BREAKING NEWS: NEW CONTROLLED DRUG DISPOSAL OPTIONS FOR PHARMACISTS

DEA Finalizes Rule Today Allowing Additional Options for Collection

and Disposal of Unneeded Controlled Drugs

Written for APA by Sara Ransom, PharmD Candidate 2015, Harrison School of Pharmacy

Summary Pearls: Pharmacies can now participate in controlled substance disposal via two methods: collection receptacles and mail-back programs. Pharmacies must first obtain authorization from the DEA to become a “collector” through the DEA registration process. Read the DEA Final Rules published in the Federal Register today. (09/09/14) For more DEA Resources on Drug Disposal, visit http://www.deadiversion.usdoj.gov/

In the last decade, non-medical use and abuse of prescription drugs has become more prevalent. The 2012 National Survey on Drug Use and Health (NSDUH) estimated that 6.8 million persons twelve years and older used a prescription drug for non-medical purposes in the past year[1]. In Alabama, NSDUH found that 2.7% of citizens aged 12 or older reported illicit drug dependence or abuse in the year prior to the survey[2]. Non-medical use of prescription drugs is particularly prevalent in teenage populations; this is partly due to the ease of access. The Partnership for a Drug Free America found that 6 out of 10 teenagers believe that their peers get prescription drugs from their family's medicine cabinet[3]. Therefore, it makes sense that removing these unused drugs from the home after they are no longer needed is a good way to make them inaccessible for abuse. Increasing options for people to safely dispose of their unneeded controlled prescription drugs became the goal of the Secure and Responsible Drug Disposal Act of 2010.



Prior to passage of the Secure and Responsible Drug Disposal Act , legal barriers in the Controlled Substances Act (CSA) prevented Americans from bringing legally attained controlled substances back to the pharmacy for disposal[4]. The CSA called for a closed system of distribution, and did not allow DEA registered drug manufacturers and distributors, including pharmacies, to accept drugs for disposal after dispensing to the patient. Passage of the Secure and Responsible Drug Disposal Act in 2010 authorized the U.S. Attorney General to create regulations within CSA that will allow the patient (ultimate user) additional voluntary options to safely dispose of controlled substances. The Attorney General has delegated this responsibility to the DEA[5]. The resulting final rule, published in the Federal Register on September 9, 2014, removes some of the previous barriers to DEA registrants accepting dispensed controlled drugs. The rule allows them to voluntarily participate in the safe collection and disposal for destruction of these drugs. While the rule creates additional options for more convenient and environmentally responsible methods for removing unused and unwanted controlled drugs from American homes, it also establishes procedures and other controls to prevent diversion of returned drugs into licit and illicit channels.



Over the past several years, one-day drug take-back events hosted by law enforcement, where both controlled and non-controlled medications are collected for disposal, have become increasingly popular. These programs are legal under the CSA because law enforcement officers are allowed to take possession and responsibility for the safe destruction of the drugs. Unfortunately, these one-time events take a large amount of effort and resources, and they do not reach the majority of the American population. The final rule creates a combination of methods for collection and destruction of medications that provides the greatest benefit to public safety and health. Participation in a collection program is voluntary, with no federal or state funds appropriated for such use. The rule aims to enable Americans additional safe and secure disposal options in addition to take-back events to prevent diversion of these controlled substances for illicit use.



Several different methods for drug disposal for destruction are included in the final rule of the Secure and Responsible Drug Disposal Act of 2010[6]. As before, law enforcement can sponsor drug take-back events, but the rule includes provisions to allow pharmacies (and other entities registered with the DEA) the option of taking a more defined and active role in responding to this public health need. In addition to drug take-back events, the rule allows for collection receptacles in authorized locations and also mail-back programs. The three methods of collection and destruction of unused drugs increase accessibility to safe disposal.



REGISTER AS AUTHORIZED COLLECTOR

Pharmacies can now participate in controlled substance disposal via two methods: collection receptacles and mail-back programs. Pharmacies must first obtain authorization from the DEA to become a “collector” through the DEA registration process. A collector is a registrant authorized by the DEA to receive controlled substances from patients or other entities in lawful possession of the controlled substance (e.g. long-term care facilities). Pharmacies must weigh the cost of such programs against the potential benefits. There is no fee associated with becoming a collector, but the initial cost of setting up the receptacle and the recurring cost associated with replacing liners should be considered. The potential benefits range from increased foot traffic to the pharmacy to generating a positive impact on public health and safety by reducing risks of accidental overdose or poisoning from unneeded medications left in the home. All drugs collected must be destroyed in an environmentally responsible manner consistent with all state and federal laws; reverse distributor programs, such as the Takeaway Environmental Return System offered by Sharps Compliance, Inc., can assist pharmacies in this regard. The rule provides options for those that are concerned about the environmental impact of placing unused drugs in the household trash and waste water. Since participation as a collector of medications for destruction is strictly voluntary, pharmacies may stop their collection program at any time without penalty.



COLLECTION RECEPTACLES

After a pharmacy has registered with the DEA as a collector, they must meet several requirements prior to beginning a collection receptacle program. Collection receptacles are securely locked containers into which a patient may deposit their unused or expired controlled substances, along with other medications. Pharmacists and pharmacy employees may not directly handle the returned drugs, so they must be deposited into the container by the patient. The collection receptacle itself is permanently fastened to a structure, and features a small opening for the deposit of medications. Pharmacies must prominently display a sign indicating that schedule II-V controlled and non-controlled substances will be accepted. Receptacles contain a liner that is waterproof, tamper-evident, tear-resistant, and sealable. When these liners are removed or transferred, it must occur under the supervision of two employees of the collector, and stored securely until pickup by a DEA-registered reverse-distributor. For additional specifications on maintaining collection receptacles, refer to the official rule in the Federal Register.



The rule also allows pharmacies to manage secure collection receptacles in long-term care facilities (LTCF). LTCFs handle palliative care more often than some other care settings, resulting in increased use of controlled substances on the premises. This could increase the need for safe disposal options in these facilities. According to the Rules of the Alabama State Board of Health for nursing facilities, LTCF have thirty days to dispose of controlled substances that are no longer needed for individual patients[7]. LTCF, which are not registered with the DEA to handle controlled substances, have had to handle this disposal without any clear guidance. Under the new rule, pharmacies servicing LTCFs can become DEA-authorized to maintain and service collection receptacles at LTCFs, where they will be responsible for oversight of the drug collection and destruction process. Collection receptacles on-site at LTCFs have the potential to unburden employees of these facilities, and they also reduce the possibility for diversion and abuse of unused controlled substances.



MAIL-BACK PROGRAMS

The second new option for drug disposal outlined in the final rule is the mail-back program. This collection method expands upon the mail-back programs already established for non-controlled drugs. This collection method is only available to those authorized collectors with an approved on-site disposal method, so manufacturers, reverse distributors, and law enforcement will be handling the majority of mail-back programs. The mail-back program sponsor can provide pharmacies with pre-addressed, postage-paid envelopes, which may then be sold to the ultimate user. These packages cannot have any markings that distinguish them as containing controlled substances. Patients may then place their unused controlled substances into the envelopes and mail them back to the reverse distributor.



Take-back events, collection receptacles, and mail-back programs can provide patients with a safe and convenient alternative way to dispose of unwanted or expired controlled substances. The methods described in the rule were created to increase access to save and environmentally responsible disposal of controlled substance, while decreasing the likelihood of diversion. The success of this Act depends on the participation of entities registered with the DEA to handle controlled substances. Pharmacies can positively impact the health and safety of their communities by participating in one of these programs. Pharmacists have a responsibility to reach out to the public and address their needs. Opportunities exist to market disposal services in a way that highlights the caring nature of the profession of pharmacy. This is a chance for the pharmacists of Alabama to help in the fight against prescription drug abuse.



For more information about the final rule, visit http://www.deadiversion.usdoj.gov/.

Figure 1.



U.S. map showing non-medical use of pain relievers in the past year among persons aged 12 or older, by sub-state region: percentages, annual averages based on 2010, 2011, and 2012 NSDUHs[8].



REFERENCES:

[1] Substance Abuse and Mental Health Services Administration. Results from the 2012 National Survey on Drug Use and Health: summary of national findings. NSDUH Series H-46. Rockville, MD: 2013. HHS Publication No.: (SMA) 13-4795.



[2] Substance Abuse and Mental Health Services Administration. Behavioral Health Barometer: Alabama. Rockville, MD: 2013. HHS Publication No.: SMA-13-4796AL.HHS Publication No. SMA-13-4796AL.



[3] Partnership for a Drug-Free America, Metlife Foundation. 2009 parents and teens attitude tracking study report. 2010 Mar 2. [Internet]. Available from: http://www.drugfree.org/wp-content/uploads/2011/04/FULL-REPORT-PATS-2009-3-2-10.pdf



[4] Controlled Substances Act (CSA) of 1970, 21 U.S.C. § 801 (2014).



[5] Secure and Responsible Drug Disposal Act, S. 3397, 111th Cong., 2nd Sess. (2010).



[6] Disposal of Controlled Substances, 21 CFR 1307.21 (2014).

[7] State of Alabama Department of Public Health. Chapter 420-5-10. Rules of the Alabama State Board of Health, Alabama Department of Public Health. Montgomery, AL. Amended July 28, 2004.



[8] Substance Abuse and Mental Health Services Administration. Substate Estimates of Substance Use and Mental Disorders from the 2010-2012 National Surveys on Drug Use and Health: Results and Detailed Tables. Rockville, MD. 2013. Available from: http://www.samhsa.gov/data/NSDUH/substate2k12/toc.aspx