Dr. Carson Gardner Judy Rose, PharmD. January 2013

Transcription

1 Dr. Carson Gardner Judy Rose, PharmD January 2013

2 Describe White Earth s efforts to address prescription drug abuse Discuss disposal practices and proposed DEA rule changes Review enforcement trends

3 : WEIHS staff noticed increased demand of opiates by patients with patterns of concern 2006: limited formulary substances of abuse (ie, T#3, Vicodin, Morphine) Multidisciplinary group convened to establish protocols to address prescribing habits, misuse, diversion of substances of abuse

4 2006: Chronic Pain Management Policy & Protocol Limit quantity dispensed for urgent care with no refills Follow-up care coordinated with PCP Advised against prescribing opiates for sprains, abrasions, headaches, and bruises.

5 Pain contract implemented if med use becomes long term (ie, 3 months) Random drug screens and pill counts Patterns of concern addressed Loss/stolen meds Escalating doses Early refill requests Belligerent behaviors Reports from community members of patient abusing/selling medications

6 Primary care providers, internal medicine provider, pharmacists, mental health providers, nurses and administrator Met twice monthly Review/approve new pain contracts 3-6 month review of existing pain contracts Review cases to discontinue pain contract (ie, make patient opioid ineligible) Recommend non-pharmacologic treatments including referral to mental health

7 2009: provider turn over led to re-assessment of existing practices, protocols and contracts Rejected addition of suboxone and methadone to WEIHS formulary Extended scope to include tramadol Collected, analyzed and shared prescribing habits/trends of providers Held 1 st Take Back Event administered by Tribal Police Dept in community

8 2010: Bemidji Area 2-day educational seminar Dr. Decker, PIMC Attendees included medical providers, pharmacists, nurses, mental health providers, administrators, lab technicians and traditional healers Continued participation in DEA Take Back community events

9 2011: White Earth Tribal Council declared a state of emergency against prescription drug abuse Chairwoman, Erma Vizenor Led to increased involvement by Tribal Police Dept, Tribal Courts and various community members and groups. Pharmacists utilize MN & ND PDMP Screen every RX for controlled substances and gabapentin and tramadol Apprise provider of non-weihs activity before medication is dispensed Upload prescription information daily

10 2012: continued participation in local and regional meetings Collaboration continues between IHS and Tribe Pharmacists educate community members of problem through health fairs and community group presentations Administrative support of providers cancelling pain contracts Continuously assess practices and adopt change accordingly (ie, proxy pick up prevents UDS) Monitor and share information

11 Example of Information Monitored and Shared # Tabs of Vicodin Dispensed Per Month at NTW 2012 Decreased ~45%

12 Use safe disposal practices to discard unused, unneeded, or expired medications Secure and convenient disposal to reduce abuse and environmental contamination No flushing, with a few exceptions Cannot return to pharmacy

13 Department of Environmental Protection Homeowner's Guide to Disposal of Unwanted Medications Do Not give drugs to anyone else Do Not put drugs in the trash without disguising them. Human or animal scavengers may find them and misuse them. Do Not flush leftover medicine. It can cause contamination to the aquatic environment because of wastewater treatment systems are not designed to remove many of these medications.

14 To protect the environment, please use these guidelines instead of flushing medications: Place capsules or tablets in a sealable plastic bag Add a small amount of water to dissolve; crush if needed Add dirt, coffee grounds, kitty litter to bag Dispose of bag with household trash Alaska Native PSA on safe medication disposal household practices: See also FDA guidelines

15 Shortly after DEA s first Take-Back Day event just over two years ago, President Obama signed the Secure and Responsible Drug Disposal Act of 2010 DEA to develop permanent, ongoing, and responsible methods for disposal Until the creation of permanent regulations, DEA will continue to hold Take-Back Days

16 DEA Take Back: 5 events held Most recent (Sept 2012), DEA s state, local, and tribal law enforcement partners at more than 5,263 locations, collected 488,395 pounds (244 tons) of prescription medications Combined with previous events, more than 2 million pounds (1,018 tons) of prescription medications were removed from circulation Next Take Back Event: Saturday, April 27, 2013, 10am-2pm

17 White Earth Tribal Police Department 1 st event: Just a few RX meds; mostly OTC; less than 1 pound Last event (Sep 2012): meds were not separated or classified; nearly 10 pounds of meds collected Partnered with WE IHS Pharmacy Stickers publicizing the event were placed on pharmacy bags County Drop Off boxes also available

18 Drug Enforcement Administration Disposal of Controlled Substances 21 CFR Parts 1300, 1301, 1304, 1305, 1307, 1317, and 1321 Proposed Rules 12/21/2012; open for comments until 2/19/2013 The goal of this proposed new part on disposal, consistent with Congress's goal in passing the Disposal Act, is to set controlled substance diversion prevention parameters that will encourage public and private entities to develop a variety of methods for collecting and destroying controlled substances in a secure, convenient, and responsible manner. Also, to decrease the amount of controlled substances introduced into the environment, particularly into the water DEA is proposing new regulations for the disposal of controlled substances by ultimate users DEA reviewed policies and regulations related to each element of the disposal process (transfer, delivery, collection, destruction, return, and recall of controlled substances) by both registrants and non-registrants (e.g., ultimate users). This rule proposes three voluntary options for ultimate user disposal: (1) Take-back events, (2) mail-back programs, and (3) collection receptacles. DEA proposes to authorize certain registrants (manufacturers, distributors, reverse distributors, and retail pharmacies) to be "collectors," with authorization to conduct mail- back programs. Retail pharmacies that are authorized to be collectors may maintain collection receptacles at long term care facilities (LTCFs).

19 Should be conducted only by law enforcement agencies because such events are highly publicized, are often held at easily accessible locations No other person, such as a take-back event volunteer, may handle or touch the controlled substances at any time.

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21 DEA aims to limit the number of transfers to minimize risk of diversion (USPS) May receive mail-back packages from ultimate users if the collector has and utilizes on-site destruction; law enforcement??? Collectors that conduct mail-back programs must have and utilize an onsite method of destruction Specified packages: can be tracked, postage paid; pre-addressed, nondescript, tamper-evident, etc If the authorized collector inadvertently accepts controlled substances in a package that they did not make available for the collection of controlled substances, the authorized collector shall notify the DEA within three business days of receipt and securely store the package until the collector receives further instructions from DEA Collector must inventory packages & maintain records

22 Authorizes law enforcement agency to maintain a collection receptacle at the law enforcement agency's physical location as well as to authorize any DEA registered manufacturer, distributor, reverse distributor, or retail pharmacy authorized as a collector to maintain a collection receptacle at their DEA registered location Authorize retail pharmacies because such registrants are open to the public and have theft and loss prevention measures within the pharmacy processing area as well as outside the confines of the prescription processing and pick-up area, which easily lends itself to secure collection receptacle placement. Retail pharmacy personnel also routinely handle controlled substances Securely fastened to a permanent structure such as a wall, floor, or immovable countertop; specified inner liners Receptacle must be located within the immediate proximity of a designated area where controlled substances are stored and where an authorized employee is present Retail pharmacies that are authorized to be collectors may maintain collection receptacles at long term care facilities (LTCFs) Must follow the physical security controls for inventorying & storing Schedule II controlled substances Collection receptacles and mail-back packages are likely candidates for diversion because these collection methods are highly publicized and accessible to the public, and, as a result, any theft or loss from these collection methods is considered significant

23 Currently, DEA authorizes ultimate user distribution for the purpose of recall under existing 21 CFR , but the language in this section is overly broad. Reduces ambiguity by specifying to whom an ultimate user is permitted to deliver their recalled controlled substance and by outlining consistent and clear requirements for registrants authorized to receive those recalled substances from ultimate users. In the event of a product recall, the manufacturer of the recalled controlled substance or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf is authorized to receive recalled controlled substances from an ultimate user and does not need to be an authorized collector to do so

24 Doctor shopping RX Fraud Drugged Driving Providers illegally prescribing or dispensing Pill mills: often disguised as independent pain-management centers Florida, Texas 10 days ago: Operation: Doc-In-A-Box a multi-year Organized Crime Drug Enforcement Task Force Operation along with the cooperative efforts of the Miami Division DEA, the IRS s Criminal Investigation Tampa Field Office, Florida law enforcement, Santa Rosa County Sheriff s Office and the U.S. Attorney s Office. Over a four-year period, the two doctors garnered nearly $8.5 million illegally One doctor, age 62, was sentenced to one year imprisonment plus one additional year of home confinement; another doctor, age 61, received a two-year prison sentence plus one additional year of home confinement for his role as the part owner Business owner was sentenced to 20 years in prison Pain management clinics required to register and be inspected by the Texas Medical Board if half of their patients receive controlled substances. Changing name to wellness or rehabilitation clinics

25 Tribal Drug Courts refer substance users in the criminal justice system to treatment and recovery services in lieu of jail Play an important role in breaking the cycle of drug use and crime. As of December 31, 2009, there were 89 Tribal Drug Courts, nearly twice the number (45) in Indian tribal governments may apply for drug court funding through the Bureau of Justice Assistance's Drug Court Discretionary Grant Program.

26 Pain Contracts Random Urine Drug Screens (UDS) Addresses all meds with abuse potential regardless of DEA classification (gabapentin, pregabalin, tramadol) Zero tolerance of lost/stolen meds w/abuse potential

27 Lamar Associates, 100% Native-Owned Professional Training and Technical Assistance company National Association of Drug Diversion Investigators (NADDI): trained over 6000 tribal law enforcement, health care professionals, and communities in the investigation and prevention of prescription drug abuse National Indian Child Welfare Association (NICWA) US Department of Justice, Office of Community Oriented Policing Services; Narcotics Overdose Prevention and Education:

28 Share A Dose of Reality, SADD Florida advisor Sherry Viersen (far left) and teen ambassadors Naya Zapata, Destiny Ramos, and Julissa Pardomo are joined by U.S. Surgeon General Regina M. Benjamin, M.D., M.B.A. (center).

29 Parents: The Anti-Drug: Prescription Danger Zones: Search starts at the home: Home Tour, Parenting Tips Newsletter SmarRxT Disposal: