E-DRUG: substandard propofol supplied by UNIMED in Zambia
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Dear E-Druggers,
A scientific paper published one year ago describes a case of substandard
propofol detected in Zambia in 2015. It's abstract is available at
https://www.ncbi.nlm.nih.gov/pubmed/28682949
The product had been procured via an European broker, and it may be
difficult to estimate how many patients had been affected.
Importantly, as stated by the authors, anecdotal accounts of substandard anaesthetic medicines in other countries abound and warrant further investigation to
provide estimates of the prevalence and scope of this global problem.
Even if with some delay, it would therefore be interesting to hear if other
countries or purchasers have experienced similar problems, either concerning
the specific issue of substandard anaesthetics (this is a category of
medicine for which to the best of my knowledge no prospective quality
surveys have ever been conducted), or in a broader sense concerning the
quality of medicines procured via international wholesalers
With kind regards
Raffaella
Raffaella Ravinetto, PharmD, PhD
Medicines Research & Networking
ITG Antwerp, Belgium
"Rafaella Ravinetto"<rravinetto@itg.be>
[Moderator comment: the full article being discussed is unfortunately
behind a paywall at: https://insights.ovid.com/pubmed?pmid=28682949
so we can only reprint here the abstract as published in Pubmed.
E-drug moderators however obtained the full article, and confirmed that the
substandard propofol was identified as:
Unimed Propofol Injection British Pharmacopoeia, 1% w/v (10 mg/mL), a
sterile emulsion for intravenous anaesthesia.
According to the supplied picture, the product was supplied by Unimed
International Ltd (Leicester, UK), and manufactured by Kwality
Pharmaceuticals (P) Ltd (Amritsar, India).
Please note that the original article says incorrectly that the product was
supplied by Unimed Pharmaceuticals Ltd (Kent, UK). This organisation is not
involved in the supply of this substandard propofol. The authors have
submitted a correction to the journal.
E-drug moderators confirmed the presence of substandard propofol with ZAMRA,
the Zambian medicines regulatory authority.
Moderators will summarize their response in a follow-up message.
Below we reproduce the abstract of Pubmed - Source:
https://www.ncbi.nlm.nih.gov/pubmed/28682949 ]
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Anesth Analg. 2017 Aug;125(2):616-619.
doi: 10.1213/ANE.0000000000002226.
An Analysis of Substandard Propofol Detected in Use in Zambian Anesthesia.
Mumphansha H, Nickerson JW, Attaran A, Overton S, Curtis S, Mayer P, Bould
MD.
Abstract
BACKGROUND:
In early 2015, clinicians throughout Zambia noted a range of unpredictable
adverse events after the administration of propofol, including urticaria,
bronchospasm, profound hypotension, and most predictably an inadequate depth
of anesthesia. Suspecting that the propofol itself may have been
substandard, samples were procured and sent for testing.
METHODS:
Three vials from 2 different batches were analyzed using gas
chromatography-mass spectrometry methods at the John L. Holmes Mass
Spectrometry Facility.
RESULTS:
Laboratory gas chromatography-mass spectrometry analysis determined that,
although all vials contained propofol, its concentration differed between
samples and in all cases was well below the stated quantity. Two vials from
1 batch contained only 44% ± 11% and 54% ± 12% of the stated quantity,
whereas the third vial from a second batch contained only 57% ± 9%. The
analysis found that there were no hexane-soluble impurities in the samples.
CONCLUSIONS:
None of the analyzed vials contained the stated amount of propofol; however,
our analysis did not detect additional contaminants that would explain the
adverse events reported by clinicians. Our results confirm the presence of
substandard propofol in Zambia; however, anecdotal accounts of substandard
anaesthetic medicines in other countries abound and warrant further
investigation to provide estimates of the prevalence and scope of this
global problem.
E-DRUG Moderator
E-drug@healthnet.org