Letters to the Editor In-House Drug Diversion by Hospital Personnel To the Editor: I just downloaded and read Stephen Barlas’ September 2013 article in P&T titled: “Prescription Drug Abuse Hits Hospitals Hard: Tighter Federal Steps Aim to Deflate Crisis” (pages 531–534). I want to commend him on the thoroughness and clarity he showed in this piece for a very complicated and sometimes arcane issue. I have been writing about similar subjects for a number of years, and his quote of Dr. Frieden of the Centers for Disease Control and Prevention was somewhat reminiscent of something that Lyndon E. Lee Jr., MD, a noted surgeon and leader in the medical community, once said: “The use of narcotics in the terminal cancer patient is to be condemned if it can possibly be avoided. Morphine and terminal cancer are in no way synonymous. Morphine usage is an unpleasant experience to the majority of human subjects because of undesirable side effects. Dominant in the list of these unfortunate effects is addiction.” The difference here is that Dr. Lee was saying this in a Journal of the American Medical Association article published in 1941! (See: Medication in the control of pain in terminal cancer. JAMA 1941;116(3):216–220.) As Mr. Barlas’ article seems to suggest, hospitals have become natural targets for drug-seeking patients and would-be patients obtaining drugs to feed their addictions. The widespread of use of technology by our hospitals today, in my opinion, may have weakened the supervision of nursing staff and other health care workers who are in charge of dispensing and delivering drugs to patients. The emphasis on preventing medication errors has increased the use of technology. It also has provided ways and means for corrupt employees to game the systems by defeating inventory systems and other computer-based systems designed to keep track of controlled substances in the hospital setting.
Quality Measures at Compounding Facilities To the Editor: Your article on FDA regulation of compounding pharmacy and outsourcing facilities (“FDA Draft Guidances Compound the Compounding Uncertainty,” June 2014 [pages 424–426, 435]) did not present readers with a full and complete picture of quality measures in place at FDA-registered outsourcing facilities, and instead relied on a series of FDA reports that in many instances predated the law that created the new outsourcing facility category. In the case of Cantrell Drug Company, we never received an FDA warning letter, as the article asserts. We received a Form 483, and the period it covered was before the Drug Quality and Security Act (DQSA) was passed and before we became an outsourcing facility. Moreover, the author seems to use “Form 483” and “warning letter” interchangeably, but they are separate and distinct actions. We provided a detailed response to the FDA’s Form 483. As the author himself noted, the FDA generally leaves “open” Form 483s, even when they have received a thorough response and all observations have been addressed, which occurred in the instance of Cantrell. Prior to its registration with the FDA as an outsourcing
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Since the beginning of the modern drug abuse epidemic (circa mid-1990s) involving prescription opioids, for example, the regulatory focus initially was placed on the prescribers and dispensers of the drugs—the most visible and obvious “sources.” About 10 years ago, the Drug Enforcement Administration added a new target to its strategy, the wholesale distributor. As Mr. Barlas notes, there have been a number of large fines imposed on errant distributors accused of not preventing diversion of controlled substances. It is my belief that the third and possible final target in this trilogy will be the hospitals and long-term care facilities where large-scale diversion of controlled substances occurs, often with catastrophic consequences for patients and the institutions that must spend millions of dollars in judgments and remedial health care costs for exposed patients. When it comes to protecting against in-house drug diversion by hospital personnel, the literature is almost nonexistent. The Mayo Clinic has done some recent publishing of articles in its house journal, but that has been part of its own expensive and extensive cleaning up of a lot of problems detected in the seven major facilities that it owns and operates. Most books written on the subject of hospital security deal with equipment and inventory protection. Very little has been written about drug diversion within the hospital environment itself, and what little there is, is obsolete, to say the least. John J. Coleman, PhD Assistant Administrator (retired) Drug Enforcement Administration Chicago, Illinois  Editor’s note: Mr. Coleman is seeking a collaborator to coauthor a book with him about drug diversion in the hospital environment. He can be reached at [email protected]. facility, Cantrell Drug Company for many years maintained a valid FDA registration for drug manufacturing/compounding, an uncommon and deliberate quality assurance decision at the time. We have had an impeccable record on quality and compliance, as a result of a rigorous quality assurance program that adheres to applicable current Good Manufacturing Practices (cGMP). Through the passage of the DQSA and enhanced state oversight and regulation, the quality of compounded medications has never been better, and that is the point that should have been communicated in P&T. Dell McCarley, PharmD Chief Executive Officer Cantrell Drug Company Little Rock, Arkansas Editor’s note: The author of the article, Stephen Barlas, notes that he attempted via telephone, and in an email exchange with Dr. McCarley’s assistant, to arrange an interview to discuss this issue prior to the article’s publication. However, he did not receive a response. The statement that the quality of compounded medications has never been better is open to debate.
Quality Measures at Compounding Facilities To the Editor: Your article on FDA regulation of compounding pharmacy and outsourcing facilities (“FDA Draft Guidances Compound the Compounding Uncertainty,” June 2014 [pages 424–426, 435]) did not present readers with a full and complete picture of quality measures in place at FDA-registered outsourcing facilities, and instead relied on a series of FDA reports that in many instances predated the law that created the new outsourcing facility category. In the case of Cantrell Drug Company, we never received an FDA warning letter, as the article asserts. We received a Form 483, and the period it covered was before the Drug Quality and Security Act (DQSA) was passed and before we became an outsourcing facility. Moreover, the author seems to use “Form 483” and “warning letter” interchangeably, but they are separate and distinct actions. We provided a detailed response to the FDA’s Form 483. As the author himself noted, the FDA generally leaves “open” Form 483s, even when they have received a thorough response and all observations have been addressed, which occurred in the instance of Cantrell. Prior to its registration with the FDA as an outsourcing
534 P&T • ®
August 2014 • Vol. 39 No. 8
Since the beginning of the modern drug abuse epidemic (circa mid-1990s) involving prescription opioids, for example, the regulatory focus initially was placed on the prescribers and dispensers of the drugs—the most visible and obvious “sources.” About 10 years ago, the Drug Enforcement Administration added a new target to its strategy, the wholesale distributor. As Mr. Barlas notes, there have been a number of large fines imposed on errant distributors accused of not preventing diversion of controlled substances. It is my belief that the third and possible final target in this trilogy will be the hospitals and long-term care facilities where large-scale diversion of controlled substances occurs, often with catastrophic consequences for patients and the institutions that must spend millions of dollars in judgments and remedial health care costs for exposed patients. When it comes to protecting against in-house drug diversion by hospital personnel, the literature is almost nonexistent. The Mayo Clinic has done some recent publishing of articles in its house journal, but that has been part of its own expensive and extensive cleaning up of a lot of problems detected in the seven major facilities that it owns and operates. Most books written on the subject of hospital security deal with equipment and inventory protection. Very little has been written about drug diversion within the hospital environment itself, and what little there is, is obsolete, to say the least. John J. Coleman, PhD Assistant Administrator (retired) Drug Enforcement Administration Chicago, Illinois  Editor’s note: Mr. Coleman is seeking a collaborator to coauthor a book with him about drug diversion in the hospital environment. He can be reached at [email protected]. facility, Cantrell Drug Company for many years maintained a valid FDA registration for drug manufacturing/compounding, an uncommon and deliberate quality assurance decision at the time. We have had an impeccable record on quality and compliance, as a result of a rigorous quality assurance program that adheres to applicable current Good Manufacturing Practices (cGMP). Through the passage of the DQSA and enhanced state oversight and regulation, the quality of compounded medications has never been better, and that is the point that should have been communicated in P&T. Dell McCarley, PharmD Chief Executive Officer Cantrell Drug Company Little Rock, Arkansas Editor’s note: The author of the article, Stephen Barlas, notes that he attempted via telephone, and in an email exchange with Dr. McCarley’s assistant, to arrange an interview to discuss this issue prior to the article’s publication. However, he did not receive a response. The statement that the quality of compounded medications has never been better is open to debate.
