Medicine shortages
Medicine shortages occur when the demand exceeds supply at any point in the supply chain and may ultimately lead to the unavailability of medicines to the patient. Medicine shortages are a complex and growing issue worldwide, with multifactorial causes, such as issues in manufacturing, supply chain disruptions, market fluctuations, etc.
The pharmaceutical supply chain has been defined as: “The management of product supply from raw material sourcing to active ingredient manufacturing through formulation, packaging and distribution to the patient. It encompasses all related activities across the product lifecycle, including clinical supply, scale-up and transfer as well as outsourcing and product discontinuation. A key requirement is the safe and reliable supply of quality medicines through a supply chain which is responsive to true demand and understands the voice of the customer.”
Causes and contributing factors to medicine shortages can be classified in two groups:
- Demand: Inaccurate forecasting and predictions of market variations, including price, tenders, epidemics, composition, and emergencies.
- Supply: Reduced or ceased production related to quality assurance decisions, availability of raw materials, or a batch recall.
Medicine shortages can result in delayed or unavailable treatment, resulting in a worsening of a patient’s condition. This has an impact on human lives, finances and indirect costs.
In 2024, the FIP Council adopted a FIP Statement of Policy on improving access to safe and quality essential medicines and medical devices. Through this policy statement, FIP published recommendations for governments and policymakers, organisations in membership, patient organisations, industry, and pharmacists. Included in this statement was FIP’s commitment to:
- Collaborate closely with organisations promoting equitable access to medicines and medical devices, such as the United Nations, World Health Organization (WHO), governments, and international patient and industry organisations.
- Encourage collaboration with other healthcare professionals to enhance access to care and facilitate transfer of knowledge and information on medicines and medical devices.
- Promote the global adoption of the recommendations in this statement and a set of harmonised criteria to promote access at national, regional, and international levels.
- Advocate for a regulatory and policy framework that enables pharmacists to exercise their professional competence and responsibility to increase access to medicines and medical devices and ensure timely access for patients.
- Develop evidence-based policies and competency development programmes targeting pharmacists’ roles in mitigating the impact of medicine shortages in industry, hospital, healthcare facility and community settings.
The 2020 FIP Statement of Policy on Medicines shortages recommended that:
- Each country establishes a publicly accessible means of providing information on medicines shortages.
- A global process to determine the list of critical or vulnerable products should be developed.
- All procurers of medicines are urged to move towards active procurement processes that assures the continuity of supply of quality medicines.
- All countries are encourage to remove unnecessary variability of regulatory practices within and between countries.
- Medicines regulatory agencies should gather and share information about demand for, and supply of medicines (and particularly essential medicines) within their jurisdictions. Countries without a medicines regulatory agency should investigate the potential to establish a national body charged with this task.
- All countries are encouraged to develop evidence-based risk mitigation strategies which might include contingency plans, pandemic planning and capacity redundancy appropriate to their national needs and strategic buffer stockpiles.
The policy also presents recommendations for governments as well as all supply chain stakeholders (pharmaceutical industry, parallel traders, full-service healthcare distributors and other pharmaceutical wholesalers, hospital and community pharmacies). We all need to work together to develop and improve medicines shortages reporting systems in order to share, in a timely manner, information that provides transparent insights on potential unavailability problems.
At the 71st World Health Assembly (WHA), FIP delivered an intervention on agenda item 11.5: Addressing the global shortage of, and access to, medicines and vaccines. FIP reiterated that pharmacists are needed at every stage of the pharmaceutical supply chain. The development, production, procurement, distribution and appropriate use of medicines, as well as the supportive function of regulation, all require a competent, equitably distributed pharmaceutical workforce.
In 2018, FIP published the report, “Pharmacists in the supply chain: The role of the medicines expert in ensuring quality and availability". Pharmacists are medicine experts with an essential role to play in the full range of activities of the supply chain. These roles stretch from the production of medicines (both industry scale and extemporaneous) to their administration to patients, and after. Pharmacists are involved in the production and supply of active pharmaceutical ingredients and the manufacturing of medicines, followed by the distribution of medicines to wholesalers and pharmacies. In addition, supply chain activities include medicines selection and administration, and end with the appropriate use of medicines by patients, accompanied by individual patient counselling, follow-up and pharmacovigilance.
Through this publication, FIP provides a global picture of the role of the pharmacist in supply chains. It takes the scarcity of pharmacists in many countries and settings into consideration and identifies where the competencies of pharmacists are best used and most needed. Since the maturity of supply chains varies across the globe, particular attention is given to differences that may exist between low- and middle-income country contexts compared with high-income, more developed supply chain environments.
In May 2017, FIP released an overview of eight models used in Australia, Canada, the Netherlands, Slovakia, South Africa and the USA for reporting medicines shortages. This document titled "Reporting medicines shortages: Models and tactical options," aims to support the information sharing on what different reporting systems exist and support the implementation of the WHA Resolution 69.25. In a number of countries, shortage reporting systems are being implemented by national associations of pharmacists.
Substandard and falsified medicines
The WHO defines substandard and falsified medical products as major threats to public health. Through increasing globalisation, the problem has expanded in both developed and developing countries.
Pharmacists are key to combatting substandard and falsified medical products because they are healthcare professionals with direct access to patients. Pharmacists are the gatekeepers for appropriate medication management, not only to ensure the supply of medicines in a proper and just manner, but also to detect unauthorised sales of medicines or medical products that are not of certified quality. As the final member of the pharmaceutical distribution chain as well as often being supply chain managers, pharmacists are crucial in preventing the introduction of substandard and falsified medical products into the supply chain and in promoting adherence to good distribution practices.
Policy and advocacy
We believe that pharmacists, pharmacy educators and pharmaceutical scientists can be a vital asset in assuring the safety of patients through their active participation in the fight against substandard and falsified medical products. In its 2024 Statement of Policy on improving access to safe and quality essential medicines and medical devices, FIP called for minimisation of the risk of substandard and falsified medical products through stringent quality control measures at each point of the supply chain and post-marketing surveillance (e.g., pharmacovigilance). FIP also advocated for ethical practices and opposed the manufacture and distribution of substandard and falsified medical products and predatory pricing practices, as part of wider goal of equitable access to quality and safe essential medicines and medical devices.
Annually, substandard and falsified medicines are on the agenda at the WHA.
- In 2026, FIP reminded member states that pharmacists are the experts in medication safety and the final link in the pharmaceutical distribution chain, therefore pharmacists are uniquely positioned in educating and advising patients who have been exposed to substandard and falsified medical products. FIP also urged member states to take globally coordinated action to improve professional education and public awareness to prevent the use of substandard and falsified medical products.
- In 2025, at the 78th WHA, FIP assured member states that pharmacists have the necessary knowledge and skills to use the appropriate medicines authentication system of medicines as well as to educate patients on the availability of legal online channels based on the five new modules to be embedded into existing substandard and falsified medical product curricula.
- At the 76th WHA, FIP encouraged member states to leverage pharmacists’ expertise and accessibility to combat substandard and falsified medicines. Pharmacists are on the frontline for minimising and eliminating harm from substandard and falsified medical products.
- In 2021, FIP was part of a constituency statement to member states, calling for strong legislative frameworks that address criminal networks seeking to profit from producing, distributing or selling falsified medical products, including the danger of illegal online pharmacies.
- At the 72nd WHA, FIP shared with member states its collaboration with WHO on training modules on substandard and falsified medical products to be embedded in pharmacy school curricula and FIP’s work with universities and member organisations in Africa where the need was acute at the time.
Raising awareness and building capacity through education
If well trained, pharmacists in community and hospital settings can quickly detect substandard and falsified medical products that have penetrated the supply chains and report them to authorities, educate patients and advise those who have been exposed to such products. However, too few pharmacists receive formal training as part of their pharmacy degree or post-registration.
Having considered the need for standardised, formal training to be systematically incorporated in the pharmaceutical curricula, and the pivotal role that can be played by pharmacists to prevent substandard and falsified medical products from causing harm, FIP partnered with the Commonwealth Pharmacists Association, the European Commission, the International Conference of French-Speaking Chambers of Pharmacists, and the WHO, and five universities in sub-Saharan Africa on a project to target pharmacists and improve their awareness and understanding of substandard and falsified medical product threats through effective communication, education and training.
As a result, a competency framework for pharmacists was developed in 2021 that outlines a menu of core knowledge, skills and attitudes relating to substandard and falsified medical products for pharmacy undergraduates. It lists the requisite competencies (at the pre-service level) to address substandard and falsified medical products in policy and practice settings.
Based on the framework, a comprehensive course on substandard and falsified medical products for pharmacy students was developed. The course formalises and structures information available to pharmacists, covering the root causes of substandard and falsified medical products, early warning signals, good procurement practices, working with authorities, and advice to patients. To date, the course has been successfully deployed in universities in Cameroon, Senegal, Tanzania and Uganda.
The course is available in English and French and is supported by a curriculum guide and a learner management site. The curriculum guide serves as a tool for education on substandard and falsified medical products and can be adapted to the needs of individual training institutions. It provides practical tips and is supplemented with modules aligned with the WHO prevention-detection-response strategy.
These tools were presented at a roundtable hosted by WHO in March 2022, and the results of the course implementation were published in BMJ Global Health in 2023. The results showed that an undergraduate pharmacy course on substandard and falsified medical products successfully improved students' knowledge.
In 2024, FIP developed five modules focused on online pharmacy and the risks associated with substandard and falsified medical products sold online, along with a handbook for educators. The course is suitable for educators, faculty of pharmacy training institutions, health regulatory institutions and others who wish to meet their respective needs for strengthening pharmacists’ contributions to containing the substandard and falsified medical products threat to public health.
If you are interested in deploying the course, please contact fip@fip.org
Toolkit from the FIP Regulators Advisory Group
FIP’s Substandard and falsified medical products: Regulatory self-assessment tool, published in 2023, seeks to aid the detection, quarantine and removal of substandard and falsified medical products from the pharmaceutical supply chain.
It is available in several languages. If you wish to support the translation of the tool, please contact fip@fip.org