The US Food and Drug Administration (FDA) has had no shortage of critics of its regulation of opioid analgesics, including a controversial decision in 2013 to approve Zohydro (hydrocodone bitartrate), a pure hydrocodone product notable for its lack of either acetaminophen or abuse-deterrent qualities.
But after facing withering criticism and mounting pressure from legislators and even state regulators, FDA is moving to try to establish a constructive dialogue on how it can better prevent misuse and abuse of opioid analgesics through the use of innovative packaging technologies.
A Broader Abuse Deterrence Strategy
In an 8 April 2014 Federal Register posting, FDA said it wants public input on how the packaging used to deliver drugs might be used as part of a broader abuse deterrence strategy.
The problem, as FDA explains, isn't just people trying to abuse an opioid, such as those who crush or inject the pills in pursuit of an ill-advised "high." People using a drug legitimately and for prescribed purposes are just as big a problem.
Those people also run the risk of misuse and addiction, FDA notes. How can those patients be helped?
FDA says it has some ideas, but is also looking for public input.
Key to FDA's envisioned approach is the use of technology and electronic monitoring systems.
"For example, these systems may include functionality to remind patients to take a dose, track when a dose is taken and how much is taken, and limit further access until it is time for the next dose," FDA muses in its Federal Register notice. "Additionally, many of these drug-device combinations electronically encrypt and capture the accumulated adherence data, which can be downloaded directly from the device or wirelessly transmitted to the prescriber. These technologies have not only been used in clinical management and monitoring of protocol compliance in clinical trials, but have also been applied to combat the problem of prescription opioid misuse and abuse."
FDA also highlighted the potential of "track and trace" technologies, RFID-equipped ID-based systems, microchips embedded within tablets, and in-home medication deactivation and disposal systems.
"Many of the features of medication adherence monitoring technologies could be used or adapted to help prevent serious complications (e.g., overdose, addiction) by supporting proper dosage and administration, and could also help prescribers monitor for signs of abuse or medication sharing by facilitating effective patient management and followup," FDA hypothesized.
Technologies might also aid in preventing access or facilitating disposal of medications, such as by chemical deactivation, FDA said.
The agency has established a docket within the Federal Register (FDA-2014-N-0233) to receive comments, which it said should be focused on proposed (and feasible) packaging, storage and disposal designs. Such designs should "not impair access for patients who have legitimate prescriptions," FDA added.
FDA said it's looking for proposals to include eight details in particular:
- design features and functionality
- results of any formative or summative human factors assessments conducted
- applications to date, including information on the effectiveness and acceptability of those applications (with literature references or other documentation)
- recommendations for how the system/technology design could be applied or adapted (either alone and/or in combination with other systems/technologies) to help prevent or deter misuse and abuse, and any limitations of that application
- specific problems that could be addressed (e.g., serious complications such as addiction or overdose due to improper dosage and/or administration, improper disposal, accidental use by someone for whom the medication was not prescribed)
- to the extent possible, considerations for implementation into routine dispensing and clinical use (e.g., how the solution would impact the workflow in a retail pharmacy)
- real-world impact potential of the devices (e.g., actual ability to prevent or deter misuse and abuse, effect on access for appropriate patients, patient confidentiality, burden on the healthcare system, feasibility of implementation, whether the design could create unintended medication errors)
- how further research and development could be encouraged
Comments are due to FDA by 8 May 2014.
Federal Register notice