Short lecture to medical students on risks, prevalence and identification of fake medicines to help them to protect patient safety. Essential training for doctors, nurses and pharmacists.

1. Fake Medicines: What a Doctor Needs to Know
Monday 4th January, 2016
Mark Davison
mark.davison@bluespherehealth.com
Twitter: @StopFakeDrugs

2. 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?

3. 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.

4. Not just erectile dysfunction or “lifestyle” drugs

5. Well known brands and low cost products are affected

6. 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?

7. How common are fake drugs?
10 years ago 5 years ago Now

8. World Health Organisation estimates of prevalence
Probably <1% in developed economies
Much higher in developing world
Can be >50% in some cities

9. 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

10. Discourage patients
from buying drugs
over the internet !

11. 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?

12. 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.

13. If the drugs don’t work…

14. …it can be more than disappointing.

15. 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.

16. Over 100 Nigerian children killed by diethylene glycol
poisoning due to adulterated teething mixture

17. 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

18. Don’t assume expensive, injectable drugs are safe

19. Even complex drug presentations can be faked

20. 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!

21. 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

22. US example
• Alli ®
• Weight loss pills
• Small differences
– Seals
– Granularity

23. Viagra ®

24. 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

25. Medical devices are affected as well as drugs

26. Relative Share of Land (i.e. a world map)
26
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)

27. Relative Public Health Spending
27
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)

28. Relative Share of Malaria
28
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)

29. Relative Share of Tuberculosis…
29

30. 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

31. 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?

32. Counterfeits are easy to make and hard to track

33. Where do fakes come from?
• Local production for local markets
• China
• India
• Russia and Eastern Europe

34. Who is making them?
Local criminals making small amounts
Organised 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

35. 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?

36. What to look for during consultation or history-taking
Keep an open mind to possible causes of:
unexpected symptoms
worsening of a treatable condition
unexpected lack of symptom resolution or improvement
unexplained allergic reactions
reported burning sensation at injection site
Ask to see the medication the patient is using

37. What to look for in medication
Be alert for:
Poor quality packaging (but often copies are very good)
Crumbly, chipped, cracked or mis-shapen pills
Unexpected tastes, odours or colours
Apparent tampering or unexplained damage

38. 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?

39. Report concerns to local regulator (MHRA in the UK)*
Dedicated 24-hour hotline: 020 3080 6701
Email: counterfeit@mhra.gsi.gov.uk
Counterfeits, Case Referral Centre, MHRA,
151 Buckingham Palace Road,
Victoria, London, SW1W 9SZ
*Medicines and Healthcare products Regulatory Agency

41. Thank You. Any questions?
Mark Davison
mark.davison@bluespherehealth.com
Twitter: @StopFakeDrugs