intro Flashcards
community form dosage forms (non parenterals)
solid, liquid, semi solid
solid dosage form (community)
powders and capsules
liquid dosage form (community)
solutions and suspensions
semi solid dosage form (community)
ointments and suppositories
hospital pharm dosage forms
parenterals, non parenterals
hospital parenteral dosage forms
IV admixture, mEQ, TPN, radiopharmaceuticals
pt consulting tips
listen carefully, don’t assume, ask open ended q’s, don’t use fancy language, don’t state risk vs benefit comparisons, don’t guarantee anything and don’t blame anyone
history of compounding
More than 5000 years old
– “One-man” show
Compounding versus manufacturing
Specific physician-patient-pharmacist relationship
– The quantity prepared is very small
– Condition of sale is different in both situations
condition of compounding
limited to specific rx order
condition of manufacturing
intended for public at large
Is compounding legal?
yes but there are restrictions imposed on extemporaneous compounding
what can’t one compound
commercial products and drugs for the physician’s office
rx for compounding must be
UNSOLICITED
One can compound a product prior to receiving prescription, but only in
limited quantity (based upon history of rx’s)
Can a pharmacy advertise their compounding services?
YES, but only the service and not the products
Authorized prescribers
Physicians, midwives, optometrists, veterinarians, dentists, nurse practitioners, podiatrists
historical background of compounding
- Patient counseling
- Assistance by unlicensed personnel
- identification of pharmacists
- Pharmacy
- Licensing examinations
Compounding environment components
facilities and equipment
Stability of compounding preparations components
primary packaging, sterility, stability criteria and beyond use dating
space in compounding facilities
should have adequate space for orderly placement of equipment and materials to prevent mix-ups between ingredients, containers, labels, in-process materials, and finished preparations
cross contamination in compounding facilities
should be designed, arranged, used, and maintained to prevent adventitious cross-contamination
sterile preparations in compounding facilities
should be separate and distinct from the compounding area for non-sterile preparations
water for hand and equipment washing in compounding facilities
For washing hands and equipment, use potable water which meets the standards prescribed in Environmental Protection Agency’s National Primary Drinking Water Regulations (40 CFR Part 14)
water for non sterile products in compounding facilities
Purified water must be used when formulations indicate the inclusion of water and must also be used for rinsing equipment and utensils
____ for injection
sterile water and bacteriostatic
The equipment part deals essentially with
Weights and Balances, Prescription Balances, and Volumetric Apparatus
The equipment should be of _____ for compounding
appropriate design and size
The equipment should be ______ at appropriate intervals to ensure the accuracy and reliability of their performance
inspected, cleaned, maintained, and validated
The USP defines stability as
“the extent to which a preparation retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding”
chemical stability
each active ingredient retains its chemical integrity and labeled potency within the specified limits
physical stability
appearance, palatability, uniformity, dissolution, and suspendibility are retained
microbio stability
sterility or resistance to microbio growth (antibmicrobio agents retain effectiveness)
therapeutic stability
unchanged therapeutic effect
toxicological stability
no increase in toxicity
The USP requires that compounded preparations should be packaged in
containers that meet USP standards
Primary packaging
The container is that which holds the compounded preparation and is or may be in direct contact with the compounded preparation
is the closure part of the container
yes
Four types of containers
light resistant container, well-closed container, tight container, hermetic container
Stability of Compounded Preparations
primary packaging
sterility
stability packaging
guidelines for BUD for compounding preparations
storage temps
freezer temps (C)
between -25 and -10
cold temps (C)
between 2 and 8
cool temps (C)
between 8 and 15
room temps (C)
temp in the working area
controlled room temps (C)
between 20 and 25
warm temps (C)
between 30 and 40
excessive heat temps (C)
above 40
protect from freezing temps (C)
store above 0
refrigerator temps (C)
between 2 and 8
freezer temps (F)
between -13 and -14
cold temps (F)
between 36 and 46
cool temps (F)
between 46 and 59
controlled room temps (F)
between 68 and 77
warm temps (F)
between 86 and 104
excessive heat temps (F)
above 104
protect from freezing temps (F)
store above 32
refrigerator temps (F)
between 36 and 46
The USP uses the term “beyond-use date” as the date after which
a compounded preparation should not be use (determined from the date the preparation is compounded)
BUD for nonaq formulations
not later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient or 6 months, whichever is earlier
Water-containing oral formulations BUD
not later than 14 days when stored at controlled cold temperatures
Water-containing topical/dermal and mucosal liquid and semisolid formulations BUD
no later than 30 days
Chapter 1075 of the USP classifies pharmaceutical compounding into ____categories
7 (to provide the compounding personnel an understanding when different forms of preparations are compounded)
Categories 1 and 2
non sterile compounding
Categories 3, 4, and 5
deal with compounding of sterile products and risk levels associated with them.
Categories 6 and 7
radio-pharmaceuticals and veterinary compounding
category 1
nonsterile simple
mixing of 2+ commercial products
category 2
nonsterile- complex
compounding with the bulk drug substances when calcs are required
category 3
sterile: Risk Level 1
low risk level
category 4
sterile risk level II
medium levels
category 5
sterile risk level III
high risk levels
category 6
radiopharmaceuticals
category 7
vet
Reference Resources for compounding
- U.S. Pharmacopeia/National Formulary
- FDA Regulations of Hospital Compounding
- State Regulations of Compounding
- National Association of Boards of Pharmacy
nonsterile preparation components
- Preparation
– Official substance
– Active ingredient
-Added substances
– Compounded preparation
active ingredient
could be compounded prep
Compounded preparation
compounded dosage forms
» compounded drugs
» compounded formulations
abbreviations for sterile preparations
- for container specifications (LR, W, T)
- for solubility parameters (VS, FS, Sol, etc)
- for drugs (Table 1-10)
Many common abbreviations and notations may cause
errors or confusion
which one is correct: 0.25mg or .25mg
0.25mg
Terms used in prescription writing
Tables 1-12 and 1-13
as (left ear) may be misread as
os (left eye)
HS (bed time) may be misread as
half strength
q.d (every day) may be misread as
q.i.d (four times a day
MUg (microgram) may be misread as
mg (milligram)
OD
right eye and once daily
NC
no complaints and no code
QOD
every other day (read as “every once a day”
Abbreviated drug names that should not be used
6MP, 5 ASA, ddI, 5FU, PBZ, ARA A, ARA C, AZT, ASA, HCTZ, HCT, MS, MSO4 (shouldn’t be abbreviated for safety)
All written prescription or medication orders must be
legible and abbreviation free
All prescriptions and medication orders should be written using the
metric system
Prescribers should provide
age and, when appropriate, the weight of the patient on the prescription order
The prescriptions or medication order should include
the name of the drug, metric weight or concentration, and dosage form
A leading zero should always precede a
decimal point in quantities less than one
Prescription and medication orders should include
notation of purpose of the medication
Prescribers should not use unclear or imprecise instructions such as
“Take as directed” or “Take as needed”
