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Understanding and conceptualising irrational prescription pattern for antimicrobials in Nigeria: economic and other implications Obinna Onwujekwe Professor of Pharmaco-economics and Pharmaco-epidemiology College of Medicine, UNEC, Enugu Prescription pattern in Nigeria: abuse and implications for the health of Nigerians Two main disciplinary domains 1. PHARMACO-ECONOMICS 2. PHARMACO-EPIDEMIOLOGY –They are new emerging areas of study –Both were conceived in the 1980s. –Both deal with health outcomes –Both are linked, but are individual disciplines. –Central goals are improving drug prescribing, provision and utilisation PHARMACO-ECONOMICS • It is the systematic assessment of the costs and consequences (outcomes) of pharmaceutical products and services • Research in this field identifies, measures and compares the costs (i.e. the resources consumed) and outcomes (clinical, economic, humanistic) of pharmaceutical products and services Components of Pharmaco-economics • Costs and outcomes measurements • Economic techniques that are used in pharmacoeconomics for decision making • Economic and non-economic techniques for measuring the burden of disease and quality of life, so that we will know whether our patients are improving in ways that clinical parameters cannot easily measure. Principles • Central theme for maximising the pharmaceutical services is the ECHO model – Economic; Clinical Science; Humanistic outcomes • The optimal decisions for pharmaceutical products and services are those which balance the ECHO model ECHO principle • Treating patients with pharmaceuticals has to be a balance of good clinical science, economics, and outcomes • For example, the best drug therapy for a patient from a clinical point of view may not be the "best" option overall if the patient either cannot afford to take it (e.g. economic), of if there lives are so disrupted by the treatment that they refuse to comply with it (e.g. humanistic outcomes) (Cosler, 2002). ECHO in practice • Economic principles: – Cost minimisation analysis (CMA); Cost-effectiveness analysis (CEA), Cost-benefit analysis (CBA), Cost-Utility analysis (CUA). – Measurement of outcomes: Natural units (deaths averted, cases prevented, Quality Adjusted Life Years (QALYs), Disability Adjusted Life Years (DALYs), etc); Monetary units in terms of willingness to pay as a valuation of benefit. • Humanistic principles: Quality of life measurements, talking to the patients • Clinical: Symptoms, Signs, investigations etc PHARMACOEPIDEMIOLOGY • Specialised area specialised area of epidemiology that uses various research tools to determine the best pharmaceutical treatments in a population. • Traditionally called drug epidemiology • Investigates the use of drugs and adverse effects of drug therapy in populations to improve the individual patient's regimen with respect to effectiveness and safety (Heidelberg University). Definition • It is the application of epidemiological reasoning, methods and knowledge to the study of the uses and effects (beneficial and adverse) of drugs in human populations (Trinity College, Dublin). • It examines the population and the diseases for which drugs are used to treat, and the problems and benefits, which these medications may bring. • Such research is critical for assuring that drugs meet health needs and are used safely, optimally and efficiently. Components: • • • • • • Prescribing patterns Rational Drug use Adverse drug reactions Drug resistance Drug interactions Pharmacovigilance - It is the process of identifying and then responding to safety issues about marketed drugs • Post-marketing drug surveillance Antimicrobial resistance • The evolving public health threat of antimicrobial resistance (AMR) is driven by both appropriate and inappropriate use of anti-infective medicines for human and animal health and food production (WHO, 2012). • Today many common and life threatening infections are becoming difficult or even impossible to treat Rational use of drugs • It requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community (WHO, 2001) Case study of irrational prescribing: Treatment of malaria in Enugu state • Study in Enugu urban and Udi LGA • Findings – 22.4% of febrile patients for whom treatment was sought received an ACT – 57.8% of the ACTs were dispensed in the correct dose – 37% of patients received SP in public facilities and 39% in drug retailers – 14% of patients received artemisinin monotherapy – Most of the facilities had ACTs in stock and artemisinin-based monotherapy in stock Findings CONTD • 0.7% of febrile patients received malaria diagnostic test at the health facility (3% in public facilities) • Many health workers did not know nationally recommended treatment for uncomplicated malaria and the correct dosage • 28.6% of HW knew the regimen for AL in a child aged 2yrs • These variables varied by location and type of facility • Some providers, especially in the rural areas do not stock ACTs because people do not ask for them. • Some patients still ask for Chloroquine because they think it still effective in treatment of malaria. Fawibe et al (2012). Drug prescription pattern for asthma among Nigerian doctors in general practice • About 48% of the doctors had never attended any form of update training on asthma management • Only 16.3% attended update training on asthma within the last year preceding the study. • Only 16.4% were able to mention any correct guideline on asthma management • Poor anti-asthma prescribing behavior among doctors is associated with a low level of participation at update training on asthma management and poor awareness of asthma guidelines Adebayo ET, Hussain NA (2012).Pattern of prescription drug use in Nigerian army hospitals. • 90.5% of prescribers were. aware of the existence of national essential drugs list • 58.1% of them did not use it as basis of prescriptions. • Only 12.1% of prescribers could accurately detail the 5 steps of rational prescribing. • The pattern of prescription drug use in Nigerian Army hospitals is characterised by high number of drugs per prescription, high rate of antibiotic usage and unscientific prescription by doctors. • There is a need for further education and research on rational drug use among prescribers in Nigerian military health facilities. Irrational use of drugs (WHO, 2012) includes: • Over prescription (too many drugs) • Under prescription • Prescription and dispensing of unnecessary drugs • Overtly expensive drugs when there are inexpensive alternatives (branded vs generics) • Prescription of inappropriate drugs Why over prescription by doctors and other healthcare providers (WHO, 2012)? • Because of fear of treatment failure • Lack of knowledge of the local AMR situation • Real or perceived patients’ expectations • Drug company promotional efforts • Personal financial gain Consequences • Leads to high levels of health and economic burden – Increased burden of diseases – High level of costs due to diseases, which could become catastrophic • Costs to the health system (providers, individuals, households, the government etc) Cause and effect (WHO, 2012) • Bacteria and other microbes react to drugs that are used as treatment by becoming resistant to them sooner or later – this natural process adaptation means that the effective lifespan of antibiotics and other antimicrobials is limited • Unnecessary use and inappropriate use of antibiotics favours the emergence and spread of resistant bacteria Common examples of drug resistance to antimicrobials (WHO, 2012) • Multidrug-resistance tuberculosis (TB) • Malaria – resistance exists for all classes of anti-malarials • HIV infection – resistance rates to anti-HIV drug regimens range from 10 – 20% in Europe and USA. • Antibiotic-resistant bacteria The 2001 WHO Global Strategy for the containment of AMR • Reducing the disease burden and spread of infection • Improving access to appropriate antimicrobials • Improving the use of antimicrobials • Strengthening health systems and their surveillance capabilities • Enforcing regulation and legislation • Encouraging the development of appropriate new drugs and vaccines Five domains targeted for AMR containment (WHO, 2001) • Surveillance of antimicrobial resistance and use • Rational antimicrobial use and regulation • Antimicrobial use in animal husbandry • Infection prevention and control • Fostering innovations • Political commitment Six-point policy package for tackling antimicrobial resistance (WHO, 2011) • All countries should – Commit to a comprehensive, financed national plan with accountability and civil society engagement – Strengthen surveillance and laboratory capacity – Ensure uninterrupted access to essential medicines of assured quality – Regulate and promote rational use of medicines in animal husbandry and to ensure proper patient care – Foster innovations and research and development of new tools Organisational frameworks for promoting rational use of drugs • International conference for the improved use of medicines (ICIUM) – once every seven years • International Network for the Rational use of drugs - INRUD • International Society for Pharmaco-economics and outcomes Research (ISPOR) • Etc etc The Nigerian Health System and rational drug use • One of the worst in the world • Ranked 187 out of 191 in 2000 • Now second worst in terms of maternal mortality • Is not primed to achieve MDGs and Universal Coverage • Role of healthcare providers is critical WHAT DO WE MEAN BY A HEALTH SYSTEM A health system is the sum total of all the organisations, institutions and resources whose primary function is to improve health. The term includes all levels from service delivery, to policy making and implementation. A Health system needs staff, funds, information, supplies, transport, communication and overall guidance and direction. It needs to provide services that are responsive and financially fair, while treating people decently. The Nigerian health system should achieve Universal Health coverage • Providing financial risk protection for all (100%) from the costs of health care – Everybody should have access to pre-payment mechanisms such as Health insurance • Enabling access to needed health care for all (100%) - financial and geographic access – Rational drug use and prescription for all – Optimal quality health services to all Four target indicators proposed by WHO to M&E progress to achieving universal coverage • Total health expenditure should be at least 4% 5% of the gross domestic product • Out-of-pocket spending should not exceed 3040% of total health expenditure • Over 90% of the population is covered by prepayment and risk pooling schemes • Close to 100% coverage of population with social assistance and safety-net programmes Is Nigeria on track to achieve Universal Health coverage (UHC)? • Nigeria decides! – Total health expenditure is 0.7% of GDP instead of the recommended 4% - 5% – Out-of-pocket spending is more than 60% of total health expenditure instead of the recommended 30-40% – Less than 5% the population is covered by prepayment and risk pooling schemes instead of the recommended 90% – Less than 2% coverage of population with social assistance and safety-net programmes instead of the recommended 100% • All hands at the federal, state and LGA levels must be on deck References and further reading • • • • • • • Adebayo ET, Hussain NA. Pattern of prescription drug use in Nigerian army hospitals. Ann Afr Med. 2010 Jul-Sep;9(3):152-8. Fawibe AE, Onyedum CC, Sogaolu OM, Ajayi AO, Fasae AJ. Drug prescription pattern for asthma among nigerian doctors in general practice: A crosssectional survey. Ann Thorac Med. 2012 Apr;7(2):78-83. WHO (2001) WHO Global strategy for the containment of antimicrobial resistance. Geneva: World Health Organization WHO (2001). How to develop and implement a national drug policy. 2nd ed. Geneva: World Health Organization WHO (2011). World Health Day 2011: Policy briefs. Geneva: World Health Organization World Health Organization (2012).The evolving threat of antimicrobial resistance: options for action. Geneva: World Health Organization Mangham L, Cundill B, Ezeoke O, Nwala E, Uzochukwu BSC, Wiseman V, Onwujekwe O (2011). Treatment of uncomplicated malaria at public health facilities and medicine retailers in south-eastern Nigeria. Malaria Journal, 10:155