The Pharmaceutical Journal
Vol 270 No 7250 p721
24 May 2003

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Two clear dispensing alternatives — a community pharmacist's view

By Gerald Fox

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It was during the late 1970s that I first became involved in what is now known as patient packaging (PP). From then, until the early 1990s, apart from my work as a community pharmacist, I undertook freelance work in the pharmaceutical industry on drug registration files and licence acquisitions for the generic market. At one company, the chief executive officer, an economist, often asked for my input as a community pharmacist. This was particularly the case when the company decided to move from loose packaging to foils.

Packaging then was in pots of 500 or 1,000 for most tablets. Over the years I had frequently expressed my incredulity over the stringent controls in production I witnessed compared with the dispensing of drugs in the pharmacy.

On any visit to the production line we sacrificed all dignity to wear production staff coats and shower-caps. Packs were sealed and marked with batch numbers and dates. The machinery was completely cleaned between every production run. The integrity of the product was paramount from its registration file and every phase of manufacture to the finished article.

In pharmacies, we were potentially ruining all those safeguards. Tablets were dispensed 10 to 20 times from a single pack, risking contamination on every occasion. If electronic or tray counters were used, the tablets inevitably suffered minor chipping or other damage. They almost certainly collected the dust trails of other, different products, no matter how diligent the cleaning routine. Furthermore they were presented to patients with no batch number or expiry date and could only be securely identified by tablet production charts.

It was, therefore, with great enthusiasm that I became involved in packaging policy in the 1980s.

There was a concerted effort to make the company and prescribers decimal quantities. It was not surprising. Pharmacists had switched from scruples to grams and UK currency from florins to 10p pieces during the previous decade. Doctors who had made any attempt at patient compliance or rational prescribing to save waste used 30 or 60 days as a treatment period. Although only four months in the year actually had 30 days, this reflected the average number of days in a month. The obvious conclusion was to follow major drug companies and produce 100 packs in foils of 10. The manufacturer concentrating on future EC regulations that would have to be respected decided to pack new products out of house, with the vogue of foils of 10s holding sway.

The contraceptive pill, with dosage critical, had always been presented in a patient compliance pack. My view was that a pack of four complete weeks with marked days could be applied to most medicines. As with my concerns over loose packaging I regularly put forward to the chief executive my growing desire for 28-day patient packs.

Matters came to a head in the late 1980s when it was decided that all products would be foil-packed in-house with a massive investment in the latest machinery. The company wanted to get ahead of its competitors but had to justify costs. The Department of Health and its Minister would not allow any increase in National Health Service prices to cover foil packaging.

After several board meetings the company decided to produce almost everything in packs of 28, 56 or 84 with foils of 14 or 28 dosage forms. The decision was made to match proprietary packs and to help conform to EC directives. I was delighted. Such packs would facilitate prescribing and dispensing. Increased patient compliance would reduce drug wastage, and NHS costs.

Ever since then all arguments for uniform 28-day prescribing have been scorned by the Department of Health. The costs argument is now reversed with foil packs as cheap as bulk packaging. Presented only with a bulk pack, pharmacists can legitimately charge for a full pack of a small quantity one-off item, increasing NHS costs.

I accept that there are certain prescriptions that could not conform to 28-day formatted packaging. Analgesics and laxatives and other "when required" medicines would not need it, and it is not appropriate for Controlled Drugs. Antibiotics are best packed to conform to dose and course.

With electronic transfer of prescriptions approaching, however, the need for standard 28-day patient packs is more important than ever. A computer program defaulting to 28-day supplies to produce an easily monitored repeat system would be difficult to dismiss. Doctors would simply prescribe the medication and its dose. ETP would convert that to prescriptions at the pharmacy along with the necessary labels to cover a 28-day period for all medicines. The number of labels for patient packs would mirror the dose regimen of each drug. A once daily dosage would generate one label and three times a day, three, etc. The costs to the NHS would fall dramatically because wastage would be reduced and over-prescribing minimised. Patient compliance would be strongly enhanced creating more savings. Pharmacists would have an easier monitoring task.

The labour saved dispensing complete packs and the transfer of tidy data to the pricing bureaux would further reduce NHS costs. This time, perhaps, the Department of Health will see reason and bear in mind the savings to taxpayers.

There are other advantages that have been studiously rejected in the past. Patient packs satisfy all the criteria for current European regulations regarding identification, batch, expiry date, and patient information leaflets. The DoH has had major problems coming to terms with PILs. EU directive 92/97 obliges supplies of medicines with "clear and understandable" information. Each patient pack comes with its own PIL. Under current NHS regulations pharmacists are exhorted to dispense exact quantities even though this disturbs the integrity of a patient pack, leaving snipped foils unidentifiable, without a batch number or expiry date. But even worse this creates the problem of having enough PILs to go with such material.

Recently the DoH came up with the most bizarre scheme I have ever encountered in over 40 years as a pharmacist. Someone decided to spend over £5m of taxpayers' money to provide every pharmacy with a photocopier to copy PILs. The practicalities of producing a legible copy to comply with the European directive let alone the bulk size of such copies did not form part of DoH thinking. That coupled with the odd, stubborn manufacturer still producing packs of 30, not 28, as a standard pack presents us with two clear dispensing alternatives to carry out our medicine management role in the Government's pharmacy programme.

Do we supply 14 x 2 tiny snipped foils, from untraceable packs of 30 to the unlucky 15th patient on a 28-day regimen, packed in a cigar box-sized cardboard skillet to accommodate a bulky photocopied PIL as the DoH would have us do? Or, like every other sensible country in the world, do we dispense whole patient packs, complete with original PILs, that comply with laws, facilitate prescribing and dispensing, aid patient compliance and monitoring, and save wastage and public money?

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