Pharmacovigilance in resource-limited countries

Abstract

In the past 20 years, many low- and middle-income countries have created national pharmacovigilance (PV) systems and joined the WHO’s global PV network. However, very few of them have fully functional systems. Scientific evidence on the local burden of medicine-related harm and their preventability is missing. Legislation and regulatory framework as well as financial support to build sustainable PV systems are needed. Public health programs need to integrate PV to monitor new vaccines and medicines introduced through these programs. Signal analysis should focus on high-burden preventable adverse drug problems. Increased involvement of healthcare professionals from public and private sectors, pharmaceutical companies, academic institutions and the public at large is necessary to assure a safe environment for drug therapy. WHO has a major role in supporting and coordinating these developments.

Keywords:

• adverse drug reactions
• consumer involvement
• drug regulation
• harm
• low and middle income countries
• medicines
• patient safety
• Pharmacovigilance
• public health programs

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Key issues

• PV programs in most low- and middle-income countries (LMICs) are young, underfunded and not underpinned by strong legal or regulatory provisions. Stronger regulations are needed to engage local industry and healthcare professionals. Principles of good governance need to be applied for monitoring and enforcement of pharmacovigilance (PV) regulations.

• Local scientific evidence on the burden of medicine-related harm and their preventability needs to be created.

• Very few PV systems in LMICs currently have the capacity to collect sufficient and relevant local safety information to inform, and the analytical competence to carry out independent benefit/harm assessments.

• Public health programs need to urgently engage in PV, particularly active methods of patient follow-up, since new medicines and vaccines not introduced in the developed world, are being launched.

• Recent technological development offers new opportunities for collecting safety information from all sectors in society.

• Signal analysis in LMIC should focus on identifying high-burden preventable drug-related problems, rather than problems that have never been described before.

• Academic institutions need to be engaged in providing undergraduate PV training, ensuring that all new healthcare professionals know their role in documenting, reporting and learning from experience of medicine-related harm, including medication errors.

• As LMICs generally have a high level of self-treatment, active campaigns should be undertaken to engage the public in the process of reporting and learning about medicine-related problems.