Pharmacovigilance Requirements for NCD Medicines
The article emphasizes that pharmacovigilance for noncommunicable disease medicines must be continuous, product-specific, and grounded in real-world use because these medicines are often taken for years or lifelong. It explains that clinical trials cannot detect all long-term, rare, cumulative, or interaction-related risks, especially among patients with multimorbidity, polypharmacy, organ impairment, pregnancy, or other vulnerabilities. Pharmaceutical companies should therefore strengthen safety systems through risk-management planning, high-quality adverse-event reporting, active surveillance, real-world evidence, targeted clinical monitoring, signal management, risk communication, and product-quality oversight. Overall, the article frames pharmacovigilance not as a compliance exercise, but as a scientific and ethical responsibility to detect preventable harm early while preserving access to beneficial NCD treatment.
Noncommunicable diseases (NCDs) – principally cardiovascular diseases, cancers, chronic respiratory diseases and diabetes – require treatment that may continue for years or throughout life[1]. The World Health Organization estimates that NCDs caused more than 43 million deaths in 2021, representing three-quarters of non-pandemic-related deaths globally[2]. Medicines are therefore central to reducing NCD morbidity and mortality, but prolonged exposure also creates safety questions that short pre-authorization trials cannot fully resolve.
Before authorization, clinical trials usually involve selected populations, controlled conditions and limited follow-up. They may not detect rare events, long-latency harms, cumulative dose effects or interactions arising from multimorbidity and polypharmacy. After market entry, patients may be older, pregnant, living with renal or hepatic impairment, using herbal products, switching brands or taking several medicines concurrently. For NCD therapies, pharmacovigilance (PV) must therefore be a lifecycle scientific system that continually tests whether a medicine’s benefits continue to outweigh its risks in real-world use.
Relevant long-term concerns include cumulative renal, hepatic, cardiac, hematological or retinal toxicity; metabolic and cardiovascular effects; reproductive or developmental harm; neurological, psychiatric and immune effects; dependence, withdrawal or rebound after discontinuation; drug–drug and drug–disease interactions; medication errors; adherence-related harm; loss of effectiveness; and delayed reactions in under-studied groups. The importance of each risk depends on the product, dose, duration, indication and patient population, so a generic compliance model is insufficient.
The following are some measures pharmaceutical companies dealing in NCDs medicines should implement:
Product-specific risk planning and accountable governance. Each medicine should have a safety specification and risk-management plan identifying important known risks, potential risks and missing information. The plan should define routine and additional PV activities, milestones, escalation routes and measurable risk-minimization actions. A qualified PV lead, trained staff, documented procedures, adequate resources, audit trails and business-continuity arrangements should provide clear accountability.
High-quality adverse-event capture and exposure surveillance. Companies should collect reports from patients, healthcare professionals, distributors, medical-information services, patient-support programmes, digital channels and scientific literature. Cases should be validated, medically assessed, followed up, coded consistently and reported within regulatory timelines. Databases should also capture treatment duration, cumulative dose, interruptions, switching, rechallenge and relevant comorbidities so analyses can evaluate latency, dose–response, reversibility and risks that increase with prolonged exposure.
Active surveillance and real-world evidence. Spontaneous reporting alone cannot quantify incidence reliably and is vulnerable to under-reporting. Depending on the risk, companies should use registries, cohort-event monitoring, post-authorization safety studies, electronic health records, claims data or sentinel sites. These methods are particularly important for rare outcomes, delayed toxicity, pregnancy exposure and events with high background rates.
Targeted clinical monitoring and interaction surveillance. Product-specific protocols should define appropriate laboratory and diagnostic monitoring, such as renal and liver function, blood counts, electrolytes, electrocardiograms, glucose, lipids, bone health or eye examinations. Companies should analyze drug–drug, drug–disease, food–drug and herb–drug interactions, with focused evaluation of older adults, children, pregnant or breastfeeding patients, and people with multimorbidity or organ impairment.
Structured signal management and cumulative benefit–risk review. Internal and external data should be screened at a frequency justified by the medicine’s risk profile. Potential signals must be validated, prioritized, investigated and tracked to closure, without treating temporal association alone as proof of causality. Periodic safety reports should integrate worldwide case data, exposure estimates, observational evidence, class effects and subgroup analyses to determine whether labelling, monitoring or regulatory action is required.
Monitoring of medication use and treatment discontinuation. PV systems should capture overdose, underdose, misuse, dependence, withdrawal, abrupt discontinuation, device or administration errors, duplicate therapy and treatment gaps, even when no adverse reaction is initially reported. Because poor adherence and inappropriate cessation can destabilize chronic disease, these data are part of the safety profile rather than solely matters of patient behavior.
Risk minimization, communication and evaluation. Prescribing information, patient leaflets and educational materials should be current, understandable and consistent with emerging evidence. Where routine labelling is inadequate, companies may require monitoring checklists, patient cards, targeted professional communication or controlled-access measures. Their effectiveness should be measured through knowledge, prescribing behavior, monitoring uptake and clinical outcomes; ineffective measures should be revised.
Integration with product quality and supply-chain oversight. PV should be linked to post-market quality surveillance to detect contamination, degradation, stability failures, falsification, storage problems and batch-related patterns. Safety-data exchange agreements with distributors, licensees, contract organizations and programme vendors should specify responsibilities, reporting timelines, reconciliation, record retention and audit rights.
Data integrity, inspection readiness and continuous improvement. Safety records must be complete, traceable, secure and auditable. Companies should monitor compliance indicators, investigate deviations, implement corrective and preventive actions, train employees and partners, and test whether the system can detect and manage a serious emerging risk. Systems should align with applicable national requirements, including Kenya’s Pharmacy and Poisons (Pharmacovigilance and Post Market Surveillance) Rules, and with international frameworks such as ICH E2E and good pharmacovigilance practices.
For NCD medicines, robust PV is not an administrative exercise but a scientific and ethical requirement. A system that combines high-quality case reporting, active surveillance, exposure-based analysis, disciplined signal management and effective risk minimization can identify preventable harm earlier while preserving access to beneficial treatment. Pharmaceutical companies should therefore design PV around the realities of lifelong therapy, multimorbidity and diverse patient populations, and continuously demonstrate that their controls improve patient safety especially for NCDs. This was our call as we commemorated World Patient Safety Day 2026[3].