What is Patient Information Leaflet (PIL) ? Why it is important?

The abbreviation PIL meant for Patient Information Leaflet. Though its not available in almost all the drugs available products in emerging markets like Nepal, India, Africa, Bhutan, but these leaflets are essentially important for any therapeutics goods.

PIL, in regulated countries like USA, Europe is enclosed in all the therapeutics goods irrespective of the category of medicaments.  Let’s discuss on the PIL.

PIL is a leaflet which contains all the necessary technical information about drug which is useful to patients or doctors or pharmacist. It includes basic information of drug , its indication, pharmacology, pharmacokinetics details, possible  side effects, interaction, special warnings, storage conditions and some more information if necessary. Each regulatory body has their own format but, so far Nepal has not set any guideline regarding this.  

In some PIL, warning is given the first preference so that, the drug won’t do any ill-effect on the consumer.

Why PIL is important?

In recent days, the patients are more conscious regarding their health and the drugs they consume. The recent promulgated constitutions also protects the rights of a consumer or patients as fundamental right where a individual has right to ask about the product they are consuming.

For doctors, each year new molecules comes in market and doctors may not be thoroughly aware about the medication so, PIL can be a informative document as a reference for them as well. Same goes to pharmacist and nurse as well.

In general practice in Europe, PIL  or leaflet is written or printed in the local language, lets say, medication in protugal has PIL in protuguese language, spain in spanish, USA in American English. SO, if Nepali regulatory bodies wishes to implement the PIL in their country, the most practiced language can be used as the communication language in the PIL, so that general public can understand rather than English.

PIL also improves the patient’s acceptance and satisfaction but in some cases it has been found that patients are hesitant against the drug after they go through adverse reactions and side effects.

Basic features of PIL

PIL should be authentic and unbiased, information given in the leaflet text that too in a easily understandable language in simple statement format. It should not contain long sentences, and should discourage the medicine sharing, avoiding self-medication, and readers should be motivated to take consultation from Pharmacist.

The complete layout should be attractive and readable; if possible addition of pictogram is necessary.

Though the additional leaflet or PIL will increase the cost of the medicament but, it will definitely going to make a positive impact on consumers. Its quite difficult in a country like Nepal where, the market is completely based on price control , extra burden of PIL won’t be welcoming, but, PIL is essential part of medication and it is unavoidable.