P&T Journal...May 2012
The Scott and
White Health Plan, which laps over 50 counties in central, east and west Texas,
owns 12 drug stores which are part of the health plan network, which also
includes 2,400 physicians, 30 hospitals and another 400 or so independent
community pharmacies. Twelve pharmacists shuttle between the 12 company-owned
S&W drug stores each day performing pharmacist-plus duties because of a
collaborative practice agreement signed by each one of those pharmacists and
one of the health plan's physicians. Each pharmacist has either completed a
12-month, post-doctoral training program in ambulatory pharmacy practice or a
special certification program. The 12 pharmacists saw 500 diabetes patients in
2011, all of whom agreed to an initial one hour visit with one of the 12
pharmacists and monthly 15-30 minute follow visits. For agreeing to participate
in the diabetes control program, the health plan members were freed of co-pay
requirements and given other concessions.
The collaborative practice
agreement--blessed by the Texas state medical and pharmacy boards--allows the
pharmacists to do for those diabetic patients some of what pharmacists
traditionally do not do: adjust and even implement medication for diabetes medications
(for a pre-selected group of pharmaceuticals) including insulin, a medication
usually not subject to pharmacist "intervention" in any state in the
union. The pharmacists also have leeway to adjust medications for
co-morbidities such as hypertension and hyperlipidemia.
Rumor has it, because of all these
unconventional, extra responsibilities, the 12 pharmacists at the S&W
pharmacy come to work each day with a cape with an "S" engraved on
its back. But if that were true, the "S" would not stand for
"Superman," it would stand for "Savings." Paul Godley,
Pharm.D., Director, Clinical Pharmacy Services, Scott and White Health Plan,
says the 12 pharmacists saw about 6,000 patients in 2011. The S&W health
plan "reimbursed" the pharmacists an average of $70 per visit ($105
for initial, $55 for monthly follow-up). However, the health plan saved $1800
per person enrolled in the diabetes program compared to a control group. Given
500 health plan members participated, that is an annual savings to the S&W health
plan of $900,000. Patients in the intervention group also demonstrated an
improvement in medication adherence and a trend of greater decline in
hemoglobin A1c.
The S&W diabetes management program
and the collaborative practice agreement which allowed it to go forward
resonate loudly in the current discussion about whether the Food and Drug
Administration (FDA) should create a new class of over-the-counter drugs which
would be available to customers only with "conditions of safe use (CSU)"
in place. These conditions would in some instances require pharmacist
interaction with patients considering purchase of a CSU drug, and concomitant
payment to the pharmacist for time spent with the customer helping him or her
decide whether a CSU drug was right for them, entering the drug into a
patient's medical record and other administrative and counseling tasks.
The
FDA announced in February that it is considering this new "paradigm"
for switching more Rx drugs to OTC and followed up with a two-day public
meeting at its White Oak headquarters in Silver Spring, Maryland on March 22
and 23. The idea is to increase access to prescription drugs which might not
otherwise be approved for OTC status minus the "conditions of safe
use" the FDA would attach to
drugs in this new OTC class. FDA is also considering whether the same drug
product could be simultaneously available as both a prescription and
nonprescription product with conditions of safe use. Pharmacists and pharmacies
would play an important role in the success of this new paradigm, if the FDA
decides to move forward. That led to numerous questions from the 12 FDA
officials on the "questioning" panel about collaborative practice
agreements and their potential application to the new paradigm.
Making available
drugs currently classified as prescription only as presumably less expensive OTC with CSU would be important especially for the
poor and uninsured, but would undoubtedly improve compliance for a broad
range of patients and have subsidiary benefits such as unclogging
emergency rooms, reducing the impact of
the shortage of primary care
physicians and lowering costs for health plans, both private
and federal, meaning Medicare
and Medicaid. The kinds of drugs which could fit into
this new class, according
to the American Society of Health System Pharmacists (ASHP),
are HMG-CoA reductase
inhibitors, or statins, inhaled
corticosteroids and beta-2 agonists used in the treatment
of asthma, and select therapies for
hypertension, osteoporosis and diabetes,
and vaccines.
A recent Booz & Company study reported that 240 million
people each year treat
illnesses with OTC medicines. According to the study,
an estimated 60 million of these
consumers would not otherwise seek treatment. OTC medicines
save the U.S. healthcare
system $102 billion annually. The study goes on to note that
for every dollar spent on OTC
medicines, the healthcare system saves six to seven
dollars.
The paradigm will shift some of the
balance of power in drug prescribing from the
physician to the pharmacist and pharmacy. The FDA has
outlined a potentially broad role
for pharmacists in this new paradigm. For example,
some diseases or conditions might
require confirmation of a diagnosis or routine
monitoring using a diagnostic test
(e.g., a blood test for cholesterol levels or liver
function) that could be available in a
pharmacy. A pharmacist, or consumer, could then use the
results to determine
whether use of a certain drug product is appropriate. Other
potential roles for
the pharmacist include assessing whether the consumer has
any conditions or other
risk factors that would indicate that the drug should
not be used, or assisting the
consumer in choosing between various drug products. For
drugs that require use of
a diagnostic test, creating a pathway for nonprescription
use may result in the development
by industry of diagnostics suitable for use by the patient
or a pharmacy
professional.
Depending on how aggressive the FDA decides to be, changes for the
pharmacy industry could be cataclysmic, in both good and bad ways. The paradigm
opens the door to pharmacists achieving a long-term goal: the ability to
perform a broad menu of medication therapy management (MTM) services and, more
importantly, to be paid for performing those services. Currently, Medicare, for
example, pays for some MTM services for some Part D recipients. But Medicare,
and a few private payors, has only dipped its toe in that water, and it is a
pinky toe at that. Any "New World Order" would also impose
considerable new administrative burdens on pharmacists, such as perhaps
verifying the accuracy of a customer's use of an algorithm, entering customer
information into electronic health records, sending data to the manufacturer of
a drug and more.
Just the prospect of pharmacists invading their turf has put physician stethoscopes in a tizzy. At the
meeting at the FDA on March 22, Sandra Adamson Fryhofer, M.D., MACP, FRCP, who
was representing the American Medical Association, answered an FDA official who
had asked her what training pharmacists should get in order to obtain broader
authority to initiate drug intervention. "They should go to medical
school," she answered. "Bypassing physicians for chronic disease is a
mistake," she added. It hurts patients and could threaten their
lives."
Pharmacists, on the other hand, contend they are already saving payors
and patients large sums of health care dollars through MTM programs designed to
serve patients with chronic diseases such as diabetes, asthma and chronic heart
failure. Many of these MTM programs, such as the Scott & White diabetes
program, function because of "collaborative practice agreements" which
are legal in 46 states. Those agreements between specific physician groups and
specific pharmacies allow the pharmacist to make patient drug decisions that a
physician might normally make. These collaborative agreements allow pharmacists
to work at a "higher power," a level at which they perform exactly
the kind of services that the FDA anticipates would be included in the services
required to be provided if the agency switches an Rx drug to OTC under this new
paradigm.
The new paradigm will affect community retail pharmacies, of course. But
Cynthia Reilly, B.S., Pharm, ASHP, says hospitals and health systems will be
affected, too. The reason for that is that 50 percent of hospitals have
out-patient pharmacies. In addition, health systems often have satellite clinics,
often numerous ones, some of which also have pharmacies attached. "Those
pharmacies are in an ideal position to contribute to the new paradigm,"
Reilly says. That is particularly true because pharmacists in hospital and
clinic pharmacies are must closer to physicians, often in a geographic sense,
but certain operationally, given the health plan setting and the integration
of health plan staffs. That integration
is also, more and more these days, "electronic," given the broadening
use of electronic health records in health plans and hospitals. Moreover,
hospitals are under increasing pressure to reduce readmission rates. One way
they could do that, explains Reilly, is by giving out-patient pharmacists
access to broader "chronic"-targeted OTC drugs and a broader role in
assuring departing hospital patients either stay on those drugs, such as
anticoagulants, for example, or are switched to more amenable alternatives,
insuring higher compliance rates and fewer return trips to the hospital.
Reilly says that the FDA should approve drugs for the new "OTC with
CSU" class on a drug by drug basis, not on a class-by-class basis. Beyond
that, the ASHP has four conditions of safe use it would like the FDA to adopt: 1) meet many of the criteria currently used to reclassify
prescription drugs to nonprescription status such as the drug product having a
well-established benefit-to-risk ratio, a wide safety margin, and is not a
systemic or other anti-infective agent to which emergence of resistance is a
concern; 2) have been marketed as a prescription product for a sufficient
length of time and been used in sufficiently large numbers of patients to
detect serious adverse effects; 3) have evidence of effectiveness and safety at
the dose and regimen that would be available without a prescription; and 4) be
used to treat a disease, symptom, or condition that can be readily detected or
diagnosed by the patient, pharmacist, or health care provider. Further, if the
drug is used for a condition that requires laboratory or other medical
monitoring, the pharmacist should be able to perform or obtain the results of
the monitoring.
Given the fact that the paradigm would switch some of the balance of
power from physician to pharmacist, and potentially open up new sources of
payment, pharmacy groups are enthusiastic about the new paradigm. "We view
the new drug paradigm concept being considered by the FDA as an exciting
opportunity to utilize this open access to pharmacists to safely increase the
availability of certain medications and to optimize the important role
pharmacists play in improving public health," says Thomas Menighan, BS
Pharm, MBA, FAPhA, Executive Vice President of the American Pharmacists
Association.
In one sense, it is a bit surprising that pharmacy groups would be,
essentially, "all in" for a new class of OTC drugs which would have
special conditions of use often involving pharmacist attention. The
"conditions of safe use" the FDA would attach to this new OTC
category sound a lot like the Risk Evaluation and Mitigation Strategies (REMS)
Congress in 2007 gave the FDA authority to require of important new prescription drugs that the agency might
not otherwise have approved. The REMS that drug companies have produced--the
FDA has not established a standard format--have come in different sizes and
colors, making life difficult for pharmacists. The drug companies themselves
haven't been much happier with the FDA's unfocused administration of its REMS
authority. That has led to industry pressure on Congress to rewrite the REMS
provisions in the 2007 law as it reauthorizes the Prescription Drug User Fee
Act (PDUFA), the law first passed in 1992. The REMS provision was inserted into
PDUFA IV, passed in 2007.
However, the "REMS resemblance" has caught the eyes of some
pharmacy groups. Anita Ducca, Vice President, Regulatory Affairs, Healthcare
Distribution Management Association, notes that REMS such as the
"iPledge" program require wholesale distributors to verify the status
of eligible pharmacies and requires manufacturers to maintain registries of
qualified dispensing sites. The iPledge program requires physicians and
pharmacists to take certain steps, too, and to record those steps, to verify
that a female patient taking Accutane or another isoltretinoin medicaiton such
as Sotret, or Amnesteem does not become pregnant. The pharmacist filling a
prescription must verify through the iPledge system website (or over the phone)
that all criteria has been met. The pharmacist must obtain authorization before
dispensing the medication.
"We have found through experience with REMS programs that
variations in the elements of data to be communicated among these organizations
increases the complexity of the data sharing," explains Ducca. "This
complexity would only be magnified if,
as with REMS, drugs in this class experience varying restricted distribution
data, requirements and components."
Pharmacy groups certainly have some qualms about workflow burdens that
may be imposed by a new "OTC with CSU" category, not to mention
concerns about whether payment for added responsibilities would be forthcoming,
much less sufficient. However, they cite perhaps a somewhat more
"telling" piece of history as they look on the bright side of the
potential new OTC class. That would be the shift of flu immunization from the
physician's office to the pharmacy. Of course, the states, not the FDA, passed the necessary laws to expand
pharmacist scope of practice to allow that shift. But the APhA says about
175,000 pharmacists have completed a certificate training program allowing them
to immunize. And, in the 2010-2011 influenza season, it is estimated that
pharmacists administered approximately 20 million influenza vaccinations.
"APhA believes that the new paradigm being considered can build on the
successful immunization public health model," states Menighan.
But Adamson Fryhofer, Chair-Elect of the AMA's Council on Science and
Public Health and a primary care physician in Atlanta, argues the immunization
model doesn't apply to chronic disease. "Treating chronic disease is much
different," she explains. "Other co-morbidities might evolve or a
different therapy might be needed."
But Menighan answers that broader pharmacist involvement in a new OTC
category would improve, not hinder, as Adamson Fryhofer implied, care
coordination. "It is widely known in pharmacy, but often not well
documented, that pharmacists routinely refer patients to an appropriate
provider, and improve care coordination everyday," he states. "The
new paradigm being considered should not segment or silo patient care activity
in the pharmacy but rather provide for redirecting undertreated patients back
into care to reduce morbidity and decrease costs."
That, of course, is what the FDA hopes to accomplish by establishing
this new category. It believes that the requirement to obtain a prescription
for appropriate medication may contribute to undertreatment of certain common
medical conditions including hyperlipidemia (high cholesterol), hypertension
(high blood pressure), migraine headaches, and asthma. Some medications require
routine monitoring through the prescribing practitioner--i.e. currently the
physician--such as blood tests to assist in the diagnosis of a condition, or to
determine whether or how well the medication is working, or to adjust the dose.
The new paradigm might require an initial visit to a physician who might
approve a certain number of refills beyond those that would normally be
authorized without a return visit under specialized conditions of safe use.
This paradigm might be useful for certain rescue medicines, such as inhalers
used to treat asthma or epinephrine for allergic reactions, that patients need
to keep on hand for use in emergencies.
One thing that
is a bit unclear at this point is whether the FDA has the authority to
establish a new "OTC with CSU" category without a congressional
blessing. Janet Woodcock, Director of the FDA Center for Drug Evaluation and
Research, has said that Congress could give the FDA the authority when it
reauthorizes PDUFA this year. The FDA made a PDUFA V proposal to the Congress
in January. It did not include a request for "OTC with CSU" authority.
The FDA's current authority allows it to
approve an Rx to OTC switch if it is convinced all of the necessary safety
information that needs to be conveyed to consumers can be included in the Drug
Facts label which appears on the package. That label is a limiting factor, and
it has stood in the way of FDA approval of some switches, for example, in the
case of statins. For example, three FDA advisory panels have rejected Merck
& Co. Inc.'s Mevacor Daily (lovostatin) for OTC use. In that instance, FDA
officials were left wishing they had additional tools for helping a consumer
decide they had hypercholesterolemia and were "right" for a statin.
Drug
manufacturers have been testing algorithms that are consumer friendly in an
effort to rectify the Mevacor
"problem," David Schifkovitz, Vice President, Wellness Category,
Global Regulatory and Quality, GlaxoSmithKline Consumer Healthcare. He walked
the audience at the March 22 FDA meeting through an algorithm his company has
developed for Cardiocor, an Rx betablocker.
However, Schifkovitz fielded a number of
probing questions from the 12 FDA officials sitting as inquisitors at the dais.
He really didn't have an answer for a question about how the FDA could be
assured a consumer actually correctly completed an algorithm, whether at a
kiosk, at a home computer or on a cell phone. He admitted that the
proliferation of kiosks in drug stores, not to mention in other less
floor-space friendly venues such as convenience stores, would pose a problem.
Asked whether senior citizens would be able to navigate algorithms,
Schifkovitz responded, "It would be
up to the designers to make the algorithms as simple as possible."
Whether it would have helped Merck to
have a highly-rated algorithm in place back in 2007 when Mevacor last banged
its knee on the FDA OTC hurdle remains to be seen. What is clear, however, is
that the FDA has been very hesitant to approve prescription to OTC switches. There were no switches in 2010 (no 2011 data on FDA website),
two in 2009, and none in 2008. The FDA did approve the switch of Allegra in
2011; but that was hardly path-breaking given the approval of the same for
Claritan a decade ago.
While FDA has been very tough on switches
in recent years - like everything at FDA - the pendulum continues
to swing," says Cindy DiBiasi, partner, 3D Communications, LLC. "I
think what’s most promising of all is that there seems to be a lot of interest,
motivation, and activity from both the FDA and industry on switch – and
sometimes it just takes that type of momentum to get things moving again."
