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Fake Medicines: What a Doctor Needs to Know
Monday 4th January, 2016
Mark [email protected]
Twitter: @StopFakeDrugs
Learning points
• What is a fake drug?• How common are they?• Why are they dangerous?• Where do they come from?• How can I spot them?• What should I do if I find one?
Fake = “Spurious/falsely-labelled/falsified/counterfeit”
World Health Organisation definition:“Spurious/falsely-labelled/falsified/counterfeit (SFFC)
medicines are medicines that are deliberately and
fraudulently mislabelled with respect to identity and/or
source.”
Intellectual property violations are deliberately excluded.High quality, unauthorised “generics” don’t kill people.
Not just erectile dysfunction or “lifestyle” drugs
Well known brands and low cost products are affected
Learning points
• What is a fake drug?• How common are they?• Why are they dangerous?• Where do they come from?• How can I spot them?• What should I do if I find one?
How common are fake drugs?
10 years ago 5 years ago Now
World Health Organisation estimates of prevalence
Probably <1% in developed economiesMuch higher in developing world
Can be >50% in some cities
What about the internet?
Research showed*:
• 62% of medicines purchased online are fake or substandard• 95.6% of online pharmacies researched are operating illegally• 94% of websites do not have a named, verifiable pharmacist• Over 90% of websites supply prescription-only medicines without a
prescription
*European Alliance for Access to Safe Medicines (EAASM) Survey “The Counterfeiting Superhighway” including test purchases
Discourage patients from buying drugs over the internet !
Learning points
• What is a fake drug?• How common are they?• Why are they dangerous?• Where do they come from?• How can I spot them?• What should I do if I find one?
Why are fake drugs so dangerous?
Most people don’t think about it even when buying low cost drugs.
Of those who do, most assume only two scenarios:1. Pills work. They save money.2. Pills don’t work. They waste money.
If the drugs don’t work…
…it can be more than disappointing.
Toxic contaminants can kill you quickly
A healthy Canadian woman died from cardiac arrhythmia caused by metal toxicity from counterfeit medication
Mercury, lead, cadmium, arsenic, chrome, uranium, strontium, selenium, and aluminium have all been found in fake drugs.
As have: boric acid, rat poison, road paint and printer ink.
Over 100 Nigerian children killed by diethylene glycol poisoning due to adulterated teething mixture
Lack of drug can kill you slowly
• Little or no active drug• Disease not treated• Symptoms get worse• No-one may ever know
– Cancer: they expected you to die anyway– Stroke: they assume you weren’t taking the blood
pressure pills
Don’t assume expensive, injectable drugs are safe
Even complex drug presentations can be faked
Some worrying flaws:
Three separate incidents of switching of Nurofen Plus (painkiller) for Zyprexa (anti-psychotic) were traced to one man who was swapping the blisters between boxes whilst being served at the pharmacy counter!
How good are the copies?
• Sometimes excellent• Usually not perfect• Packaging better than the
pills• Careful vigilance picks up
most cases before they reach the patient
US example
• Alli ®• Weight loss pills• Small differences
– Seals– Granularity
Viagra ®
Don’t rely on holograms
• Two of these holograms are fake• >20 fakes of this design are known• Product: Artesunate• Region: SE Asia• Indication: Malaria• Consequence of counterfeiting:
Severe
Medical devices are affected as well as drugs
26
Relative Share of Land (i.e. a world map)
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
27
Relative Public Health Spending
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
28
Relative Share of Malaria
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
29
Relative Share of Tuberculosis…
Conclusion
• Counterfeit medicines are in all markets• They are not just Viagra• They kill or harm by direct toxicity• They kill or harm by lack of efficacy• Fake drugs in Africa could kill people in the UK too
– Drug-resistant TB and other infectious diseases
Learning points
• What is a fake drug?• How common are they?• Why are they dangerous?• Where do they come from?• How can I spot them?• What should I do if I find one?
Counterfeits are easy to make and hard to track
Where do fakes come from?
• Local production for local markets• China• India• Russia and Eastern Europe
Who is making them?
Local criminals making small amountsOrganised crime is heavily involved in large scale production
Fake drugs are a better investment than narcotics and much less dangerous to be caught with
Some evidence that terrorist groups use counterfeit drugs to raise money – Hezbollah, ISIS etc
Learning points
• What is a fake drug?• How common are they?• Why are they dangerous?• Where do they come from?• How can I spot them?• What should I do if I find one?
What to look for during consultation or history-taking
Keep an open mind to possible causes of:unexpected symptoms worsening of a treatable conditionunexpected lack of symptom resolution or improvementunexplained allergic reactionsreported burning sensation at injection site
Ask to see the medication the patient is using
What to look for in medication
Be alert for: Poor quality packaging (but often copies are very good)Crumbly, chipped, cracked or mis-shapen pillsUnexpected tastes, odours or coloursApparent tampering or unexplained damage
Learning points
• What is a fake drug?• How common are they?• Why are they dangerous?• Where do they come from?• How can I spot them?• What should I do if I find one?
Report concerns to local regulator (MHRA in the UK)*
Dedicated 24-hour hotline: 020 3080 6701
Email: [email protected]
Counterfeits, Case Referral Centre, MHRA,151 Buckingham Palace Road,Victoria, London, SW1W 9SZ
*Medicines and Healthcare products Regulatory Agency
Thank You. Any questions?
Mark Davison
Twitter: @StopFakeDrugs
