The quality of medicines plays
a crucial role in achieving optimal health outcomes, particularly in countries
like Nepal, where regulatory oversight is still developing. Nepal currently
stands at WHO Maturity Level 1 for regulatory systems, indicating limited
regulatory capacity and enforcement mechanisms. This environment poses
significant challenges for clinicians and pharmacists who must work
collaboratively to ensure the availability of high-quality medicines,
particularly branded generics, which dominate the pharmaceutical market in the
region. This article explores actionable steps and critical considerations for
such collaboration.
Understanding the Regulatory
Landscape
In Nepal, weak regulatory frameworks
result in inconsistent enforcement of Good Manufacturing Practices (GMP),
limited post-market surveillance, and the circulation of substandard or
falsified medicines. With limited capacity for routine inspections, product
recalls, and independent quality testing, the burden of ensuring medicine
quality often falls on healthcare professionals.
To address this, clinicians and
pharmacists must actively participate in medicine/brand selection, monitoring,
and feedback processes. They can leverage their positions to advocate for
better practices by pharmaceutical companies and engage with regulators to
strengthen systems.
Key Considerations for Ensuring
Medicine Quality
1. Past Recall Record
- Voluntary
or Mandatory Recalls: Clinicians and pharmacists should prioritize medicines from
companies with a clear history of addressing quality issues through
voluntary recalls. Companies that proactively address quality problems
demonstrate responsibility and commitment to safety.
- Transparency
of Recall Processes: Collaborators should assess whether companies have transparent
recall mechanisms and communicate effectively with stakeholders about
quality concerns.
2. Batch Records and Certificate
of Analysis (CoA)
- Documentation
Review: Pharmacists
can request for batch records and CoAs from manufacturers as part of their
due diligence. These documents provide insights into the consistency of
production processes and adherence to quality standards.
- Spot
Audits: Randomly
verifying CoAs against independent testing results can ensure the data
provided by companies is accurate. The pharmacist can seek help from the
independent third party lab for ensuring the quality as per CoA.
3. Good Manufacturing Practices
(GMP) Compliance
- Minimum
Experience Threshold: Medicines should be sourced from companies with at least two
years of consistent GMP compliance. New entrants may lack the operational
stability needed to produce high-quality medicines consistently. One can
ensure the drugs to be prescribed which has at least one complete
lifecycle of a product which is around 2 years.
- Inspection
Reports: GMP
compliance should be verified through publicly available inspection
reports or direct communication with regulatory bodies. Normally
Department of Drug administration releases such reports annually.
4. Insights from QC Departments
- Employee
Feedback: Pharmacists
should build relationships with Quality Control (QC) employees of
pharmaceutical companies to gain insights into production challenges,
potential quality risks, and the company’s approach to addressing them.
- Whistleblower
Policies: Country
should adopt whistleblower-friendly policies can facilitate transparency
and proactive issue identification.
5. Comparative Evaluation with
Innovator Products
- Evidence
of Bioequivalence: Whenever possible, pharmacists should request bioequivalence
data or any comparative analysis that demonstrates therapeutic equivalence
between branded generics and their innovator counterparts or if possible
from Stringent regulatory authority countries.
- Clinical
Feedback: Clinicians
should document patient responses to branded generics that he/she has been
prescribing compared to innovator products and share findings with
pharmacists for quality monitoring. Pharmacist can assist on this,
especially on drugs used on chronic diseases.
6. Batch-to-Batch Variation
Records
- Consistency
Monitoring: A
history of batch-to-batch variations can indicate production instability.
Pharmacists and clinicians should regularly communicate about observed
variations in clinical effectiveness or adverse effects.
- Trend
Analysis: Maintaining
records of batch variations over time can help identify patterns or
recurring issues with specific brands.
7. Voluntary Recall Commitments
- Proactive
Responsibility: Companies
should demonstrate a commitment to quality by implementing voluntary
recall policies even in the absence of regulatory pressure.
- Internal
Quality Assurance Programs: Companies with robust internal quality assurance
programs are more likely to identify and address quality issues early.
8. Third-Party Testing
- Independent
Lab Reports: Encouraging
manufacturers to invest in independent third-party testing can provide an
additional layer of assurance. Pharmacists should verify the credibility
of testing laboratories and demand regular updates.
Additional Strategies for
Clinician-Pharmacist Collaboration
1. Strengthening Procurement
Policies
- Jointly
develop procurement guidelines for hospitals and pharmacies that emphasize
quality over cost. Selection criteria should include GMP compliance,
recall history, and independent quality testing. The team can blacklist
those companies which don’t have good history of product with reference to
product recall.
2. Building Trust with
Manufacturers
- Engage
directly with pharmaceutical companies to understand their production
processes and quality assurance measures. Transparent communication can
lead to collaborative quality improvement efforts.
6. Involvement in Clinical
Trials
7. Preparing internal formulary
- Doctor and Pharmacist should collaborate to prepare a formulary based on their best knowledge and prescribe and maintain the same stock for dispensing. All the above information and knowledge should be used to make the formulary. In a bigger institution like hospitals Drug therapeutic committee can play a vital role to ensure the best quality medicine.