The Pharmaceutical Journal
Vol 270 No 7250 p722
24 May 2003

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Today we have a chaotic mismatch of pack sizes — a general practitioner's view

By Peter Fellows

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Counting tablets from bulk bottles is time consuming and inefficient. There is scope for error and the storage conditions are not ideal. The use of properly marked blister packs is much more efficient. They are also more convenient for patients. Advances in packaging technology made it possible to develop the concept of patient packs, which we all believed would simplify dispensing and benefit patients. It required a huge investment from the pharmaceutical industry.

Moves to patient packs would require GPs to prescribe quantities more precisely than many had previously been accustomed to doing. Some patients found removing tablets from blister packs difficult, but generally there were few problems. Clear marking of packaging with the drug name, expiry date and dosing instructions was easy. Unfortunately, the European Union had an early impact. Shrewd dispensers who were able to buy the same drug more cheaply from Europe then imported foreign patient packs resulting in endless queries to prescribers. "Parallel imports" were to become a new problem closely linked to the development of patient packs.

Nevertheless, there were clear benefits. Doctors were happier about storage conditions. There is some potential to reduce waste since the sealed nature of the packaging makes it more feasible to reuse returned drugs that have been recently dispensed, even if they are only reused through collection for charitable use in developing countries. More thought perhaps needs to be given to relaxing the rules for such reuse, taking into account the changes which patient packs have brought about.

The European Union brought in regulations on the 1 January 1994, in the form of EC directive 92/27/EEC concerning the labelling of medicines and the requirement for detailed patient leaflets. All new medicines had to comply immediately, and all existing licensed medicines by January 1999. The UK government had to comply in a relatively short timescale. The way of solving the problem was seen as to refine the development of the patient pack concept, with a suitable leaflet inserted automatically in every pack. The full-scale transition to patient packs in the UK would be phased in gradually from 1 December 1995. A series of meetings was then set up to involve all stakeholders. I took part in those discussions.

Given the variety of interests the progress and the level of agreement was surprising, and arrangements went ahead swiftly and efficiently. The pharmaceutical industry accelerated its investment in new production lines. The problems that remained difficult to solve revolved around issues like split packs. Pharmacists did not want to be left with residual bulk supplies or remnants of split packs. The provision of an emergency out-of-hours supply of a drug from the doctor's bag presented problems. It was believed that such drugs could be deemed as being "supplied" rather than "dispensed" in order to circumvent the wording in the EU directive and the need for a leaflet. That problem still persists and is partly behind the new requirement for all accredited "out-of-hours providers" to have to supply complete courses of medicines.

The industry generously agreed in 1996 to implement patient packs at no additional cost, something which the Department of Health was insisting upon in our joint discussions. Gerald Malone, the then Minister for Health, wrote the foreword in an Association of the British Pharmaceutical Industry booklet designed to explain and promote the scheme to the public. A series of seminars was held to explain the scheme to doctors and pharmacists.

Unfortunately it eventually became apparent that there would be some small additional costs, especially those related to probable drug wastage with fixed pack size dispensing. To alleviate much potential waste, various smaller pack sizes, reflecting the varying prescribing habits for drugs such as antibiotics, antihistamines and analgesics were agreed by the industry. A complete course of tablets, or otherwise 28-day packs, would become the norm.

Co-operation up to this stage had been exemplary, but split packs would require some mechanism for additional leaflets. Copyright law, differing licences for different brands and generic forms of the same drug, the additional time taken to dispense fractured packs and the problem of residues caused unresolved difficulties. On realising that there would have to be some degree of increased cost, the DoH simply insisted that the whole thing had always been conditional on cost neutrality, and pulled the plug on the scheme in November 1997. The Patient Pack Implementation Group was disbanded. We were astounded.

By that time the Patient Pack Initiative was in reality up and running. A massive investment had already been made in good faith by the pharmaceutical industry in order to assist the Government in reaching its deadline for complying with European law.

The important final parts of the Patient Pack Initiative were therefore never agreed, and we are left today with a chaotic mismatch of pack sizes, which should all have been standardised as either a complete course of treatment, or on the basis of 28-day supply or fractions and multiples of that. There are consequences for all prescribers, who not infrequently forget the relevant pack sizes even when prompted by their clinical computers. Dispensers often have to chase prescribers to request changes to prescriptions or else split the packs. Patients are often inconvenienced when drug quantities soon tend to get out of synchronisation, necessitating more frequent visits to the surgery and pharmacy, and leading to increased pressures on doctors' telephone lines and reception staff. There are huge hidden costs.

Now, faced with requirements to tighten up on the leaflet provision, the rather cynical response of the DoH has been to pay £500 to every pharmacy so that a photocopier can be purchased in order to photocopy drug information leaflets, downloaded from the internet if necessary, so that split packs can all comply with European law. There are currently protests about this from the industry regarding copyright of its leaflets.

The Patient Pack Initiative promised to be an exciting and efficient development with unprecedented co-operation between pharmacists, doctors, the industry and government. Some of the benefits have been realised, but the scheme was left as an unfinished mess, and key players were left mistrusting the government.

As a doctor deeply concerned with prescribing issues, I am tired of penny-pinching moves by our Government to contain our drug expenditure regardless of long-term benefit. We are already the most cost-effective and efficient prescribers in Europe. The all embracing emphasis on cost that dominates the DoH and primary care organisations now repeatedly hinders new developments, such as compliance with national service frameworks, National Institute for Clinical Excellence guidance, the provision of monitored dosage systems, repeat dispensing and the end of postcode prescribing. Remaining problems with patient packs are but one symptom of that unfortunate and short-sighted attitude.

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