Changing Liability Issues for Hospital Pharmacists: Protecting Yourself and Your Hospital 2011 Midyear Clinical Meeting

Transcription

1 Changing Liability Issues for Hospital Pharmacists Disclosures The program chair and presenters for this continuing pharmacy education activity report no relevant financial relationships. Protecting Yourself and Your Hospital Kenneth R. Baker, B.S.Pharm, JD Of Counsel / Pharmacy Consultant RENAUD COOK DRURY MESAROS, PA 2 Objectives 1. Discuss the concepts of legal liability for pharmacists 2. Describe changes in pharmacy law as they may affect hospitals and pharmacists 3. Explain documentation in relationship to errors and lawsuits 4. Consider the new roles of the hospital pharmacist and how that may affect changes in liability Disclosure & Bias Practiced pharmacy managed chain pharmacy in Indianapolis Trial lawyer Prosecutor Pharmacists Mutual Renaud Cook Drury Mesaros, Phoenix, AZ Of Counsel Consult Quality Assurance & Pharmacy Law Teach: Midwestern University & University of Florida Liability Issues Expanding Liability: Special Knowledge Deep Pockets Retribution Criminal Prosecutions Administrative Liability & HIPAA New Tools & Corresponding Responsibility PROTECTING YOURSELF 2 Kinds of Negligence Liability: CIVIL, CRIMINAL Document Document document Page 1 of 8

2 Civil Law Tort Law: the tort of negligence: Elements Duty Breach of Duty Damages Proximate Cause: But for Other torts Infliction of mental distress Trespass False arrest Burden: Preponderance of the evidence Lawsuit & Trial Concern Expert witness standard of practice: What would the reasonable, prudent pharmacist have done? Jury: preponderance of the evidence Money damages Deep Pockets $7 Million verdict Pharmacists Mutual Claims Study Drug Review Claims as % by Year ( ) 1997 (Children's Hospital, Boston) Tech dilution: enalaprilat (ACE inhibitor) for baby Rx 6 mcg/dose GAVE 750 mcg/dose Sued pharmacist; technician & pharmacy supervisor Hospital not sued Massachusetts law: Damages limit $20,000 Limits on physicians & hospitals not pharmacists and technicians MASS: H. $500,000 limit for non economic damages, some exceptions released from limitations. ~ 35 states have some form of medical malpractice cap Page 2 of 8

3 When is a mistake a crime? Criminal Prosecution & Mens Re Special Knowledge: Plaintiff allergic to aspirin, ibuprofen, Possible allergy cross-sensitivity with the drug Toradol Manslaughter in UK Criminal Intent mental states (Mens Re) McDowell SE1, Coleman JJ2 & Ferner RE First Degree Murder Specific Intent Intentionally or Purposefully Malice (murder {common law or 2 nd deg} & arson) knowingly General intent (all not listed above or strict liability) e.g., rape & battery Manslaughter Knowingly, recklessly, negligently Strict liability (no intent) according to formula. Formula: If administrative, regulatory or morality area and statute does not give intent. Criminal Negligence A lot different Crime Question of Intent & Facts Must prove intent Facts must match crime Facts and intent must come together Page 3 of 8

4 State of Ohio vs. Eric Cropp 19 Ohio Law A. Purposely: specific intention to cause a result, or B. Knowingly: conduct will probably cause a certain result C. Recklessly: heedless indifference to the consequences, perversely disregards a known risk - heedless indifference to the consequences D. Negligently: when, because of a substantial lapse from due care, he fails to perceive or avoid a risk that his conduct may cause a certain result E. Strict Liability All Ohio criminal law involves some Mens Re (except strict liability) Negligence is Not Negligence Difference - An element of Mens Re (intent) A person is [criminally] negligent when, because of a substantial slip from the standard of care fails to take steps to evade a risk that his conduct may cause a certain result. Higher degree of negligence than ordinary negligence. - must be guilty of a substantial departure from due care, whereas ordinary negligence merely requires a failure to exercise due care. Roszman v Sammett, 26 Ohio St 2d 94 (1971). When is Malpractice a Crime? A Philosophical Answer... What is the purpose to be served? Purpose to change conduct to protect public How many patients does this save or put at risk? How to conform actions to avoid being charged? If cannot, then criminal law is ineffective, at best and dangerous, at worst. Purpose to punish... For what The act or the death? October 7, 2008: The urge to punish seems very strong * The conscious psychological motive -not deterrence but just-deserts retribution. Princeton University 2002 study: People... valued punishment for its own sake, as a measured consequence for behavior, not as a deterrent Citizen Enforcers Take Aim By BENEDICT CAREY *Quoting Jeffrey P. Carpenter and Peter Hans Matthews, economists at Middlebury College in Vermont Page 4 of 8

5 Important Issues Punishment or prevention? Technician legislation In Ohio passed senate (Emily s law)in 6/08 Quote from father: We want people like us to be able to protect themselves and be able to protect their families. The only way we can see to do this right now, immediately, is with the public outcry we are trying to produce. Prescription Monitoring Program What duties if you have or could have special knowledge? Pharmacy Malpractice Issue HIPAA & Liability LIABILITY FOR HIPAA VIOLATIONS HIPAA provides no private cause of action Only US Office of Civil Rights (OCR) may enforce Can HIPAA be used as pharmacy standard of practice to bring a negligence suit? Pharmacy Case: HIPAA as a Pharmacy Standard? Court: A court may adopt a statute as the relevant standard of care if it first determine 1. statute s purpose is in part to protect a class of persons that includes the plaintiff and 2. the specific interest at issue from the type of harm that occurred and against the particular action that caused the harm. 3. Violation of the statute thus stamps the defendant s conduct as negligence per se 4. violation must be legal cause of the plaintiff s injury and no other defenses negate liability. HIPAA May not use or disclose, except: (Arizona state law) A.R.S (A) requires a pharmacy to keep records of prescriptions open for inspection at all times by... officers of the law in performance of their duties. A.R.S provides immunity for disclosure of medical records in good dfaith and a presumption of good faith. Liska v Walgreen, et al: Walgreen pharmacy disclosed Liska s prescription history in good faith belief that it was required to permit Dodge, a law enforcement officer investigating Liska s (RN) possible prescription fraud, to inspect Liska s records. Walgreens dismissed with prejudice Case against Page 5 of 8

6 OCR can and will enforce examples Enforcement: Office of civil rights Office of Civil Rights, HIPAA Enforcement Pharmacy Chain Institutes New Safeguards for PHI in Pseudoephedrine Log Books Covered Entity: Pharmacies Issue: Safeguards A grocery store based pharmacy chain maintained pseudoephedrine log books so that individual protected health information was visible to the public at the pharmacy counter. Initially, the pharmacy chain refused to acknowledge that the log books contained protected health information. OCR required that the pharmacy chain implement national policies and procedures to safeguard the log books. National Pharmacy Chain Extends Protections for PHI on Insurance Cards Covered Entity: Pharmacies Issue: Impermissible Uses and Disclosures; Safeguards A pharmacy employee placed a customer's insurance card in another customer's prescription bag. individual's health insurance card meets the statutory definition of PHI corrective actions to resolve the specific - pharmacy revised its policies regarding PHI and retrained its staff. Private Practice Implements Safeguards for Waiting Rooms Covered Entity: Private Practice Issue: Safeguards; Impermissible Uses and Disclosures A staff member discussed HIV testing procedures with a patient in the waiting room, thereby disclosing PHI to several other individuals. Also, computer screens displaying patient information were easily visible to patients. OCR required the provider to develop physical safeguards related to the communication of PHI. reposition its computer monitors to prevent patients from viewing information on the screens, computer monitor privacy screens to prevent impermissible disclosures. Public Hospital Corrects Impermissible Disclosure of PHI in Response to a Subpoena Covered Entity: General Hospital Issue: Impermissible Uses and Disclosures subpoena (not accompanied by a court order), disclosed information (PHI) of patients. failed to determine that reasonable efforts had been made to insure that the individual whose PHI was being sought received notice of the request and/or failed to receive satisfactory assurance that the party seeking the information made reasonable efforts to secure a qualified protective order. revise procedures. the hospital contacts the party seeking the subpoena Page 6 of 8

7 Clinic Sanctions Supervisor for Accessing Employee Medical Record Covered Entity: Outpatient Facility Issue: Impermissible Use and Disclosure A hospital employee's supervisor accessed, examined, and disclosed an employee's medical record. Among other corrective actions letter of reprimand was placed in the supervisor's personnel file supervisor received additional training counseled supervisor about appropriate use of the medical information of a subordinate. State Hospital Sanctions Employees for Disclosing Patient's PHI Covered Entity: Health Care Provider / General Hospital Issue: Impermissible Disclosure A nurse and an orderly discussed HIV/AIDS status of a patient and the patient's spouse within earshot of other patients both employees placed on leave; (orderly resigned). further disciplinary action with the nurse, which included: documenting the employee record one year probation; referral for peer review; Patient received monetary settlement Corresponding Responsibility CONTROLLED SUBSTANCES & THE CORRESPONDING DUTY Purpose of issue of prescription. A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. [emphasis added] 21 CFR ; also see United States v. Moore, 423 U.S. 122 (1975) Corresponding Responsibility An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription... and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. Page 7 of 8

8 Sanchez v Wal-Mart Stores Nevada Sup Ct Sanchez v Wal-Mart Stores Nevada Sup Ct June 03 letter: from May 2002 to May 2003, Copening had obtained ~ 4,500 hydrocodone pills at 13 pharmacies. (+Soma) June 04: wrongful death (7 pharmacists) Does a pharmacy owes a duty of care to unidentified third parties injured by a pharmacy customer driving under influence of controlled prescription drugs? Suit: because the pharmacies had knowledge of patient s excessive prescription-filling activities, the pharmacies owed 3 rd party duty to not fill Rxs Court Majority (5 justices): No duty to unidentifiable members of the general public unknown to the pharmacies Rx Monitoring Program law did not creates a public policy duty for pharmacies to protect third parties The duty owed under these statutes or regulations is to the person for whom the prescription was written, the pharmacy s customer, if anyone, and not for the general public s protection Sanchez v Wal-Mart Stores Nevada Sup Ct Documentation Court Minority (2 justices) Dissent: A pharmacist s professional standards of care, considered with the notice contained in the Task Force letter, justifies extending the duty owed by the pharmacies under a common-law negligence Pharmacists required DUR Dispensed only for medically necessary purposes If Rx not issued in the normal course of a professional s practice, a pharmacist is prohibited from filling the prescription Questions? Page 8 of 8