Global Surgery & Anesthesia

In one part of Uganda we encountered lidocaine for local anesthesia wherein the entire lot seemed total ineffective. It had been manufactured in China.

Xylocaine, Lidocaine, Mulago Hospital, Kampala, Uganda. Very much ineffective or the Ugandans have an incredible tolerance to it! It could also be the way it was stored. It should not be stored where UV light, even from fluorescent light, can affect it.

Many examples. Antibiotics and diabetic medicines that do not work. Harms many people.

Just recently (January) in Pakistan locally dispensed spurious drugs were given to thousands of patients with heart disease- the death toll was above 100!
This is a major problem in the developing world. There are numerous local pharmaceutical companies dispensing and selling medicines with no regulations.
Why people buy them - they are much cheaper, they give kick-backs to doctors and hospital administrators to use those drugs in their hospitals.

In the surgery ward in a public hospital where I used to work at. We were provided with some locally manufactured ceftriaxone which was available for Rs 35. (USD= <50cents) per dose. We used to encourage patient (if they could afford it) to buy Rocephin (Roche) from an outside pharmacy -which costed Rs400 (>10 times the price) per dose.

Until these medicine remain extremely expensive - locally manufactured medicines will have a huge market and a definite need - either medicines need to be cheaper or there needs to be regulation in place.
No one fakes Flagyl (Metronidazole) (<Rs 1.5 per tab, USD= <2cents)



http://www.bbc.co.uk/news/world-asia-16742832

We had a batch of heavy bupivacaine for spinal anesthesia that was ineffective and required redosing about half the time. Very frustrating, and certainly makes you wonder about meds that are being passed/ sold that lack such a clear and present indication of efficacy.

I can recall two examples. The first was several years ago in Northeastern India. The only opioid we had access to on a short trip was Indian made demerol. It had a great atropine effect, but offered very little analgesia. So, side effects were pronounced with little desired effect.

The second I encountered recently in Rwanda. The bupivicaine available for spinal anesthesia was suspect as the anesthesia providers I was working with related multiple episodes of failed spinals when there was little doubt the anesthetic was injected intrathecally. The feeling was that the bupivicaine was simply bad or unreliable at best.

In Zambia, the adult induction dose for Thiopental is 8-10mg/kg - and I wonder if that is due to manufacturing/storage issues?? (vs a potentially interesting study in pharmacogenomics...)

In Niger, we had 16 kids coming for cleft lip repairs at our 24 bed surgical hospital in the capital Niamey. They received some cheaper artemether/lumefantrine drug available in the remote areas of Niger. The program coordinator said he had a choice of the more expensive drug from Europe, or a cheaper one available on the street. So he chose the cheaper one. Of the 16 kids, 9 had fevers diagnosed as malaria in the perioperative period, including one that developed a fever in the Recovery Room.

For the next surgical camp 2 months later for 30 kids with cleft lips, we asked that all 30 kids receive the good-quality artemether/lumefantrine a week prior to surgery. (Cost effective since we have 60% of kids with positive malaria smears prior to surgery.) Not one of the 30 kids developed a fever in the perioperative period, vs the 9 out of 16 on the first camp, who received presumably counterfeit antimalarials. Huge statistical difference.... We use only WHO-certified drug manufacturers for this reason.
Gary Roark MD

Thanks to everyone who replied to this thread. We are attempting to put together a study to evaluate both the incidence of counterfeit/substandard medicines in anesthesia, as well as potential causes. As many of you have suggested, the reason for the lack of effectiveness or disastrous adverse events are vast - counterfeit medicines, poor storage, expired contents, contamination, etc.
Is anyone aware of case reports in the published literature documenting adverse drug events related to substandard medicines in low- and middle-income countries? We have heard several accounts of the disastrous effects, but need to be able to point to specific pieces of evidence for funders. Can anyone point to case reports, studies by drug manufacturers, or even NGO or Ministry of Health reports that document substandard medication concerns related to anesthesia?

WHO has a section that addresses the issue of counterfeit or mislabeled drugs:

http://apps.who.int/gb/ssffc/
http://www.who.int/medicines/services/counterfeit/en/index.html
http://www.eweek.com/c/a/Application-Development/IBM-Helps-Sproxil-Reduce-Cou...
IBM reports that of the one million malaria deaths that occur worldwide each year, 200,000 are the result of counterfeit anti-malarial drugs. Additionally, the World Health Organization reports that 700,000 African dies each year from fake anti-malarial and tuberculosis drugs.
http://www.huffingtonpost.com/john-clark/counterfeit-drugs-pfizer_b_1435111.html

As an update to this post, we have applied for funding through Grand Challenges Canada to try and better understand the issue of counterfeit and substandard medications in anesthesia. We are hoping to use existing technologies try and collect point of care data to intercept these medicines before they are delivered to patients and to better define what the major concerns are. We hope that this project will give us some rigorous data on what the problems are with anesthetics and analgesics (counterfeiting? degradation? toxic mixtures?) and that we can identify these problems early on in the supply chain. But, we need some help to support our project.
Part of the process is the submission of a video, which people can then vote for, which can influence the final funding decision. Please check out our video, register, and vote for us. Please share with others! Thanks!
Video link: http://bit.ly/PBlLTS

Hi,

Is anyone currently working somewhere, or have contacts, where the are current suspect/ineffective/problematic medications? We are looking for current samples that might provide some indication of a problematic supply chain, and have the resources available to likely be able to 'diagnose' potential quality issues.

Does anyone have current access to medications believed to be falsified/counterfeit/substandard? Ideally should be from a Lot of suspect drugs, rather than one-offs.

If so, please either reply here, or e-mail at .

Just back from Uganda, and strongly considered bringing some back with me, but didn't. Local anesthetic never seemed to work despite injecting twice what I would normally do at home. Used 1:50,000 adrenalin whereas at home use 1:100,000 adrenalin. Child with meningitis died while on IV ceftriaxone, with no apparent response.
This really needs to be looked at.
Brian

Brian D. Westerberg, MD
Head, Division of Otolaryngology-Head and Neck Surgery, PHC
Clinical Professor, Department of Surgery, UBC
Otology & Neurotology
St. Paul's Rotary Hearing Clinic
1081 Burrard St.
Vancouver, B.C. CANADA V6Z 1Y6
Phone: 604-806-8540
Fax: 604-806-8777

On my way to Uganda in 2 weeks. I always bring lots of local anesthetic and other key drugs for that reason. I can bring back some samples for analysis.

Eleanor Reimer
Clinical Professor, UBC
Pediatric Anesthesia

Dear Brian,
Your story is a pathetic one. That's the woes of the developing countries where these substandard products are pushed in with impunity suffer . Nigeria is better today because of the activities of the national agency for food and drug control (NAFDAC) National commission set up for the regulations and thorough scrutiny of any drug/food coming into the control. The quality and safety of such products are verified before permission. Reports and information are sent to this body on identification of any fake /substandard products.

Please contact tracing is a very key weapon for fighting the war against fake and substandard drug.
Dear Brian, was this experience reported to the regulatory authorities in Uganda? If NOT please I suggest you encourage the hospital authorities in the center you visited to do so.
Secondly, could you encourage them to find means of sending some of these samples to you for the purpose of analyses and contact tracing.

This will surely help. I am also on the look out around my clime . If I come across such drugs will surely alert us. A stitch in time saves nine.
Thank you Brian and all for the great job.
Titus Ibekwe ...

Dear Brian,
Your story is a pathetic one. That's the woes of the developing countries where these substandard products are pushed in with impunity suffer . Nigeria is better today because of the activities of the national agency for food and drug control (NAFDAC) National commission set up for the regulations and thorough scrutiny of any drug/food coming into the control. The quality and safety of such products are verified before permission. Reports and information are sent to this body on identification of any fake /substandard products.

Please contact tracing is a very key weapon for fighting the war against fake and substandard drug.
Dear Brian, was this experience reported to the regulatory authorities in Uganda? If NOT please I suggest you encourage the hospital authorities in the center you visited to do so.
Secondly, could you encourage them to find means of sending some of these samples to you for the purpose of analyses and contact tracing.

This will surely help. I am also on the look out around my clime . If I come across such drugs will surely alert us. A stitch in time saves nine.
Thank you Brian and all for the great job.
Titus Ibekwe
Nigeria

Sent from my iPad

Brilliant Eleanor,
Let's start from somewhere. An analyses will bring out the essence and arm us with evidence based first hand information for the war ahead. Please, do not stop at bringing a sample for analyses. Endeavor to make a formal report/protest to designated authorities based on your observation.
Wishing you a safe trip.
Titus

Sent from my iPad