OST : Procurement, Supply Chain and Service Delivery
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1 OST : Procurement, Supply Chain and Service Delivery
2 Structure of the presentation International regulatory framework for narcotic / psychotropic substances Procurement procedures Supply chain mechanism OST Delivery System
3 International regulatory framework for narcotic / psychotropic substances
4 Life cycle of opioids
5 Convention on Narcotic Drugs (1961) Convention on Psychotropic Substances (1971) Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) Common objectives: Provide legal foundation for action in drug control Ensure that drug production, distribution and consumption is limited to medical and scientific purposes Prevent diversion to illicit channels
6 International regulatory framework Different mechanism for narcotics / psychotropics Methadone Covered under the 1961 convention Prior quota and annual consumption reporting required Buprenorphine Covered under the 1971 convention Annual quota not required to be allocated Annual reporting for Buprenorphine (optional) Essential medicine list WHO Methadone and buprenorphine in the list
7 Laws / policies of countries Drawn in accordance to the conventions Support the use of narcotics/psychotropics for medicine and scientific purpose Example India: use of opioids for OST (de-addiction) mentioned under NDPS act Nepal: harm reduction and OST endorsed in the National Drug policy
8 Supply chain mechanism Procurement Replenishment of stocks Supply Stock management
9 Procurement procedures 1. Determining type of medicine required Methadone: syrups Buprenorphine tablets: 8 mg, 2 mg, 0.4 mg, 0.2 mg 2. Determining the quantity No. of patients X no. of days X average dose per patient per day
10 3. Request for QUOTA Required only for Methadone Nodal Ministry requests INCB for a quota for Methadone Example Department of Narcotics Control (Bangladesh) Ministry of Home Affairs (Nepal) Central Bureau of Narcotics (India)
11 Procuring agency Each country has a nodal agency for procurement of goods and supplies Maldives State Trading Organization Nepal Sajha trust India NACO through its procurement agency (UNOPS/RITES) (for NACO sponsored OST programme)
12 Bidding agency Agency Manufacturer / supplier Must have a WHO-GMP certificate or equivalent certificate For export, supplier would need Certificate of Pharmaceutical Product (COPP) as recommended by WHO.
13 Eligibility criteria Manufacturers incorporated in country of manufacture & licensed by regulatory authority evidence of its technical, financial and production capability Distributors Duly authorised by the manufacturer to supply goods within a country Finalise vendor Technical and financial qualification Negotiate Rates
14 Supply Chain Mechanism
15 Establishing a supply chain mechanism Supply chain A Vendor Supply chain B Vendor Clinic Patient Central Stock Clinic Patient
16 Stock management Licenses from relevant authorities for storage and transport Central stocks Storage area of central stock Responsible officer for central stock Safe keeping: secure system Flow of stocks from central to OST clinic Chain of custody Clinic stocks Storage area Secure system Staff-in-charge?
17 Record maintenance for stock management Central stock register Inventory of the stock to be maintained Signed by the officer supplying the stock to clinic Clinic stock register Inventory of the stock to be maintained Signed by the officer receiving the stock in clinic Dispensing register Total quantity of methadone dispensed in the clinic in the given day Daily stock register Information on the daily stock transaction being made
18 OST Delivery
19 Directly observed treatment strategy in South Asia
20
21 Securing sustained supply: considerations Clear understanding of the various Ministries/departments dealing with quota, licensing and procurement Ensure clear commitment from the ministries licensing, narcotics control / home Ensure procurement is made well in-advance Prepare a standard supply chain protocol / guideline
22 Securing sustained supply: considerations Stock replenishment Stock projection Rotate stocks with eye on expiry dates Establish a strong supply chain mechanism Identify officers responsible in-charge of the stock at every point Maintain records strictly Check at regular intervals
23 Further areas & Conclusion Advocacy for inclusion of narcotics/psychotropics in the national essential medicine list Removal of import duties Use of computer based software for stock management (copy right issues, monopoly of pvt sector!) Robust supply chain an important part of scale up plan for OST
24 Thank you
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