Legal Risk Management Opportunities, Pharmacy Practice, and P&T Committees

HealtH Care & law Legal Risk Management Opportunities, Pharmacy Practice, and P&T Committees Part 1: Deconstructing Dispensing Errors James O Donnell, PharmD; and F. randy Vogenberg, rph, PhD The insurance giant CNA, through its professional liability insurance partner Healthcare Providers Service Organization (HPSO), recently released 2013 Pharmacist Liability, a comprehensive analysis of claims experience. This report, which looks at 10 years of closed claims, details rates of dispensing and other errors as well as injuries and adverse outcomes associated with these claims. 1 An article on pharmacy-related professional liability risk exposures, based on an insurance company s claims analysis? Why does a P&T committee member need this information? Because, by examining practices that lead to malpractice claims and economic losses, P&T committees can better understand the risks and challenges they encounter on a daily basis. Could you imagine watching a news story reporting that a 5-year-old nearly Dr. O Donnell is an Associate Professor of Pharmacology at Rush University Medical Center in Chicago, Illinois. As a pharmacist and pharmacologist, he is engaged in academic and consulting practice. His career includes extensive hospital and community practice experience, as well as support to P&T committees, state drug formulary committees, and third party/insurance formularies. He has consulted as an expert witness in dozens of cases, including numerous pharmacy policyrelated cases. F. Randy Vogenberg, the editor of this column, is a pharmacist with a doctorate in health care management. He is a member of P&T s editorial board and a Fellow of the American Society of Health-System Pharmacists. He has lectured on health care policy and law and has presented continuing education seminars on risk management in the health professions throughout his career. Dr. Vogenberg is Principal at the Institute for Integrated Healthcare (IIH) in Greenville, South Carolina, and Adjunct Professor of Pharmacy Administration at the University of Rhode Island, College of Pharmacy, in Kingston, Rhode Island. His email address is randy@iih-online.com. died from taking a toxic prescription drug your organization erroneously gave to him? In this real-life case, the prescription was intended for an adult with the same name. 2 This case involved a community pharmacy, but similar errors have occurred in hospitals. It could have been your hospital, with a different patient, a different drug, or a different set of circumstances. Aside from the devastating effects on the patient and family, what consequences could a situation like this have on the institution or corporation? This two-part review should be of critical interest not only to P&T committee members and pharmacists, but also to health care professionals in other departments, such as medical, nursing, and administration. Pharmacists are not the only professionals involved with medication dispensing, so it is important to take into account the experiences of other fields, such as nursing, when considering health-system risk management. Drug errors in an institution are usually the result of systems failure, not just pharmacy failure. This article will review the findings of the CNA/HPSO claims study, as well as two similar claims studies in allied health professions. In part 2, next month, we will discuss preventive steps that a P&T committee, pharmacy, or health institution or system can take to minimize legal risks for medication-related errors, patient injury, and malpractice suits. EVOLVING ROLE OF THE P&T COMMITTEE In the 1950s, the Joint Commission on Accreditation of Hospitals (now the Joint Commission) recognized the value of formularies and P&T committees. Since then, the role of the P&T committee has expanded. Over time, it was established that the P&T committee should adapt formularies to ever-changing practice guidelines and individual situations. P&T committees also compare therapies and choose the most cost-effective medications, not just the cheapest drug within the class. Because of the availability of drugs with a lower margin of safety and their potential for higher rates of adverse effects and related costs the role of the P&T committee has evolved to assess safe, efficient, and effective ways to treat diseases. 3 This evolution has required P&T committees to use many sources of information beyond published clinical trial data to incorporate such factors as likely rates of adherence and persistence, the potential for medical errors, and effects on prescribing behaviors into their decision-making. 4 As hospitals consolidate and grow into larger health systems, formulary decisions are also being aligned with predischarge and postdischarge outcomes, with an eye toward improving clinical and economic performance for the integrated entity. Health care reform has generated payment methodologies that focus on value-based reimbursement, as opposed to volume-based fee-for-service arrangements. Bundling of payments, for instance, allows physicians and hospitals to share in the savings gained from efficient patient care, and it engages physicians to consider the effects of drug choice on total costs of care. As the role of the P&T committee continues to evolve, then, members must determine the committee s place at the core of an integrated system, sharing involvement in the development of contracting and reimbursement strategies. The P&T committee must also consider itself to be part of an integrated team that manages episodes of illness. In order to fulfill these functions, a committee s composition must include professionals from outside the hospital, such as primary care physicians and data analysts. 5 Increasingly, medication choices, use, and misuse can affect institutional performance on quality-of-care standards. In efforts to reduce readmissions, for instance, medication reconciliation has become an important process. Medica- Vol. 39 No. 8 August 2014 P&T 559

Table 1 Medication-Error Claims, by National Coordinating Council for Medication Error Reporting and Prevention Category 1 NCC MERP Category Permanent patient harm % of All Claims % of All Money Paid Notable Cases 11.7% 41.1% Infant born at 23 weeks when Prostin was dispensed to the mother instead of progesterone Child suffered brain damage after receiving improperly compounded total parenteral nutrition Adult suffered brain damage after simultaneous overdoses of Phenergan and fentanyl Patient death 11.7% 29.6% Clonidine compounding error in a child Dispensing of wrong drug resulted in a child not receiving chemotherapy for leukemia Adult given intrathecal morphine Intervention to sustain patient s life 9.3% 12.2% Wrong dose of fentanyl resulted in respiratory arrest, resuscitation, and permanent brain damage Wrong dose of tacrolimus led to failure of the patient s transplanted liver and necessitated a second liver transplant The use of a brand name in tables is intentional because this is a closed-claim study. Generic names are used where no specific brand name was indicated. tion reconciliation is the act of the clinician (physician, nurse, or pharmacist) comparing the list of medications that a patient should be (and actually is) taking against new medications that are ordered to resolve medication discrepancies. Performance in this area is part of a hospital s accreditation score and, to that end, a Joint Commission National Patient Safety Goal (NPSG) directs hospitals to coordinate information during transitions of care, communicate with other providers, and educate the patient about medication safety. Because it recognizes that medication reconciliation is riddled with challenges primarily when it comes to relying on the patient to provide an accurate list of drugs being taken the Joint Commission has added a new requirement to this NPSG: Organizations should inform the patient about the importance of maintaining updated medication information. 6 The P&T committee may have a consultative role in helping hospitals and health systems achieve higher performance with Joint Commission standards such as these. MALPRACTICE CLAIMS ANALYSES To examine the nature and scope of medication risk management issues, let s review CNA liability analyses in which medication errors are prominent. In professional practice, learning from common and unusual mistakes promotes performance improvement and reduces the risk for future errors. In studying its claims experience, an insurance company does the same, though on a larger scale. Prior to the release of the CNA/HPSO report on pharmacist liability, CNA the nation s largest commercial insurance underwriter released analyses of claims against registered nurses (RNs) and nurse practitioners (NPs). Topline findings of the RN and NP liability reports show that medication errors expand beyond pharmacists, who are considered to be the primary health care professionals responsible for medication safety in a health system. Closed RN claims study. This analysis focused on 512 closed claims between 2006 and 2010 that resulted in an indemnity of more than $10,000. More than 30% of the claims involved nurses in an inpatient medical or surgical setting. After issues involving patient treatment and care, the most frequent allegations of wrongdoing centered on medication administration. Medication administration accounted for about one in every seven cases CNA examined and resulted in payouts totaling almost $9 million. The three most common errors involving medication administration were wrong dose (26.3%), improper technique (19.7%), and wrong medication (18.4%). 7 Closed NP claims study. Another claims analysis covered CNA-insured nurse practitioners. This report analyzed 523 claims between 1994 and 2004 that accounted for more than $38 million in total paid indemnity, expense, and reserves. While representing only 4.7% of the closed claims against NPs, claims related to inpatient services had, by far, the highest average payout $531,333 per claim. Allegations of medication errors accounted for 15.9% of all closed claims. NP-administered medication errors involving wrong dose, wrong medication, or medication contraindication accounted for almost 65% of medication-related claims. One claim stemmed from an NP administering the wrong medication, resulting in a $766,666 indemnity. 8 CNA/HPSO PHARMACIST LIABILITY STUDY The CNA/HPSO pharmacist report discusses the circumstances leading to liability claims, examines patterns of liability, and reports financial outcomes stemming from settlements and jury verdicts. The study also reports the costs of defending pharmacists before boards of pharmacy. 1 The report contains several detailed case studies and high-level risk management recommendations, which, if implemented, may facilitate medication safety and minimize the likelihood of patient injuries and pharmacist liability exposure. A self-assessment checklist is intended to help pharmacists improve their own risk awareness and safety practices. HPSO insures approximately 70,000 pharmacists who work in a variety of practice sites, including community, hospital, infusion center, long-term care, and compounding pharmacies. Over the study period (2002 2011), there were 1,409 reported medication-related incidents, 560 P&T August 2014 Vol. 39 No. 8

Table 2 Costliest Wrong-Drug Claims 1 Medication Prescribed Medication Dispensed Cost of Closed Claims Progesterone suppository Prostaglandin suppository $1,000,000 6-mercaptopurine Propylthiouracil $900,000 Primidone* Prednisone $450,000 Diamox Diabinese $275,000 Tegretol Theophylline $200,000 Isosorbide Glipizide $185,000 Klonopin and Tinzanidine 2 prescriptions of Klonopin $137,500 and no Tinzanidine Tarceva Tambocor $100,000 Amaryl Coumadin $87,500 * Separate claims for one incident were filed against the pharmacist and pharmacy, each for $225,000. The use of a brand name in tables is intentional because this is a closed-claim study. Generic names are used where no specific brand name was indicated. adverse patient outcomes, and actual claims against pharmacists, pharmacy technicians, and other pharmacy personnel and entities insured through CNA/ HPSO. Claims that were closed during the study period and that resulted in an indemnity payment of $1 or more were included in the dataset (N = 162). The vast majority 93.8% of claims analyzed involved pharmacists with individual professional liability policies, while 5.6% involved pharmacists employed by a corporate entity. Only one claim involved a lawsuit against a pharmacy technician. In all, closed claims resulted in payments totaling more than $14 million over the study period. 1 CNA/HPSO grouped claims into National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) categories. Three of the 10 categories resulted in a higherthan-average paid indemnity, accounting for only 32.7% of all claims but 82.9% of all dollars paid (Table 1). The report also identified the categories of errors and omissions that are most responsible for malpractice claims against pharmacists. Wrong drug (43.8%) and wrong dose (31.5%) represent more than three-quarters of all closed claims reported (Figure 1). wrong-drug claim payouts (Table 2). Some elements appear to have contributed to the frequency and/or severity of these errors. The most common causes of wrong-drug dispensing errors included pharmacist failures to differentiate among sound-alike/look-alike drugs (SALAD) and to check the drug container s label against the actual prescription. Three factors CNA/HPSO identified in wrong-drug claims resulted in higherthan-average paid indemnity 1 : Failure to question the prescriber about an unusual prescription (1.9% of claims) Failure to question the practitioner about unusual numbers or amounts (1.2%) Figure 1 Distribution of Claims by Type of Allegation 3.1% 2.5% 3.7% 3.1% 4.9% 7.4% 43.8% Failure to obtain a patient s history, profile, and current drug therapies (0.6%) Label switches can result when a pharmacist multitasks, filling multiple prescriptions for a single patient. For example, a patient may have a prescription for Coumadin once a day and Lasix twice a day. If the labels are switched and the patient takes Coumadin twice a day, he may have a serious hemorrhage. Table 3 lists prescribed medications that were involved in more than one wrong-drug claim in the CNA/HPSO report. Eleven medications accounted for 15.4% of wrong-drug claims, suggesting they may be prone to wrong-drug errors. Table 4 lists the classes most frequently involved in wrong-drug cases. Some parallels can be drawn from a similar study by Pharmacists Mutual in 2013. In an examination of closed claims against retail pharmacists, drugs most frequently involved in mechanical errors (i.e., dispensing or wrong-drug errors to the patient) were, in order of frequency: Coumadin (warfarin, anticoagulant); levothyroxine sodium (thyroid replacement), antidiabetics; lisinopril (ACE inhibitor); Toprol-XL (metoprolol succinate, beta blocker); insulin; Augmentin (amoxicillin, antibiotic), Deltasone (prednisone, synthetic corticosteroid); Elavil (amitryptiline, antidepressant); and hydrocodone and oxycodone (opioid analgesics). 9 Wrong dose A wrong dose error occurs when instructions on dose (amount taken at one Wrong drug Wrong dose Failure to consult with prescriber Compounding error Failure to identify overdose Wrong drug Wrong-drug errors are those in which the drug dispensed is different from the one prescribed. In the CNA/HPSO study, 14.2% of claims (10 of 71) for wrongdrug errors accounted for 80.7% of all Prescription given to wrong patient 31.5% Wrong form/route Other Source: Adopted from Figure 9 in 2013 Pharmacist Liability 1 Vol. 39 No. 8 August 2014 P&T 561

Table 3 Prescribed Medications Involved in More Than One Wrong-Drug Claim 1 Aciphex Amaryl Celexa Claritin Clomiphene Clonidine Hydroxyzine Primidone Progesterone Tegretol Topamax Use of a brand name in tables is intentional because this is a closed-claim study. Generic names are used where no specific brand was indicated. time) or dosage (frequency of a regimen) given to the patient differ from what is written on the prescription. A common example would be receiving a prescription for digoxin 0.125 mg, and accidentally filling it with digoxin 0.25 mg. A pharmacist taking the wrong bottle off a shelf when filling the prescription is a common way that these errors occur. The drugs with the greatest numbers of available dosage forms offer the greatest probability for a dosage error. Misplacement of a decimal point may be the most common route to a wrong dose. Even old, familiar drugs are subject to this kind of error. Medications that are filled most often are going to be involved in more errors; this is simply a matter of statistics. For example, Haldol is commonly used for senile dementia. It would be unusual for Haldol 5 mg to be prescribed for an ambulatory elderly patient. A more common dosage is 0.5 mg. In the CNA/HPSO report, three claims involved prescriptions of amitriptyline prescribed at 10 mg but dispensed at 100 mg. 1 Wrong-dose errors can be dangerous or fatal. In fact, 57.9% of claims involving a patient death in the CNA/HPSO study resulted from overdoses. Adverse outcomes, however, may arise not only from too much drug but also from too little drug, leading to lack of efficacy. If too low a dose of warfarin is administered, for example, the medication could fail to prevent a fatal blood clot. Moreover, the potential for toxicity is a predictive factor for dosage error litigation. If the patient suffers some type of damage or adverse effect even if the only consequence is an unplanned visit to the emergency room action against the pharmacist and/or the pharmacy may result. The most common drug involved in wrong-dose errors cited in the CNA/ HPSO report was warfarin. Of the 51 wrong-dose claims cited, 11 (22%) involved warfarin or Coumadin. 1 LACK OF DRUG REVIEW OBRA-90 (the Omnibus Budget Reconciliation Act) required pharmacists to conduct a drug utilization review (DUR) checking for interactions, allergies, and a list of other potential problems on all prescriptions prior to filling them. Because pharmacy technicians are increasingly used to reduce the pharmacist s workload, this category of error, once almost unheard of, now represents, in general, about 8% of all claims. Reports from the field indicate that technicians frequently override DUR alerts and do not involve the pharmacist, leading to errors and injuries. OBRA requires medication profiles, as well as reviews for therapeutic duplication, allergy, cross-sensitivity, druginduced disease, and contraindications. Failure to provide a meaningful drug review has resulted in claims and lawsuits that plead error of omission. An example of this could be the use Table 4 Classes Most Frequently Involved in Wrong-Drug Claims (Either Prescribed or Received) 1 Class Number of Claims Antidepressants 13 Hypotensive agents (not including beta blockers) 10 Benzodiazepines (alprazolam and clonazepam) 8 Hypoglycemics (all sulfonylureas) 6 Beta blockers 5 Antihistamines 5 Anticoagulants (all warfarin) 4 of Toradol, a pain medication, for a patient who has a documented aspirin allergy. The standard of care requires that the pharmacist call the physician and inform him of the patient s aspirin allergy. Because there is cross-sensitivity for Toradol in the patient s allergy to aspirin, giving that product is contraindicated. In this case, the pharmacist should suggest an analgesic with no cross-allergenicity to aspirin. In any case, the pharmacist should refuse to dispense a drug to a patient who is at risk. DISCUSSION In each of the three CNA analyses, medication errors accounted for a significant portion, in terms of either monetary value or frequency, of total claims. In the pharmacist claims report, wrong drug and wrong dose were the most common types of claim. Specifically, the factors affecting dispensing errors linked to pharmacists included failure to differentiate SALADs and failure to check the drug against the label and the prescription. The P&T committee s role is relevant to drugs on the formulary as well as drugproduct selection for administration and/ or dispensing. Therefore, some key questions for P&T committee members or their advisors would include: What could a P&T committee do to limit the errors identified in the CNA analyses? Would it be beneficial for the committee to assure adequate staffing, policies and protocols, and quality assurance of the entire medication use and information process? Does the P&T committee s oversight of drug selection and use have the potential to reduce medication errors and improve the dispensing system in a way that ensures better patient safety and clinician performance? In part 2, we will discuss risk management recommendations for pharmacy and P&T committees in health care organizations, including suggestions for ways to avoid malpractice claims and legal or regulatory liability risks for clinicians, pharmacies, and medication use. ACKNOWLEDGEMENTS The authors thank Judith Gomes and John Mark Dias, PharmD candicontinued on page 579 562 P&T August 2014 Vol. 39 No. 8

continued from page 562 dates, Presbyterian College School of Pharmacy, Clinton, South Carolina, for research assistance in the preparation of this article. References 1. CNA/Healthcare Providers Service Organization. 2013 Pharmacist Liability. A Ten- Year Analysis. Available at: https://www. hpso.com/pdfs/db/pharmacist_claim_ Reprot_2013.pdf?fileName=Pharmacist_ Claim_Report_2013.pdf&folder=pdfs/ db&islivestr=y. Accessed June 11, 2014. 2. Coffey C. Family says pharmacy error nearly killed boy. NBC Chicago. February 26, 2014. Available at: http://www. nbcchicago.com/investigations/family- Says-Pharmacy-Error-Nearly-Killed- Boy--247413951.html. Accessed June 11, 2014. 3. Balu S, O Connor P, Vogenberg FR. Contemporary issues affecting P&T committees. Part 1: the evolution. P&T 2004;29:709 711. 4. Balu S, O Connor P, Vogenberg FR. Contemporary issues affecting P&T committees. Part 2: beyond managed care. P&T 2004;29:780 783. 5. Shulkin D. Reinventing the pharmacy and therapeutics committee. P&T 2012;37:623 624, 649. 6. The Joint Commission. National Patient Safety Goals Effective January 1, 2014: Hospital Accreditation Program. Available at: http://www.jointcommission.org/ assets/1/6/hap_npsg_chapter_2014. pdf. Accessed June 11, 2014. 7. CNA Healthpro and Nurses Service Organization. Understanding nurse liability, 2006 2010: a three-part approach. Available at: http://www.nso.com/ pdfs/db/rn-2010-cna-claims-study. pdf?filename=rn-2010-cna-claims- Study.pdf&folder=pdfs/db&isLiveStr=Y. Accessed June 12, 2014. 8. CNA. Nurse practitioner claims study. An analysis of claims with risk management recommendations, 1994 2004. Available at: http://www.cna.com/vcm_content/ CNA/internet/Static%20File%20for%20 Download/Risk%20Control/Medical%20 Services/NursePractitionerClaimsStudy. pdf. Accessed June 12, 2014. 9. Pharmacists Mutual Companies. Drugs most involved in mechanical error claims. Available at: http://www.phmic.com/ RM/Pages/DrugsMostInvolved.aspx. Accessed June 12, 2014. n Vol. 39 No. 8 August 2014 P&T 579