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The Salvadore
Vol 270 No 7251 p750-751
31 May 2003

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PDF* 85K

Patient packs

Let us hope a door may be opened to further discussion — campaign summary

Idris Hughes looks back on our patient packs campaign
article index

Idris Hughes is a pharmacist from Trefriw, Gwynedd with a special interest in patient packs

What are we to make of this campaign's opening shots, with a stream of wordy missiles arriving from all directions? Does this "well founded initiative" herald the demise of pharmacy's "anachronistic cottage industries", will it end this "messy patient pack situation"? Are we to see "mangled remains" and an "antiquated relic of pharmacy's past" cast into the "dustbin of history"? Are these patient groups who cry "We deserve better", accusing us of a "dolly mixture approach" or declaring that "the role of the pharmacist is critical"?

Jonathan Buisson's question "Patient pack dispensing: why has such a good idea been so long in arriving?" appears above a photograph of the "drug counter" of a 1950s pharmacy — and yet nearly all of the consumer packs displayed are unchanged today. That would not generally have been the case had this been a photograph of the dispensary, where the products and the packaging are now vastly different in appearance. Have these changes in labelling and package design been an ordered development?

Today we are used to seeing "consumables" presented as prepacked products in standard-size offerings — liquorice allsorts in 25g packs, number 8 woodscrews in packs of 12, four shrink-wrapped apples, engine oil in one litre bottles. The techniques and styles used in packaging are more sophisticated and we have become less brand-conscious, seeking value for money alongside acceptable quality, rather than slavishly demanding a national or international brand at a premium price.

This generally seems to be an advance in product presentation, a "good idea" and a continuing process. This will be sustained in a competitive free-market environment by the demands and expectations of the consumer, in turn influenced by the ingenuity of the producer. Does pharmacy appear in this scenario? Does the presentation of prescription medicines in the dispensary enjoy a parallel development? Or is pharmacy a complete exception?

Contributors to this series are agreed that patient packs are indeed a "good idea". In the United Kingdom, however, when we take into consideration the influences that have come to bear upon their introduction and development, there can be little wonder as to why this good idea has been so long in arriving. The weight of influence has predominantly had a pecuniary flavour about it, reflecting the often disparate concerns of the various bodies involved and too often neglecting the prime interests in the introduction of patient packs — which should be those of the patient and those of safety, efficiency and economy in the processes of distribution, dispensing and administration.

These interests are a million miles from those presented by the Department of Health (PDF 200K), which are typified in the words of Dr Jim Smith, the DoH's chief pharmacist in the 17 May issue (p685): "We do not intend to move to a system under which only whole packs would be dispensed by community pharmacies." This Canute-like attitude seems to be typical of the Department's intransigence which spills over, thoroughly and stubbornly, into its attitude over the provision of patient information leaflets (PILs). These two related issues are brought together in the comments of Kailas Mahadevaiah of the SalvaDore — in the same issue he writes: "Supply of medicines via patient packs would negate the need for government proposals for pharmacists to photocopy patient information leaflets so as to comply with EU Directive (92/27)."

Sophisticate medication

In today's world of sophisticated medication, the whole of the European health community is in agreement over the importance of information for the patient. The PIL is regarded as an intrinsic component of the patient pack. Interfere with the distribution of patient packs and you inevitably interfere with the flow of information for patients via the PIL.

There are wide-reaching and important corollaries for the successful introduction of patient packs and PILs. In last week's issue, both Sue Mitchell, for Epilepsy Action, and Tom Thorpe for the Parkinson's Disease Society, emphasised the importance of product presentation in patient compliance and the benefits their members have derived from the introduction of the patient pack. (Gerald Fox, in the same issue, reminds us that the dosage-critical contraceptive pill was the first widely distributed patient pack with its own PIL.) Beyond purely clinical considerations Dr Peter Fellows states that he is "tired of penny-pinching moves by our Government to contain our drug expenditure" and he points out some of the financial, as well as clinical, benefits that accompany the proper introduction of patient packs. Mr Buisson details these and other benefits in his article and reminds us of the CASE acronym for the Compliance, Assurance, Safety and Effectiveness that patient packs would bring.

It is Dr Smith's Department that is paying the piper and the tune they call has us all in a reel. If prescribers elected to prescribe in whole-pack quantities then only whole packs, complete with their PILs, would be dispensed by community pharmacies. Our industry, however, continues to produce a variety of packs and the prescribers do not know where they stand. The continuing plague of parallel imports has not helped this situation and we can read of some dubious practices in this particular arena. Contributors here have detailed a hundred different facets and knock-on effects of the part-implementation of the original, national plan for patient packs in the early 1990s. To date it has been impossible for us to climb out from under the debris left over from the abandonment of that plan and the DoH still appears to be unaware of our problems.

What of the patient pack and the PIL itself? There are some excellent examples in evidence and some are, in Stein Lyftingsmo's words (see p753), "scandalously bad". It is probably true to say that most patient packs still leave much to be desired. This is by no means a personal criticism, it is implied by just about every contributor in this series that "it simply causes confusion and anxiety". "Clear and accurate information may increase compliance with treatments", "causes difficulties for pharmacists, but what about patients?" — these are typical comments.

In April 2000 appeared on the web (it is the product of my own efforts in concert with Simon Whitaker). This at first appears to be a somewhat satirical attempt to bring the shortcomings of current patient packs, and those of pharmaceutical packaging in general, to the attention of the industry. Its deadly serious purpose has always been to inform the industry of pharmacists' reasonable expectations for product presentation (ie, packaging and labelling) and to highlight the dangers presented by poor design.

In the three-year life of the website we have had a remarkable, global response. Our early fears, that designers in the industry simply were not consulting with the end user, were confirmed. In its first year a packaging design executive told us of his own small son's life-threatening experience, attributed to the change in label design of his insulin. This year we learnt of a Cleckheaton packaging design company's dedication to intensive research into pharmaceutical labelling design. We learnt last year, when more than 20,000 visits to the site had been recorded, that many designers were taking full note of the 'Golden Rules' that we had proposed. It is worth reproducing them here (Panel below).

Golden rules for patient packs

1. Recognise first the essential information for product and pack identification. This includes the brand name, the form of the drug, the strength, the variant, the generic name and the pack size (contents)

2. Always present this information on every surface of the pack

• Using an area of the pack's surface devoted exclusively to content description

• Ensuring the this area is in proportion both to its importance and to the overall size of the pack

• Employing a style and size of print that is adequate

• Giving due consideration to an appropriate order of emphasis

3. Take proper and full account of the practical requirements that the design is expected to fulfil:

• Insisting that the pack meets all criteria for child resistant containers

• Remembering that the prime object and essential function of product representation is that of establishing product identity without ambiguity, rapidly and clearly

In summary, this series of articles has provided a valuable assembly of information about the origins and early history of patient pack policy in the EU, it has detailed the benefits of their introduction and it gives an insight into the past efforts of pharmacy and the industry to implement a patient pack programme for prescribing and dispensing in the UK. Every pharmacist will hope that it might assist in opening a door to further discussion with the Department of Health — a discussion that might eventually contribute to a revised and successful programme for patient packs.

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