US Pharm. 2018;43(3):4.
Since 1999, the number of opioid-related mortalities has quadrupled. In response, pharmaceutical companies are developing a variety of novel formulations with abuse-deterring characteristics, placing pharmacists in a key position to help stem the epidemic by imparting their unsurpassed knowledge of drug mechanisms and safety.
This issue’s continuing education article, “Combating Opioid Abuse Through New Formulations and Policy,” by Kimberly Ng, PharmD, BCPS, and Josh Rickard, PharmD, BCPS, CDE, highlights key reformulated medications and drug-development strategies. An oral medication, Hysingla ER (hydrocodone bitartrate extended-release) was approved in November 2014 and employs Purdue Pharma’s proprietary extended-release solid oral platform, RESISTEC. As Hysingla’s labeling indicates, the drug has been redesigned to reduce chewing, snorting, and IV forms of abuse.
MorphaBond ER, as the CE authors write, is an extended-release morphine formulation bioequivalent to MS Contin that was approved by the FDA in October 2015. MorphaBond ER utilizes SentryBond technology to mix inactive excipients with active pharmaceutical ingredients in tablet form. Another Purdue product, OxyContin, was reformulated and, in 2013, became the first opioid with abuse-deterrent characteristics to feature FDA-approved labeling. Injection and abuse via the intranasal routes, in vitro data showed, would be difficult since, when dissolved, the drug forms a hard-to-inject viscous gel. (In February, however, Purdue Pharma, said that it would stop marketing OxyContin to doctors.)
The rise in opioid-overdose deaths has also spawned prescription drug monitoring programs to identify overprescribing, diversion, and dispensing of naloxone to reverse opioid overdoses without prescription in pharmacies. According to this issue’s feature article, “Expanding Access to Naloxone,” by Ed DeSimone, RPh, PhD, FAPhA, as of July 2017, laws had been passed in all 50 states and the District of Columbia to increase public access to naloxone.
Still, despite greater access, naloxone remains underutilized in overdose situations. As DeSimone et al write, many first responders have access to naloxone and have been trained to administer it in an emergency. Unfortunately, many overdoses occur in locations where access to the life-saving medication is not available and emergency personnel cannot reach patients quickly enough. As the authors point out, “brain damage occurs within 4 to 5 minutes; however, it takes an average of 9.4 minutes for first responders to arrive at an emergency.” Naloxone-access laws vary significantly from state to state.
Solving the opioid problem will require a variety of tactics, from developing new formulations to weaning the healthcare community off currently available medications. Scientific strategies will work much better, clearly, if they are teamed with thoughtful legislative fixes that consider the impact on patients with bona fide pain. The pharmacist is well positioned to help patients utilize many of these tools and, thereby, can help save lives.
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