The US FDA is to assist the pharmaceutical industry in developing abuse-deterrent opioids and in making these safer formulations available sooner, according to a final guidance document issued on 1 April 2015.

These safer opioids are to be formulated in ways that make it more difficult to snort or inject the medications.

The document, titled “Abuse-Deterrent Opioids – Evaluation and Labelling Guidance for Industry”, is part of the FDA’s efforts to curb the escalating misuse or abuse of prescription opioids in the US, which has become a public health concern. [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf;Addiction 2014;109:177-181; Addiction 2014;109:185-186]

“The science of abuse-deterrent medication is still relatively new and rapidly evolving. The FDA is eager to engage with manufacturers to support advancements in this area and make these medications available as quickly as possible,” said FDA Commissioner, Dr. Margaret Hamburg.

In the Asia-Pacific region, Australia takes the lead in the opioid epidemic and the development of measures against abuse.

“The prescription of oxycodone and tramadol in Australia saw dramatic increases between 1992 and 2007,” said William Chui, President of the Society of Hospital Pharmacists of Hong Kong. “In Victoria, a 21-fold increase was seen in the detection of oxycodone in deaths reported to the Coroner between 2000 and 2009. Almost 54 percent of the death cases were the result of drug toxicity.” [Inj Prev 2011;17:254-259]

“Diversion of prescription opioids to drug abusers or dealers is very common in Australia. To curb the opioid epidemic, a formulation of hydromorphone is enteric-coated with a hard substance to prevent abuse through injection,” he told MIMS Oncology. “Furthermore, community pharmacists actively provide counselling and monitoring for patients on opioid therapy through a government-run programme.”

“In the rest of Asia Pacific, little data is published on the prevalence of opioid diversion,” he continued. “In Hong Kong, opioid diversion is uncommon because these analgesics are generally underused except in oncology settings. Also, our choice of opioid analgesics is limited, and no abuse-deterrent opioids are currently available on the Hong Kong market.”

Although the development of abuse-deterrent opioids can help reduce diversion and abuse, Chui said pharmacists also play important roles in ensuring appropriate use of these medications. “Their roles include opioid prescription monitoring, identification and referral of patients at risk of opioid abuse, and collaborative care with physicians in cases of misuse, abuse or diversion,” he suggested.

“In Hong Kong, opioid registries should be implemented and made mandatory for all prescribers, including those in the private sector,” he added.