Michael Jackson, BSPharm, knows “the tremendous, overwhelming pressure” that pharmacists are under these days. He’s the executive vice president and CEO of the Florida Pharmacy Association in a state “above the curve” in dispensing and prescribing controlled substances.
“You’ve got pressure from consumers who are needing their prescription filled. You actually have … consumers who are looking to get prescriptions filled … illegitimately. You have to now serve as the steward to prevent that from happening,” Jackson said. “You have the Drug Enforcement Administration that’s looking very closely at you, and pharmacists are not wanting to be on their radar screen. You have prescription drug wholesalers that are trying to protect the integrity of their businesses, limiting what’s being issued to pharmacies.”
He continued that employee pharmacists in large pharmacy organizations must adhere to certain protocols, standards, and procedures for dispensing controlled substances “for fear of violating that policy and coming under employment scrutiny by the folks that they work for.”
It gets dangerous for pharmacists who discover that a prescription was issued for other than a legitimate medical purpose and is clearly intended for drug diversion, or who have to say no because “some very aberrant behavior is going on”—there’s no telling what kind of reaction they’ll get from the consumer in the pharmacy. “You don’t know what’s going to come out from underneath the overcoat,” Jackson said. “I’ve had to look down the barrel of a gun before. So I know precisely how that feels.”
This article on the law enforcement side of prescription drug abuse—including the rise in pharmacy crime, such as robberies, and DEA’s aggressive approach to enforcing the Controlled Substances Act in health care facilities like pharmacies—is the second in Pharmacy Today’s “Challenges of Pain” series. The series shows how pharmacists and their patients with legitimate pain needs are affected by issues and efforts around prescription drug abuse. Last month’s article focused on the impact of federal and state government responses to the crisis. A third article will highlight potential solutions.
“You’ve heard the story of the pharmacist on Long Island,” Jackson said, referring to the senseless killings at Haven Drugs in Medford, NY, in 2011. “Innocent people killed—and it happens with alarming regularity within our industry.” APhA Immediate Past President Matt Osterhaus, BSPharm, FASCP, FAPhA, a co-owner of Osterhaus Pharmacy in the small town of Maquoketa, IA, said, “We’ve had friends and colleagues who’ve been killed or injured.”
Jackson noted that pharmacies are located at street level and that pharmacists aren’t behind bulletproof glass like certain banks are. “Our job gets us face to face with consumers. We have to be in a position to be able to touch them to give immunizations and things like that,” he said. “As an association, we’re very concerned over the safety of our pharmacists, and [the risk to] safety is not going to go away—especially when we’re asking our pharmacists to get closer to patients and help them to understand their therapy.”
On September 30, Pharmacists Mutual Insurance Company announced publication of a report, Pharmacy Crime: A Look at Pharmacy Burglary and Robbery in the United States and the Strategies and Tactics Needed to Manage the Problem (https://apps.phmic.com/RMNLFlipbook/PharmacyCrime2015/).
“What’s reported is our own research and the best that we could gather from other sources like the DEA,” said Michael L. Warren, ARM, OSHT, risk manager of Pharmacists Mutual Companies, based in Algona, IA. “We need pharmacists to understand the problem’s not getting better. It’s getting worse.”
According to the Pharmacists Mutual report, the number of robberies reported to DEA has trended up from 2011 to 2014 and was projected to continue to increase for 2015. The report explained that not all robberies are reported to DEA. (See Figure 1.)
Pharmacy crime is always on the mind of pharmacists. “A lot of it is the frustration—some claims can be very, very expensive—but it’s mostly the hassle and the emotional shock,” Warren said. “Hearing on the phone what pharmacists go through when they put up with this—it’s an absolute nightmare.”
Warren said that after a claim is reported to the claims department, his role includes telling pharmacists what they can do to help prevent it from happening again. Following are some of his recommendations:
The pharmacies that end up having to spend the most to protect themselves are in the areas of the country getting hit the most frequently. “For example, if you’re in Houston, that’s one of the hot spots in the country. … Now you also have to deal with people coming in through the roof or coming in through an adjacent occupancy, or crawling across the floor to avoid motion sensors. So you have to ramp up the expense.”
The demand for these drugs remains the same, but it’s harder than ever to obtain them, Warren said. “Our concern is that this will mean more burglaries and robberies.”
According to the Pharmacists Mutual report, DEA “currently devotes over 50% of its resources on prescription narcotics.” The number of DEA investigations of pharmacies “over the last 5 years has become rampant,” said Dan Buffington, PharmD, MBA, the practice director at Clinical Pharmacology Services in Tampa, FL, and an APhA Trustee-elect. “These are becoming commonplace.” He also is an expert witness in DEA cases involving medical or pharmacy practice and controlled substance issues.
On top of DEA’s historical focus on illicit substance abuse, the agency has added to its responsibilities the increasing problem of prescription drug abuse, Buffington said. But “DEA does not appear to have changed its tactics and methods [for] health care settings. The DEA’s not a health care organization, by any means. It’s a law enforcement organization.” While bad physicians and pharmacists have participated in illegal activity for financial gain, they represent a small subset of their professions.
“Drug wholesalers are inappropriately pressured by the DEA,” Buffington explained. “Same thing at the point of care and pharmacies. There’s ambiguity over the DEA’s current methods and messaging.”
Demetra Ashley, associate deputy assistant administrator for DEA’s Office of Diversion Control, who was a diversion investigator, said, “Our mission ultimately is to protect the public. In doing so, certainly we work with pharmacies—all DEA registrants—to ensure that they’re in compliance with federal regulations.”
In June, the Government Accountability Office (GAO) released a report, More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access (www.gao.gov/products/GAO-15-471). Requested by seven U.S. senators, the GAO report said in a background section that “questions have been raised about how and the extent to which DEA interacts with its registrants and other nonfederal stakeholders on issues related to reducing prescription drug abuse and diversion, as well as whether DEA’s enforcement actions have struck the right balance between reducing diversion and ensuring access for legitimate medical needs.”
GAO administered “nationally representative” Web-based surveys in 2014 to DEA-registered distributors, “individual” (independent or small chain) pharmacies, chain pharmacy corporate offices, and “practitioners” (DEA-categorized practitioners such as physicians, and DEA-categorized midlevel practitioners such as nurse practitioners and physician assistants). GAO also interviewed DEA officials; national associations and other nonprofits; and government agencies in four representative states.
According to the GAO report, from fiscal years 2009 to 2013, the total number of DEA-scheduled regulatory investigations initiated for pharmacies trended up from 15 in 2009 to 97 in 2013, based on a GAO analysis of DEA data. Over the same time period, the total number of DEA complaint investigations initiated for pharmacies rose from 99 in 2009 to 383 in 2013.
According to the GAO report, since January 1, 2012, many individual pharmacies and pharmacy chains have been influenced by DEA enforcement actions—or the business climate those actions may have created—to make changes to business practices related to controlled substances.
For example, an increase in the number of delays in filling prescriptions to check for legitimate medical need took place at 58% of individual pharmacies and 91% of pharmacy chains. Also, an increase in the number of denials of prescription requests that couldn’t be verified for legitimate medical needs occurred at 45% of individual pharmacies and 84% of pharmacy chains. The decision to no longer dispense a specific controlled substance was made at 24% of individual pharmacies and 25% of pharmacy chains.
Further, distributors have put thresholds on the quantity of substances that could be ordered for 62% of individual pharmacies and 91% of chain pharmacies. And distributors have canceled or suspended pharmacy orders for 25% of individual pharmacies and 81% of chain pharmacies.
Osterhaus noted that a couple of years ago, his pharmacy’s wholesaler was unable to fulfill an order because the monthly limit had been reached. Osterhaus got on the phone with the wholesaler, started to investigate, and was able to resolve the problem in about 48 hours. The wholesaler’s stance was DEA had put them in that position, but there was no need to have a crisis situation, Osterhaus said. “DEA and wholesalers and community pharmacists need to sit down together.” Other reports suggest that a positive outcome is not always the case.
A section of the GAO report noted how “many registrants have changed certain business practices as a result of DEA enforcement actions and reported these changes have limited legitimate access.” GAO wrote that in the open-ended responses to its survey, a chain pharmacy corporate office reported that “pharmacists are afraid of being the target of DEA enforcement actions even if they fill a prescription in good faith and with good judgment.”
In these open-ended responses, GAO continued, an independent pharmacy reported that “it turned away patients without taking steps to verify whether a controlled substance prescription was legitimate because the pharmacy could not serve new controlled substance patients without risking being cut off by its distributor.” This pharmacy told GAO, “DEA has clearly stated it is not calling for distributor cutoffs (i.e., thresholds), but their distributors have communicated that these changes are made because of fear of DEA enforcement actions, which has led many pharmacies to refuse to fill legitimate prescriptions.”
But DEA officials in the four DEA field office divisions GAO spoke with said that “they generally did not think that their enforcement actions have had a negative effect on access,” and headquarters officials from DEA’s Office of Diversion Control “indicated that they did not believe their enforcement actions had any bearing on access issues.”
In DEA’s May 29 response to the report before it was published, Joseph T. Rannazzisi, BSPharm, JD, then deputy assistant administrator for DEA’s Office of Diversion Control, wrote, “DEA does not take administrative enforcement action against pharmacies that fill prescriptions in good faith and with sound professional judgment. However, it should be noted that one of the purposes of administrative enforcement actions is to serve as a deterrent to other registrants.”
Rannazzisi continued, “DEA has repeatedly stressed to pharmacists that they have a professional responsibility to dispense prescriptions to benefit their patients, they must rely on their education, training, and experience when dispensing prescriptions, and the importance of seeking guidance from the state pharmacy board as well as the DEA when in doubt about the legitimacy of the prescription.”
Pharmacists “need to be aware and prepared for potential fraudulent prescriptions,” Buffington explained. What can pharmacists do to improve their position with DEA? Following are some of his recommendations:
Buffington said, “Physicians, pharmacies, hospitals, and clinics around the country are pleading with the DEA to change their tactics and to collaborate with health professionals to identify and eliminate the small number of inappropriate prescribers and pharmacists.”