PRS 101 FOUNDATIONS OF PHARMACY REGULATION PRS 101.3: THE DRUG ENFORCEMENT ADMINISTRATION REGULATORY ROLE DR. BRUSHWOOD S MONOGRAPH

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1 PRS 101 FOUNDATIONS OF PHARMACY REGULATION PRS 101.3: THE DRUG ENFORCEMENT ADMINISTRATION REGULATORY ROLE DR. BRUSHWOOD S MONOGRAPH

2 PRS THE DRUG ENFORCEMENT ADMINISTRATION REGULATORY ROLE ACTIVITY DESCRIPTION This class explores how a law enforcement agency with a traditional supply-side focus on the interdiction and elimination of illicit drugs with no medical value, can expand its role into reducing abuse of prescription drugs that do have a legitimate role in medicine. The success of the War on Drugs is considered, along with the consequences of the warfare strategy toward drug abuse. The class compares the regulatory approaches of voluntary compliance and strong enforcement. The class reviews the regulatory implications for pharmacists of state assisted suicide and medical marijuana laws. This monograph can be taken as a standalone 1 credit hour home study in law (ACPE accredited) but is also a component of the Pharmacy Regulatory Specialist curriculum. To qualify as a PRS, one must enroll in each of the five (5) live PRS pharmacy law webinars given throughout the year and successfully complete twenty-six (26) one-credit monographs. Once all requirements have been completed, the participant must pass a final comprehensive exam (70% or higher) and pay $199 for the recording and issuing of the Pharmacy Regulatory Specialist Certificate. TARGET AUDIENCE The target audience for this activity is pharmacists and pharmacy technicians in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist will be able to: Describe the authority of the DEA under the CSA Discuss the crisis of prescription drug abuse List major requirements for pharmacies under DEA regulations. ACCREDITATION PHARMACY PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. NURSING PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number ). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit Universal Activity No.: H03-P&T Credits: 1 contact hour (0.1 CEU) Release Date: April 1, 2014 Expiration Date: April 1, 2016 ACTIVITY TYPE Knowledge-Based Home Study Monograph FINANCIAL SUPPORT BY PharmCon After completing this activity, the pharmacy technician will be able to: Describe the authority of the DEA under the CSA Discuss the crisis of prescription drug abuse List major requirements for pharmacies under DEA regulations 1

3 ABOUT THE AUTHOR David Brushwood is professor of Pharmaceutical Outcomes and Policy at the University of Florida College of Pharmacy. A graduate of the schools of pharmacy and law at the University of Kansas, professor Brushwood practiced both professions prior to entering academia. Professor Brushwood has developed error prevention programs for several pharmacy chains. His research interests are in the areas of regulating for outcomes, medication error prevention, and pain management policy. He has received grant funding from numerous agencies including the Robert Wood Johnson Foundation, the National Institutes of Health, and the National Community Pharmacy Foundation. Professor Brushwood received the 2012 Pellegrino Medal. The award honors nationally-recognized leaders for contributions to healthcare ethics in the selfless spirit of Edmund D. Pellegrino. He also has twice been selected as a Mayday Scholar in Pain Policy by the American Society of Law, Medicine & Ethics. Professor Brushwood is a frequent contributor to pharmacy journals and to law journals. He developed, and serves as an advisor for the UF online Master of Science in Pharmacy, a graduate program offering seven areas of specialization in regulatory pharmaceutical fields. David Brushwood, JD, RPh Professor, University of Florida School of Pharmacy FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. David Brushwood reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, authors may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient or pharmacy management. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this monograph and other unrelated sources. 2

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12 ACTIVITY TEST 1. In what year did US Congress pass the Harrison Narcotics Tax Act? A B C D According to the Federation of State Medical Boards (FSMB), there is a state of biologic adaptation evidenced by a withdrawal syndrome when the drug is abruptly discontinued. What is this called according to FSMB definitions? A. Abuse. B. Tolerance. C. Dependence. D. Addiction. 3. According to the Supreme Court of the United States, what is the status of state-approved medical marijuana under federal law? A. Legal, because states have the right to determine what constitutes appropriate medical use. B. Legal, because the DEA approves of medical marijuana. C. Illegal, because consuming one s locally grown marijuana affects interstate commerce in marijuana. D. Illegal, because users of marijuana are hardened criminals who threaten society. 4. According to the Supreme Court of the United States, what is the status of state-approved assisted death under federal law? A. Legal, because states have the right to determine what constitutes appropriate medical use. B. Legal, because the CSA specifically approves assisted death as a legitimate medical purpose. C. Illegal, because assisted death in one state affects the dying process in all states. D. Illegal, because assisting death is immoral and it threatens society. 5. In what year was OxyContin approved? A B C D

13 6. What is the best solution to the problem of prescription drug abuse? A. Abuse-deterrent technology that uses an opioid antagonist. B. Abuse-deterrent technology that creates a gummy matrix when a tablet is crushed. C. Abuse-deterrent technology that includes a low dose of an aversive drug. D. A new molecule that is not abused. 7. If a wholesaler discovers a suspicious order from a pharmacy, to whom must this suspicious order be reported? A. The pharmacy s pharmacist in charge. B. The local police. C. The state board of pharmacy. D. The DEA. 8. With what frequency must a pharmacy DEA registration be renewed? A. Every year. B. Every two years. C. Every three years. D. Every four years. 9. If a pharmacy experiences a theft or significant loss of controlled substances, on what form must this be reported to the DEA? A. Form 41. B. Form 106. C. Form 222. D. Form 222a. 10. In a LTCF that has an automated dispensing system (ADS), drugs still contained within the system are considered whose property? A. They are considered LTCF property. B. They are considered pharmacy stock. C. They are considered the patient s property. D. They are considered the prescriber s property. Please submit your final responses on freece.com. Thank you. 12