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FDA Considers a New Paradigm For Over-the-Counter Medications

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
     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."