
[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19619-19620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0233]


Center for Drug Evaluation and Research; Use of Innovative 
Packaging, Storage, and/or Disposal Systems To Address the Misuse and 
Abuse of Opioid Analgesics; Request for Comments; Establishment of a 
Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a docket to receive suggestions, recommendations, and 
comments on innovative packaging, storage, and disposal systems, 
technologies or designs (``designs'') that could be used to prevent or 
deter misuse and abuse of opioid analgesics by patients and others. FDA 
is interested in receiving comments on new designs as well as 
enhancements to existing designs, and is particularly interested in 
comments from academic institutions, regulated industry, technology 
companies (e.g., those producing technologies for medication adherence, 
disposal, or tracking), healthcare professionals, patient 
representatives, clinical trial service providers, and other interested 
organizations. Comments submitted in response to this notice will help 
the Agency determine whether innovative designs for opioid analgesic 
packaging, storage, and/or disposal systems could help prevent or deter 
misuse and abuse without diminishing access for patients with 
legitimate prescriptions.

DATES: Submit either electronic or written comments by June 9, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
301), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Colleen Brennan, Center for Drug 
Evaluation and Research, Office of Surveillance and Epidemiology, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4410, 
Silver Spring, MD 20993-0002, 301-796-2316, email: 
Colleen.Brennan@fda.hhs.gov, with the subject line identified as 
``Packaging Abuse Deterrence Strategies.''

SUPPLEMENTARY INFORMATION:

I. Background

    Prescription opioid analgesics are important medications that are 
widely prescribed for the treatment of both non-cancer and cancer-
related pain. When used properly for their approved indications, opioid 
drugs provide significant benefits for patients. However, they also 
carry a risk of misuse, abuse, addiction, overdose, and death. 
According to an analysis from the Centers for Disease Control and 
Prevention, in 2010, prescription opioid drugs were involved in 16,651 
overdose deaths, which represented a 313 percent increase over the past 
decade (Ref. 1). The Substance Abuse and Mental Health Services 
Administration (SAMHSA) reports that for each overdose death, there 
were an additional 11 treatment admissions (Ref. 2), 33 emergency 
department visits (Ref. 3), and 880 non-medical users of these drugs 
(Ref. 4).
    Although inappropriate or illicit use, such as sharing the drug 
with family and friends or using drugs stolen from home medicine 
cabinets account for some of the problems with prescription opioids, 
legitimate use of opioids for pain may also lead to adverse events, 
addiction, and death. FDA plays a central role in the development, 
review, and approval of opioid drug products and must strike a balance 
between their benefit in the legitimate treatment of patients with pain 
and the risks to those patients and others associated with misuse, 
abuse, and addiction.
    Combating opioid misuse, abuse, and addiction has long been both a 
public health priority and a priority for the Agency. FDA has taken 
many steps to address these problems; however, we recognize that more 
can be done and have established a task force that has embarked on a 
multi-pronged approach, building upon existing initiatives and 
developing new initiatives (http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337852.htm). Exploring innovative designs for 
drug packaging, storage, and/or disposal is one of the many initiatives 
targeted by the task force.
    Designs for drug packaging, storage, and disposal have evolved 
considerably in the past decade to include many technology-based 
features such as electronic systems for monitoring, assessing, and 
improving adherence to medication regimens. For example, these systems 
may include functionality to remind patients to take a dose, track

[[Page 19620]]

when a dose is taken and how much is taken, and limit further access 
until it is time for the next dose. 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.
    Other potentially relevant technologies include ``track and trace'' 
capabilities, radio-frequency identification-based systems, microchips 
embedded within tablets, and in-home medication deactivation and/or 
disposal systems.
    FDA is interested in further exploring the role of existing and 
innovative designs for drug product packaging, storage, and/or disposal 
in mitigating opioid misuse, abuse, and addiction. For example, 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. 
Additionally, medication packaging and/or storage designs that limit 
access could help prevent use of the medication by someone for whom it 
was not prescribed, thereby, preventing accidental exposure (e.g., by a 
child or other household contact) or theft. Finally, medication 
packaging, storage, and/or disposal designs could be applied or adapted 
to help ensure safe disposal, including chemical deactivation, of any 
unused or residual medication.

II. Establishment of a Docket

    FDA is announcing the establishment of a public docket to provide 
an opportunity for interested persons to share information, research, 
and ideas on how drug product packaging, storage, and/or disposal 
systems could be designed or adapted to address problems associated 
with prescription opioid abuse and misuse. These comments will help the 
Agency explore whether existing or innovative designs can be applied or 
adapted to prevent or deter misuse and abuse, while ensuring that 
patients in pain have appropriate access to opioid analgesics.

III. Suggestions for Those Submitting Comments in Response to This 
Notice

    Proposed packaging, storage, and/or disposal designs should be 
feasible to implement, and should not impair access for patients who 
have legitimate prescriptions. Comments about specific system or 
technology designs should include a description of the following: (1) 
Design features and functionality; (2) results of any formative or 
summative human factors assessments conducted; (3) applications to 
date, including information on the effectiveness and acceptability of 
those applications (with literature references or other documentation); 
(4) 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; (5) 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); 
and (6) 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).
    To help FDA prioritize among proposed approaches, the Agency is 
also interested in receiving feedback about methods that could be used 
to assess a system or technology's potential abuse-deterrent 
characteristics and real-world impact (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). Finally, FDA is interested in receiving feedback on 
methods for encouraging further research and development in this area, 
and, if promising technologies are identified, incentivizing the 
pharmaceutical industry (e.g. via patent extensions) to adopt such 
technologies.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. The Agency will carefully consider all comments 
submitted. FDA generally will not respond directly to the person or 
organization submitting the comment.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

    1. Centers for Disease Control and Prevention. ``Opioids drive 
continued increase in drug overdose deaths'' [Press Release] (2013). 
http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html.
    2. SAMHSA, Center for Behavioral Health Statistics and Quality. 
Treatment Episode Data Set (TEDS): 2001-2011. National Admissions to 
Substance Abuse Treatment Services. BHSIS Series S-65, HHS 
Publication No. (SMA) 13-4772. Rockville, MD: Substance Abuse and 
Mental Health Services Administration, 2013.
    3. SAMHSA, Center for Behavioral Health Statistics and Quality, 
``Drug Abuse Warning Network,'' 2011. http://samhsa.gov/data/dawn/nations/Nation_2011_AllMA.xls.
    4. Substance Abuse and Mental Health Services Administration, 
Results from the 2012 National Survey on Drug Use and Health, 
detailed table 1.1A, NSDUH Series H-46, HHS Publication No. (SMA) 
13-4795. Rockville, MD: Substance Abuse and Mental Health Services 
Administration, 2013.

    Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07909 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P


