Adverse Drug Reaction (ADR) may be new word for Non health care professionals but, it should be a common term for Health Care Professionals (HCP). In layman language it is known as side effects which is not the exact term but somewhere close to it.
It is very important to be shared with all the people if you want to enhance the condition of the health of people in your country.
हिंदी में पढ़ने के लिए यहां क्लिक करें
Here in this article I will explain you how ADRs are so important to be reported and how it affects the entire population.
What is Adverse drug reaction reporting?
Currently, India contributes 3% to the global ICSR (Individual Case Safety Report) database of WHO. However, India is the 4th largest producers of pharmaceuticals.
The numbers of reporting are increasing year by year but not all the adverse events are reported.
Any unwanted effect of a drug/medicine can come under Adverse Drug Event. Commonly in layman language, it is known as Side effects of drug.
Study of Adverse Event Reporting comes under Pharmacovigilance domain which deals with detection, assessment, understanding and prevention of ADRs to medicine.
“Whenever you consume a medicine it acts on the disease for which it has been taken but sometimes it gives other effects also. These side effects could be mentioned inside the PIL (Patient Information Leaflet) or SPC (Summary of Product Characteristics) of that particular drug but there is possibility that it could not be.”
However, in both cases the side effects must be reported.
Reporting a ADR refers that informing to the Health Authority of that country about side effect of a drug.
Reporting can be done via some channels as follows-
- Via Patient or relative or any witness
- Via Health Care Professional
- Via Pharmaceutical company
- Direct to Health Authority (HA)
When to report an adverse event?
Reporting of any adverse event should be done as soon as it comes into the picture, so that it can be processed on time. There are different timelines to different type of ICSRs to be submitted to the authority. It also varies in different countries.
Why you should report the ADRs?
Many times a question arises in our mind that a particular drug is banned in some countries but not in our country. And also for some drugs we think it should have been banned.
“A drug could be banned but it needs sufficient data and valid evidences in the forms of reports. If no or very less number of ADRs are reported to authority, then it does not present a clear picture. As a result, drugs/medicines are prescribed and consumed even after having many mild to severe side effects.”
Many time you experience side effects after taking a medicine, but do you inform your doctor every time?
Most of the time NO.
Now, we have to change it because it is very important to report any adverse event to identify Risk benefit ratio of that drug.
When you report the adverse event it goes through many process and authority analyze the data for that drug from all location.
If Health Authority found that adverse events are more than the beneficial effect of that drug, then authority can take appropriate action.
Read also- Drug withdrawal from the market: How and why
HA can ban that drug in a particular country or they can take other possible actions as well.
How it affects the pharmaceutical industry?
ADR reporting affects pharmaceutical industries in many ways as below-
- It’s a mandatory process for any pharma company to submit reports of ADR to authority for every drug manufactured
- A drug ban can lead to financial loss to any pharma company which no company wants
- 100% ADR reporting can force pharma companies to follow all the standards strictly and also conducting clinical trials in very crucial approach
- 100% ADR reporting can create more jobs for pharma graduates in pharma companies
How ADR reporting affects a country?
Last published reports says that around 3.4 – 7 % of hospitalization occurs due to ADRs in USA. Also, around 1% in Australia and England.
In a territory referral center in south India, 1.8 % death from total hospitalization occurs due to ADRs.
Click here for full report.
ADR reporting can improve the health of any country in following ways-
- It can reduce the rate of death and serious health conditions due to Adverse Event of drugs
- Improves overall health condition of people lives in the country which result in better health care facilities
- It prevents low standard companies to be formed which do not follow all the rules seriously
- ADR reporting prevents adverse event generated diseases in long term for any person
- Reduction of extra cost to the medicine
What to report as an adverse event?
Anything you feel is not correct after taking the medicine and it does not limit to only side effects after consuming the drug.
Below are few examples for your understanding-
- Adverse Event- If you experience any effect other than the treatment of disease. eg- If you take a medicine for diabetes to lower the blood glucose levels but apart from this it also gives you virtigo or vomitting
- Overdose +/- AE- If a drug has been consumed in higher dose than recommended/mentioned in the leaflet (PIL) of the drug
- Drug abuse/misuse +/- AE- If a drug has been used in different way than prescribed or mentioned in the PIL. Medicine is used in an amount or with methods which is harmful to themselves or others
- Drug Exposure During Pregnancy (DEDP) +/- AE- If a drug has been used during pregnancy and Embryo or foetus exposed to the medicinal product
- Medication Error +/- AE- Any failure in treatment process which results in or can lead to harmful effects to the patient
- Off-label use +/- AE- Use of a drug for a disease, age group or route which is not approved for that drug and not mentioned in PIL
- Lack of efficacy of drug- If a drug is fail to produce desired effect
- Occupational Exposure- If a drug has been used in a concentration more than accepted
- Therapeutic response increased and/ or unexpected benefit- If a drug shows any positive effect other than its indication
- Adverse Events when breastfeeding
- Interactions with other drug
- Technical product complaint with an adverse event or other special situation
Where to report Adverse Drug Reaction (ADR)?
Initially, ADR should be reported to your HCP. You can directly report it to the Health Authority of your country.
In India, government started the PvPI programme to spread the awareness regarding reporting of adverse events.
- Call- 1800 180 3024
- E-mail- email@example.com “OR” firstname.lastname@example.org
- Form- Fill the form and send it to the nearest AMC or NCC. You can find the list of AMC here
- ADR form: you can download the form from this link
Apart from above information you can report ADRs directly to pharma company of that medicine or Doctor and other health care professional.
You can read the WHO guidelines on Pharmacovigilance here.
I hope you understand the importance of ADR reporting to improve the overall health of population.
For any query or suggestion please comment in the below box.