William E. Fassett, PhD, RPh, FAPhAProfessor of Pharmacy Law & Ethics

Washington State University - Spokane

ObjectivesObjectives• Know situations where pharmacists have expanded

duties to patients beyond merely correct dispensing• Identify high-alert situations that have led to

significant lawsuits in recent years• Understand strategies to deal with high-alert • Understand strategies to deal with high-alert

situations• Use on-line search engines to find reliable

information on unusual/off-label uses of drugs

Pharmacists’ Legal DutiesPharmacists’ Legal Dutiesto Patientsto Patients

• Dispense the prescription accurately and lawfully

• Generally, no “duty to warn” – 7 exceptions*o Obvious error on the face of the Rxo Pharmacist has specific knowledge of patient’s allergies, conflicting

drug use, or other propensity for harmdrug use, or other propensity for harmo When the prescription is contraindicated based on the package

inserto When the pharmacy has undertaken to provide a service like

screening or patient educationo When representations have been made to the public that promise

special serviceso When a drug has been withdrawn from the market but the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

*Brushwood DB. Recent trends in pharmacy law and regulation. Pharm in Hist 2009; 51(3):98.

DisclaimerDisclaimer• The cases have been adapted and altered from

actual cases, and are intended for educational purposes only.

• All of the patient names, prescriber names, and pharmacy names used in this presentation are pharmacy names used in this presentation are fictitious. Any similarity to any actual person or firm is coincidental.

• Dates and locations have been changed. • Cases have been abridged and not all relevant

factual elements have been included.

What did the doctorWhat did the doctororder? Or, how not toorder? Or, how not tocompound your owncompound your owncompound your owncompound your own

risk.risk.

The phone callThe phone call• “MasterCare Pharmacy, this is Julie speaking.”• “Hi, Julie. This is Dr. Foote. I need 30 cc of 1%

tetracaine solution for a patient who’s coming in next Tuesday.”

• “OK, Dr. We’ll get it to you by Friday.”• “OK, Dr. We’ll get it to you by Friday.”

The “refill”The “refill”• Julie: {Hmmm. I don’t see tetracaine solution in Dr.

Foote’s prior orders. But I know we make the oral solution, so that must be what he wants.}

• “Dr. Foote’s Foot Clinic … this is Marge.”• “Hi Marge, this is Julie at MasterCare Pharmacy. I • “Hi Marge, this is Julie at MasterCare Pharmacy. I

just talked with Dr. Foote … did he want that solution to be oral?”

• “He’s not here, but let me ask the nurse. … Okay, yes.”

• “OK, thanks! – Bye.”

The “review”The “review”• Jane, the pharmacist: “So, Julie, what do we have

here?”• “I’ve prepared some refills for clinics.”• “OK. Hmmm, 1% tetracaine oral solution for Dr.

Foote. I see you modified the 0.5% recipe. Are you Foote. I see you modified the 0.5% recipe. Are you sure he wanted 1%?”

• “Yes … I double-checked.”• “OK … looks good.”

What theWhat thetechniciantechnician

sent.sent.

What theWhat thePODIATRISTPODIATRISTPODIATRISTPODIATRIST

did …did …

Is 240 mg of prednisone perIs 240 mg of prednisone perday enough?day enough?day enough?day enough?

Selections fromSelections fromGillian’s ProfileGillian’s Profile

Date Rx # Drug Dr Qty DS12/10 …99 Prednisone 10 mg J.B. 45 58/3 …78 Flovent HFA 110 J.B. 12 308/3 …79 Proair HFA J.B. 8.5 308/3 …79 Proair HFA J.B. 8.5 308/3 …80 Prednisone 20 mg J.B. 10 58/27 …42 Azithromycin 250 R.T. 6 59/4 …34 Prednisone 20 mg J.B. 72 6

What the Dr. wantedWhat the Dr. wanted• Please call in –

Prednisone 60mg i po QD x 6 days x 6 days then stop.

What the pharmacistWhat the pharmacistrecordedrecorded

• 9/4 –Gillian Cooke DOB 3/12/69

Pen V K Prednisone 60 mgPen V K Prednisone 60 mgi PO QID x 6D

Dr. J.B.Leslie 828-2345

What the label saidWhat the label said

DOLLAR/WISE PHARMACYDOLLAR/WISE PHARMACY

TAKE 3 TABLETS BY MOUTH FOUR TIMES A DAY FOR 6 DAYS

PREDNISONE 20MG TABLET

When Gillian called theWhen Gillian called theclinicclinic

• Telephone Call Memo: “9/5 -- PT SAYS DOSE SEEMS HIGHER THAN SHE USUALLY TAKES – PLEASE CONFIRM AND CALL”

• Note by Dr.: 60 mg per day – that’s ok.

• Note by RN: “DONE – RMN, 9/5”• Note by RN: “DONE – RMN, 9/5”

Wrong kind of mountainWrong kind of mountainhigh?high?

Is dexamethasone 12 mg/day forIs dexamethasone 12 mg/day for30 days a reasonable dose?30 days a reasonable dose?

• Patient is 23-yo male who intended to climb Mt. Everest• Prescription issued for “Dexamethasone

4 mg #90; 1 tid with food”• Patient had no history of prior steroid use, of asthma, any

immune disorder, or cancer• Patient started the dexamethasone upon arrival at the

Everest base camp, prior to ascent. He believed that the Everest base camp, prior to ascent. He believed that the dexamethasone was to be used as prophylaxis for Acute Mountain Sickness (AMS)

• He never made the climb - required emergency treatment at base camp clinic, and airlift to hospital at Kathmanduo Acneform lesions over entire bodyo Muscle weakness and fatigueo Disorientationo Headacheo Rectal bleeding and occult blood in feceso Hematemesiso Severe anemia (WBC 22,800, Hgb 8.5 g/dL)o Continues to have symptoms of steroid psychosis

DexamethasoneDexamethasone for Altitude Sickness for Altitude Sickness –– What What

You Could Quickly Find on You Could Quickly Find on

• Is 4 mg tid a normal dose of dexamethasone?• Is dexamethasone indicated for prevention of altitude

sickness?• What is the difference between

o Acute Mountain Sickness (AMS)• Incidence related to rate of ascent• Headache above 2,500 m plus anorexia, nausea, vomiting, insomnia, dizziness,

lassitude, fatigueo High Altitude Cerebral Edema (HACE)

• End stage of AMS• Ataxia, altered consciousness, or both in someone with AMS or HAPE

o High Altitude Pulmonary Edema (HAPE)• Major cause of death due to altitude illness• Incidence related to rate of ascent• Often occurs on the 2nd night at a new altitude• Dyspnea with reduced exercise tolerance • Crackles on auscultation

What you could find onWhat you could find onGoogle (cont’d)Google (cont’d)

• Treatmentso AMS

• Acetazolamide – the only “prophylaxis” – aids acclimatization (250 mg bid-tid)

• Dexamethasone – treats hypoxia, does not help acclimatization (dose for AMS = 2 doses of 4 mg, 6 hrs apart). Dexamethasone is not indicated for prophylaxis.prophylaxis.

o HACE• Immediate descent is the key treatment and is essential to save the

climber’s life• Dexamethasone 8 mg stat then 4 mg q 6 h• Oxygen and hyperbaric treatment

o HAPE• Immediate descent is essential• Nifedipine 10 mg swallow or chew then 20 mg q 6-12 h• Oxygen• Hyperbaric treatment

Dealing with UnusualDealing with UnusualPrescriptionsPrescriptions

• Be alert to strange uses: if you aren’t aware why a strange dose is being prescribed, ask

• Make sure the patient has clear instructions and knows how to take the drug

• Take time to learn more – remember that you are • Take time to learn more – remember that you are expected to know the proper use of every drug you dispense

Mix orMix orMatch is OKMatch is OK

forfor SomeSomeforfor SomeSomeThings …Things …

LookLook--alike/Soundalike/Sound--alikealikedrugsdrugs

• Patient #1: 84-yo female had been on CLONIDINE 0.2 mg bid for several years. On a routine refill, the pharmacy dispensed a round, white tablet labeled with a stylized “R” and “35.” The product turned out to be CLONAZEPAM 2 mg.CLONAZEPAM 2 mg.o The patient took the drug for 21 days and had

several falls, resulting in a hip injury

• Patients #2 and #3: 8-yo female had been on CLONIDINE 0.1 mg daily for 4 yrs. 12-yo male had been on CLONAZEPAM 1 mg for some time for seizures. The pharmacy apparently placed each child’s drug in the other child’s container.o Patient #2 ended up with severe acute paradoxical

reactions to the clonazepam, which are often noted in children.

o Patient #3 ended up with seizures due to the sudden withdrawal of clonazepam.

Opioids are Narrow Therapeutic Opioids are Narrow Therapeutic Index Drugs in the ElderlyIndex Drugs in the Elderly

What the Doctor OrderedWhat the Doctor Ordered• Elderly female, opiate naïve, seen in ED for wound

pain, treated with 1 mg hydromorphone in ED, discharged with e-printed Rx:

• “Hydromorphone (Dilaudid) 2 MG TAB1-2 MG PO Q4 HOURS”1-2 MG PO Q4 HOURS”

What the pharmacyWhat the pharmacydispenseddispensed

• “TAKE ONE OR TWO TABLETS BY MOUTH EVERY FOUR HOURS”EVERY FOUR HOURS”

How Narrow?How Narrow?• Prescribed dose: 1 to 2 mg hydromorphone

o Morphine equivalent: 4 to 8 mg morphine

• Dispensed dose: 2 to 4 mg hydromorphoneo Morphine equivalent: 8 to 16 mg morphine

• Apparently-consumed dose: 2 mg followed by 4 mg • Apparently-consumed dose: 2 mg followed by 4 mg 4 hours latero Morphine equivalent: 24 mg in 5 hours

• Hydromorphone therapeutic BL: 1 – 30 ng/mL• Hydromorphone fatal BL: 20 – 120 ng/mL• BL at autopsy: 70 ng/mL

SummarySummary –– Keep YourselfKeep YourselfOut of TroubleOut of Trouble

• Do not ignore high dose alerts

• Do counsel patients and ask them what medications they’re taking; advise patients

• Do recalculate all doses for:o Pediatric patientso Oncology drugso Opiate conversionso Elderly patients with

concomitant conditionstaking; advise patients to report rashes immediately

• Do not assume that specialists cannot make mistakes

• Do not dispense a drug if you don’t KNOW the dose is correct

oconcomitant conditions

• Have evidence that the patient is opiate tolerant before dispensing long-acting opiates.

• Do learn how to use the internet to quickly confirm unusual or off-label uses of drugs