Nepal Case Study

International Pain Policy Fellowship

Training ProgramMadison, Wisconsin, USA

6 August 2012

Bishnu D. Paudel, MDNepal

Nepal

The Lord Buddha born in 623 B.C

Nepal

• 2/3rd Cancer are in advanced stage

• Pain was most common symptom in these advanced cancer patients.

Penis Cancer

Cancer in advanced stage

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

International Pain Policy Fellowship 2008

• Ministry of Health Representative

• International Pain Policy Fellow

Barriers of opioid availability

1) Policy

2) Drug Distribution System

3) Cost of Opioid Analgesics

4) Knowledge & Attitudes

Drug Distribution System

• Collaboration with different people including importers to improve opiod availability by timely reporting and proper action

• 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)

•

• 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.

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

Oral morphine production in Nepal

• Explore the possibility of production oral morphine in Nepal.

• Discussion with Nepalese drug company

Oral morphine production in Nepal

• Sharing of morphine consumption data

• Humanitarian approach

• Business nationally & (Internationally!)

Oral morphine production in Nepal

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

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

Oral morphine production in Nepal

• Morphine syrup in 2009

Oral morphine production in Nepal

Starting manufacturing immediate release morphine tablet since 2011.

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

SR morphine production in Nepal

Commitment to continue production of immediate release tablet.

Morphine SR Tablet in 2012.

Morphine Tab(10mg) PR

Morphine Tab 30mg (PR)2012

Morphine sulphate

• Switzerland

• Iran

• India

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.

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 Center8)Thankot Hospice Center

9)Nepalese Network Cancer Treatment and Research

Nepalese Association of Palliative CareS.N. Name Position Organization

1 Dr. Pradeep Vaidya President Hospice Nepal2 Dr. Bijaya Raj Neupane Vice President BPKM Cancer Hospital3 Dr. Sudip Shrestha Vice President Bhaktapur C. Hospital

4 Dr. Bishnu Dutta Paudel Secretary Bir Hospital

5 Radha Piyari Vice Secretary NNCTR

6 Ms. Narbada Khanal Tresurer NIHS

7Ms. Usha Thapa Vice Tresurer BPKMCH

8 Dr. Yogendra Prasad Singh Member T.U.Teaching Hospital9 Dr. Surendra B. Bade Member NNCTR10 Mr. Padma Raj Bharati Member P.A. Service Center

11 Dr. Bal Kumar Subba Member Sechen Hospice

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.

Knowledge & Attitude

Educational activities

Four weeks training in 2009 in capital

six weeks training in 2010 & 2011 out of capital

Dr. Eric in Nepal to support different activities

Fellow talking about Pain

Palliative care conference(2009)

Prescription Form for morphine & opiods

Annual consumption morphine in Nepal

Year Morphine in KG

2007 1.08935

2008 2.57785

2009 4.04325

Conclusion

• All forms of morphine available in Nepal

• People are working jointly

• Knowledge and awareness of regarding opioid use has been improving.