Objectives. PHARMACY MALPRACTICE 3 Emerging Issues. Civil Law. Board of Pharmacy Charges. Criminal law

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1 PHARMACY MALPRACTICE 3 Emerging Issues DUTY TO WARN LIABILITY FOR HIPAA VIOLATIONS THE CORRESPONDING DUTY Kenneth R. Baker, BS Pharm, JD Ken Baker Consulting Of Counsel, Renaud Cook Drury Mesaros, PA Objectives STUDY THE LAW OF HIPAA AS IT PERTAINS TO LIABILITY SUITS DETERMINE A PHARMACISTS CORRESPONDING DUTY AS IT RELATES TO CIVIL LIABILITY DISCUSS THE IMPORTANCE OF PRESCRIPTION MONITORING PROGRAMS IN MALPRACTICE EXPLORE PHARMACISTS EVOLVING DUTY OF PROSPECTIVE DRUG REVIEW DISCUSS PHARMACISTS POSSIBLE LEGAL LIABILITY FOR FAILURE TO COUNSEL PATIENTS Ken Baker, 2011 Civil Law Liability is more than a suit for mis-filling a Rx CIVIL, CRIMINAL & ADMINISTRATIVE LIABILITY 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 Criminal law violation of a criminal statute: usually requires intent Knowingly Purposefully recklessly (negligently), Requires proof beyond a reasonable doubt Board of Pharmacy Charges Administrative law Violation of pharmacy practice act or board of pharmacy rule Unprofessional Conduct / unethical conduct Burdon of proof (state law): Clear and convincing evidence Preponderance of the evidence ken@kenbakerconsulting.com 1

2 Evolving in One Generation No duty beyond filling Rx correctly as written Ingram v Hooks (Indiana, 1985) Kampe vs. Stark Pharmacy (Missouri, 1992) Counseling & Prospective Drug Review DUTY TO WARN Duty began changing Hand v. Krakowski(New York, 1982) The pharmacist could be liable for not warning a customer that he should not take the prescribed medication with alcohol. The pharmacist knew the customer was an alcoholic and that the medication was contraindicated with alcohol, The pharmacist had special knowledge which he had the duty to share with the patient. Older cases overrules in some state Horner v Spalito(Missouri, 1999) - overruled Kampe The pharmacist had a duty beyond correctly filling the prescription. Dangerously high dose of Placidyl Duty to warn patient of high dose Duty to inquire of the physician Duties Not Uniform Among the States Courts have been reluctant to broaden duty without some special reason in facts of case Deed v. Walgreen (Connecticut, 2007) No duty to warn unless the pharmacists had knowledge patient or the prescriber did not Allberry v Parkmore Drug (Indiana, 2005) no duty to counsel unless special knowledge Special Knowledge Happel v. Wal-Mart (2002) Pharmacist knew: Plaintiff allergic to aspirin, ibuprofen, and acetaminophen, Possible aspirin allergy cross-sensitivity with the drug Toradol ken@kenbakerconsulting.com 2

3 Special Knowledge DiGiovanni v. Albertson s (Illinois, 2010) The physician] prescribed Tenoreticto treat high blood pressure while she was already taking lithium for manic depression. computer indicated pharmacist called the physician -indicated that he would monitor Laverne. Took notice of the warning in the system, notified the physician of the potential interaction prior to filling the prescription. pharmacist was under no duty to warn the customer of the possible interaction between the two drugs under the learned intermediary doctrine. duty of extending warnings to patients concerning prescription drugs belongs with physicians. 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? Release of Confidential Records to Police LISKAv US, Walgreens and others (2010) Nurse Sues: US, police, ex-doctor/lover, Walgreens and more The police officer allegedly made knowingly false statements to the Arizona Board of Nursing that the nurse was a drug user, a felon, and that the nurse had been criminally arrested and indicted. The officer s statements caused the nurse to lose her job and not be able to be employed as a registered nurse The nurse sufficiently stated a claim of slander per se under Arizona law against a police officer. Pharmacy Case: HIPAA as a Pharmacy Standard? Court: A court may adopt a statute as the relevant standard of care if it first determine statute s purpose is in part to protect a class of persons that includes the plaintiff and the specific interest at issue from the type of harm that occurred and against the particular action that caused the harm. Violation of the statute thus stamps the defendant s conduct as negligence per se violation must be legal cause of the plaintiff s injury and no other defenses negate liability. HIPAA not use or disclose, except: may disclose protected health information for a law enforcement purpose to a law enforcement official... in compliance with... an administrative subpoena or summons, a civil or an authorized investigative demand, or similar process authorized under law. 45 C.F.R (f)(1)(ii)(C). may disclose to a law enforcement official protected health information that the covered entity believes in good faith constitutes evidence of criminal conduct that occurred on the premises of the covered entity. 45 C.F.R (f)(5). (good faith presumed) ken@kenbakerconsulting.com 3

4 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 faith and a presumption of good faith. Walgreen pharmacy disclosed Liska sprescription history in good faith belief that it was required to permit Dodge, a law enforcement officer investigating Liska s possible prescription fraud, to inspect Liska s records. Case against Walgreens dismissed with prejudice OCR can and will enforce examples html#case13 ENFORCEMENT: OFFICE OF CIVIL RIGHTS Pharmacy Chain Enters into Business Associate Agreement with Law Firm Office of Civil Rights, HIPAA Enforcement Covered Entity: Pharmacy Chain Issue: Impermissible Uses and Disclosures; Business Associates A complaint alleged that a law firm working on behalf of a pharmacy chain in an administrative proceeding impermissibly disclosed the PHI of a customer of the pharmacy chain. found no evidence that the law firm had impermissibly disclosed the customer s PHI. However, the investigation revealed that the pharmacy chain and the law firm had not entered into a Business Associate Agreement, OCR required the pharmacy chain and the law firm to enter into a business associate agreement. 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. ken@kenbakerconsulting.com 4

5 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 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 purposeby 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) ken@kenbakerconsulting.com 5

6 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 providedfor violations of the provisions of law relating to controlled substances. Corresponding Responsibility In its Pharmacists Manual, the DEA notes: The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. The pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted... for knowingly and intentionally distributing controlled substances. pharm2/pharm_content.htm#9 Accessed May 20, 2011 Sanchez v Wal-Mart Stores Nevada Sup Ct June 03 letter: Copening obtained 4,500 hydrocodone pills at 13 pharmacies. (+Soma) from May 2002 to May 2003 One year later: wrongful death against 7 pharmacies Question: Does a pharmacy owes a duty of care to unidentified third parties injured by a pharmacy customer driving under influence of controlled prescription drugs? Sanchez v Wal-Mart Stores Nevada Sup Ct Court Majority (5 justices): No duty to 3 rd parties not known to the pharmacies Rx Monitoring Program Law 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 Dissent: (2 justices) 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 Prospective Drug Review To dispense only for medically necessary purposes For Rx issued in the normal course of a professional s If these not present, a pharmacist is prohibited from filling the prescription ken@kenbakerconsulting.com 6

7 PHARMACY MALPRACTICE 3 Emerging Issues 1. DUTY TO WARN special knowledge 2. LIABILITY FOR HIPAA VIOLATIONS may define standard of practice 3. THE CORRESPONDING DUTY -legitimate medical purpose, in the usual course of professional practice. Ken Baker, 2010 Kenneth R. Baker, BS Pharm, JD ken@kenbakerconsulting.com 7