PHARMACIST S LIABILITY IN THE 21 ST CENTURY

Transcription

1 PHARMACIST S LIABILITY IN THE 21 ST CENTURY SUNDAY/9:45-10:45AM ACPE UAN: L03-P 0.1 CEU/1.0 hr L03-T 0.1 CEU/1.0 hr Activity Type: Knowledge-Based Learning Objectives for Pharmacists & Pharmacy Technicians: Upon completion of this CPE activity participants should be able to: 1. Describe the potential legal liabilities, including malpractice exposure, associated with pharmacist prescriptive authority, collaborative practice agreements, and medication therapy management. 2. Discuss recent case law regarding pharmacist prescriptive authority, collaborative practice agreements, the provision of medication therapy management and other patient care services by pharmacists. 3. Identify best practices to minimize exposure to malpractice claims. Speaker: Don McGuire, Jr., RPh, JD Don McGuire is a pharmacist and an attorney. Don received his B.S. in Pharmacy (cum laude) from Butler University College of Pharmacy in He practiced in community pharmacies and was a manager in Richmond, Indiana and Greenwood, Indiana. In addition to community practice, Don practiced hospital pharmacy, including four years as Director of Pharmacy for Hendricks Community Hospital in Danville, Indiana. Don attended Indiana University School of Law - Indianapolis, where he was a member of the Indiana Law Review. After graduating magna cum laude in 1993, Don maintained a general practice of law in Danville and Indianapolis, Indiana. He practiced law for five years before joining Pharmacists Mutual in 1998 as an attorney in the pharmacy professional liability claims area. Don is currently General Counsel for Pharmacists Mutual and its subsidiaries. Don also writes and lectures on pharmacy liability issues, patient safety, and pharmacy risk management. Speaker Disclosure: Don McGuire, Jr. reports no actual or potential conflicts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation.

2 Pharmacist's Liability in the 21st Century Don R. McGuire Jr. General Counsel & Sr. Vice President Pharmacists Mutual Insurance Company Disclosure Don McGuire reports no actual or potential conflicts of interest associated with this presentation. 1

3 Learning Objectives Upon successful completion of this activity, participants should be able to: Describe the potential legal liabilities, including malpractice exposure, associated with pharmacist prescriptive authority, collaborative practice agreements, and medication therapy management. Discuss recent case law regarding pharmacist prescriptive authority, collaborative practice agreements, the provision of medication therapy management and other patient care services by pharmacists. Identify best practices to minimize exposure to malpractice claims. 1. Which is NOT a feature of Medication Therapy Management? A. Enhancing appropriate medication use B. Increasing detection of adverse drug events C. Written practice agreements D. Improving outcomes 2

4 2. A written collaborative pharmacy practice agreement may include which of the following? A. The nature and scope of authorized drug therapy management to be provided by a pharmacist B. A description of specific disease states to be managed C. Protocol authorizing the ordering and interpretation of laboratory tests D. All of the above 3. Which practice involves the greatest risk of legal liability for pharmacists? A. Prescriptive authority B. Collaborative practice C. Medication therapy management D. All of the above have the same level of risk 3

5 4. True or False? According to recent case law, Pharmacists engaged in collaborative practice with Physicians are afforded protection from lawsuits. 5. What should you do in order to minimize your liability exposure? A. Pharmacist must be experienced and maintain training to recognize treatment issues B. Critically examine the facts of each patient case C. Assume that someone else will handle the issue/problem D. A & B 4

6 Why Is This Topic Important? The patient care duties of pharmacists have evolved in the last 30 years and continue to evolve Some pharmacists view this evolution with trepidation rather than seeing opportunity Making well-informed decisions is the key to evolving with minimal exposure Stevens v. Rite Aid Pharmacist discharged because he refused to administer immunizations Claimed trypanophobia (fear of needles) Jury awarded him over $2.5 million Verdict reversed on appeal providing immunizations was an essential function of a pharmacist s job duties at the chain Stevens v. Rite Aid, 2017 U.S. App. LEXIS 4985 (2 nd Cir. March 21, 2017) 5

7 Jeffries v. United States Patient s anticoagulation therapy was managed by a pharmacist for 6 years Patient was scheduled for dental therapy, so Coumadin was held and Lovenox introduced At subsequent appointment, patient s INR was low. Pharmacist recommended resumption of Coumadin and return in 3 weeks Five days later, patient suffered a massive stroke Bridgette Jeffries, as Guardian for Melvin Eason v. United States of America, No. C RSL (W. D. Wash., Oct. 28, 2009) Alrazzaq v. Walgreen Pharmacist prepared herpes zoster vaccine for administration, but vaccine was contraindicated for the patient Pharmacist offered vaccine to store manager who was 31 and had no prescription Pharmacist terminated for breaching protocol Pharmacist admitted that she didn t thoroughly complete the training It s basically the same as the flu vaccine training Alrazzaq v. Walgreen Co., 2014 U.S. Dist. LEXIS 37192, (Mar 21, 2014) 6

8 What Is Risk Management? The process of identification, analysis, and either acceptance or mitigation of uncertainty in a decision-making process. Webster s Dictionary The use of specific strategies in an effort to minimize an organization s exposure to liability in the event a loss or injury occurs. Risk Management Strategies 4 Major Strategies to Manage Risk: 1. Avoid the risk 2. Accept the risk 3. Reduce the Probability 4. Transfer the risk 7

9 Controlling the Environment (Reducing the Probability) The Risk Management Process 1. Identify the Risk 2. Select the Technique 3. Implement the Technique 4. Monitor and Make Necessary Changes The Risk Management Process Step 1: Identify the Risk Take a step back and observe Where could a mistake be made in your pharmacy? Analyze each step of the dispensing process; receiving an Rx, entering, filling, bagging, and counseling Track and Trend Monitor and Improve Identify the Risk Implement the Technique Select the Technique Perform this analysis for each new service contemplated 8

10 The Risk Management Process Step 2: Select the Technique (Best Practices) What types of changes would reduce errors that are occurring? Where could those changes most logically be made? Write down all ideas! Select those that seem most appropriate Monitor and Improve Identify the Risk Implement the Technique Select the Technique The Risk Management Process Step 3: Implement the Technique Incorporate the change into the current process Communicate with your staff Identify the Risk Monitor and Improve Select the Technique Implement the Technique 9

11 The Risk Management Process Step 4: Monitor and Improve The changes probably won t be perfect on the first try Be willing to try again, but be sure to allow enough time for a true trial Encourage your staff to keep an open mind about changing the process Monitor and Improve Identify the Risk Implement the Technique Select the Technique TRANSFER OF RISK The easiest and most popular way to do this is to purchase insurance 10

12 Negligence Elements - Duty - Breach of Duty - Damages - Proximate Cause Duty The requirement to behave in a certain manner for the benefit of another Does not mean warning about everything The actor must take reasonable steps to prevent foreseeable harm Professionals have different duties than ordinary people 11

13 Breach of Duty Standard of Care how you know when the duty is performed Reasonable Person Standard what would a reasonable person do in the same or similar circumstances? Legal Standard law requires certain behavior Others professional oaths, codes of ethics, etc. Breach of Duty Failure to perform the duty (nonfeasance) Duty performed inadequately or incorrectly (malfeasance) Breach is easy to spot when an Rx is filled incorrectly 12

14 Proximate Cause The breach of the duty must be the direct cause of the injury Superseding or Interceding Cause Damages (Harm) Patient must have been harmed in order to be compensated Many states require underlying physical injury to make claim for emotional injury Harm if not taken? 13

15 Contributory Negligence Common law concept In order to recover, the plaintiff cannot be even 1% at fault Defense merely needs to show some fault by plaintiff to win Comparative Fault Replaces Contributory Negligence Plaintiff has their percentage of fault subtracted from the damages award 2 versions: - Pure - plaintiff recovers damages, less their % of fault - Modified If plaintiff is responsible for 50% or more of fault, then no recovery 14

16 Past Changes in Liability Exposure Nichols v. Central Merchandise 16 Kan. App. 65 (1990) Rx for Gantanol Patient was pregnant absent a contraindication or error on the face of the prescription, the pharmacist has no duty to warn Kampe v. Howard Stark Professional Pharmacy 841 S.W.2d 233 (Mo.App. W.D., 1992) Rx s were filled correctly, but usage of the Rx s was not monitored Pharmacy s duty is limited to properly filling lawful prescriptions 15

17 Horner v. Spalitto 1 S.W.3d 519 (Mo. Ct App. Western Dist. 1999) Placidyl Patient received Rx s for Placidyl 750mg q8h and Diazepam 10mg q8h Rx s were filled correctly Horner v. Spalitto (cont.) Relegating a pharmacist to the role of order filler fails to appreciate the role recognized in the PPA & OBRA 90 Holding as previous cases did would denigrate the expertise which a pharmacist s education provides concerning drugs & their use 16

18 Collaborative Practice Agreements Tremendous variation by state Technical and clinical exposures to consider Collaborative Practice Agreements Technical Exposures Must know what practices are allowed in your state/practice setting Moving outside legal parameters could expose you to Punitive Damages Make sure your patients know who you are and your role 17

19 Collaborative Practice Agreements Case - a Pharmacist was engaged in collaborative practice with an internal medicine Physician. The Physician was allegedly over-prescribing pain meds and controlled substances. The Pharmacist was sued along with Physician by three separate patients. All of the patients alleged that the Pharmacist represented himself as a Physician in the practice. Collaborative Practice Agreements Clinical Issues Pharmacist must be trained and experienced to recognize treatment issues Exposure will differ based on activity; initiating, modifying or discontinuing therapy, ordering and/or interpreting lab results Exposure will differ based on the patients being treated 18

20 Collaborative Practice Agreements Two cases involved monitoring of Gentamicin dosing. In both cases, Pharmacist did not act quickly enough when receiving lab results showing high blood levels. Transition of care could impact these situations; what in-patient care knew vs. what home-care knows Another case Patient received both Gentamicin and Vancomycin. Vanco levels were ordered & drawn, but Gent levels were not ordered. Patient eventually suffered kidney damage and ototoxicity. Medication Therapy Management Generally, exposure here would be less than Collaborative Practice because therapy isn t initiated by pharmacists Pharmacists make recommendations regarding therapy, but don t order anything There is exposure for missed clinical interventions; interactions, contraindications, overdosage, underdosage, etc. Similar exposure as DUR/Counseling and LTC Consulting 19

21 Medication Therapy Management Pharmacist must be trained and experienced to recognize treatment issues Must be able to communicate effectively with other Health Care Professionals and patients Research and find answers to questions don t guess Don t assume that someone else will handle the issue Prescriptive Authority Again, variation by state Exposures will depend on type & extent of prescriptive authority Would expect to see the highest potential exposures here because of the initiation of therapy. Training is the key to minimizing these exposures Have no claims or court cases to present here 20

22 Key Points All forms of Advanced Practice carry additional levels of liability exposure Training and critical examination of the facts of each case can lessen these exposures Never assume that someone else will handle the issue/problem! Potential exposure alone is not a sufficient reason to not advance 1. Which is NOT a feature of Medication Therapy Management? A. Enhancing appropriate medication use B. Increasing detection of adverse drug events C. Written practice agreement D. Improving outcomes 21

23 C. Written practice agreement MTM doesn t require any written agreement 2. A written collaborative pharmacy practice agreement may include which of the following? A. The nature and scope of authorized drug therapy management to be provided by a pharmacist B. A description of specific disease states to be managed C. Protocol authorizing the ordering and interpretation of laboratory tests D. All of the above 22

24 D. All of the above CPPA should cover all aspects of the collaboration so that each party is aware of their responsibilities 3. Which practice involves the greatest risk of legal liability for pharmacists? A. Prescriptive authority B. Collaborative practice C. Medication therapy management D. All of the above have the same level of risk 23

25 A. Prescriptive authority Initiation of therapy can entail significant risks, especially as compared to MTM 4. True or False? According to recent case law, Pharmacists engaged in collaborative practice with Physicians are afforded protection from lawsuits. 24

26 False There is no immunity provided by CPPA s 5. What should you do in order to minimize your liability exposure? A. Pharmacist must be experienced and maintain training to recognize treatment issues B. Critically examine the facts of each patient case C. Assume that someone else will handle the issue/problem D. A & B 25

27 D. Both A & B are correct Training and experience are crucial in limiting exposure in any situation. Staying focused and critically examining the case in front of you is also important. Questions? Don R. McGuire Jr., R.Ph., J.D. General Counsel, Sr. Vice President Risk Management & Compliance Pharmacists Mutual Insurance Company PO Box 370 Algona, IA P ext E. don.mcguire@phmic.com 26