The Pharmaceutical Journal
Vol 270 No 7251 p753
31 May 2003

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Let the UK be a forerunner in the user-testing of patient pack labels and leaflets — a European perspective

By Stein Lyftingsmo

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Patient packs allow better compliance, reduce medication errors and improve traceability of faulty products. There is room for improvement in patient packs in all European countries, but the situation in the United Kingdom is so bad that drastic change is needed. And the UK is sufficiently large in an increasingly international pharmaceutical world, that I believe the change (or debate) will have impact outside its borders.

What is the problem with UK patient packs? First, the information design on many of them is bad. Secondly, it is a matter of luck whether the packages pass through pharmacies undamaged and with the critical information still visible (ie, not covered by a pharmacy label). Thirdly, the design of the pharmacy label is poor.

The pharmacy label It is perhaps unfair to criticise UK pharmacy labels, since many countries never individualise patient packs. But, frankly, the 15-year-old design and format should be looked at. Critical information elements should be given a better layout and better wording.

Tampering with packages The UK is one of four countries in Europe (the others are Croatia, Hungary and the Netherlands) where it is not unusual for pharmacists to tamper with patient packs: splitting, snipping, rebottling, repackaging etc. There are several explanations for this (for example, reimbursement rules, a strong tradition of dispensing from bulk), but no longer for any good reasons. Quality standards in pharmacy and pharmacies were once far ahead of those in other professions. Today consumer goods like Coca-Cola, cornflakes and toilet paper are better labelled and easier to trace backwards than UK prescription medicines. Patients should be allowed to demand sealed, traceable and originally labelled prescription medicines.

How the patient sees it Patient packs cannot be discussed properly without looking at how they are used. Few manufacturers have realised that a pharmacy label is put on every UK prescription patient pack.

Not only can the pharmacy label destroy a company profile and costly artwork, in many cases it is not possible to avoid covering critical information with it. The size of the pharmacy label is the same as it has always been. But many patient packs are too narrow for that, even if they are produced on exclusively British packing lines.

There is something wrong when these things are not recognised as breaches of quality standards.

Parallel imports Manufacturers of original brands fight hard against parallel imports and labelling is a major battlefield. Parallel importers are not allowed to use the original trademark, nor are they allowed to disguise it or build up a company profile of their own. In certain circumstances, importers are allowed to repack medicines and it is in such repacking that one can find examples of excellent parallel import label design. For one-to-one parallel import, which is more usual in the UK, importers must use an additional label on the top of the original label, sometimes allowing key elements to peep out through holes in the covering label. Such labelling is usually — sometimes scandalously — bad.

Identification number Every country has label peculiarities that will be questioned in the process of international harmonisation. Every community pharmacist in the UK knows which medicines are POM and which are P without looking at the package. It is in the pharmacy software, and that ought to be sufficient. "BP" is another unnecessary remnant.

Several countries demand identification numbers to be printed on the packages (eg, a national drug code in the United States, a commodity number in the Nordic countries, etc). These numbers are unique for every strength and pack size, and are usually the main element in barcodes. The UK does not have a system for identification numbers, and this is an important weakness. Unique identification of medicine packs, both human and machine readable, is a quality element that, I believe, prevents many medication errors.

Barcodes A barcode is a machine-readable string of numbers or characters. Discussing barcodes has little meaning without also discussing the elements of this string of characters. Different purposes for the barcodes give different results.

The upcoming demand in the US from the Food and Drug Administration is a barcode containing the NDC number (which is a regulatory identifying number). The purpose of the barcode is to reduce medication errors, and to increase traceability. The FDA also wants to include the batch number and expiry date in the barcode, but I believe that is not achievable at this stage.

In Italy and Belgium the approach to barcoding is purely economic. For reimbursement reasons they demand sequential numbered barcode stickers on every package. In Italy the stickers even have to be produced by the state banknote printer. Since the barcode cannot be printed on the packages, but stuck on them at the end of the packaging line, the packaging process is considerably slowed down.

I strongly believe that barcodes based on an identification number will give the best therapeutic outcome.

Critical information One of the major problems internationally, but especially in the UK, is the lack of emphasis on critical information. It is not possible to see the essential elements of information in one glance, they are scattered on several panels of the package. This sometimes causes difficulties for pharmacists, but what about patients? They usually do not know which information elements are critical. Market authorisation number and instructions about not storing above 25C should not be given the same prominence as the strength of the medicine. Critical information should also be easily readable.

What is critical information? That depends on the situation. Guidelines from the International Pharmaceutical Federation use the expression "primary patient information", ie, information that is important for the patient to read and understand before he or she starts using the medicine. Most of these elements are on the package when it leaves the manufacturer. But individual instructions for use and dosage are not known before the prescription is issued. The patient should find these on the package.

User testing Modern medicines have three major components: active substance, drug form and information. In these days of evidence-based medicine it is not possible to imagine that both active substance and drug form have been scientifically tested in clinical trials on patients.

We know that non-compliance has a magnitude of 30 per cent for many medicines. The rates of medication errors are largely unknown. A large portion of hospital beds are occupied by those suffering adverse drug reactions. In this light it is difficult to understand why medicines information is not performance-tested.

My wish is for the UK authorities to turn the messy patient pack situation into the complete opposite. May the British be forerunners in developing user testing of patient pack labels and patient information leaflets.

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