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Why the profession needs a national formulary of non-standard preparations

The current situation, where multiple formulae exist for the same non-standard preparation, is a poor reflection on the science-based profession of pharmacy

By Margaret Gilmour

The current situation, where multiple formulae exist for the same non-standard preparation, is a poor reflection on the science-based profession of pharmacy

Paul McCague and colleagues (PJ 2012;288:722) are seeking pharmacists’ views on specials and extemporaneous preparation of medicines. I hope that those views will include pharmacists’ concerns about a large and long-neglected problem, namely, the multiplicity of formulae in existence for non-standard preparations and the problems this situation creates for pharmacists and patients. I believe that the time has come for the profession to create an official national formulary of these preparations.

Older pharmacists will remember the current British National Formulary’s predecessor: a book containing a collection of official formulae designed for extemporaneous preparation in pharmacies.

Pharmacy has moved on. In-pharmacy compounding of official formulae has dwindled, but there has been a slowly increasing demand over the years for a different kind of compounding: that of non-standard medicines for clinical situations where there is no suitable licensed product. This demand will continue to grow, because non-standard medicines are increasingly needed for the treatment of neonates, older people, those with unusual conditions, or with feeding tubes, or people with swallowing difficulties.

The ability to dispense medicines extemporaneously has long been regarded as a skill unique to pharmacy, and one which medical professionals and the public still expect pharmacists to exercise competently. Over the years, pharmacists, particularly in hospitals, have responded to demands for non-standard medicines by creating special, but often untested, preparations. Formulae for these preparations were then passed to other pharmacists. This began the national situation of multiple formulae existing for the same preparation.

The growing number of “specials” manufacturers added to the problem, with each manufacturer likely to have its own version of a particular preparation. This further increased the chances of patients receiving repeat supplies of a preparation not made to the same formula as a previous supply. This is not good pharmaceutical or clinical practice, and the current situation is a poor reflection on the science-based profession of pharmacy.

What is now needed is an official national formulary of scientifically validated non-standard preparations, giving prescribers and pharmacists access to the same formulation information. Such a national formulary would ensure that patients receive their medicine in an acceptable form and to the same standard wherever they are in Britain.

Various attempts have been made over the years to create unofficial formularies of non-standard preparations, but these have usually been compiled as small projects by pharmacists whose main job involved running sections of the NHS.

A ray of hope dawned with the publication of Jackson and Lowey’s ‘Handbook of extemporaneous preparation: a guide to pharmaceutical compounding’ (London: Pharmaceutical Press; 2010). This book contains a validated formulary of the top 50 most commonly extemporaneously prepared medicines in NHS hospitals. The preface states: “It will be adopted as the standard for extemporaneous dispensing for NHS patients … the principles should be equally applied across the profession.” It is unclear whether this has happened, or what steps are being taken nationally to make it happen. Perhaps any pharmacists involved in implementing such standardisation could let the rest of the profession know of their progress.

Jackson and Lowey have shown that some standardisation is possible. There is now a need for directed effort to build on this work. The new formulary of non-standard preparations should also incorporate information, currently available elsewhere, on how to deal with medicines administration problems in specific situations. All this information should form part of the relevant BNF monographs. Yes, it is a large task and, yes, there are many who will say it cannot be done, but the current situation is professionally unacceptable. Pharmacy has coped well with difficult tasks in the past, such as the introduction of nomen proprium labelling. We now take it for granted that dispensed medicines are labelled with their name, strength and dose form, but considerable official effort was required to overcome opposition to that change.

Ideally, the Royal Pharmaceutical Society should lead the new formulary project by appointing a dedicated team of experienced pharmacists to work alongside BNF staff. The new team should include pharmacists with recent experience in community and hospital pharmacy, so that the many practical considerations and existing day-to-day problems with non-standard medicines can be fully aired and remedied. Pharmacists in specials companies have developed their formulation and quality assurance skills, and should be appointed to make a positive contribution to the formulary team. The team should seek innovative ways of addressing the misinformation and many obstacles and myths that surround the subject of non-standard medicines.

Specials manufacturers present both a problem and a solution to formulae standardisation. They may not wish to reveal their validated formulae to the formulary compilers, but this could be done anonymously. Whichever formula for a particular product is selected as the national formula, specials manufacturers would not lose business: they would simply all change to using the official formula.

If some of the less stable non-standard preparations in the new formulary could be formulated using ingredients readily available to community and hospital pharmacists, this would assist in providing prompt patient treatment. The use of older and potentially confusing products, such as double strength and concentrated waters, should be discontinued, remaining stocks discarded and their names consigned to history.

Encouraging the resurrection of in-pharmacy compounding would need to be accompanied by a nationwide pharmacy staff skills refresher programme to ensure competence.

By supporting this project, the RPS would be doing something practical to rectify the currently unsatisfactory situation around non-standard preparations. Action on this subject is long overdue. In the interests of our patients and of our professional credibility with the public and the medical profession, can we afford to wait any longer?

 

Margaret Gilmour, MRPharmS, of Bolton

 

Citation: The Pharmaceutical Journal URI: 11103462

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