BRP Pharmaceuticals

EMERGING PARADIGMS: PHYSICIAN DISPENSING

Mark A. Munger, Pharm.D., F.C.C.P., F.A.C.C.

Professor, Pharmacotherapy

Adjunct Professor, Internal Medicine

University of Utah

NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 1

PRESENTER DISCLOSURE INFORMATION

�I will not discuss off-label use or investigational use in my presentation.

�I have no financial relationships to disclose.

�Employee of: None

�Consultant for: None

�Stockholder in: None

�Research support from: Utah Legislature and Department of Commerce

�Honoraria from: None


SELF-ASSESSMENT QUESTIONS

Physician dispensing in the United States is:

A. Rare

B. Practiced daily or weekly

C. Commonplace across all practice settings

D. Under the direction of the Board of Pharmacy in most states

Physicians perceive drug dispensing as:

A. Reducing the drug cost to my patients

B. Reducing the cost of healthcare

C. Improving drug adherence

D. All of the above



Physician perception of the highest burden of pharmacy practice rules on dispensing practice is:

A. Labeling the prescription bottle

B. Keeping a medication profile system

C. Drug stock labeling and inventory control

D. Maintaining prescription and drug record keeping


UTAH PHYSICIAN DISPENSING LEGISLATION

� 2010 Legislative Session: SB 88 exempted physicians and clinics from pharmacist and pharmacy licensure if dispensing a cosmetic drug or injectable weight loss drug.

� 2011 Legislative Session: SB 128 exempted prescribing practitioners from pharmacist and pharmacy licensure if dispensing a cosmetic drug or injectable weight loss drug.

� Prescribing practitioner: licensed physicians, APRNs, PA, and optometrists.


UTAH PHYSICIAN DISPENSING LEGISLATION

� 2012 Legislative Session: SB 161 permitted prescribing practitioners to dispense certain oncology drugs without a license provided they meet established requirements.

� Required that prescribing practitioners qualifying for a drug dispensing exemption relating to oncology drugs, selling contact lenses, or cosmetic or injectable weight loss drugs notify the Division (DOPL) in writing of their intent to dispense a drug

� Excluded Schedule I, II, and III drugs from the drugs that oncologists could dispense

� Required the Division (DOPL) to conduct a study evaluating:

� National compilation of state dispensing laws; and

� Current research on non-pharmacist dispensing and patient safety


RESEARCH SERIES ON HEALTHCARE PRACTITIONER DISPENSING 2012

Mark A. Munger, Pharm.D., Michael Feehan, Ph.D., Emily Rumanek, M.A., M.B.A., Lynsie Ranker, B.S., Kristen Vincent, Sc.B., Scott Silverstein, Pharm.D., and Jim

Ruble, Pharm.D., J.D.

Collaborative Study Team (University of Utah Health Sciences Center and Observant, LLC. Boston, MA.)

Funding: State of Utah Legislature and Department of Commerce Grant-in-Aid


RESEARCH SERIES: THREE INDEPENDENT STUDIES

I. Healthcare Practitioner Prescribing in 50 State Statutes and Rules

A. Lexus Nexus: Academic Universe 1. Search Terms: Physician, dispens*, Practitioner

B. State Websites for Boards of Pharmacy C. National Association Boards of Pharmacy Survey of Pharmacy Law 2012

II. Healthcare Practitioner Dispensing of Prescription and OTC Products A. 379 healthcare practitioners completed a 15-minute online survey in September and October 2012. B. Nurse practitioners, optometrists, oncologists, dermatologists, and plastic or reconstructive surgeons were selected due

to state of Utah statues. C. Respondents were recruited by email from an pre-registered (“opt-in”) online panel to participate in market research

studies.

III.Consumer Perceptions of the Dispensing of Prescription and OTC Products by Healthcare Practitioners

A. A total of 999 adult consumers in the USA completed a 15-minute online survey in October 2012. B. All respondents had been dispensed a prescription and/or an OTC product, by a healthcare practitioner in the past 12

months. C. Participants were recruited by email from an online panel of consumers pre-registered (“opt-in”) to participate in

market research studies

Non-Pharmacist Dispensing in the US Allowed (44 States) Restricted (6 States)

MA– no specific law authorizing MT – dispensing prohibited; some exceptions NJ – dispensing allowed; but limited to 7-day supply NY – dispensing allowed; limited to 72 hour supply TX – dispensing not allowed; 72 hour immediate need UT – dispensing limited to cosmetic drugs


PRACTITIONERS QUALIFIED TO DISPENSE

MD, DO, DDS, DPM, DVM, PA, NP (38 States)

Restricted to MD, DO, DDS, DPM, DVM (6 States)


DISPENSING PRACTITIONER REGISTRATION

Registration Required (16 States)

No Registration Required (28 States)

States require registration with respective professional board, except: NE – register with BoP as “delegated dispenser” NH – register with BoP as “limited retail drug distributor”


COMPLIANCE WITH PHARMACY REGULATIONS WHEN NON-PHARMACIST DISPENSING

Some Dispensing Requirements (17 States)

No Specific Dispensing Requirements (23 States)

Must Follow All Pharmacy Requirements (4 States)


HEALTHCARE PRACTITIONER DISPENSING OF PHARMACEUTICAL RX PRODUCTS

QUALITATIVE RESEARCH


METHODOLOGY

� Sample targets were n=80 per specialty group split evenly between dispensers (in the past 3 months) and non-dispensers.

Specialty Type Dispensers Non-Dispensers Total

Nurse Practitioners 32 32 64

Dermatologists 40 39 79

Plastic and Reconstructive Surgeons

39 38 77

Hematologist-Oncologists 27 21 48

Medical Oncologists 13 19 32

Primary Care Physicians (Family Medicine and General Practice)

40 40 80

Psychiatrists 40 40 80

Internal Medicine Doctors 41 40 81

TOTAL 311 309 620

RESPONDENTS CAME FROM ACROSS THE COUNTRY

Northeast Region 100 (26%)

South Region 118 (31%)

Midwest Region 83 (22%)

West Region 78 (21%)

DISPENSING IS MOST COMMON AMONG DERMATOLOGISTS OR SURGEONS

Percent Dispensing

Nurse Practitioners (n=96)

56%

Optometrists (n=273)

54%

Oncologists (n=298)

67%

Dermatologists (n=207)

75%

Plastic and Reconstructive Surgeons (n=185)

72%

Prevalence of Dispensing by Specialty

17

Rx Dispensing is Done Very Frequently

e 48%

34%

10% 2% 6%

0%

100%

Rx Dispensers(n=174)

Frequency of Dispensing Rx Products (% Rx Dispensers)

1/Three Months

1/ Two Months

1/Month

Weekly

Daily

82% dispense daily or weekly

18

OTC Dispensing is Done Very Frequently

e 51%

32%

11% 2% 4%

0%

100%

OTC Dispensers(n=171)

Frequency of Dispensing OTC Products (% OTC Dispensers)

1/three months

1/two months

1/month

Weekly

Daily

83% dispense daily or weekly

19

Patients Dispensed Medications Are As Likely To Be Aged 65+

e

37% 33% 32%

0%

100%

General Non-DispensedPatients(n=190)

Patients DispensedRx products

(n=174)

Patients DispensedOTC Products

(n=171)

%H

CPs

� Pat

ient

s Ag

ed 6

5+

Patients Aged 65+ (Among Dispensers)

20

HCPs are directionally more likely to dispense to patients without prescription insurance coverage

e

54% 47% 45%

0%

100%

General Non-DispensedPatients(n=190)

Patients DispensedRx products

(n=174)

Patients DispensedOTC Products

(n=171)

% H

CPs

� Pat

ient

s W

ith In

sura

nce

C

over

ing

Rx

Med

icat

ion

Patients With Insurance Covering Rx (Among Dispensers)

21

3%

4%

5%

6%

7%

14%

21%

40%

25%

31%

28%

35%

61%

44%

100%

Patient Factors Dispensers (n=190) Non-Dispensers (n=189)

Dispensers more likely than non-dispensers to perceive patient benefits to dispensing

e

63%

50%

47%

45%

45%

32%

23%

7%

21%

16%

14%

16%

8%

10%

0% 100%

My patients are pleased that I dispense medications to them.

Dispensing by physicians in my specialty improves patient adherence.

Dispensing by physicians in my specialty reduces the cost of healthcare to my patients.

Dispensing by physicians in my specialty improves patient safety.

Dispensing by physicians in my specialty reduces the cost of healthcare to society.

My patients request that I dispense medication to them.

My patients are willing to pay a premium for the convenience of receiving their medication at my practice, rather than at a pharmacy.

*

*

*

*

*

*

*

*

*

*

*

*

*

*

Strongly Disagree (1-3) Strongly Agree (8-10)

22

Non-dispensers have greater appreciation for the pharmacist role

e

6%

18%

41%

49%

38%

33%

31%

70%

100%

Healthcare Providers and Pharmacists Dispensers (n=190) Non-Dispensers (n=189)

51%

35%

20%

10%

15%

28%

29%

8%

0% 100%

Dispensing medications to my patients makes me feel I provide a higher level of care.

Physicians in my specialty should receive training in how to dispense medications

It is important for pharmacists to double check my work.

Pharmacists make too many medication errors when they dispense medications.

*

*

*

*

*

*


23

Many procedures perceived as not highly important and burdensome

e

78%

78%

72%

70%

64%

58%

54%

38%

32%

0% 100%

Perceived Importance of Procedures Highly Important (8-10)

Patient Counseling for Dispensed Medications

Proper Drug Storage (i.e., lighting, temperature, security)

Maintaining Prescription and Drug Record Keeping

System Verification of Product before Dispensing (i.e., double check)

Drug Stock Labeling and Inventory Control

Prescription Labeling

Medication Profile System/ Medication Dispensing System

Generic Substitution

US Pharmacopeia Standard Sterile Compounding Facility

13%

13%

27%

16%

24%

24%

33%

18%

48%

0% 100%

Perceived Burden of Procedures

Highly Burdensome (8-10)

Among Dispensers (n=190)

24

More than a quarter intend to dispense more in the next 2 years

e

28%

61%

11%

0%

100%

Dispensers(n=190)

Future Dispensing Behavior (% Dispensers)

I will dispense tofewer patients in thenext two years.

I will dispense to thesame proportion ofpatients in the nexttwo years.

I will dispense tomore patients in thenext two years.

�Dispensing is getting to be an issue with proper record keeping---too much time involved.� �The time and effort is burdensome to our busy practice.� �It is not financially worth my time.�

�It is more convenient for the patients.� �As more medications become available for me to dispense, I will take advantage of the opportunity.� �People like the service as it saves time and money. They are spreading the word to others.�

25

More than 1-in-5 non-dispensers are likely to dispense in the next 2 years

e

22%

39%

17%

17% 4% 1%

0%

100%

Non-Dispensers(n=189)

Likelihood of Dispensing in the Future

(% Non-Dispensers)

Definitely will

Very likely to

Somewhat likely to

Somewhat unlikely to

Very unlikely to

Definitely will not

22%

�It makes it very convenient for the patient and this way, I will know that they are getting the correct OTC and RX medication.� �I believe dispensing may allow patients to start using the medication sooner and may provide some financial benefit to the practice.�

�I believe there needs to continue to be a check and balance in the healthcare system�I think patient safety is far more important that convenience.� �It is not practical to stock all of the possible medications...You may be inclined to use a specific medication rather than the appropriate medication.� The benefit to my patients does not outweigh the extra work involved for my staff.

CONSUMER PERCEPTIONS OF THE DISPENSING OF PRESCRIPTION AND OTC PRODUCTS BY HEALTHCARE

PROFESSIONALS QUALITATIVE RESEARCH


RESPONDENTS CAME FROM ACROSS THE COUNTRY

Northeast Region

199 (20%)

South Region

331 (33%)

Midwest Region

258 (26%)

West Region 211 (21%)

Total (n=999)

Rx Purchasers

(n=762)

OTC Only Purchasers

(n=237)

Consumer Age (mean) 46.6 46.7 46.3

Racial Background (%)

Caucasian 82% 81% 85%

Black or African American 10% 10% 8%

Asian or Pacific Islander 7% 7% 5%

Native American or Alaskan Native 1% 1% 1%

Other Race 2% 2% 3%

Hispanic Background (%) 7% 7% 8%

DEMOGRAPHIC INFORMATION

Age ≥ 65 y.o.: 15.5%, Without private insurance: 42.5%

29

Two-thirds of Rx purchases are from a local pharmacy or supermarket

e

3% 14%

16%

17%

50%

0%

100%

Total(n=762)

Where Rx Products are Purchased (% Rx medications purchased in last 12 months )

Local Pharmacy

Local Supermarket /Convenience Store

Mail Order

Physician�s Office or Clinic

Other

14% of Rx purchases are directly from the Healthcare Practitioner

30

One quarter believe Rx products cost less when purchased from a Healthcare Practitioner

e

23%

58%

19%

0%

100%

Total(n=762)

Perceived Cost of Rx Products from a Healthcare Practitioner

(% Rx Purchasers)

The cost is higher thanin a pharmacy

The cost is about thesame as in a pharmacy

The cost is lower than ina pharmacy

31

Most likely to purchase Rx from a General Practitioner or Internal Medicine Physician;

around three times per year.

75%

50%

37%

36%

28%

25%

23%

18%

49%

0% 100%

Purchased Rx from a Given Health Care Practitioner

Total (n=762)

General Practitioner / Family Practitioner

Internal Medicine / Internist

Mental Health Professional

Dermatologist

Obstetrician / Gynecologist

Cardiologist

Nurse / Nurse Practitioner

Oncologist

Other

Mean Times Rx Purchased

3.02

3.03

4.02

2.00

3.42

3.21

2.87

2.50

2.99

32

Pain, antibiotic, and heart medications most likely to be purchased from Healthcare Practitioners

e

Pain Medications (Ibuprofen or similar, Codeine or similar, Celebrex, or Skeletal Muscle Relaxants)

Antibiotics or Antiviral Medication

Heart Medications (Blood Pressure, Heart Disease, Heart Rhythm, or Water Pills)

Central Nervous System (Headache, Depression, Anxiety, Anti-Parkinson�s, Anti-seizure, Medications for Sleep)

Drugs for the Stomach or Intestines (Antacids, Digestants, Anti-ulcer Medication)

Eye, Ear, Nose or Throat Medications

Contraceptives

Medications for the Lungs

Blood Thinners

Other Prescription Medication

20%

18%

14%

12%

8%

8%

5%

4%

3%

8%

0% 100%

Rx Products Purchased (% Rx Purchasers, n=762)

Other medications varied, but most common mentions were diabetes medications, hormone replacement therapies and dermatological agents

33

Three-quarters of Rx purchases from Healthcare Professionals are �routine� purchases

e

24% 76%

Proportion of Purchased Rx Products that were Emergency vs. Routine Refill:

(% of Rx Purchasers, n=762)

Emergency Refill (i.e., when you ranout of a medication and were unableto get to a pharmacy)

Routine Purchase

34

10-20% of HealthCare Provider dispensed Rx�s are missing �important� labeling information

Name of the prescription product

The directions for use

Your name

The fill date of the prescription or its last dispensing date

The name of the prescriber

Any cautionary statements about the prescription product

The prescription number assigned by the practitioner

The name, address, and telephone number of the practitioner

93%

92%

86%

85%

85%

83%

79%

76%

0% 100%

Included on Rx Product Label % Answering Yes

(n=762)

35

At least a quarter do not get adequate counseling and information at time of sale

e

How often to take the medication

The name of the medication

How to take the medication (e.g., with food, certain times of the day, etc.) What are the

serious side effects to watch for

Why you were being prescribed and sold the medication

What side effects the medication might have

What to do in the case of any serious side effect occurring

77%

76%

71%

65%

61%

59%

0% 100%

Often/Always Reviewed by Healthcare Practitioner

%Often/Always (n=762)

36

93% 7%

Occurrence of Serious Side Effect on Rx from Pharmacist: (% of Rx purchasers, n=762)

No Yes

Primary Care Physician or pharmacist consulted for adverse drug reaction from

pharmacist dispensed Rx

e

My Primary Care Physician

The pharmacist who sold you the prescription

An urgent care / Emergency room physician

Another Pharmacist

Another Healthcare Professional

42%

30%

15%

11%

2%

0% 100%

Medical Professional First Consulted

(% Experiencing a serious side effect, n=53)

37

93% 7%

Occurrence of Serious Side Effect on Rx from Healthcare Practitioner:

(% of Rx purchasers, n=762)

No Yes

e

64%

28%

6%

2%

0% 100%

Medical Professional First Consulted

(% Experiencing a serious side effect, n=53)

The healthcare professional who sold you the prescription

A pharmacist

An urgent care / Emergency room physician

Another healthcare Professional

Dispensing Healthcare Professional more likely to be consulted for dispensed Rx

adverse drug reaction

9% ↓

38

13%

22%

19%

20%

37%

36%

17%

27%

22%

24%

39%

42%

100%

Patient Factors Rx Purchasers (n=762) OTC Only Purchasers (n=237)

44%

36%

36%

35%

26%

25%

37%

29%

31%

25%

17%

18%

0% 100%

It appears some purchase from Healthcare Practitioners � even if they strongly disagree

with purported benefits

e

I am pleased that my physician / nurse sells me the medication directly.

Dispensing by a healthcare professional other than a pharmacist improves how likely I am to comply with the instructions for taking the medication (number of doses, when to take it, etc.)

Dispensing by a healthcare professional other than a pharmacist improves how safe it is for me to take the medication.

Dispensing by a healthcare professional other than a pharmacist reduces the cost of my healthcare.

I am willing to pay a premium for the convenience of receiving my medication at the physician�s office or clinic, rather than at a pharmacy.

I request that my physician / nurse sell me the medication directly.


*

*

*

SUMMARY OF RESEARCH SERIES OF HEALTHCARE PRACTITIONER ©.2012MARK MUNGER, PHARM.D. ALL RIGHTS RESERVED

� Dispensing of legend and OTC medications by healthcare practitioners is firmly entrenched in the U.S. healthcare

marketplace.

� The practice is driven by practitioner perceptions of better convenience (consumer agreement) and medication adherence

with healthcare cost reductions.

� Healthcare practitioner dispensing will continue to expand with greater consumer knowledge of the practice.

� There appears to be no direct signal of adverse safety from healthcare practitioner dispensing.

� Collaborative discussions among all healthcare providers must occur towards provision of a consistent dispensing practice

model for optimal consumer safety.



Physician dispensing in the United States is:

A. Rare

B. Practiced daily or weekly

C. Commonplace across all practice settings

D. Under the direction of the Board of Pharmacy in most states

Physicians perceive drug dispensing as:

A. Reducing the drug cost to my patients

B. Reducing the cost of healthcare

C. Improving drug adherence

D. All of the above



Physician perception of the highest burden of pharmacy practice rules on dispensing practice is:

A. Labeling the prescription bottle

B. Keeping a medication profile system

C. Drug stock labeling and inventory control

D. Maintaining prescription and drug record keeping


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