Monitoring, adverse reactions and pharmacovigilance

Baseline/follow-up monitoring, ADRs, Yellow Card, toxicity, safety-netting and incident learning.

Pre-prescribing foundation: this module develops knowledge and judgement for formal prescribing education; it does not authorise prescribing.

• Define the purpose of baseline and follow-up monitoring.
• Recognise suspected adverse drug reactions and toxicity signals.
• Explain the role of the Yellow Card Scheme and current safety alerts.
• Use safety-netting and review points to make prescribing safer.
• Learn from medicine incidents and near misses without hiding uncertainty.

Monitoring should be linked to a question: efficacy, toxicity, dose adjustment, adherence or disease progression.

An adverse event is not automatically an adverse drug reaction; causality may be uncertain.

Yellow Card reporting is a pharmacovigilance mechanism for suspected problems and should not wait for absolute proof of causality.

Safety alerts should lead to patient-level and system-level action where relevant.

1. Define the clinical problem and whether prescribing is indicated.
2. Gather the patient-specific assessment and diagnostic information needed.
3. Check competence, professional authority and employer/service scope.
4. Compare reasonable options using current authoritative sources.
5. Agree the plan with the patient, including uncertainty and alternatives.
6. Prescribe accurately only when the decision is justified.
7. Document, monitor, review and safety-net.

Module emphasis: Define what is being monitored, when it should be checked, what threshold triggers action, and how suspected adverse reactions or incidents will be reported and reviewed.

Scenario 1. A new symptom appears after a recently started medicine but causality is uncertain.

Reasoning prompt: Define what is being monitored, when it should be checked, what threshold triggers action, and how suspected adverse reactions or incidents will be reported and reviewed.

Scenario 2. A safety alert recommends action for patients on a specific medicine.

Reasoning prompt: Define what is being monitored, when it should be checked, what threshold triggers action, and how suspected adverse reactions or incidents will be reported and reviewed.

Scenario 3. Monitoring is overdue for a medicine with recognised toxicity.

Reasoning prompt: Define what is being monitored, when it should be checked, what threshold triggers action, and how suspected adverse reactions or incidents will be reported and reviewed.

• Only proven ADRs should be reported.
• Normal baseline monitoring means later monitoring is unnecessary.
• Safety alerts are pharmacy department issues rather than prescriber issues.

• What clinical problem am I trying to solve, and is prescribing indicated?
• What information is missing before a safe decision can be made?
• Is this within my current competence, professional authority and employer/service scope?
• Which current authoritative medicine or guideline source should I check?
• What patient-specific factors change benefit, harm, dose, route or monitoring?
• What will I document, monitor, review and safety-net?
• When should I seek supervision, pharmacy advice, specialist input or urgent escalation?

Optional reflection: Without entering identifiable patient or employer information, identify one capability you would need to strengthen before prescribing independently in this area.

• Monitoring should be linked to a question: efficacy, toxicity, dose adjustment, adherence or disease progression.
• An adverse event is not automatically an adverse drug reaction; causality may be uncertain.
• Yellow Card reporting is a pharmacovigilance mechanism for suspected problems and should not wait for absolute proof of causality.
• Safety alerts should lead to patient-level and system-level action where relevant.

Check current versions for time-sensitive decisions.

• MHRA-01 - MHRA: Yellow Card Scheme / Drug Safety UpdatesOpen official source
• MHRA-02 - MHRA: MHRA Safety Roundup July 2026Open official source
• NICE-01 - NICE: NG5 Medicines optimisationOpen official source
• RPS-01 - Royal Pharmaceutical Society: A Competency Framework for All Prescribers (2021)Open official source