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The World Health Organization (WHO) defines an ADE as “any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment” (WHO 2005). The WHO defines an ADR as “a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.”

Objectives

  • To make the students to learn ADR detection and classification.
  • To make the students to learn causality and severity assessment methods.
  • To make the students to learn management the reported ADR.
Procedure

The NCC has designed a ‘Suspected Adverse Drug Reaction Reporting Form’ to record adverse reactions related to drugs (page no 14). Separate forms are available to record adverse reactions associated with transfusion of blood and blood related products and Adverse Event Following Immunization (AEFI). A report that contains information describing a suspected ADRs related to the administration of one or more medicinal products to an individual patient is termed as ICSR. Following are the points to be filled in an ADR form.

A. Patient Information

1. Patient initials: Write only the initials of a patient instead of full name. For e.g.: Srinivas Sadagoban should be written as SS.

2. Age at time of event or date of birth: Write either the date of birth or age of the patient at the time of event or reaction occurred.

3. Sex: Mention the gender of the patient.

4. Weight: Mention the weight of the patient.

B. Suspected Adverse Reaction

5. Date of reaction started: Mention the date on which the reaction was first observed.

6. Date of recovery: If the reaction recovered, the date on which the patient recovered from the reaction should be report.

7. Describe reaction: Provide the description of the reaction in terms of nature, localization etc. For example, patient developed erythematous maculopapular rash over upper and lower limb.

C. Suspected Medications

8. The details of suspected medication(s) such as drug name (brand or generic name), manufacturer, batch no/lot no, expiry date, dose used, route used, frequency, dates of therapy started and stopped, and indication should be provided by the reporter.

9. Dechallenge details: Mention the status on dechallenge a

- ‘Yes’- if reaction abate after dechallenge
- ‘No’- if reaction did not abate after dechallenge
- ‘Unknown’- if the effect of dechallenge is not known'
- ‘Not Applicable’ or ‘NA’- if dechallenge is not applicable as in case of vaccines, anesthesia, where a single dose is given, death, or treatment is completed prior to reaction or event
- ‘Reduced dose’- If dose at which the reaction occurred is reduced

Note: Also mention the reduced dose and date.

10. Rechallenge details: Mention the status on rechallenge

- ‘Yes’- if reaction reappeared after rechallenge
- ‘No’- if the reaction does not reappear after rechallenge
- ‘Unknown’- if the effect of rechallenge is not confirmed
- ‘Not Applicable’ or ‘NA’- if rechallenge is not applicable as in case of anaphylaxis reaction
- ‘Re-introduced dose’- Mention the dose and date of rechallenge

11. Concomitant drugs:

Write the details of all concomitant drugs including self- medication, OTC medication, herbal remedies with therapy dates.

12. Relevant tests/ laboratory data: Mention all laboratory data (if available) relevant to the reaction occurred.

13. Other relevant history: Write the relevant history persistent to patients including pre-existing medical conditions (e.g. allergies, pregnancy, smoking, alcohol use, hepatic/ renal dysfunction) and concurrent condition can be describing in this section.

14. Seriousness of the reaction: If any reaction is serious in nature, tick the appropriate reason for seriousness as:

- ‘Death’ - if the patient died due to adverse event
(Note: Mention the death cause & date in the seriousness of the reaction.)
- ‘Life-threatening’- if the patient was at substantial risk of dying at the time of the adverse event
- ‘Hospitalization/prolonged’- if the adverse event caused hospitalization or increased the hospital stay of the
patient
- ‘Disability’- if adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions
- ‘Congenital anomaly’- if exposure of drugs prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
- ‘Required intervention to prevent permanent impairment/damage’- if medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure
- ‘Other’ -when the event does not fit the above conditions, but the event may put the patient at risk and may require medical or surgical intervention to prevent one of the above conditions. Examples include serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization, development of drug dependence, or drug abuse.

15. Outcomes: Tick the outcome of the event as:

- ‘Fatal’- if the patient dies
- ‘Continuing’- if the patient is continuing to experience the reaction
- ‘Recovering’- if the patient is recovering from the reaction
- ‘Recovered’- if the patient has completely recovered from the reaction (mention the date of recovery)
- ‘Unknown’- if the outcome is not known

D. Reporter

16. Name and Professional address: A reporter must mention his/her name and professional address on the form. The identity of the reporter will be maintained confidential

17.Causality assessment:
The reporter (if trained) must perform the causality assessment and justify the assessment

18. Date of report:
Mention the date on which he/she reported the adverse event. Collect all the information required to be filled in the suspected ADR reporting form. In case complete information is not available fill all the Essentially Required Items (ERI) for a quality ICSR. In case ERI are not available make sure that the form contains all the mandatory fields.

Note: For a valid case report mandatory fields are the minimum requirement.

To Download ADR Documentation Form - Click Here

To Download the ADR reporting Mobile Application ( PvPI) - Click Here
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Last bumped by Admin on 02 Mar 2020, 20:32.
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