[Pharmwaste] Rx Abuse Stats and Controlled Substances at Take-Backs
Jaramillo, Jeanie
Jeanie.Jaramillo at ttuhsc.edu
Thu Aug 6 12:47:16 EDT 2009
I’m going to continue the dialogue with the hopes that we’re not cluttering your inboxes. I would have loved to have all of this information a few years back, so I’m hopeful it is helping somebody out there.
You’re right – it is virtually impossible to have a take-back event without collecting controlled substances. If you tell the public “don’t bring controlled substances”, the average person has no idea what that means. Also, one of the earlier emails seemed to imply that anything not over-the-counter is a controlled substance. I may have misread it, but that certainly is not true. There are OTC meds, non-controlled prescriptions, and controlled substance prescriptions.
From our perspective, it is necessary to include controlled substances in take-back events. These are your OxyContin, Vicodin, Lortab – some might recognize the C-I, C-II, C-III nomenclature. As I am from a poison center, these are some of the most dangerous substances out there in terms of poisonings. These can result in respiratory depression and death. (Others can as well.) As one of our goals is to prevent poisonings, we feel it important to include controls. Controlled substances are also highly abused – particularly by teens who participate in “pharming” (raiding of medicine cabinets for prescription drugs.) Prevention of abuse is another goal of our take-back events. The stats on abuse are astounding:
· 62% of teens report prescription pain relievers are easy to get from parents’ medicine cabinets (2005 Partnership Attitude Tracking Study)
· Prescription drug abuse is second only to marijuana use (2007 National Survey on Drug Use and Health)
· Each day 2,500 teens use a prescription medication for the first time for a non-medical reason (Prescription for Danger: A Report on the Troubling Trend of Prescription and Over-the-Counter Drug Use Among the Nation’s Teens, 2008; Office of National Drug Control Policy, Executive Office of the President)
· There are now more people aged 12 and up who use psychotherapeutic drugs for non-medical reasons than those who abuse cocaine, heroin, and methamphetamine combined (2007 National Survey on Drug Use and Health)
When we began collaborating with our local law enforcement to participate in our events, we had drafted a letter for them to send to the DEA to obtain “authorization” for the collection of controlled substances. DEA National Headquarters had stated that a letter would be needed, that it should come from the participating law enforcement agency, that it should detail the steps taken to prevent diversion, should state that LE will witness the burn of the controls, etc. We were told by our regional DEA office (Dallas) yesterday that the requirement for a letter of authorization from DEA is at the discretion of the regional Special Agent in Charge (SAC). Our does not require a request for authorization as long as law enforcement is involved and they handle the drugs in accordance with their local policy.
The difficult thing about the DEA is that they are not consistent (case in point – regional SAC has discretion to determine need for letter of authorization) and they generally will not provide anything in writing unless it is through the Federal Register. (On a personal level, I do not like the idea of participating in something that could result in criminal prosecution, not to mention the loss of my license, based on someone’s word-- i.e “You don’t need a letter of authorization from us.”) Work is currently being done to amend the Controlled Substances Act to make drug take-back programs easier to conduct, but it will be at least 1-2 years before that is done. I don’t mean to degrade the DEA. When we started working on this ~ 5 years ago, we met road block after road block. The DEA is much better now as this problem has grown and they’ve become more aware.
We’d be happy to complete the survey.
Jeanie Jaramillo, PharmD
Managing Director, Texas Panhandle Poison Center
Assistant Professor, Texas Tech UHSC School of Pharmacy
1501 S. Coulter St.
Amarillo, TX 79106
P: (806) 354-1611
C: (806) 672-0833
F: (806) 354-1667
Cisco IP: 30412
From: Matthew C. Mireles [mailto:mirelesmc at earthlink.net]
Sent: Wednesday, August 05, 2009 4:01 PM
To: Jaramillo, Jeanie; Tony Madruga; McKinley, Gena; pharmwaste at lists.dep.state.fl.us
Cc: john.r.prince at dvault.com; easmith at communityofcompetence.com; Gressitt Stevan; karen.bartkowiak at dvault.com
Subject: RE: [Pharmwaste] RE: Texas Pharmaceutical Disposal Programs
Jeanie, many thanks for your input. I just returned from a meeting with DEA folks in DC. Yes, there many programs that do not involve law enforcement and might get by with it. the main challenge for these program is to ensure that no controlled substances are collected and handled. Our research has indicated that this is almost impossible.
Invariably controlled substances are commingled in the return.
The question is "would the DEA come down on you if you stated that you're not collecting FCS and they show up in your sample?" Here's an unofficial statement from the DEA. "They might if they want to."
Drug take-back program is a relatively new movement in the US whereas other countries have successfully implemented return systems without much problems, mostly direct return to the pharmacies. Historically, there has been a great deal of diversion in the US that spans all sector but particularly in our healthcare system (hosp, clinic) and pharmacy system (retail pharmacy, etc.). This is the rationale behind the DEA's "closed loop system" with first registrant and the Controlled Substance Act of 1970.
Believe me, everyone wants to do the right thing but don't put yourself in any risk with the law. While our group work closely with federal agencies in the research of unused and expired medicines in the US, we DO NOT work for any federal or state agency. We are completely independent. We provide research support (data collection, analysis, reporting, etc.) to anyone or any group that wants to have the info for any number of reasons (program eval, monitoring, policy, QC, reliability, community education, etc.). We help groups do sampling to basically ensure that they are not collecting FCS when they are not supposed to. And we don't report any group to the law enforcement or DEA, because we are researchers only!
Interestingly, our data are showing unusual post-market side effects. This is the only area where our researchers believe it is ethically an obligation for us to notify the FDA or drug manufacturers.
I'd like to send your our Annual Survey so your group can be included in our National Directory. Again, congrats on your tremendous leadership and work in TX. Let me know how we can help.
Matt
-----Original Message-----
From: "Jaramillo, Jeanie"
Sent: Aug 5, 2009 2:25 PM
To: "Matthew C. Mireles" , Tony Madruga , "McKinley,Gena" , pharmwaste at lists.dep.state.fl.us
Cc: john.r.prince at dvault.com, easmith at communityofcompetence.com, karen.bartkowiak at dvault.com
Subject: RE: [Pharmwaste] RE: Texas Pharmaceutical Disposal Programs
I am from the Texas Panhandle Poison Center which is in Amarillo (not Lubbock). We are having our first take back program on September 12th. Law enforcement is involved. DEA has been our most significant obstacle, but we are finally getting there. We’ve also had discussions with the TX State Board of Pharmacy. It is my belief that there are programs in the State that are conducted without law enforcement involvement. From my correspondence with the DEA, they are beginning to “crack down” on these. There are many groups who do not understand all of the regulations and unfortunately, they are not summarized in any one place.
Jeanie Jaramillo, PharmD
Managing Director, Texas Panhandle Poison Center
Assistant Professor, Texas Tech UHSC School of Pharmacy
1501 S. Coulter St.
Amarillo, TX 79106
P: (806) 354-1611
C: (806) 672-0833
F: (806) 354-1667
Cisco IP: 30412
From: Matthew C. Mireles [mailto:mirelesmc at earthlink.net]
Sent: Wednesday, August 05, 2009 9:44 AM
To: Tony Madruga; McKinley,Gena; 'pharmwaste at lists.dep.state.fl.us'
Cc: john.r.prince at dvault.com; easmith at communityofcompetence.com; Karen Bartkowiak (karen.bartkowiak at dvault.com)
Subject: Re: [Pharmwaste] RE: Texas Pharmaceutical Disposal Programs
Gena,
We run the National Unused and Expired Medicines Registry and conduct an annual survey of all the drug take-back programs in the US. We publish the survey data in our National Directory of Drug Take-Back and Disposal Programs. The Directory lists all the programs in the nation. Please contact me if you wish to have a copy.
Our group is based in Houston, but most of our work in drug return system are in Maine and CA. We also are consulting with federal agencies in designing a national drug take back system.
There are a few take-back programs in TX (Plano, Dallas area). One is beginning in Corpus I believe. All of these are small community-based programs. In Houston, we ran one pilot study with senior citizens. One for-profit company in Houston has a mail-back system set up with shipping kits and an incineration unit in Carthage TX. Another large company in anticipation for a business venture has purchased a large industrial incineration facility in Chamber Co.
Since we provide technical assistance in designing these programs around the country, we highly encourage the involvement of law enforcement whenever there's a possibility of collecting controlled substances. Most of the programs in TX mentioned above all have law enforcement involvement.
We also publish a comprehensive manual of procedures for drug take back. This manual has been selected as the official reference of instructions for an upcoming international conference on drug disposal in Maine (mainebenzo.org).
As far as partnership between city govt and retail pharmacies in TX, we have not seen this in our survey. CA, OR, and WA use this model for their take back system. In TX, the most promising initiative and partnership are coming from the Poison Center (Lubbock, Galveston, etc.) You may want to join the listserv and get involved right away. My advice for now is to proceed carefully. The DEA is keeping a close eye on TX. Our programs are in compliance with DEA regs.
I hope my info is useful. Please contact me if you have questions. By the way, I worked at UTMB before I move to Houston for grad school.
Matthew C. Mireles, PhD, MPH
President and CEO
Community Medical Foundation for Patient Safety
6300 West Loop South, Suite 288
Bellaire, TX 77401
832-778-7777
www.communityofcompetence.com
-----Original Message-----
From: Tony Madruga
Sent: Aug 4, 2009 4:18 PM
To: "McKinley, Gena" , "'pharmwaste at lists.dep.state.fl.us'"
Cc: "john.r.prince at dvault.com" , "Karen Bartkowiak (karen.bartkowiak at dvault.com)"
Subject: [Pharmwaste] RE: Texas Pharmaceutical Disposal Programs
Hi Gena,
I am not aware of any current programs in your area, however we can provide all of your unattended collection unit needs through our sister company Take Back Express.com.
More information can be found at: http://www.takebackexpress.com <http://www.takebackexpress.com/>
Regards,
Tony O. Madruga
President
dVault® Companies, Inc.
www.dvault.com <http://www.dvault.com/>
voice: 720.895.1908
fax: 720.895.1909
tony.madruga at dvault.com <mailto:tony.madruga at dvault.com>
**** dVault® Confidential ****************************************
This email and any files transmitted with it are confidential
and intended solely for the individual or entity to
whom they are addressed. If you have received this email
in error destroy it immediately.
**********************************************************************
________________________________
From: pharmwaste-bounces at lists.dep.state.fl.us [pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of McKinley, Gena [Gena.McKinley at h-gac.com]
Sent: Tuesday, August 04, 2009 2:01 PM
To: 'pharmwaste at lists.dep.state.fl.us'
Subject: [Pharmwaste] Texas Pharmaceutical Disposal Programs
Hello!
I am in the process of working on a BMP guide for the management of pharmaceutical waste, and am looking for example programs in the State of Texas. I am also interested to know if any pharmacies in the State of Texas have partnered with municipalities in the collection of pharmaceuticals. Please contact me if you have any information.
Thanks!
Gena
Gena McKinley, MPH
Environmental Planner
Houston-Galveston Area Council
Tel: 713-993-4529
Fax: 713-993-4503
www.RecycleInfo.org <http://www.h-gac.com/recycleguide>
-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20090806/868281f9/attachment.html
More information about the Pharmwaste
mailing list