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Again, FDA, please stop their ‘big English’ drugs leaflets!

BY: Ajoa Yeboah-Afari
The writings drugs leaflets must be in plain English Language
The writings drugs leaflets must be in plain English Language

With so much attention on health now because of COVID-19, it seems opportune to revisit a concern that has long bothered me: the tendency for pharmaceutical companies to ‘bamboozle’ users of their products with overly medical terminology.
Therefore, the following is the abridged version of a column previously published in this space:

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!

In most cases, it’s only the dosage (‘Adults 2 caplets twice a day’, etc.) that a layperson can read and understand.

So this is my petition to the Ghana Food and Drugs Authority, to advise their international partners responsible for approving drug information texts, that such information should be in PLAIN LANGUAGE, understandable by the average person.

Generally, 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.   

But what do we read? 

The following are some examples of the baffling drug literature:

(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 ….”

(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 ….”

(c) “Adults, Adolescents and children aged 10 years or older with primary hypercholesterolaemia (type 11a including heterozygous familial hypercholesterolaemia) or mixed dysipidaemia (type 11b)…”

(d) “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.”

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.”

What is one to do when seeking clarification of what one’s doctor said, one is confronted with such medical terms?  

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?

I first noticed this penchant of medical professionals to approach writing for the public as if writing for their fellow healthcare 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.

These days, as increasingly many of the leaflets come in English and French, or even with Arabic translation, I wonder why the producers can’t go the extra mile and include a version for the ORDINARY person.

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:    

Wikipedia states: “For prescription medications, the insert is technical, and provides information for medical professionals …
“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”.

So my repeat request to the FDA is to kindly pass on this plea to drug manufacturers targeting the Ghanaian market: drug inserts should be in laypersons’ language, please!

Or, the companies should endeavour to provide two separate inserts, one intended for health professionals, and the other for those of us using their medicine. No ‘big English’ for us!
(Column of September 7, 2019,’A petition: Food and Drugs Authority, stop their ‘big English’ drug leaflets!’)    
      
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I strongly believe that there are many others who have problems understanding the language of most drug inserts.

So, FDA, I’m waiting to hear from you soonest, please!

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