Contraceptive Pharmacovigilance and Reporting

Pharmacovigilance is the detection, assessment, understanding and prevention of adverse effects and other problems with medicines and devices. For contraception it covers serious reactions to hormonal methods, device complications, medication errors, product quality defects and unexpected treatment failure. Reporting is a professional duty, and reports allow the authorities to find risks that individual clinicians and premarketing studies cannot detect.

What to report.

• Serious events: death, life-threatening illness, hospital admission or prolonged stay, persistent disability, congenital anomaly.

• Unexpected events not listed in the product information, and any reaction to a newly introduced product.

• Device-related events: uterine perforation, expulsion, embedded or broken IUD, deep, migrated or non-palpable implant, difficult removal, implant site infection.

• Treatment failure: pregnancy with an IUD or implant in place, pregnancy after correct pill, injectable or emergency contraceptive use, and clusters of failures with one batch.

• Medication errors: wrong product, dose, route or interval, and wrong device inserted.

• Product quality problems: damaged or defective packaging, applicator or inserter failure, missing implant in the needle, discolouration, wrong labelling, suspected falsified or substandard product, and unexpected expiry.

• Other significant events: venous thromboembolism, stroke, myocardial infarction, liver injury, severe allergy.

Not reported individually. Expected minor effects that are listed in the product information, such as spotting, nausea or breast tenderness, unless they are severe, unusual or prompt discontinuation in large numbers.

Who reports. Any health worker: doctors, nurses, clinical officers, pharmacists and community providers. Patients and their carers can also report.

Responsibilities of the provider.

• Recognise and treat the event first.

• Record the event in the client file.

• Complete and submit a report form promptly.

• Keep the product and packaging (quarantined) for investigation where possible.

• Inform the patient that the event has been reported.

Responsibilities of the facility. Provide forms, a reporting route, and a focal person for pharmacovigilance; display reporting instructions; review reports each month; protect patient identity.

Responsibilities of the national system. Receive and assess reports, look for patterns, communicate safety information to providers, and act on signals (labelling changes, restrictions, batch recalls).

Confidentiality. Reports contain no patient names; use age, sex and a code.

Reporting process.

• Treat the patient and stabilise the condition.

• Complete the adverse event or product problem report form with:

- Patient: code or initials, age, sex, weight, pregnancy or breastfeeding status.

- Product: generic name, strength, formulation, dose, route, frequency, dates started and stopped, batch number, expiry date and manufacturer.

- Event: description, date of onset, duration, severity, seriousness, treatment given and outcome (recovered, recovering, not recovered, fatal, unknown).

- Other medicines, relevant medical history and risk factors.

- Causality as judged by the reporter: certain, probable, possible, unlikely, or unclassifiable.

- Reporter: name, role, contact details and date.

• Submit the form through the national reporting route (paper form, electronic form or phone application). Report serious events immediately, then follow with the form within days; send other events promptly.

• Keep a copy in the facility file.

• Record the event in the patient's file and in the register.

Suspected product quality problem. Stop using that batch, quarantine the remaining stock, record the batch and number of units affected, and report with a sample if requested.

Cluster of events. Report together and inform the supervisor.

Feedback. The facility reads and acts on safety communications, including product recalls and updated warnings, and shares them with staff.

Quality indicators. Number of reports each quarter; share that are serious and complete; time from event to report; reports with batch and expiry; staff who know how to report.

Common reasons for under-reporting. Uncertainty about causality, fear of blame, lack of forms, belief that only serious events matter, and not knowing the route. A report does not need proof that the product caused the event.

Safety actions.

• Stop or substitute a product when a risk is identified.

• Update counselling and consent information.

• Withdraw a batch when quality is in doubt.

Escalation.

• Death, life-threatening events and suspected product contamination: notify the facility lead and the national authority at once.

• Clusters of events or suspected falsified products: quarantine stock and escalate immediately.

• Persistent failure to receive acknowledgement: follow up with the sub-national pharmacist or focal person.