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How Stable Are Medicines Moved from Original Packs Into Compliance Aids?

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How Stable Are Medicines Moved from Original Packs Into Compliance Aids? For personal use only. Not to be reproduced without permission of the editor ([email protected]) Articles How stable are medicines moved from original packs into compliance aids? In this article, Claire Church and Jane Smith have compiled a table based on information received from manufacturers about the possible stability of their medicines after removal from their packaging and placement in compliance aids he use of compliance aids has increased in longer than eight weeks” and that “certain original packs to compliance aids as it may be both primary and secondary care over re- medications should not be placed in moni- outside the terms of their product licence. For Tcent years. Compliance aids aim to act as tored dosage systems.These include efferves- the majority of manufacturers any informa- a reminder for patients to take their medi- cent tablets, dispersible tablets, buccal tion they provide is based on anecdotal evi- cines, enabling them to manage their own tablets, sublingual tablets, significantly hygro- dence or in-house studies as no formal studies often complex and confusing drug regimens. scopic preparations and solid dose cytotoxic would have been carried out.” They also act as a visual prompt for carers, in- preparations.” Wyeth Laboratories requested its own dis- dicating that patients have taken their medi- A general article by Roger Walker in The claimer to be used as well, since it believed cines, or at least removed them from the Pharmaceutical Journal in 19922 contained in- this would be a more accurate reflection of its device. formation on around 70 products from 53 products and is as follows: “The product in- The use of these aids involves the transfer pharmaceutical manufacturers. The leading formation provided in this article has been of medicines from the manufacturer’s original article in the same journal discussed the lack provided by the marketing authorisation packaging to the compliance aid. The origi- of data and concluded: “Manufacturers and holders for these products.The marketing au- nal packaging is designed to protect the con- regulatory authorities urgently need to catch thorisation holders only recommend that tents to appropriate pharmacopoeial and up with current practice.”3 In response to their products are stored in accordance with quality standards for a variety of criteria, eg, these articles a series of letters appeared a few the summary of product characteristics for water vapour transmission, as required in the weeks later.4 each product and that storage of products in product licence. However, the compliance A medicines and prescribing bulletin for any other way is entirely at the pharmacist’s aid cannot guarantee the same level of health care professionals in East Lancashire own risk.”These products are highlighted in protection. published data on approximately 30 products the Table by an asterix (*) in the additional Many systems are not disposable and are in November 2000.5 information column. frequently reused without cleaning.The haz- The medicines information department at ards associated with physical, chemical and Pinderfields General Hospital has collated Data presentation microbiological cross-contamination could data that are largely derived from pharmaceu- The Table now contains a list of 392 products be a major risk factor. All other dispensing tical manufacturers and not in-house stability in alphabetical order by generic name. containers are designed for single use. data. This was last updated in January 2004 Defined against each name is the brand name Compliance aids have limited available and contains information on 176 products. (if applicable), company, stability code and space for each dose, are not airtight and offer This currently unpublished document is any other additional information relating to less moisture and light protection than origi- available to other medicines information de- stability.The stability data have been classified nal packs. Doubts are raised as to the stability partments and may be available in the future into six groups according to the data re- of medicines that have been transferred to on the UK Medicines Information website: ceived. Each group was allocated a code for compliance aids: is there a deterioration in www. ukmi.nhs.uk. ease of numbering in the Table linked to the quality and can this result in a reduction of In an attempt to provide clearer updated extent of suitability for use in a compliance efficacy to an unacceptable level? guidance on potential stability problems, we aid. Stability codes were allocated as follows: Despite the increased dispensing of medi- approached pharmaceutical manufacturers cines in this way,guidance on their stability in for their opinion on the stability of their 1. Do not put into a compliance aid. these systems is limited and little new infor- products in compliance aids. 2. No stability data available, therefore com- mation has been published in recent years. pany does not recommend putting in a Certain products are particularly unsuitable Data collection compliance aid. (Refer to SPC for addi- for transferring into compliance aids, but Fifty medical information departments of tional stability information.) even this information is often not readily pharmaceutical companies in the UK were 3. No stability data available, therefore com- available. contacted by telephone during November pany does not recommend putting in a The Royal Pharmaceutical Society, in it and December 2002 and asked whether their compliance aid. Reason for concern is “Medicines, ethics and practice” guide (sec- solid oral dosage forms could be transferred stated, eg, light-sensitive. Individual phar- tion 3.4.7) says that “medicines should not be to a compliance aid. No specific brand of aid macists must accept responsibility for put- left in sealed monitored dosage systems for was specified. ting in a compliance aid. Risks can be Information in writing was received from minimised by additional safeguards, eg, use Claire Church, BPharm, MRPharmS, is all the pharmaceutical companies contacted of a black bag. community liaison pharmacist at and these data covered 243 products. A fur- 4. No stability data available, but it is proba- Southmead Hospital, Bristol. ther exercise to confirm data was carried out bly suitable to put in a compliance aid. Jane Smith, MSc,MRPharmS, is acting in September 2004 and we now have infor- 5. Stability data available in an alternative principal pharmacist, service development, mation on 392 products (see Table). container, but not necessarily in a compli- at North Bristol NHS Trust (formerly senior All but one company agreed to their data ance aid. pharmacist, patient services at Southmead to be used in this article provided the follow- 6. Stability data available which state that it is Hospital). ing disclaimer is included and strongly em- suitable to put in a compliance aid. phasised: “It is important to note that the Correspondence to: Mrs Church (e-mail individual manufacturers do not endorse this The additional information that relates to [email protected]). practice of transferring medicines from the stability is based on that received from the www.pjonline.com 21 January 2006 The Pharmaceutical Journal (Vol 276) 75 Articles manufacturers and is the best available from are unstable.This information could be made the resources at the time of compilation. General exclusions available in the SPC. It is essential that action The Table does not represent an exhaustive is taken now to fill this information gap and list and many companies were keen to remind Using the information obtained, more general so benefit patients and practice in the future. professionals that the most suitable and cur- guidelines for the transfer of solid oral dosage rent source of information regarding the sta- forms from original packs to compliance aids have Conclusion bility of a medicinal product can be obtained been written. They assume that all compliance This survey has revealed that although some direct from the medicine information depart- aids will be stored at ambient temperature, in a information can be obtained from the phar- ment of the respective pharmaceutical dry environment and away from direct sunlight. maceutical companies there is still a shortage companies. However, we would suggest some general of short-term stability data for the transfer of SPCs may be a reference source for deter- exclusions, based on the published and medication to compliance aids. Since the mining the stability of a product within unpublished data reviewed: publication of the leading article in The the original packaging.These can be accessed Pharmaceutical Journal in 19923 little appears to online on the Electronic Medicines Comp- ■ Medicinal products which are likely to be have changed in the availability of this stabil- endium website at www.medicines.org.uk. susceptible to the effects of moisture, ity information. It is impracticable to prevent Omission of a medicine from the Table including the use of compliance aids until such data be- does not mean that the medicine is suitable — Effervescent, dispersible, and soluble comes available. It is hoped that this collec- for putting in a compliance aid. products, which are unsuitable for packing in tion of data in a compact format will provide compliance aids owing to their hygroscopic some assistance in the interim. Discussion nature. Ingress of moisture into the Out of 392 products investigated, none had compliance aid may impair dispersal or
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