You just received a prescription from your doctor for a new medication. Your doctor told you why he was prescribing the medicine, gave you the name and some information about common side effects. Your pharmacist is also available to help you use the medicine correctly, but you want more details and general information.
You may also want to know things like how quickly Health Canada approved the drug, whether there have been any recent safety warnings about the drug, how the drug compares to other drugs for the same condition, and what information it had on account Health Canada when it approved the drug.
You are aware that a general Internet search may yield unreliable information, so you decide to look at what is available on the various Health Canada websites.
General information: The monograph of the product
All medicines approved by Health Canada include what is known as a product monograph (PM). According to Health Canada, a PM is a scientific and factual document about the drug that, without promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal use, safe and effective drug.
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PMs can be downloaded from the drug product database after typing in the brand name or generic name of the drug. Most of the document is written in language that would be difficult for the average consumer to understand, but at the end there is usually a consumer information section of seven or eight pages that provides more detailed information on issues such as safety, what the medicine is used for and when it should be avoided.
Although the PM must be approved by Health Canada, it is actually written by the company marketing the drug and the actual content is often subject to negotiation. It is also not clear how often a PM is reviewed. All Health Canada says is that reviews happen when there’s new safety information or when there’s new uses for the drug, but there’s no timetable for how quickly those reviews should happen.
Security information
The PM will give you aggregated safety information, but it doesn’t tell you how many times doctors, consumers, and manufacturers have reported safety problems or whether Health Canada has issued a safety advisory.
For reported safety issues, go to the Canada Vigilance Adverse Reactions Online Database.
For health warnings from Health Canada, you will need to go to the Recalls and Safety Alerts website. However, when you get there, there are no instructions on how to search, so it’s trial and error and hopefully you’ll find what you need.
Information on clinical trials
Clinical trials are the studies that companies must do before a medicine can be marketed. But these studies usually include only a small subset of people who have the condition that the drugs are designed to treat. They often leave out groups such as the elderly, children, women who may become pregnant, and people who take multiple other drugs.
Read more: Yes, black patients want to help with medical research, here are ways to overcome barriers that prevent clinical trials from recruiting diverse populations
If you want to know whether the medicine you have been prescribed has been tested on people similar to you, you can read section 7.1 of the Summary of Decision Basis where clinical trials are detailed. There is information about the age and gender of trial patients, but unfortunately Health Canada only discloses this information in a minority of cases.
How well does the drug work?
Will the drug make you feel better? Sometimes drugs are approved using what are called hard clinical endpoints, such as you living longer and/or your quality of life is better. But drugs are also approved based on surrogate endpoints.
Surrogate endpoints are measures of things like changes in blood chemistry, blood pressure, or how hard you can blow into a machine. They are supposed to predict what matters to patients, such as survival and quality of life, and sometimes do so as with HIV/AIDS drugs that lower viral load, which correlates with improved mortality But surrogate endpoints often do not. For example, only a minority of cancer drugs approved by the US Food and Drug Administration on the basis that they reduced tumor size, a surrogate endpoint, actually helped people live longer.
The summary of the decision basis documents will tell you whether clinical or surrogate criteria were used, and it turns out that more than 50 per cent of the drugs approved by Health Canada between 2012 and 2022 used surrogate effects. So the benefit you will get may be questionable.
How quickly was the drug approved?
You may want to know how long it took Health Canada to approve the drug. There are studies that show that the faster a drug is approved, the more likely it is that safety issues will arise once it’s on the market.
Information on how quickly a drug was approved used to be available by writing to publications@hc-sc.gc.ca for annual reports and using information from those reports to calculate review times. But in August 2022, an unannounced decision was made to cancel annual reports. Therefore, for now, there is no information covering the period after March 31, 2022. It is unclear whether annual reports will resume.
How does one drug compare to another?
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You may notice that the medicine you were prescribed for your problem is not the same medicine your friend was prescribed for the same problem. You might want to know which drug, on average, does a better job.
The Patented Medicines Pricing Review Board (PMPRB) used to rank the additional therapeutic value of new drugs compared to existing ones on a scale from breakthrough to slight/no therapeutic value. These classifications were made by a group of independent experts and published each year in the CEPMB’s annual report. At least they were until the long-delayed 2022 report, which didn’t come out until February 2024. That report did not contain any rankings, and the PMRB has not said that publicly available information on the rankings will return.
Orphan drugs
If you have an orphan or rare disease (affecting fewer than 1 in 2,000 people), you often don’t have many treatment options, if any. In these cases, you’ll want to know when new medications are available that can help.
Beginning in 2018, Health Canada published an annual report listing the new orphan drugs it approved. But the latest report covered 2021; since then, there has been no new edition. Therefore, new information about new orphan drugs is not readily available now.
Finding out safety and efficacy information about drugs shouldn’t be a chore. Health Canada needs to do a much better job of providing all the information that concerned patients (and their caregivers) need to ensure that patients get the best possible results from the medicines they use.
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