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12/9/2011

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Hot Topics in Pharmacy Law

Karen M Ryle, M.S., RPhAssociate Chief of Pharmacy

Ambulatory CareMassachusetts General Hospital

Objectives

� Describe the future online Prescription Monitoring Program and how it will affect prescribing and dispensing of controlled substances.

� Identify the types of medication errors that are required to be reported to the Massachusetts Board of Pharmacy.

� Explain the new interim policy on changes permitted to schedule II prescriptions.

� Discuss the mandatory education requirements for ALL prescribers.

� Review the new policy on prescriptions for sex partners of patients being treated for Chlamydia.

Disclosure

� Although I am currently the Treasurer of National Association of Boards of Pharmacy and a member of the Massachusetts Board of Registration in Pharmacy, I am giving this presentation on behalf of myself and not as an official representative of either organization.

Continuing Pharmacy Education (CPE) Monitor

� National collaboration between National Association of Board of Pharmacy (NABP) and Accreditation Council for Pharmacy Education (ACPE)

� Create a CE profile at mycpemonitor.net� Obtain an e-profile ID� CPE providers will be sending continuing

education credits electronically to ACPE, then to NABP to record in your e-profile

CPE monitor

� In 2012, the service will make available the CPE data to boards of pharmacy who request information on licensee CPE as part of their compliance activities.

� Your e-profile will store a comprehensive list of all your CPE activities completed and will allow you to verify your compliance with CPE requirements in the state that you are licensed in.

Expedited Partner Therapy (EPT)

� Regulatory Changes: Effective September 2, 2011� 105 CMR 700.00: Implementation of M.G.L. Chapter 94C (the

Controlled Substance Act)� 105 CMR and 721.00: Standards for Prescription Format and

Security in Massachusetts� Authorize a prescriber to provide treatment of chlamydia

infection by dispensing or prescribing a schedule VI controlled substance for immediate treatment of the sex partner(s) of a patient diagnosed with chlamydia infection.

� Chlamydia has become endemic in the Boston area with a very high rate if re-infection.

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Provisions of EPT

� The prescriber has the following options when providing EPT:

1. The clinician provides a written prescription for a named sex partner of the infected patient;

2. The clinician provides a written prescription using, in place of the partner�s name and address, �Expedited Partner Therapy�, �EPT�, which can be filled at any Massachusetts pharmacy; or

3. The clinician dispensed the medication directly, one dose to be take immediately by the patient, and an additional dose to be delivered by the patient to the sex partner (s) for each sex partner

Pharmacist

� OK to dispense a prescription without a patient name as long as �EPT� is written in place of the name and address

� Partner Information Sheet must accompany the prescription.� This will be provided by Department of Public Health in an

easy-to-read language.� The standard treatment for chlamydia infections is

one oral dose of 1g of the antibiotic Azithromycin � Regulations do not state a particular antibiotic� Massachusetts will be the 27th state to provide

regulations to help stop the spread of Chlamydia

Error Reporting Requirements

� Duty to Report Certain Drug Dispensing Errors to Board (Required 1/1/2010) � Improper dispensing of a Rx resulting in serious

injury or death

�Within 15 business days after informed of error

� Retain records for 2 years from date filed with board

� Continuous Quality Improvement (CQI) Program

Definitions

� Improper dispensing� Incorrect dispensing of a prescribed medication received

by a patient� Serious injury

� Life threatening, results in serious disability or death or required significant treatment measures

� Serious disability� Injuries requiring major intervention and loss, or

substantial limitation, of bodily function lasting greater then 7 days.� Breathing, dressing, drinking, eating, eliminating waste, in/out of

bed, hearing, seeing, sitting, sleeping or walking

What is a Medication Error?

� A preventable event that may cause inappropriate medication use or patient harm.Institute for Safe Medication Practices (ISMP)

� Errors of Commission� An act of doing something wrong that leads to an undesirable outcome

� Dispense, Prescribe, Administer:wrong drug, wrong strength, wrong directions, wrong route,wrong patient, wrong dosage form etc

� Errors of Omission� A failure to do the correct act that leads to an undesirable outcome.

� Action is not taken� A failure to identify over utilization, therapeutic duplication, drug-drug interaction,

drug-disease interaction, drug allergy, clinical abuse/misuse, incorrect drug dosage or duration of drug treatment

Three Behaviors We Can Expect

� Human error -inadvertent action; inadvertently doing other that what should have been done; slip, lapse, mistake.

� At-Risk behavior- behavioral choice that increases risk where risk is not recognized or is mistakenly believed to be justified.

� Reckless behavior � behavioral choice to consciously disregard a substantial and unjustifiable risk.

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Human Error At Risk Behavior

Reckless Behavior Accountability for Our Behaviors

HUMAN ERRORInadvertent action: slip, lapse, mistakeManage through changes in:1. Processes2. Procedures3. Training4. DesignMost medication errors are in this categoryAction: Console

Accountability for Our BehaviorsAT-RISK BEHAVIOR

A choice: risk not recognized or believed justified

Manage through:1. Removing incentives for At-Risk Behavior2. Treating incentives for healthy behaviors3. Increasing situational awareness

Action:coach

Accountability for Our Behaviors

RECKLESS BEHAVIOR

Conscious disregard of unreasonable risk

Manage through:

1. Remedial action

2. Punitive action

Action: Punish

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Board of Pharmacy

� Has jurisdiction over the licensee and is charged with the duty to protect the public

� Discipline includes:� Advisory letter (dismissal) with 2 CE�s � Formal Reprimand� Probation� Suspension� Revocation

� Other state boards may impose a fine

Report Submitted to the Board

� 89 year old in SNF

� Order for Nortriptyline 20mg

� Nurse transcribed it as 200mg, MD signs

� Pharmacist fills Rx for 200mg

� Patient takes 4 X 50mg capsules for 10 days

� Patient expires shortly after of pneumonia

Nortriptyline Report

� Reported to the board under new regulation

� Geriatric dose 30-50mg/day

� Use with caution in the elderly

� Pharmacist performed DUR override for high dose alert

� High dose alert fatigue

2nd Report

� 92 year old

� Received Glyburide 5mg TID

� Drug prescribed: Ditropan 5mg TID for bladder

� Patient blood glucose less than 10mg/dl

� Patient hospitalized and transferred to SNF

� Error reported under new regulation

Contributing Factors

� Both on the shelf under �D�� Ditropan/Diabeta

� Tablets round/green, round/blue

� No bar code scanning

� In medicine on time blister packs

� NDC not on the label to match

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3rd Report

� 70 year old male with BPH (Benign Prostate Hypertrophy

� Profile contains Doxazocin and Finasteride� New Rx for Promethazine DM� 2 tsp every 4-6 hours

� Pharmacist Reviews Drug Utilization Review (DUR)� Contraindicated with patients with BPH� Anticholinergic effects

� Pharmacist overrides Drug/Disease DUR� Fills as Is

BPH patient

� Patient hospitalized

� Caused catheterization

� Sentinal event reported to the Board

� Pharmacist indicates she was rushed

� Alert fatigue?

PROPERTIESOn passing, 'Finish' button: Goes to Next SlideOn failing, 'Finish' button: Goes to Next SlideAllow user to leave quiz: After user has completed quizUser may view slides after quiz: At any timeUser may attempt quiz: Unlimited times

4th Report

� 4 year old with Bipolar

� Rx written Risperidone 1mg/ml � 2.5ml BID

� Normal Pediatric dose=0.25mg QD or

0.125mg BID

� Physician error

� Maximum dose 1mg QD

Risperidone

� Pharmacy system did not indicate a high dose alert.

� 3 rd party insurance did alert Pharmacist of high dose

� Physician meant 0.25mg BID

� Patient got 10 times the dose

� Patient hospitalized

Fentanyl Case

� 52 Year old-day surgery for rhinoplasty for snoring

� Prescribed Hydrocodone Liquid� Nausea and vomiting

� Then prescribed Fentanyl 75mcg patch

� Daughter picks it up through the drive through and tells the pharmacist it is for her father that just had surgery

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Fentanyl Case

� The daughter reads the patient information and warnings to her father

� Not for short time pain

� Not for post-operative pain

� Not to use unless you have been on other narcotic pain medicine regularly

� Applies the patch in the late afternoon

� Patient found dead the next morning

� Cause of death: Fentanyl overdosePROPERTIESOn passing, 'Finish' button: Goes to Next SlideOn failing, 'Finish' button: Goes to Next SlideAllow user to leave quiz: After user has completed quizUser may view slides after quiz: At any timeUser may attempt quiz: Unlimited times

Board of Pharmacy New Policy

� Policy 2011-03: Permitted Schedule II prescriptions changes after consultation with Practitioner.

� Approved by the Board of Pharmacy� Background:

� November 19, 2007, the Drug Enforcement Agency (DEA) published a Final Rule in the Federal Register titles Issuance of Multiple Prescriptions for Schedule II Controlled Substances. In the preamble to the Rule, DEA stated that �the essential elements of a schedule II prescriptions written by the practitioner (Such as the name of the controlled substance, strength, dosage form and quantity prescribed)�.may not be modified orally�

� The DEA later acknowledged that these instructions conflict with DEA�s previous policy permitting these changes to a schedule II prescription that a pharmacist may make after consultation with the prescriber.

� On April 19,2010 DEA advised pharmacists to make changes in accordance with the laws, regulations and policies of their particular state.

Policy 2011-03

� The Board advise Massachusetts Pharmacists that, until any new DEA rule is effective, schedule II prescription changes should be made with the following guidelines:

1. Methods of Changing Prescriptions/orders:1. A prescriber may provide a written change to the

prescription or order. This can be done by mail or electronic transmission including e-mail and facsimile.

2. The change can be communicated orally. The Pharmacist shall record the date, changes on the front or back of the prescription after consultation with the prescriber.

Policy 2011-032. Schedule II prescription Information that MAY be changed or

added by a pharmacist following consultation with the prescriber.

� Date written� Patient�s address� Drug form� Drug Strength� Quantity� Prescriber�s Address� Prescriber�s DEA No.� Directions for use� Substitution permitted� Refill information

Policy 2011-03

� Schedule II prescription information that may NEVER be changed or added by a pharmacist (regardless of whether consultation with the prescriber occurred)

� Patient�s name� Drug (controlled substance) name (except for

generic substitution permitted by state law)� Prescriber�s name� Prescriber�s signature

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Hydromorphone 4 mg

#50

Sig: Take 1 tablet every 4 hours as needed for pain.

No refills

Dr. Charles Feelgood

1-800-222-1111

AF 12345678

Signature Charles FeelgoodInterchange is mandated unless the practitioner indicates �no substitution�

September 22, 2011 Back order of Hydromorphone 4mg

RPh calls MD to change to 2mg

MD authorizes 2mg #100With directions to take 2Tablets every 4 hours as needed for pain

Mickey Mouse100 Main StreetDisney World, FL

September 22, 2011

Minney Mouse100 Main StreetDisney World, Fl

Oxycodone/APAP 5mg/325mg#100Sig: Take 1-2 tablets every 4 hours as needed for pain

No refills

Dr. Charles Feelgood1-800-111-2222AF12345678

Signature Charles Feelgood

Interchange is mandated unless the practitioner indicates �no substitution�.

Patient presents the prescription to your pharmacy and indicates that she would like liquid since she has difficulty swallowing pills.

RPh calls the prescriber and the prescriber and he authorizes the pharmacist to dispense liquid Oxycodone/APAP 1-2 teaspoonfuls every 4 hours as needed for painQuantity 500cc

September 22, 2011

Chip Andale100 Main StreetDisney World, FL

Oxycodone ER 10mg#60

Take one tablet every 12 hours as needed for cancer pain.

No refills

Dr. Charles Feelgood1-800-111-2222

Signature Charles Feelgood

Interchange is mandated unless the practitioner indicates �no substitution�

Patient present the prescription to your pharmacy but is uncomfortable taking Oxycodone ER for fear of recent robberies. He would like you to call the doctor to change it to something else

MD authorizes you to switch theMedication to Morphine ER 10mg#60 same directions.


September 22,2011

Actiq 200mcg Lozenge

#100Sig: Suck on one Lozenge every 4 hours for breakthrough painNo refills

Dr. Charles Feelgood1-800-111-2222AF12345678Signature Charles Feelgood

Interchange is mandated unless the practitioner indicates �no substitution�

Donald Duck100 Main StreetDisney World, FLA

Patient presents prescription to your pharmacy. You do not have Actiq in stock but you dohave Fentora Buccal tabs.You call the prescriber to seeIf you can switch to Fentora.


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Prescription Monitoring Program(PMP)

� Changes to the PMP program went into effect on January 1, 2011

� Requires pharmacies to report the dispensing of all schedule II-V prescriptions

� Requires the pharmacy to collect a customer ID for all new prescriptions in schedules II-V

� Requires reporting of out of state mail order pharmacies

� Pharmacies are now required to report weekly

On Line Prescription Monitoring Program

� Secure Internet Portal

� Pharmacists and Prescribers enroll through the virtual gateway

� Database contains 4 million Rx�s now of just C2�s

� Will be updated monthly and include all schedules

Benefits of having a PMP

1. Support access to legitimate medical use of controlled substances

2. Identify and deter or prevent drug abuse and diversion

3. Facilitate and encourage the identification, intervention with and treatment of persons addicted to prescription drugs

4. Inform public health initiatives through outlining of use and abuse trends, and

5. Educate individuals PMPs and the use, abuse and diversion of and addiction to prescription drugs

Prescription Monitoring Programs

� Currently 35 states have operational PMPs

� States differ in the types of controlled substances that are reported

� States differ on the requirement of a proper identification

� Each state controls who has access and for what purpose

Massachusetts On Line PMP

� Can look up a single patient at a time

� You cannot look up prescription history of anyone that is not your patient

� Detailed record of Controlled Rx�s� Fill date

� Quantity

� Prescriber

� Pharmacy

� Includes both insurance and cash

1. Instructions for EnrollmentVirtual Gateway Home Page

To logon to the Virtual Gateway (VG), go to www.mass.gov/vg and click on Logon to the Virtual Gateway.

http://www.mass.gov/vgand

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Search CriteriaTo search for an individual, complete the following required fields:

1. last name2. first name

3. date of birth (ddmmyyyy, no slashes)Click Search.

Record OverviewThe record overview shows information about each prescription filled.

Click on the patient�s name to see a Person Summary. You also have the option to return to the main screen if you want to search for another record. Or you can logout from this page.

Who can access the On line PMPInformation?

� Licensed Health Care Professional authorized to prescribe and dispense controlled substances. � Pharmacist

� Prescribers

� State and Federal Investigative agencies to address drug diversion� State Police

� DEA

� Licensing Boards

Emergency Room

� The on line prescription monitoring program will become particularly useful for emergency room physicians that are being asked to prescribe controlled substances

� Prevents the frequent flyers that bounce around to different hospitals that are drug seeking

� Provides access to controlled substance to those patients who truly need it

NABP Interconnect PMP

� Interstate PMP Data sharing through NABP PMP Interconnect is now available

� It provides a way for States to report into ONE database

� NABP is a system that Links PMPs across states to facilitate data exchange

� Interconnected hub

� Used only to facilitate the communication process.

� NABP will not retain any prescription data

Purpose if PMP InterConnect

� Reduce prescription drug abuse� Reduce doctor shopping� Early detection, intervention and prevention

of substance abuse and diversion of controlled substances

� Ohio, Indiana and Virginia have begun deploying PMP InterConnect

� NABP anticipates that 30 states will be participating in 2012

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Florida Case

� Dr. Barney Vanzant-License restricted in 2008, revoked in 2009.

� Accused of over prescribing controlled substances to at least 2 patients that both died, now up for 2 counts of manslaughter

� Daniel Joseph Lewis-31 yr old� Prescribed 1070 Alprazolam, 1040 Methadone and 670

Lortab in 4 months� Travis Bryan Walls- 25 yr old

� Prescribed 1938 methadone and 996 Alprazolam as well as Lortab and Ultram

What is the Pharmacist Liability?

� 3 month supply of Methadone

� Visited 13 different pharmacies

� Schedule of pharmacy visits

� Paid cash, never early

� Both died of multiple drug overdose

� Does the pharmacist share responsibility?

� What role could a PMP play in this case?


Florida Begins State PMP program

� September 1, 2011 Pharmacist began submitting data to the PMP program

� Controlled substances reported weekly� Health care providers will have access to PMP

data beginning October 2011� Tougher Florida laws to address �Pill Mills�.� Recent shut down of 4 pain clinics resulted in

32 indictments for illegally distributing 20 million Oxycodone pills

Sanchez v. Wal-Mart� Patricia Copening killed Gregory Sanchez Jr.

while driving under the influence of drugs

� Patricia Copening received 4500 Hydrocodonetabs and 1300 Carisoprodol tabs from 13 different pharmacies over the course of 1 year

� Mr Sanchez was helping Robert Martinez change a tire when he was struck and killed

� Police found prescription bottles and loose tablets in the car and Patricia appeared confused

Sanchez v. Wal-Mart

� Prior to the accident, the Nevada Prescription Controlled Substance Abuse Prevention Task Force sent letters to 14 Las Vegas area pharmacies informing them that Copeningmay be abusing drugs.

� Pharmacy was aware that Copening was filling Hydrocodone from 12 other pharmacies but went ahead and filled the prescription anyway.

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Sanchez v. Wal-Mart

� Does the Pharmacy owe a duty of care to Mr. Sanchez?

Sanchez v. Wal-Mart

� Nevada Supreme Court dismissed 7 chain pharmacies and 1 independent pharmacy

� Under the circumstances of this case, pharmacies do not owe a duty of care to a third party (Mr. Sanchez)

� There is no pharmacist/patient relationship with Mr. Sanchez

� However, there is a duty of care to Mrs. Copeland.

Policy on the Management of Pain

� Revised August 16, 2011 to reflect addition of education requirements

� Purpose: To Insure Patient Access to Appropriate and Effective Pain Management

� Inappropriate management of pain includes non-treatment, under-treatment, over treatment and the continued use of ineffective treatment

Policy on the Management of Pain

� The Board encourages pharmacists to view pain management as part of pharmacy practice for all patients in pain, whether acute or chronic.

� Pharmacist should provide access to pain medication to patients with legitimate needs in accordance with accepted standards of pharmacy practice.

Mandatory Educational Requirements for Prescribers

� January 1, 2011, pursuant to MGL c. 94C section 18 (e)

� All prescribers including pharmacists engaged in collaborative drug therapy management (CDTM) who are authorized to prescribe controlled substances pursuant to a CDTM agreement (247 CMR 16.00), upon initial application for MA Controlled Substance Registration and subsequently during each pharmacist licensure renewal period (2 yr), must complete education requirements.

Education Requirements

� Must include:� Effective pain management;

� Identification of patients at high risk for substance abuse; and

� Counseling patients about side effects, addictive nature and proper storage and disposal of prescription medications.

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Corresponding Responsibility

� CFR, Title 21 sec 1306.04,Purpose of Issue of Prescription

� A prescription for a controlled substance to be effective must be issues for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice

� The responsibility for the proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner, but a corresponding responsibility shall rest with the pharmacist who fills the prescription

Violation of CFR, 21,1306.04

� A prescription purporting to be a prescription issued NOT in the usual course of professional treatment and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violation of the provisions of law relating to controlled substances

Case Study #1

� Doctor shopper-2 pharmacies-5 MD�s� Multiple Rx�s for controlled substances for many years� Pharmacy A fills

� Hydrocodone/APAP� Oxycodone/APAP� Oxycodone ER

� Pharmacy B fills� Hydrocodone/APAP� Fentanyl� Rx for Fentanyl 75mcg written by a friend of the family

� Patient expires within 24 hours of Fentanyl Rx� Cause of death-Multiple drug poisoning

Discussion

� Multiple Physicians treating patient� Rx�s not filled early� Pharmacy A-Insurance� Pharmacy B- Cash� Should the Pharmacist question the Fentanyl

Rx from out of state?� Is there a Patient/Doctor relationship?� Should Pharmacy question therapy of

Hydrocodone to Fentanyl switch?

Case #2

� Pharmacy receives prescription from patient for Fentanyl 75 mcg patch for back pain (not indicated on Rx)

� New to pharmacy

� Rx written from Ophthalmologist

� Pharmacy fills Rx

� Patient expires within 48 hours from overdose of Fentanyl

Discussion

� Patient works in the MD office

� Patient/Physician relationship

� Scope of Practice

� Diagnosis

� Counseling

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Case # 3

� Pharmacy repeatedly fills �cocktail� prescriptions for multiple patients from the same physician.

� Cocktail known as �home run� includes:� Hydrocodone 10mg� Carisprodol 350mg� Alprazolam 2mg

� No individualization of dosing by the prescribing physician

� Prescribing and dispensing the strongest formulations

Stop and Think Question

� Is the pharmacist violating �Corresponding Responsibility� by filling these prescriptions?

DEA�s Ten Red Flags

1. Repeatedly dispensing �cocktailed� prescriptions

2. No individualization of dosing by the Prescriber

3. Filling multiple prescriptions for the strongest formulations

4. Request for early refills5. Doctors located 100 miles away from

pharmacy

DEA�S Ten Red Flags

� 6. A large proportion (75%) of prescriptions filled by the pharmacy were controlled substances written by one particular physician

� 7. Pharmacist doesn�t reach out to other Pharmacists to see why they aren�t filling the particular doctor�s prescription

� 8. Patients travel in groups to the pharmacy� 9. Filling a large percentage of cash prescriptions� 10. �verification� of a prescription as �legitimate�

was not satisfied simply because the practitioner said so.

Evaluation and Post-Test Instructions

� Close out of this window

� Click �Take Post-Test� listed under Instructions Section

� Complete activity payment

� Complete evaluation and post-test with a passing score of at least 70%

� Receive statement of credit immediately via email (you will have the option to print).

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