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Category: Volume 06 Issue 05 May 2018
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Title: Blood and Blood Products Regulation in Bhutan: Progress and Challenges

Author: Pelden Chejor

 DOI:  https://dx.doi.org/10.18535/jmscr/v6i5.182

Abstract

Bhutan is a small Himalayan Kingdom situated between the two giants of the world, India and China. The road to modern healthcare system in Bhutan began in 1961 coinciding with the first Five Year Plan. Healthcare service in Bhutan is provided free by the government. The existing 27 blood banks in the country are located within the hospital setting under the laboratory sections. The Blood and Blood Products Regulation (BBP Regulation) of Bhutan was launched on 14 June 2016. Blood and Blood Products (BBPs) are regulated by the Drug Regulatory Authority (DRA).

Safe blood, safe donor and safe transfusion are the three elements of blood safety. BBPs are potential source of infections and other adverse events although millions of lives are saved each year through blood transfusions. The BBP Regulation of Bhutan, 2016 is the guiding regulatory tool to ensure the quality and safety of BBPs in the country. The regulatory provisions includes requirement for premise, personnel, equipment and quality assurance system for blood centers (BC) and blood storage centers (BSC) among others.

The DRA is faced with several challenges while implementing the BBP Regulation due to lack of expertise in regulating BBPs. Similarly, the existing blood banks in the country are not able to meet the requirements of BBP Regulation. Ministry of Health and relevant agencies should collaborate to comply with the BBP Regulation and ensure quality BBPs for safer transfusions. This article attempts to describe the key components of BBP Regulation, 2016 and highlights the progresses and challenges of the BBP Regulation in Bhutan.

Keywords: Drug Regulatory Authority, Regulation, Transfusions, Blood and Blood Products, Bhutan.

References

  1. National Statistics Bureau. Statistical Yearbook of Bhutan. National Statistics Bureau, Thimphu, Bhutan. National Statistics Bureau, Thimphu, Bhutan, 2017.
  2. National Statistics Bureau. National Accounts Statistics. National Statistics Bureau, Thimphu, Bhutan. National Statistics Bureau, Thimphu, Bhutan, 2007.
  3. Dorji, T. 2018. Bhutan among the fastest growing economies in Asia: ADB. Available from http://www.kuenselonline.com/bhutan-among-fastest-growing-economies-in-asia-adb/. Cited on 24 May 2018.
  4. Tobgay T, Dophu U & Na-Banhchang K. 2011. Health and Gross National Happiness : review of current status in Bhutan. J Multidiscip Healthc, 4,293–8.
  5. Yangchen S, Tobgay T & Melgaard B. 2017. Bhutanese Health and the Health Care System:Past, Present, and Future. Druk J, 2(1).
  6. The Constitution of The Kingdom of Bhutan. 2008. National Council of Bhutan. Available from http://www.nationalcouncil.bt/assets/uploads/files/Constitution%20%20of%20Bhutan%20English.pdf. Cited on 18 April 2018.
  7. National Health Policy. 2011. Ministry of Health, Thimphu, Bhutan. Available from http://www.gnhc.gov.bt/wp-content/uploads/2012/04/nationalHpolicy.pdf. Cited on 20 April 2018.
  8. Chandrashekar S & Kantharaj A. 2014. Legal and ethical issues in safe blood transfusion. Indian J Anaesth. 58(5),558–64.
  9. Smit Sibinga T. 2017. Existing and Recommended Legislative Framework for a National Blood Transfusion Policy. Glob J ofTransfusion Med, 2,89–96.
  10. Resolutions and Decisions of the 63rd World Health Assembly, 2010. World Health Organization. Available from http://apps.who.int/gb/ebwha/pdf_files/WHA63-REC1/WHA63_REC1-en.pdf. Cited on 12 April 2018.
  11. Recommendations of the 14th International Conference for Drug Regulatory Authorities (ICDRA), 2014. World Health Organization. Available from http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/14-ICDRA_recommendations.pdf. Cited on 12 April 2018.
  12. Aide Mémoire for Ministries of Health. Developing a National Blood System. Available from http://www.who.int/bloodsafety/publications/am_developing_a_national_blood_system.pdf. Cited on 17 April 2018.
  13. Assessment Criteria for National Blood Regulatory Systems. World Health Organization. Available from http://www.who.int/bloodproducts/NationalBloodRegSystems.pdf. Cited on 14 April 2018.
  14. National Blood Policy. 2007. Ministry of Health, Bhutan. Available from http://www.health.gov.bt/wp-content/uploads/moh-files/nationalbloodpolicy.pdf. Cited on 2 March 2018.
  15. Minutes of the 14th Bhutan Medicines Board Meeting. 2016. Drug Regulatory Authority, Bhutan. Available from https://drive.google.com/drive/folders/0Bzj2O5Bryu-LdHVxclhUcGFfWEE. Cited on 24 May 2018.
  16. Blood and Blood Products Regulation of Bhutan. 2016. Drug Regulatory Authority, Bhutan. Available from http://dra.gov.bt/wp-content/uploads/2017/07/Blood-and-Blood-Products-Regulation-of-Bhutan-2016-1.pdf. Cited on 3 April 2018.
  17. National Standards for Blood Transfusion Services Guideline. 2013. Ministry of Health, Bhutan. Available from http://www.health.gov.bt/wp-content/uploads/moh-files/2014/11/Ntl-Stds-for-BTS.pdf. Cited on 20 May 2018.

Corresponding Author

Pelden Chejor

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