1. High Risk and High Alert Situations William E. Fassett, PhD, RPh, FAPhA Professor of Pharmacy Law & Ethics Washington State University - Spokane

2. Objectives Identify high-alert situations that have led to significant lawsuits in recent years Know situations where pharmacists have expanded duties to patients beyond merely correct dispensing Understand strategies to deal with high-alert situations

3. Disclaimers Unless cases are presented with citations to specific legal opinions, be aware of the following: o The cases have been adapted and altered from actual cases, and are intended for educational purposes only. o The patient names, prescriber names, and pharmacy names are fictitious. Any similarity to any actual person or firm is coincidental. o The dates and locations have been changed. In general, cases have been abridged and not all relevant factual elements have been included. The purpose of this discussion is intended to be educational, and any advice I provide is that of a pharmacist interpreting the clinical and operational issues involved from an experienced pharmacist’s perspective. I am not an attorney and am not offering legal advice. Any legal applications of this discussion to your practice should be discussed with your attorney.

4. Pharmacists’ Legal Duties to Patients Dispense the prescription accurately and lawfully Generally, no “duty to warn” – 7 exceptions* o Obvious error on the face of the Rx o Pharmacist has specific knowledge of patient’s allergies, conflicting drug use, or other propensity for harm o When the prescription is contraindicated based on the package insert o When the pharmacy has undertaken to provide a service like screening or patient education o When representations have been made to the public that promise special services o When a drug has been withdrawn from the market but the pharmacist compounds the drug or otherwise continues to dispense it o When a MedGuide is mandated for a drug and the pharmacist does not provide it When you are the prescriber or modifier of an order, you are responsible for all the duties of any prescriber *Brushwood DB. Recent trends in pharmacy law and regulation. Pharm in Hist 2009; 51(3):98.

5. Today’s Cases Why we should still teach “Inorganic Medicinal Products” in pharmacy school Don’t be afwaid of the your growing scope of practice, but do be vewwy, vewwy, caweful. Nocturnal choices: Neil Young or Shakespeare? o “They were flying Mother Nature’s silver seed to a new home in the sun” o “Devoutly to be wish’d. To die, to sleep; to sleep: perchance to dream: ay, there’s the rub.” Some recurrent identity crises

6. A basic misunderstanding of acidic nomenclature Or, it’s time for the Glacial Age to come to an end in medicine.

7. The stock order “Clinic Pharmacy” “Yes, this is Nurse Bedside. Do you have acetic acid in stock?” “We have a pint in stock.” “OK. We’ll pick it up for use in the outpatient clinic.”

8. What did the clinic pick up from the pharmacy?

9. What are the clinical uses of acetic acid? Otitis externa – 2% solution (“Domeboro Otic”) Identify dysplasias of mucous membranes – 3-5% solution (vinegar = 5%) Wound or bladder irrigation solution – 0.25% acetic acid irrigation, USP Iontophoreses treatment of upper extremity soft tissue injuries – 2% -10% solution Assess subclinical genital HPV – 3-5% solution o The physician applied the product directly to the patient’s genital area to assess possible HPV.

10. What is Glacial Acetic Acid? Called “glacial” because at the concentration of this particular solution, when it freezes, produces crystals that look like glaciers. What is this freezing point? o 17° C (62° F) What is this concentration? o Anhydrous or nearly so (  99.5%)

11. Repeat Safety Alert (1 st ISMP alert issued in 2005) National Alert Network – January 23, 2013 WARNING! Severe burns and permanent scarring after glacial acetic acid (≥ 99.5%) mistakenly applied topically Recent cases nationally: o Severe burns and permanent scarring after GAA applied to skin instead of 5% solution during surgery o Nurse requested “acetic acid for irrigation” for a young woman with paraplegia, osteomyelitis, and bilateral greater trochanter wounds. GAA used for 2 days instead of diluted form o Ambulatory surgery center requested 4% acetic acid for use during anoscopy. GAA purchased by staff and patient suffered severe anal burns. o GAA placed in bowl in OR; intended use to identify rectal condyloma. Patient required extensive treatment and prolonged hospitalization. Our patient would be at least number 5!

12. ISMP Recommendations Do not stock glacial acetic acid in the pharmacy o Stock 5% or vinegar or commercial 2% or 0.25% products Restrict purchasing of acetic acid to pharmacy Make glacial acetic acid “invisible” in purchasing and ordering software Ensure correct strength is ordered Educate staff Order 5% acetic acid as “vinegar” Verify product – independent double-check of all acetic acid solution orders before dispensing or delivery

13. Collaborative Drug Therapy Agreements Or, be sure to put the “management” in collaborative drug therapy management

14. Must avoid SUBtherapeutic drug therapy management

15. “Pharmacist to Dose” Patient started on clindamycin + gentamicin presumptively secondary to diagnosis of pelvic abscess o Treatment phase 1: “Pharmacy to dose gentamicin” Initial dosing followed protocol : o 2 mg/kg IV loading o 1.5 mg/kg IV every 8 hours (4.5 mg/kg per day) Trough and peak levels ordered per protocol; WNL IV treatment continued x 48 hrs No c/s of abscess is performed Abscess not drained o Treatment phase 2: Discharged to home on clindamycin orally 400 mg q.i.d. plus gentamicin 1.5 mg/kg IM daily Pharmacy accepts physician’s request to give IM dosing at 1.5 mg/kg/day and responsibility to monitor therapy Pharmacy continues to monitor and orders peak and trough levels Patient continues on 1.5 mg/kg IM daily for 15 days o Treatment phase 3: Readmitted – placed on daily IV gentamicin dosed per pharmacy Inpatient dosing is established by pharmacy at 5-7 mg/kg/day Dosing continued for 6 days, then discontinued At discharge, patient’s abscess is cleared, but her SCr has risen clinically significantly 7 days post-discharge, patient experiences signs of vestibular toxicity

16. Issues at Trial Plaintiff alleged that the physician and the institutional pharmacists were negligent; particular emphasis on treatment phase 2: o Use of prolonged gentamicin without evidence of gentamicin-sensitive infection o Use of prolonged sub-therapeutic gentamicin o Management of gentamicin therapy by pharmacists not in accordance with the approved protocol Defendants claimed that the low dose IM may have been used for synergism Clinda-gent not “synergistic” therapy Extended interval gentamicin therapy not to be used according to the protocol for synergism with beta-lactam antibiotics o Lengthy unnecessary gentamicin therapy was proximate cause of vestibular toxicity Patient also alleged a separate cause of action: o Neither physician nor pharmacists obtained informed consent before prescribing gentamicin o Neither physician nor pharmacists warned of risk of vestibular toxicity o Physician and pharmacy representative essentially claimed in deposition testimony that they were unaware of the risk of vestibular toxicity from gentamicin Defendants moved for summary judgment on issue of pharmacists’ duty to obtain informed consent; motion denied Case settled for undisclosed amount just before trial

17. When you Prescribe, YOU must Follow Up

18. Pharmacist PCA dosing: Elderly patient admitted to hospital for pain management Pharmacists managed PCA therapy Final timeline: hydromorphone PCA as ordered by pharmacists: *- MD note: “pt can’t keep eyes open – D/C basal rate” At 1900 hours, patient suffered respiratory/cardiac arrest TimePCA dose LockoutCont rate1-hr lim 07304 mg8 min5 mg/hr20 mg 20103 mg8 min3.5 mg/hr18 mg 10153 mg8 min“D/C”*18 mg 12002 mg8 min0 mg/hr10 mg

19. RCA Cardiac arrest was secondary to respiratory arrest Respiratory arrest likely due to narcotics Question: what if the pharmacist’s orders at 1200 hours were never actually implemented?

20. Key CDTA Issues It is unwise for a pharmacist to take over management of a drug that in not indicated or is ordered at the wrong dose A pharmacist does not normally bear the burden of obtaining informed consent, but does so if he or she is the prescriber o In a collaborative relationship, the pharmacist must at least determine if informed consent has been obtained o Obtaining informed consent is not a one-time event, but a process o Patients may sue for failure to obtain informed consent as a separate cause of action from negligence When the pharmacist initiates or modifies therapy, he or she becomes the prescriber, and OWNS the outcome of the therapy o If it is to be, it is up to thee

21. Informed consent: Elements to disclose to patient The nature and purpose of the proposed therapy The expected benefits of the proposed therapy The known likely material risks associated with the proposed therapy o Not necessary to disclose every risk Risks in the general population  1% probably should be disclosed Risks in the particular patient population of which the patient is a member should be discussed (e.g., NSAIDs in the elderly) If applicable, disclose risks experienced in the particular prescriber’s population or institution’s population o “Material” means risks a reasonable patient would want to know in deciding whether to undergo the proposed treatment Available alternatives to the proposed therapy (including the possibility of doing nothing)

22. So, What is the “Ambien” Temperature?

23. “All in a dream …” West Virginia: woman, while sleeping following a dose of zolpidem, got up, drove her car into ditch, and suffered severe injuries. o Sues pharmacy for, in part, failing to distribute required medication guide. o Defendant pharmacy moves to dismiss under West Virginia law, citing the Learned Intermediary Doctrine. o Court denies motion, holding that plaintiff had stated a colorable cause of action under the specific circumstances of the case. (Hartman v. Caraco et al. 789 F.Supp. 2d 701, S.D. W.Va. 2011) FDA discloses that it has received over 700 reports of automobile accidents related to drivers who had taken zolpidem o A New Jersey man sentenced to 41 months in prison for causing a fatal head-on collision while impaired by zolpidem (USA v. Smentkowski, No. 3:11-cr-00279-JAP, D. N.J., December 18, 2012)

24. Ambien doses too high Impaired ability to drive or operate machinery associated with zolpidem blood levels of 50 ng/mL or greater Results of pharmacokinetic trials, n = 250 men, 250 women, all trials – blood levels 8 hours following the dose: Dose% women  50 ng/mL % men  50 ng/ml Other results 10-mg IR15%3%3 women, 1 man  90 ng/mL 12.5 mg CR33%25%5% of pts  100 ng/mL 6.25 mg CR15%5%10% of elderly  50 ng mL

25. New doses and recommendations FDA tells producers to change zolpidem labeling for women : o Immediate-release: 5 mg/day o Extended-release: 6.25 mg/day o Recommend that prescribers consider same doses for men o FDA notes that it does not yet understand the mechanism that reduces zolpidem clearance in women compared to men Particular caution should be given to patients who need to drive in the morning following taking zolpidem Dosage recommendations do not apply to Intermezzo ®

26. What to tell our patients Make sure every prescription container for zolpidem products has a warning label concerning driving Counsel all patients receiving refills of or new prescriptions for zolpidem about the new recommendations o Women on higher doses should consult their prescribers about reducing their dose, especially if they need to drive the next morning o Note that 15% of women will still be exposed to driving risk the next morning at the lower dose o Let patients know that being arrested while impaired by zolpidem will have the same legal effect as being DUI for alcohol or pot Be sure to always dispense the FDA required Medication Guide – whether on new or refill Rxs Confirm dosing on new Rxs for women that exceed the new doses

27. “What you talkin’ about? Ahm bein’ good!” From 2006 through mid-2010, patient receives long-term zolpidem therapy for severe insomnia from 2 physicians o Through 2007 (Dr. A.), average consumption averaged 28 mg/day; instances existed of multiple prescriptions filled at multiple pharmacies o Later (Dr. B.), consumption increased to around 100 mg/day o The patient also was prescribed, and consumed, a variety of opioids, as well as diazepam and sertraline o Around 2008 “bad behavior” was reported to occur, culminating in criminal charges for assault o A pharmacologist expert hired for his criminal case opines that his sexually aggressive and assaultive behavior was caused by his becoming addicted to zolpidem The plaintiff subsequently sues the pharmacies that dispensed the prescribed doses of zolpidem, which were as high as 10 tablets (100 mg total) per day on the face of the prescription However, at one point, when the pharmacist at one pharmacy tried to refuse his prescriptions, he presented them with a copy of his medical record to show that his use was medically necessary

28. What the pharmacists at one pharmacy did Faced with the long-term very high dosing, the pharmacists in one pharmacy took several actions: o Repeatedly consulted with the prescriber about the recommended doses and duration of therapy o Obtained new prescriptions for each dispensing o Contacted the manufacturer of Ambien® to learn whether there was an absolute upper limit to zolpidem dosing What they learned from the manufacturer o No known upper or lethal dose of zolpidem o Several studies in the literature demonstrate patient survival and long-term recovery from doses exceeding 400 mg/day o Detoxification from zolpidem is possible, according to literature reports o Abrupt discontinuation will lead to withdrawal effects What they also did o Eventually, they determined to discontinue providing services to the patient, owing to his abusive behavior and a perception that he was a danger to employees and other clients

29. “Here’s to you, Mrs. Robinson … or is it Robertson?”

30. What the labels said Life Balance Pharmacy 200 W 1 st St. – Blue Hills, CA – 416-255-2555 Lennette Taylor DOB 4/8/63

31. What the patient said “I want to pick up the prescriptions for Lieutenant Taylor.” The patient’s first name was “Lieutenant” – it was not a rank The patient had diabetes and hypertension The patient was functionally illiterate He consumed his own meds and those intended for Lennette Taylor He later sued, alleging that the prescriptions dispensed to him for Lennette Taylor were the cause of his subsequent kidney failure The pharmacy argued that he signed for the prescriptions and was counseled on them Because a medical expert at trial testified that the error was not the proximate cause of the kidney failure, the jury found for the defendant pharmacy Taylor v. Thrifty Payless, Inc., B232635, Cal. App. Dist. 2 Div. 3, Unpublished, October 30, 2012

32. What are the odds? Two women not related to each other: o Yolanda Vessell, DOB Oct 1955 (Yolanda Vessell 1) o Yolanda Vessell, DOB not Oct 1955 (Yolanda Vessell 2) Both Yolanda’s saw local dentists o Yolanda Vessell 1 was a patient of Dr. Beier, a dentist o Yolanda Vessell 2 was a patient of Dr. Fallin, a dentist o Dr. Fallin purchases Dr. Beier’s practice. Yolanda Vessell 1’s records become merged with Yolanda Vessell 2’s records – what could possibly go wrong? November 2005 – Dr. Fallin telephones an Rx for amoxicillin for Yolanda Vessell 2 to Walmart Pharmacy o The pharmacist notes a PCN allergy, and calls dentist, who changes Rx to clindamycin. When confirming the change, the dental office tells Walmart that the patient’s DOB is October 1955 o The pharmacy assigns the order to Yolanda Vessell 1, on the basis of the DOB By coincidence, Yolanda Vessell 1’s husband picks up her Rxs, including the clindamycin Rx o In spite of never being a patient of Dr. Fallin, whose name is on the label, Yolanda Vessell consumes the clindamycin, is injured, and sues Walmart The Court granted Walmart’s motion for summary judgment, holding that the pharmacy properly filled the prescription, relying on the patient name and birthdate provided by the dentist. Vessell et al. v. Fallin Family Dentistry et al., No. 2011 CA 1702, La. App. 1 st Cir., (unpublished opinion), May 3, 2012

33. Across the pond … “Blind man dies in Boots blunder with wrong prescription after he is unable to tell the difference” – London Mail Online, 2012 Sep 8 83-yr old Douglas Lamond received someone else’s medications from a Boots pharmacy in the UK. He was unable to recognize the error owing to his visual deficiencies. “Boots, which has sent a message of condolence to his family, has refused to reveal which branch mixed up the prescriptions or which drugs were involved. Extra safeguards have been put in place at the pharmacist’s branches to ensure the mistake is not repeated.”

34. Problems with dispensing to wrong patient Possible liability for harm to patient receiving the wrong drug Loss of the cost of the medications when wrongly dispensed o If Medicaid or Medicare Part D, certainly cannot re-bill for the mis- dispensed drug HIPAA violations – disclosing to the wrong patient information concerning the other patient’s medications DEA violations – if the “missing drug” is a controlled substance, must file a statement of loss with DEA

35. So, What to Do about ID? Don’t forget the lesson of the railroad crossing: Always seek multiple ways to identify the patient o Full name o Date of Birth o Medical ID number o Address o Gender o Photo Counseling will overcome o If the patient doesn’t know the purpose of the drug you are dispensing, why not? o If the patient is seeking something for cough, why should the prescription contain estrogen? National Patient Safety Goal: 2 forms of ID

36. Any Questions?