Pharmabiz
 

Patient information leaflets and medicine safety in Great Britain

AN Nagappa and Ina DonatThursday, July 30, 2009, 08:00 Hrs  [IST]

The safe use of medicine is an issue of global concern. It is estimated that even in developed countries, 10 per cent of patients are exposed to harm due to the wrong use of medicines and devices. Pharmaceutical illiteracy is a universal phenomenon. Most of the people regardless of their educational background will remain ignorant about the medicines they have been prescribed to treat their conditions. Community pharmacists are in an ideal position to provide information and advice on the use of medicines and devices when patients come to collect their medication. They possess the necessary knowledge and skills to help patients take their medicines correctly and thereby get the most benefit from their treatment. All pharmacists in Great Britain are expected to counsel patients on the use of their medicines, be they purchased over the counter (OTC) or on prescription. Pharmacy in Great Britain Every pharmacy in Great Britain must keep certain reference sources in order to retrieve information quickly and accurately should the need arise. The following publications are mandatory: British National Formulary (BNF), Medicines, Ethics and Practice guide (MEP), Stockley's Drug Interactions, and the Martindale Drug Reference. The latest edition of each is required. Many pharmacies use the online version of the above literature. The British National Formulary is by far the most used source of information when counselling. It is also used by doctors, dentists and nurses. The British pharmaceutical industry provides its own resource to pharmacies in the form of the Association of the British Pharmaceutical Industry (ABPI) compendium, which contains the patient information leaflets (PIL) for every licensed medicine in Great Britain. Patient information leaflets have to be included in every container. If the pharmacist dispenses original containers, the PIL will already be inside. If she/he dispenses from a stock bottle or divides original containers into smaller quantities, PILs must be included before handing out to the patient. PILs contain all the necessary information for the patient to ensure the medication is taken correctly. The information is written in plain language (no medical jargon). The content of the PIL is standardised in accordance with European law. Examples of the content are given at the end of this article. Ideally, the patient should be counselled by the pharmacist when the medication is collected. It should be pointed out to the patient that a PIL is included for their information to which they can refer should the patient have forgotten how to take the medicine. If the medication is handed out by another member of staff, they need to ask the patient if she/he requires any more information about their medicines and/or if they would like to speak to the pharmacist. If special advice is needed, i.e., on inhaler technique, the pharmacist should be able to show the patient how to use his inhaler correctly. The PIL then serves as a reminder to the patient. Additional information leaflets are available for the use of eye drops, suppositories, etc. Patients on lithium, warfarin, and steroids will receive a little booklet in addition to their PILs which contains detailed information and a diary to monitor their treatment. PILs are just one way of disseminating information to the patient. Since it is written information, the patient must be literate and able to see. The community pharmacist is the last healthcare professional to see the patient before he starts taking his medication and should therefore talk to the patient to ensure that the patient has all the relevant information for the safe and effective use of his medication. The recommended format of patient information leaflets is along the lines of "frequently asked questions" followed by straightforward answers leaving little room for confusion. There are two examples of content - Model A and Model B. Model A ● What should you know about this medicine? ● What is this medicine? ● What does this medicine do for you? ● You should know this before using this medicine for the first time. ● How to use this medicine? ● While you are using this medicine there may be possible side effects ● How to store this medicine? ● A statutory warning stating that this medicine can be used only on prescriptions of a GP (registered medical practitioners). ● Help line phone number (if any). ● Date of printing of the leaflet with manufacturer's address. Model B ● Name of your medicine. ● Active ingredient. ● What else is in your medicine? ● What for is this medicine used? ● Before taking your medicine, what are the precautions to be taken? ● While taking this tablet, do not take double of the amount of the tablet if you missed a dose. ● Instructions while taking and after taking this medicine. ● Precautions. ● Help line phone number (if any). ● Date of printing of the leaflet with manufacturer's address. The content of patient information leaflets has to be reviewed regularly by the manufacturer and approved by the regulatory authority. The PILs are an important part of ensuring patient safety. (The authors Anantha Naik Nagappa is professor at Manipal University and Ina Donat is community pharmacist at Boots UK, Edinburgh, Scotland, GB)

 
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