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National Medicines Policies & Monitoring Implementation Richard Laing EMP/MIE With materials developed by Edelisa Carandang Department of Medicines Policy.

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Presentation on theme: "National Medicines Policies & Monitoring Implementation Richard Laing EMP/MIE With materials developed by Edelisa Carandang Department of Medicines Policy."— Presentation transcript:

1 National Medicines Policies & Monitoring Implementation Richard Laing EMP/MIE With materials developed by Edelisa Carandang Department of Medicines Policy and Standards

2 Department of Essential Medicines & Pharmaceutical Policy 2 |2 | Objectives zReview the history of NDPs zDiscuss the background to NDPs zList the Components of a NDP zReview actors involved in the NDP process zDebate characteristics of an NDP zDiscuss the Global Pharmaceutical Market zDiscuss Monitoring Implementation of NMPs

3 Department of Essential Medicines & Pharmaceutical Policy 3 |3 | History of National Drug Policies z1985 Nairobi Conference of Experts on rational Use of Drugs z1987 Working group of Experts to draft guidelines for NDPs z1988 Guidelines for NDPs released 1995 Expert Committee on NDPs met report issued z2002 New Guidelines published

4 Department of Essential Medicines & Pharmaceutical Policy 4 |4 | Background to NDPs zNeed for common framework to coordinate many different actors in the pharmaceutical field: zThese include regulators (quality, safety and efficacy), producers (local & international), users (prescribers & consumers), health planners & managers, health finance authorities and researchers. zEach have valid interests in the field which may be contradictory or supportive zInvolves both public & private sectors

5 Department of Essential Medicines & Pharmaceutical Policy 5 |5 | Components of a NDP zLegislation, Regulation and Guidelines zSelection of Drugs zSupply (incl. procurement & production issues) zQuality Assurance zRational Drug Use zEconomic Strategies for Drugs zMonitoring & Evaluation of NDPs zResearch zHuman Resources Development zTechnical Cooperation among Countries

6 Department of Essential Medicines & Pharmaceutical Policy 6 |6 | Overview of Components zEach component has a crucial part in the overall policy! zEmphasizing one component at the expense of others, weakens the entire policy zMany different actors are involved. Some are outside MoH, some outside government, some outside country zMeans that NDP planners need to be aware, though not expert, in all areas!

7 Department of Essential Medicines & Pharmaceutical Policy 7 |7 | Many Actors Involved! Some pro, some against! zDoctors, specialists, public/private zPharmacists retail and manufacturing zLocal and international producers, importers zConsumers/Patients zMedia zRegulators zInsurance Companies zEtc, Etc,

8 Department of Essential Medicines & Pharmaceutical Policy 8 |8 | Characteristics of a National Medicines Policy z Essential part of health policy, must fit within the framework of a particular health care system. z Goals should be consistent with broader health objectives z Health policy and the level of service provision in a particular country are important determinants of drug policy and define the range of choices and options. z Implementation of an effective drug policy promotes confidence in and use of health services.

9 Department of Essential Medicines & Pharmaceutical Policy 9 |9 | Global Pharmaceutical Market 2008 $740 billion Source www.ims-global.com/insight/report/global/report.htm US, Europe & Japan 78% 1.3% Market projected to grow 7.8% annually 5% Situation in 2002

10 Department of Essential Medicines & Pharmaceutical Policy 10 | Monitoring Implementation of NMP's zConcepts on pharmaceutical assessment/monitoring zThe WHO process on assessing and monitoring pharmaceutical situation zUndertaking survey, sampling and concepts on indicators

11 Department of Essential Medicines & Pharmaceutical Policy 11 | Who can use the results from assessment and monitoring? zCountries - focus action, prioritize, measure achievement zNational policy-makers zInternational agencies zProfessional groups, NGOs and academia zHealth facilities to be aware of institutional problems & improve situations

12 Department of Essential Medicines & Pharmaceutical Policy 12 | Develop implementation plans and identify strategies & interventions based on data/information on: availability, affordability, pricing, drug use and regulatory profile, TRIPS, drug management situation. Support implementation of activities and advise in the execution of work plans Indicator-based tools to evaluate structures, processes, outcomes of in countries WHO Evidence-Based Planning and Interventions Guiding Country Works in Medicines WHO Evidence-Based Planning and Interventions Guiding Country Works in Medicines

13 Department of Essential Medicines & Pharmaceutical Policy 13 | National Medicines policy process Formulation and Updating NMP u Identify problems u Define objectives u Develop strategies Monitoring & evaluation u Develop system u Identify tools u Use results Implementation u Develop and execute action plan based on available resources u Prioritize and implement strategies

14 Department of Essential Medicines & Pharmaceutical Policy 14 | WHO hierarchical approach to monitoring and assessing pharmaceutical situations Level I Core structure & process indicators Level II Core outcome/impact indicators & household survey Level III Indicator tools for specific components of the pharmaceutical sector PricingTraditional medicine HIV/AIDS Assessing regulatory capacity TRIPS Systematic survey Questionnaire (Health Officials) Level I Questionnaire/rapid assessment/checklist Arrays achievement & weaknessess, illustrate sectoral approaches Level II Comprehensive monitoring of pharmaceutical strategy outcome and impact Measures attainment of objectives Level III More detailed indicators for monitoring and evaluating specific areas/components

15 Department of Essential Medicines & Pharmaceutical Policy 15 | Why is it important to use indicators? zStandard indicators facilitates: ycomparing the performance of facilities, districts, urban vs rural, private & public sector, overall situations in countries yseeing trends over time ysetting target

16 Department of Essential Medicines & Pharmaceutical Policy 16 | Level I indicators: structure and process indicators zRegular survey questionnaire yInexpensive process to get information across countries yCan be done repeatedly/regular period yAutomated questionnaire and data encoding processing zContents yNational Medicines Policy yRegulatory system (marketing authorization, licensing, regulatory inspection, etc) yMedicines supply system, medicines financing, production and trade yRational use of drugs

17 Department of Essential Medicines & Pharmaceutical Policy 17 | Level II- facility outcome and impact indicators: WHO Operational Package for Monitoring and Assessing County Pharmaceutical Situations" zSystematic survey zIndicators yon availability, stock out, record keeping and expiry of key drugs yconservation conditions and handling of medicines yaffordability (child and adult moderate pneumonia and option for other disease condition ydrug prescribing, dispensing, patient knowledge zpractical/operational system of managing a systematic survey and resources z17 survey forms-public health facilities, public pharmacy/dispensary, private pharmacy, warehouses zmanual calculation and automated system for descriptive analysis

18 Department of Essential Medicines & Pharmaceutical Policy 18 | Generic prescribing and substitution regulations in 1999 and 2003 Generic Prescribing

19 Department of Essential Medicines & Pharmaceutical Policy 19 | Generic prescribing at public sector

20 Department of Essential Medicines & Pharmaceutical Policy 20 | Measuring access to essential medicines ( Household Survey) zLevel I and Level II- facility surveys do not measure access from the patient/consumer perspective. zOnly household surveys can provide population-based information about how pharmaceutical policies affect the well- being of individuals.

21 Department of Essential Medicines & Pharmaceutical Policy 21 | Importance of household survey zHousehold situations yHow they access their medicines, where they get them yHow much they pay zIdentify access and affordability in relation to socio economic indicators, barriers zExamine use of medicines (acute and chronic diseases) zPerceptions on access, use and quality; handling of medicines

22 Department of Essential Medicines & Pharmaceutical Policy 22 | Indicators: (few examples) Affordability zAverage household medicine expenditures as % of total/non- food/health expenditures zAverage household medicine expenditures for a reported illness (acute, chronic, by illness) z% of households with at least partial medicine insurance coverage Mixed Indicators of Access (availability) zPercent of households reporting a serious acute illness who sought care outside but did not take any medicine. zPercent of households who do not have at home a medicine prescribed to a chronically ill person.

23 Department of Essential Medicines & Pharmaceutical Policy 23 | Indicators: (few examples) Rational Use of Medicines zPercent of antibiotics kept for future use zPercent of household medicines with adequate label/ adequate primary packaging Perception of quality zPercent of respondents who agree that quality of services at their public health care facility is good / quality of services by private provider is good zPercent of respondents who agree that brand name medicines are better than generics/ imported medicines are of better quality than locally manufactured medicines.

24 Department of Essential Medicines & Pharmaceutical Policy 24 | Current issues on household survey process zChallenge to use population based data to policy evaluation, development and planning zSegregation by socio economic profile zNo basic guideline standard???on household survey yWhat is a household / who is a household member ySampling yRecall periods- ( number of days, self report, caregivers) yType of survey (general population, disease based survey)

25 Department of Essential Medicines & Pharmaceutical Policy 25 | Level III Indicators zSystematic survey and monitoring yDrug price survey and monitoring yWHO/INRUD RDU indicators zRapid assessment yGlobal survey on Paediatrics medicines yQuestionnaire on public sector medicines procurement and supply management systems in countries yAssessment of regulatory capacity

26 Department of Essential Medicines & Pharmaceutical Policy 26 | Sampling issues for systematic survey zFollow specific procedures to minimize selection bias and is representative of the reference population zA balance between what is desirable and what is feasible- smallest one with a degree of precision

27 Department of Essential Medicines & Pharmaceutical Policy 27 | Sampling Recommendation for Level II facility survey zSampling (stratification, random) y5 regions/districts x1 should be among the lowest income generating areas x1 should be the largest or capital city x3 others should be randomly selected y30 facilities each y30 cases per facility zSystematic sampling zNon probability / purposive/ quota sampling

28 Department of Essential Medicines & Pharmaceutical Policy 28 | The household survey sampling scheme (non probability, convenient z5 regions in the country zFrom each region select 6 public health facilities (30 reference public health facilities) zIn each of reference facility, select 30 households (900 households)

29 Department of Essential Medicines & Pharmaceutical Policy 29 | Is the sampling frame valid? (clustering in drug supply or drug use data) zGeographic Characteristics yAdministration and drug supply system yEpidemiologic or socio-economic differences zHealth Facility Characteristics yDifferences in management yPeer norms and collective habits zProvider Characteristics yTraining, knowledge, clinical experience yEconomic incentives yIndustry pressure Result: Effective sample size is reduced

30 Department of Essential Medicines & Pharmaceutical Policy 30 | Error due to simple random sampling Margin of error Sample size

31 Department of Essential Medicines & Pharmaceutical Policy 31 | Who can be trained to do the survey? zPhysicians, nurses, pharmacists or paramedical staff zHealth ministry/department staff and temporary employees (health related background and experience) zdata collectors from different parts of the country (language differences)

32 Department of Essential Medicines & Pharmaceutical Policy 32 | Preparing and implementing systematic survey zAdministrative preparation: yCoordinating with WHO, ministry/department of health, public health facilities, private drug outlets, warehouses yMaking logistic arrangements and budget allocations zTechnical requirements: yTailoring the tool-specific items of the survey forms, e.g. key basket of medicines, treatment guidelines, etc. yTraining data collectors to carry out the survey and use the survey and summary forms yAnalyzing and computing the data yPreparing a report and using result

33 Department of Essential Medicines & Pharmaceutical Policy 33 | Pharmaceutical indicators zVariables that measure situations and change zNumerical ( numbers, percentage, or averages) Binomials (yes and no) zLinked to an important input, process, or outcome zWell-established indicators can be adapted/ modified to reflect the realities zField test

34 Department of Essential Medicines & Pharmaceutical Policy 34 | Indicator allows comparison

35 Department of Essential Medicines & Pharmaceutical Policy 35 | Monitoring if there is progress or none

36 Department of Essential Medicines & Pharmaceutical Policy 36 | Setting target Ministry Target = 90%

37 Department of Essential Medicines & Pharmaceutical Policy 37 | Indicator measure: group norm Example: % antibiotic prescribing (logical value is <30%) Easy for region/facilities to relate to peers Norms may be wrong

38 Department of Essential Medicines & Pharmaceutical Policy 38 | Summarizing indicator measures zPercentage: yes or no over total zMeasures of central tendency yMean: average value, sensitive to outliers, weighed toward skewed value, best summary of normally distributed values yMedian: middle value, resistant to outliers, good summary of any distribution Equivalent if data are normally distributed zMeasure of variation y25 th and 75 th percentiles: boundaries of middle half of values, good summary of the overall spread of values, better summary of skewed data

39 Department of Essential Medicines & Pharmaceutical Policy 39 | Indicator measure: Ideal/logical values Logical value exist for some zLogical value (100%-adequate labelling, meds dispensed, adherence to STG, availability of medicines, generic, adequacy of storage; 0 days of stock out,) Others need further studies z affordability ( economic profile) zAntibiotic use and injection, meds prescribes are more complex- are (<30, <20 and < 2 and can be controversial) yOptimal value largely depend on disease pattern, policies and treatment G/L and vary from country to country yThese values can be calculated empirically

40 Department of Essential Medicines & Pharmaceutical Policy 40 | Connecting Survey Results and Interventions

41 Department of Essential Medicines & Pharmaceutical Policy 41 | The way forward on country monitoring zEvidence through systematic but feasible data collection process is necessary in policy making and activity implementation. This should include population based information zShould demonstrate that in the long run regular monitoring and evaluation is not difficult and can be done in a cost efficient manner zPortion of country support budget and project grants should be allotted to monitoring and evaluation using indicators zTimely report and information/data sharing

42 Department of Essential Medicines & Pharmaceutical Policy 42 | z THANK YOU


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