Adverse Drug Reaction
Adverse Drug Reaction
All of us take drugs some time or other : either to alleviate symptoms or cure a disease. Drugs are foreign bodies and considered safe. However, we often realise that the drugs administered have not had the desired effect. We also face situations where they have produced adverse effects, doing more harm than good.
Adverse Drug Reaction (ADR) or in simpler terms, side effects of medicines you take, can be — and is — a serious problem in healthcare today with thousands of medications available both over the counter and against prescription.
What is ADR?
The World Health Organisation (WHO) describes ADR as any response to a drug which is noxious, unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function.
There however is a problem with the definition. Noxious literally means injurious or harmful. However, is not a adverse effect that does not cause harm but interferes with the quality of life of the consumer an adverse reaction ? For instance, ACE inhibitors causing cough and verapamil causing constipation.
Secondly, take the words “Doses normally used in humans” in context of the drug paracetamol, normally considered to be very “child friendly” in the minds of both parents and physicians. Hence higher than recommended doses have been used for quite sometime without any problems. But when new infections come on the scene (e.g. influenza) then this apparently standard dose that the physicians / parents are used to, causes hepatotoxicity — isn’t that a unintended adverse effect.
Again, what reason can be given to the deterioration of a patient’s illness inspite of giving an effective treatment at standard doses ? It could be due to ineffectiveness of the drug due to quality problems. Is that not an adverse effect from the consumers perspective?
In the recent past we have had several promotional advertisements for herbal products in the print and audio visual media. These products do not come under the purview of Drugs and Cosmetics Act. Regulation of traditional medicines is still in its infancy. Hence they by pass the available systems and the consumer is exposed to drugs disguised as safe and effective when they have not even been minimally evaluated. Our recent tests of Ayurvedic eyedrops in our inhouse laboratory showed a leading brand not even sterile. How does one accept a product as sensitive as an eyedrop haveing microbial contamination.
Does the consumer have a role to play in such a scenario?
Why does ADR Happen ?
Manufacturers do test all new drugs and medications for safety and efficacy; but only on a limited number of people, instead of all people. Rare side-effects may not be observed in the small groups used for the tests.
Also, because people vary greatly in terms of their individual responses to medications, pre-approval testing with a limited number of subjects does not reveal all possible adverse side-effects of the medication being researched. Only when the new medication hits the market and millions of people use it, ADR becomes apparent.
Another reason for ADR is that there is no systematic mechanism in India by which data on ADR is reported. Physicians are under no mandatory obligation to report instances of ADR to the authorities.
The Scene Abroad
In the US and Europe, during the first one year of marketing, the manufacturer is required by law to collect and collate the data about the safety of the drug and about ADR. With reports coming in, the manufacturers often change the label information or withdraw the drug.
Developments in India
In India, a very interesting development has taken place : after persistent follow-up and petitions by Consumer Education and Research Society (CERS), the Food and drug Control Authorities (FDCA) has eventually issued an order on the drug Cisapride, requiring its sale only against prescription by gastroenterologists. It also has to be done only in the case of specific problems.
The FDCA has also issued similar orders in connection with PPA, an active ingredient in all anti-cold medicines.
Keeping the developments abroad and the initiative in India in view, we at CERS have decided to try and help prevent ADR by collecting and collating data, to begin with. The objective will be to eventually set up a mechanism for the prevention of ADR. This massive goal cannot be attained without an all-out cooperation.
You, too, may contribute to the cause by doing your bit. We request you to fill in this form, reporting all details of any adverse drug reaction that you may have encountered. Also encourage others to come forward with similar information. Let’s work together to collect the data.
Remember, proof that a drug caused an undesirable effect on the patient is NOT a requirement for reporting an adverse drug reaction. If you suspect an adverse drug-related event, particularly if unusual, report it to us.
Doctors, please report
Consumers are the users of the medicines prescribed by his/her physician. Quoting Harry Dowling
“Nowhere else does one person do all the ordering of goods that are delivered to be used and paid by another person”
Rarely do you see such a one sided transaction. This shows the immense trust placed by the consumer in his/her physician. Should not this tribute paid to the physician be mutual.
Do you as a doctor, always report an adverse drug reaction to either the company or to a regulatory authority?
The current day scenario is such that ADR reporting amongst our doctors is low. But when the doctor fits into the shoes of a consumer, the opposite is seen. The only report of angioedema following the use of ranipril was when the son of a doctor got swelling of his body after 7 years of use.
The only report of neutropenia with clozapine was from a doctor whose daughter was using it.
Do not let this become an ideal situation, when a doctor reports only when he becomes a consumer.
Report all adverse durg reactions of your patients!
All data provided by you will be treated as confidential. Our panel of doctors will collate the data and, depending on the pattern emerging, we propose to involve the regulatory authorities in arriving at a logical conclusion.