FDA's REMS deadline helping to drive US traceability projects?

A concerted effort by the FDA to demand risk evaluation and mitigation strategies (REMS) for pharmaceuticals at high risk of diversion, such as opioid analgesics, could help drive adoption of track-and-trace technology such as serialisation in the USA.

While much attention in the supply chain security field in pharma has been devoted to tackling the issue of falsified medicines and ingredients, diversion of legitimate medicines for illegal purposes is a huge and growing problem, according to traceability specialist Covectra.

"The FDA estimates that more than 33 million Americans age 12 and older misused opioids during 2007 - up from 29 million just five years earlier - and it's clear that abuse and diversion are issues which the industry needs to address," according to Steve Wood, Covectra's president and CEO.

The US government is taking note. In April, the White House unveiled a multi-agency plant aimed at tackling what it described as an "epidemic" of prescription drug abuse, which will focus on diversion, misuse and misprescribing of opioid analgesics.

At the heart of the programme is an updated REMS system specifically for extended-release and long-acting opioid analgesics, including Purdue Pharma's OxyContin (oxycodone), King Pharma's Avinza (morphine sulphate), Eli Lilly's Dolophine (methadone), Jannsen's Duragesic (fentanyl transdermal system), and eight other brands which according to the FDA are "extensively mis-prescribed, misused, and abused."

The FDA first came up with the concept of REMS back in 2007, and has already approved dozens of strategies - ranging from a simple medication guide to more intensive approaches such as allowing a drug to only be prescribed by certified and trained physicians, wholesalers and pharmacies.

The latest proposals also include an expansion of state-based prescription drug monitoring programmes, projects aimed at clearing unused drugs from homes, increased education for patients and healthcare providers and higher levels of enforcement.
 
Covectra believes that applying technologies such as unit-dose serialisation and track-and-trace can help drugmakers satisfy REMS requirements and improve patient safety "without creating barriers to medication access by the patient."

"An unintended consequence of this prescription drug problem in the US is the impact on healthcare costs, as well as physicians increasing reluctance to prescribe prescription painkillers due to fact that they are subject to controls that limit the number of patients they prescribe to,” said Wood.

Covectra's AuthentiTrack traceability platform includes a dedicated Patient Tracking, Abuse and Diversion module that helps brand owners monitor and control the distribution of abused and misused products.

Coding of medicine packs with unique serial numbers provides a simple and common solution to not only prescription drug diversion, but also other supply chain threats such as counterfeiting and theft.

"Serialisation technology offered by companies like Covectra will speed up the securing of the opioid supply chain for a very low cost investment to brand owners," said Wood.

The FDA is now notifying opioid makers that they must propose a REMS strategy within 120 days of the April announcement, and is working to encourage them to develop a single system for REMS implementation.

Doctor training, patient counselling, and other risk reduction measures developed by opioid makers as part of the REMS are expected to become effective by early 2012.


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