The issue here is that ICSR pharmacovigilance is defined as “the systematic collection, use, and analysis of adverse drug reactions.” The term “adverse drug reaction” means any health-related condition, abnormal physical or mental state, or any other change to an individual’s well-being or physical appearance that is caused by the use of a drug or other medical condition.
This sounds like the sort of thing that happens at a medical conference, right? But unfortunately, it happens at home too. While a patient may come to me for various reasons, I can’t really diagnose a condition or treat a disease without going through the same process we go through in the medical setting. Because we’re not actually physicians, I can’t actually collect data for an adverse drug reaction myself.
What makes this especially frustrating is that there are a number of drugs and medical conditions that are covered by the European Union’s comprehensive reporting scheme for pharmacovigilance. By participating in this scheme, a doctor, pharmacist, or other health professional is able to collect and report data about adverse drug reactions, drug-drug interactions, and other health conditions. It’s not a mandatory process because these medicines and conditions are very rare and doctors are always hesitant to prescribe them.
It’s not like prescription drugs are a panacea. The European Union’s scheme allows doctors to prescribe drugs, but not to prescribe them. This means that the drug companies are the ones who have to report adverse reactions (and thus warn people of the risk of a reaction) and the doctors are the ones who only report adverse reactions when they happen to them.
So, with the caveat that these are very rare drugs and conditions, ICSR does cover conditions that are not often reported to the medical community, such as certain types of tumors, rare diseases, aplastic anemia, and severe burns. This means that when doctors prescribe these medicines on their own (or even with a referral) they are responsible for reporting the reactions and the side effects.
The ICSR system is also called “pharmacovigilance” because the data is collected by medical professionals and submitted to medical journals and databases, and then the reported adverse reactions are reported. This data can then be cross-checked with the drug companies to see if there is a connection between the two.
There are over 50 drug companies that are involved in pharmacovigilance, and most of the ones involved are responsible for reporting the reactions. It is a good idea to be aware of the possibility that your own medicine may be involved in a serious reaction, and always be cautious when taking it for any reason.
If you have any questions about a drug you are taking, do a search online on the subject. If you can’t find an answer, ask your doctor. If the answer is “no,” then the drug probably isn’t involved. But just because it isn’t involved doesn’t necessarily mean that it is safe. The FDA is the regulator for the drug companies to make sure the safety of the drug has been thoroughly tested.
Of course, in the same way that you have to make sure that the safety of your prescription drugs has been thoroughly tested, you also have to make sure that any drug you are taking is not unsafe. If you are taking any prescription drug and its not covered by the drug company, you should stop taking it. So if there is some reason to believe that your medicine may be involved in a serious reaction, ask your doctor or pharmacist. Be sure you are getting the right medication.
A drug that is not included in the formulary of a drug company can only be dispensed in the form of a prescription. There are some drugs that may affect the action of another drug, which may make the drug not available for any amount of time. There are drugs that may affect the action of your medicine, which could possibly cause an overdose, or even result in death. So make sure you are getting the right drug.