An Advisory Committee on Medicinal Product Safety has been established under the auspices of WHO to respond promptly and efficiently to medicines safety issues of potential global importance. The first meeting of the Committee was held from 20-22 October 2003. Members are drawn from WHO Expert Advisory Panels and selected with regard to their experience in clinical pharmacology, pharmacovigilance, pharmaco-epidemiology, clinical medicine, drug regulation, international public health, and risk-assessment. A report of the meeting is available on http://www.who.int/medicines.

The Committee has been set up to provide advice on policy and issues related to the safety and effectiveness of medicinal products in general and specific issues that:

• are important to national or international programmes;
• cannot be met by structures, institutions or systems in place;
• respond to identified needs of a country that may be beyond their capability; and
• advance and promote the future development of pharmacovigilance as a discipline.

During the meeting, discussion focused on how safety surveillance can strengthen the WHO 3 by 5 Initiative aimed to provide HIV treatment to three million people by 2005. It was agreed that patient safety issues should be integrated into the 3 by 5 initiative from the outset to ensure the most effective delivery of long-term benefits to patients and ensure success.

In 2002, the World Health Assembly urged Member States to establish and strengthen science-based systems for quality of care and patient safety, including the monitoring of medicines safety, using reporting systems and implementing measures to reduce risk.

The 3 by 5 initiative proposes the use of antiretroviral medicines (ARVs) for HIV treatment. There is already considerable experience of ARV use in industrialized countries and significant safety issues have been reported. However, there are a number of additional challenges facing developing countries targeted to receive ARVs, including:

• lack of an adequate infrastructure and trained health care professionals for monitoring of safety and use;

• complex co-morbid conditions including malnutrition, tuberculosis and other infectious diseases specific to HIV populations;

• use of alternative therapies and medicines and potential interactions;

• sociocultural and educational particularities and vulnerable populations; and

• lack of adequate regulatory systems or capacity to deal with safety outcomes.

Safety issues

Antiretrovirals have been associated with numerous adverse reactions, some of which may be serious. The outcome of long-term adverse effects is unknown. The reactions may be common or unusual, such as altered body fat distribution (lipodystrophy), hypersensitivity reactions, or muscle damage (myopathy) of the newborn. Besides causing harm to patients, these and other reactions may damage confidence in HIV treatment and reduce patient compliance and patients may stop taking life-prolonging ARVs. In the case of ARVs, poor compliance is known to lead to the development of resistance as well as therapeutic failure.

Contribution of patient safety strategies to public health programmes

There is evidence that knowledge and understanding of medicines safety through provision of public education improves patient compliance and confidence in public health programmes such as the 3 by 5 initiative. With efficient monitoring, better understanding of the safety of antiretrovirals will lead to the development of improved treatment and a more rational use of existing therapies. Furthermore, once a basic monitoring infrastructure is in place, this can contribute to improved strategies for other public health programmes. The cost of a medicines safety system is small compared to the benefits gained in patient wellbeing and in reducing the costs of treating adverse reactions. The ultimate contribution that safety monitoring systems would make to international public health and clinical practice in the treatment of HIV disease are thus of high priority.

Resources a key to success

The following are a number of ways in which patient safety programmes can be integrated into the 3 by 5 initiative.

• Utilize the technical expertise of the WHO International Drug Monitoring Programme.

• Collaborate with existing national pharmacovigilance centres in the targeted countries.

• Call on expert advice on causality assessment and systematic data collection and sharing.

• Seek access to the WHO ADR database including information on drug-drug interactions.

• Educate, train and empower health professionals by improving access to medicine information resources.

• Use existing infrastructures for monitoring patient safety, such as for the Roll Back Malaria programme.

• Work with other organizations that have medicine safety experience in order to enhance patient communication and information.

It was also recognized that the pharmaceutical industry had a role to play by contributing experience and information on safety monitoring of HIV products and in implementing fully their own safety requirements.

There will be no delay in integrating a patient safety component into the 3 by 5 initiative, because it will build on existing medicines safety experience and framework. Additionally, the Advisory Committee will be available to advise on patient safety issues and activate the required support systems.

Conclusions

A well-defined patient safety programme is essential to the overall success of the 3 by 5 initiative by ensuring positive treatment follow-up. Medicines effectiveness and safety management is an essential and cost-effective means of maximizing the success of treatment interventions. Patients should be provided with health programmes that are structured and planned and that maximize health benefits while minimizing risk.