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Policy  –  Implement the 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, as well as animal welfare, health and productivity. This results in increased health care and societal costs. Unsatisfactory access to some antibiotics is a global problem today. Access to antibiotics varies globally and is dependent on a number of factors, including a country’s 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.

While limiting the sale of antibiotics to prescriptions 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 and in resource-limited settings that lack access to prescribers.

Monitoring access

An important factor in the availability of antibiotics is the price of medicines, both in the health and agriculture sector. In the former, survey methodology for measuring medicine prices, availability, affordability and price components has been developed and tested in over 50 countries.

Essential medicines lists

The WHO model list of essential medicines “presents a list of minimum medicine needs for a basic health-care system, listing the most efficacious, safe and cost–effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment”.

The WHO Model List of Essential Medicines provides guidance for the development of national and institutional essential medicine lists. A similar list has been developed by the OIE. The WHO list promotes health equity and aim to assure availability of quality, affordable and effective medicines for treatment of widespread or high-priority diseases.

WHO Antibiotic Categorization – Access, Watch, Reserve (AWaRe)

WHO provides advise on which antibiotics to use to treat common bacterial infections, and which antibiotics to save for severe disease. It categorizes antibiotics into 3 groups based on the potential to induce and propagate resistance:

  • 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 limited set of infections. These are more prone to be a target of antibiotic resistance and thus prioritized as targets of stewardship programs and monitoring
  • RESERVE: Antibiotics that should only be used as the last resort for highly selected patients. Should be closely monitored and prioritized as targets of stewardship programs to ensure their continued effectiveness.

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. Clear standard operating procedures on drug procurement and ensuring first line antibiotics are available and used correctly can improve 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, including appropriate infrastructure, is required. Functional supply chains can promote public and animal 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. More than 2,400 health workers have been trained in the implementation of the guidelines.
  • Accredited the private sector and 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

Tools and methodology

Resources Description
WHO Model Lists of Essential Medicines Guidelines. The WHO EML provides advise on which antibiotics should be available to treat bacterial infections. To assist rational use, it categorizes antibiotics into 3 groups: Access, Watch and Reserve. There are separate lists for adults and children.
Selection of essential medicines at country level Manual from the WHO intended to assist policymakers in the process of developing or updating their national essential medicines lists.
MedMon – WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application Mobile app from the WHO. Enables measurements and monitoring of the price and availability of medicines. For both online and offline use.
Global Essential Medicines Database visualizing the essential medicines lists (EML) of 137 countries and their compatibility to WHO’s EML. Can also display which countries that have specific medicines included on their EMLs.
Improving Medicines Access and Use for Child Health -A Guide to Developing Interventions Manual for those developing interventions to improve access to and use of medicines, including antibiotics, for child illnesses. Target groups: health policy makers, CSOs/NGOs and health care professionals. Contains practical 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 Manual 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 format facilitates national and international comparisons of medicine use.
Medicines Supply Information portal. 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 Manual developed by USAID that 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 (PDF 126kB) Guidelines from WHO that provide an overview of methods to ensure the quality of pharmaceutical products along the entire supply chain, including storage, transport, sale and distribution. The guidelines also address the issue of counterfeit drugs and quality assurance schemes.
Medicines policy Information portal. 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 Manual. 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.
Knowledge Portal on Innovation and Access to Medicines Information portal. Open access knowledge hub from the Graduate Institute, with information, analysis and research synthesis on policies relating to innovation and access to pharmaceuticals. Presents materials under 3 overarching themes: Pricing, Intellectual Property and Innovation.
Procurement and Supply Management Toolbox Information portal. 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 Information portal. 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 Information portal. 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.
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