EXTEMPORANEOUS COMPOUNDED DRUGS

COMPOUNDING
• patient information
• prescriber’s information
• date prescription was written
• SUPERSCRIPTION (RX) – take thou/recipe
• INSCRIPTION – medication prescribed
• SUBSCRIPTION – instruction to pharmacist
• SIGNA – direction for patient
• SPECIAL INSTRUCTION – refill
• sum of processes performed by pharmacist
in drug preparation including calculations,
mixing, assembling, packaging/labeling of a
drug
• as the result of prescription/drug order by
physician, dentist/veterinarian
• for purpose of/in relation to, research,
teaching/chemical analysis (RA10918)
EXTEMPORANEOUS COMPOUNDING
• timely preparation of drug product
according to physician’s prescription, in wc
amounts of ingredients are calculated to
meet needs of particular patient/group of
patients according to good manufacturing
practice

United States Pharmacopeia (USP 795) define COMPOUNDING

COMPOUNDING as:
• preparation, mixing, assembling, altering,
packaging, and labeling of a drug, drug-
delivery device/device in accordance w
licensed practitioner’s prescription,
medication order/initiative based on
practitioner-patient-pharmacist-
compounder relationship in course of
professional practice
• EXTEMPORANEOUS COMPOUNDING
➢ on-demand preparation of drug
product
➢ according to physician’s prescription
➢ meets unique needs of individual
patient
• MANUFACTURING
➢ production/processing of drug in
LARGE quantity by various mechanisms

COMPOUNDING INCLUDES: WHY COMPOUND?

• preparation of drug dosage forms for both • pediatric patients requiring diluted adult
human & animal patients strengths of drugs
• preparation of drugs/devices in • patients needing oral solution/suspension
anticipation of prescription drug orders, on of product that is only available in another
basis of routine, regularly observed form
prescribing patterns • patients w sensitivity to dyes,
• reconstruction/manipulation of preservatives/flavoring agents found in
commercial products that may require commercial formulations
addition of one/more ingredients • dermatological formulations w fortified
• preparation of drugs/devices for purposes (strengthened)/diluted concentrations of
of/as an incident to, research commercially available products
(clinical/academic), teaching/chemical • specialized dosages for therapeutic drug
analysis & preparation of drugs & devices monitoring
for prescriber’s office use were permitted • care for hospice patients in pain
by law management
• compounding for animals
EXTEMPORANEOUS COMPOUNDING –
preparation of therapeutic product for an
individual patient in response to an identified
need
 EXTEMPORANEOUS COMPOUNDED DRUGS
COMMON PROBLEMS W SPECIALS
PRESCRIPTIONS
1. if short dated-will patient uses up quantity
prescribed w/in that time
2. cost if using specials company-very
important if private prescription
3. lack of detail on prescriptions especially
creams & ointments where no base is
indicated
4. computer generated prescriptions where
unlicensed preparations are not in standard
menus
5. finding a formula
6. national differences w non-compendial
formula
PRESCRIPTION ANALYSIS COMPOUNDING
CONSIDERATIONS
1. always consider use of commercially
available products as far as possible
2. if no suitable commercial product exists,
consider therapeutic alternative that is
available in suitable dosage form; this must
be discussed w physician
3. extemporaneous preparations should be
done based on evidence-based references
4. always check for suitability of product/
brand for extemporaneous preparations
5. preparations should be done according to
what is stated as far as possible unless
stated otherwise in product leaflet
6. when no information is available,
compound an oral medication by
dispensing a tablet &/or capsule & directing
caregiver to mix just prior to administration
7. stability of shelf storage in pharmacy is
applicable w/o opening; once opened,
stability of preparation should be no longer
than 30 days; maximum quantity of
extemporaneous preparations to be
dispensed should not exceed one month
8. refrain assumptions on therapeutic
equivalence in case of suggesting
alternative agents as possibilities &
supporting data may be limited
9. techniques in compounding preparations &
manipulations should always be in line w
standard good preparation practice as
delivering accurate dose in paramount
10. documentation after each preparation
should include details on materials used,
processes involved & the responsible
personnel in-charge
CONSIDERATIONS FOR PREPARING
EXTEMPORANEOUS COMPOUNDS
1. pharmacy personnel are reminded not to
empirically change flavorings/suspending
agents because they can affect pH &
stability of product & result in an unstable
product
2. please consider ingredients in formulations
that require special precautions in neonates
3. mixing of a compound formulation should
always be in line w the following principles:
• ensure all ingredients used are w/in
the expiry date
• ensure all utensils are clean; including
mortar & pestle, graduates, pill cutters
& stirring rods
• product should be labelled clearly &
stored as recommended w/in formula
• for solution/suspension products,
emphasize on importance of thorough
shaking before administration
4. if compounding preparation using contents
from an ampoule, remember to withdraw
solution (medication) from ampoule using a
filter needle to ensure no glass particles are
incorporated into the compound
5. place tablets/s w/in mortar & pestle to
grind tablets to fine powder; for film-
coated tablets, it may be necessary to add
small amount of diluents such as water, to
soften coating prior to grinding tablets; this
 EXTEMPORANEOUS COMPOUNDED DRUGS
will ensure that compound will not have an ORAL LIQUIDS
eggshell appearance from film coating • is drug soluble in vehicle at dose required?
floating throughout suspension; if you are • if not, could a suspension be prepared
using capsules, open the capsule & empty • crush tables/use powder
powder into mortar & discard capsule shell • use highest strength tablets to reduce
6. solutions will have clearer appearance overall excipients
versus compounded suspension • check tablet characteristics: controlled
release, sugar coated, film coated, enteric
SOURCES OF FORMULAE coated
• Compendia e.g. BP, Martindale 28th/ • good practice: always use same brand &
USP/NF etc strength; care w generics
• Hospital-often continuation of treatment in • good practice: standardize to dose/5mL or
primary care dose/1mL
• GP’s own e.g. Dr. Ives wart pain etc. • may dilute injection fluid from ampoules
• Published literature/journal articles
available on internet; Often MAKING SUSPENSION FROM TABLETS
American/European • crushing, grinding
• wetting & pasting
FORMULATION GENERAL • these steps are vital to give homogenous
• physical problems – cracking, caking, product
precipitation
• chemical degradation – usually pH IMPORTANCE OF CALCULATION SKILLS
dependent • full understanding of what’s required can
• BP limits for actives are usually 95-105%; prevent dispensing errors
published data may accept wider limits • ensures correct clinical interpretation of
such as 90%; what are acceptance criteria? prescription
• microbial-preservative system, closed pack • overdose/sub-therapeutic?
shelf life may be longer than opened pack • letter from dermatologist translated into
e.g., use 14 days after opening computer generated prescription
• beware of progressive misinterpretation!
COMMONLY REQUESTED DOSAGE FORMS-
NON-STERILE BEWARE OF COMPLACENCY
• for application to skin • we all know
• creams, ointments, pastes, lotions, external • 1+1=2
solutions • check this everyday as a pharmacist
• for oral ingestion-liquids • errors are usually silly mistakes
• suspensions, solutions, mucilage • consequences can be tragic
• traditional terms: elixir, mixture, linctus • establish rules & routines
• now all referred as oral • standard operating procedures &
solution/suspension unless using worksheets
compendial title
SUMMARY-DEALING W PRESCRIPTION
LESS COMMON DOSAGE FORMS (NON-
• often lacking in detail
STERILE)
• don’t take at face value
• reefers (cigarettes injected w drug)
• usual clinical assessment
• capsules & powders
• has patient had medicine before-possibly
• bars of soap
from hospital
• lozenges/pastilles
• save details-worksheet/record
• lollipops
• consider shelf-life, close & open, pack size
• suppositories/pessaries – need & storage conditions
displacement value of ingredients
• use scientific knowledge
 EXTEMPORANEOUS COMPOUNDED DRUGS
SUMMARY-MANAGING YOUR PATIENT • batch number of preparations & starting
• collections & delivery arrangement materials
• good practice-establish routine • name & signature of preparing personnel
• consider bank holidays • name & signature of checking personnel
• logistics-especially fridge lines
• compliance – e.g., administering 1mL may
be easier than administering 5mL
• accurate dosing – counselling, oral syringes
• accurate packaging

AVAILABILITY OF RAW MATERIALS

• need to obtain pharmaceutical grade, BP,
PhEur/USP
• laboratory grades analaR may be all that’s
available
• may be using licensed medicine e.g.,
crushing tablets, diluting steroid cream
such as Betnovate
• difficult to obtain small quantities of pure
drug powders
• need to consider TSE-transmittable
spongiform encephalopathy e.g., Lanolin
• good practice to obtain certificate of
analysis
• may need to use another unlicensed
medicine e.g., imported tablets; need to be
assure of quality

LABEL FOR EXTEMPORANEOUS

PREPARATIONS
• details of community/hospital
• expiry date
• drug’s name w strength
• details of patient
• administration instructions
• storage
• special instructions/precautions
• pharmacist name prepared

WORKSHEET OF THE PRODUCT SHOULD

CONTAIN THE FOLLOWING DETAILS
• patient’s name
• ID number
• prescription number
• date of preparation
• name of drug
• dose
• volume of diluent/vehicle
 EXTEMPORANEOUS COMPOUNDED DRUGS

CROSS CONTAMINATION
• at worst complete mix up e.g., product
labelled as another product
• MICROBIAL – bacteria/fungi; does the
product have preservative system
• PHYSICAL – particle e.g., dust, plastic
• CHEMICAL – residues/particles of another
drug

BASIC APPROACH TO RISK ANALYSIS

• picture worst case scenario
• what would be the consequences to patient
• how likely (frequency) is this type of error to
occur?
• would checking pharmacist/patient be able
to detect the error?

NEED TO DEVELOP BEST PRACTICE

• simple but effective methods on batch
sheets
• standard operating procedures
• perform risk assessments
• in house risk mitigation techniques to
prevent errors
• e.g., empty blister strips supplied to
releasing pharmacist