Pharmaceutical system

• Structure of Complete National Medicine Policy

  • Leadership/Governance and HIS
  • Financing and Workforce
  • Medical Products, Technologies and Service Delivery
• Goals for National Medicine Policies and Pharmaceutical Management Initiatives

  • Health-related Goals
  • Economic Goals
  • National Development Goals
• Why Medicines are Important to Healthcare
• 4 Dimensions of Access to Essential Medicines, Vaccines and Other Health Commodities

  • Availability
  • Affordability
  • Accessibility
  • Acceptability
  • Strategies to Increase Access
• Pharmaceutical Management Framework


  1. Management Support

  2. Selection: Treatment Guidelines, Formulary Manual

  3. Quantification

  4. Procurement: Good Pharmaceutical Procurement Principles, Who are involved in the procurement process?

  5. Distribution: Primary Distribution Management Goal, Distribution Cycle, A well-run distribution system should

  6. Use: Rational Drug Use, Factors affecting Drug Use, Investigating Drug Use
• Pharmaceutical System Components


  • Pharmaceutical Products and Related Services
  • Policy, Laws, and Governance
  • Regulatory Systems
  • Innovation, Research, and Development, Manufacturing and Trade
  • Financing
  • Human Resources
  • Information
• The Pharmaceutical Strengthening Framework

  1. United States Agency for International Development (USAID) Pharmaceutical System Strengthening Approach

  2. Defining Pharmaceutical System Strengthening
• Inputs to Drug Policies

  • Policy Audits
  • Staff training (Healthcare workers)
  • Consensus on DUR Methods
  • DUR Studies
  • Legal (Different laws)
  • Methods Research/Therapy
  • Official Guidelines (Disease guidelines)
  • Studies of Future Policy Needs
  • Foreign Influences
  • Lobbies
  • Global Trends
• Policy Tools


  • Education
  • ADR Study
  • Costs
  • Distribution (Mostly on the drug industry)
  • Advertising (For the consumer body)
  • Independent Info
• Metrics to control medicine use

  • Education
  • ADR Study
  • Costs
  • Distribution
  • Advertising
  • Independent Information
  • Research Funds
  • Registration
  • Quality
• Contributors to the policy

  • Universities, Schools
  • Dispenser (Pharmacist, MD)
  • Pharmaceutical Industry
  • Prescriber (MD)
• Link between DISPENSER and PRESCRIBER

  There should be a link between your DISPENSER and PRESCRIBER
• The goal of the establishment of the NDP is to have Acceptable, Affordable, Accessible Drugs That Are Rationally Used
• Corrective mechanisms for medicine use

  • Courts of Justice
  • Public Acceptance
  • Consumer Bodies
  • Mass Media
• The end user and the one that will benefit the most from the drug policy will be the consumers
• Take note of the arrows to identify the different actors that influence the different structures within the National Drug Policy
• Goals for National Medicine Policies and Pharmaceutical Management Initiatives

  • Health-related Goals
  • Economic Goals
  • National Development Goals
• Essential Medicines are indispensable and necessary for the health needs of the population. They should always be available, in the proper dosage forms, to all segments of society (WHO, 1975)
• Medicines save lives and improve health
• Essential Medicines


  • Medicines that are indispensable and necessary for the health needs of the population
  • They should always be available, in the proper dosage forms, to all segments of society (WHO, 1975)
• Medicines save lives and improve health – essential medicines provide a direct, low-cost response for many diseases
• Medicines promote trust and participation in health services – the credibility of a health worker depends on their ability to save lives, restore and relieve suffering
• Medicines are costly
• Consumers often do not choose the medicine – it is prescribed by a clinician or recommended by pharmacy staff
• Substantive improvements in the supply and use of medicines are possible
• Dimensions of Access to Essential Medicines, Vaccines, and Other Health Commodities

  • Availability
  • Affordability
  • Accessibility
  • Acceptability
  • Quality of Products and Services
• Strategies to Increase Access

  1. Education: Patient consultation, Social marketing

  2. Management: Business management, Financial management

  3. Regulation: Standards development, Task shifting

  4. Economic: Insurance plans, Pooled procurement
• Pharmaceutical Management Framework provides the underpinning for improving access to medicine
• Management Support


  1. Organization

  2. Financing and sustainability

  3. Information management

  4. Human resources management
• Selection


  1. Will be based on treatment guidelines, treatment protocols, clinical guidelines

  2. Main question: “What are the medicines that have a considerate impact on the quality of care, cost of treatment, and therefore, what are the areas where the intervention is most cost-effective?”
• Treatment Guidelines


  1. Are used to indicate systematically developed statements that help practitioners or prescribers make decisions about appropriate treatments for specific clinical conditions

  2. The guidelines are reviewed by experts to check
• Guidelines review


  Reviewed by experts to check if they are updated or applied to all patients
• Starting with no existing guidelines


  Gathering data and using it to interpret by prescribers to make the proper treatment
• Pharmacological treatment


  Refers to medical treatment involving drugs
• Contents of a Formulary Manual


  • Summary information on a selected number of medicines
• Contents of a Therapeutic Formulary

  • Detailed and comprehensive therapeutic information on each medicine listed, may include guidelines on rational prescribing and dispensing
• Steps for a drug included in the formulary

  1. Product Registration

  2. HTA and Formulary Inclusion

  3. Quantification

  4. Forecasting

  5. Sourcing/Supply Planning

  6. Budget Analysis
• Quantification


  Estimation of quantities of specific medicines needed, calculation of financial requirements for purchasing
• Procurement


  Quantifying medicine requirements, selecting procurement methods, managing tenders, establishing contract terms, assuring pharmaceutical quality, ensuring adherence to contract terms
• Good Pharmaceutical Procurement Principles

  • Reliable payment and good financial management
  • Procurement by generic name
  • Procurement limited to essential medicines list or formulary list
  • Procurement in large volume
  • Formal Supplier qualification and monitoring
  • Competitive procurement
  • Monopsony commitment
  • Order quantities based on reliable estimate of actual need
  • Transparency and written procedures
  • Separation of key functions
  • Product quality assurance program
  • Annual financial audit with published result
  • Regular reporting on procurement performance