The Pharmaceutical Journal
Vol 270 No 7230 p14-15
4 January 2003

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  Locum pharmacy
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Letters to the Editor

PILs

Putting the PIL debate into perspective

From Mr D. K. Page, MRPharmS

With respect to the letter from G. J. Weaver, and the response from Stephen Lutener (PJ, 23 November 2002, p744) it is worth putting the whole debate in perspective. The requirement to supply printed patient information, and incidentally to supply appropriate external labelling on the container, was enshrined in a directive from the European Commission relating to consumer information and patient safety. This directive applies to all medicinal products placed for sale, including on prescription. (Since there was a similar directive to enforce the listing of contents and nutritional value of packaged foods, it seems fair that the customer/patient should know something about their medicines.) It was the choice of the pharmaceutical industry, as a whole, to implement Unit Pack Dispensing, using the EC Directive as a lever to achieve a cherished aim. (Unit Pack Dispensing is not the only solution to the requirements of the directive, but it is the most elegant.)

Given that the directive dates from 1992, that there was supposed to be a five-year implementation period, which the Medicines Control Agency managed to comply with, the question now sits as to why full implementation regarding labelling and printed information did not occur on 1 January 1999? It is too easy to say because the Department of Health and others did not come to an agreement regarding reimbursement rules so many years ago. It was known that not every product was available in treatment packs at that stage. There probably was not sufficient impetus to resolve the matter then. The question remains as to why after a further three years that "loose pack" bulk tablets are still available and that, where there is a choice, contractors are not buying sealed unit packs.

The current situation is far from ideal, and there is a need to resolve this matter for the sake of the patient as well as pharmacy contractors.

There are two interesting points from Mr Weaver's letter. The first is the assertion that prescribers will vigorously defend the right to prescribe part packs. That is not actually a problem, once it is pointed out that the occasions where it is clinically necessary to prescribe a part pack are probably few, and that if that is the case, surely the negotiators can take that on board. There is no problem in defending a right. It is only when the right is unnecessarily asserted that it becomes an issue.

The second point is more interesting, regarding the pack size of Buccastem 3mg tablets. This is probably not the only product where the quantity regularly prescribed is smaller than the usual container. I would suggest that where this is the case, Mr Weaver and other pharmacists lobby the manufacturers concerned in writing, and copy the letters to the Pharmaceutical Services Negotiating Committee, or equivalent body in the home countries, as evidence. If the industry is against copying of leaflets, it could strengthen its case by ensuring that the packs supplied are sufficient for one month's supply, or are in accordance with usual prescribed quantities, with no need to break the seal on the pack, or have to resort to either a photocopier or trying to get a decent copy off the internet. (This latter action assumes that the pharmacist has the time and resources to locate the appropriate information sheet and print it off.)

With respect to Mr Lutener's comments, there are a number of practical issues to be considered. The first is that prescribers, particularly GPs, are not in the habit of memorising pack sizes. The computer system on the GP's desk might prompt a pack size, but he or she is not obliged to follow it. The failure of the industry to agree whether a month is 28 days or 30 days is no assistance to this process. Although there is the facility of the "calendar pack rule" available, it is by no means clear if it is being used to a significant degree. There is also the detail that patients do read what is on their prescription, and if they have paid the charge of £6.20 and receive 28 tablets instead of 30, they are entitled to ask if they are getting their "money's worth". This matter will have to be addressed in negotiation.

There is one further point that has been raised infrequently. No matter how old pharmacists that are reading this letter might be, I am sure that few, if any, were taught how to count loose tablets as an examined part of the formal training. Although the act of juggling tablets in a counting triangle might be a therapeutic break in the dispensing process, it adds nothing to the safety of the patient. Worse still, noting that not all tablets are film-coated, there is the residual possibility of cross-contamination from a mechanical tablet counting device. Likewise, skill in the use of scissors for modifying blister strips is probably not going to be accepted as a positive part of CPD or effective use of a pharmacist or dispenser's time. The sealed package, with proper external labelling and the leaflet supplied from the manufacturer is a safer option.

Don Page
Edinburgh

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