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Global Pharmacovigilance ADR Spontaneous Report Form short version Local case ID: Initial report Followup report Yes No Give information on the patient who has experienced the Adverse Event. Initials

How to fill out adr spontaneous report form

1. To fill out an ADR spontaneous report form, start by gathering all necessary information. This includes the patient's details (name, age, gender), the healthcare professional's information, and the relevant medical history.
2. Next, carefully document the details of the adverse drug reaction (ADR). Include the date and time it occurred, the symptoms experienced, and any prior or concomitant medications the patient was taking.
3. It is important to provide a clear description of the adverse event. Include any relevant lab results, diagnostic tests, or medical imaging that supports the ADR.
4. Make sure to include the details of the drug(s) involved in the ADR. Provide the brand name, generic name, strength, dosage form, and route of administration. Include the date of initiation and discontinuation of the drug(s) if applicable.
5. Provide a summary of the ADR by highlighting the severity, duration, outcome, and any actions taken by the healthcare professional in response to the ADR.
6. If available, include the lot number, expiration date, and any other identifying information for the drug(s) involved.
7. Finally, ensure that all sections of the ADR spontaneous report form are complete and legible. Review the form for accuracy before submitting it to the appropriate regulatory agency or pharmacovigilance system.

Who needs an ADR spontaneous report form?

1. Healthcare professionals: Physicians, nurses, and pharmacists who suspect or have identified an adverse drug reaction in a patient should use the ADR spontaneous report form. It allows them to document and report the ADR to the appropriate regulatory agencies or pharmacovigilance systems.
2. Patients: If a patient experiences an adverse drug reaction, they can also request an ADR spontaneous report form from their healthcare professional. By filling out this form, they contribute valuable information that can help improve drug safety and patient care.
3. Regulatory agencies and pharmacovigilance systems: These organizations rely on ADR spontaneous report forms to monitor the safety of drugs on the market. By reporting ADRs, healthcare professionals and patients assist them in identifying potential safety concerns and taking appropriate actions to protect public health.

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What is adr spontaneous report form?

ADR spontaneous report form is a form used to report adverse drug reactions that occur spontaneously.

Who is required to file adr spontaneous report form?

Healthcare professionals, such as doctors and pharmacists, are required to file adr spontaneous report form.

How to fill out adr spontaneous report form?

To fill out adr spontaneous report form, one must provide details of the adverse drug reaction experienced by the patient, including the drug involved, symptoms, and outcome.

What is the purpose of adr spontaneous report form?

The purpose of adr spontaneous report form is to monitor and track adverse drug reactions in order to improve patient safety.

What information must be reported on adr spontaneous report form?

Information such as the drug involved, patient demographics, adverse reaction details, and outcome must be reported on adr spontaneous report form.