Counterfeit drugs: what a doctor needs to know

Fake Medicines: What a Doctor Needs to Know

Monday 4th January, 2016

Mark Davisonmark.davison@bluespherehealth.com

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: counterfeit@mhra.gsi.gov.uk

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

mark.davison@bluespherehealth.com

Twitter: @StopFakeDrugs