Opioids are all over the news. Negative effects related to Opioid prescription fraud involving patients or pharmacists, to habitual abuse by prescribed patients and non-patients, to counterfeiting, and a path to heroin addiction, are getting national attention.
The pharmaceutical industry is focused on the rollout of the Drug Quality and Security Act (DQSA) and improving the “safety of the supply chain”. Unfortunately, the problems surrounding opioid abuse happen in or after pharmacy. Pharmacy safety and safe use by patients has been left out of DQSA. Yes, we need a secure channel but if that security doesn’t extend to the patient and we don’t facilitate proper use by the patient, a safe supply chain has not accomplished much.
There are more than 4 billion prescriptions dispensed each year in the US. Estimates say that 1% of those could be counterfeit equaling 40 million prescriptions! By comparison, 207 million were prescriptions for hydrocodone and oxycodone in 2013, versus 71 million prescriptions for these types of painkillers in 1991.1 What percent were unnecessary or frivolous? Estimates range high and low but let’s use 30%. That would mean 62 million abusive prescriptions, greater than what we think might be counterfeit. If we expended as much effort to address opioid abuse as we have addressing a secure supply chain we could possibly see equal or greater benefit to national healthcare costs.
So we have two distinct problems, a secure supply chain and opioid abuse. Is there any common ground? Possibly. Serialized container distribution could help improve drug control. In the near future, serial numbers could trigger prescription reimbursement instead of NDC’s used today. Serial numbers at the back door of pharmacy thwart counterfeit introduction. Serial numbers going out the front door would give visibility. Serial numbers associated with prescriptions would show abusive dispensing by pharmacies and could expose frivolous prescribing by physicians.
Today’s repackaging of prescriptions into amber vials in pharmacy and/or mail order will defeat the purpose of serialized containers. This antiquated practice is fraught with opportunity for error and abuse. The rest of the world dispenses in unit dose or unit of dispense packaging which, in most cases, is the manufacturer’s original container. Unit dose packaging could close gaps in our system. In fact, the CDC recently issued guidelines on opioid prescription limits. They suggest providing opioid prescriptions for acute pain for only three to seven days; prescribing the lowest possible effective dose; and giving patients immediate-release formulations.2
Given the suggested limited number of pills, it would make sense to have these highly addictive painkillers packed in a 3 or 7 cavity, original manufacturer’s blister with F=1 child resistant packaging. This pre-packed blister would ensure accurate dispense counts, facilitate safe delivery to the patient in a serialized package, maintaining supply chain integrity and preventing children from gaining access to these dangerous drugs.
In addition, these serialized packages could allow tracing of packages found on the street back to the pharmacy that dispensed them or the patient who received it. Of course product on the street may not be kept in its original package but some would, allowing visibility.
By modifying our packaging methods, we can reduce or eliminate introduction of counterfeit and gray market product, by dispensing smaller dose serialized blister packages in pharmacy we eliminate the need for counting and filling. Lastly, we can reduce accidental poisoning events by packaging these opioids in F=1 Child Resistant packaging.
- https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/americas-addiction-to-opioids-heroin-prescription-drug-abuse
- C.D.C. Painkiller Guidelines Aim to Reduce Addiction Risk, New York Times, By SABRINA TAVERNISE MARCH 15, 2016
The Healthcare Compliance Packaging Council is a not-for-profit trade association whose mission is to promote the greater use of compliance-prompting packaging to improve patient adherence and patient outcomes which will lead to reduced healthcare costs. The positive effects of this style of packaging have been proven by numerous studies over the past twenty years, yet U.S. pharmaceutical distribution still clings to an antiquated amber vial for a majority of prescriptions. While advances have been made in every facet of our daily lives, life-saving medication packaging remains in a vial introduced in the 1950s. The HCPC is working to change this.
For more information on HCPC, please visit www.hcpconline.org.
