Is Pharma’s Language Too Confusing?
Have you ever been confused by instructions on a medicine bottle or packet of pills? When it says “avoid alcoholic drinks”, does it mean avoid completely or just cut down? And how exactly should the word “drowsiness” be interpreted? Sleepy? A bit tired?
If you are sometimes a bit baffled by the instructions accompanying your medicines then you are not alone. Research conducted in the UK by the university of Leeds and Luto Research shows that many commonly-used phrases on medicine labels are easily misunderstood, which is why the latest version of the UK’s British National Formulary (a kind of drugs bible used by doctors, nurses, pharmacists and other health professionals) will feature revised, simplified language and phrases. One of the changes, for instance, will change the phrase “avoid alcoholic drinks” to “do not drink alcohol while taking this medicine — which eliminates any confusion!
The changes are expected to appear on UK medicine bottles and packets within the next 6 months.
But should the pharma industry also be taking action? The research applies to the labels that are applied when medicines are dispensed by pharmacies, but medicines also usually include a leaflet supplied by the manufacturer. Should this language also be simplified into a more easy-to-understand format? I’m sure I’m not the only one who’s been baffled at times when reading a medication leaflet! Pharma companies want their medicines to be as effective and as safe as possible, so it makes sense that they should be encouraging people to take their medicines correctly — and surely one of the best methods is to use simple instructions that leave no room for misunderstanding.
At Pharmaceutical Technology Europe, we’re busy working on our April issue at the moment, but in May we’ll be running a special feature on pharmaceutical packaging where we’ll be interviewing Professor D.K. Raynor from the University of Leeds about the research, and questioning whether pharma should also be getting in on the act. What do you think about this subject? Should pharma’s medicinal information be simplified? We’ll also be looking at other aspects of pharma packaging, including trends and innovations. Tell us what you think by signing up to the PharmTech LinkedIn group.
Information for patients should probably actually have higher priority for reform.
Drs and pharmacists are experts who are competent to accurately interpret package inserts/product labeling info, not so the patients.
BTW, “Do not drink alcohol whilst taking this medicine” is not there yet! (As i think you intended to imply?)
It could mean:
1) Do not drink alcohol at exactly the same time as you are swallowing the current dose of your medicine, or within a few minutes after (or before);
2) Or for a period of several hours after (or before) each dose;
3) Or at any time during a course of treatment.
One of the problems here is simple–there are different levels of oversight for the industry in different parts of the world. What can be done in the EU is not necessarily allowed in the US. What is ok in Japan is not always acceptable to Canada, etc. Here is a perfect example:
A company in the US routinely has a dialog with the US FDA before a product is allowed to be marketed. The company prepares what it believes is an acceptable (for the time) labeling leaflet (or as we call it in the US a Patient Information Sheet). The FDA reviews the document and then either “suggests” or “prescribes” certain changes. The company representatives and the agency then begin negotiating the “final” document. Once that document is approved by the agency, it is not so easy to change the document unless the agency is convinced there is a problem. This is a significant issue because if the company simply decides on its own to change the document, the company faces significant potential regulatory action.
While I agree that the situation is difficult and that the documents should be more “user-friendly”, unfortunately, I think to get there is a long way and significant work that will be required by industry, the medical and allied health professions and the regulatory agencies. If any of these groups decide not to participate completely….it is likely a lost cause.
agree with the writer. There is need for easy to understand instructions on the leaflets.