Transcript "Nepal Case Study" - Pain & Policy Studies Group

Nepal Case Study
International Pain Policy Fellowship
Training Program
Madison, Wisconsin, USA
6 August 2012
Bishnu D. Paudel, MD
Nepal
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.
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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 Care
NAPCare
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
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
S.N.
Name
1
Dr. Pradeep Vaidya
2
Dr. Bijaya Raj Neupane
3
Dr. Sudip Shrestha
4
Dr. Bishnu Dutta Paudel
5
Radha Piyari
6
Ms. Narbada Khanal
Ms. Usha Thapa
Position
President
Vice President
Vice President
Secretary
Vice Secretary
Tresurer
Vice Tresurer
Organization
Hospice Nepal
BPKM Cancer Hospital
Bhaktapur C. Hospital
Bir Hospital
NNCTR
NIHS
BPKMCH
7
8
9
10
Dr. Yogendra Prasad Singh
Dr. Surendra B. Bade
Mr. Padma Raj Bharati
Member
Member
Member
T.U.Teaching Hospital
NNCTR
P.A. Service Center
11
Dr. Bal Kumar Subba
Member
Sechen Hospice
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.
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.