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Doc Number: GLFCEMPV06A [Old Doc no. 6.04]ADVERSE DRUG REACTION (ADR)/ PRODUCT QUALITY PROBLEM REPORT FORM (PUBLIC AND PRIVATE SECTOR) (Including Herbal Products)Revision: 2.0Effective date: 20 January

How to fill out adverse drug reactions and

How to fill out adverse drug reactions and

1. Obtain the necessary forms or documents for reporting adverse drug reactions.
2. Fill out the patient information section, including name, age, sex, and contact information.
3. Specify the drug name, dosage, frequency, and route of administration.
4. Describe the adverse reaction experienced by the patient, including symptoms, severity, and timing.
5. Include any other relevant information such as concurrent medications, medical history, and laboratory test results.
6. Submit the completed adverse drug reaction report to the appropriate regulatory agency or healthcare provider.

Who needs adverse drug reactions and?

1. Healthcare providers such as doctors, nurses, and pharmacists who encounter patients experiencing adverse drug reactions.
2. Pharmaceutical companies and drug manufacturers who are responsible for monitoring and reporting adverse reactions associated with their products.
3. Regulatory agencies such as the FDA or EMA who use adverse drug reaction reports to evaluate the safety and efficacy of medications.

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What is adverse drug reactions and?

Adverse drug reactions are undesired or harmful reactions that occur after taking a medication.

Who is required to file adverse drug reactions and?

Healthcare professionals, pharmaceutical companies, and regulatory authorities are required to file adverse drug reactions.

How to fill out adverse drug reactions and?

Adverse drug reactions can be filled out by collecting information about the reaction, the patient, the medication, and submitting it to the appropriate regulatory authority.

What is the purpose of adverse drug reactions and?

The purpose of adverse drug reactions reporting is to monitor the safety of medications, identify potential risks, and take necessary actions to protect public health.

What information must be reported on adverse drug reactions and?

Information such as the patient's details, the medication involved, the adverse reaction observed, and the outcome of the reaction must be reported on adverse drug reactions.