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Policy  –  Elements of a plan

Access

Reducing overuse of antibiotics is key, but equally important is ensuring access to these essential medicines for those in need.

Regulations to control the distribution and use of antibiotics can help to minimize the development of resistance and conserve the effectiveness of this non-renewable resource. However, limited access to effective treatment in many low- and middle-income countries compromises health and results in increased health care and societal costs. Even high-income countries experience unsatisfactory access to some antibiotics today. Access to antibiotics varies globally and is dependent on a country’s capacities, regulatory framework and robustness of the health system. Regulation for access without excess must be instituted worldwide and supported by strong political will and leadership.

Where limiting the sale of antibiotics to prescription may seem like an easy solution and functions well in some countries, enforcing prescription-only laws may cut off access to antibiotics for parts of the population, particularly in rural areas in resource-limited settings that lacks access to prescribers.

Monitoring access

An important factor in the availability of antibiotics is the price of medicines. Survey methodology for measuring medicine prices, availability, affordability and price components has been developed and tested in over 50 countries.

Essential medicines lists

As stated by WHO, “Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford”.

The WHO Model List of Essential Medicines provides guidance for the development of national and institutional essential medicine lists. These lists promote health equity and aim to assure availability of quality, affordable and effective medicines for treatment of widespread or high -priority diseases.

Access watch and reserve.

In 2017, the biggest revision to date of the antibiotics section of the essential medicines list was released. It provides advise on which antibiotics to use to treat common bacterial infections, and which antibiotics to save for severe disease. It recognizes the importance to optimize antibiotic use and reduce antibiotic resistance without restricting access. It categorizes antibiotics for the most common general infections into 3 groups:

  • ACCESS: Antibiotics that should be available at all times, at an affordable cost and of good quality. Example: amoxicillin, widely used to treat pneumonia.
  • WATCH: Antibiotics that are recommended as first- or second-choice treatments for a small set of infections. Use of some antibiotics is recommended to be dramatically reduced to avoid further resistance development.
  • RESERVE: Last resort antibiotic options such as colistin and some cephalosporins. Should only be used for the most severe cases when all other options have failed.

Having an essential medicines list can result in higher quality of care, better management and use of medicines and more cost-effective use of resources . In countries where essential medicines policies have been implemented to coordinate long-term interventions at multiple levels of their health systems, a reduction in antibiotic use has been shown. Merely making people aware of which drugs are on the list does not seem to make an impact. However, by bringing order to drug procurement and ensuring that only those drugs that are useful in a country are included in reimbursement schemes, the use of medicines can be improved in the public and private sectors .

Improving logistics and supply chain management

To secure access to medicines in general and to antibiotics in particular, a well-functioning supply system that relies on strong organizational and management support is required. Functional supply chains can promote public health by increasing program impact, enhancing quality of care, improving cost effectiveness and efficiency. The supply chain of pharmaceutical products relies on several activities including product selection, quantification and procurement, and inventory management, storage and distribution. To ensure that these activities are performed in an effective and efficient manner, logistic management information systems, organization and staffing, budgeting, supervision and evaluation are all key components. Working with improvement of pharmaceutical management can ensure proper access to antibiotics but it can also create the right preconditions for appropriate use of antibiotics and ensure quality of antibiotics in the market.

A legal and technical approach to improving the quality of medicines – Rwanda.

  • Late 1990’s – Rwanda mandated that all drug contracts awarded by the Ministry of Health must be to manufacturers with WHO-approved certificates of Good Manufacturing Practices.
  • 2011 – Formed pharmacovigilance sub-committees at all 469 health centers that are overseen by the country’s 42 district hospitals. 2,400 health workers and more have been trained in the implementation of the guidelines.
  • Accredited private sector integrated with public sector supply chain on medicines for high priority diseases.
  • Agencies involved for inspection, testing and legal actions – Bureau of Standards, Customs Services Department, Ministry of Health, Rwandan police force and Interpol.
  • Working with East African Community in drafting regional law.

Selected Resources

Resource Description
WHO Model Lists of Essential Medicines The WHO model list of essential medicines is updated every two years. There are 2 versions, for adults and children respectively. Current and past versions of the lists are available in English, French, Spanish, Chinese, Russian and Arabic.
Improving Medicines Access and Use for Child Health -A Guide to Developing Interventions Practical manual for those developing interventions to improve access to and use of medicines, including antibiotics, for child illness. Target groups: health policy makers, CSOs/NGOs and health care professionals. Contains guidance on all steps of the process, as well as examples of instruments and interventions. Special focus on low-resource settings.
Measuring medicine prices, availability, affordability and price components This manual has been produced by WHO and Health Action International. It contains a methodology as well as tools for conducting reliable medicine prices and availability surveys in a standardized way. Collecting data in this standardized format facilitates national and international comparisons of medicine use.
Medicines Supply This WHO website provides an overview of tools for the evaluation of medicines supply management systems at the national level.
The Logistics Handbook: A Practical Guide for the Supply Chain Management of Health Commodities This guidance document was developed by USAID and contains advice on the management of health care supply chains, including the design of logistics systems. The document is also available in French, Hindi, Spanish and Portuguese.
WHO Good Distribution Practices for Pharmaceutical Products This WHO guideline provides an overview of methods to ensure the quality of pharmaceutical products along the entire supply chain, including storage, transport, sale and distribution. The guideline also addresses the issue of counterfeit drugs and quality assurance schemes.
Medicines policy This website provides resources on how to develop and implement a national drug policy in your country, as well as examples of already established national drug policies.
How to Develop and Implement a National Drug Policy Chapter 7.2 on drug procurement describes twelve operational principles for good pharmaceutical procurement, which are listed under four strategic objectives. Provided by the WHO and available in French and Spanish.
Procurement and Supply Management Toolbox WHO AIDS Medicines and Diagnostics Service (AMDS) set up an online platform to improve access to procurement and supply management (PSM) tools. It provides a searchable database of available PSM tools.
The need to look at antibiotic resistance from a health systems perspective Review article analyzing the emergence of antibiotic resistance based on interdependencies between health systems resources, and discussing the importance of multi-level governance for successful containment strategies.
Essential medicines and health products – Innovation Access and Use Landing page of access in Essential medicines and health products of the World Health Organization, with several resources for access issues.
Essential Medicines Teaching Resources This WHO online resource offers free teaching material on a number of topics, including access to medicines, rational use and quality and safety of medicines.