Combating Counterfeit Medicines

Prof Tony MoffatThe School of Pharmacy University of LondonUK

WHO Definition of a Counterfeit Medicine

A product that is deliberately and fraudulently mislabelled with respect to source and/or identity. Counterfeiting can apply to both generic and branded products. Counterfeit products may include: products with the correct ingredients, with the wrong ingredients, without ingredients, with incorrect quantities of active ingredients, with fake packaging.

Types of Medicinal Product Affected by Counterfeiting

–High volume (high level of prescribing)–High price–Known brand–“Lifestyle”/non-reimbursed–Blockbusters–Parenterals (in developing world)–All generics–Off-label use drugs–Drugs in short supply

– Council of Europe Survey Report 2006

Estimates of Counterfeit Medicines

WHO estimates counterfeit medicines account for 6% of the world market

EU 2 – 10%Europe (non EU) 2 – 25%Asia 10 – 40%Africa 10 – 80%Other 5 – 40%

– Council of Europe Survey Report 2006

Council of Europe Survey Report 2006

– There are 46 member states

– Since 1999–

– New cases 26– Situation unknown 12– No cases 8

– Council of Europe Survey Report 2006

Causes of Counterfeiting

–There is a lot of money to be made–Lifestyle medicines are wanted–Equipment is widely available–Distribution is now easy, eg Internet and postal

delivery–Patients are self-prescribing–Weak legislation and enforcement–Organised crime has moved in

Correct drug, correct ingredients

–Viagra (not made by Pfizer)–Cialis (not made by Lilly)

–Kamagra (generic Viagra from India)

Wrong ingredients, but therapeutically active

–Cialis (sildenafil instead of tadalafil)

–Levitra (sildenafil instead of vardenafil)

–Lipitor (lovastatin instead of atorvastatin)

No active ingredients

1995 Niger - Fake meningitis vaccine led to 3,000 deaths

1998 Uganda - 60% of all malaria deaths attributed to fake quinine sulphate

2000 Cambodia - 30 people died after taking fake malaria drugs being sold as mefloquine or artesunate

Toxic ingredients

1990 Nigeria - 109 children die after taking a fake preparation containing diethylene glycol

1992 Bangladesh - paracetamol preparation containing diethylene glycol believed to have killed hundreds of children

1995 Haiti - 30 children die after taking medicines containing diethylene glycol

1998 India - 30 infant deaths (diethylene glycol)2006 China – 11 people died from an antibiotic which

was not properly sterilised

BBC News 11 July 2007

Whose problem is it ?

–Police–Regional Drug Squad–Customs–Trading Standards Office–Regulatory Agency (MHRA)–Pharmaceutical company–Pharmacy organisations–Pharmacists

BBC Today 1 June 2007

–Counterfeit medicines have increased five times in Europe in the last year.

–The origin of these counterfeits is mainly India via the United Arab Emirates.

–It mostly concerns lifestyle drugs such as Viagra obtained via the Internet.

RPSGB Code of Ethics

–Requires that pharmacy web sites display:

–The name of the owner of the business–The address of the pharmacy at which the business

is conducted–The name of the Superintendent pharmacist–Details of how to confirm the registration state of the

pharmacy and pharmacist

The Mail on Sunday

Ordered seven batches of medicines from the Internet but only received two of them!

GPHF-Minilab Solution

Simple drug quality testingand patient protection in65 countries

Protection against counterfeits and substandard drug products

German Pharma Health Fund (GPHF) Minilab

NIR Second Derivative of Absorbance Spectra of Lipitor Tablets (Savitzky-Golay, 11 point filter, cubic

polynomial)

-0.0015

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0.001

1100 1300 1500 1700 1900 2100 2300 2500Wavelength/nm

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10 mg

20 mg

40 mg

Plavix Tablets 25 mg

UK Wholesaler

R = 0.970

Plavix Tablets 25 mg r = 0.718

PHAZIR from Polychromix

Manufacturers’ Secure Packaging

–Tamper-proof outer packaging–Covert markers eg Cryptoglyph encryption–Radiofrequency identification (RFID)–Holograms–Security Inks–2-D Bar Coding–Medicines Passports (Pedigrees)

AstraZeneca

Is one of the first pharmaceutical companies to make all individual packs of a medicine traceable throughout the supply chain. Packs of Nexium (esomeprazole) are to be sealed with new tamper-proof seals and marked with unique carton numbers using a two-dimensional matrix code.

– Pharmaceutical Journal, 24 March 2007

Pfizer

–“To take full responsibility for our medicines from the point at which they leave our manufacturing centres until they are sold to our customers who dispense them.”

–Only distributed via UniChem

Pfizer

–David Watson, head of Trade at Pfizer in the Pharmaceutical Journal, 5th May 2007 said:

–“We have a responsibility to make sure that our prescription medicines are being distributed in the correct manner and sold accordingly to our terms and conditions.”

THE CPA urges national administrations to:

–Recognise the serious risk to public health and make the public aware

–Recognise and promote the safeguards provided by traditional supply channels

–Put in place effective measures for detection and prevention

–Adopt and implement WHO guidelines–Impose punitive sanctions for manufacture or trading

The CPA urges national pharmacy associations to:

–Develop, implement and monitor Good Pharmacy Practice (WHO/FIP/CPA)

–Report to national authorities any instances of counterfeiting

–Include in their Code of Professional Practice and Ethics requirements for co-operation with regulatory authorities and manufacturers to detect and prevent circulation of counterfeit medicines

CPA urges pharmacists to:

–Implement Good Pharmacy Practice–Purchase medicines only from reputable sources–Be alert to differences in quality of packaging,

labelling or leaflets and in physical appearance of medicines

–Report to national authorities and suspected instances of counterfeit medicines

Identifying Counterfeit Medicines

–Evidence of tampering with packaging

–Switched or altered labels–Altered expiry dates–Compare packaging – read labels,

font size, colour orientation of label–Compare containers – size, shape,

colour–Compare products – shape, colour,

weight

Ensuring Security of Distribution

–Buy from known sources–Make a list of approved suppliers–If using an alternative source obtain the pedigree of

the product or a form of certification it is an authentic product

–Be wary of cheap deals–Check with professional colleagues and the local

Pharmaceutical Society if in doubt

WHO’s Rapid Alert System (RAS)

–Minimise the adverse impacts of counterfeit medicines–Monitor actions taken by countries–Rapidly distribute alert notifications about counterfeit

incidents–Promote intensified surveillance in high risk areas–Stimulate swift follow up action–Encourage public warnings

The International Medical Products Anti-Counterfeiting Taskforce (IMPACT) aims to put a stop to the deadly trade in fake drugs