International Pain Policy Fellowship
Training Program
Madison, Wisconsin, USA
6 August 2012
Bishnu D. Paudel, MD
Nepal
The Lord Buddha born in 623 B.C
• 2/3 rd Cancer are in advanced stage
• Pain was most common symptom in these advanced cancer patients.
Cancer in advanced stage
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
• 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
• Explore the possibility of production oral morphine in Nepal.
• Discussion with Nepalese drug company
• Sharing of morphine consumption data
• Humanitarian approach
• Business nationally & (Internationally!)
National Healthcare Ltd. ,Nepalese Drug
Company willing start manufacture of oral morphine when we assured help from government side.
• 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
• Morphine syrup in 2009
Starting manufacturing immediate release morphine tablet since 2011.
• 200,000 morphine SR tabs imported in August
21 st 2008, with expiry date July 2011
• Stock balance 97,130 in July 15 th ,2011
Commitment to continue production of immediate release tablet.
Morphine SR Tablet in 2012.
• Switzerland
• Iran
• India
Nepalese Association of Palliative Care
NAPCare
22 representatives from 13 different institutions had joint meeting in July 2009
NAPCare Officially registered 16 th December,
2009 and 11 member body was formed.
1) Bir Hospital
2)Bhaktapur Cancer Hospital
3)TU Teaching Hospital
4)Stupa Community Hospital
5)BPKM Cancer Hospital
6)OM Hospital
7)Pashupati Aryaghat Service Center
8)Thankot Hospice Center
10)Hospice Nepal
11)Nepal Institute of Health
Science
12)B.P.K.M. Cancer Hospital
13)Sechen Hospice
9)Nepalese Network Cancer Treatment and Research
Nepalese Association of Palliative Care
2
3
1
S.N.
Name
Dr. Pradeep Vaidya
Dr. Bijaya Raj Neupane
Dr. Sudip Shrestha
Position
President
Organization
Hospice Nepal
Vice President BPKM Cancer Hospital
Vice President Bhaktapur C. Hospital
4 Dr. Bishnu Dutta Paudel
5 Radha Piyari
6 Ms. Narbada Khanal
Ms. Usha Thapa
7
8
9
Dr. Yogendra Prasad Singh
Dr. Surendra B. Bade
10 Mr. Padma Raj Bharati
11 Dr. Bal Kumar Subba
Secretary Bir Hospital
Vice Secretary NNCTR
Tresurer NIHS
Vice Tresurer BPKMCH
Member
Member
Member
T.U.Teaching Hospital
NNCTR
P.A. Service Center
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.
Four weeks training in 2009 in capital six weeks training in 2010 & 2011 out of capital
Dr. Eric in Nepal to support different activities
Prescription Form for morphine & opiods
Annual consumption morphine in Nepal
Year Morphine in KG
2007 1.08935
2008 2.57785
2009 4.04325
• All forms of morphine available in Nepal
• People are working jointly
• Knowledge and awareness of regarding opioid use has been improving.