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QUALITY AND SAFETY
IN COMPOUNDING
NON-STERILE
PREPARATIONS
28
ĞŷpľŷÐpŹ
̈˷̕˷ʌʏ̅áƧ̿Ƨʭʼɇ̅VŎȹɇ̅úŎȹɇ̅VŎȹĸʌʧ̅ZƧʭɊʏɊƧ̈ɗ Patients are put at risk !hen compounded preparations
School of Pharmacy, University of Waterloo are belo! regulatory standards. Multiple studies have
Analyst, ISMP Canada sho!n pharmacy-compounded products (for example,
Certina Ho, BScPhm, MISt, MEd bio-identical hormones, nitroglycerin ointments) are
Project Manager, ISMP Canada at risk for quality issues resulting in sub-potency,
1,2,3
Adjunct Assistant Professor, School of Pharmacy, supra-potency, and even contamination. This article
University of Waterloo outlines important considerations !hen compounding
non-sterile preparations by referring to the ne!ly revised
United States Pharmacopeia (USP) Chapter <795>
Pharmaceutical Compounding – Nonsterile Preparations
(as of May 2011) and the Ontario College of Pharmacists
(OCP) Guidelines for Compounding Preparations. The USP
<795> Chapter defines the specific criteria required to
compound preparations of acceptable strength, quality,
and purity !ith appropriate packaging and labeling in
accordance !ith regulatory agencies. In Canada, drug
manufacturing is regulated by Health Canada and
compounding is an authorized act regulated by provincial
4
authorities. The 2006 OCP Guidelines for Compounding
Preparations (available at http://!!!.ocpinfo.com and
currently under revie!) set standards for the quality and
5
safety of compounding practices in Ontario pharmacies.
The follo!ing section supports the preparation of
non-sterile compounds !ithin the context of USP
specifications and provincial regulatory standards. Relevant
medication incidents voluntarily reported to ISMP Canada
(for instance, via the Community Pharmacy Incident
Reporting (CPhIR) Program at http://!!!.cphir.ca) are
used to highlight potential outcomes that may result !hen
non-sterile compounding guidelines are not follo!ed.
Before compounding a non-sterile preparation, the need
for the compounded product is confirmed by checking for
commercially available preparations in the Health Canada’s
Drug Product Database (http://!ebprod3.hc-sc.gc.ca/dpd-
bdpp/index-eng.jsp), and contacting manufacturers. To
comply !ith the Health Canada policy on compounding,
this confirmation is required in order to validate the lack of
product availability and avoid duplicating an approved drug
4
product.
ĸÌľúZƇ̅ZĞĀĀpZŘÐĞĀ̅̅̅Ȩ̅̅̅ŎĸľÐĀÀ͓̅̒˅̒̅̅̅Ȩ̅̅̅ĸÀp̅̒ʶ
ISMP C!N!D! REPORT
-1- PERSONNEL 1,000 times more concentrated than the intended
7
prescription. This incident emphasizes the importance
"fter confirming the need to compound a preparation, of independent double checks and follo!ing standard-
designated managers need to ensure compounders ized procedures to confirm accuracy and quality of
(!ho are responsible for compounding preparations compounded preparations. "long !ith defined policies
that are accurate and adhere to provincial standards) and procedures, compounding preparations require the
5
have accurate kno!ledge and expertise. The use of proper resources. This includes using equipment
5,6
compounder must use professional judgement that is clean, and properly maintained. Compounding
!hen deciding !hether they have the expertise ingredients must be purchased from reliable sources
5
to compound a specific product. This includes that are of appropriate identity, quality, and purity.
understanding chemical and physical properties of
ingredients, using appropriate equipment, and perform- Sample Case (from CPhIR): ! male patient received a
5
ing necessary calculations. prescription for a 1% hydrocortisone in clotrimazole
[cream]. The compounded preparation contained a
piece of "ax paper. The prescription "as prepared from
ʎ̒ʎ̅pĀŷÐľĞĀúpĀŘ̅ pre-made stock. The pharmacist did not notice the "ax
paper in the compounded product and the patient used
Compounders need to prepare non-sterile the preparation containing the "ax paper.
preparations in designated areas. Designated areas are
described as an appropriate environment (i.e. adequate Quality control procedures are required to ensure
8
space, lighting, and storage) to prevent cross-contam- accuracy and completeness. In the Sample Case
ination and the inadvertent addition of extraneous described above, the pharmacy used pre-made stock
5,6
material to the medication. The OCP Guidelines for to fill the prescription. Unfortunately, the pre-made
Compounding Preparations supports this practice by stock contained !ax paper that !as included in the
5
including provisions for sanitation. OCP recommends dispensed container. "lthough the !ax paper did
the pharmacy have a !ritten sanitation program that not cause harm to the patient, compounders are
5
specifies cleaning and disposal requirements. The responsible for ensuring the final product appears
8
!ritten program should also address hygienic behaviors as expected. If discrepancies are found in the final
(such as, !ardrobe, hand !ashing, management of preparation, compounders need to resolve such
injuries) of pharmacy staff engaging in compounding discrepancies in preparation and/or appearance before
5
activities. Furthermore, the designated area should dispensing to the patient.
have access to potable !ater (i.e. drinking !ater) for
hand and equipment !ashing.5,6
-4- STABILITY ASSESSMENT
-3- PROCEDURES AND RESOURCES Sample Case (from CPhIR): ! patient "as prescribed
sulfatrim oral suspension to be taken over a period of
7
Sample Case : ! pharmacist intended to compound 90 days. ! compounded oral suspension of sulfatrim
9
an oral suspension of clonidine (using clonidine po"der) is only stable for 20 days from its day of preparation.
for a 15-year-old male. The pharmacist incorrectly The pharmacist prepared and dispensed a 90 day
compounded the clonidine suspension (due to mixing supply of sulfatrim oral suspension. The medication
up during calculations/conversions among grams, error "as caught during dispensing and the patient
milligrams, and micrograms) resulting in a preparation "as given a 20-day supply "ith the remaining amount
1,000 times more concentrated than prescribed. Before credited as refills.
the error "as discovered, the patient "as admitted to
hospital multiple times. "s seen in the Sample Case described above, sulfatrim
or co-trimoxazole oral suspension !as not commer-
Designated managers need to provide compounders cially available at the time of dispensing due to drug
!ith necessary resources to consistently and accurately shortages, resulting in the need for the pharmacy
9
produce the intended preparation. Formulations to compound or prepare the oral formulation. The
should be accessed from a reputable source. If no pharmacist in this particular near-miss situation almost
formulation is available, a formula should be completed dispensed a compounded preparation intended to
using kno!ledge in pharmacology, chemistry, and be used past the acceptable beyond-use date. This
5
therapeutics. "s seen in the Sample Case described illustrates the need for compounders to understand the
above, a miscalculation led to dispensing a preparation concept of beyond-use dates.
P!GE 30 ~ SPRING 2012 ~ PH!RM!CY CONNECTION
ISMP C!N!D! REPORT
!hat is the difference bet#een expiry dates and cannot be used solely to assign a beyond-use date.
beyond-use dates? Beyond-use dates should be assigned conservatively,
!hile using professional judgment based on pharma-
The manufacturer or distributor gives an expiry date to ceutical education and experience. For non-sterile
a drug product based on kno!n stability data. It indi- compounded preparations that are packaged in tight,
cates the expected timeframe in !hich a drug product light-resistant containers and stored at proper temper-
meets the therapeutic and stability requirements based atures, consider the recommendations in Table 1 for
on the published monograph or literature. Beyond-use beyond-use dates !hen established stability informa-
11
dates, on the other hand, provide the date after !hich tion is not available. It is presumed that recommended
a compounded preparation shall not be used and are beyond-use dates are for compounded preparations
determined from the date !hen the preparation is that are suitably preserved, !here applicable, to protect
11
compounded. Compounders provide the beyond-use against bacteria, yeast, and mould contamination.
date (based on the manufacturer’s stability information
and the literature !ith respect to stability, compatibility, Should consideration be given to the suitability
and degradation of ingredients) to limit patient use of containers used for non-sterile compounded
10
of the compounded preparation. "ll compounded preparations?
10
preparations must contain a beyond-use date.
Sample Case: ! child "as prescribed an oral Prevacid®
Ho# do I figure out the beyond-use date for a suspension. The pharmacist compounded the oral
10
compounded preparation? preparation and put it in a plastic amber bottle, instead
of a glass amber bottle. !lso, the mother "as not a"are
The beyond-use date is determined from the date of that the oral preparation had to be refrigerated (no
compounding by applying drug-specific and general auxiliary label "as placed on the prescription container)
10
stability resources, !hen available. These resources and [she] stored it at room temperature. The issues "ere
should consider the nature of the drug, degradation, resolved before the child took the medication.
packaging containers, storage conditions, and the
10
duration of therapy. USP <795> states that !hen a Compounders are responsible for selecting the
manufactured product is used as an active ingredient appropriate container for non-sterile compounded
10
in a compounded preparation, the product expiry date preparations. In the Sample Case described
11
T!BLE 1: RECOMMENDED M!XIMUM BEYOND-USE D!TES FOR NON-STERILE COMPOUNDED PREP!R!TIONS:
NON-STERILE PREP!R!TION BEYOND-USE D!TE
Non-aqueous Formulations (such as ointments, Not later than the time remaining until the
suppositories, troches, and others !here no ɗƧ˨ʞʏɗ˷̈̅ɗͅˎʏ˨Ƨ̈ʏʼʭ̅ɊƧ̈ɗ̅ʼɩ̅Ƨʭ͆̅ʏʭɾ˨ɗɊʏɗʭ̈̅ʼ˨̅̂̅
!ater is contained) months, !hichever is earlier
"ater-containing Oral Formulations Āʼ̈̅ʞƧ̈ɗ˨̅̈ʌƧʭ̅˅ɻ̅ɊƧ͆˷̅ɩʼ˨̅ʞʏ˜̕ʏɊ̅ˎ˨ɗˎƧ˨Ƨ̈ʏʼʭ˷̅
!hen stored at controlled cold temperatures
(i.e. temperature thermostatically maintained
Ȯɗ̈́ɗɗʭ̅̒ʼZ̅ƧʭɊ̅ɞʼZ˒
"ater-containing Topical/Dermal and Mucosal Āʼ̈̅ʞƧ̈ɗ˨̅̈ʌƧʭ͓̅̌̅ɊƧ͆˷
Liquid and Semisolid Formulations (such as
preparations for topical application, like
creams, gels, ointments, etc.)
PH!RM!CY CONNECTION ~ SPRING 2012 ~ P!GE 31
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