Christine Clark BSc, MSc, PhD, FRPharmS, FCPP(Hon)
The results of a recent survey showed that there were wide variations between European countries in quality assurance and standards for pharmacy-made medicinal products. There was a gap in quality assurance between preparation in pharmacies and manufacture at the industry level. The terminology used for pharmacy-made medicinal products varied greatly between the member states. There was also a quality and safety gap between medicinal products prepared in pharmacies and in hospital wards. In most countries even fewer quality and safety requirements were defined for preparations in hospital wards.
As a result of these findings, in January this year, Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients, was published by the Council of Europe. This document aims to harmonise the quality and safety measures applied to the preparation of medicinal products in pharmacies throughout Europe.
Some of the key elements are:
- Products should not be made in pharmacies if a product with a marketing authorisation is commercially available
- Risk assessments for products should be undertaken and the level of quality assurance applied determined accordingly
- Product dossiers should be produced for stock products
- Reconstitution of products should preferably be done in pharmacies.
These provisions could have far reaching effects. Hospital pharmacies that have hitherto been preparing products that are commercially available will need to rethink their policies. Those preparing in environments that fail to meet either the Good Manufacturing Practices (GMP), for high-risk products, or the Good Preparation Practices (PIC/S GPP), for low-risk products will need to question whether they should be doing it at all. The resolution places considerable emphasis on risk assessment and provides a scheme for determining whether pharmaceutical preparations are high risk or low risk. It also distinguishes between ‘preparation’ of pharmaceutical products and ‘reconstitution’ of products for administration to patients. It states that reconstitution of medicinal products should preferably take place in a pharmacy (assuming that conditions are suitable). Conceivably, some pharmacy departments could give up large-scale preparation work and take on reconstitution of products for immediate use on hospital wards.
The requirement for product dossiers is interesting. In addition to the things that might be expected such as the ingredients, manufacturing process and testing, etc, the dossier should contain a “demonstration of the added value of the pharmacy preparation” and information about “use of the product including information for the patient and the prescriber”. It acknowledges that this might not be possible for extemporaneously prepared items but reminds pharmacists and prescribers to consider the risk of supplying such products without such documentation. This brings to mind the insistence by the UK National Patient Safety Agency (NPSA) of the critical importance of information available at the pointed use of an injectable product.
This Council of Europe resolution provides pharmacists and the pharmaceutical industry with opportunities to improve the quality of injectable products used in our patients – these are opportunities that should not be missed.