Healthcare Compliance Packaging Council Comments on FDA's Look at Unit of Use Blister Packaging for Certain Opioids

The Council notes that limited doses in properly designed blisters will not only mitigate overuse, but also limit excess unused doses—frequently the source of diverted and misused pills.

Healthcare Compliance Packaging Council Comments on “Fixed Quantity Unit of Use Blister Packaging for Certain Immediate Release Opioid Analgesics for Treatment of Acute Pain
Healthcare Compliance Packaging Council Comments on “Fixed Quantity Unit of Use Blister Packaging for Certain Immediate Release Opioid Analgesics for Treatment of Acute Pain

The HCPC supports Congress’ and the FDA’s admission that packaging can play an important role in discouraging opioid misuse by patients and others as noted by the SUPPORT Act of 2018. Unit dose blister packaging can fulfill the CDC’s and the FDA’s requirement to limit initial prescriptions for acute pain by providing pre-packed doses.

Unit dose blister packaging can be designed to contain a 3, 5 or 7 day initial prescription opioid pain treatment for acute care patients. The limited doses in properly designed blisters will not only mitigate overuse by the patient, but limit excess unused doses which are frequently the source of diverted and misused pills. A properly designed blister pack will include messaging to warn patients of addiction risk, provide visible evidence of doses taken and provide child-resistance superior to that offered by standard pharmacy packaging.

Another issue that could be mitigated by unit dose packaging is the onset of decreased dosing intervals some chronic care patients develop. According to Dr. Allan Wilson, MD, PhD, former Full Professor and Head, Section of Addiction Psychiatry, University of Ottawa, some patients develop the need to alleviate the anxiety of anticipated pain between dosing intervals, convincing them to seek another dose even before actual pain is felt. Properly designed packaging can provide dosage reminders for patients and caregivers alike, reducing the likelihood of under or overdosing.

Utilizing unit dose packaging with specific time reminders may help chronic patients better understand the dangers of overdosing and the reduced dosing intervals referenced in Dr. Wilson’s work. The unit dose packaging could provide risk reminders through billboard messaging, or simply provide space for recording dispense events directly on the package. In addition, the dispensing events could be coupled with an app that allows for scanning at each dispense event to notify a medical professional or caregivers. And finally, digital capture of dispense events via Near Field Communication (NFC) or Radio Frequency Identification (RFID) can be designed into the package for added verification. Unit dose compliance prompting packaging can be designed to accommodate the needs of different patient groups.

Blister packaging would protect our smallest population, children.The incidence of hospitalization for prescription opioid poisonings among children and adolescents 1 to 19 years of age increased nearly twofold from 1997 to 2012, with the largest percentage increase occurring among the youngest children, aged 1 to 4 years.1This includes the drug Buprenorphine, an opioid used to treat opioid addiction, which the CDC cited as the number one solid dose drug causing hospitalizations by children less than 5 years old. The CDC equated this to “For every 500 adults treated with Buprenorphine, 1 child was hospitalized from 2007 through 2011.” The 2012 packaging and delivery form change correlated to a 65% drop in Emergency Department visits.2

Smarter Technology, Smarter Packaging (or Modern Packaging for Modern Problems)

For over 50 years the amber vial and cap closure has been offered in every pharmacy in America. Unit dose blisters allow for coordination with today’s technological breakthroughs to provide passive, active, interactive and verifiable features to combat the opioid epidemic and improve pharmaceutical safety. Passive features would simply be graphics or text reminders and warnings. Active features could be simple electronics that provide reminders or warnings in the case of a shortened dosing period. Interactive means the patients would have to respond to prompts from the packaging such as a recording of doses taken and their timing to provide data for caregivers which could give warning of addictive behavior. Verifiable elements would include electronic tracking of doses taken and provide real time feedback to caregivers to allow intervention. Any of these packaging features, from simple messaging printed on the packaging to electronic dosing recording, can educate patients, warning of the risks of addiction and overdose while assisting with dose tracking which can also prevent third party misuse and abuse.

Unit Dose Blisters readily support the Drug Supply Chain Security Act

Serialized unit dose packaging would allow better tracking of doses dispensed which would give better visibility to abusive prescribing and dispensing practices. With serialized unit dose blisters, product reaching the street could be tracked back to the patient, pharmacy and prescribing physician which means patterns of abuse would be easier to spot by law enforcement, FDA and DEA.

Serialized unit dose packaging will also aid in the roll out of the Drug Supply Chain Security Act, signed into law in November 2013, by allowing serialized packages to reach patients, ensuring them delivery of a pristine product. The patient can track the source of supply. In addition pre-packed unit dose blisters eliminate repackaging in the pharmacy which reduces the opportunity for filling errors and the introduction of counterfeit drugs.3[1]The US accepted practice of bulk packaging in larger bottles (500 or 1,000 count) forces repackaging product in the pharmacy. Bulk packaging is less expensive for the pharmaceutical manufacturer, yet these same manufacturers pack in blisters everywhere else in the world.

The Healthcare Compliance Packaging Council, (www.hcpconline.org), a non-profit trade organization comprised of pharmaceutical packaging machinery and materials manufacturers and pharmaceutical contract service companies, focuses on unit dose pharmaceutical packaging that improves patient adherence and patient safety by reducing errors in pharmacy, protecting the efficacy of pharmaceuticals, ensuring child safety and enhancing supply chain security. We applaud the inclusion of unit dose packaging in the Support for Patients and Communities Act and would welcome an opportunity to assist the industry in packaging research and development to stem the opioid crisis thereby reducing healthcare spending by improving the overall health of US citizens while improving the safety of products in the US supply chain.

 

References

[1] https://www.medpagetoday.com/painmanagement/painmanagement/61130,https://jamanetwork.com/journals/jamapediatrics/fullarticle/2571466

[2] Pediatric Emergency Department Visits for Buprenorphine/Naloxone Ingestion — United States, 2008–2015,Budnitz, Lovegrove, Sapiano, Mathew, Kegler, Hampp, MMWR / October 21, 2016 / Vol. 65 / No. 41, https://www.cdc.gov/mmwr/volumes/65/wr/mm6541a5.htm

[3] https://psnet.ahrq.gov/resources/resource/28670,http://www.highlighthealth.com/healthcare/pharmacy-errors-avoid-prescription-dispensing-mistakes/

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