Have you ever opened up a box of prescription medicine and found that sheet of paper filled with tiny text? Did you throw it away? Consumer Medicine Information (CMI) leaflets are often seen as the “terms and conditions” you get with prescription medicines, full of technobabble. However, Consumer Medicine Information leaflets are filled with essential information regarding how, who, why, and when you should be taking the prescription medication. Consumer Medicine Information leaflets are a simplified version of the Product Information (PI) documents submitted to the Therapeutic Goods Administration (TGA) by companies manufacturing prescription medicine as a part of product registration. A product needs to have a Product Information document before being registered on the ARTG but a Consumer Medicine Information leaflet only needs to be created before the product is released for use.
This blog post will answer the questions of “What is actually in these documents?” and “How are they important to me?” and will hopefully encourage you to think twice about throwing this important little document away!
The importance of pharmacology
To further understand Consumer Medicine Information leaflets and Product Information documents, it is helpful to have a basic understanding of pharmacology.
Pharmacology is the study of drugs; particularly how they are made, what they do and how they work. There are two key aspects of drug activity that are particularly important to Consumer Medicine Information leaflets and Product Information documents: pharmacodynamics and pharmacokinetics. Essentially, pharmacokinetics are what your body does to a drug, and pharmacodynamics is what a drug does to your body.
Pharmacokinetics concerns the absorption, distribution, metabolism and excretion of a drug. All of these influence how long a medication stays in your system, where it goes, and how much it does while it’s there. Every person has a different level of metabolism, and every medication has different metabolism characteristics. A key concept of pharmacokinetics is bioavailability, which is essentially how much of a medication enters circulation as opposed to being digested and excreted. These factors are particularly important for those whose metabolism is abnormal, such as patients with kidney disease or the elderly.
Pharmacodynamics involves the mechanism of action (MOA) of a medication. This explains exactly how a medication has an effect, whether it interrupts a signaling pathway, changes the metabolism of key molecules or stimulates a new or extra signal. This is very important to patients of multiple medications, or if an initial medication is not effective and a new pathway is needed.
The importance of a clinician’s understanding of the pharmacokinetics and pharmacodynamics of a medication can be highlighted by comparing two different hypertension medications, Norvasc and Zanidip. Norvasc has no interactions with food and can be safely taken around meals, whereas Zanidip must be taken at least 15 minutes before food. This is because the the way Zanidip interacts with your body changes if it is taken after meals – if you have a high-carbohydrate meal, the bioavailability increases 2-fold, and if you have a high-fat meal, it increases 4-fold. Both medications use the exact same pathway, but how they are made differs, and this impacts their absorption. If this intake information was not accurately conveyed to healthcare professionals or patients, it could result in a dangerous situation for people who are particularly sensitive to medication, or have other health conditions.
What are the differences between Consumer Medicine Information and Product Information?
Both Consumer Medicine Information and Product Information are written by the company developing the medicine (the sponsor), and detail essential information about the medication they concern. The key difference between the two is the intended audience: Consumer Medicine Information is primarily written with the customer in mind, whereas Product Information is directed at health care professionals. Due to this, Product Information contains significantly more jargon and scientific explanations, while the Consumer Medicine Information acts as a summary of the Product Information, only translated from scientific language into plain English.
Almost all prescription medicines (and some non-prescription and biologics) have Product Information documents available on the TGA’s website. Similarly, almost all prescription medicines have Consumer Medicine Information leaflets, and these must be in a form that is directly available to the customer, either physically within the respective pack of medication, or by other means.
What is in Consumer Medicine Information and Product Information documents?
Consumer Medicine Information leaflets guide the consumer about what their medication is used for, considerations before, during and after commencing treatment, how to take the medication, who can’t take it, common side effects, use with other medication, storage and disposal – It is essentially information to answer frequently asked questions. This is particularly important for medicines with a higher risk of overdose, to communicate any special conditions on its administration in a way that a person of non-scientific background can understand.
Product Information documents, on the other hand, go much further into the pharmacological aspects of a medicine. They contains clinical information (approved conditions to treat, dose/dosing guidelines, contraindications, adverse effects, overdose), pharmacological properties (pharmacodynamic properties, clinical trial information, pharmacokinetic properties), pharmaceutical properties and the medication schedule. These are listed in full scientific detail so that a healthcare professional can choose the right medication for the right person and condition.
The Black Triangle Scheme
A final important aspect of promoting drug safety monitoring that Consumer Medicine Information and Product Information help with, is pharmacovigilance. This is the concept of continuous drug safety monitoring and reporting adverse events (AEs) after a medication has been licenced. As clinical trials cannot plausibly discover every side effect associated with using a medication, it is important that a reporting system is present and trends in AEs can be thoroughly investigated.
Consumer Medicine Information leaflets and Product Information documents both contain a section about how to report AEs to the sponsor, and their name and address. They also may contain a section with the symbol of a black triangle (Black Triangle Scheme) which is a coding system created by the TGA to indicate a medicine that is new to the market or has recently been granted permission to be used for a distinctly different purpose to the original intention. The black triangle indicates that there is still only limited safety data from clinical trials available, as the medication has not been on the market for long. The Consumer Medicine Information leaflets and Product Information documents will have the symbol and accompanying text for five years after the product’s initial release, and it is encouraged that any AE is reported.
So, is it time to fish your Consumer Medicine Information leaflets out of the bin? While these documents contain essential information about how to safely take a medication, whether to prescribe and how and when to report adverse events, if you do happen to throw them away, not all hope is lost. On the TGA website there is a search function that allows you to find both the Consumer Medicine Information and Product Information for any registered prescription medicine on the ARTG.
This guest blog is brought to you by Eleanor Mills (she/her), a student at Monash University in her final semester of a Bachelor of Science in Immunology and Pharmacology, and studying Honours in Pharmacology in 2022. Eleanor is completing a 5-week internship at PharmOut, facilitated by Monash’s Workplace Integrated Learning (WIL) program. She is excited for this experience and how it will enrich her career journey.
If you liked this content and want more, these blogs may also be of interest:
- Non-medical use of prescription drugs
- Whitepaper on how to list or register medicines in Australia
- Whitepaper on how to register a prescription medicine in Australia.
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