ph 5 michel ward_warren

Liabilities for Pharmacists

April 23, 2014 Atlanta Marrio2 Marquis

Troubles Along The Way

Disclosure Statements

•  Alix C. Michel •  David J. Ward

•  Michael L. Warren

The three faculty for this activity have disclosed no relevant, real or apparent personal or professional financial relationships.

Learning Objectives

1.  IdenGfy current liabiliGes facing pharmacists. 2.  Evaluate cases brought against a pharmacist

to show best pracGces.

3.  Establish methods for improving a pharmacist’s pracGce.

Overview of Pharmacist Liabilities

•  Pharmacy Robberies •  Criminal Liability

•  Civil Liability •  CMS Issues

•  Board InvesGgaGons

Troubles That Break Down Your Door

Pharmacy Robberies

•  Chain Pharmacies reported 517 armed robberies January ‘12-‐January ’13

•  Retail Pharmacies reported 214 armed robberies January ‘12-‐January ’13

How Robberies Impact Pharmacies

•  Psychological impact

•  Loss of employees

•  Loss of business •  Time and expense – DEA, police and insurance invesGgaGon and reporGng

What keeps pharmacists up at night Police Arrest Second Suspect In Pharmacy Robbery, Murder Sep 22, 2013 - myfoxphili.com

Prosecutors to seek death penalty against ex-lawman in pharmacy slayings, robbery Sep 17, 2013 - Knoxnews.com

Pharmacy Shooting: 2 people dead, 2 injured in shooting at East Tennessee pharmacy May 24, 2013 - WBIR-TV

NY Pharmacy Robbery Leaves Suspect, ATF Agent Dead in Confused Shootout Jan. 1, 2012 - WACB-TV Suspect Arrested in New York Pharmacy Killings June 22, 2011 - ABC News

“Hardening the Target” – Making the store less attractive

•  Employees trained on suspicious persons and behaviors and what to do if a robbery occurs

•  Front counter easily visible from the outside

•  Video surveillance prominent

•  High pharmacy counter

•  Bullet resistant glass •  Time delay safe

“2nd level” Protection

•  Tracking devices •  DNA and other marking technologies

•  Verified alarms

•  Community policing – – Know the police – Share informaGon – Suspicious person alerts

Response to a Robbery

What to Do If Robber Enters Building

•  Remain as calm as possible •  Comply but don’t volunteer

•  Make sure the robber understands what you are about to do

•  Observe •  Do not a2empt to chase or apprehend the robber

What to do after Robber has left

•  Immediately lock all doors •  Call police •  Take notes on what happened •  Preserve evidence

Mama Bear

Other Pharmacist’s Responses

Problems that Knock at Your Door

Why pharmacist liability is so high

•  Pharmacists are consistently viewed as the “last line of defense” in making sure a prescripGon is right – that it is the correct drug, that dosage is correct and that the person should be receiving the prescripGon

How that applies to prescrip/on narco/cs

Problems that Knock at Your Door

The Corresponding Responsibility Doctrine

•  The United States Controlled Substances Act (CSA) is the statutory basis for federal oversight of controlled substance regulaGon in the United States.

•  The CSA provides the pharmacist an affirmaGve obligaGon to only fill prescripGons that are “issued in the usual course of professional treatment,” and prescripGons that do not meet this requirement are considered improper.

•  The pharmacist must exercise sound professional judgment regarding the validity of a prescripGon prior to dispensing. The pharmacist should not assume that every controlled substance prescripGon is improper, but rather take affirma8ve steps to ensure the prescrip8on’s validity

Source of Pharmacists’ Corresponding Responsibility

•  (A)n order purporGng to be a Rx issued not in the usual course of professional treatment or in legiGmate and authorized research is not a Rx within the meaning and intent of secGon 309 of the Act (21 U.S.C. § 829) and the person knowingly filling such a purported Rx, as well as the person issuing it, shall be subject to the penal8es provided for violaGons of the provisions of law relaGng to controlled substances. 21 C.F.R. § 1306.04(a)

Corresponding Responsibility Doctrine

U.S. v. Hayes 1979 (Texas)

•  Pharmacist filled 34 prescripGons for Dilaudid for paGent (3400 pills) and 75 prescripGons for Preludin in month 1

•  101 prescripGons for Dilaudid and 137 prescripGons for Preludin in month 2

•  Prescribing Doctor was transient alcoholic that lived part-‐Gme with pharmacist


U.S. v. Hayes 1979 (Texas) •  Pharmacist: Cannot have a "corresponding responsibility" to that of a pracGGoner because he cannot prescribe at all but only dispense; an a2empt by regulaGon to impose on him the obligaGons of a prescriber must, therefore, be ineffectual.

•  Court: Pharmacist may not fill a wri2en order from a pracGGoner, appearing on its face to be a prescripGon, if he knows the pracGGoner issued it in other than the usual course of medical treatment. The regulaGon gives "fair noGce that certain conduct is proscribed.“ We affirm the Convic8on.


U.S. v. Irwin 1981 (Texas)

•  Delivery of Controlled Substance •  Delivery of controlled substance was other than for a legiGmate medical purpose and in the usual course of professional pracGce

•  Conduct was knowing and intenGonal


Med. Shoppe-Jonesborough v. DEA 2008

The regulaGon requires pharmacists to use common sense and professional judgment, which includes paying a2enGon to the number of prescrip8ons issued, the number of dosage units prescribed, the dura8on and paNern of the alleged treatment, the number of doctors wri8ng prescrip8ons and whether the drugs prescribed have a

high rate of abuse. When pharmacists' suspicions are aroused as reasonable professionals, they must at least verify the prescrip8on's propriety, and if not saGsfied by the answer they must refuse to dispense.


Holiday CVS 2012 FL

ViolaGon of “corresponding responsibility” in administraGve cases required

•  Delivery of controlled substance •  Red flag that was or should had been recognized

•  QuesGon raised by the red flag not resolved conclusively prior to dispensing


Holiday CVS 2012 FL The “irresolvable” red flags: •  Prescriber in Fort Lauderdale, paGent had out of state address, and paGent paid cash for oxycodone

•  Same red flags + prescripGon filled in close sequence for individuals from out of state


Holiday CVS 2012 FL

The “irresolvable” red flags: •  Dispensing oxycodone 30 mg and 15 mg products to the same paGent

•  Prescribers whose prescribing pa2ern suggests a one size fits all concept


Holiday CVS 2012 FL


Top Rx Pharmacy (2013)

ViolaGon of “corresponding responsibility” in administraGve case required

•  Delivery of controlled substance •  A red flag that was or should have been recognized

•  The quesGon raised by the red flag is not resolved conclusively prior to dispensing


Top Rx Pharmacy (2013) Red flags based on state law •  Dispensing is unlawful if pharmacist knows or should know

that the prescripGon was issued outside a valid physician-‐paGent relaGonship

•  Can judge validity of physician-‐paGent relaGonship on 1.  Manner in which prescripGons are received

2.  Number of prescripGons for controlled substances issued by the pracGGoner

3.  Number of paGents receiving controlled substances



Red flags based on statements made by pharmacy employees: “To the extent [the] statements consGtuted a red flag, [the pharmacy] should have stopped all controlled substances dispensing unGl resolved.”



Conclusively resolving red flags •  Judged using “reasonable pharmacist standard”

•  Steps necessary to resolve red flags are influenced by circumstances giving rise to the red flags.

What are “Red Flags”?

•  PrescripGons for controlled substances from mulGple doctors

•  PaGent receives more than one controlled substance to treat the same indicaGon

•  PaGent has prescripGons for large quanGGes/doses of controlled substances


•  PaGent seeks early refills •  PaGent travels long distance •  Prescribing physician located at great distance •  PaGent receives opiate, benzodiazepine and carisopridol (cocktail)


•  Filling mulGple prescripGons for strongest formulaGon

•  PaGents travelling in groups •  Large porGons of prescripGons for controlled substances issued by one prescriber

•  Large percentage of prescripGons paid for in cash.


•  Failing to call other pharmacists to inquire as to why they refuse to fill prescripGons filled by a parGcular prescriber

•  Cash payments in combinaGon with other red flags

•  Drug is inconsistent with prescriber area of pracGce


•  PaGent refers to drug in street slang •  MulGple people from same address receive controlled substances

•  Family members receive controlled substances from same prescriber

•  State board or law enforcement acGon against prescriber

•  Lack of valid doctor-‐paGent relaGonship

How to Resolve Red Flags

•  Use PDMP •  Talk to paGents you know •  Extensively talk to paGents you don’t know •  Contact the Prescriber •  Document all communicaGon with Prescriber

•  Verify Prescriber DEA number

How to Resolve Red Flags

•  Talk with other pharmacists •  Use your insGncts •  If not comfortable, refuse to fill the prescripGon

NBC News 10/23/13

DEA INVESTIGATING COSTCO

Other Problems

Inadequate Supply of Pain Meds to Meet the Medical Needs of the

Community

Pharmacies Wholesalers

DEA

blame

blame

One Response

Possible “red flags” that could lead to the prescripGon being denied include:

• A pain medicaGon not previously filled at Walgreens

• A new doctor wriGng a prescripGon for the same pain medicaGon

• A doctor wriGng a prescripGon who is not in a “reasonable geographic locaGon” near the pharmacy.

• A paGent paying for a prescripGon in cash • A paGent seeking an early refill of a prescripGon

• A paGent seeking an “excessive” number of pills

• A paGent taking the same pain medicaGon for more than 6 months

Viscous cycle

Prescribers fearful of liability

Wholesalers fearful of DEA

Pharmacies fearful of

being cut-off

What’s old is new again…

1914

1940

1970

2001

2010

?

The Harrison Act and Restricted Access

Death bed or Combat

The pendulum shifts

The 5th Vital sign, “non-addictive” Oxycontin

CDC declares an epidemic

History doesn’t repeat itself, but it rhymes - Mark Twain

Congress declares a pain free decade.

But Wait…What a Generation of Doctors Learned Was Wrong.

PBS special, 5/2/13

Troubles With Your License Board Investigations

TRENTON — The licenses of three New Jersey pharmacists have been suspended following their arrests last month and allegations that they participated in an illegal prescription drug ring, state authorities said today. The suspensions — handed down against Daniel Podell, 87, of Clark; Howard Hirsh, 61, of Cranbury; and Lawrence Zaslow, 59, of Cherry Hill — will remain in effect until further action by the state Board of Pharmacy and the resolution of the criminal charges. Authorities allege several pain management clinics in Florida provided prescriptions for painkillers such as oxycodone, hydromorphone and morphine sulfate to patients who had no medical need for them.

More Legal Troubles

Huntington Beach Pharmacy Shutdown, connected to Dr. Tseng

Emerging Trends Walgreens Loses $1.4M for Sharing Patient’s

Private Medical Info

Walgreens pharmacist whose husband was the ex-‐boyfriend of customer at the pharmacy suspected ex of giving her husband a sexually transmi2ed disease, so she used her authority at the pharmacy to access ex’s medical records. She shared ex’s sensiGve medical details with her husband, who later sent ex a text message indicaGng he knew the records’ contents.

Even though ex called the pharmacy to complain, pharmacist was allowed to access the informa8on a second 8me. The suit accused Walgreens of negligence in its supervision of pharmacist, though the company fought back by arguing that pharmacist’s illegal acts weren’t associated with her employer-‐authorized conduct. A judge disagreed and sent the quesGon to a jury, which found the company liable for 80% of the damages owed to ex. Walgreens indicated it would appeal the decision. (Indiana)

Prescriber Education

•  In April 2011, FDA announced the elements of a Risk EvaluaGon and MiGgaGon Strategy (REMS) to ensure that the benefits of extended-‐release and long-‐acGng (ER/LA) opioid analgesics outweigh the risks.

•  As part of the REMS, all ER/LA opioid analgesic companies must provide:

•  EducaGon for prescribers of these medicaGons, which will be provided through accredited conGnuing educaGon (CE) acGviGes supported by independent educaGonal grants from ER/LA opioid analgesic companies.

•  InformaGon that prescribers can use when counseling paGents about the risks and benefits of ER/LA opioid analgesic use.

TIRF REMS Access Program

•  The Transmucosal Immediate Release Fentanyl (TIRF) Risk EvaluaGon and MiGgaGon Strategy (REMS) program is an FDA-‐required program designed to ensure informed risk-‐benefit decisions before and during treatment, to ensure appropriate use of TIRF medicines.

•  The purpose of the TIRF REMS Access program is to miGgate the risk of misuse, abuse, addicGon, overdose and serious complicaGons due to medicaGon errors with the use of TIRF medicines.

•  You must enroll in the TIRF REMS Access program to prescribe, dispense, or distribute TIRF medicines

http://healthyamericans.org/health-issues/rx-drug-abuse-report-app

Questions?

Alix C. Michel [email protected]

(423) 602-‐9522

David J. Ward [email protected]

(423) 602-‐9523

Michael L. Warren, ARM, OHST, CCLS Risk Manager, Pharmacists Mutual Insurance

(800) 247-‐5930 ext. 7229

Disclaimer

This presenta8on is provided with the understanding that the presenters are not rendering legal advice or services. Laws are constantly changing, and each federal law, state law, and regula8on should be checked by legal counsel for the most current version. We make no claims, promises, or guarantees about the accuracy, completeness, or adequacy of the informa8on contained in this presenta8on. Do not act upon this informa8on without seeking the advice of an aNorney.

This outline is intended to be informa8onal. It does not provide legal advice. Neither your aNendance nor the presenters answering a specific audience member ques8on creates an aNorney-‐client rela8onship.

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