What is the SmPC and how does it differ from the PIL?
Most people know that there is a piece of paper included with every medicine, the Patient Information Leaflet (PIL) or “Package insert” / “Package leaflet”. Most of the time this is discarded or ignored, but this contains the lay language version of the Summary of Product Characteristics (SmPC). The SmPC and PIL contain a summary of the most important information on the medicine, including how it should be used, warnings and precautions, potential interactions and possible side effects.
Where can I find the SmPC or PIL? |
Many years ago, during my time at medical school and while training as a junior doctor in the UK, there was an annual release of the ABPI Compendium sent for every prescriber in the country. This was a book collating every SmPC for every product licenced in the UK. It was massive. They filled an entire room in our hospital and we used piles of them as coffee tables. In 1999 an online version called the electronic medicines compendium (the “emc”) was launched and has become an established website, trusted for reliable information about medicines:
This website was actually brilliant even from the very start. The search function worked, and it was easy to rapidly find the information you needed in both the SmPC and the PIL, plus it was available free of charge to prescribers. This quickly became the key source of information on any medicine licenced in the EU.
Where does the information come from?
When a manufacturer applies for a licence for a new medicine they submit a dossier of every piece of available data on that medicine, to the regulatory agency governing the licensing of medicines in that country. In the UK the regulator is called the Medicines and Healthcare products Regulatory Agency (MHRA). They carefully and thoroughly review all of the data and ensure that the wording of the SmPC and PIL accurately reflect the key information needed by patients and prescribers in that country. The same process applies in each country where the manufacturer applies for a licence, and different countries have different names for the product information with slightly different approaches. For example, in the US the regulatory agency is called the Food and Drug Administration (FDA) and the summary of product characteristics is called the US prescribing information (“US PI”), which has a different format to the UK / EU SmPC. They all share a common purpose: to give patients and prescribers in that country the most important information on that medication.
Every time the manufacturer finds new information (e.g. a new way to use the product, new undesirable effects etc) they must submit the data to the regulatory agency, who review it and ensure the updated product information accurately reflects the changes to the data.
Why is the SmPC important?
Although there are other sources of data on medicines, the official product information (e.g. SmPC, US PI etc) has been thoroughly reviewed and approved by a regulatory agency in that country. Risk minimisation measures, such as recommendations for additional monitoring for specific effects, or special precautions, will be listed in this document. It is regularly updated whenever there is a change to the benefit-risk profile of the medicine.
Therefore, in order to use the product appropriately, it is important to follow the guidance in the current SmPC.
Take home message:
Don’t throw away the package leaflet! Read it and make sure to follow the instructions in it carefully. It could prevent serious side effects. But if you are unfortunate enough to experience any adverse reactions, please report them right away in as much detail as possible.
