E-DRUG: Substandard propofol supplied by UNIMED in Zambia (6)
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[E-drug moderator researched the questions of Jason and Truls. WB]
Further to Jason's and Truls' queries:
The answer is in the original article:
An Analysis of Substandard Propofol Detected in Use in Zambian Anesthesia.
Authors: Hazel Mumphansha, MBChB, Jason W. Nickerson, PhD, Amir Attaran, DPhil, Sean Overton, Sharon Curtis, PhD, Paul Mayer, PhD, and M. Dylan Bould, MBChB.
Anesth Analg 2017;125:616-9
Corresponding author: jason@jasonnickerson.ca
The manufacturer of the substandard propofol is:
Kwality Pharmaceuticals Ltd (Amritsar, India)
Its website
http://www.kwalitypharma.com
shows that Kwality Pharmaceuticals Pharma Products are exported to following countries:
Dominican republic, Chile, Honduras, German, Italy, Nigeria, Niger, Mali, Gambia, Burkina Faso, lvory coast, Mozambique, Chad, Zambia, Malawi, Madagascar, Myanmar, Iran, Afghanistan, Turkmenistan, Uzbekistan, Kirgiz, Tadzhik, Kazakhstan.
The Zambian regulatory authority (ZAMRA) website however has no products registered of Kwality Pharmaceuticals or UNIMED International.
The EMA database of all registered products did not find Kwality Pharmaceuticals or UNIMED International as a registration holder in Europe
The substandard propofol was supplied by UNIMED International
The company website
http://unimed.eu.com/who-we-are/
states that UNIMED International is based in UK:
13 Pomeroy Drive
Oadby Industrial Estate
Leicester, LE2 5NE. UK
Tel: +44 (0)116 272 9955
The UNIMED website claims:
'Unimed proudly holds a Wholesaler Dealer Licence (WDL) issued by the Medicines and Healthcare products Regulatory Agency UK (MHRA), which also incorporates Good Distribution Practice (GDP).
'Unimed has also been awarded BS EN ISO 9001: 2015 in recognition for sound and tested Quality Management Systems for the supply, delivery of Pharmaceuticals and Hospital & Medical Equipment.
'Unimed also holds a UK Home Office (Drugs Licensing and Compliance) to procure, hold, supply and export controlled drugs - Home Office License No 284400.
Unimed is an approved partner for Delivering Procurement Services for Aid (DPSA) - a service for procuring goods and equipment to support aid and humanitarian organisations in the delivery of aid programmes worldwide. For further information please visit http://www.dpsa.org.uk'
E-drug moderator checked these claims:
According to MHRA
https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites
UNIMED holds Wholesale Dealer License nr 23057.
However, the MHRA does not have any control over products that would have been shipped directly from India to Zambia.
MHRA can only inspect whether the warehouse and procedures are according to UK legislation.
On Google Maps the warehouse looks rather small.
The ISO 9001: 2015 standard certifies the quality management system in a company. All procedures should be standardised. It does not however say anything about the quality of the supplied products, only about the procedures that the company uses. In this case it could be expected that UNIMED would have arranged pre-qualification of the manufacturer (using MQAS), pre-shipment inspection of the products to be supplied, and quick responses to any sign that the product was possibly suspect (recall). E-drug has asked UNIMED whether such actions were taken.
Details for procuring or supplying controlled drugs are at https://www.gov.uk/guidance/controlled-drugs-licences-fees-and-returns
This includes criteria like security and standard operating procedures.
Propofol is however not a controlled drug https://www.gov.uk/government/publications/controlled-drugs-list--2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation
UNIMED says it is an approved partner in DPSA
http://www.dpsa.org.uk
This is confirmed on http://www.dpsa.org.uk/about/our-partners/
DPSA won the tender to supply goods and pharmaceuticals to DFID projects worldwide some time ago
https://www.aecom.com/uk/press-releases/aecom-provide-procurement-services-critical-uk-aid/
Previously this contract was held by Crown Agents.
DPSA says on its website: "DPSA wants to work with reliable, cost-effective and quality suppliers".
DPSA is based in Dubai and London, and is part of AECOM, a global company based in USA. AECOM also has big military contracts for the US Army.
E-DRUG moderator has sent messages about the substandard propofol to UNIMED for comments, but has not received a reply.
Wilbert Bannenberg
Wilbert Bannenberg, public health consultant
Founder and co-moderator of E-drug
Moderator email: owner-e-drug@healthnet.org