Frequently Asked Questions
About adverse drug reaction reporting and this tool
What is an adverse drug reaction (ADR)?+
The World Health Organization defines an adverse drug reaction (ADR) as a response to a medicine that is noxious and unintended, occurring at doses normally used in humans for prophylaxis, diagnosis, or therapy. It differs from an adverse event, which is any untoward medical occurrence that may not have a proven causal link to the medicine. Reporting suspected ADRs lets regulators monitor the safety of medicines once they are in real-world use.
Who can report an adverse drug reaction in Kenya?+
Any healthcare professional can report, including doctors, pharmacists, pharmaceutical technologists, nurses, and clinical officers, and patients or their carers are encouraged to report too. Marketing authorisation holders and Local Technical Representatives carry a legal duty to report suspected reactions for their products. The PPB encourages reporting even when you are not sure the medicine is to blame, summed up in the phrase you need not be certain, just be suspicious.
Which form does the PPB use for ADR reporting?+
The PPB uses the Suspected Adverse Drug Reaction Reporting Form, reference FOM001/MIP/PMS/SOP/001. It captures patient information, the suspected medicine, a description of the reaction, seriousness and grading, dechallenge and rechallenge, and the reporter's details. This tool reproduces that official layout so you can fill it in on screen and save a clean PDF.
What makes an adverse drug reaction serious?+
A reaction is classed as serious if it results in death, is life threatening, requires or prolongs hospitalisation, causes persistent or significant disability or incapacity, leads to a congenital anomaly or birth defect, or is otherwise medically important. Serious reactions usually need to be reported promptly. The grading section of the form lets you tick the criteria that apply.
What is causality assessment in pharmacovigilance?+
Causality assessment is the structured process of judging how likely it is that a medicine caused a reaction. The WHO-UMC system uses categories such as certain, probable, possible, unlikely, conditional or unclassified, and unassessable. Assessors weigh the timing of the reaction, the dechallenge and rechallenge response, plausible alternative causes, and what is already known about the medicine.
What are dechallenge and rechallenge?+
Dechallenge asks whether the reaction improved when the medicine was stopped or the dose was reduced. Rechallenge asks whether the reaction came back when the medicine was given again. A positive dechallenge followed by a positive rechallenge strengthens the case that the medicine caused the reaction, though deliberate rechallenge is often avoided because it can put the patient at risk.
Is this ADR report generator free and private?+
Yes. This ADR report generator is completely free and needs no account or sign-up. Everything you type stays in your browser and is never sent to our servers, so patient information remains confidential on your own device. When you are done you can print the form or save it as a PDF for your records.
How do I submit my completed ADR report to the PPB?+
This tool only drafts and prints the form. Submit the official report through the PPB Pharmacovigilance Electronic Reporting System (PvERS) online portal, or deliver or email the completed form to the Pharmacy and Poisons Board National Pharmacovigilance Centre. From there the data feeds into the WHO global safety database that pools reports from across the world.