Rational Use of Drugs The India Perspectives and Contexts Dr Santanu K Tripathi MD, DM Professor of Pharmacology Burdwan Medical College, Bardhaman, INDIA firstname.lastname@example.org Presentation Plan History and definitions Problems and concerns in India Strategies / interventions recommended to improve the drug use situation Efforts and struggle in India towards changing the scene Much more needed Rational Drug Use – Historical Perspective Rational Use of Drugs SIR, -In common with other medical practitioners I have received a copy of the very helpful booklet' which sets out the relative cost of proprietary preparations and their equivalents. Recently, when wishing to prescribe a suitable preparation for threadworm infestation, I referred to the booklet to see whether there was any difference in cost between " elixir antepar " and the B.N.F. equivalent, elixir piperazine citrate. Discovering that the latter is considerably cheaper, I duly ordered that. However, the dispenser actually issued the proprietary, as that was the only preparation in stock. As a result, my earnest endeavour to play a part in the much-needed drive for economy was frustrated. What is the answer to this ? I imagine that this is by no means an isolated example. -I am, etc., - Halifax. Yorks. MALCOLM B. BUTLER. REFERENCE: N.H.S. Pharmaceutical Services: Costs of British National Formulary and Proprietary Preparations. July, 1958. 1536 DEC. 20, 1958 CORRESPONDENCE BRITISH MEDICAL JOURNAL What is Rational Use of Drugs? The rational use of drugs requires that patients receive medicines 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 the community. ---------- (WHO conference of experts, Nairobi 1985) What is Rational Use of Drugs? The rational use of drugs requires that 1. Receive medicines patients receive medicines - Availability Industry/Govt Policy appropriate to 2. Appropriate to clinical needs their clinical needs, - Diagnosis, Right Choice Physician Education 3. Dose/durn - individual need in doses that meet their - Individualisation Physician Education own individual requirements, 4. Lowest cost for an adequate period of time, - Affordability Industry/Govt Policy and at the lowest cost to them and the community. The 1. and 4. are in fact components of ACCESS Major Stakeholders in RUD People Care providers Industry Government University Irrational use of medicines – a global concern Irrational use of medicines is a major problem worldwide. WHO estimates that more than half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them correctly. The overuse, underuse or misuse of medicines results in wastage of scarce resources and widespread health hazards. Examples of irrational use of medicines #Use of too many medicines per patient ("poly-pharmacy") #Inappropriate use of antimicrobials, often in inadequate dosage, for non-bacterial infections #Over-use of injections when oral formulations would be more appropriate #Failure to prescribe in accordance with clinical guidelines #Inappropriate self-medication, often of prescription-only medicines #Non-adherence to dosing regimes - Joint NGO/WHO briefing presentations on Rational Use of Medicines, 60th World Health Assembly, 2007 RUD : Barriers and Problems in India Problems of availability and affordability Far too many products in the market Unethical promotion of products Irrational prescribing - quackery Lack of diagnostic facility Irrational Prescribing - Rampant - Use of drugs when no drug therapy is needed - Use of wrong drugs - Use of drugs with doubtful efficacy - Use of drugs with uncertain safety status - Unnecessary use of injections and antibiotics - Incorrect administration, dosages, or duration RUD : Barriers and Problems in India Lack of medicine literacy among people Poor adherence Inadequate or inappropriate dispensing Ignorant or ill-informed self-medication Inadequate control and poor enforcement No clear strategy by the government Affordability Problem and Self Medication Illness seen versus costs incurred - OTC Policy? Illness seen in Hospital costs Innovative hospital Prescription Illness seen Medicines by general GP costs practitioner Self-Medication Self-care not seen Self- treat- by medical service ment Medicines Cost transfer Unscientific FDCs Historical connection with the RUD movement in India – many battles fought in the Court of Law The publication of the National EDL may be considered to be an outcome of such legal battle. FDCs - Irrationalities Ranbaxy, others to scrap 60 drug combinations Leading drug makers - Ranbaxy, Cipla, Cadila, Nicholas Piramal and Wockhardt, will soon withdraw about 60 drug combinations from the market. The voluntary move comes a year after the Indian DRA had asked them to withdraw the „combination drugs' as they are "unnecessary" and may pose health hazards. The DCGI had banned 294 combination drugs sold under nearly 1,053 brand names from the market in June 2007. Since then, the pharma industry and the the drug authority have been locked in a legal battle. Source: P B Jayakumar & Joe C Mathew / Mumbai/New Delhi July 7, 2008. Business Standard Oct 12, 2008 RUD - Drug Quality and Safety For patients, quality means consistently and reliably meeting their needs. Controlling GMP requirements not enough - shift the paradigm from GMP control to risk control. This necessitates better interpretation of risk. RUD - Drug Quality and Safety Risk is the probability and severity of undesired effects, that can be measured through product performance. Risk-based assessment system focuses on evaluating critical quality attributes that are essentially associated with the molecule, formulation behaviour and manufacturing process in relation to the product performance. The issue oversimplified in India - emphasis on GMP only, that too with dual standards. Dual standards in GMP compliance The industry in India adopting dual standards in compliance to GMP requirements - separate facilities for domestic supplies and international supplies. How to ensure RUD? “Monitoring medicine use and using the collected information to develop, implement and evaluate strategies to change inappropriate medicine use behaviour are fundamental to any national programme to promote the rational use of medicines. A mandated national body to co-ordinate all activities and sufficient government funding are critical to success.” -- WHO Policy Perspectives on Medicines - Promoting rational use of medicines: core components, 2002 RUD Principles RUD means therapeutically sound and cost- effective use of medicines by health professionals and consumers achieved at all levels of the health system, and in both the public and the private sectors This is crucial both to reducing morbidity and mortality from communicable and non- communicable diseases, and to containing drug expenditure. RUD Principles RUD integrates two major principles: Use of drugs according to scientific data on efficacy, safety and compliance Cost-effective use of drugs within the constraints of a given health system RUD Parameters Parameters that are linked to RUD are Treatment guidelines Essential Drug list Perception of drug quality Medical education and culture Patient education Prescriber monitoring Incentives for providers and physicians Dispensing rights for physicians RUD Programme A sound RUD programme in any country has three elements: RUD strategy and monitoring -- implementing and monitoring a national strategy to promote RUD by health professionals and consumers, and securing responsible medicines promotion. RUD by health professionals -- developing and updating treatment guidelines, national essential medicines lists and formularies, and supporting training programmes. RUD by consumers -- supporting the creation of effective systems of medicines information, and empowering consumers to take responsible decisions regarding their treatment. Key interventions to promoting RUD as advocated by WHO Establishment of a multidisciplinary national body to coordinate policies on medicine use Use of clinical guidelines Development and use of national essential medicines list Establishment of drug and therapeutics committees in districts and hospitals Inclusion of problem-based pharmacotherapy training in undergraduate curricula Continuing in-service medical education as a licensure requirement Key interventions to promoting RUD as advocated by WHO Supervision, audit and feedback Use of independent information on medicines Public education about medicines Avoidance of perverse financial incentives Use of appropriate and enforced regulation Sufficient government expenditure to ensure availability of medicines and staff. RUD – Role of CSOs in India Civil Society Organisations championing the cause of RUD in India – KSSP, DSF, LOCOST, VHAI, AIDAN, DAF, CDMU-Bengal, CUTS, CDMU-Orissa, CHMU-Patna, CMAI, DSPRUD, NETRUM-India Strategies adopted by NGOs Law suits – PILs Awareness campaigns Workshops and Training Programmes Lobbying and Advocacy for Policy Changes Parliament questions Newsletters – Bulletins E-Networks and E-Conferences Research Activities Media coverage Drug Information Centre (DICs) The Lentin Commission Report 1986 Between January 21 and February 17, 1986, 14 patients died in J.J. Hospital, Bombay of acute renal failure after being administered adulterated glycerol which contained 18.5% diethylene Glycol (even 1% diethylene glycol can cause damage). The Lentin Commission probed into the deaths and succeeded in exposing the nexus between politicians, the Food and Drugs Administration (FDA) and the drug manufacturers. In the course of the hearing - between January and September „86, 582 formulations were found to be substandard with hardly any action taken against the offenders, many of whom were the "reputed" big companies. The Lentin Commission Report 1986 "These pages describe and illustrate the ugly facets of the human mind and human nature, projecting errors of judgment misuse of ministerial power and authority, apathy towards human life, corruption, Nexus and quid pro quo between unscrupulous license holders, analytical laboratories elements in the industries department controlling the award of rate contracts, manufacturers, traders, merchants, suppliers, the Food and Drugs Administration and persons holding ministerial rank." RUD Newsletters Newsletters and Bulletins NETRUM-India Newsletter BODHI CDMU Rational Drug Bulletin CMAI Rational Drugs Drug Disease Doctor Medico Friend Circle Bulletin TNMSC Times Bulletin of the Society for Rational Therapy Curricular Reforms Curricular reforms in medical and pharmacy education – challenges in implementation Trainings and workshops The Delhi Model Immense role played by DSPRUD Working mainly with care providers for capacity building and the government for policy reform – both national and state Addressing the Access Issue Rational procurement model – Tamil Nadu Medical Services Corporation (TNMSC) 1994 Access to low cost medicines India improves access to low cost medicines Mohali | Monday, Oct 13 2008 India has become a leading international player in generic medicines and has been able to considerably improve access to low cost medicines for the common people not only within India but in many developing countries. ---- Mr Ashok Kumar, Secretary, Department of Pharmaceuticals, Union Ministry of Chemicals and Fertilizers, India Source : http://news.webindia123.com/news/articles/India/20081013/1077565.html Regulatory Agency Changing in India! Restructuring/Strengthening of regulatory framework with proposed creation of an independent Central Drugs Authority (CDA) MOH&F - CDA - DCGI Bill Pending in Parliament Proposed Divisions in the CDA Pharmacovigilance Regulatory Affairs & Enforcement New Drugs & Clinical Trials Biological & Biotechnology Products Medical Devices and Diagnostics Imports Organizational Services Training and Empowerment Quality Control Affairs Legal and Consumer Affairs Parliamentary panel rejects proposal for new CDA The Parliamentary standing committee on health and family welfare has virtually shot down the proposal for a new Central Drug Authority (CDA) and instead recommended setting up of a 'central drug administration„. Who could change the scenario ? Government – Central and State Universities and Academic Councils Professional Societies Civil Society Organisations Lay Press and Media Court of Law Industry – Corporate Social Responsibility Hospitals – Administrative Authority Analogy with Indian understanding that precedes the WHO concept of RUD “Eternal vigilance is required to ensure that the health care system does not get medicalised, that the doctor-drug producer axis does not exploit the people and that the 'abundance' of drugs does not become a vested interest in health.” - ICMR/ICSSR Health for All Report, 1981 Thank You!
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