Reporting adverse reactions to prescribed drugs
Discussion
On the 'possible side effects' that a prescribed drug leaflet describes for the user - there is often a long list of ailments under the headings:-
common side effects occur in more than 1 in 100 patients
uncommon side effects occur in less than 1 in 100 patients
rare side effects occue in less than 1 in a 1000 patients
If you have an adverse side effect it's recommended that you see your GP for advice...who will then suggest an alternative. So far, so good.
What I'm interested in knowing is - are these adverse reactions ever reported back to the company that makes the pills? Putting more than 1 in a 100 implies it's still a very small number of patients that could be affected when the wording could also be read to mean nearly 90 in a 100 will suffer adverse side effects.
Presumably clinical trials have a cut off point before the drug is allowed to be licenced for use on patients. Is this regulalry checked up on? Are tests more rigorous for branded pills than the generic ones that are so much cheaper?
Thanks if anyone can help with my query
common side effects occur in more than 1 in 100 patients
uncommon side effects occur in less than 1 in 100 patients
rare side effects occue in less than 1 in a 1000 patients
If you have an adverse side effect it's recommended that you see your GP for advice...who will then suggest an alternative. So far, so good.
What I'm interested in knowing is - are these adverse reactions ever reported back to the company that makes the pills? Putting more than 1 in a 100 implies it's still a very small number of patients that could be affected when the wording could also be read to mean nearly 90 in a 100 will suffer adverse side effects.
Presumably clinical trials have a cut off point before the drug is allowed to be licenced for use on patients. Is this regulalry checked up on? Are tests more rigorous for branded pills than the generic ones that are so much cheaper?
Thanks if anyone can help with my query
condor said:
On the 'possible side effects' that a prescribed drug leaflet describes for the user - there is often a long list of ailments under the headings:-
common side effects occur in more than 1 in 100 patients
uncommon side effects occur in less than 1 in 100 patients
rare side effects occue in less than 1 in a 1000 patients
If you have an adverse side effect it's recommended that you see your GP for advice...who will then suggest an alternative. So far, so good.
What I'm interested in knowing is - are these adverse reactions ever reported back to the company that makes the pills? Putting more than 1 in a 100 implies it's still a very small number of patients that could be affected when the wording could also be read to mean nearly 90 in a 100 will suffer adverse side effects.
Presumably clinical trials have a cut off point before the drug is allowed to be licenced for use on patients. Is this regulalry checked up on? Are tests more rigorous for branded pills than the generic ones that are so much cheaper?
Thanks if anyone can help with my query
Google MHRA common side effects occur in more than 1 in 100 patients
uncommon side effects occur in less than 1 in 100 patients
rare side effects occue in less than 1 in a 1000 patients
If you have an adverse side effect it's recommended that you see your GP for advice...who will then suggest an alternative. So far, so good.
What I'm interested in knowing is - are these adverse reactions ever reported back to the company that makes the pills? Putting more than 1 in a 100 implies it's still a very small number of patients that could be affected when the wording could also be read to mean nearly 90 in a 100 will suffer adverse side effects.
Presumably clinical trials have a cut off point before the drug is allowed to be licenced for use on patients. Is this regulalry checked up on? Are tests more rigorous for branded pills than the generic ones that are so much cheaper?
Thanks if anyone can help with my query
Hi, simply googling MHRA won't give you the information you need. Ideally as a sufferer of an adverse event you should report it to your Physician who has an obligation ( although more often than not they do not) to report the AE to the MHRA or other regulatory body dependant on country. In the UK this is done via the yellow card scheme. Google that.
The MHRA would then notify the drug companies around what AEs are being reported. Let's say 1000 people had the same AE, known (as described on Patient Info Leaflet) or unknown then this is what is called a safety signal. Dependant on prevalence then this could be adopted into a SPC which is essentially all the regulatory information about a product. See medicines.org.uk for that.
Some patients and physicians report AEs to drug companies directly and the same process follows, they look for signals and see of any other clinical trials need to be conducted or if SPC needs updating etc.
There are large teams within the drug companies who look after safety of products, tracking and monitoring. Not only is it a regulatory requirement but ethically this is something that they do.
With regs to clinical trials and testing for branded vs generic. Branded drugs (here comes sweeping statement) are generally of a higher quality. This could be as simple as the pressure used to press a tablet. The large pharma company knows exactly how to produce their medications and that is what is tested in clinical trials. A generic house will not know this although may have an idea.
The burden of clinical efficacy and testing lies with the branded drug manufacturer and they would have to spend more time money etc to bring the drug to market, where as a generics house would not have this burden and the testing is a lot less...
Knowing this makes me want to ask for branded drugs where I can, although the cost to the NHS is large, having said that if a loved one was going to be given a drug, I would definitely want the branded equivalent.
Happy to give more information if you need. Just shout. Good question!
ETA: branded vs generic info
The MHRA would then notify the drug companies around what AEs are being reported. Let's say 1000 people had the same AE, known (as described on Patient Info Leaflet) or unknown then this is what is called a safety signal. Dependant on prevalence then this could be adopted into a SPC which is essentially all the regulatory information about a product. See medicines.org.uk for that.
Some patients and physicians report AEs to drug companies directly and the same process follows, they look for signals and see of any other clinical trials need to be conducted or if SPC needs updating etc.
There are large teams within the drug companies who look after safety of products, tracking and monitoring. Not only is it a regulatory requirement but ethically this is something that they do.
With regs to clinical trials and testing for branded vs generic. Branded drugs (here comes sweeping statement) are generally of a higher quality. This could be as simple as the pressure used to press a tablet. The large pharma company knows exactly how to produce their medications and that is what is tested in clinical trials. A generic house will not know this although may have an idea.
The burden of clinical efficacy and testing lies with the branded drug manufacturer and they would have to spend more time money etc to bring the drug to market, where as a generics house would not have this burden and the testing is a lot less...
Knowing this makes me want to ask for branded drugs where I can, although the cost to the NHS is large, having said that if a loved one was going to be given a drug, I would definitely want the branded equivalent.
Happy to give more information if you need. Just shout. Good question!
ETA: branded vs generic info
Edited by dhalv on Saturday 26th July 23:01
Edited by dhalv on Saturday 26th July 23:03
Thanks for your replies
I spoke to the pharmacist yesterday and mentioned the adverse reaction and 'yellow card' reporting process. She gave me a pamphlet on it, that was available on the counter. She was very helpful and said she'd put a note on my records about not being given that drug again.
I spoke to the pharmacist yesterday and mentioned the adverse reaction and 'yellow card' reporting process. She gave me a pamphlet on it, that was available on the counter. She was very helpful and said she'd put a note on my records about not being given that drug again.
Pharma companies are required, by law, to track adverse reactions. To this end - most have what is known as a Pharmacovigilance team. Their aim is to collate, track and act on adverse event information.
You can report them directly to the company via their contact details on the label/leaflet - or if you know somebody who works for the company - report it to them - they will be contractually (and legally?) bound to pass the information on to their companies pharmacovigilance team.
Alternatively - you can report it to the MHRA's pharmacovigilance team via the yellow card form (see bottom of this link).
http://www.mhra.gov.uk/Safetyinformation/Howwemoni...
You can report them directly to the company via their contact details on the label/leaflet - or if you know somebody who works for the company - report it to them - they will be contractually (and legally?) bound to pass the information on to their companies pharmacovigilance team.
Alternatively - you can report it to the MHRA's pharmacovigilance team via the yellow card form (see bottom of this link).
http://www.mhra.gov.uk/Safetyinformation/Howwemoni...
Edited by Moonhawk on Tuesday 29th July 11:00
Gassing Station | Health Matters | Top of Page | What's New | My Stuff