Drugs and Supplies

Ensuring the quality, safety, and efficacy of health products can be achieved through the following levers ¹:
- Regulatory system strengthening: National Medicines Regulatory Authorities are responsible for the safety, quality, and efficacy of medical products. An effective regulatory authority gives communities confidence that the products they need and use are safe and effective. This lever focuses on developing countries’ ability to deliver regulation that protects the public and enables timely access to, and innovation for, quality products. Various tasks and competencies may be required of Regulatory systemsNational regulatory authorities (NRAs) provide regulatory oversight of all medical products. They perform their mandate based on a legal framework and a set of recommended regulatory functions that span the medical product lifecycle including clinical trial oversight, marketing authorization and registration, licensing and inspection of premises, market surveillance and enforcement activities when required. to ensure high-quality access to drugs and supplies. These include:
  - Appropriate innovation to foster R&D for affordable, suitable new treatments, Diagnostic suppliesDiagnostic supplies are the materials needed to conduct essential diagnostic tests, with the aim of providing information on a patient’s condition for diagnosis, monitoring, screening, prediction, or prognosis purposes at the primary care facility level., and devices
  - Evidence-based selection for resource allocation to satisfy the priority health care needs of the population
  - Supply chain support and governance
  - Strategic local/regional production of Essential medicinesEssential medicines should satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness, and compiled in the WHO Essential Medicines List. 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 adequate information, and at a price the individual and the community can afford. and health products
  - Pricing-financing reimbursement to promote affordability and fair pricing
  - Quality use of medicines and health products (particularly antibiotics)
  - Data systems for supporting decision making and managing access to medicines, vaccines, and other health products ³
- Assessment of the quality, safety and efficacy/performance of health products through prequalification: PrequalificationPrequalification of medicines and health products is a United Nation program managed by WHO. The purpose is to assess the quality, safety and efficacy of medicinal products and work with national regulatory authorities to support countries in building regulatory capacity through networking, training and information-sharing. “aims to ensure that diagnostics, medicines, vaccines and immunization-related equipment, supplies, and medical devices meet global standards of quality, safety and efficacy” ¹ by providing a list of products that comply with unified international standards.
- Market surveillance and assessment of quality, safety & performance: This lever focuses on activities to strengthen post-market surveillance, including monitoring of substandard and falsified health products. A country’s capacity to collect, organize, analyze, and use quality data is a critical element of understanding the availability, quality, and safety of drugs and supplies on the market and take corrective action, when needed. Surveillance requires robust safety data and corresponding infrastructure for pharmacovigilance in support of the prevention, detection and response to substandard and falsified health products, as well as dedicated personnel to oversee supply chain implementation and monitoring.
The relevant resources section below contains links to a curated set of resources tagged to each of these levers.
Improving equitable access requires policy and programmatic efforts throughout the value chain from development through delivery, and can be achieved through the following levers ¹:
- Research and development (R&D) that meets public health needs and improves access to health products: Health R&D is especially important for neglected diseases, emerging infectious disease pathogens, new antibiotic therapies, medical product innovations, and neglected target populations such as children and pregnant women. Effective research and development require setting priorities that align with population health needs and incentivizing investment in this area to ensure that available drugs and supplies keep pace with changing demand.
- Application and management of intellectual property to contribute to innovation and promote public health: Intellectual property (IP) protection has a large impact on innovation and access to health products. Activities related to this lever promote medical research and development, innovation, and increased access to drugs and supplies by incentivizing needs-driven innovation and access to affordable health products through appropriate trade and IP policies that reflect public health objectives.
- Evidence-based selection and fair and affordable management: Essential medicines and supplies are those that satisfy the priority health care needs of the population. They must be selected with regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. When a drug or supply is considered priority or essential, it is especially important to ensure fair pricing to alleviate the expensive burden of out-of-pocket payments. A fair price is one that is affordable for health systems and patients and that also provides sufficient market incentive for industry to invest in innovation and the production of medicines. Countries can use the following lists to guide their procurement of drugs and supplies.
- Procurement and supply chain management (SCM): The continuous supply of quality, safe, effective, and affordable drugs and supplies is one of the key building blocks of every well-functioning health system. Good procurement practices play a key role in securing affordable prices and ensuring adequate and timely supply, while good supply chain management ensures that quality products are available at all levels of the health system. This lever focuses on the need for improved capacity for procurement and supply chain management and for better data and market analysis to inform policy decisions. For more information on supply chain management, see the section “Deeper Dive on Supply Chain Management” below.
- Appropriate prescribing, dispensing, and rational use: Appropriate prescribing, dispensing, and use of medicines is essential for ensuring health impact and effective use of resources. Achieving this requires provider competence to reach accurate diagnoses, affordable and available medications, and adequate marketing, education, and promotion for appropriate use. More information on training and competence can be found in the provider competence Improvement Strategies module.
The relevant resources section below contains links to a curated set of resources tagged to each of these levers.
The supply chain refers to the resources needed to deliver goods or services to a consumer. In healthcare, Supply chain management Supply chain management encompasses the planning and management of all activities involved in sourcing and procurement…and all logistics management activities. Importantly, it also includes coordination and collaboration with channel partners, which can be suppliers, intermediaries, third party service providers, and customers. In essence, supply chain management integrates supply and demand management within and across companies. (SCM) involves obtaining resources, managing supplies, and delivering goods and services to providers and patients. Good supply chain management ensures that quality products are available at all levels of the health system.
SCM activities include: ⁴
- Serving customers – Customer needs are central to selection, procurement, storage, distribution, and dispensing products. Maintaining this focus and adhering to relevant protocols helps ensure that customers receive the right products at the right times.
- Product selection – Country committees, usually with membership drawn from regulatory agencies and regulatory professionals in pharmacy, medicine, and nursing practices, are typically the responsible group for decision making regarding product selection. Often the outputs of this committee are national essential medicines and essential supplies lists, typically developed following the essential medicine lists patterned on the World Health Organization (WHO) Model List.
- Quantification – Post-selection, product quantities and costs must be determined. Quantification ensures an uninterrupted supply of products by projecting the quantity and cost of the products needed by a health unit or program and determining when the products should be procured and delivered.
- Procurement – Once a quantification supply plan is complete, drugs and supplies must be procured. A strategic approach is critical to this process of procurement – through careful research, planning, monitoring and attention to applicable regulations, health systems and programs will enable timely and quality-assured supply procurement.
- Inventory strategy - Inventory policies are central to meeting supply chain objectives and enable organizations to balance supply and demand. Integrated inventory strategies define policies that guide product selection, quantification, and storage plans.
- Warehousing & distribution - After procurement, there must be a structured approach to the physical management of a product through each of the supply chain. This protects the item from environmental harm or handling to ensure its quality and condition upon use.
Underlying each of these supply chain elements are management components that support the operational functions: ⁴
- Logistics Management Information Systems (LMIS) - A LMIS facilitates supply and demand data tracking and analysis, which informs supply chain decisions and future commodity-related logistics actions. LMIS are frequently used for facility operations such as ordering and replenishing supplies.
- Supply chain workforce - Ensuring an effective flow of public health supply chain logistics requires motivated and competent staff at all levels. Their performance must be supported and honed through supervision, continuous learning, and opportunities for professional development.
- Financing - Distribution and administration of finances affects all elements of the supply cycle. As such, drugs and supplies - and the supply chains that deliver them - need to be sufficiently resourced. Assuring a budget line item for health commodities and associated management is critical to availability of drugs and supplies and smooth systems operations.
- Performance management - Continuous monitoring of the supply chain’s key performance indicators is important to rigorously evaluate the status, effectiveness, and efficiency of supply chain operations and gauge if adjustments are needed.
- Risk management – In an effort to hone manager’s focus and efforts where they are most needed, risk management is a formal approach to recognizing and alleviating dysfunction within the supply chain.
The supply chain can also be an opportunity to engage the private sector. The following resources orient implementers to ways in which the private sector operates and how they can be engaged:
Strong PHC that is capable of providing a comprehensive suite of promotive, preventive, and curative services is dependent on affordable, timely, and dependable access to safe, effective, and high-quality drugs and supplies. Countries often face a range of obstacles in achieving this, including rising prices for new drugs and supplies; shortages and stock outs of essential medicines and health products - especially for noncommunicable diseases; and the growing problem of substandard and falsified medical products entering the global supply chain. ² Ensuring that the right high-quality drugs and supplies are available when needed in primary health care settings requires sufficient financing, effective management of funds at the facility level, appropriate facility infrastructure to store drugs and supplies, and information systems to track procurement and distribution. Additionally, appropriate use depends on provider competence and training.
Supply chain management (SCM) - Supply chain management encompasses the planning and management of all activities involved in sourcing and procurement…and all logistics management activities. Importantly, it also includes coordination and collaboration with channel partners, which can be suppliers, intermediaries, third party service providers, and customers. In essence, supply chain management integrates supply and demand management within and across companies. ⁴
Regulatory systems - National regulatory authorities (NRAs) provide regulatory oversight of all medical products. They perform their mandate based on a legal framework and a set of recommended regulatory functions that span the medical product lifecycle including clinical trial oversight, marketing authorization and registration, licensing and inspection of premises, market surveillance and enforcement activities when required. ⁵
Essential medicines - Essential medicines should satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness, and compiled in the WHO Essential Medicines List. 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 adequate information, and at a price the individual and the community can afford. ⁶
Essential consumable commodities - Essential consumable commodities are the items and products identified as necessary to treat, cure, and/or prevent health system priorities. These may include vaccines, contraceptives, malaria products, sterile gauze, disposable needles, etc. ⁷
Basic equipment - Basic equipment are the essential supplies needed for “the safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease" at all primary care facilities. ⁸
Diagnostic supplies - Diagnostic supplies are the materials needed to conduct essential diagnostic tests, with the aim of providing information on a patient’s condition for diagnosis, monitoring, screening, prediction, or prognosis purposes at the primary care facility level. ⁹
Prequalification - Prequalification of medicines and health products is a United Nation program managed by WHO. The purpose is to assess the quality, safety and efficacy of medicinal products and work with national regulatory authorities to support countries in building regulatory capacity through networking, training and information-sharing. ¹⁰

What questions should be considered to begin improvements?

The questions below may be a useful starting place for assessing drugs and supplies in your context and determining whether it is an appropriate area of focus and how one might begin to plan and enact reforms.

How effective are existing regulatory systems?

Effective regulatory systems are an essential component in ensuring the availability and quality of drugs and supplies. A particularly helpful tool in identifying gaps in the regulatory system is the WHO Global Benchmarking Tool (GBT), the primary means by which WHO objectively evaluates regulatory systems. It incorporates the concept of ‘maturity level’, allowing WHO and regulatory authorities to assess the overall maturity of a regulatory system on a scale of 1 to 4. The case study on Tanzania describes how the GBT can lead to system improvements.

In addition to completing the GBT, to start considering where regulatory system strengthening could occur, implementers can explore: What is our system of adherence to WHO guidelines and norms? Is there collaboration between regulatory systems and health systems? Is there a system in place to identify gaps in our supply chain management of drug and supplies? How would our country fare in dispersing drugs and supplies in the event of a public health emergency?

Is there a country-wide supply chain model?

Having a clear understanding of the current state of the supply chain is the first step towards knowing what questions need to be asked to guide innovation and change. Effective supply chains not only help ensure commodity security, they also contribute to the success or failure of any public health program that depends on drugs and supplies. Tools such as the Supply Chain Compass can provide a high-level diagnosis of supply chain maturity. Other assessment tools can help to further diagnose bottlenecks and pain points in the supply chain.

In addition to completing supply chain diagnostic tools such as the Supply Chain Compass, implementers may ask themselves the following questions to explore the state of supply chains in their country: Is there one central governing body or regulatory system that oversees the human and financial resources and operations of the supply chain? Is there a supply chain strategy? Is it being implemented? Are key performance indicators defined and used to monitor supply chain performance? How might the private sector bolster effectiveness in the supply chain?

What processes are in place for evidence-based selection of drugs and supplies that are delivered in the PHC system?

Drugs and supplies, including medicines, vaccines, diagnostic supplies, and consumable commodities (the items and products identified as necessary to treat, cure, and/or prevent health priorities) are essential elements of all functioning health systems. As such, it is important to have a structured approach to ensure all essential drugs and supplies necessary for high quality primary health care are available when needed.

To assess performance in this area, implementers might ask: are evidence-based essential medicines and health products lists in use? Is there a system for monitoring the need, availability and inventory of essential medicines and health products?

Is there responsibility for market surveillance and assessment of quality, safety and performance of drugs and supplies?

As identified through the WHO's Roadmap for Access 2019-2023, a global priority is having regulatory systems prioritize authoritative guidance in meeting standards for ensuring drugs and supplies are accounted for, knowing if they are effective by the time they reach end-users, and subsequently taking action to improve the system. Surveillance requires robust safety data and corresponding infrastructure for pharmacovigilance in support of the prevention, detection and response to substandard and falsified health products. As such, these systems require dedicated personnel to oversee supply chain implementation and monitoring.

Implementers may ask themselves the following questions to understand the state of market surveillance and quality assurance in their country: What data are being collected for surveillance and assessment of quality, safety and performance? Who is responsible for collecting this data and with which entities is it shared? Are there opportunities to improve efficiency in these processes?

Is there a systematic approach to supporting, supervising, and maintaining supply chain management (SCM) staff?

Because of the wide array of staff needed to ensure successful SCM, implementers at the management level of regulatory systems should be dedicated to estimating appropriate system-wide human resource needs, recruiting and deploying staff competent in supply chain and logistics tasks, and increasing the professionalization of these cadres to include data skills for continual market surveillance and assessment and evidence-based selection. Staff need to be supported by strong human resource policies and plans and supervised using performance management designed specifically to support them and build their capacity in SCM.

The following resources have valuable insights on strengthening the human resources in the supply chain:

Implementers may ask themselves the following questions to further assess supply chain management in their country: What are the SCM tasks that need to be completed at various levels of the health system? What competencies are necessary for implementing these SCM tasks? Are the personnel assigned to these SCM tasks properly trained to complete them?

What is the role of the pharmacist in this country? Do pharmacists have the training, regulation, and incentives they need to perform this role?

In LMICs, the pharmacist’s role has changed significantly in recent years. The WHO identified appropriate prescribing, dispensing, and rational use as a lever for improving access and ensuring health impact and effective use of resources. Providing consumers with medicines alone is not sufficient to achieve treatment goals. Pharmacists now often hold responsibility for patient uptake and adherence in medication use; in order to fulfill this role, they must often be readily available to patients with or without an appointment and manage/triage health-related problems. To address these medication-related needs, pharmacists must accept greater responsibility for the outcomes of medicine use and are evolving their practices to provide patients with enhanced medicines-use services. ¹¹

Implementers can explore the state of pharmacist role by asking: Are pharmacists integrated into care delivery networks to ensure coordinated and comprehensive patient care across settings and to promote primary health care as the first point of contact? Are pharmacists in this setting charged by the relevant authorities with the management of the distribution of medicines to consumers? Are they required to engage in appropriate efforts to assure the safe and efficacious use of medicines? Do they have the appropriate training to provide these functions? What regulations already exist to ensure the quality of pharmacist practice? What incentives do pharmacists have to perform this expanded role?

Is the need for assistive products being met?

Assistive products are any external product (including devices, equipment, instruments or software) with the primary purpose of maintaining or improving an individual’s functioning and independence, and thereby promote their well-being.¹² These products range from a simple as a pair of eyeglasses (needed by 970 million people worldwide) to more complex technologies such as wheelchairs (needed by 75 million people).

Countries can use the WHO Priority Assistive Products List (APL) to determine which assistive products are needed. The list responds to a growing need for quality-assured, useful, and affordable assistive products as life expectancy increases across many regions and countries strive to fulfil global commitments to people living with disabilities.

To get started, implementers can explore whether there is a system for monitoring the need, availability and inventory of assistive products in their country.

Case studies for Drugs & Supplies

To ensure quality and safety of medicines, Tanzanian health authorities built on existing infrastructure and undertook a long process of converting informal vendors into accredited drug dispensing outlets (ADDOs). By June 2014, this program had trained over 19,000 providers - each linked directly to local primary care facilities - in almost 6,100 shops. In December 2018, the United Republic of Tanzania became the first WHO-recognized country in Africa to achieve a well-functioning regulatory system for medical products.

After creating a Single System for Managing Medicines and Medical Supplies (SUGEMI, in Spanish), the Dominican Republic has decreased the frequency of stock-outs and waste of unused, expired commodities and has decreased overall purchasing prices for drugs and supplies.

Relevant resources

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PHCPI is a partnership dedicated to transforming the global state of primary health care, beginning with better measurement. While the content on this website represents the position of the partnership as a whole, it does not necessarily reflect the official policy or position of any partner organization.

References:

WHO. Draft road map for access to medicines, vaccines and other health products, 2019 – 2023. World Health Organization; 2018. Available from: https://apps.who.int/iris/bitstream/handle/10665/327421/B144_17-en.pdf
WHO. WHO Medicines, Vaccines and Pharmaceuticals, Annual Report 2018. World Health Organization. 2018. Available from: https://www.who.int/medicines/publications/annual-reports/mvp_annual-report2018/en/
WHO. Towards Access 2030: WHO Essential Medicines and Health Products Strategic Framework 2016-2030. 2017. Available from: https://www.who.int/medicines/publications/towards_access2030/en/
John Snow, Inc. The Supply Chain Manager’s Handbook: A Practical Guide to the Management of Commodities . John Snow, Inc; 2017. Available from: http://supplychainhandbook.jsi.com/wp-content/uploads/2017/02/JSI_Supply_Chain_Manager%27s_Handbook_Final-1.pdf
WHO. Regulatory system strengthening [Internet]. [cited 2019 Jul 17]. Available from: https://www.who.int/medicines/regulation/rss/en/
WHO. Essential medicines [Internet]. [cited 2019 Mar 15]. Available from: https://www.who.int/topics/essential_medicines/en/
USAID. The Logistics Handbook: A Practical Guide for the Supply Chain Management of Health Commodities. 2011. Available from: http://apps.who.int/medicinedocs/documents/s20211en/s20211en.pdf
WHO. Medical Device [Internet]. [cited 2019 Jul 25]. Available from: https://www.who.int/medical_devices/full_deffinition/en/
WHO. Fifty-first report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva; 2017. Available from: https://apps.who.int/iris/handle/10665/258720
WHO. Prequalification of medicines [Internet]. 2013 [cited 2019 Sep 24]. Available from: https://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who
WHO. Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services. 2011. Available from: https://apps.who.int/medicinedocs/en/m/abstract/Js18676en/
WHO. Priority Assistive Products List: Improving access to assistive technology for everyone, everywhere. World Health Organization. 2016. Available from: https://www.who.int/phi/implementation/assistive_technology/global_survey-apl/en/

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Drugs and Supplies

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