Substandard and Falsified Medical Products

Substandard Medical Product

• substandard medicines fail to meet their quality standards or specifications, or both

• manufacturer can be prosecuted for negligence if standard is not met

• also called “out of specification”

Falsified medical product

• falsified medicines are medical products that deliberately or fraudulently misrepresent their identity, composition or source

• AKA: counterfeit

Unregistered/unlicensed

• Medical products that have not undergone evaluation and/or approval by the NRRA for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation

DEG (Dietheylene glycol) Poisoning

Dietheylene glycol:

• Toxic

• Colourless

• Odorless

• Used in antifreeze, brake fluids

OTC cough syrups for children with confirmed or suspected contamination with high levels of DEG and ethylene glycol (EG)

• DEG poisoning leads to acute kidney failure

• Many children got poisoned from cough syrup

What are the causes of SFMPs?

• For substandard medicines, the national regulator has the authority to act against unscrupulous or careless manufacturers

• No such recourse available in the case of falsified when the manufacturer is falsely represented

• Regulator can only confirm that the producer is unknown and turn the case over to law enforcement

• Crime and corruption

  • Difficult to prosecute as often there is little evidence trying falsified drug in the market to the culprit

Drivers of SF medical products

• Globalised supply chain

  • Everytime you change the middle man, the higher the risk of something going wrong

• all countries vulnerable

• misinformation pandemic

• online verification

• public awareness is low

• lack of transparency

Fight the Fakes: prevent, detect, respond

• legislative reform and extended penalties for SF crime is required for inclusion in the UNOTC

• education and awareness on dangers of SF must be improved

• Emerging Track and Trace Tech:

  • blockchain

  • drones

  • 2D barcodes

  • mobile phone apps

  • nanoscanners

• Improved reporting systems and greater transparency within and between countries is required

Identifying a substandard or falsified medical product

• Examine the packaging for condition, spelling mistakes or grammatical errors

• Check the manufacture and expiry dates

• Ensure any details on the outer packaging matches inner packaging

• Ensure the medicine looks correct (ie. not discoloured, degraded or has an unusual smell)

• Report suspicious medical products to the National Medicines Regulatory Authority

Illegal internet pharmacies

• No guarantee that the product supplied will be that which was originally ordered.

• No guarantee of where the product was manufactured or how it was stored.

• No guarantee that the supplier is authorised or qualified to dispense medical products.

• No guarantee that the medical product is appropriate, or may react with other medicines you are taking.

• Personal data may be misused.

• Payment card details may be misused.

• SPAM email advertising medicines has been found to contain hidden software which will compromise your computer and privacy

Legal online pharmacy logo

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Detection Technology

• visual inspection of product and packaging

• physical properties tests - reflectance and refractive index

• chemical tests - colorimetry, disintegration, dissolution, chromatography

• spectroscopic techniques - mass spectrometry

• novel technologies are constantly being developed

Use of FT-IR spectroscopy can also determine falsified packaging

Some manufacturers label their packaging to take advantage of the fact that only inks that absorb in the infrared range will be visible under infrared radiation

• If it doesn’t come up, it’s falsified

• Sometimes, only the box packaging is stolen but the product is still false