1 [PHARMACISTS IMPROVING OUTCOMES IN DIABETES]
Pharmacists Improving
Outcomes in Diabetes
An argument for expanding scope of practice
Liseli Mulala-Simpson Rph CDM
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PHARMACISTS IMPROVING OUTCOMES IN DIABETES
Abstract
Diabetes is a problem in the United States and Worldwide and less than 15% of people in the US
with diabetes are meeting established treatment goals. Despite the multitudes of medications
available to treat the disease, health goals are not being met and costs are rising. The only thing
that is consistently working is diet, lifestyle change, medication compliance and self monitoring
of blood glucose. One of the best ways to make this happen is with health coaches. Legislation in
California and North Carolina is giving pharmacists more autonomy to help patients manage
their disease better. The Asheville project in North Carolina is a prime example of how
pharmacists as health coaches can improve outcomes in patients with diabetes. With ongoing
assistance from the pharmacists, patients with diabetes are meeting health goals. With the
pharmacists working closely with patients, outcomes are improved, complications are reduced
and healthcare costs are reduced. The health belief model posits that if people believe that they
are susceptible, the disease is serious, the benefits of action outweigh the cost, the benefits and
barriers are surmountable and they believe in their self efficacy, they can manage their disease.
This review of the literature, the legislation and a case study of the Asheville project will show
that pharmacists are improving outcomes in patients with diabetes and that successful
interventions are using some if not all of the tenets of this theoretical model.
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 3
I. Background
According to the World Health Organization (WHO) 346 million people worldwide
have diabetes (WHO 2011) and 25.8 million people, 8.3% of the U.S. population, have
diabetes (CDC 2011). The diabetes epidemic is ongoing and it is a national as well as a
worldwide phenomenon. Many patients with diabetes are not meeting health goals as set
by the American Diabetes Association (ADA), even though the average Hemoglobin A1C
(also called A1C, a standard marker for diabetes control) has been reduced from 7.82% in
1999-2000 to 7.18% in 2004 (ADA 2012). ADA goals for A1C, cholesterol and blood
pressure are still not being met. Only 57% of patients have achieved the A1C goal of less
than 7%, only 45.5% have blood pressure of less than 130/80 mmHg and only 46.5% had a
total cholesterol of less than 200mg/dL with only 12.2% achieving all 3 treatment goals
(ADA 2012). Total costs for diabetes care in 2007 were estimated at $124 billion (ADA
2002) and individual employers can spend up to $4410 more per year on the health costs
of their employees with diabetes ( Cranor and Christensen 2003).
Current literature suggests that pharmacists can help to improve patient outcomes
with diabetes and get more patients to achieve goals (Cranor,Bunting and Christensen
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2003, Giberson et al 2011). Pharmacists are an underutilized resource for diabetes
management and legislation that would expand their scope of practice can make it easier
for them to assist patients ( Giberson et al 2011). Another avenue for pharmacists to
improve patient outcomes is by implementation of best practices utilized in successful
programs such as the Asheville project. The Asheville project is a joint project in Asheville,
North Carolina between the City of Asheville, University of North Carolina, Mission St John
Healthcare and the North Carolina Pharmacists Association ( NCPhA). The project has been
running since 1997 and uses pharmacists as health coaches. The patients meet with the
pharmacists regularly and pharmacists in this program have the ability to adjust/change
medications as needed and order necessary laboratory tests to track patient progress. The
project has shown marked improvements in A1C, Cholesterol and blood pressure, much
more than usual and customary care ( Mattson 2013). Pharmacists are among the most
trusted of health professionals and more accessible than most (Survey 2012). Using
pharmacists to improve patient outcomes in diabetes can reduce costs and giving them the
tools such as increased autonomy with expanding scope of practice will allow them to more
effectively assist patients ( Giberson et al 2011). Once equipped with the ability to monitor
and change therapy if needed pharmacists can empower patients through face to face
interactions and encourage beneficial changes to improve A1c, cholesterol and blood
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 5
Pressure. If pharmacists were allowed the autonomy to practice as a recognized provider at
the state and federal level, they could participate more fully in direct patient care, provide a
solution to the primary care shortage and improve patient care and reduce costs ( Giberson
et al 2011, When 2012).
II.Methods
In this paper the sources were literature from peer reviewed articles, the ADA, the CDC and
WHO websites and position papers. There will also be discussion of the Ashville project to
establish the utility of pharmacist interventions to improve patient outcomes. In the review
of the literature the following key words were used: pharmacist patient outcomes
diabetes health belief model intervention Asheville project. The following databases were
searched: google scholar, web of science and pub med. In addition to the above this paper
used articles found through a review of critical research and professional communications
or professional referrals of articles.
III. Purpose of Study
The purpose of this study will be to show that utilization of pharmacists as integral
members of the healthcare team can lead to improvements in outcomes for patients with
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PHARMACISTS IMPROVING OUTCOMES IN DIABETES
diabetes. Specifically that greater involvement of pharmacists in direct patient care will
lead to a larger percentage of patients meeting all three ADA goals. One of the ways this
paper will show this, is through review of the literature. We will look at the already
established Asheville project currently using pharmacists for chronic disease management,
specifically diabetes. The focus will be on patients with diabetes and interventions where
the pharmacist is involved whether as the main healthcare provider or as an important
part of a healthcare team. Best practices for retail pharmacy, hospital pharmacy and
managed care pharmacy will all be different to cater to the specific needs of those
environments. Even though the Asheville project is based in community pharmacies some
of the practices that worked there can be used in both hospital and managed care as well.
Exactly how these methods should be translated for the different pharmacy environments
is work for a different paper.
The theoretical framework for this analysis will be based on the health belief model,
looking at the best practices at the Asheville project where pharmacists are successfully
intervening with patients with diabetes and improving outcomes. Analysis will be done of
how these practices best fit in with the model. Recommendations will be based on what is
working in current sites and what could possibly work based on the Health Belief Model.
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 7
IV. Theoretical Framework
The Health Belief Model is one of the longest established theoretical models to try to
explain health behavior change and was developed by Irwin Rosenstock in 1966 to explain
why people used health services, the original model in 1966 only included three ideas
(Rosenstock,1966) . The model has since been modified to include perceived benefits, cues
and self efficacy (Nutbeam et al 2010). The model consists of the following main ideas:
1.Perceived susceptibility to the disease or condition.
2.Perceived seriousness of consequences of the disease or condition
3.Perceived benefits of taking action and barriers to taking action
4.Perceived benefits of taking action outweigh the costs
5.Cues to action
6.Perceived ability to successfully perform the action (self-efficacy). ( Nutbeam et al,
2010, Rosenstock, 2005)
This particular idea applies to diabetes since as with any chronic disease, the
prognosis depends on patients’ ability to take their medications, change their behavior and
change their diet and lifestyle. Some studies have shown that up to 18% of patients with
diabetes have made drug errors, 80% have made errors with insulin, 73% did not follow
their diets , 50% had poor foot care and 45% did not test their urine correctly (Bloom,
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Cerkoney, and Hart 1980). Despite receiving diabetes education these patients were still
not successfully performing the necessary actions required to manage their diabetes
effectively. This paper will discuss how to incorporate the tenets of the health belief theory
as well as adding variables that would make the model more clinically applicable to a
chronic disease state. Variables like “ referral systems, the role of significant others, doctor
patient relationships and the social presentation of symptoms and illness” (Bloom
Cerkoney & Hart 1980).
Bloom and colleagues in their 1980 paper posited that the health belief model
would be more applicable to chronic disease if in addition to addressing the 6 basic tenets
of the health belief model, we also looked at whether or not the patients had adequate
referral systems among their healthcare providers. From general practitioner to
endocrinologists, to nurse educators ( Certified Diabetes Educators (CDEs)), dietitians and
pharmacists. Another significant relationship to address would be the direct one between
the patient and their doctor as well as their significant other. Bloom and his colleagues also
thought it important to discuss and address the social presentation of symptoms and
illness such as negative and positive emotions. As well as the very real social implications
of the illness such as when to tell someone you’re dating, how to inject or test in public,
how and what to order at a restaurant and what to bring to the family party. All of these
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 9
variables have a direct effect on diabetes management and by addressing them with the
patient in addition to the main tenets of the health belief model we are holistically helping
the patient to increase self efficacy and acknowledging their challenges without dismissing
them. Ongoing education addressing all these different ideas can go very far in helping the
patient to reach a better level of comfort with their ability to deal with the disease.
V. Legislative Policy
Established Legislation
Legislation, is another way to help the pharmacist in practice. Some current and
future legislation can be helpful to a pharmacist who wishes to expand their scope of
practice and become a more interactive and helpful member of the healthcare team,
especially with the patient with diabetes. California currently has legislation that allows
the pharmacist more leeway to practice direct patient care such as a Collaborative Practice
Agreement (CPA) in California between a pharmacist and a physician, which allows the
following:
1)
Ordering or performing routine drug therapy-related patient assessment
procedures including temperature, pulse and respiration.
2)
Ordering drug therapy-related laboratory tests.
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3)
Administering drugs and biologicals by injection pursuant to a prescribers order.
4)
Initiating or adjusting the drug regimen of a patient pursuant to an order or
authorization made by the patient’s prescriber and in accordance with the policies,
procedures or protocols of the licensed healthcare facility.
(California Board of Pharmacy
2012).
When supervised by a physician and under protocol (CA Board of Pharmacy 2012),
a pharmacist can take a much more active role in direct patient care. The caveat is that they
must follow the protocol and document and report any changes made to patient therapy to
the physician by written notification or electronically within 24 hours ( CA Board of
Pharmacy, 2012). New Legislation that went into effect January 1st 2013 allows California
pharmacists to perform some heretofore restricted clinical duties without a physician’s
clinical oversight. SB 1481 went into effect January 1st 2013 and allows pharmacists to
provide certain tests as provided by the Clinical Laboratories Improvement Amendment of
1988 ( CLIA) as long as the pharmacy obtains a certificate of waiver and complies with all
CLIA requirements . The new law waives the previous requirement of having a physician as
laboratory directory with one lab director for each 4 sites. Allowing each pharmacist in
charge to be the laboratory director of their own pharmacy makes it feasible for
community pharmacies to take on the extra responsibility of adding point of sale
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 1
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laboratory testing to pharmacy services without the added expense of hiring a physician as
laboratory director (SB1481 2011-2012). Just adding the ability to perform point of sale
testing can allow the pharmacist to provide additional value with chronic disease
management and check patients progress in managing their disease, with the ability to
check A1c, LDL, HDL ,blood pressure and body composition onsite without waiting for a
physician to order lab tests. This would allow the pharmacist to get an approximate idea of
a patients progress and then they can be referred to their physician to order official
laboratory results. ( See complete bill Appendix A)
An established bill in North Carolina allowed for the creation of a Clinical
Pharmacist Practitioner (CPP). The Clinical Pharmacist Practitioner Act came into effect
July 1st 2000 this act allows for qualified pharmacists with established collaborative
practice agreements to order, change, substitute therapies or order tests according to an
established protocol. (Dennis 2012). In North Carolina there are specific requirements that
have to be met before you can apply for CPP status. Having a certification such as Board
Certified in Pharmaceutical Sciences (BCPS) or Certified Geriatric Pharmacist (CGP)) or
completion of an Association of the Society of Health System Pharmacists (ASHP) residency
including 2 years clinical experience. If you don’t have one of the previous certifications the
pharmacist can have a PharmD degree with three years experience, plus completion of one
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Accreditation Council of Pharmacy Education (ACPE) approved Certificate Program . If you
don’t have a PharmD but have a BS degree, you can still qualify with five years experience,
plus completion of 2 ACPE approved certificate programs.
(Dennis 2012).
Pending/Future Legislation
One piece of legislation that has not yet been approved, but pharmacists across the
country are advocating for, is that of provider status for pharmacists. “Pharmacists with
approved privileges who currently perform in expanded clinical roles to manage disease
and deliver other patient care functions are not recognized by the Social Security Act or
Centers for Medicare and Medicaid Services ( CMS) as health care providers or as Non
Physician Practitioners ( NPPs)” (Giberson, Yoder and Lee 2011). This is a grave oversight
when other health professionals , physician assistants, nurse practioners, certified nurse
midwives, registered dietitians/nutritionists, clinical social workers and clinical
psychologists are recognized as providers and are thus able to bill CMS for services
(Giberson et al 2011).
If pharmacists providing these same services were recognized and reimbursed, they
could be a much more effective part of the healthcare team and this would lead to better
patient outcomes and cost savings for the healthcare system as a whole. The “combination
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of legislation, policy and compensation mechanisms thus limit optimal patient outcomes
and reduce the positive impact on the patient and the health care system” (Giberson et al
2011). If we were to recognize pharmacists as providers at a state and federal level this
would allow much more active participation as a part of the healthcare team.
There is new legislation introduced this year in California by Senator Ed Hernandez
(Hernandez 2013) which advocates for provider status for pharmacists, nurse practitioners
and optometrists, and to give them the ability to prescribe new and or change existing
therapy as well as to order lab tests. Without this autonomy it is much harder for
pharmacists to effectively help manage the patient with diabetes. Pharmacists are already
working with a certain level of autonomy with the Asheville project and as Clinical
Pharmacist Practitioners in North Carolina but they are limited to only being able to help
patients in specific health plans and of specific physicians. But what is happening in North
Carolina enables us to show that pharmacists are making a difference by improving
outcomes for these patients (Mattson 2013, Cranor 2003) and has given rise to multiple
projects across the country ( Fera et al 2008) . Federal pharmacists also practice with much
more autonomy in federal facilities and have been doing so for years with excellent results
( Giberson et al 2011). Federal and/or statewide provider status would allow pharmacists
the autonomy to practice to the full extent of their training and patients with diabetes
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across the country would be receiving the benefits of chronic disease management from
their pharmacists and the improved outcomes and cost savings would be commonplace (
Giberson et al 2011). Unfortunately there is currently no federal bill pending despite the
recommendation for such from Chief Pharmacist Rear Admiral Scott Giberson to the
Surgeon General in his report on advancing the practice of pharmacy ( Giberson et al 2011).
The new package of bills that has just been introduced in the California Senate by
Senator Ed Hernandez, would remove some of the state restrictions on pharmacists, nurse
practitioners and optometrists (Hernandez 2013). The bill is intended to allow these highly
trained practitioners to practice to the full extent of their education and training and thus
expand access to healthcare in the light of the shortage of primary care physicians (
Hernandez 2013). The bill cites an editorial in the New York Times that makes the same
arguments as the chief pharmacist of the United States Public Health Service, Rear Admiral
Scott Giberson stated in a report to the surgeon general, that pharmacists are
“underutilized” and if given the ability can be an effective weapon in the arsenal to reduce
patient complications, improve outcomes and reduce costs in healthcare (When 2012
pSR10). The chief pharmacist went on to argue in his report to the surgeon general that
currently federal pharmacists in the Veterans Administration, Indian Health Services and
the Department of Defense manage patients with minimal supervision where medications
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are the primary treatment ( Giberson et al 2011). These pharmacists are starting, stopping
or adjusting medication and coordinating follow up care after an initial diagnosis by a
doctor because as federal pharmacists they are exempt from state regulations. But in
private practice state and federal laws make it difficult for a pharmacist without a
collaborative care practice protocol to do the same.( When 2012 pSR10, Giberson et al
2011).
The new Senate Bill 493 proposed by Senator Hernandez was amended April 1st
2013 to create a separate category of Pharmacists similar to the North Carolina CPP ( SB
493 2013). The amendments create a new category called Advanced Practice Pharmacists (
APP). An APP must meet the following criteria to become licensed as such:
- Hold an active license to practice pharmacy an earn a certification in a specialty or do a
residency or be a PharmD with 3 years in practice and one ACPE recognized certification
or a Bpharm with 5 years in practice and two ACPE recognized certifications. Once the
pharmacist has applied for and received the APP certification they can do the following
order and interpret laboratory tests, initiate and adjust drug therapy, perform basic
physical exams and initiate or adjust controlled substances once registered with the DEA.
( see Appendix B for a complete text of SB 493( SB493 2013))
4210.
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All of these advanced practice abilities would improve pharmacists ability to assist
their patients with diabetes. Even the ability to initiate or change controlled substances for
pain relief can be especially helpful in patients with severe diabetic neuropathy. In addition
to creating this new category of pharmacists the law would allow all pharmacists to
administer vaccinations without a physician protocol as long as they follow Advisory
Committee on Immunization Practices ( ACIP) guidelines and routine immunization
schedules and complete a Centers for Disease Control ( CDC) or ACPE recognized
immunization training program . Immunizations especially influenza and hepatitis B are
required for all patients with diabetes so it would be a boon to this population to be able to
receive such at their pharmacy visit without waiting for physician approval.
Under this new law all pharmacists would be allowed to prescribe prescription
medication for smoking cessation as long as they were certified in smoking cessation by a
California Board of Pharmacy (CBP) recognized organization ( SB 493 20130) . Smoking is
a well known risk factor for heart disease and increases complications of diabetes. Being
able to intiate smoking cessation in patients with diabetes right away could improve the
likelyhood of patients staying compliant and increase successful cessation. If this bill were
to pass it would give pharmacists the autonomy needed to play a more active role in
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patient care and management as well as providing patients with a more accessible and less
expensive avenue for many primary care needs. This bill is a step in the right direction but
federal legislation is needed to expand this to all pharmacists.
VII. Best Practices
There are multiple projects across the country that are showing pharmacists
improving outcomes in diabetes, DOTxMED is one where the pharmacists were taught
motivational interviewing and increased personal communication with patients at routine
pharmacy visits, to deliver behavioral interventions. There was a modest increase in
adherence and overall patients, pharmacists and providers reported satisfaction with the
program. ( Skelton, 2012). A study sponsored by CVS pharmacy looked at a variety of
healthcare providers using in-person, electronic and telephone communications to counsel
patients. The study found that of all healthcare providers in-person communications with
retail pharmacists were the most effective at counseling patients on how to use their
medications effectively (Alexander 2011). The Diabetes Ten City Challenge (DTCC) is a
project across 10 different geographic locations nationwide. This was “an employer funded
collaborative health management program using community based pharmacist coaching,
evidence based diabetes care guidelines and self management strategies”. (Fera et al 2009,
p. 385). The study showed evidence of savings on average of $1,079 per patient along with
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statistically significant improvements in A1c, cholesterol and blood pressure. The
improvements were most probably due to faster adjustments in patient regimens and
improved adherence due to increased pharmacist interactions. This in turn would lead to
improvements in patient compliance and reduction in hospitalizations and emergency
room visits which reduced costs (Fera et al 2009). A British study by Ali et al in 2012
showed that 91% of their patients met their A1c goal and 100% of patients where satisfied
with the extent of time, flexibility and information given by the pharmacist. Of patients
surveyed, 90% said that talking with pharmacist improved their understanding of their
diabetes and their medications. 100% of patients were satisfied with the pharmacist
provided services and would recommend the service to their family and friends ( Ali et al
2012).
The majority of examples in the first paragraph used evidence from the Asheville
project to create their model or as evidence that it could be done. There are thousands of
patients enrolled in similar programs across the country based on the Asheville project
(Mattson 2013). The Ashville Project is a ongoing project where City of Ashville, NC
employees (group1) enrolled in 1997 and an employer group the Mission –St. Joseph’s
health system group (MSJ) enrolled their employees in 1999 ( group 2). This project was
one of the first models of this type to use pharmacists as health coaches. They used
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 1
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certified diabetes educators to provide the initial patient education. Then pharmacists who
completed a diabetes certificate training program at specific community pharmacies would
provide long term follow up with consultations, clinical assessments, goal setting,
monitoring and collaborative drug therapy management with physicians ( Bunting,
Christensen and Cranor 2003). In North Carolina the CPP certification made it easier to
implement the project, but any state that has collaborative care agreement legislation can
establish the same type of program with a protocol.
The actions taken by the pharmacists were labeled Pharmaceutical Care Services
(PCS) and over the 7-9 months of the initial intervention led to a statistically significant
improvement in A1c and a reduction in overall medical costs as well a reduction in sick
time and an increase in productivity due to increased compliance with medications and
reduced hospitalizations ( Bunting et al. 2003). Though there was a corresponding increase
in costs and utilization of prescriptions it was more than offset by the resulting savings
leading to a $1200-$1872 saving per patient per year due to improved adherence and
reduced hospitalizations(Bunting et al 2003). The Asheville project was the first to prove
the effectiveness of pharmacists at managing diabetes. The fact that pharmacists were able
to start, stop and adjust medications as well as order lab tests due to the North Carolina
CPP initiative, allowed them more flexibility and increased effectiveness to improve
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diabetes outcomes. Due to increased pharmacists interventions the patients were more
compliant and hospitalizations were reduced.
The project was the brain child of the Pharmacy Director from Mission Hospital,
some pharmacists from University of North Carolina (UNC) Chapel Hill and the North
Carolina Pharmacists Association ( NCPhA). The program then evolved into a collaborative
partnership between physicians , Mission Hospital Systems , NCPhA, North Carolina
Centers for Pharmaceutical Care and the City of Asheville ( The City) (Mattson 2013),.
Since it was conceived by pharmacists they ended up being a big part of the program but in
addition to professional bias, there are some concrete reasons why pharmacists were the
main point of contact in the program. Studies have consistently shown that pharmacists
are one of the most accessible of healthcare providers and consistently alternate with
nurses between number one and number two on the list of most trusted healthcare
professionals (Survey 2012). When pharmacists are paid for the time they spend with
patients, they can justify this to employers and spend the needed time with their patients.
This combination of accessibility and trust makes them a good candidate for main contact
for patient care. Studies have also shown that more people have access to some form of
healthcare via the pharmacy than any other source and that preventative care is much less
costly than sick care. Initially apprehensive, physicians who participated in the planning
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 2
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and training process realized over time that patients were actually coming to see them
more often but with less severe issues. In addition pharmacists’ training in medication
management allowed them to notice drug interactions and duplications early on which
they could remedy and pass the information on to the physicians to update patient records.
The collaboration among physicians, pharmacists and diabetes educators has resulted in
improved patient care and satisfaction ( Mattson 2013).
Pharmacists were initially recruited by an open call to all local pharmacists at chain
and independent pharmacies. Interested candidates then had to attend 32 hours of training
led by physicians and Certified Diabetes Educators ( CDE’s). The training is still required
but now recruitment is done by word of mouth and in addition many schools of pharmacy
teach some variant of the “Asheville Model “ as an example of the type of care they may be
expected to practice upon graduation ( Mattson 2013). The patients once identified or
volunteered for participation are required to complete all enrollment paperwork and
submit it to human resources. Then they are scheduled to participate in the ADA prescribed
diabetes education classes , about 9 hours of class time , and their card is activated to waive
any copays that are disease related. Initially it was just for diabetes but now with the
expansion to additional disease states patients can participate in more than one module of
the program and receive waived copays relative to all their disease conditions ( eg diabetes,
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hypertension and hypercholesterolemia) . At that time they are also assigned a certified
pharmacist care manager to work with them ( Mattson 2013).
The pharmacists are paid by visit and the payment is based on the length of the visit,
initially the visit can last anywhere from 1 to 1and ½ hours whereas follow up visits tend
to be anywhere from 30-45 minutes. Payment allows the pharmacist to justify to their
employer the time spent with the patient When the pharmacist meets with the patient they
are providing the following services:
-Counseling the patient and reinforcing what the doctor may already have told them about
their disease and their medications.
-Establish goals for patient self-management.
-Check blood pressure and provide Glucose monitors ( where applicable).
-Perform basic eye exam
-Perform basic foot exam
-Track data on oral hygiene
-Determine when to send patients to their Doctor when problems arise ( Mattson 2013).
In this first visit the pharmacist is establishing some of the basic ideas in the health
belief model by establishing the seriousness of the disease, encouraging and building their
self efficacy by establishing goals for patient self management and giving them a glucose
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 2
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monitor to self monitor their condition. The mandated diabetes education can also help
patient to identify and surmount possible barriers to self management
Contrary to expectations first year data showed that as a result of these
pharmacists/patient interactions patients had over 200 more outpatient visits with their
physicians than they did the year before. But the care under this model was still less
expensive because patients blood glucose levels were well controlled they were not
experiencing high or low blood sugar exacerbations, they are not being seen in ER’s or ICUs
(Mattson 2013).
The Asheville project has inspired a new healthcare model for management of
chronic disease states that is more patient-centered and payer-driven ( Mattson 2013). The
city of Asheville saves about $4.00 for every $1.00 they invest in the program and it has
been so successful with diabetes that the program has been expanded to include high
cholesterol, hypertension, asthma and depression (Mattson 2013).
The project itself is now running very well and all employees of the City of Asheville
as well as all employees of MSJ with diabetes, asthma, hypertension, high cholesterol and
depression are invited to participate in this service. (Mattson 2013). The payers ( the city
and MSJ) have seen the benefit of the return on investment and are encouraged to offer this
to all their employees. The employees receive the following benefits :
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- All rx copays specific to the disease state are paid at 100%
- All rx supplies specific to the disease state are paid at 100% ( Pumps, glucometers, test
strips etc.)
-All education classes are paid at 100%
- All pharmacists visits are paid at 100%
-All lab visits related to disease state are paid at 100%. (Mattson 2013).
Some might suppose that the improvements in diabetes outcomes could be
attributed to the zero copayment for the medications. But studies have shown that zero
copays only increase compliance by 2-3 percentage points for 1-2 weeks (Motheral 2011).
With the Asheville project more than 50% of patients showed improvements in A1c and
lipid levels, this is much too high an improvement to be explained by zero copays alone (
Cranor et al 2003). Pharmacists interaction with patients increases their knowledge about
seriousness, susceptibility, benefits, cues and self efficacy as described in the health belief
model, all of which are reinforced by the mandatory ADA self management education. (
Rosenstock 1966, 2005,Mattson 2013).
All participants sign a HIPPA ( Health Insurance Privacy and Portability Act )
compliant release form to allow their providers to share relevant information with each
other to optimize their care. (Mattson 2013) .
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V. Recommendations
Though there is significant evidence that pharmacist interventions are helpful to
improve patient outcomes both clinically and economically as well as increase patient
knowledge and self efficacy, there is still lot more to be done to make such interventions
more readily accessible and more widely utilized. There are multiple ways to promulgate
these beneficial interventions . One way would be to allow Clinical Pharmacists Practitioner
( CPP) status in California like they have in North Carolina (Dennis , 2012), approval of the
bill proposed by Senator Hernandez SB493 creating the Advanced Pharmacy Practice
option would give pharmacists the type of autonomy enjoyed in North Carolina and
perhaps allow them to impact patient care in the same way as the Asheville project (SB 493
2013). But we would still need an amendment to CMS regulations to acknowledge
pharmacists as Non Physician Practitioners, so they can bill for their services( Giberson et
al 2011). Unfortunately this has not been pursued at the Federal level but was proposed by
the Chief Pharmacist of the United States to the Surgeon General in his 2011 report
(Giberson et al 2011).
Another way would be by publicizing and using more frequently the established
collaborative practice agreements in California to have more pharmacists practicing a more
active role in patient care. Establishing more certificate programs for diabetes management
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and making them more accessible. Expansion of and improving access to American
Pharmacists Association (APhA) Certification in Diabetes Management (CDM), by offering
the certification more times per year and not just at the annual APhA meeting or the annual
state pharmacists association meeting ( such as California Pharmacists Association CPhA
meeting ).
Modifying requirements for the Certification in Diabetes Education (CDE) to make it
more feasible for pharmacists in a retail setting to achieve the requirement of 1000 hours
of patient time in 2 years with diabetic patients. Without having clinic hours it is not a
realistic option in a retail pharmacy environment. But retail pharmacists with a CDE would
be a great resource for improving patient outcomes in diabetes by allowing billing to the
Centers for Medicaid Services and would improve the incentive for retail pharmacists to get
the certificate and provide effective and recognized education for patients with diabetes.
Another option would be to get the APhA certification in diabetes management(CDM) and
work towards a Board Certification in Advanced Diabetes Management (BCADM) which is
run by the nurses certification board and is slightly more realistic at goal of 500 hours in 4
years prior to sitting the exam and then 1000 hours every 5 years to recertify. Though it is
run by the Nurses board Registered Dietitians (RDs),Doctors of Pharmacy ( PharmDs) and
Bachelors in Pharmacy ( Bpharm) can also apply. Then the pharmacy would have to create
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 2
7
a diabetes education program that meets American Association of Diabetes Educators (
AADE) requirements and once they are AADE certified then they can bill CMS for their
diabetes education services. This is a lengthy and expensive process and just recognizing
pharmacists as NPP’s would be a much easier route. Then pharmacies can use already
established AADE or ADA recognized programs and bill for their education services as well
as other PCS services like in the Asheville project, without the need of a Collaborative
Practice Agreement with a physician.
Conclusion
Allowing pharmacists provider status and otherwise expanding their scope of
practice would expand the pool of available disease management services. Overall
improvements in outcomes of patients with diabetes would reduce healthcare costs,
mortality, morbidity and complications in patients with diabetes. Pharmacists are a readily
available healthcare resource and evidence shows that face to face pharmacist
interventions and use of pharmacists as members of the healthcare team are effective at
improving patient outcomes (Alexander 2011, Fera et al 2008 and 2009) . In collaboration
with physicians, nurses, dietitians, employers and health benefits organizations,
pharmacists can be a great tool to reduce morbidity and mortality and reduce healthcare
costs in diabetes and many other chronic disease states.
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PHARMACISTS IMPROVING OUTCOMES IN DIABETES
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American Diabetes Association. Third-party reimbursement for diabetes care, selfmanagement education, and supplies.
Diabetes Care. 2002;25:S134–5.
Alexander, A. 2011 Pharmacists, Nurses prove most effective in promoting Rx adherence.
DrugStoreNews.com p 32.
Ali, M., Schifano, F., Robinson, P. , Phillips, G., Dhillon, (2012) Achieving HbA1c targets with
patient satisfaction in community pharmacy presentation at the 2012 International
Pharmaceutical Federation (FIP) Congress in Amsterdam
American Diabetes Association ( ADA) 2012 Standards of Medical Care in Diabetes 2012
Diabetes Care v.35 supplement 1
Bloom Cerkoney, K.A., Hart, L.K. 1980 The Relationship Between the Health Belief Model
and Compliance of Persons with Diabetes Mellitus Diabetes Care v.3 (5)
Blumi, B. , Garrett,D., 2005 Patient Self Management Program for Diabetes: First Year
Clinical, Humanistic, and Economic Outcomes .Journal of the American Pharmaceutical
Association v. 45 pp130-137
California Board of Pharmacy (2012) Lawbook for Pharmacy Article 3 Scope of Practice and
Exemptions 4052.2 Permitted Pharmacist Procedures in Health Care Facility; Home Health
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 2
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Agency or Clinic with Physician Oversight p26 Retrieved from
www.pharmacy.ca.gov/laws_regs/lawbook.pdf December 20,2012
Centers for disease control and prevention 2011. National diabetes fact sheet: national
estimates and general information on diabetes and pre-diabetes in the united
states,2011Atlanta,GA: US Department of Health and Human Services, Centers for disease
control and prevention,2011
Cranor,C.W., Bunting, B.A., Christensen D.B., 2003 The Asheville Project: Long-Term Clinical
and Economic Outcomes of a Community Pharmacy Diabetes Care Program Journal of the
American Pharmaceutical Association v.23 no.2
Cranor, C.W., Christensen D. B. 2003 The Asheville Project: Short term outcomes of a
Community Pharmacy Diabetes Care Program. Journal of the American Pharmaceutical
Association v43 pp149-169
Dennis, B. Overview of the Clinical Pharmacist Practitioner in NC North Carolina Association
of Pharmacists website retrieved
fromhttp://www.ncpharmacists.org/displaycommon.cfm?an=13 on December 21,2012
Drug Topics April 17th 2012 CPhA pushing bill to allow California Pharmacists to perform
OTC lab tests retrieved from
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http://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=769366
December 20,2012.
Edlin, M. 2012 CDTM ideal for managing chronic diseases like diabetes. Drug Topics
supplement November pp6-7s
Fera, T. PharmD, Bluml, B. Bpharm, Ellis, W. Bpharm MS, Shaller, C.W. MBA, Garrett, D.G.
BPharm, MS, FASHP 2008 The Diabetes Ten City Challenge : Interim Clinical and
Humanistic Outcomes of a Multisite Community Pharmacy Diabetes Care Program Journal
of the American Pharmacists Association v.48 pp181-190
Fera, T. PharmD; Blumi, B. BPharm; Blis, W. BPharm, MS 2009 Diabetes Ten City Challenge:
Final Economic and clinical results. Journal of the American Pharmacists Association v.49 pp
383-391
Giberson S, Yoder S, Lee MP (2011) Improving Patient and Health System Outcomes
through
Advanced Pharmacy Practice : A Report to the U.S. Surgeon General Office of the Chief
Pharmacist U.S. Public Health Service. Dec 2011.
Hernandez, E. 2013 Utilizing the Health Care Continuum to Increase Access to Care of 2013
SBs 491/492/493 Retrieved from www.bridgingtheprovidergap.com 3/22/13
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 3
1
Kolb, L. (2012) Board Certification in Advanced Diabetes Management (BC-ADM) Summary
Report prepared on April 24th 2012 American Association of Diabetes Educators AADE
retrieved from www.diabetesed.net/page/_files/BC-ADM-AADE-History-2.pdf on March
10th 2013.
Mattson, Destiny The Asheville Project retrieved from www.theashevilleproject.net on April
4th 2013.
Motheral, B. Bpharm, MBA, PhD 2011 “ Are drug copay waivers a good idea?” retrieved from
www.rxoutcomesadviser.wordpress.com/category/medication-compliance/ on April 30th
2013
Nutbeam,D. , Harris, E. , Wise, M. , Theories which explain health behavior and health
behavior change by focusing on individual characteristics. Mcgraw-Hill Australia Theory in
a Nutshell A practical guide to health promotion theories 3rd edition
Rosenstock, I.M. (1966) Why People Use Health Services. The Milbank Memorial Fund, Q.44
(pp. 94-124)
Rosenstock, I.M. (2005) Why People use Health Services. The Milbank Quarterly v.83 no.4
(pp1-32)
SB-493 Pharmacy Practice (2013-2014) California legislative Information retrieved from
www.leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140SB493 4/6/2013
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SB-1481 Clinical laboratories: community pharmacies. (2011-2012) California Legislative
information Retrieved from
www.leginfo.legislature.ca.gov/billNavClient.xhtml201120120SB1481 3/10/2013
Skelton, J.B., 2012 DOTx.MED: Pharmacist-delivered interventions to improve care for
patients with diabetes. Journal of the American Pharmacists Association v 2 (52) pp14-22.
Survey: Doctors, nurses and pharmacists most trusted professions Editorial published
December 17th 2012 retrieved from www.healthjobsnationwide.com/news/Survey-Doctors,nurses-and-pharmacists-most-trusted-professions/1816.html 4/6/2013
Talsma, J., 2012 Diabetes Initiatives How chains, independents are working to improve
diabetes care.. Drug Topics supplement November pp2-3s
Webb , M. The Asheville Project Wellness Program power point file retrieved from
www.thestettlergroup.com/Asheville_Project_Wellness_Program
Venkatesan, R., Manjula Devi A.S., Parasuraman, S. , Sriram, S. 2012 Role of community
pharmacists in improving knowledge and glycemic and control of type 2 diabetes
Perspectives in Clinical Research v. 3(1) pp 26-31
Webb, Michael Innovations in Quality Patient Care : The Asheville experience Smith Premier
Services Inc. retrieved from
www.thestettlergroup.com/Asheville_Project_Wellness_Program[1].ppt 3/30/13
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 3
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When the Doctor is not Needed [Editorial](2012, December 16).The New York Times, pSR10
World Health Organization(WHO) Diabetes Fact Sheet no.312 August 2011
Appendix A
SB 1481, as introduced, Negrete McLeod. Clinical laboratories: community pharmacies.
Existing law provides for the licensure and regulation of clinical laboratories and various
clinical laboratory personnel by the State Department of Public Health, subject to certain
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PHARMACISTS IMPROVING OUTCOMES IN DIABETES
exceptions. Existing law, the Pharmacy Law, provides for the licensure and regulation of
pharmacists by the California State Board of Pharmacy and authorizes a pharmacist to
perform skin puncture in the course of performing clinical laboratory tests classified as
waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988
(CLIA). This bill would exempt a community pharmacy that solely provides certain tests
classified as waived under CLIA from the clinical laboratory regulations, provided that the
tests are performed by a pharmacist, as specified, and the pharmacy obtains a certificate of
waiver and complies with all other requirements under CLIA. Vote: majority.
Appropriation: no. Fiscal committee: yes. State-mandated local program: no.
(SB1481 2011-2012)
Appendix B
SB 493
PHARMACISTS IMPROVING OUTCOMES IN DIABETES 3
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(a) A person who seeks recognition as an advanced practice pharmacist shall meet all of the
following requirements:
(1) Hold an active license to practice pharmacy issued pursuant to this chapter that is in
good standing.
(2) Satisfy any one of the following criteria:
(A) Earn certification in a relevant area of practice from an organization approved by a
board-recognized accrediting agency or another entity recognized by the board.
(B) Complete a one-year postgraduate residency where at least 50 percent of the
experience includes the provision of direct patient care services with interdisciplinary
teams.
(C) Have actively managed patients for at least one year under a collaborative practice
agreement or protocol with a physician, advanced practice pharmacist, pharmacist
practicing collaborative drug therapy management, or health system.
(3) File an application with the board for recognition as an advanced practice pharmacist.
(4) Pay the applicable fee to the board.
(b) An advanced practice pharmacist recognition issued pursuant to this section shall be
valid for two years, coterminous with the certificate holder’s license to practice pharmacy.
(SB493 2013).
Once pharmacists have achieved the new designation APP they will be allowed to
do the following advanced procedures:
4052.6.
(a) A pharmacist recognized by the board as an advanced practice pharmacist may do all of
the following:
(1) Perform physical assessments.
(2) Order and interpret drug therapy-related tests.
(3) Refer patients to other health care providers.
(b) In addition to the authority provided in subdivision (a), a pharmacist recognized as an
advanced practice pharmacist who is acting in collaboration with a patient’s health care
providers, operating under a protocol with a physician, health care facility, or health plan
or disability insurer, or participating in a medical home, accountable care organization, or
other system of care, may do both of the following:
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PHARMACISTS IMPROVING OUTCOMES IN DIABETES
(1) Initiate, adjust, or discontinue drug therapy. As used in this section, “adjust” means
changing the dosage, duration, frequency, or potency of a drug.
(2) Participate in the evaluation and management of diseases and health conditions in
collaboration with other health care providers.
(c) A pharmacist who adjusts or discontinues drug therapy shall promptly transmit written
notification to the patient’s diagnosing prescriber or enter the appropriate information in a
patient record system shared with the prescriber. A pharmacist who initiates drug therapy
shall promptly transmit written notification to, or enter the appropriate information into, a
patient record system shared with the patient’s primary care provider or diagnosing
provider, as appropriate.
(d) This section shall not interfere with a physician’s order to dispense a prescription drug
as written, or other order of similar meaning.
(e) Prior to initiating or adjusting a controlled substance therapy pursuant to this section, a
pharmacist shall personally register with the federal Drug Enforcement Administration.
( SB 493 2013)