Nepal Case Study

1. Nepal Case Study International Pain Policy Fellowship Training Program Madison, Wisconsin, USA 6 August 2012 Bishnu D. Paudel, MD Nepal

2. Nepal

3. The Lord Buddha born in 623 B.C

4. Nepal • 2/3rd Cancer are in advanced stage • Pain was most common symptom in these advanced cancer patients.

5. Penis Cancer Cancer in advanced stage

6. 2008 in Nepal Pain was not treated optimally due to multiple reasons. Unavailability of opioids was most important cause. No morphine syrup Morphine Tablet supply was irregular

7. International Pain Policy Fellowship 2008 • Ministry of Health Representative • International Pain Policy Fellow

8. 1) Policy 2) Drug Distribution System 3) Cost of Opioid Analgesics 4) Knowledge & Attitudes Barriers of opioid availability

9. Drug Distribution System • Collaboration with different people including importers to improve opiod availability by timely reporting and proper action

12. Dear Dr. Paudel, • 1) Order and the permission to import Morphine tablets granted to the overseas buyer by the Drug Control authority of the country is send to the concerned Manufacturing unit. • 2) Based on the ordered quantity, the requirement of active drug Morphine Sulphate is worked out and a separate application for allotment of quota of Narcotic Drug (Morphine Sulphate) is made to the State Drug Control authority. (period 45 to 60 days subject to availability of material) • 3) The necessary allotment is given after scrutiny of the application for obtaining Morphine sulphate from the manufacturer namely Govt. Opium Alkaloids Works (Neemuch/Ghazipur). • 4) Necessary Transport Authorization (for movement of goods from Manufacturer to Buyer premises) is obtained from Local F.D.A authority is given along with Purchase Order and advance payment to Govt. Opium Alkaloid, so as to enable them to supply the active drug. Based on the availability of drug the Govt. Opium Alkaloid executes the order. The validity of the transport authorization is generally two month within which the order has to be executed. (it takes  8 to 10 days)

13. 5) Intimation of receipt of drug is given to the State Excise Authority under the provisions of Medicine and Toiler Preparation Act. • 6) The drug is then analyzed (One week) and subjected to manufacturing process so as to obtain the required Morphine tablets to execute the overseas order. • 7) After completion of manufacturing process (15 - 20 days), the necessary transport authorization to transport the finished product from the factory to nearest port of shipment is obtained from the Local F.D.A (10 - 15 days) • 8) The said transport authorization is send to Narcotic Commissioner at Gwalior, for obtained the required NOC to export Morphine tablets from India. • 9) Meanwhile the State Excise duty payable on the finished product is discharged. • 10) On receipt of NOC from The Narcotic Commissioner of India, the goods are released for shipment.

14. Nishant Dale • Export - Department • Cipla Ltd, Mumbai • Ph: +91-22-23025601 • Mobile: +91 – 9930964677

15. Oral morphine production in Nepal • Explore the possibility of production oral morphine in Nepal. • Discussion with Nepalese drug company

16. Oral morphine production in Nepal • Sharing of morphine consumption data • Humanitarian approach • Business nationally & (Internationally!)

17. Oral morphine production in Nepal National Healthcare Ltd. ,Nepalese Drug Company willing start manufacture of oral morphine when we assured help from government side.

18. Steps • They applied to Department of Drug Administration (DDA) for manufacturing license of morphine syrup. • 6 months duration of stability testing • National Medicine Laboratory • Marketing license

19. Oral morphine production in Nepal • Morphine syrup in 2009

20. Oral morphine production in Nepal Starting manufacturing immediate release morphine tablet since 2011.

22. New problem • 200,000 morphine SR tabs imported in August 21st 2008, with expiry date July 2011 • Stock balance 97,130 in July 15th,2011

23. SR morphine production in Nepal Commitment to continue production of immediate release tablet. Morphine SR Tablet in 2012.

24. Morphine Tab(10mg) PR

25. Morphine Tab 30mg (PR)2012

26. Morphine sulphate • Switzerland • Iran • India

27. Nepalese Association of Palliative CareNAPCare 22 representatives from 13 different institutions had joint meeting in July 2009 NAPCare Officially registered 16th December, 2009 and 11 member body was formed.

28. Groups involved to form NAPC 1)Bir Hospital 2)Bhaktapur Cancer Hospital 10)Hospice Nepal 3)TU Teaching Hospital 11)Nepal Institute of Health Science 4)Stupa Community Hospital 12)B.P.K.M. Cancer Hospital 5)BPKM Cancer Hospital 13)Sechen Hospice 6)OM Hospital 7)Pashupati Aryaghat Service Center 8)Thankot Hospice Center 9)Nepalese Network Cancer Treatment and Research

29. Nepalese Association of Palliative Care

30. Knowledge & Attitude Educational activities for medical staff at major hospitals and hospices on pain relief and palliative care. Cancer pain Relief topic was included in March 2010 National Cancer Conference & first ASCO MCMC course.

31. Educational activities Four weeks training in 2009 in capital six weeks training in 2010 & 2011 out of capital

32. Dr. Eric in Nepal to support different activities

33. Fellow talking about Pain

34. Palliative care conference(2009)

35. Prescription Form for morphine & opiods

36. Annual consumption morphine in Nepal Year Morphine in KG 2007 1.08935 2008 2.57785 2009 4.04325

37. Conclusion • All forms of morphine available in Nepal • People are working jointly • Knowledge and awareness of regarding opioid use has been improving.

38. THANK YOU