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CHAPTER 5 DRUGS, BIOLOGICALS, MEDICAL EQUIPMENT AND INFRASTRUCTURE

CHAPTER 5 DRUGS, BIOLOGICALS, MEDICAL EQUIPMENT AND INFRASTRUCTURE. Ts. Nguyễn Thị Kim Chúc. UPDATE ON MAJOR POLICIES (1). Quality of pharmaceuticals:

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CHAPTER 5 DRUGS, BIOLOGICALS, MEDICAL EQUIPMENT AND INFRASTRUCTURE

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  1. CHAPTER 5DRUGS, BIOLOGICALS, MEDICAL EQUIPMENT AND INFRASTRUCTURE Ts. Nguyễn Thị Kim Chúc

  2. UPDATE ON MAJOR POLICIES (1) Quality of pharmaceuticals: • Circular43/2010/TT-BYT of the MOH regulating the roadmap for implementation of the principles, standards of Good Pharmaceutical Practice (GPP); location and scope of operations of retail drug outlets. • Decision issuing the Action plan of the Government on development of Traditional medicine in Vietnam to the year 2020, including contents on standardizing traditional pharmaceuticals. • Circular 16/2011/TT-BYT Regulating principles for production of herbal medicines and the roadmap for applying Good manufacturing practice (GMP) for herbal medicines.

  3. UPDATE ON MAJOR POLICIES (2) Drug prices: • Circular 15/2011/TT-BYT regulating organization and activities of retail pharmacies at hospitals (replaces MOH Decision 24) Domestic drug and medical equipment production: • Prime Ministerial Decision 81/2009/QĐ-TTg approving the Master plan for development of the pharmaceutical and pharmacochemical industries to 2015, vision to 2025.5 • Decision 49/2010/QĐ-TTg approving the list of high technology sectors that are prioritized for investment in development and the list of high tech products that are encouraged for development (including medical equipment)

  4. UPDATE ON MAJOR POLICIES (3) Blood safety • Decision 2331/2010/QĐ-TTg issuing the list of National Health Target Programs for 2011-2015, including a project on blood safety • Draft Decision of the Prime Minister approving the Strategy for the Development of voluntary blood drives 2009-2015 and vision to 2020. Vaccines • Decision 14/2008/QĐ-TTg approving the master plan for development and application of biotechnology in Vietnam to the year 2010, including development of quality vaccine and biological production technology. • 23/2008/QĐ-BYT issuing detailed professional regulations on use of vaccines, medical biologicals in prevention and treatment.

  5. UPDATE ON MAJOR POLICIES (4) Medical equipment and infrastructure • Prime Minister decided to establish a National Steering committee on medical equipment headed by the Deputy Prime Minister, with Minister of Health as deputy director (831/2010/QĐ-TTg) • Decision 184/2011/QĐ-TTG allocating the 2010 plan for use of capital mobilized through treasury bonds, including 2 projects 47/2008/QD-TTg and 930/2009/QĐ-TTG developing infrastructure of district, regional, specialist and mountainous province hospitals.

  6. IMPLEMENTATION OF TASKS • Attention: Blue letters indicate lack of information to conclude on progress. • Red letters indicate the task was not yet implemented

  7. Drug quality management Implemented Difficulty, impediments, not yet implemented Although production facilities meet GMP, retailers and hospitals are not obliged to only sell drugs that meet GMP standards. Not yet an inter-ministerial committee to control fake drugs, substandard drugs. Workforce for inspection and checking on drug quality is understaffed. • 63/64 provinces have pharmaceutical quality testing labs. • GMP-WHO implemented in 100% of facilities producing modern drugs in Vietnam. • Circular 16/2011/TT-BYT regulating the production of herbal medicines following GMP standards for herbal medicines. • In the process of implementing the roadmap for application of GPP. • Draft decree on penalties for administrative violations in the area of pharmaceuticals, cosmetics and medical equipment.

  8. Drug price management Implemented Difficulties, impediments, not yet implemented Not yet developed policy on generic drugs. Not yet applying reference pricing for controlling drug prices Not yet applying capitation or case mix payments widely. Health insurance not yet applying information technology effectively to control drug prescribing in hospitals. • Circular 15/2011/TT-BYT regulating organization and operations of retail pharmacies in hospitals. • Currently requesting feedback for revising Joint Circular 10 guiding competitive bidding for pharmaceuticals. (unclear whether revisions in the direction of national procurement, or whether there are provisions for making transparent any conflicts of interest in procurement)

  9. Rational and safe use of drugs Implemented Difficulties, impediments, not yet implemented Preliminary study by the Medical Services Administration in2009 fond that the Drug and Therapy Committee activities were weak in the area of appropriate choice of drugs and surveillance of pharmaceutical use. Microbiology labs are not being fully used to contribute to appropriate choice of drugs. Excessive community use of antibiotics not prescribed by a doctor has not yet been controlled.. MOH has issued a decision to establish a program for surveillance of antibiotic use and antibiotic resistance, but lacks funding for operations.. Still lacking effective mechanism to ensure proper compliance with prescription regulations.. • 100% of public hospitals have established Drug and Therapy Committees (08/1997/BYT-TT) • In the GARP project, data are being collected on the extent of antibiotic resistance and consumption of antibiotics. • The MOH has issued an official document regarding the need for special care in prescribing drugs and use of drugs on the list of 59 drugs under surveillance for side effects. • The MOH is developing an updated list of essential drugs (Version 6) Unclear whether cost-effectiveness criteria or standard protocols are being used to inform choice of drugs) • Vietnamese Drug Formulary 2009-2010 being updated. • Dec/2010 Workshop on strengthening the drug safety and pharmacovigilance network.

  10. Rapid development of pharmaceutical and medical equipment industries Implemented Difficulties, impediments, not yet implemented Vietnam is still dependent on importation of pharmaceutical ingredients and packaging as inputs for the pharmaceutical industry. At many enterprises, the packaging technology does not yet meet high quality standards for proper preservation of pharmaceuticals. Pharmaceuticals • Master plan for development of the pharmaceutical industry to 2015, vision to 2025 (81/2009/QĐ-TTg) • Developing detailed plans for development of the pharmaceutical industry.. Equipment • List of high technology that is prioritized for development, and list of high tech products that are encouraged to be produced includes medical equipment (49/2010/QĐ-TTg) • Review of facilities meeting conditions for production of medical equipment. • Workshop “Promoting domestic production of medical equipment- Integration and Development “ (June/2010) • Preparation of plan to develop medical equipment standards in 2011 and the 2011-2015.

  11. Ensuring blood safety Implemented Difficulties, impediments, not yet implemented Contents of the Blood safety project have not yet been issued, cannot yet assess whether it addresses priority problems. • Prime Minister decided to create a Blood safety component project as part of the National Health Target Program 2011-2015. • Draft Decision approving the Strategy for development of voluntary blood drives 2009-2015, vision to 2020.

  12. Improve quality of vaccines; Increase ability to supply vaccines Implemented Difficulties, impediments, not yet implemented Challenges: Ensuring the current funding needs, and mobilizing additional funding to meet the needs of rising costs and introduction of new vaccines. Introducing new vaccines is slow compared to need (Hib, Rubella, mumps, rotavirus) Need for development of new vaccines for newly emerging diseases ((SARS, H1N1, H5N1), lacks funding for research • Master plan for development and application of biotechnology in Vietnam to 2010 (including development of vaccine production) (14/2008/QĐ-TTg) • 4/6 vaccine producers int he country meet GMP-WHO standards. • 23/2008/QĐ-BYT issuing detailed technical regulations on use of vaccines and biologicals in prevention and treatment

  13. Strengthen effectiveness of investments, use of medical equipment, ensure quality of equipment Implemented Difficulties, impediments, not yet implemented Not yet developed database on medical equipment, situation of maintenance of medical equipment Not yet research on health technology assessment. Not yet program on ensuring adequate qualified human resources to maintain, repair medical equipment. Not yet mechanism to ensure adequate funds for medical equipment maintenance Not yet mechanism for establishing center to ensure maintenance, calibration, repairs of medical equipment • National Steering committee on medical equipment set up (831/2010/QĐ-TTg) • Preparing to issue national policy on medical equipment for the period after 2010. • Preparing Decrees on management of medical equipment. • Developing draft national standards for medical facilities. • MOH is reviewing implementation of the investment plan for facilities under MOH management.

  14. Continue to invest in developing medical facilities at all levels Implemented Difficulties, impediments, not yet implemented No information yet on total hospitals receiving investments. No evaluation of the effectiveness/impact of these investments on health, access to quality health services. • By 5/2009, 3750 billion VND had been mobilized from issuing treasury bonds in 2008 for investing in 425 district hospitals/ health centers and some regional polyclinics, meeting 100% of plan • Decision 184/2011/QĐ-TTG allocated the plan for use of treasury bond mobilized funds for 2011, including the 2 projects 47 and 930 investing in infrastructure of district and regional hospitals, specialist and mountainous provincial hospitals.

  15. Ensure treatment of medical waste according to regulations Implemented Difficulties, impediments, not yet implemented . • MOH submitted to the Prime Minister for approval the Comprehensive project for medical waste treatment 2011-2015 • World Bank has approved a credit for medical waste treatment support • Approval of projects for wastewater treatment of facilities directly under the Ministry of Health management. • The MOH is coordinating collection of reports on the situation of wastewater treatment in hospitals at the district level and proposals for appropriate technology models. • The MOH has developed guidelines for management of CHS waste

  16. Thank you!

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