We rely on medicines to get better from illness, and almost immediately after taking them we intrinsically believe they will make a difference.
Medicines are potent. That’s why they work. But, taken incorrectly, even a harmless medication can be dangerous to you and your family. So it’s important to be familiar with the effects of anything you ingest.
As Adepu and Swamy (2012) point out, however, it isn’t always easy to remember what the doctor or pharmacist tells you to do. Nor can medical professionals be familiar with all of the medical information included in a new medication. This is where Professional Information and Patient Information Leaflets (PILs) come in.
PIs & PILs: What’s the difference?
PILs and a medicine’s Professional Information (PI – previously known as a Package Insert) have, until recently, been the little folded documents that sit inside your medicine packaging. But according to the August Government Gazette (2017), a PI can now be published electronically (with the link provided on the PIL), rather than in print only.
There’s a lot of overlap between the two documents, with both including information such the medicine’s administration, precautions, and potential side effects. But, while they’re similar, it’s important to note that they are two distinct documents that have their own regulations and formal approvals processes; the major difference being that a PIL is written with specific guidance for the consumer, while a PI is written for healthcare practitioners.
As the Government Gazette (2017) highlights, a PI includes more complex medical data, like the medicine’s “pharmacological action and, where applicable… [its] pharmacokinetic properties, pharmacodynamic properties; and…pre-clinical or clinical studies”.
Medical information to help you
Although the information in both documents is detailed for a patient’s safety, the potential risks aren’t meant to scare you – they’re there to ensure that you’re aware of the (often rare) issues that could come up, so you can respond to them swiftly and accurately if necessary.
Adepu and Swamy (2012) advise that this kind of information is also important if you have a complex or chronic disease, like diabetes or hypertension. This is because some medicines can affect your symptoms or interact with other medication you’re taking for those conditions.
What these documents include
By law, all medications must include a PI and/or a PIL (although the PI can be electronic). But that’s just the start. According to Hela (2015) of the Medicines Control Council, the language used in these documents should also be legible, and the style and format consistent across all medications. PILs also need to be written in such a way that a patient can easily understand any instructions given.
Both Hela (2015) and the Government Gazette (2017) further explain that, legally, PIs and PILs must include comprehensive details on:
· Active ingredients: including strength, pharmaceutical form, and common names
· Other ingredients: including sugar, lactose monohydrate, preservatives, or alcohol
· Indications: what the medicine is used for
· Contraindications: including chronic accompanying diseases (e.g. kidney insufficiency, liver insufficiency, or diabetes); interactions with other medicines and non-medicinal substances; potential interactions with other ingredients; and conditions for certain types of users, such as children or the elderly
· Warnings: potential allergens, symptoms that may be masked by the medication, and outside influences that may need to be avoided, like sunlight
· Precautions: including the influence the medicine could have on behaviour, cognitive and physical abilities, reactivity, and judgment
· Directions: how to take / use / receive the medicine, including the consequences of stopping treatment early, and the usual and maximum durations of therapy
· Dosage: intended dosage ranges; the maximum daily dose; the frequency, method, route of administration; and the duration of treatment
· Overdose: what effects this could have and how to treat them
· Opening: opening techniques for child-resistant containers
· Storage: how to store the medicine
· Presentation and identification: what the packaging and medicine units look like
· Registration: the number, name and address of the registration-holder
· Important dates: relating to the leaflet’s publication and the medicine’s manufacture and expiry
What’s excluded from a PI or PIL
PIs and PILs may be comprehensive, but there are some things about a medicine that you don’t need to know. The way it was manufactured, for instance, may not be important and will not be included in the PI or PIL. All known side effects are important and will be included, however that’s not to say that potentially unknown side effects will be included. It is therefore vital to talk to your healthcare professional if you experience anything worrisome after taking any medication.
They say that knowledge is power, and that’s certainly the case when it comes to PIs and PILs. Read what’s relevant to you and you’ll be better prepared to prevent any surprises.
(adapted from a press release)