A petition: Food and Drugs Authority, stop their ‘big English’ drugs leaflets!

Every time I come across a drug package insert, those leaflets supposed to provide information about the medicine, the question that comes to mind is: are the people who write these texts assigned to test the medical or scientific knowledge of the users of the medication?

Why do they terrorize us with such ‘big English’? In fact, some of the terms are so scientific that they’re not even recognizable as English – which we’re already struggling with – and the leaflets might as well be in Greek! In most cases, it’s only the dosage (‘Adults 2 caplets twice a day’, etc) that a layperson can read and understand.

So this week my column is a petition to the Ghana Food and Drugs Authority to forward a concern to their international partners which approve drug information texts, that such information should be written in PLAIN LANGUAGE, understandable by the average person.

Again, the leaflets or inserts seem to be written for doctors or other healthcare professionals, although they accompany drugs meant for patients. Indeed, some of the packages have the instruction, “Read enclosed leaflet before use”, meaning that the text is for the user, NOT the doctor!

Moreover, obviously the leaflets are supposed to help the user to understand what the drug is for and its side effects, if any; and also provide some dos and don’ts. Evidently, because usually doctors in consulting rooms don’t have the time – or inclination – to give the patient all the details about the prescribed medication or the patient forgets, it is the leaflets or inserts that respond to that need.

But what do we read? The following are some examples of the baffling texts:

(a) “Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As pregabalin clearance is directly proportional to creatininine clearance, dose reduction in patients with compromised renal function must be individualised according to creatinine clearance ….”
Or,

(b)“Nucleo CMP Forte provides the phosphate groups necessary for the union of the monosaccharides with ceramins, to form the cerebrosides and phosphatidic acids constituting the sphingomyelin and glycerophospholidipids, main components of the mylenin sheath, thus achieving greater trophic properties for the maturation and axonal regeneration of the nervous tissue.”
Then there is this one:

(c) “Adults, Adolescents and children aged 10 years or older with primary hypercholesterolaemia (type 11a including heterozygous familial hypercholesterolaemia) or mixed dysipidaemia (type 11b) as an adjunct in diet when responses to diet and other … is inadequate.”

Also:

(d) “Gastric acid suppression during treatment with esomeprazole and other PPIs might decrease or increase the absorption of drugs with gastric pH dependant absorption. As with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, itraconazole and erlotinib can decrease while the absorption of drugs such as digoxin can increase during treatment with esomeprazole.

“Concomitant treatment with omeprazole … and digoxin in healthy subjects increased bioavailability of Digoxin ….”

Even with medication information for a simple eye infection, there is no respite for the hapless patient:
(e) “Cromoglycic acid (sodium cromoglycate) inhibits the degranulation of sensitized mast cells, preventing the release of histamine and other inflammation mediators. It has none of the collateral effects of the antihistamines, corticosteroids, anticholinergic or vasoconstricting agents ….”

What is one to do when seeking clarification of what the doctor said one is confronted with such gobbledygook or jargon?

Yet, the person being intimidated with the kind of technical language quoted above, the person who is the USER of the drug, has never set foot in a Medical School lecture hall!

Why can’t the manufacturers ensure that those assigned to compose their text write in language that laypeople can understand? Why must they write as if the target readership is medical doctors or other health professionals?

I first noticed this penchant of medical professionals to approach writing for the public as if writing for their fellow health practitioners when as Deputy Editor of this paper, I had the duty of engaging such experts to write for the paper.

Whenever I had been lucky enough to get a medical doctor to write for the paper, their initial articles invariably would be hard to understand because they wrote as if they were writing for their colleague medical doctors or other healthcare professionals. I then had the task of diplomatically reminding them that their article would be read by ordinary people.

But these days, increasingly, many of the leaflets come in English and French or even with Arabic translation, so I wonder why the producers can’t go the extra mile and include a version for the ORDINARY person. That way, the leaflet part that has ‘big English’ can be for doctors and other health professionals while the second version can be for the people the medicine is actually meant for, and who really NEED TO UNDERSTAND the text.

Interestingly, information from “Wikipedia, the free encyclopedia”, paints another picture, that what I’m proposing is actually already being done by some of the drug production companies:

It states: “A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical and provides information for medical professionals about how to prescribe the drug.

“Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user -- the person who will take the drug or give the drug to another person, for example a minor. Inserts for over-the-counter medications are also written plainly.”

However, I have never seen any drug package here in Ghana with “a separate document called a ‘patient package insert’ with information written in plain language”.

If that is happening elsewhere, why is it that the drugs sold in Ghana come in packages with information leaflets that one needs a Medical School qualification to understand?

So my plea is to the Ghana Food and Drugs Authority, to kindly pass on this petition to drug manufacturers targetting the Ghanaian market: drug inserts should be in laypersons’ language, please!

The manufacturers should endeavour to provide two separate texts, one intended for health professionals, and the other for those of us using their medicine. No ‘big English’ for us!

(ajoayeboahafari@yahoo.com)