for injection can be used
as a substitution, and vice versa.
 SOURCES OF FORMULAE
 Compendia e.g. BP, Martindale 28th/USP/NF etc
 Hospital-often continuation of treatment in primary care.
 GP’s own e.g Dr Ives wart paint etc
 Published literature/journal articles available on internet. Often
American/European
Chapters <795>- called Pharmaceutical Compounding
- Nonsterile Preparations
 Published in 2000
 Enforceable

Chapter <797> - called Pharmaceutical Compounding - Sterile Preparations,

 Became official in 2004.
Other Chapters
 Containers <661>
 Good Compounding Practices <1075>
 Pharmaceutical Stability <1150>
 Pharmaceutical Dosage Forms <1151>
 EQUIPMENT FOR WEIGHING, MEASURING, AND
COMPOUNDING
• Balances: Balance measurements using a
counterbalance are made using sets of standardized
pharmaceutical weights. An electronic balance is easier to
learn and use and is more accurate than other types of
balances.
• Forceps and Spatulas: Forceps should be used when
picking up weights so that moisture and oils are not
transferred to the weights. Spatulas are used in
compounding tasks such as preparing ointments and
creams or loosening material from the surfaces of a
mortar and pestle.
 EQUIPMENT FOR WEIGHING, MEASURING, AND
COMPOUNDING

• Compounding Slab: This is an ideal surface for mixing

compounds because of its nonabsorbent surface.
• Mortar and Pestle: The coarser the surface of the
mortar and pestle, the finer the triturating, or grinding,
that can be done.
• Graduates and Pipettes: Graduates come in two
varieties: conical and cylindrical. A pipette is used for
measuring liquids with a volume less than 1.5 mL
 EQUIPMENT FOR WEIGHING, MEASURING, AND
COMPOUNDING

• Master Formula Sheet: Prepared by the

pharmacist, this sheet indicates the amount of
each ingredient needed, lists the procedures to
follow, and provides the labeling instructions.
 TECHNIQUE FOR WEIGHING PHARMACEUTICAL
INGREDIENTS

• Weighing of the product is one of the most

essential parts of the compounding process.
• Weighing the exact amount prescribed is
essential in compounds for several reasons: the
product cannot be “checked” for content once
mixed, the quantities weighed out are often very
small, and a slight overage could mean a serious
overdose for the patient.
Weighing Pharmaceutical
Ingredients
1. Unlock the balance and confirm that it is
leveled, front to back and side to side, using the
leveling screws at its base. Once this is done, the
balance is ready to use. Lock the balance once
again, before transferring weight to it.
Weighing Pharmaceutical
Ingredients
2. Place weighing papers on the two pans of the
balance. These papers should be of exactly the
same size and weight. The edges of the paper on
the left-hand pan may be folded upward, to hold
the substance to be weighed. Do not place any
materials on the weighing pans without using
weighing papers.
Weighing Pharmaceutical
Ingredients

3. Unlock the balance to confirm that the

balance is still leveled, and then lock it again.
Weighing Pharmaceutical
Ingredients
4. Add the forceps to transfer the weight from
the weight container. desired weight to the right-
hand pan, using
Weighing Pharmaceutical
Ingredients
5. Place an approximate amount of the material
to be weighed onto the left-hand pan, using a
spatula to transfer it.
Weighing Pharmaceutical
Ingredients
6. Slowly release the beam using the unlocking
device at the front of the balance, and check the
balance.
Weighing Pharmaceutical
Ingredients
7. If the amount of the substance being weighed
is too great or too small, lock the balance again
and use a spatula to add or remove material.
Weighing Pharmaceutical
Ingredients

8. Slowly release the beam using the unlocking

device and check for equilibrium.
Weighing Pharmaceutical
Ingredients
9. Once a nearly precise amount of material has
been transferred to the pan, a very small
adjustment upward can be made by placing a
small amount of material on the spatula, holding
the spatula over the left pan, and lightly tapping
the spatula with the forefinger to knock a bit of
the substance onto the pan. This is done with
the balance unlocked and the balance beam free
to move.
Weighing Pharmaceutical
Ingredients
10. Lock the balance, close the lid, and then
unlock the balance to make a final
measurement.
Weighing Pharmaceutical
Ingredients
11. Lock the balance before removing the
measured substance. Use transfer forceps to
remove the weights and return them to their
storage case.
TECHNIQUE FOR MEASURING LIQUID VOLUMES

A general rule of thumb is to always select the

device that will give you the most accurate
volume. Selecting a container that will be at least
half full when measuring, or using the smallest
device that will hold the required volume, is
considered good practice.
Measuring Liquid Volumes
1. Choose a graduate with a capacity that equals or very
slightly exceeds the total volume of the liquid to be
measured. Doing so reduces the percentage of error in the
measurement. In no case should the volume to be
measured be less than 20% of the total capacity of the
graduate. For example, 10 mL of liquid should not be
measured in a graduate exceeding 50 mL in capacity.
Again, the closer the total capacity of the graduate to the
volume to be measured, the more accurate the
measurement will be.
Measuring Liquid Volumes

2. Bear in mind that the more narrow the column

of liquid in the graduate, the less substantial any
reading error will be. Thus for very small volume
measurements a cylindrical graduate is
preferable to a conical graduate.
Measuring Liquid Volumes

3. Pour the liquid to be measured slowly into the

graduate, watching the level of the liquid in the
graduate as you do so. If the liquid is viscous, or
thick, then you should attempt to pour it toward
the center of the graduate to avoid having some
of the liquid cling to the sides.
Measuring Liquid Volumes

4. Wait for liquid clinging to the sides of the

graduate to settle before taking a measurement.
Measuring Liquid Volumes

5. Measure the level of the liquid at eye level and

read the liquid at the bottom of the meniscus
(see Figure 8.3).
Measuring Liquid Volumes

6. When pouring the liquid out of the graduate,

allow ample time for all of the liquid to drain.
Bear in mind that depending on the viscosity of
the liquid, more or less will cling to the sides of
the graduate. For a particularly viscous liquid,
some compensation or adjustment for this
clinging may have to be made.
 PERCENTAGE OF ERROR

Error in measurement in pharmacy-

prepared products is expected, and
allowances are made for a certain
percentage of error over or under the target
measurement. This percent of error is
considered to be a range both above and
below the target measurement, and being
over or under (i.e., positive or negative)
within this range is not consequential.
 COMMINUTION AND BLENDING OF DRUGS

• Geometric Dilution Method: A way to combine drugs

using a mortar and pestle.
• Examples of Compounding Preparations: The
following are some common examples of compounding in
the community pharmacy: solutions, suspensions,
ointments and creams, powders, suppositories, and
capsules.
 COMMINUTION AND BLENDING OF DRUGS

• Labeling, Record Keeping, and Cleanup: After

compounding, the product must be labeled with a
prescription label, and a careful record of the
compounding operation should be kept. Once the
compounding operation is finished, the equipment
and area should be cleaned and everything should
be returned to their proper places in storage.
 COMPOUNDING OF SOLUTION
Definition:
A solution as a liquid preparation that contains one or more
chemical substances dissolved in a suitable solvent or
mixture of mutually miscible solvents. Although the
uniformity of the dosage in a solution can be assumed, the
stability, pH, solubility of the drug or chemicals, taste (for oral
solutions) and packaging need to be considered.

Types of solutions
1. Sterile parenteral and ophthalmic solutions: These
solutions require special consideration for their preparations.
2. Nonsterile solutions: Include oral, topical and otic solutions
 COMPOUNDING OF SOLUTIONS
Preparations of Solutions:
1. Each drug chemical is dissolved in the solvent in which it is most soluble.
Thus, the solubility characteristics of each drug or chemical must be
known.
2. If an alcoholic solution is used, the aqueous solution is added to
the alcoholic solution.
3. The salt form of the drug and not the free-acid or base form, which
both have poor solubility, is used.
4. Flavoring or sweetening agents are prepared ahead of time.
5. If the required chemical or drug is in bulk or powder from, then the
particle size is reduced first, using a mortar and pestle, a sieve or other
suitable means.
6. The proper vehicle (e.g. syrup, elixir aromatic water, purified water) must
be selected.
COMPOUNDING OF SUSPENSION

• Definition: Suspensions are defined by the USP as liquid

preparations that consist of solid particles dispersed
throughout a liquid phase in which the particles are not
soluble.
• Preparation of suspensions
1. The insoluble powders are triturated to a fine powder,
using a Wedgwood mortar.
2. A small portion of liquid is used as levigating agent and
the powders are triturated until a smooth paste is
formed. The levigating agent is added slowly and mixed
COMPOUNDING OF SUSPENSION
3. The vehicle containing the suspending agent is added in
divided portions. A high-speed mixer greatly increases the
dispersion.
4. The product is brought to the required volume using the
vehicle.
5. The final mixture is transferred to a “tight” bottle for
dispensing to the patient.
6. All suspension are dispensed with a “shake well” label.
7. Suspensions are never filtered.
8. The water-soluble ingredients are mixed, including flavoring
agents, in the vehicle before mixing with the insoluble
ingredients.
 EMULSIONS
• Definition: Emulsions are produced by a two-phase
system in which one liquid is dispersed throughout
another liquid in the form of small droplets.

• Preparation of emulsion:
1. A mortar and pestle are frequently all the equipment
that is needed.
2. Electric mixers and hand homogenizers are useful for
producing emulsions after the coarse emulsion is
formed in the mortar
 EMULSIONS
3. The order of mixing of ingredients in an emulsion depends on the type of
emulsion being prepared (i.e., O/W or W/O) as well as the emulsifying
agent chosen. Methods used for compounding include the following.
a. Dry gum (continental) method
b. Wet gum (English) method
c. Bottle method
d. Beaker method

4. Preservatives: If the emulsion is kept for an extended period of time,

refrigeration is usually sufficient. The product should not be frozen. If a
preservative is used, it must be soluble in the water phase to have any
effect.
5. Flavoring agents: If the addition of a flavor is needed to mask the taste of
the oil phase, the flavor should be added to the oil before emulsification.
POWDERED DOSAGE FORMS
Definition: Powders are dry mixtures of drugs or chemicals intended
for internal or external use. The two major types are powder papers
and bulk powders.
• Preparation of powder dosage forms
1. Bulk powders, which may be used internally or topically, include
dusting powders, douche powders, laxatives, antacids and
insufflations powders.
2. After a bulk powder has been pulverized and blended, it should be
dispensed in an appropriate container
3. Eutectic mixtures of powders can cause problems since they liquify.
One remedy is to add an inert powder, such as magnesium oxide, to
separate the eutectic materials.
4. Powder papers are also called divided powders.
CAPSULES
Definition: Capsules are solid dosage forms in which the drugs is enclosed
within a hard or soft soluble container or shell made form suitable
gelatin. Hard gelatin capsules may be manually filled for extemporaneous
compounding.

Preparation of hard and soft capsules

1. As with the bulk powders, all ingredients are triturated and blended,
using geometric dilution.
2. The correct size capsules must be determined by trying different
capsule sizes, weighing them and choosing the appropriate size.
3. Prior to filling capsules with the medication, the body and cap of the
capsule are separated. Filling is accomplished by using the “punch”
method.
4. The capsule is wiped clean of any powder or oil and dispensed in a
suitable prescription vial.
 MOLDED TABLETS (TABLET TRITURATES)
Definition: Tablet triturates are molded tablets made of powders
created by moistening the powder mixture with alcohol and
water. They are used for compounding potent drugs in small
doses.
Formulation and preparation of tablet triturates
1. Tablet triturates are made in special molds consisting of a pegboard and a
corresponding perforated plate.
2. In addition to the mold, a diluent, usually of lactose and sucrose (80/20),
and a moistening agent, usually a mixture of ethyl alcohol and water
(60/40) are required.
3. The diluent is triturated with the active ingredients.
4. A paste in then made, using the alcohol and water mixture.
5. This paste is spread into the mold, allowed to dry and then punched
OINTMENTS, CREAMS, PASTE
AND GELS
General characteristics: These dosage forms are semisolid
preparations generally applied externally.
Semisolid dosage forms may contain active drugs intended to:
1. Act solely on the surface of the skin to produce a
local effect (e.g. antifungal agent)
2. Release the medication, which, in turn, penetrates
into the skin (e.g., cortisol cream)
3. Release medication for systemic absorption through
the skin (e.g., nitroglycerin)
 OINTMENTS, CREAMS,
PATES AND GELS
• Preparation of ointments, creams, pastes and gels
1. Mixing can be done in a mortar or on an ointment slab
2. Liquids are incorporated by gradually adding them
to an absorption-type base, using levigation
3. Insoluble powders are reduced to a fine powder
and then added to the base, using
geometric dilution
4. Water-soluble substances are dissolved with water
and then incorporated into the base.
5. The final product should be smooth (impalpable)
and free of any abrasive particles.
 SUPPOSITORIES
• General characteristics:
1. Suppositories are molded solid dosage forms
intended for insertion into a body cavity. They are
used to deliver drugs for their local or systemic
effects.
2. Suppositories differ in size and shape and include:
a. Rectal
b. Vaginal
c. Urethral
d. Nasal
 SUPPOSITORIES
• Methods of preparation and dispensing suppositories
1. Molded suppositories: are prepared by first melting the base and then
incorporating the medications uniformly into the base. This mixture is then
poured into the suppository mold (fusion method).
2. Hand-rolled suppositories: required a special technique. With proper
technique, it is possible to make a product equal to the molded
suppositories.
3. Containers: for the suppositories are determined by the method and base
in preparation. Hand-rolled and molded suppositories should be dispensed
in special boxes that prevent the suppositories from coming in contact
with each other.
4. Storage conditions: If appropriate, a “refrigerate” label appear on the
container. Regardless of the base or medication used in the formulation,
the patient should be instructed to store the suppositories in a cool dry
place.
PARENTERAL PRODUCTS
• General requirements. The extemporaneous compounding of sterile
products is no longer confined only to the hospital environment; it now is
done by community pharmacists engaged in home care practice. Minimum
requirements include:
1. Proper equipment and supplies.
2. Proper facilities, including a laminar flow clean bench.
3. Proper documentation of all products made.
4. Quality control, including batch sterility testing.
5. Proper storage both at the facility and while the product is in transport
to the patients home.
6. Proper labeling of the prescription product.
7. Knowledge of products stability and incompatibilities.
8. Knowledge of all ancillary equipment involved in production or delivery of
the medications.
PARENTERAL PRODUCTS
Preparation of parenteral products
1. Preparation of sterile products requires special skills and training.
Attempts to prepare parenteral products or provide this service
without proper training should not be made.
2. These products must be prepared in a clean room, using aseptic
technique (i.e., working under controlled conditions to minimize
contamination).
3. Dry powders of parenteral drugs for reconstitution are used for drug
products that are unstable as solutions. It is important to know the
correct diluents that can be used to yield a solution.
4. Solutions of drugs for parenteral administration may also be further
diluted prior to administration. If further dilution is required, then the
pharmacist must know the stability and compatibility of the drug in the
diluent.
 Discussion
The art of compounding uses a whole different language,
and you have been asked to describe the following terms to
a pharmacy student who is visiting your pharmacy. Use
simple terms.

a. levigate f. tumbling
b. punch method g. solute
c. triturate h. solvent
d. spatulation i. geometric dilution
e. diluent j. comminution