DEA Offers New Prescription Drug Return Policy

3 Indest-2009-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.

Hopefully this will help to eliminate many of the problematic situations that pharmacists and physicians found themselves in when they accumulated returned or unused medications from patients for destruction.

This move intends to address the rising number of injuries and deaths associated with controlled substance drugs, particularly opioids. Reducing the stockpile of unneeded prescription drugs from American homes will limit teenagers’ accessibility to their parents’ medications and reduce burglaries for such substances. According to The New York Times, this demographic is known to be the most prevalent abuser of such controlled substances.

To read the full story from The New York Times, click here.

Prior Methods of Prescription Drug Disposal.

Under the Controlled Substances Act, patients were only allowed to dispose of unused drugs themselves or surrender them to law enforcement. Personal disposal of controlled substances typically means flushing pills down a toilet or throwing them in the trash. Because this can pose a risk toward animals and clean drinking water, these methods are frowned upon by environmentalists and the Environmental Protection Agency (EPA).

Drug “take back” programs are another option when it comes to disposing of unused prescription drugs. These events are organized by the DEA and are held twice a year at local police departments across the country. During these programs, citizens can anonymously drop off any unused prescription drugs. According to The Wall Street Journal, the Department of Justice (DOJ) reported that a nationwide event in April 2014 brought in 390 tons of prescription drugs at more than 6,000 sites. In the past four years, these collection events have removed from circulation more than 4.1 million pounds of prescription medication from across the country.

Although these events prove successful, many healthcare professionals are optimistic for the bigger impact the pharmacy “take back” programs may have. Providing consumers convenient year-round access to medication disposals will be positive reinforcement to regularly dispose of unused prescription medications. This method is believed to be more likely to accomplish the mission of shrinking the pool of unused and potentially fatal controlled substances in American homes.

To read the full article from The Wall Street Journal, click here.

Ironing Out Details of the New Plan.

There are many logistics to consider to ensure these pharmaceutical “take back” programs will be successful. The programs will not be mandatory, as the decision to take part will be the under the sole discretion of each company. The pharmacies must voluntarily choose to register with the DEA in order to start receiving the leftover prescriptions. In the past, pharmacies have not generally wanted to accept the hassle of offering such a program. However, the DEA expects many pharmacies to jump on the bandwagon to showcase good-faith effort of keeping drugs out of the wrong hands.

DEA-approved organizations collecting the unused drugs will include hospital pharmacies, narcotic treatment programs, and companies contracted by other collectors to destroy controlled substances.

There are concerns circling the initiative. Some pharmacies do not have the resources required to accommodate incinerators, thus limiting the locations available to consumers. In addition, professionals are concerned with the lack of regulations listed in the new plan. There are no set requirements on how the prescriptions should be destroyed. The rules simply mandate that the drugs are altered into a permanent, irreversible state.

The burden of payment has also not been discussed or outlined in the new plan. Who will cover the cost of packaging and disposal has yet to be decided. Also, to be considered is the challenge of keeping the returned prescriptions safe until destruction. An unsecured, unmonitored return site containing stock piles of addictive drugs would be a gold mine for many addicts and criminals. Should a theft occur at one of these drop-off receptacles, who would be held liable? The American Pharmacists Association has already expressed concern of pharmacy legal liability.

The biggest obstacle of all, however, may be convincing the general public that returning unused pills is a necessary moral obligation.

Comments?

Would you participate in this type of prescription drug return program? As a pharmacist or someone who works at a pharmacy, what are your concerns with this take back program? Please leave any thoughtful comments below.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals. We can review business referral arrangements and provide legal counsel on whether they are not in violation of federal and state anti-referral laws. The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings.

To contact The Health Law Firm, please call (407) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Barrett, Devlin. “U.S. to Allow Pharmacies to Take Back Unused Prescription Drugs.” The Wall Street Journal. (September 08, 2014). From: http://online.wsj.com/articles/u-s-to-allow-pharmacies-to-take-back-unused-prescription-drugs-1410186602

Saint Louis, Catherine. “D.E.A. to Allow Return of Unused Pills to Pharmacies.” The New York Times. (September 08, 2014). From: http://www.nytimes.com/2014/09/09/health/unused-pills-return-to-pharmacies.html?_r=0

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

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Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases

Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal

Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application).

Federal preemption stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling. This interpretation was affirmed by the U.S. Supreme Court in 2011 in the Pliva, Inc. v. Mensing case. The Court, however, left the door open when it added “Congress and the FDA retain the authority to change the law and regulations if they so desire.”

In November 2013, the US Food and Drug Administration (FDA) began the process to do just that when it published a proposed rule that will require generic drug companies to update the labeling of their drugs in light of new safety risks even though the RLD labeling for those products has different information on warnings, precautions, contraindications, adverse reactions and the like.

Under the proposed regulation, when the ANDA holder has “newly acquired information” that presents “sufficient evidence of a causal association” between the unlabeled warning and the approved generic drug, the generic manufacturer must submit a Changes Being Effected (CBE-0) supplement to its ANDA and immediately change its label. Also, the ANDA holder will be required to send the NDA holder both the labeling change and a copy of the information supporting the change. Any changes ultimately approved by FDA would affect both the generic label and the RLD holder’s labeling.

The FDA has noted that “if this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.”

Interested parties wishing to provide input on the proposed rule must submit comments by January 13, 2014. The full text of the proposed rule is available at this link.

The Pliva v. Mensing, 131 S.Ct. 2567 (2011) decision is available at this link: http://www.supremecourt.gov/opinions/10pdf/09-993.pdf.

About the Author: Alina Denis Jarjour is a business attorney, corporate governance / compliance professional and mediator. In addition to being a private practitioner, Alina has served in executive level legal, operational and governance/compliance roles within life sciences, telecommunications and technology companies. Her firm, Jarjour | Legal, works closely with clients engaged in the life sciences, tech / telecom, media, healthcare, consumer products and non-profit activities in and outside of the United States. Alina is an alumna of the University of Pennsylvania Law School, is bilingual (English/Spanish) and speaks frequently on business development, regulatory, compliance, conflict resolution and legal topics.

This article was originally published in the Florida Bar December 2013 Health Law Monthly Updates.

Crackdown in the Supply of Prescription Medications Drive Floridians to Heroin

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

For the past three years, Florida lawmakers and officials have waged war against prescription drug abuse. At the peak of the pill abuse epidemic, seven people a day reportedly died of a prescription drug overdose in Florida. As the Sunshine State became known as painkiller capital of America, officials worked quickly to enact legislation against prescription drugs, develop and monitor the statewide prescription drug monitoring database, and crackdown on prescription drug abusers and pill mills. Flash forward to summer 2013, prescription pills are harder to come by and more expensive, therefore making them less appealing to addicts. However, that does not mean the war is over. Now addicts are finding their replacement fix in heroin, according to the Miami Herald.

Click here to read the entire article from The Miami Herald.

Oxycodone-Related Deaths Down, While Heroin Numbers Rise in Florida.

According to the Florida Department of Law Enforcement’s (FDLE) semi-annual report, oxycodone-related deaths dropped statewide between January and June of 2012, compared to the same period of time in 2011. I previously wrote a blog on the decline of oxycodone-related deaths in Florida. To read that blog, click here.

Now that oxycodone-related deaths are down, heroin numbers are on the rise. According to the Florida Medical Examiners Commission, from July 2010 to June 2011, there were 45 heroin-related deaths statewide. From July 2011 to June 2012, the number jumped to 77 heroin-related deaths. The FDLE is seeing the same trend. In the first three months of 2013, heroin-related charges totaled 948 and in the same three months in 2012, that number was 772.

Florida Officials Try to Fight Heroin.

Lawmakers took dramatic actions to reduce the supply of prescription drugs on the streets. According to the Miami Herald, lawmakers are now trying to fight heroin before it takes off.

Broward County’s substance abuse commission and the Sanford-Brown Institute hosted a workshop to share the news about the growing heroin trend. The commission’s board of governors has formed a task force to put together an anti-heroin campaign. The group is also publicizing the 911 Good Samaritan Act. This Act protects callers from prosecution for possessing or ingesting low-level controlled substances under some circumstances.

The Ultimate Results of Such Crackdowns.

The war on prescription drug abuse took away the supply, but not the demand. Since the crackdown we have seen the largest legitimate pharmacy chains in the state and nation not allowed to fill prescriptions for painkillers. Click here to read a blog on a Walgreens distribution center that was served with an immediate suspension order from the Drug Enforcement Administration (DEA). To read a blog on the DEA pulling the controlled substance licenses from two Central Florida CVS pharmacies.

This has left some patients in dire straits. They are suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think about the increase in heroin use? Is one drug more dangerous than another? Please leave any thoughtful comments below.

Sources:

Burch, Audra. “As Pill Mills Fade Away, Heroin Fills the Void.” The Miami Herald. (May 11, 2013). From: http://www.miamiherald.com/2013/05/11/3392908/as-prescription-pills-fade-heroin.html

Gillen, Michele. “Dangerous Drug Creating New Addicts.” WBFS. (May 22, 2013). From: http://miami.cbslocal.com/2013/05/22/dangerous-drug-creating-new-addicts/

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Two Pharmacists and One Dentist in Central Florida Arrested for Prescribing and Dispensing Prescription Drugs

By Danielle M. Murray, J.D., and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Lakeland Ledger reports that Polk County Sheriff’s Detectives arrested a dentist and two pharmacists on September 5, 2012, in three unrelated cases dealing with illegally prescribing and dispensing painkillers. The sheriff’s office said the three arrests are part of its efforts to target prescription drug abuse.

To read the entire Lakeland Ledger article, click here.

The Arrest of the Dentist’s Daughter Led to His Investigation and Arrest.

In May 2012, the dentist’s daughter was arrested for allegedly forging more than 500 hydrocodone prescriptions. That arrest led deputies and the Department of Health (DOH) to search the dentist’s clinic. According to the Lakeland Ledger article, out of 43 patient files randomly selected, 31 patients were being prescribed hydrocodone without any documentation.

The Polk County Sheriff’s Office stated that the dentist has been charged with knowingly overprescribing controlled narcotics.

To see the press release from the sheriff’s office on the dentist’s arrest, click here.

Both Pharmacists Caught by Undercover Detectives.

According to the Lakeland Ledger, the two pharmacists that were arrested allegedly illegally dispensed either oxycodone or hydrocodone to undercover detectives. The pharmacists have been charged with trafficking prescription painkillers.

Click here to see the press release on the pharmacists’ arrests from the Polk County Sheriff’s Office.

Arrests Part of Crack Down on Abuse of Prescription Drugs.

According to the Polk County Sheriff’s Office, these arrests are part of an ongoing investigation to target doctors and pharmacists that are improperly prescribing and dispensing prescription medications.

There is an article on our website on legal tips for physicians to manage pain patients. To read that piece, click here.

Criminal Arrest of Over-Prescribers May come From Many Different Agencies.

Physicians and pharmacists who are involved in schemes relating to overprescibing or trafficking in narcotics may be targeted by many different agencies. The local sheriff’s office or police department is just one of them.

We have represented physicians who have been the subjects of Drug Enforcement Administration (DEA) investigations. The DEA will often use undercover agents and informants to pose as patients, wired for audio recording. The DEA will often work with local law enforcement authorities and the Department of Health (DOH).

Other investigations and arrests may be initiated by a statewide prosecutor’s office, which is under the Attorney General. Still others have been initiated by the Medicaid Fraud Control Unit (MFCU) where Medicaid funds are used.

Contact Health Law Attorneys Experienced in Representing Health Care Providers in DOH Cases.

The Health Law Firm represents pharmacists, pharmacies, physicians, nurses, and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.

If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Malagon, Elvia. “Lakeland Dentist and Two Pharmacists Charged with Prescription Drug Violation.” The Lakeland Ledger. (September 5, 2012). From: http://www.theledger.com/article/20120905/NEWS/120909682?template=printart

Eleazer, Carrie. “PCSO Detectives Arrest Two Pharmacists from Trafficking in Prescription Drugs.” Polk County Sheriff’s Office. (September 5, 2012).  From: http://www.polksheriff.org/NewsRoom/Pages/09-05-2012PCSO%20DetectivesArrestTwoPharmacistsForTraffickinginPrescriptionDrugs.aspx

Eleazer, Carrie. “Dr. William Johnson of Sonrise Dental Clinic Arrested.” Polk County Sheriff’s Office. (September 5, 2012). From: http://www.polksheriff.org/NewsRoom/News%20Releases/Pages/09-05-2012.aspx

About the Authors: Danielle M. Murray is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.