Semester 9 Handout (1)

Pharmacy Practice Drug supply management

TOPICS National drug policy DRUG MANAGEMENT CYCLE Need assessment Selection Procurement Distribution and use

NATIONAL DRUG POLICY

The main reference is Managing Drug Supply,the Selection, Procurement, Distribution, and use of pharmaceuticals Jonathan D Quick et al Objectives of the topic By the end of this lectures student should be able to: Define the national drug policy Define its impact ( )on health care systems Discuss its different components What is a national drug policy?

It is a commitment ( (to a goal and a guide for action A commitment to a goal and a guide for action ) the medium- to long-term goals Expresses and prioritizes ( set by the government for the pharmaceutical sector, and Identifies the main plans for making the goals Provides a frame within which the activities of the pharmaceutical
sector can be coordinated Covers both the public and the private sectors, and Involves all the main players in the pharmaceutical field It is presented and printed as an official government report It is important as it acts as a formal record of aims, decisions and commitments What if we do not have a NDP? There may be no general overview of what is needed; as a result, some government measures may conflict with others, why?
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Because the various goals and responsibilities are not clearly defined and understood Why is a national drug policy needed? There are many reasons. The most important are to: Present a formal record of values, aims, decisions and medium- to long-term government commitments; Define the national goals and objectives for the pharmaceutical sector, and set priorities to; Identify the strategies needed to meet those objectives, and identify the various factors responsible for implementing the main components of the policy; Create a forum for national discussions on these issues. The importance of consultations and national discussions preceding the drug policy document they create a mechanism to bring all parties together and achieve a sense of collective ownership of the final policy It is necessary for implementing the policy The policy process is important as the policy document is Why is a national drug policy needed? (Continued)

usually found in all national drug policies, the main objectives are ensuring equitable access, good quality and rational drug use

But not all of theseNDP policies are the same. The final definition of objectives and strategies The final definition of objectives and strategies depends on : o the level of economic development o resources, o cultural and historical factors, o Political values and choices. WHO guidelines for NDP The guidelines are set by WHO and are intended to help countries develop and implement a comprehensive policy framework that is appropriate to their own needs, priorities and resources A national drug policy is an essential part of health policy A national drug policy cannot be developed in a vacuum An Integral part of a national health policy
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 It must fit within the framework of a specific health care system, a national health policy and, perhaps, a program of health sector reform. The targets of the national drug policy should always be consistent with broader health objectives, and policy implementation should help to achieve those broader objectives. Importance of the ESSENTIAL DRUGS concept The essential drugs concept is central to a national drug policy The EDC promotes equity and helps to set priorities for the health care system The central part of the idea is the use of a limited number of carefully selected drugs based on agreed clinical guidelines leads to : a better supply of drugs more rational prescribing and to Lower costs. Importance of the essential drugs concept (continued) Essential drugs, which are selected on the basis of safe and cost-effective clinical guidelines, give better quality of care and better value for money. The procurement of fewer items in larger quantities results in more price competition and economies of scale. Quality assurance, procurement, storage, distribution and dispensing are all easier with a reduced number of drugs. Training of health workers and drug information in general can be more focused, and prescribers gain more experience with fewer drugs and are more likely to recognize drug interactions and adverse reactions. Some history In 1975, the World Health Assembly in resolution WHA28.66 requested WHO to develop means to assist Member States in formulating national drug policies The first WHO Model List of Essential Drugs was published in 1977. In 1979, the WHO Action Programme on Essential Drugs was established By end of 1999, 156 countries had national or institutional lists of essential drugs for different levels of care, private and public sectors; There is significant evidence that the use of NLEDs has contributed to an improvement in the quality of care and to a considerable saving in drug costs. In 1981 the MoH (Sudan) formulated a (NDP) based on the concept of essential medicines. The first component of the NDP to be implemented was the selection of a (NLED).
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Although the first NLED was selected in 1981 and first published in 1982 yet it was not officially adopted. In 1985 a national workshop was convened in Khartoum in which the 1982 NLED was revised and updated and levels of use allocated, but again it was not officially adopted. In 1987 the NLED was revised by the Standing Committee for Drug Products Registration. The revised NLED was adopted by Ministerial Order No. 7 dated 15 October 1987 , printed in English and widely distributedIn November 1993 a national workshop was convened in Khartoum and revised 1987 NLED. The updated NLED was adopted by Ministerial Order No. 4 dated 15 April 1995 printed in English (original) and Arabic and widely distributed. In November 2001 a national workshop was convened in Khartoum and revised 1995 NLED. The updated list although not officially adopted, yet it was widely accepted and used. Eventually the NLED was updated by the Standing Committee for Drug Products Registration in May 2004 and its title was changed to the National List of Essential Medicines Please complete as part of ur /presentation Key components of a national drug policy A national drug policy is a comprehensive framework in which each component plays an important role in achieving one or more of the general objectives of the policy (Access, quality and rational use). The policy should balance the various goals and objectives, creating a complete and consistent entity. For example, access to essential drugs can only be achieved through rational selection, affordable prices, sustainable financing and reliable health and supply systems. Each of the four components of the access framework is essential but not sufficient in itself to ensure access. Similarly, rational drug use depends on many factors, such as rational selection, regulatory measures, educational strategies and financial incentives.

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Components of a national drug policy and link to key policy objectives Objectives :{ Access-Quality-Rational use} Components Selection of essential drugs Affordability Drug financing Drug supply systems Regulations and quality assurance Rational use Research Human resources Monitoring and evaluation X= direct link; = indirect link (X) X X X X X X Access X X X X X (X) X X X X X X Quality (X) Rational use X

As can be seen from the Table on the previous slide, most components cannot be linked to one objective only.

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Approaches to be used

A national drug policy is an essential part of health policy (continued)

The health policy and the level of service are important determinants of drug policy and define the range of choices and options. The drug situation also affects the way in which health services are regarded. Services lose their credibility if there is no adequate supply of good quality drugs, or if these are badly prescribed. Thus the implementation of an effective drug policy promotes confidence in and use of health services. There are also economic arguments. In many countries a large proportion of health care spending is on drugs. Health care financing is therefore closely related to drug financing It is very difficult to implement a health policy without a drug policy National drug policy-(NDP) o Central objectives: o In the broadest sense a national drug policy should promote equity and sustainability of the pharmaceutical sector o The general objectives of a (NDP) are to ensure: o Access: o equitable availability and affordability of essential drugs o Quality: o the quality, safety and efficacy of all medicines
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o Rational use: o the promotion of therapeutically sound and cost-effective use of drugs by health professionals and consumers The specific goals and objectives of a national drug policy will depend upon: The country situation The national health policy, and The political priorities set by the government In addition to health-related goals there may be others, such as economic goals. For example, an additional objective may be to increase national pharmaceutical production capacity. It is critical that all the drug policys objectives are clear, so that the roles of the public and private sectors and of the various ministries (health, finance, trade and industry) and government bodies (such as the drug regulatory authority) can be specified. Partnership/Group effort Governments states and territories health educators health practitioners other healthcare providers Suppliers The drug industry Healthcare consumers the media ALL OF THEM Need to understand the payback of a National Drug Policy and decide to work together as partners to promote the objectives of the policy. All must be engaged in a cooperative attempt to bring about better health outcomes for all citizens Focus is especially on peoples access to, and wise use of drugs Partners have to accepts the responsibility to contribute to the achievement of the objectives of the policy, drawing on their unique point of view and abilities Thus co-ordination + integration with each other can lead to better outcomes

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The general objectives : access to drugs A number of aspects to providing access to medicines There may be potential risks as well as benefits associated with the use of medicines The relative benefits and risks need to be considered Cost should not constitute a substantial barrier to peoples access to medicines they need Therefore normal market mechanisms may be mitigated in access arrangements, to increase the affordability of important medicines Mechanisms for subsidizing costs free drugs systems by community participation etc can be of great help access to medicines should support the rational use Users should be encouraged to understand the costs, benefits and risks of medicines The public benefit of provision of medicines should be achieved through the regulated marketplace in which medicines are placed. new medicines are often relatively expensive Effectiveness and cost-effectiveness of the treatments need to be considered in making decisions about subsidization. Components of national drug policy 1. Legislative and regulatory frame work 2. Choice of drugs 3. Supply 4. Rational use of drugs 5. Economic strategies for drugs 6. Human resources development 7. Monitoring and evaluation 8. Research 9. Technical cooperation among countries 1-Legislative and regulatory frame work a. Legislation and regulation b. Drug regulatory authority c. Drug registration and licensing d. Pharmaceutical Quality assurance e. Post marketing surveillance f. Regulations for prescription and distribution
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Legislative and regulatory frame work A legal basis for policy and making it enforceable is by passing a law and putting regulations after the formulation of a drug policy Legislations define the actors in the systems and their responsibilities Suitable legislations are to be accompanied by a functioning quality assurance systems Poor quality drugs should never reach the patient Therefore efficient system of quality control and an efficient inspection administration should always be there Regulation and quality assurance The drug regulatory authority is the agency that develops and implements most of the legislation and regulations on pharmaceuticals, to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. Key policy issues are: government commitment to drug regulation, including the need to ensure a sound legal basis& adequate human and financial resources; independence and transparency of the drug regulatory agency; relations between the drug regulatory agency and the ministry of health (MoH); stepwise approach to drug evaluation and registration; definition of current and medium-term registration procedures; Regulation and quality assurance commitment to good manufacturing practices (GMP), inspection and law enforcement; access to drug control facilities; commitment to regulation of drug promotion; regulation of traditional and herbal medicines; need and potential for systems of adverse drug reaction monitoring; International exchange of information. 2. Choice of drugs Principles of drug selection Selection process Selection criteria Use of essential drug lists Traditional medicine Essential drugs to meet the health needs of the population and

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The registration of safe, high quality and effective drugs are important. Other registration criterion may a competitive price or a restrictive attitude towards fixed combination The national essential drugs list has become the foundation of public drug supply in many countries

Selection of essential drugs

Drug selection o Preferably linked to national clinical guidelines o a vital step in ensuring access to essential drugs and in promoting rational drug use, because no public sector or health insurance system can afford to supply or reimburse all drugs that are available on the market. o Key policy issues are: o the adoption of the essential drugs concept to identify priorities for government involvement in the pharmaceutical sector, and especially for drug supply in the public sector and for reimbursement schemes; o procedures to define and update the national list(s) of essential drugs; selection mechanisms for traditional and herbal medicines Affordability Affordable prices are an important prerequisite for ensuring access to essential drugs in the public and private sectors. Key policy issues are: government commitment to ensuring access through increased affordability; for all drugs: reduction of drug taxes, tariffs and distribution margins; pricing policy; for multi-source products: promotion of competition through generic policies, generic substitution and good procurement practices; for single-source products: price negotiations, competition through price information and therapeutic substitution, and TRIPS-compliant measures such as compulsory licensing, early workings of patented drugs for generic manufacturers and parallel imports. 3. Supply Local production Supply system strategies and alternatives Procurement mechanisms Distribution and storage
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 The policies in production, procurement and distribution has to be defined Policies in supply what is feasible in short term and what is needed for sustainable systems Improvement of organization, management and financing is required Supply systems An essential component of strategies is to increase access to essential drugs is a reliable supply system. Key policy issues are: public-private mix in drug supply and distribution systems; commitment to good pharmaceutical procurement practices in the public sector; publication of price information on raw materials and finished products; drug supply systems in acute emergencies; inventory control, and prevention of theft and waste; Disposal of unwanted or expired drugs. 4. Rational use of drugs 1. Objective drug information 2. Rational use of drugs by health personnel 3. Rational use of drugs by consumers 4. Promotional activities Drugs should be used appropriately, safely and only when needed Irrational use includes: overuse, underuse and in appropriate use An NDP should specify major activities and responsiblilties to promote;

Dispensing and patient drug use The rational use of drugs means that patients receive medicines: a. appropriate for their clinical needs b. in doses that meet their individual requirements c. for an adequate period of time, and d. at the lowest cost to them and their community Irrational drug use by prescribers& consumers o is a very complex problem
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Rational prescribing

o It calls for the implementation of many different interventions at the same time. o Efforts to promote rational drug use should also cover the use of traditional and herbal medicines. Rational Drug USE development of evidence-based clinical guidelines, as the basis for training, prescribing, drug utilization review, drug supply and drug reimbursement; establishment and support of drugs and therapeutics committees; promotion of the concepts of essential drugs, rational drug use and generic prescribing in basic and in-service training of health professionals; the need and potential for training informal drug sellers; continuing education of health care providers and independent, unbiased drug information; consumer education, and ways to deliver it; financial incentives to promote rational drug use; regulatory and managerial strategies to promote rational drug use] 5. Economic strategies for drugs Ensuring stable and adequate financing of drugs is a major challenge Role of government in the pharmaceutical market Measures to encourage competition to keep prices as low as possible Public drug financing mechanisms Policies to maximize resources for drugs Measures to improve efficiency and cost effectiveness 6. Human resources development Role of health professions Implementation of NDP and achieving its objectives depend on hums therefore have a Human resources development plan The plan identifies Education , training and courses required National collaborating net works Motivation and continuing education
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 It includes the policies and strategies chosen to ensure that there are enough trained and motivated personnel available to implement the components of the national drug policy. Lack of motivation and appropriate expertise has been a decisive factor in the failure to achieve national drug policy objectives. Key policy issues are: government responsibility for planning and overseeing the development and training of the human resources needed for the pharmaceutical sector; definition of minimum education and training requirements for each category of staff; career planning and team building in government service; the need for external assistance (national and international). Drug financing It is another essential component of policies to improve access to essential drugs. Key policy issues are: commitment to measures to improve efficiency and reduce waste; increased government funding for priority diseases, and the poor and disadvantaged; promotion of drug reimbursement as part of public and private health insurance schemes; use and scope of user charges as a (temporary) drug financing option; use of and limits of development loans for drug financing; guidelines for drug donations 7. Monitoring and evaluation Monitoring and evaluation are essential components of a national drug policy, and the necessary provisions need to be included in the policy.

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Key policy issues are: explicit government commitment to the principles of monitoring and evaluation; monitoring of the pharmaceutical sector through regular indicator-based surveys; independent external evaluation of the impact of the national drug policy on all sectors of the community and the economy. 8. Research Operational research aiming at improving selection, procurement, distribution and use of on hand drugs Specific provisions for drug Research and development of new drugs Research is essential for health service and health care improvements Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy. An essential tool in assessing the drug policys impact on national health service systems and delivery An essential tool in studying the economics of drug supply An essential tool in identifying problems related to prescribing and dispensing, and in understanding the socio-cultural aspects of drug use. Key policy issues are: the need for operational research in drug access, quality and rational use; the need and potential for involvement in clinical drug research and development. 9. Technical cooperation among countries Common among countries How to develop a national drug policy ? o It should be developed through a systematic process of consultation o In this process four musts must be there o the objectives must be defined o priorities must be set o strategies must be developed and o commitment must be built

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 Formulation steps Organization of policy process Identifying and analyzing problems Setting goals and objectives Drafting the policy Circulating and revising the policy Obtaining formal indorsement for the policy Launching the policy Main Components of Sudan NDP Organization and drug and pharmacy control QA of medicines Drug supply RUD Pharmaceutical services in institutions Medicinal plants Technical and scientific cooperation with other countries, regional and international organizations Monitoring and evaluation Adoption of the NDP??

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