Durban - How often have you tried to understand what the leaflet inside a box of medicine is actually saying? Or tried to read the side-effects of a medicine, only to face a row of terms such as “flushing”, “syncope”, “bradycardia” and “postural hypotension”?
Despite the National Consumer Protection Act obliging companies across most sectors to talk to consumers in plain language they can understand, pharmaceutical companies have some catching up to do.
“Medicine labels and package inserts should aim to communicate critical health information to patients, yet this communication still has a long way to go to meet consumers’ needs for clear and useful information,” says Dr Sarah Slabbert of the Plain Language Institute.
“Recent health literacy research by South African researchers Krige and De Wet, Ehlers, Swanepoel and Van der Merwe have confirmed international findings that ordinary consumers find medicine package inserts difficult to read. Moreover, they do not give patients the information they need upfront. The information is also often crammed on a single page in small print without clear headings and very little white space.
“Medication is an integral part of most people’s every-day lives – from over-the- counter cold and flu remedies, vitamins and pain tablets, to chronic medication. For anyone who uses medication, it is crucial to understand the correct way to administer the medication, the correct dosages, and the potential side-effects.
“Yet package inserts are littered with technical and medical terms that most people are not familiar with,” says Slabbert.
“For example, these leaflets use unfamiliar terms such as ‘indications’ and ‘contra-indications’ as headings for ‘what this medicine is for’ and ‘who should not take this medicine’, which is critical information.”
In another example, a medicine insert lists the following as common side- effects of the medication: anaphylaxis; tachycardia, phototoxicity; precordial pain; psychosis; oedema; agranulocytosis or thrombocytopenia.
The ordinary consumer is expected to consult a doctor, or a medical dictionary, or Google, to recognise the rapid or accelerated heartbeat that he is experiencing as tachycardia.
“The fact that less than 10 percent of South Africans have English as their home language makes this type of communication even more difficult.
“Pharmaceutical companies are restricted by legislation governing the way in which they can market medication, particularly higher-schedule medication. Marketing messages, for instance, are only approved if the benefits of use outweigh the risks of the condition.
“However, pharmaceutical companies often fail to communicate beyond marketing the benefits. Once the consumers have been convinced and purchased the product, they have very little access to proper information about taking the medication – including how to take the medicine, monitor side-effects and store medicines, among other things.
“The majority of the population is not medically educated and misunderstanding medical information not only risks the success of the treatment, but can also result in life-threatening risks,” says Slabbert.
“However, not being medically educated does not mean that you do not need or do not have the right to accurate information that affects your health. Or that you won’t be able to understand and use such information. Or even worse, that it is impossible to provide accurate medical information in clear, understandable language to ordinary consumers.
“Medical jargon in patient information leaflets serves the professional elitism of health care professionals and not patients’ right to information,” says Slabbert.
Patient information leaflets are legislated by the Medicines and Related Substances Control Act 101 of 1965 and regulations. Regulation 10 and associated guidelines by the Medicines Control Council (MCC) prescribe compulsory headings and information to be included in patient information leaflets.
An MCC guideline on information for the package inserts for human medicines reads: “The package insert is regarded as the document that ensures the safe and effective use of the medicine under most circumstances.
“Package inserts should be typed in double-spaced text in black print and should be in English (British) and at least one other official language.”
These guidelines make no mention that the communication needs of the patients should be considered.
“We still have a long way to go to provide consumers with medical information that actually meets their information and communication needs,” says Slabbert.
“The first step would be to understand these needs and then to amend the guidelines to come in line with the communication needs.”
General statements in patient information leaflets should help people understand the implications of the medication before they take it. Yet, familiar examples of these statements on patient information leaflets are often not informative at all:
“If you are taking medicines on a regular basis, using the medicine at the same time with another medicine may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice.”
“If you are pregnant or breastfeeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.”
Consulting a professional health care practitioner in most cases implies transport costs, waiting in queues or expensive fees. Patients with insufficient resources to consult a health care professional have no other recourse than the information leaflet. If the leaflet does not give specific information in clear language, it means that consumers can easily make the mistake of taking a medicine that could potentially harm them.
“What benefit does this leaflet have if not understood? Patients might not have the relevant knowledge, resources or medical books to learn more about the information given. It is therefore critical that all target markets are taken into consideration and that leaflets contain information in line with consumers’ needs,” says Doctor Micha Janse Van Rensburg, a GP.
“There is often a mismatch between what is communicated on the outside of the container and what is in the package insert. When a consumer turns to an insert inside a medicine container for more information about the medicine, it should be clear to them what the potential risks and side-effects are,” Slabbert says.
“Consumers have a right to receive information about the medication they take in a language they can understand.
“Clear communication can definitely go a long way towards building trust between pharmaceutical companies and their customers. And contribute to making sure patients take medicine correctly.” - Daily News