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1. 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
2. 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
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 2
3. 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
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4. SELF-ASSESSMENT QUESTIONS
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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5. 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.
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 5
6. 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
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 6
7. 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
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 7
8. 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
9. 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
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ
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10. PRACTITIONERS QUALIFIED TO DISPENSE
MD, DO, DDS, DPM, DVM, PA, NP (38 States)
Restricted to MD, DO, DDS, DPM, DVM (6 States)
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11. 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”
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ
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12. 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)
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ
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13. HEALTHCARE PRACTITIONER DISPENSING OF
PHARMACEUTICAL RX PRODUCTS
QUALITATIVE RESEARCH
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 13
14. 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
15. RESPONDENTS CAME FROM ACROSS THE COUNTRY
Northeast Region
100 (26%)
South Region
118 (31%)
Midwest Region
83 (22%)
West Region
78 (21%)
16. 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. 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. 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. 19
Patients Dispensed Medications Are As Likely
To Be Aged 65+
e
37%
33% 32%
0%
100%
General Non-Dispensed
Patients
(n=190)
Patients Dispensed
Rx products
(n=174)
Patients Dispensed
OTC Products
(n=171)
%HCPsPatientsAged65+
Patients Aged 65+
(Among Dispensers)
20. 20
HCPs are directionally more likely to dispense to
patients without prescription insurance coverage
e
54%
47% 45%
0%
100%
General Non-Dispensed
Patients
(n=190)
Patients Dispensed
Rx products
(n=174)
Patients Dispensed
OTC Products
(n=171)
%HCPsPatientsWithInsurance
CoveringRxMedication
Patients With Insurance Covering Rx
(Among Dispensers)
21. 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. 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.
*
*
*
*
*
*
Strongly Disagree (1-3) Strongly Agree (8-10)
23. 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. 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 to
fewer patients in the
next two years.
I will dispense to the
same proportion of
patients in the next
two years.
I will dispense to
more patients in the
next 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. 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.
26. CONSUMER PERCEPTIONS OF THE DISPENSING OF
PRESCRIPTION AND OTC PRODUCTS BY HEALTHCARE
PROFESSIONALS
QUALITATIVE RESEARCH
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 26
27. RESPONDENTS CAME FROM ACROSS THE COUNTRY
Northeast
Region
199 (20%)
South
Region
331 (33%)
Midwest
Region
258 (26%)
West Region
211 (21%)
28. 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. 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. 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 than
in a pharmacy
The cost is about the
same as in a pharmacy
The cost is lower than in
a pharmacy
31. 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. 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. 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 ran
out of a medication and were unable
to get to a pharmacy)
Routine Purchase
34. 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. 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. 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. 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. 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.
Strongly Disagree (1-3) Strongly Agree (8-10)
*
*
*
40. 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
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 40
41. SELF-ASSESSMENT QUESTIONS
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
NABP 110th Annual Meeting 05/20/14 Phoenix, AZ Munger MA et al. Pharmacotherapy 2014 41