ph 1 harris hanna_slack

Pharmacy Track: Improving Communica5ons

with Physicians

Patrice A. Harris, MD Catherine Hanna, RPh. PharmD

P. Tennent Slack, MD

•  Patrice A. Harris has no financial rela;onships with proprietary en;;es that produce health care goods and services.

•  Catherine Hanna has no financial rela;onships with proprietary en;;es that produce health care goods and services.

•  P. Tennent Slack has no financial rela;onships with proprietary en;;es that produce health care goods and services.

Disclosures

1. Outline the strategies for collabora;ng across professional lines for the adequate treatment of pa;ents.

2. Describe best prac;ces for dispensers to communicate with prescribers.

3. Evaluate the challenges for health care professionals in communica;ng about their pa;ents and offer solu;ons.

Objec;ves

America’s Rx drug abuse and diversion crisis

Patrice A. Harris, MD

National Rx Drug Abuse Summit

April 2014

Goals of presenta;on

•  What is the AMA’s interest in “pain”? •  Enhancing educa;on •  Challenges facing health care professionals •  Par;ng thoughts

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The AMA interest in “pain”

•  Support legisla;on to combat prescrip;on drug abuse and diversion

•  Enhance educa;on and appropriate efforts to ensure access to appropriate pain management

•  Increase access to treatment for substance abuse and addic;on

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NO Pain NO Gain

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Drug overdose rates by state

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736 out of 86,818 prescribers

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42 out of one million prescribers

Overcorrect. v. To correct something to an excessive or unusual degree.

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2014 State legisla;ve trends

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Educa;onal opportuni;es

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Mandatory Educa5on

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Enhancing educa;on

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Enhancing educa;on

•  What happens medical school/residency? •  What is required state-‐by-‐state?

•  Incen;vizing educa;on – why aren’t there more to help treat addic;on?

•  Just what do we mean/want by “specialist”?

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The AMA interest in “pain”

•  Suppor;ng legisla;on to combat prescrip;on drug abuse and diversion

•  Enhancing educa;on and appropriate efforts to ensure access to appropriate pain management

•  Increasing access to treatment for substance abuse and addic;on

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Curbing Prescrip;on Drug Abuse and Misuse: Communica;ng with Providers-‐

Best Prac;ces and the Role of Pharmacists

Catherine Hanna, RPh. PharmD KY Board of Pharmacy

Vice President of Professional Affairs American Pharmacy Services Corpora;on

•  One of the main problems health care professionals see when having difficulty communica;ng with other health care professionals comes down to knowledge, respect and understanding of the situa;on at hand and the challenges faced by each other.

Improved educa-on and communica-on is essen-al!

Improving Communica;ons Between Health Care Professionals

•  Increased focus on illness and deaths caused by inappropriate use of controlled substances — in par;cular opioid analgesics.

•  Opioid prescrip;ons have increased drama;cally which has led to a significant increase in prescrip;on drug diversion, abuse and misuse and a substan;al increase in the number of deaths due to overdose.

Why We are Here?

•  In the mid-‐1990s, advocates for treatment of chronic pain began arguing that pain was largely untreated.

•  New formula;ons of opioid agents became available, with purported advantages in analgesia.

•  Inappropriate prescribing has also increased drama;cally. Primarily in Pill Mills

Why We are Here?

•  Pharmacies report that DEA agents are inspec;ng prescrip;ons and other records.

•  DEA agents are focusing primarily on opiods and poly-‐substance prescribing, large doses and long-‐term therapy.

•  DEA agents are also looking for red flags from controlled substance data and prescriber’s prescribing paierns and the prac;ce site.

What Is Happening?

•  In several states providers have reported that they are experiencing problems with pharmacists refusing to fill pa;ent’s controlled substance prescrip;ons.

•  Certain pharmacies reportedly are requiring pa;ent informa;on such as diagnosis codes, treatment history, dura;on of therapy, treatment plans and payment method prior to filling a prescrip;on.

What Is Happening?

•  This informa;on is not required by state or federal law but the DEA inves;ga;on and discipline process have prompted changes in some pharmacy policies.

•  Federal privacy laws permit doctors to share pa;ent informa;on for treatment purposes with pharmacists.

What Is Happening?

•  Verifica;on of addi;onal requested informa;on may take extra ;me on the part of the prescriber. Is this informa;on necessary to fulfill the role of the pharmacist in reducing the poten;al abuse of controlled substances?

•  A pharmacist can refuse to fill a prescrip;on if professional judgment suggests the prescrip;on is in viola;on of federal or state law, would not be in the best interest of the pa;ent, or is being used to con;nue an addic;on or habit.

What Is Happening?

•  Pharmacies have a role to play in the oversight of prescrip;ons for controlled substances. Under the Controlled Substances Act, pharmacists must evaluate each controlled substance prescrip;on to ensure that it is appropriate.

•  State boards of pharmacy regulate the distribu;on of opioids and other controlled substances as mandated by state and federal regula;ons.

Understanding the Pharmacists Liability

•  In the majority of cases of poten;al abuse, pharmacists face a pa;ent who has a legal prescrip;on from a licensed prescriber without actually having access to pa;ent background informa;on.

•  This can make it difficult for the pharmacist because they may not always have all the informa;on they need to make an completely informed decision and must rely on their “gut” in some situa;ons.

Understanding the Pharmacists Liability

•  Corresponding responsibility is one of the most commonly misunderstood and in some cases unknown concepts found in DEA’s regula;ons.

•  Enforcement ac;ons are generally ini;ated against pharmacists and pharmacies when a pharmacist fails to exercise his/her corresponding responsibility.

Corresponding Responsibility

•  The DEA’s regula;ons (21 C.F.R. § 1306.04) addressing corresponding responsibility states: –  A prescrip;on for a controlled substance to be effec;ve must be issued

for a legi;mate medical purpose by an individual prac;;oner ac;ng in the usual course of his professional prac;ce. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing prac;;oner, but a corresponding responsibility rests with the pharmacist who fills the prescrip;on.

–  An order purpor;ng to be a prescrip;on issued not in the usual course of professional treatment or in legi;mate and authorized research is not a prescrip;on within the meaning and intent of sec;on 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescrip;on, as well as the person issuing it, shall be subject to the penal;es provided for viola;ons of the provisions of law rela;ng to controlled substances.


•  What does this mean? The regula;on states that the pharmacist is in the same posi;on as the prescriber who issued the prescrip;on and must exercise professional judgment to determine whether a prescrip;on for a controlled substance was issued for a legi;mate reason and to a legi;mate pa;ent.

•  Problem in the eyes of the pharmacist: without having actually conducted a medical examina-on of the pa-ent


•  DEA has made it clear that pharmacists must iden;fy and resolve certain red flags before a prescrip;on for a controlled substance is dispensed.


•  Does iden;fying red flags mean you are exercising your corresponding responsibility as required?

•  Are pharmacists exercising corresponding responsibility appropriately when they decide not to dispense controlled substances to a pa;ent whose prescrip;on sets off one or more red flags?

•  How many red flags of what combina;on of red flags must be iden;fied for a pharmacist to refuse dispensing a prescrip;on?

Corresponding Responsibility and the Red Flags Ques;ons

•  The pharmacist can not simply defer to the prescriber and is expected to exercise independent professional judgment when determining if a prescrip;on was issued for a legi;mate purpose by a prescriber ac;ng in the usual course of professional judgment.

•  Merely contac;ng the physician for verifica;on that the prescrip;on was wriien by that prescriber may not be sufficient to fulfill the pharmacist’s duty, and the pharmacist should refuse to fill the prescrip;on if there is reasonable suspicion that it is not valid.

Corresponding Responsibility and the Red Flags

•  A pharmacist who “knowingly” fills a prescrip;on that is not issued in the usual course of professional treatment is subject to the penal;es of the Controlled Substance Act.

•  The pharmacist who decides to “look the other way” and fills a prescrip;on for a controlled substance that he or she knew or should have known was not for a legi;mate purpose may be subject to prosecu;on.


•  The pharmacist is required to exercise sound professional judgment when determining the legi;macy of a prescrip;on for a controlled substance.


•  “Paiern prescribing’’ – prescrip;ons for the same drugs and the same quan;;es coming from the same doctor, strengths/no varia;on in the quan;ty and strength between pa;ents

•  Prescribing combina;ons or “cocktails” of frequently abused controlled substances

•  Geographic anomalies-‐ A prescriber’s prescrip;on paiern is different from that of other prescribers in the area (e.g., more prescrip;ons for controlled substances or prescrip;ons for larger quan;;es of controlled drugs)

Red Flags May Contain

•  Is the prescriber not familiar to the pa;ent or is the provider and/or the pa;ent from out of town

•  Shared addresses by customers presen;ng on the same day

•  The prescribing of controlled substances in general

•  Quan;ty and strength-‐large quan;;es and strengths

•  Paying cash rather than using insurance

•  Customers with the same diagnosis code from the same doctor

Red Flags-‐con;nued

•  Prescrip;ons wriien by doctors for infirmaries not consistent with their area of specialty;

•  Fraudulent prescrip;ons or prescrip;ons with irregulari;es

•  Pa;ent is asking for brand name only or a certain generic brand

•  The pa;ent is overly friendly or nervous

Red Flags-‐con;nued

–  Prescriber writes for antagonis;c drugs (e.g., s;mulant and depressant at the same ;me)

–  Pa;ent returns to the pharmacy more frequently than expected (e.g., prescrip;on quan;;es do not last as long as expected)

–  Pa;ent presents mul;ple prescrip;ons for the same drug wriien for different people

–  A number of people appear within a short ;me period for the same controlled drug from the same physician, or a large number of previously unknown patrons show up with prescrip;ons from the same physician

–  The patron presents a prescrip;on that shows evidence of possible forgery (e.g., unusual direc;ons or quan;;es, no abbrevia;ons, apparent erasures, unusual legibility, evidence of photocopying)

Red Flags -‐con;nued

•  The abuse and misuse of prescrip;on drugs is a serious problem that we all recognize, but has the response by law enforcement and other agencies to curb diversion created challenges when balancing the need for treatment of legi;mate pa;ents?

•  Are we seeing an environment where providers are reluctant to prescribe and pharmacists are reluctant to dispense medica;ons for legi;mate pa;ents?

•  How can the professions work together to improve communica;on and collaborate toward the ul;mate goal to curb prescrip;on drug diversion, abuse and misuse and insure that legi;mate pa;ents are cared for appropriately?

Challenges

•  All healthcare providers need to be aware of the poten;al for drug diversion, recognize the warning signs of possible misuse and abuse and acknowledge the legal obliga;ons we all have to minimize improper prescrip;on use.

•  The baile to prevent prescrip;on drug abuse while maintaining access to pa;ents in need is challenging, but both professions must each realize the responsibili;es of all par;es as we work toward a solu;on.


•  There are many differences between the professions of medicine and pharmacy that ul;mately influence our understanding of the other profession.

•  It is clear that effec;ve, deliberate prescriber-‐pharmacist collabora;on, improved communica;on and working rela;onships can significantly improve overall pa;ent care and help curb prescrip;on drug diversion, abuse and misuse.

•  Efforts to improve these rela;onships must focus on the strategic introduc;on of agreed changes working prac;ces between the two professions and educa;on.


•  When communica;ng and collabora;ng to improve pa;ent care the focus must: –  Place the overall care of the legi;mate pa;ent first –  Incorporate sound clinical knowledge –  Incorporate sound professional judgment – Allow each profession to act in a collegial and collabora;ve manner

–  Be based upon understanding/knowledge and respect of the role and obliga;ons of all professionals involved


•  Stakeholder: AMA, NCPA, NABP, CVS, Walgreens, NACDS, Rite Aid, American Academy of Family Physicians, American Osteopathic Associa;on, Cardinal Health, Pharmaceu;cal Research and Manufacturers of America

•  Consensus was that coordina;on and collabora;on must be improved to combat the issue of prescrip;on drug abuse and diversion while also complying with the corresponding responsibility requirements of federal and state laws and regula;ons.

Stakeholders Consensus Document on Prescribing and Dispensing Controlled Substances

Discussion of Strategies

P. Tennent Slack, MD Pain Medicine / Anesthesiology

Dept. of Interven;onal Pain Medicine Northeast Georgia Physicians Group

P. Tennent Slack has no financial rela;onships with proprietary en;;es that produce health care goods and

services

1. Outline the strategies for collabora;ng across professional lines for the adequate treatment of pa;ents.

2. Describe best prac;ces for prescribers to communicate with dispensers.

3. Evaluate the challenges for health care professionals in communica;ng about their pa;ents and offer solu;ons.

Consequences Of Prescribers Not Engaging

•  Promotes inaccurate assump;ons and inaccurate conclusions –  Pharmacists –  Law enforcement –  Government officials –  Interested organiza;ons – CDC, NADDI, etc. –  The public at large

•  Erosion of physician control over decisions that are fundamentally medical in nature

The Pain Treatment Environment

Elements of Discrimina;ng Prescribing

Opioid Rx

THE PERFECT STORM

Pain

•  Pain complaints are extremely common

•  Mind-‐body phenomenon

•  Subjec5ve

•  Difficult to measure

•  High inter-‐individual variability –  Gene5cs –  Environment / culture

•  Mood/anxiety disorders

Opioids

•  Single most effec5ve medica5on for moderate-‐severe pain

•  High addic5on liability •  High inter-‐individual

variability –  Pharmacogene5cs –  Cultural / environmental –  Socioeconomic status

More control Less control

Ability to downregulate use

Addic5on

“Legi5mate” use “Chemical coping”

Opioid use -‐ misuse spectrum

4 C’s 1.   Loss of control 2.   Compulsive

use 3.   Con5nued use

despite harm 4.   Craving

Compassion Cynicism

MAJOR CONCERNS OF OPIOID PRESCRIBERS %

Poten5al abuse / addic5on 89 %

Diversion 75 %

Opioid side effects 53 %

Regulatory / law enforcement monitoring 40 %

Hassle and 5me required to track/ refill 28 %

Upshur CC et al. J Gen Intern Med 2006

“Red Flags”

•  “Urgency” when reques;ng need for opioids •  Pa;ent reports side effects / lack of efficacy to wide variety of non-‐opioid / opioid-‐sparing treatments

•  Friday arernoon / weekend requests for medica;on or medica;on changes

•  Repeated requests for the following:  early refill  dose and/or pill volume escala;on  above requests in the face of missed follow up

•  Pa;ent reports lost or stolen prescrip;on

“Red Flags” cont.

•  Poor correla;on between complaints, physical exam, and/or imaging studies, etc.

•  “Inability” or refusal to provide urine sample for drug screening purposes

•  Drug screen posi;ve for unreported controlled substances and/or illicit drugs

“New” GA State Medical Board Pain Management Rules



Opioid Rx


Numerous opioid prescribing guidelines •  medical socie5es / organiza5ons; states; etc. •  No single defini5on for “best prac5ces”

1.   Thorough Evalua5on 2.   Prudent Treatment Plan 3.   Vigilant Follow Up

Overview of Prescribers

All other prescribers

More discrimina;ng

Less discrimina;ng

The “Pill Mill” Prescriber

Common“Pill Mill” Characteris;cs •  Nearly exclusive associa;ons with specific pharmacies •  Physicians with minimal or no training in pain medicine •  Cash-‐based payment •  Large volume of pa;ents seen daily (100 +) •  Unusually large volume of pa;ents from out of state •  Security guards on site •  Non-‐tradi;onal prac;ce loca;on – e.g. shopping center •  Minimal pa;ent work-‐up •  Lihle varia5on in choice of opioid or pill volume •  Opioids very frequently prescribed simultaneously with

benzodiazepines and/or carisoprodol •  High dosages / high pill volumes

Sources: DEA; NADDI

The University of Wisconsin School of Medicine and Public Health’s Pain and Policy Studies Group (PPSG) awarded Georgia a grade of “A” for its pain management policies in 2012, marking the largest improvement in the na;on from 2006 to 2012.

1.  How definable is the source of pain? 2.  Screen for risk of addic;on 3.  Explore all treatment op;ons 4.  If opioids are prescribed: lowest effec;ve dose lowest

number of pills 5.  Educate the pa;ent risks/benefits of opioid use

i.  sharing opioid medica;ons is ILLEGAL ii.  proper storage and disposal

6. Monitor the pa;ent for misuse / diversion i.  controlled substances agreement ii.  drug screening / pill counts iii.  PDMP

6 Point Checklist to More Discrimina;ng Prescribing

The Inescapable Slippery Slope

•  Defining that which does not have a single defini;on: – “pain” – “valid”; “legi;mate” – “red flags” – “best prac;ces”

ph 1 harris hanna_slack

Health & Medicine

md catherinehanna

pharmd p

largedosesandlong termtherapy

onis essen

mandatory educa5on