Regulation of Medical Products &
Patient Safety- A Narrative
Review
Charles Ouma
Management Sciences for Health
Kenya
Background
• Substandard, spurious, falsely labelled, falsified &
counterfeit medicals product (SSFFCs)- significant risk
to public health
– Harm patients &undermine confidence in medical products,
healthcare professions & health systems
• Adverse drug event (ADEs) from poor product quality
a growing problem- increased morbidity & mortality
• Authenticated products pose additional risks- ADRs
with considerable economic & clinical costs
Why Regulation?
• Effective regulation intended to mitigate this harm,
promote & protect public health and contribute to
better health outcomes
• Should target to ensure the quality, safety & efficacy
of medicines or performance of devices to safeguard
health of citizens
• Improve overall access to medical products and
technologies
• Effective regulatory systems an essential component of
health systems strengthening
Regulation & Dimensions of Access to
Medicines
GEOGRAPHIC
ACCESSIBILITY
ACCEPTABILITY
SAFE
EFFICACIOUS
QUALITY
COST-EFFECTIVE
AFFORDABILITY
AVAILABILITY
Scope of Regulatory Functions
• Licensing of products, manufacturers & distributors
• Inspection of manufacturing sites and distribution
facilities
• Laboratory testing/Quality validation
• Control of clinical trials
• Control of advertising and promotions
• Post Marketing surveillance of quality and safety
• Consumer education
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Government
Experts
Manufacturers
Products
Regulatory
authority
Prescribers
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
Methodology
• Narrative review of published literature on
regulation & patient safety in SSA
– Qualitatively describe the status of medicines regulation in
the region
– Determine impact on public health
– Synthesize recommendations to address identified gaps
• Literature reviewed included online databases,
libraries, journals , authoritative publications and
texts
Results
• NMRAs exist in almost all SSA countries
• Legal framework for operation is fragmented and
sometimes not well articulated
• Capacity is highly variable, some with no capacity at all
• Funding/resource constraints limit the capacity of
these NMRAs to fulfil their mandate
Differences in regulatory capacity
in WHO African Region
Due to chronic shortages of
human, technical, financial and
other resources many National
Medicines Regulatory
Authorities (NMRAs) in Africa
don't have the full capacity to
perform most core regulatory
functions
Source:
Medicines Regulatory
capacity in 46 WHO AFRO
Member States
WHO/AFRO/EDP/04.5: Availability of Drug Regulatory and Quality Assurance
Elements in Member States of the WHO African Region, 2004, Brazzaville.
Impact/Outcomes
• Inadequate capacity & resources for PV and
post-market surveillance for quality & safety –
significant impact on patient safety
• Access to required essential medicines limited by
insufficient regulatory capacity
• Poor uptake of new and existing health solutions
costs millions of lives in many of these countries
What is the situation in Kenya?
• NMRA- legal framework, capacity, funding?
• Most important question- So what?
– Are our patients protected from SSFFCs & the resultant
problems?
– Have all the dimensions of access been adequately addressed
in country? What gaps exist & how can they be addressed?
– What is the contribution of NMRA activities to public health
& patient safety?
– What is the status of pharmacy practice in the country?
Conclusion/Recommendations
• Regulatory activities have a direct and significant impact
on patient safety & public health
• Globalization has resulted in the need for strengthened
& more stringent regulation
– Regulation can no longer be implemented as a
fragmented single country activity
– Need for fast-tracking efforts to harmonize and
integrate regulatory activities across countries for
standardization & improved efficiency
Thank you