For Paul Brand, PharmD, AE-C, owner of Florence Pharmacy in Florence, MT, the prescription drug monitoring program is one of the best tools his state government has come up with recently to address the rise in prescription drug abuse and the related human tragedy. On the federal level, he feels that DEA’s 2014 final rule on the disposal of controlled substances also has the potential to help.
He’s also noticed that nationally, DEA has become more active in enforcing laws pertaining to controlled substance prescriptions. At the same time, busy physicians may not realize that the pharmacist on the phone has corresponding responsibility under the Controlled Substances Act. Meanwhile, robberies and break-ins related to prescription drug abuse have added to the challenges, and unfortunately, Florence Pharmacy has experienced this firsthand. In the first of two incidents, somebody broke into the pharmacy through a window and stole a bunch of prepared prescriptions, but didn’t get much—mostly antidepressants. After that, Brand had to spend quite a bit of money to change the alarm system and install unbreakable glass on all the windows and front doors.
“It is definitely more stressful to work in the current environment because of the explosion of prescription drug abuse. I think it’s something that we all, working together, can fix. I think there’s been great strides in the last few years,” Brand said in an interview on September 10. “We don’t let up. We continue trying to find ways to curb the abuse, and yet still help the people who need help.”
This article is the first in Pharmacy Today’s “Challenges of Pain” series. The series will show how a confluence of issues around prescription drug abuse and misuse is affecting frontline pharmacists and their patients, including those with legitimate pain needs. This month’s article focuses on the impact of federal and state government responses to the nationwide crisis. A second article in November will look at the law enforcement side. A third article in December will highlight potential solutions.
In the medical community, the concept of “pain as the fifth vital sign” took off in the second half of the 1990s. From 1999 to 2013, the quantity of prescription opioids dispensed in the United States nearly quadrupled, yet “there has not been an overall change in the amount of pain that Americans report,” according to the CDC website. Each day, 44 people across the country die from overdose of prescription opioids. The most common drugs involved in prescription overdose deaths are hydrocodone, oxycodone, oxymorphone, and methadone; these deaths also often involve benzodiazepines. People who are addicted to prescription opioids are 40 times more likely to be addicted to heroin, and as heroin use has increased, so have heroin-related overdose deaths.
At the fourth annual National Rx Drug Abuse Summit in April in Atlanta, White House Office of National Drug Control Policy (ONDCP) Director Michael P. Botticelli’s talk was titled: We Don’t Have Time to Wait. “In 1999, there was one drug overdose death on average every 30 minutes. In 2013, however, there was one overdose death on average every 12 minutes,” Botticelli said. Referring to the Obama administration’s April 2011 plan, Epidemic: Responding to America’s Prescription Drug Abuse Crisis, he said that since then, “we have made progress in accomplishing many of the goals established under each of the plan’s four pillars: education, monitoring, drug disposal, and enforcement.” According to the CDC website, 2012 saw the first national drop and leveling off in prescription overdose deaths since the 1990s.
In the plan’s area of education and research and development, pharmacists have seen FDA’s July 2012 approval of a classwide Risk Evaluation and Mitigation Strategies for extended-release/long-acting (ER/LA) opioid analgesics that was years in the making; pharmacists dispense the Medication Guide and can use it with other written information when talking with patients. On April 1, FDA issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.
FDA approved a new abuse-deterrent formulation of oxycodone with naloxone in extended-release tablets (Targiniq ER—Purdue Pharma) in July 2014. This followed the controversial October 2013 approval of Zogenix’s single-entity hydrocodone product (Zohydro ER) that lacked abuse-deterrent properties—a day after FDA had announced its intent to recommend that DEA move combination hydrocodone products from Schedule III to Schedule II. DEA did so in a final rule published in August 2014.
Alyson Roby, PharmD, CDE, practices at central Kentucky’s Medica Pharmacy & Wellness Center, with two locations in Bardstown and Bloomfield. “Every year, we run our year-end reports, and this has been consistent: our number one dispensed medication has been—for the past 10-plus years—hydrocodone,” she said. According to the National Institute on Drug Abuse, the United States consumes almost 100% of the world total of hydrocodone prescriptions and 81% of oxycodone prescriptions. “I mean, do we really have that many people who need hydrocodone? I have a hard time believing that we do,” Roby said.
On the other hand, she believes it may be more difficult for patients who need pain meds to obtain them. “I do feel, and my other pharmacist who’s with me today feels, like part of this crackdown is such a big stigma with pain medicines that your general practitioner is not as willing to write for pain patients who are legitimate,” Roby continued. “We actually had a physician [who] still has some long-term patients of his that he will prescribe hydrocodone. But we sure do see a lot more of the acetaminophen with codeine, instead of the hydrocodone, from his office.”
In the area of monitoring, when the 2011 plan was released, 43 states had authorized prescription drug monitoring programs (PDMPs). Today, Botticelli said in April, all states but one have an electronic database—and given this year’s legislative activity in that remaining state, Missouri, “we are cautiously optimistic that this means 2015 will be the year we can finally say we have a national PDMP infrastructure.” APhA policy approved by this year’s House of Delegates supports nationwide integration of PDMPs.
The National Association of Boards of Pharmacy’s PMP InterConnect facilitates the transfer of prescription monitoring program (PMP) data across state lines to authorized users, according to the NABP website. As Today went to press, authorized users in 30 states and counting may gain access to interstate data by logging directly into the state PDMP where they are a registered user. On September 4, CDC announced the launch of a new program to “help states end the ongoing prescription drug overdose epidemic,” as part of the U.S. Department of Health & Human Services’ Opioid Initiative; 16 states were selected to receive annual awards of up to $1 million to enhance their PDMPs, work with insurers to help providers make informed prescribing decisions, and for other actions related to prescription opioid abuse and heroin use.
Montana’s PDMP is a very helpful tool, Brand said. “It’s easier for us to monitor our patients, make sure they’re following what they’re supposed to be doing, and make sure they’re not doctor shopping.” In 2010, before the PDMP became operational in 2012, Montana’s people suffered 300 prescription drug overdose deaths. In 2013, the number of deaths dropped to 109. Yellowstone County, MT, reported a 70% reduction in the number of people prosecuted for prescription drug crimes from 2011 to 2013, he added.
The PDMP has technical issues that are to be expected and logs out after a little time of inactivity. “It’s not super convenient, but it’s very doable,” Brand said. “If you’re going to prescribe or dispense [a controlled substance], in my opinion, you have a responsibility to use tools such as the prescription monitoring program to ensure that the right patient is getting it for the right reasons, and decrease the chance of it getting into the wrong hands.”
In 2010, DEA legalized electronic prescription transmission of all controlled substances, with several conditions; on September 15, Vermont became the final state to allow e-prescribing for all controlled substances, according to the National Association of Chain Drug Stores website. “As we have already come to realize,” Brand said, “faxing, phoning, and even writing controlled substances can lead to diversion.”
In the area of drug disposal, Botticelli said at the summit that “since the majority of individuals who begin misusing prescription drugs get them from family and friends, we must make it easy to dispose of leftover drugs.” Noting that DEA published a final rule on changes to controlled substance disposal in 2014, he continued, “Now ONDCP and our federal partners and stakeholders are beginning to inform the public about these regulations and looking for ways to stimulate local disposal programs in partnerships with pharmacies and law enforcement.”
As previously reported in Today, the DEA final rule allows community pharmacies to partner with law enforcement agencies in take-back events and gives patients the option of mailing their unused, unwanted, or expired prescription medications or placing them in pharmacy-maintained collection receptacles, in addition to the currently authorized receptacles at local law enforcement agencies. The final rule implements the Secure and Responsible Drug Disposal Act of 2010. Following Congress’s passage of the law, DEA also held nine take-back events from 2010 to 2014—during which a total of 2,411 tons of drugs were collected. On September 12 and 26, DEA held its 10th National Prescription Drug Take-Back in every state; collection sites were set up in communities across the country.
John Clay Kirtley, PharmD, Executive Director of the Arkansas State Board of Pharmacy, said in an interview on September 11, “We’re having to educate pharmacists to help patients understand that … most of the kids who are taking these drugs are getting them from loved ones, from medicine cabinets, from friends. They’re not buying them from a dealer. They’re not growing a marijuana patch out somewhere. They’re getting prescription drugs because they are so readily available”—and deemed “safe and effective” by FDA and the medical professionals who prescribe and dispense them, even though they “absolutely take lives.”
Before the 2014 regulation was released, patients had few options for disposing of medications. Their options were primarily restricted to DEA or law enforcement take-back days and receptacles located in law enforcement agencies. Now law enforcement agencies can partner with others in the community, including pharmacies, to hold these events. In addition, pharmacies can voluntarily participate in medication disposal by providing secured receptacles. Community pharmacies can be more convenient and less intimidating, making disposal of controlled substances more accessible to the patient. Since his store started to participate in medication disposal, “we’ve taken back over 35 pounds in just a few months,” Brand said.
More pharmacies may not be participating because only a couple of companies offer disposal receptacles that a pharmacy can use and that follow all DEA regulations, and also because of the cost, Brand thinks. The day after his interview with Today, Montana’s Attorney General awarded 13 pharmacies a total of $26,000 to implement or continue take-back programs, including Florence Pharmacy. The funding can be used to pay for a permanent collection box, signage, destruction of collected materials, advertising, or any other related expense; and grant recipients are to document and submit data about their programs to the attorney general’s office on a quarterly basis.
In the area of enforcement, Botticelli said, “Work on enforcement and strengthening existing laws is ongoing at the federal, state, and local levels. Those engaged in fraud across the controlled drug supply chain are being investigated and prosecuted.” (Look for this series’ second article on law enforcement.)
An enormous, concerted, and interconnected effort at all levels of government and among stakeholders in communities is making a difference—but Sarah T. Melton, PharmD, BCPP, BCACP, CGP, FASCP, said in an interview on September 13 that “we’re not where we need to be, by any means.”
Melton, an Associate Professor of Pharmacy Practice at East Tennessee State University’s Gatton College of Pharmacy who is also the Clinical Pharmacist at the Johnson City Community Health Center in Johnson City, TN, and at Highpower PC in Lebanon, VA, testified on March 26 before the House Energy & Commerce Subcommittee on Oversight and Investigations at its hearing, Examining the Growing Problems of Prescription Drug and Heroin Abuse: State and Local Perspectives. Melton chairs One Care of Southwest Virginia, a regional consortium of 16 substance abuse coalitions.
She spoke on ensuring that prescribers and dispensers of controlled substances have adequate education on addiction and treatment of chronic pain; access to naloxone; medication-assisted treatments with methadone, buprenorphine, or naltrexone as part of a comprehensive treatment plan for opioid use disorders; PDMPs; and drug disposal and storage.
Melton was taking part in a series of subcommittee hearings—among them a hearing on May 1, What Is the Federal Government Doing to Combat the Opioid Abuse Epidemic?, a hearing on May 21, What are the State Governments Doing to Combat the Opioid Abuse Epidemic?.
“I think more pharmacists are being educated that addiction is a disease. It’s not a moral failure or just making poor decisions,” Melton told Today. “We used to hear that all the time, and it led to great stigma and patients not getting the help they need. Now I hear more pharmacists with an understanding of the process of how someone goes from taking a medicine they were prescribed for a legitimate medical purpose to behaviors of pharmacy shopping, doctor shopping, and doing things they never would’ve thought they would—because of addiction.”
Kirtley has been at the Arkansas Board of Pharmacy for more than a decade. For most of the professionals whose cases he’s worked on, “addiction started with a legitimate prescription for a legitimate medical reason,” he said. Usually that person can “literally tell you the time when it happened. They had certain stressors in their lives. And even though they may have been subjected to those substances before, that day, something clicked off in their brain. And it was off to the races.” For other people, Kirtley continued, “It’s a slow, innocent-seeming, insidious process.”
It absolutely can happen to anyone, he said. “By the grace of God.”