A. Patient Information

1. Patient Details

  • Patient name or initials: A reporter should mention the name of the patient or initials of a patient. For e.g.: Ngawang Dema or ND (whichever is convenient).
  • Age at time of event or date of birth: A reporter must report either the date of birth or age of the patient at the time the event or reaction occurred.
  • Sex: A reporter must mention the gender of the patient.
  • Weight: If known, the weight of the patient should be in kilograms (Kg).

2. Relevant tests/ laboratory data:

  • A reporter must mention any laboratory data (if available).

3. Other relevant history:

  • A reporter must mention any relevant history pertaining to the patient including pre-existing medical conditions (e.g. allergies, pregnancy, alcohol use, hepatic/renal dysfunction).

B. SUSPECTED DRUG(S)

  • It maybe one drug or more than one drug.
  • The details of suspected medication(s) such as the drug name (brand or generic name), manufacturer, batch no/lot no, expiry date, dose used, route used, dates of therapy started and stopped, and indication of use must be provided by the reporter.

C. SUSPECTED ADVERSE DRUG REACTION

  1. Describe reaction and any treatment given:
  • A reporter must briefly describe the event in terms of nature, localization etc. For eg; patient developed rash over upper and lower limbs.
  • The reporter must also indicate if any treatment is given against the Suspected Adverse Drug Reaction.
  • Date of reaction started: A reporter must report the date on which the reaction was first occurred.
  • Date of reaction stopped: If the reaction recovered, the date on which the reaction recovered should be reported.
  • Outcomes: The reporter must tick the outcome of the event as:

Recovered– if the patient has recovered from the event

Recovering– if the patient is recovering from the existing adverse event

Continuing– if the patient is continuing to have the symptoms of the adverse event which occurred

2.Seriousness of the reaction:

  • If any event is serious in nature, a reporter must select the appropriate reason for seriousness eg.:

Death– if the patient died due to the adverse event

Hospitalization/prolonged– if the adverse event led to hospitalization or increased the hospital stay of the patient

Life-threatening– if patient was at substantial risk of dying because of the adverse event

Significant Disability– if the adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions

Congenital anomaly– if exposure of drug prior to conception or during pregnancy may have resulted in an adverse outcome in the child.

Other Medically Significant-when the event does not fit the other outcomes, but the event may put the patient at risk and may require medical or surgical intervention to prevent one of the other outcomes.

D. OTHER MEDICATIONS:

  • A reporter should include all the details of concomitant drugs including self medication, Over The Counter medication, herbal remedies with therapy dates (start and stop date.)

E. REPORTER

  • 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 if necessary.
  • Date of report: Mention the date on which he/she reported the adverse event.

NOTE: For quality reporting, all the above mentioned fields are essential. In case of incomplete information, the reporter must take care that at least mandatory fields are present. Following are the mandatory fields for a valid case report and it is marked with asterisk on the form:

Patient information: initials, age at onset of reaction, gender.

Suspected adverse reaction: A reaction term(s), date of onset of reaction

Suspected medication: Drug(s) name, dose, and date of therapy started, indication of use, seriousness, and outcome.

Reporter: Name and address, date of report

Guidelines for filling in the ADR form: 2014,Version #1