You just need to look at the list of news headlines on the US Food & Drug Administration (FDA) website to realise the worldwide prevalence of counterfeit drugs.
According to the World Health Organization (WHO), the extent of counterfeit medical products is unknown because counterfeiting is difficult to detect, investigate, and quantify. However, what is known is that counterfeit drugs are found worldwide, and are more prevalent in developing countries. The WHO estimates that while the incidence of counterfeit drugs is less than 1% in developed countries, the percentage is much higher in some developing countries.
Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products are by their very nature difficult to detect and are often designed to appear identical to the genuine product, notes a factsheet produced by the WHO. In some cases, SSFFC medical products may not cause an obvious adverse reaction but will fail to properly treat the disease or condition for which they were intended. In other cases they may be toxic, containing either fatal levels of the wrong active ingredient or other toxic chemicals.
The WHO advises that consumers check for counterfeit products by examining the packaging’s condition and checking for spelling mistakes or grammatical errors; checking the manufacturing and expiry dates and ensuring that the details on the outer packaging match the dates shown on the inner packaging; ensuring the medicine looks correct, is not discoloured, degraded or has an unusual smell; and, if medication doesn’t seem to be working or is causing an adverse reaction, discussing this with a pharmacist or doctor immediately.
With the vast amount of mandatory information required on pharmaceutical packaging, it is the responsibility of the manufacturer to ensure that drug usage information is presented to patients in a way that is easy to understand and use. ‘Research shows that multi-page self-adhesive leaflet labels, such as Pyrotec PackMedia’s Fix-a-Form® booklet label attached directly to the primary packaging is far more likely to be read by patients than a loose leaflet inside the pack,’ comments Timothy Beattie, Pyrotec PackMedia’s General Manager.
‘Besides Fix-a-Form® booklet labels ensuring that the information provided by the manufacturer remains with the product throughout the entire value chain – from manufacture to consumers’ medicine cabinets – a host of anti-counterfeiting features can also be added to Fix-a-Form® labels,’ he adds.
For pharmaceutical products, labelling extends far beyond being purely functional. Packaging should not be an afterthought but rather an essential component of positive patient outcomes and part of a multilevel approach to defeating counterfeiters.
‘Pyrotec is an ISO9001-accredited organisation and is audited regularly by our pharmaceutical customers for compliance with Good Manufacturing Practices. Additionally, strict access control is maintained to ensure that finished Fix-a-Form® labels are safe from theft, and we have documented pharmaceutical printed waste disposal procedures to provide our customers with peace of mind.’
Pyrotec PackMedia’s Fix-a-Form® leaflet labels ensure protection throughout the value chain.