New drugs are developed, tested, processed, marketed, and then eventually released to the public every year. During their rigorous testing process, side effects arise in clinical trial patients and are noted by doctors. It is common for drugs to enter the market with a list of side effects, some being beneficial, but most being negative. These negative side effects are known as adverse effects.
After a drug has been released to the market, there are systems in place so that healthcare professionals can report any new issues or serious reactions to drug. These are known as adverse drug reactions (ADRs).
Adverse effects and ADRs are terms that professionals in the medical and pharmaceutical fields use often. Although they seem similar, they are very distinct in their differences. If you’re interested in clinical research training, keep reading to discover the main differences between them.
1. Students in Clinical Research Courses Might Know Doctors Are Aware of Adverse Effects
When a patient enters a doctor’s office and has something wrong, such as an ear infection, the doctor may prescribe them an antibiotic or other medication. The doctor is fully aware that secondary to the antibiotic’s main function of treating and eliminating the infection, it may also cause other effects such as vomiting and rashes. These are adverse effects, commonly known as negative side effects. Doctors are completely aware of these when they prescribe a drug, and carefully weigh the benefits of the drug with its adverse effects when writing out a prescription.
As you may learn during your studies, ADRs are different because they are unexpected and occur as a surprise to doctors. These unexpected reactions to drugs may be caused by the genetics of a patient or could even be a reaction to the combination of two drugs a patient may be taking.
2. Students in Clinical Research Training May Know ADRs Are Reported Differently
As students in clinical research training may know, adverse effects are discovered during the trial phases of testing a drug. Therefore, when a drug is released there is usually nothing to report in terms of adverse or side effects, because medical professionals are already aware of them. On the other hand, when an ADR occurs it is important for it to be reported.
As you will learn in your pharmacovigilance courses when completing your clinical research program, reporting ADRs is crucial to the public’s safety. Reporting ADRs can help detect mass issues with a drug. If a drug proves too dangerous, it may even be removed from the market or altered.
The Federal Drug Administration (FDA) and Health Canada have established a reporting system for health professionals. Despite this, many ADRs still go unreported. This may be because it can be a complicated and lengthy process to report these reactions and it is not compulsory for professionals to do so. In fact, the Department of Pharmacology at the University Of Toronto conducted a study and found that only 4 to 10 per cent of ADRs were reported to the Canadian Adverse Drug Reaction Monitoring Program.
3. Students in Clinical Research Training Should Know Adverse Effects Are Often Milder
As graduates of clinical research courses may know, adverse effects are considered minor and less severe. If they do reach the point where they could seriously harm a patient, the dosage of the drug can be scaled back or another medicine may be prescribed to offset the effects.
On the other hand, ADRs can be extremely serious. They are often characterized by death, hospitalization, life-threatening reactions, disability, congenital anomalies, or permanent impairment or damage. This is why clinical research professionals who monitor ADR reporting play a crucial role in ensuring the health of Canadians.
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