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.
Tags:
Regulatory