Reporting of Adverse Drug Reaction: Healthcare professionals should consent to in mind when reporting an ADR that the reports are only indicated for suspected connections to the administered drug which caused a particular adverse event. Reporting an ADR does not involve a causal relationship between the drug and the adverse reaction. However, in a suspicious case, it is better to report than not to report the event.
What to Report?
Any unwanted adverse event believed to be associated with the use of drugs, biological (including blood products), cosmetics or medical devices, and herbal drugs should be reported.
The report should include:
- All ADRs as a result of prescription and non-prescription drugs.
- All suspected adverse drug reactions apart from the product are used according to product information or not.
- A serious reaction, whether expected or not expected.
- Unpredicted reactions, regardless of their nature or severity.
- All suspected ADRs are associated with drug-drug, drug-food interactions.
- ADRs occur from an overdose of drugs or an error of medication.
- An observed increase in the frequency of a given reaction.
- ADRs in the special field of interest such as drug use in pregnancy and lactation.
- Remarkable lack of effectiveness because of a defect in a pharmaceutical product.
What information is required for an ADR case report?
The minimal standard information to be provided for the proper estimation of the ADR case report are:
- Patient information
- Description of adverse reactions (include laboratory results if available)
- Information related to the suspected drug(s)
- Information on the management of the adverse reactions
- Information about the reporter
I. Patient Information:
- Patient identity: It indicates initials or record number of the respective patient in the hospital, medical institution, dispensary, clinic, or pharmacy.
- Birth dates or age: It indicates the date, month, and year of the patient.
- Sex: Male or Female.
- Weight: It should be mentioned in kilograms.
II. Adverse Reaction(s):
1. Brief description of the ADR(s): It can be indicated by marking X in the appropriate box for appropriate adverse drug reactions. If possible, explain briefly the character of the adverse reaction being reported but as clearly as possible, including the location and severity of the reaction.
2. Time/date of the beginning of the adverse reactions: Mentioned the time of occurrence of the adverse reaction about the drug administration.
3. Other relevant information:
- Medical history of the patient or hematological data including dates if available.
- Report the appropriate laboratory tests done by the patient and results to confirm the adverse reaction.
III. Suspected Drug(s):
- Name of the suspected drug(s): Trade name of the drug should preferably be used at the time of reporting, if a trading name is not available, a generic name may be used. The strength of the drug(s), for example: 250 mg or 500 mg should be clearly stated.
- Dosage, frequency, and route of administration should be indicated.
- Therapy date: The dates of the start of drug therapy and the date of termination of the administration of each drug should be recorded properly. If dates are not available or remember, then record the duration of treatment.
- Batch number and expiry date: Write this information which is provided on a strip of medicines.
- Reason for use: Indicates the condition for which the drug(s) is prescribed.
- Use of other drugs: Report whether the patient has administered the drug along with other drugs, including drug administration which is administered before one month.
- Provide other relevant information.
IV. Management of the Adverse Reaction:
- Confirmation of the ADRs: Mention clearly what assisted in confirming the suspected adverse reactions. For example:
- Drug reactions are confirmed by the disappearance of the reaction after stopping drug administration or reducing the dose of the drug.
- Recovery on withdrawal of the suspected drug(s).
- Mention the severity of reactions.
- Mention any management given for ADRs observed to the patient.
- Outcome: Mention the result of the adverse reactions.
V. Reporter Information:
Details on the reporter of an ADR: There is a need to mention the name of the reporter in detail with the address of the health center (hospital, dispensary, clinic, institution, pharmacy, or maternity home). E-mail address (optional), telephone number, signature, and date of reporting the reaction (indicate the date, month, and year).
Who Should Report?
Submission of a report does not indicate that the drug causes the ADRs. The report only indicates the suspect of ADRs. The reporter should keep in mind that any information related to patient and drug-related to ADR should keep confidential.
As a responsibility the healthcare professionals should report any suspected ADR in the following forms:
- All healthcare professionals can provide information related to ADR.
- Manufacturers or Product registrants: For the safety of the drug, the manufacturers should develop a system for continuous follow-up on their products.
- All government hospitals, health centers, private hospitals, pharmacies, dispensaries, private clinics, and nursing homes have the compulsion to report all ADR cases which are reported to them by the patients. If it is possible then the organization should appoint a local person who will co-ordinate with patients for the collection of data related to ADR.
When to Report?
As soon as possible the healthcare professionals should report the suspected cases of ADR. Delay in reporting results in inaccurate and unreliable documentation. If the patient is still in hospital then it is the right time to report the suspected ADRs because reporting can clear any doubt from the patient by re-questioning or re-examining the patient.
How to Report?
Reporters should send precise and accurate information on ADRs monitoring so the authority can take further action accordingly.
All the information should send in standardized format if available with a sealed envelope. A reporter should report separately for each patient. A reporter can use a separate form for each report.
A complete report of ADR should be immediately sealed and sent directly to the National Center of ADR monitoring. If there is any follow up then report it separately or communicate by e-mail or fax. In follow-up of information the following points to be mentioned:
- Follow-up information,
- The date of the original report
- The patient identity.
Basic Principles of Efficient Reporting
- Report as early as possible whenever it occurs and report by the patients.
- If the patient is in hospital and he is reporting the ADRs to healthcare professionals then immediately report the ADR to the center.
- If there are any factors (self-medication, herbal products, food, chemicals) that may link with ADR then they should be mentioned accordingly when reporting ADRs.
- All reports must have the following four data elements:
- Identity of a patient.
- Suspected adverse effect.
- Name of suspected drug(s).
- Name of a reporter.
Where to Report?
Report any suspected ADRs for any marketed pharmaceutical products or new drug to the appropriate channels are as follows:
- Preferably directly to the Pharmacovigilance center of a hospital.
- National Pharmacovigilance centre.
- Zonal drug information centers.
Processing of Adverse Drug Reactions Report
The submitted report will be entered into the national database of adverse drug reactions and be analyzed regularly. Well completed and duly submitted ADRs report may further investigated and accordingly, the following actions are taken:
- Appropriate changes in the package insert.
- Change the schedule of the medicine.
- Enhancing educational schemes to improve the safe use of the medicine.
- Other regulatory and health promotion involvements as some time there is a situation to withdrawal or recall for assessment of cause for drug reactions.
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