Pharmacists and the Controlled Substances Act: Liability Under the Corresponding Responsibility Doctrine

Transcription

1 Pharmacists and the Controlled Substances Act: Liability Under the Corresponding Responsibility Doctrine Los Angeles, CA November 12, :15 AM 10:30 AM

2 Session 2: Pharmacists and the Controlled Substances Act: Liability Under the Learning Objectives Analyze drug enforcement regulations and recent case law decisions regarding a pharmacist s liability for dispensing controlled substances. Develop dispensing strategies to reduce potential liability for pharmacists. Faculty Paul M. Garbarini, JD, RPh Attorney, Private Practice Northampton, Massachusetts Mr Garbarini is an attorney in private practice in Northampton, Massachusetts. His practice concentrates on the area of representation of health care professionals in administrative hearings, legislative matters, and other civil and criminal matters. He is also a licensed registered pharmacist. Mr Garbarini earned a bachelor s degree in biology from the Rochester Institute of Technology, Rochester, New York, in 1985, as well as a bachelor s degree in pharmacy from the Massachusetts College of Pharmacy in Boston in He earned a doctor of jurisprudence degree from the Suffolk University School of Law in Boston in 1992 and was admitted to the Massachusetts Bar in December He is a former member of the Massachusetts Pharmacist Association board of directors, having served from 1997 through He is General Counsel to the Massachusetts Independent Pharmacist s Association and the Massachusetts Pharmacist Association. He is adjunct faculty at Bouve College of Pharmacy, Northeastern University, Boston, Massachusetts where he teaches pharmacy jurisprudence. Mr Garbarini has lectured extensively on the topic of pharmacy law, including the pharmacist s duty to warn, negligence, state and federal pharmacy law, state and federal pharmacy legislation, the Omnibus Budget Reconciliation Act (OBRA) 90, the Health Insurance Portability and Accountability Act (HIPAA), drug purchasing, 340B eligibility, and other related matters. Faculty Financial Disclosure Statement The presenting faculty reported the following: Mr Garbarini has nothing to disclose. Drug List Generic buprenorphine HCl buprenorphine HCl/ naloxone HCl dehydrate methadone Trade Subutex Suboxone various Suggested Reading List Civil penalties and multiple punishments under the double jeopardy clause: some unanswered questions. 46Oklahoma Law Review 587. Wells AC. Comment: Multiple punishment and the double jeopardy clause: the United States v. Ursery decision. 71 St John s Law Review 153 (1997). Harlow, NO. Applicability of statute of limitations or doctrine of laches to proceeding to revoke or suspend license to practice medicine. 51 ALR 4th 1147 (1987), secs. 2,6,7,10. Powers v Thobani, 903 So.2d 275 (2005). Session 2

3 Pysz v Henry s Drug Store, 457 So.2d 561 (1984). Dee v Wal-Mart Stores, 878 So.2d 426 (2004). Kvitka v Board of Registration in Medicine, 407 Mass. 190 (1990). Ohio State Board of Pharmacy v Frantz, 555 N.E. 630 (1990). Borrego v Agency for Health Care Administration, 675 So.2d 666 (1996). Session 2

4 Notes TM

5 Session 2 Pharmacists and the Controlled Substances Act: Liability Under the Corresponding Responsibility Doctrine Presenter Disclosure Information The following relationships exist related to this presentation: Mr Garbarini has nothing to disclose Accredited Provider: Pri-Med Institute Speaker: Paul M. Garbarini, JD, RPh Accredited Provider: Pri-Med Institute Off Label/Investigational Discussion In accordance with Pri-Med Institute policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations.? Pharmacists and the Controlled Substance Act: Liability under the Corresponding Responsibility Doctrine Paul M. Garbarini, RPh, JD Attorney At Law At At this this point, how how confident are are you you that that you you understand your responsibilities for for proper dispensing under the the Controlled Substance Act Act of of 1970 and and Corresponding Responsibility Doctrine. 1. Very Uncertain 2. Fairly Uncertain 3. Slightly Uncertain 4. Neutral 5. Slightly Confident 6. Fairly Confident 7. Very Confident 10 Which of the following is true regarding the ability of the DEA to seize pharmacy records? 1. The DEA can seize these records at any time. 2. The DEA may seize records once they present a Notice of Inspection. 3. The DEA must obtain a search warrant that satisfies probable cause before they seize pharmacy records. 4. The DEA may seize pharmacy records upon the serving of an Administrative Inspection Warrant 10? Which of the following statements is true? 1. A pharmacist should review every controlled substance prescription to determine legitimacy in order to avoid liability under the corresponding liability doctrine. 2. As long as the signature of the prescriber is authentic a prescription is valid. 3. A pharmacist must recommend the use of a noncontrolled substance to physicians before they may prescribe a controlled substance for a patient. 4. A simple phone call to verify a prescription s legitimacy is all that a pharmacist need do to avoid liability. 10? 1

6 Controlled Substance Act of 1970 The Act is made up of 3 Titles Title I establishes rehabilitation programs for drug abusers Title II provides for registration and distribution of controlled substances and is applicable to pharmacy practice Title III controls import and export of controlled substances Controlled Substance Act of 1970 Distribution of controlled substances is governed by the Controlled Substance Act (CSA)of 1970 It established the Federal Government as the keeper of controlled substances States may regulate, but not unduly interfere with Federal Power under Supremacy and Commerce Clauses Controlled Substance Act of 1970 The Drug Enforcement Agency (DEA) is a unit of the Department of Justice The DEA works closely with state agencies Most investigations are handled by State Boards or Commissions of Pharmacy Allegations of illegal distribution will always involve the DEA DEA is generally not concerned with cases of diversion for self-administration Controlled Substance Act of 1970 Pharmacy Inspections Does the DEA need a warrant to inspect a pharmacy? Does the Fourth Amendment protection against unreasonable searches and seizures protect pharmacy records from search and seizure? Normally a warrant is necessary to search and seize property, absent exigent circumstance Can the DEA inspect and still not violate your rights? Controlled Substance Act of 1970 Pharmacy Inspections Under the CSA, the DEA may enter and inspect any place where controlled substances are kept CSA- a DEA agent may examine and inspect all records and reports, may take an inventory Agent must state purpose of inspection and present a written notice of inspection Controlled Substance Act of 1970 Pharmacy Inspections Notice of Inspection must include - Right to refuse inspection - Evidence seized may be used against registrant - Consent is voluntary and may be withdrawn at any time 2

7 Controlled Substance Act of 1970 Administrative Inspection Warrant You can refuse consent to inspection by a DEA agent You cannot refuse entry to a DEA agent that possesses and presents an Administrative Inspection Warrant Refusal to do so can be costly, specifically up to 1 year in prison and a 25K fine No probable cause required for warrant Standard of Issuance- whether or not a valid public interest exists, not reasonable person standard Controlled Substance Act of 1970 Administrative Inspection Warrant It must contain - Name and address of premises - Statutory authority for warrant - Nature and extent of inspections - Statement of last inspection of premises Drug Addiction Treatment ACT (DATA) of 2000 Background Narcotic Addict Treatment Act of Prior to this Act, no legal or medical standards available for practitioners treating addicts - Essentially methadone was sole treatment modality - Practitioners prescribing for maintenance required to obtain separate DEA registration as narcotic treatment programs (NTP) Drug Addiction Treatment ACT (DATA) of 2000 Background Narcotic Addict Treatment Act of originally under purview of DHHS (FDA) - In May 2001, oversight was transferred to Substance Abuse and Mental Health Services Administration (SAMSHA) Drug Addiction Treatment ACT (DATA) of 2000 DATA Provides for Office Based Opioid Treatment (OBOT) Removed stigma of methadone treatment Opioid treatment programs were inaccessible both in location and waiting times for admission Act amended the CSA of 1970 to allow qualifying physicians to prescribe/dispense CIII-V opioids approved by FDA for maintenance/detoxification Drug Addiction Treatment ACT (DATA) of 2000 DATA A qualifying physician must: be Board Certified in Addiction Psychiatry or Addiction Medicine, or Obtain at least 8 hours of authorized training in treatment or management of opioid dependent patients A provider can not treat more than 30 or 100 such patients at any time (previous limit was 30 per practice) 3

8 Drug Addiction Treatment ACT (DATA) of 2000 DATA Agents used currently include - Buprenorphine for initiation of therapy, usually done in office - Once stable, patients will present prescriptions for buprenorphine/naloxone in the community, to prevent injection - Provider will have separate DEA number, with X prefix Office of National Drug Policy Reauthorization Act of 2006 (ONDCPRA) Issues for Pharmacists Number of patients under treatment is expanded for 30 to 100 patients in the following circumstances - Physician must be currently authorized under DATA Physician must have submitted the notification for initial authorization at least 1 year ago - Physician must submit a second notification that conveys the need and intent to treat up to 100 patients ONDCPRA of 2006 Public Laws Office of National Drug Policy Reauthorization Act of 2006 (ONDCPRA) Issues for Pharmacists- DEA has investigative authority over the distribution of these controlled substances DEA has investigated providers that they suspect have been treating over 30 patients at a time and now looking at those qualified to treat up to 100 at a time DEA has been investigating pharmacies that fill substantial quantities of buprenorphine/naloxone (prescriptions for buprenorphine alone should be viewed warily) Why- DEA figures that illegal distribution is or may be going on ONDCPRA of 2006 Public Laws Office of National Drug Policy Reauthorization Act of 2006 (ONDCPRA) Issues for Pharmacists- DEA has received reports from every region that this drug is being diverted by healthcare professionals Drug has street value of $25-50 per dose Some anecdotal, some via investigations, purchases Pharmacies are often used as grounds for a fishing expedition to begin when investigation of a qualified physician commences ONDCPRA of 2006 Public Laws DEA and Drug Addiction Treatment ACT (DATA) of 2000 Issues for Pharmacists Important to remember that DEA can obtain the information they are looking for against a provider via pharmacy records Other information as well may be used (Medicaid billing records, etc.) DEA is seeking to strictly enforce DATA and ONDCPRA Treatment of addictions is still stigmatized DEA and Drug Addiction Treatment ACT (DATA)of 2000 Issues for Pharmacists Remember that qualified physicians can now fall into two separate classes - Those who can treat up to 30 patients - Those who can treat up to 100 patients Insure that no single provider is writing for above the 30 or 100 respective patient limit Failing to do so may invite DEA agents Can buprenorphine/naloxone legally be prescribed for pain? 4

9 21 CFR (a)) A controlled substance prescription must be issued for a legitimate medical purpose, By an individual practitioner acting in the usual course of practice Responsibility for the proper prescribing and dispensing is upon the individual practitioner Title 21 of the Code of Federal Regulations, Available at 21 CFR (a)) A corresponding responsibility rests with the pharmacist who fills the prescription An order purporting to be a prescription issued not in the usual course of treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Controlled Substance Act. A person knowingly filling such a purported prescription and the Title 21 of the Code of Federal Regulations, Available at 21 CFR (a) person issuing it shall be subject to the penalties provided for violations of the provision of law relating to controlled substances Liability for both prescribers and pharmacists under Corresponding Responsibility Knowingly - To have actual knowledge (know) or have reason to know: deliberate or conscious Legitimate Medical Purpose - Not strictly defined by the DEA or the terms of the CSA Title 21 of the Code of Federal Regulations, Available at Prescriptions not issued pursuant to a legitimate medical purpose include: Prescriptions written by individual practitioners - for fictitious patients - for patients not named on the prescription - when no medical exam has been performed - when no medical reason exists for the prescription Prescriptions not issued pursuant to a legitimate medical purpose include: When written for office use Narcotic prescriptions to maintain or detoxify an addict Fraudulent or forged prescriptions Prescriptions issued by individual practitioners that exceed the usual course of professional practice 5

10 DEA Tips for Pharmacists to be wary of prescriptions Patients returning too frequently Prescriber writes for antagonistic drugs- stimulants and sedatives Pharmacy is suddenly flooded by numerous prescriptions for same individual prescriber Strangers suddenly appear with prescriptions from same practitioner Prescriber writes for large amounts of prescriptions United States v. Hayes, 595 F. 2d 258 (1979) Appeal of lower court conviction of pharmacist Pharmacist challenges constitutionality of corresponding responsibility doctrine Pharmacist dispenses large amount of drugs pursuant to prescriptions for a single physician Patients ended up selling/distributing drugs dispensed United States v. Hayes, 595 F. 2d 258 (1979) Pharmacist s argument- a pharmacist can only know so much about a patient if the prescription is valid Pharmacist- I called and verified- isn t that enough to avoid liability? Court- Affirmed conviction, held that burden on pharmacists is not unfair Verification may not be enough to satisfy this doctrine when other facts indicate a presumption of guilt Vermont and 110th Medical Arts Pharmacy v. State Board of Pharmacy, 177 Cal. Rptr. 807 (1981) Pharmacy dispensed over 10,000 controlled substance prescriptions for four controlled substances written by a few doctors over a 45 day period A total of 748,000 dosage units dispensed Many of the prescriptions were consecutively numbered from the same prescriber These prescriptions were for the same person with different address Vermont and 110th Medical Arts Pharmacy v. State Board of Pharmacy, 177 Cal. Rptr. 807 (1981) Many bogus patient names as well (e.g. Pearl Harbor, Ford Fairlane) Pharmacist: I did not knowingly fill prescriptions in violation of doctrine Court- telephone verification is not enough when the circumstances indicate that the pharmacist should have used discretion and investigated prior to filling Gordon v. Frost, 388 S.E. 2d 362 (1989 GA) Patient taking prescription analgesic/sedative combination Patient of pharmacy for more than 4 years Patient requests refill via phone call Intern believes call is from prescriber s office Intern asks for prescriber DEA number, patient says to call the prescriber Intern calls prescriber and determines that patient is a drug seeker 6

11 Gordon v. Frost, 388 S.E. 2d 362 (1989 GA) Intern tells pharmacist on duty Intern and pharmacist on duty wish to uphold the corresponding responsibility doctrine Pharmacist decides to call the DEA Patient arrested, sues pharmacy for false imprisonment, etc.- liability for pharmacy Patients use controlled substances legitimately- a pharmacist should not second-guess the physician when use is in good faith Ryan v. Dan s Food Stores,Inc. 972 P.2d 395 (1998 UT) Pharmacist sues employer for wrongful termination Pharmacist claim- I was discharged for complying with corresponding responsibility doctrine Facts: Pharmacist, over an 18 month period, treated each and every controlled substance prescription as though it was fraudulent Numerous complaints by customers Pharmacist second-guesses every physician Ryan v. Dan s Food Stores,Inc. 972 P.2d 395 (1998 UT) Pharmacist trying to play detective Did actually prevent a few fraudulent prescriptions from being dispensed Received commendation from law enforcement Management reprimanded pharmacist Pharmacist continued harassing prescribers and patients Terminated and sued employer No valid corresponding responsibility duty per Court Ryan v. Dan s Food Stores,Inc. 972 P.2d 395 (1998 UT) Utah Supreme Court holdings: - 21 CFR only prohibits knowingly filling an improper prescription - It does not require a pharmacist to verify all controlled substance prescriptions unless prescription issued in other than prescriber s usual course of practice - Only when the prescription is irregular on its face- no date, no prescriber signature, an obviously toxic dose is further inquiry required? Powers v. Thobani, et.al.,903 So. 2d. 275 (2005) Allegation of over-prescribing by physician Legitimate controlled substance prescriptions knowingly filled and refilled too soon Allegation that pharmacists filled controlled substance prescriptions indiscriminately Patient receiving potent narcotic prescriptions earlier than indicated and pharmacists filled these prescriptions with this knowledge Liability under corresponding responsibility doctrine? At At this this point, how how confident are are you you that that you you understand your responsibilities for for proper dispensing under the the Controlled Substance Act Act of of 1970 and and Corresponding Responsibility Doctrine. 1. Very Uncertain 2. Fairly Uncertain 3. Slightly Uncertain 4. Neutral 5. Slightly Confident 6. Fairly Confident 7. Very Confident 10 7

12 ?? Which of of the following is is true regarding the ability of of the DEA to to seize pharmacy records? Which of of the following statements is is true? 1. The DEA can seize these records at any time. 2. The DEA may seize records once they present a Notice of Inspection. 3. The DEA must obtain a search warrant that satisfies probable cause before they seize pharmacy records. 4. The DEA may seize pharmacy records upon the serving of an Administrative Inspection Warrant A pharmacist should review every controlled substance prescription to determine legitimacy in order to avoid liability under the corresponding liability doctrine. 2. As long as the signature of the prescriber is authentic a prescription is valid. 3. A pharmacist must recommend the use of a noncontrolled substance to physicians before they may prescribe a controlled substance for a patient. 4. A simple phone call to verify a prescription s legitimacy is all that a pharmacist need do to avoid liability. 10 Questions & Answers? Accredited Provider: Pri-Med Institute 8