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RANDALL LUTTER: Good morning, everyone. Welcome to FDA’s public meeting on behind the counter drugs. We’re very pleased today to see so such a great interest in this issue, and we’re looking forward to the presentations and discussions that will occur throughout the day. I’m Randall Lutter, deputy commissioner for policy at the Food and Drug Administration, and on behalf of the Commissioner Dr. Andrew von Eschenbach, I’d like to welcome everybody today to this meeting on behind the counter access.
We’re here to explore the public health benefits of behind the counter availability of certain drugs without a prescription, but after an interaction with a pharmacist, and in some countries this is called third class, pharmacists only, pharmacy only or behind the counter. We’re particularly interested today in whether behind the counter may improve patient access to safe and effective drug products. If a patient (monitor?) can’t go to a doctor because of limits to time or money, there may be a health benefit if they can get safe and effective medicines by going to a pharmacy, consulting with their pharmacist and getting a drug without a prescription.
Currently, drugs products are available with prescription or nonprescription. Nonprescription products are often referred to as over the counter or OTC products. OTC products typically have a large margin of safety, low incidence of side effects and low potential for misuse and abuse and the labeling provides adequate directions for safe and effective use by consumer. For a drug to switch from prescription to nonprescription often referred to as a OTC switch process, FDA conducts a review of the post-marketing safety data and determines whether the consumer can use a product safely without supervision of the healthcare provider.
We want to be clear at this point that FDA has not and is not putting forth a specific proposal for you to consider while we would want to hear your suggestions about how behind the counter access can be structured and implemented in such a way as to increase access, benefit patients and improve public health. I’m here with several other senior officials and representatives of the Food and Drug Administration, and at this point, I’d like to turn the microphone over to my colleague, Dr. Doug Throckmorton who is deputy director of the Center for Drug Evaluation Research. Doug.
DOUGLAS THROCKMORTON: Thanks, Randy very much. And I’d echo your interests in having a good discussion to this morning. I think it’s terribly important that we hear from all of the stakeholders to really understand where to take this. There are a couple of items just to go through.
First, at today’s meeting, we really hope to obtain information about what if any appropriate mechanisms and measures need to be put into place to assure that behind the counter availability would be efficient and effective. Specific criteria would need to be developed for determining the role that a pharmacist or healthcare professional might play and we hope to hear some ideas from you about that this morning. In the Federal Register notice we offered up some suggestions for comments such as reviewing or conducting initial screening, reviewing clinical laboratory testing, contraindications or drug interactions. Again, we hope that you’re able to give us some feedback on those ideas.
A second area that we hope we’ll be able to obtain some information from you this morning is with regards to the experience in the foreign areas, in other places in the world where systems similar to this have been put into place, important information is available and I hope that people are able to share that with us.
Finally, we are here to ask – to hear and listen to you and ask questions as we need you to clarify. We ask for information from you about whether there should be behind the counter availability, what criteria should be used to consider drugs for behind the counter availability, how this might impact healthcare including drug prices, logistical issues that pharmacies would face – effects on patient compliance and impacts on pharmacy in the practice of medicine in general. We’re sincerely interested in having your input on all of those areas and any other areas that you feel we need to fully understand to move to the next step here.
We’re doing this in part because of the changes that have occurred recently in regards to healthcare, both with regards to the technology and the promise that additional data sharing has for making it possible for patients to understand and use the medicines more effectively themselves. And additionally, the increased interest in patients in their own healthcare and their own engagement in that process. Both those things make it at least promising to consider the possibility of this third path. We have had a wonderful response. Very broad audience. Look forward to all of the conversation today. We’re very pleased to have representative from Health Canada’s Therapeutics Products Directorate to share the Canadian experience for instance.
Randy, like you I know that Dr. von Eschenbach is very interested in this and I’m looking forward to this conversation. Thank you very much.
MR. LUTTER: Thank you. We’ve broken the presentations into six groups. Each individual presentation will last no longer than 10 minutes. After all presenters in the groups present, there will be a time for questions from the FDA panel. Presenters will be given a – (unintelligible) – when they have about two minutes remaining and we ask that each presenter finish promptly in fairness to others. I’ve given a gavel here and it sounds like this and I’ll try not to be too intimidating with respect to messages about use of the clock, but I think it will be in everybody’s best interest if we try and respect everybody’s time here. With such a great turnout, we want to make sure that the presenters are on time to fit everyone into the limited time available.
The docket will remain open until November 28th, 2007 to receive comments. Comments can be mailed or emailed information can be found at the behind the counter meeting web page on FDA’s website at www.fda.gov. A transcript and all presentations will be made available after the meeting on the docket in within the next two to three weeks. The docket numbers 2007n-0356.
At this point, I’d like to turn to my colleagues from FDA so that they have an opportunity to introduce themselves. Please. Maybe we could start on the right, Diane.
DIANE MALONEY: Okay. Good morning. I’m Diane Maloney. I’m the associate director for policy in the Center for Biologics.
JANE AXELRAD: I’m Jane Axelrad. I’m the associate director for policy in the Center for Drug Evaluation and Research.
LISA BERNSTEIN: I’m Lisa Bernstein. I’m director of Pharmacy Affairs – (off mike).
SCOTT DANZAS (PH): I’m Scott Danzas. I’m an attorney with the Food and Drug and Administration in the Office of the Chief Counsel.
CHARLES GANLEY: I’m Charlie Ganley. I’m the director of the Office of Nonprescription Products in the Center for Drugs.
SUSAN JOHNSON: Susan Johnson, associate director, Office of Nonprescription Products.
MS. : (Unintelligible) – with the management team in the Office of Surveillance and Epidemiology.
DENNIS BASHAW: I’m Dennis Bashaw, division director, division of Clinical Pharmacology III, CDER.
CLARK MARTINELLI (PH): I’m Clark Martinelli, director of the economic staff, Office of the Commissioner.
CONNIE JOHN (PH): Good morning. I’m Connie John in the Office of Policy, Office of the Commissioner.
MR. LUTTER: Thank you very much. At this point, we’re ready to begin group one. We have one, two, three, four, five six speakers. Our first speaker is Mr. William Zellmer of the American Society of Health System Pharmacists. Welcome.
WILLIAM ZELLMER: Dr. Lutter, Dr. Throckmorton, distinguished members of the FDA panel, good morning. My name is William Zellmer. I’m deputy executive vice president of the American Society of Health-System Pharmacists, ASHP. ASHP represents pharmacists who practice in hospitals and in health system settings including outpatient pharmacies and ambulatory care clinics. Pharmacy practice in these institutional environments is characterized by collaboration with multidisciplinary healthcare teams, with pharmacist access to patient health records and by compliance with quality enhancing practice standards, such as those of the Joint Commission.
Pharmacists in hospital and health systems use pharmacy technicians and computer technology extensively to increase their productivity and give them more time for patient care. Pharmacists in this setting are in a good position to contribute to the public health success of a behind the counter category of medicines, and we appreciate this opportunity to share our views with you this morning.
As you probably know, outpatient care is a major part of what hospitals do today. There were nearly 700,000 outpatient visits in hospitals in 2006. Nationwide about 28 percent of general and children’s medical surgical hospitals have an outpatient pharmacy. Among hospitals with more than 400 beds, 55 percent have an outpatient pharmacy. Many of these pharmacies serve a large number of patients. For example, the outpatient pharmacies of one large health system in the southeast have 500 patient visits and dispense 1.6 million prescriptions per year.
I will discuss four topics. First of all, ASHP’s official policy on behind the counter category of medicines, secondly, our views on the optimal features of pharmacists’ enabled access to behind the counter medicines, third, our emerging policy on criteria for selecting medicines for behind the counter status, and then finally a suggestion for moving this public policy discussion forward.
My first topic: ASHP policy. Since 1985, ASHP official policy has supported the establishment of an intermediate or behind the counter class of drug products that would not require a prescription, but would be available only from a pharmacist or a licensed healthcare professional authorized to prescribe medications. ASHP believes that behind the counter availability of certain medications that are currently prescription only and that have unmet potential for improving health status would be in the public interest. It has been shown that reclassification of some prescription medications to nonprescription status resulted in improved patient autonomy and healthcare knowledge as well as improvements in self-care behavior.
However, from a safety perspective, some medications that may be potential candidates for nonprescription status may not be ready for widespread sale in any retail outlet, and for such medications, consumers should be able to draw on the education, training and experience of pharmacists to help them assess their need for the medication and if use of the medication is appropriate, to learn how to take it and monitor its effects. Additional points in our policy specify that drug products appropriate for this intermediate category would be identified through the advice of physicians, pharmacists and other healthcare professionals on the basis of the medical conditions to be treated and potential adverse effects, also that data from post marketing surveillance, epidemiologic studies and adverse drug reaction reporting would be collected to help determine a product’s eventual movement to nonprescription status or return to prescription-only status or continuation in the intermediate category.
In 2005, ASHP opposed the proposed transition of a statin to nonprescription status. Although the estimated public benefit of increased patient access to this medication was immense, ASHP did not support the switch because of the lack of safeguards and oversight that would have prevailed if the medication were a nonprescription product. However ASHP supports statin availability in an intermediate category that is designed consistent with our policy.
Let me turn to my second topic, the optimal features of pharmacist practice related to behind the counter medications. Based on best practices in hospitals and health systems, we believe that the pharmacists’ practice when providing these therapies should optimally include the following six features: first of all, an initial assessment of the patient using a standardized protocol such as might be developed by professional pharmacy associations to determine appropriateness of the medication; second, obtaining required patient health information such as laboratory data to aide in the assessment; third, counseling the patient about proper medication use at the patient’s literacy and comprehension level; fourth, maintaining a standardized record of behind the counter medication and the accompanying professional services that have been provided; fifth, with the consent of the patient, informing his or her primary care provider of any behind the counter medication provided, and finally, ongoing monitoring and effectiveness of safety.
The overall role of the pharmacist here is one of clinical interventions and consultation and that role should be recognized by appropriate payment for the service beyond the retail price of the medication.
Now, my third topic. ASHP is currently developing a policy statement under the direction of our counsel on therapeutics that will outline detailed criteria for determining if a medication is appropriate for behind the counter availability. We are seeking public comment on this document and the policy will be finalized early next year. The current draft says that medications for behind the counter status should, first of all, have a well established benefit to risk ratio and a high safety margin. Secondly, have been marketed as a prescription product for sufficient length of time and been used in sufficient numbers of patients. Third, have evidence of effectiveness and safety at the dose and regimen recommended for the specific formulation of the behind the counter product. Fourth, be used to treat a disease, symptom or condition that can be readily detected or diagnosed by the patient or pharmacist. Fifth, have a means of assessing the effectiveness of the medication and have a means of detecting symptoms of potential toxicity. And finally, not be an anti-infective agent to which emergence of resistance is a concern.
Finally, let me make a suggestion. It is entirely possible that after everything is said today some important questions about the appropriateness and practicality of a behind the counter category may go unanswered. The United States has no experience base to answer some of these questions. For that reason, we suggest that there may be merit in behind the counter demonstration projects for one or more medications in selected markets with FDA oversight and systematic data collection. The experiences documented in such projects would help answer the public policy questions in the context of conditions here in the United States. Among the settings selected for such demonstration projects, in addition to community pharmacies should be some outpatient pharmacies in hospitals and health systems that are well integrated with patients overall healthcare services, and ASHP would welcome the opportunity to help design such a study.
In conclusion, ASHP believes that a behind the counter class of medications would be in the public interest. It would give the public greater access to medications that have potential for yielding large gains in health status. It would allow manufactures and the FDA to assess the safety of moving such medications to even more widespread access as nonprescription products, and it would tap the expertise of a health professional who is well prepared to help people make the best use of medications in this category. Thank you very much.
MR. LUTTER: Thank you very much, Mr. Zellmer. Do we have questions from the FDA panel? We’ll move to Dr. Webb of the American College of Clinical Pharmacy, please.
EDWIN WEBB: Good morning, ladies and gentlemen. My name is Ed Webb. I’m director of government and professional affairs for the American College of Clinical Pharmacy, and I am a pharmacist. ACCP is a national professional and scientific society representing almost 10,000 clinical pharmacist practitioners who practice in essentially the full range of healthcare settings in which medication use and patient care is delivered.
ACCP supports the availability of certain medications without a prescription following consultation with an appropriate patient assessment and education by a pharmacist. We believe in improvements in both overall public health and enhanced patient specific medication use outcomes and quality of life would result from greater availability of appropriate medications through the establishment of a system like this when linked with clinical care and supervision of a pharmacist. We commend the agency for exploring this issue as a means to improve public health and facilitate greater access to these medications.
Studies in both the institutional and community settings have clearly demonstrated that pharmacists’ involvement in patient care in collaboration with other healthcare professionals can indeed improve patient care and outcomes. One of the most successful and frequently cited examples in the U.S. is commonly known as the Asheville Project which demonstrated that the clinical services and interventions of pharmacists in collaboration with other healthcare providers substantially improve the clinical, economic and humanistic outcomes associated with patients with diabetes, asthma and lipid disorders.
What’s in a name? We believe it’s obvious, but we want to emphasize that the benefit to patients and the healthcare system of implementing such an approach will not derive from segregation of the product within a facility, nor from a minimalist expectation of the pharmacist as a gatekeeper of these products as seen with the recent approaches with the pseudo-ephedrine or with emergency contraception. Rather the value will be achieved from an expectation of and policy support for active patient interaction between pharmacists and consumers to enhance their understanding of use of such medication. Evidence from other countries that utilize pharmacist only systems for access to certain medications suggest that these benefits are substantial and that they are valued by consumers and patients.
Therefore, we urge the FDA in subsequent notices and rulemaking activities to use the terms pharmacist-supervised medications or similar terminology to describe the framework being considered by the agency. We believe this terminology would also encourage patients and consumers to seek the clinical guidance and expertise of pharmacists for other health, wellness and disease prevention needs that they may have. Of the 25 or so areas that were raised in the notice, obviously, 10 minutes doesn’t allow us to comment on 25 issues, we’ve chosen at this point in time to comment in four particular areas anticipating that this will be the first of many discussions going forward on this issue among all the stakeholders. And these key areas for us are the criteria for medication availability, documentation and medication record issues, professional services and payment and patient safety and pharmaco vigilance.
In terms of criteria for medication and availability, we believe that pharmacists supervise medications approval should strike a logical and appropriate balance between the existing criteria categorization prescription-only and nonprescription drugs at the current time. A key element of that balance would be that the medication can be more appropriately and safely used by patients and consumers with the active involvement of a pharmacist rather than without. Such a determination should be based on sound clinical evidence and information supported by the input of health professionals, consumers, policy analysts and pharmaceutical companies. Existing methods to identify such medications such as a citizen’s petition may also be appropriate to consider.
ACCP supports what we interpret to be based on introductory comments in the October 4th notice the perspective of the agency that these medications would usually be medications that require a prescription but which could be made available without a prescription with the appropriate intervention and services of a pharmacist.
In addition, we recommend consideration of these criteria as noted in the slide above. The medication is used for a treatment of a disease on condition that can be accurately detected and monitored by the patient caregiver, pharmacist or other care providers. The medication has a demonstrated and highly positive benefit to risk profile, the medication has undergone appropriate clinical testing sufficient post marketing surveillance as a prescription medication to have identified the true rate of occurrence of serious adverse effects.
Evidence of effectiveness or ineffectiveness of the treatment clinically should be able to be assessed by the patient and or pharmacist during monitoring and follow up of therapy. Any laboratory test that might be needed to effectively monitor the patient’s disease and the therapeutic – (unintelligible) – should either be available to or performable by the pharmacist, and evidence exists to demonstrate that availability of the medication only by prescription unnecessarily restricts access to the medication due to economic or sociologic barriers.
With regard to documentation and medication records issues, the successful implementation of a system of pharmacist-supervised medications must include a requirement for consistent and accurate documentation of both the patient-pharmacist clinical encounter and a record of the dispensing of the medication to that patient. In that regard, the documentation procedures for dispensing of a pharmacist-supervised medication should generally be of the same order of rigor as for prescription-only medications. Adaptation of existing medication profile systems to include documentation of the dispensed medication should be relatively straight forward requiring perhaps some minor adaptation of a few selected data elements such as the prescriber’s name, numbering and tracking systems to accurately document the transfer of the medication to the patient.
Documentation of the clinical encounter should generally meet established standards for healthcare provider services, concise notations in the patient’s medication record that documents subjective and objective data, assessment of the patient and the suggested plan from the pharmacist perspective, the analogy being SOAP notes in the medical record relative to the pharmacist’s supervised medication should be consistently recorded and retrievable to facilitate follow-up and referral activities that might be required. Such an approach is essential to adequately serve patients and drive maximum benefit from such a system. The current procedures employed for the limited number of existing products that are sometimes characterized as behind the counter such as emergency contraceptions and pseudo-ephedrine require currently only proof of age from a government issued photo ID. ACCP believes that this technique is clearly insufficient for a system of pharmacist-supervised medications.
In terms of professional services and payment, we believe that the scope and intensity of services will vary substantially from patient to patient and from medication to medication depending on the particular medication being used. We believe that all of the areas of pharmacist professional practice that are outlined in the October 4th notice are part of the picture but there’s more to it probably than that even because patients do vary and service needs of patients will vary. ACCP does believe strongly that the professional services that would accompany the provision of a pharmacist-supervised medication are just that; they are professional services. What we envision and what the healthcare system should expect with this approach is a pharmacist-patient clinical encounter rather than a policed commercial transaction. Therefore, these services are clearly appropriate for payment by patients and by public and private payers of healthcare services. The recent approval of AMA category 1CPT codes for pharmacists face to face medication therapy services for patients provide a standardized and HIPAA-compliant framework for building and documentation of these services.
With regard to patient safety and pharmaco vigilance, any decision to develop and implement a system of pharmacist-supervised medications must have as a central tenant a firm commitment to patient safety and enhanced and targeted pharmaco vigilance activities that support examination of both the positive and negative clinical outcomes associated with the use of these medications. We therefore urge an expanded profile of the activities of the MedWatch program to include not only adverse effect reporting but successful clinical outcome reporting as well.
In summary, ACCP supports this approach to pharmacist access to prescription medications and believes that the creation of this system will substantially improve public health and access and we look forward to working with the agency and other stakeholders in moving this issue forward. Thank you very much.
MR. LUTTER: Thank you very much, Dr. Webb. Our next speaker is Dr. Moné of the American Pharmacist Association.
MICHAEL MONÉ: Good morning, and thank you for the opportunity to provide pharmacists’ perspectives on various issues related to the FDA’s interest in behind the counter availability of certain drugs.
I am Michael Moné, a pharmacist and a lawyer, and currently service the director of regulatory compliance for the Medicine Shop International. I’m here today as a representative of the American Pharmacist Association, the first established and oldest professional organization for pharmacists that represents more than 60,000 members in all practice settings.
Improving the public health and safety with respect to medication use is APhA’s highest priority. Let me restate that, please: improving the public’s health and safety with respect to medication use is APhA’s highest priority. Pharmacists, the medication experts on the healthcare team are the most accessible healthcare providers and the only healthcare provider available to interact and communicate with patients at the point of sale for prescription and OTC medications.
As such, pharmacists have demonstrated that we successfully assist patients to manage and improve their medication use. APhA applauds the FDA’s recognition that pharmacists are in an unique position to proved the oversight needed to improve medication use outcomes of certain medications used to treat patients identified conditions or symptoms. BTC medications that require a pharmacist’s clinical intervention would facilitate more pharmacist-patient communication that would ultimately lead to improved medication use outcomes and improved public health.
APhA receive feedback from more than 600 responders to a recent poll about the questions posed in the Federal Register meeting notice. More than 80 percent indicated that they support the concept of BTC status for certain drugs and would be willing to provide additional information to patients related to BTC medications. APhA supports FDA classification of certain drugs being available without a prescription but only after intervention by a pharmacist. This public health initiative will be successful only if it designed around a collaborative pharmacist-patient healthcare encounter not solely a retail transaction. The patient and the pharmacist will jointly assess the patient’s condition to determine if the BTC medication is appropriate or whether the patient requires a referral. This pharmacist-patient encounter will result in improved public health, enhance patient access to medications and will facilitate safe and appropriate use of medications.
APhA relies on the FDA to determine drug status and to establish those market factors that would ensure viability of this initiative. APhA’s support of certain drugs being available without a prescription but only after an intervention by a pharmacist is based upon four key principles: principle one, a pharmacist-patient clinical intervention is essential; principle two, the FDA must base its BTC categorization decisions on science; principle three, the processes for drug availability without a prescription must be uniform, and principle four, pharmacists must be able to bill and be paid for the clinical services provided.
Principle one: the pharmacist-patient clinical intervention is essential. BTC will be successful when a BTC medication is only available after a patient receives assessment, consultation and clinical evaluation by a pharmacist, and patients may not waive this requirement by signing an opt-out form. BTC will be successful when a BTC medication is identified as appropriate for treatment based upon a patient’s self-identified condition or symptoms for which the patient is seeking care and the pharmacist’s clinical assessment confirms that the conditions for which the patient is seeking care can be addressed appropriately with an available BTC medication.
Pharmacist interventions to determine the clinical appropriateness of BTC medication has the potential to increase appropriate patient access to medications that would otherwise be available only by prescription. This pharmacist-patient interaction is particularly relevant to patients with no health insurance and for other underserved populations who do not have ready access to healthcare providers. A benefit of certain drugs being available without a prescription but only after intervention by a pharmacist may offer an opportunity for the FDA to preserve access to certain medications in the rare case when the primary concern with that medication is preventing inappropriate use or misuse. In such a case, transition of a production from OCT to BTC could allow the medication to remain available in the marketplace with the patient care oversight provided by a pharmacist that would be required for its safe and effective use.
Pharmacists’ clinical intervention in providing a BTC medication would also serve to increase compliance with medication therapy. An additional value to the healthcare system of certain medications being available without a prescription but only after intervention with a pharmacist would be the identification of patients that require either no treatment, those that can be treated with a BTC medication, or those that require referral to a physician. In all cases, more patients would receive higher quality healthcare. Studies such as the Asheville Project that have been described earlier have demonstrated that referrals to physicians increase when pharmacists are actively engaged in clinical interventions with the patient. These studies further document that pharmacists assist patients to manage their prescription medication, increase patient compliance, improve patient safety, and the patient’s overall health outcome improves significantly.
Principle two: the FDA must base its BTC decisions on science. BTC will be successful when FDA realize on clinical evidence of medication safety and efficacy when determining which products to include as BTC medications. BTC will be successful when FDA designates a product as BTC when clinical evidence exists that a particular drug product can be used safely with the intervention of a pharmacist. And BTC will be successful when a defined standardized process is created by the FDA for BTC product designation and for movement among prescription-only BTC and OTC classes.
Opportunities for increased pharmacist-patient interaction will improve safe medication use and outcomes. A pharmacist’s intervention will include an assessment of the patient’s symptoms to confirm that a BTC medication is an appropriate therapy option for the patient. A pharmacist may review, conduct, and/or assess patient screening outcomes which may include laboratory testing data and provide patient risk assessment, counseling and education on the safe and effective use of BTC medication.
Principle three: the processes for drug availability without a prescription must be uniform. BTC will be successful when standardized, administrative and clinical processes are created to ensure an effective pharmacist-patient clinical interaction. And BTC will be successful when pharmacists are able to access and share as appropriate required patient medical information in a timely and efficient manner. The pharmacist-patient interaction would also mean that when appropriate, the pharmacist and patient could arrange for follow-up monitoring. The pharmacist would maintain a standardized electronic patient record to document the intervention and upon consent to communicate relevant data and information to a known primary care provider.
Principle four: pharmacists must be able to bill and be paid for the clinical services provided. BTC will be successful when a standardized mechanism is established and in place for pharmacists to bill and be paid for the services provided either by the patient, a third-party payer or others. And BTC will be successful when payment for related clinical services is separate from payment for the BTC product.
In conclusion, we are pleased that the FDA is recognizing the value of pharmacists and their ability to address a growing healthcare concern related to medication use. APhA firmly believes that pharmacists are a valuable and readily accessible resource to help meet patients’ healthcare needs regarding access to and the safe and appropriate use of medications. As consumers become more aware of product risks and benefits, pharmacists can play a valuable role in patient self-care decisions. Providing patients with safe and appropriate medications after consultation in clinical interventions by a pharmacist will increase patient access to medications, enhance patient education and improve medication use.
As the agency moves ahead with this concept, APhA recommends that the agency incorporate these four key principles: principle one, the pharmacist-patient clinical interaction; principle two, science based decision making; principle three, uniform administrative and clinical processes and principle four, the ability for pharmacists to bill and be paid for the clinical services provided.
APhA offers its support in this instance to the agency in future discussions and meetings about this important public health initiative. Thank you for the opportunity to present the views of the nation’s pharmacists.
MR. LUTTER: Thank you very much, Dr. Moné. Our next speaker is Ms. Eileen Harley from the Food Marketing Institute.
EILEEN HARLEY: Good morning. The Food Marketing Institute appreciates the opportunity to comment on the Food and Drug Administration’s request for input on the availability of behind the counter drugs. We applaud the FDA’s desire to study the public health implications of certain drugs being available without a prescription after intervention by a pharmacist.
There are several issues surrounding the possible creation of a BTC class of drugs that are of particular concern to FMI, specifically how products will be evaluated for inclusion in the BTC class, what protections pharmacists will receive from claims of liability, how pharmacists will be reimbursed for their time, services and expertise and the logistical issues that will arise with this new class? Given the complexity of the issues involved, FMI requests that the FDA extend the comment period to ensure that all stakeholders are given the opportunity to express their concerns.
FMI conducts programs and research education industry relations and public affairs on behalf on its 1,500 member companies, food retailers and whole sellers in the United States and around the world. FMI’s U.S. members operate approximately 26,000 retail food stores with a combined annual sales volume of 340 billion which is three-quarters of all retail food store sales in the United States. FMI’s retail membership is composed of large multi-store chains, regional firms and independent supermarkets. Its international membership includes 200 companies in 50 countries.
FMI’s retail members operate over 19,000 in-store pharmacy departments. Based on current industry trends towards larger store formats and the convenience of one-stop-shopping, we anticipate that the number of pharmacies located in supermarkets will continue to increase in the coming years as will the number of prescriptions that are dispensed on an outpatient basis from these community settings. Earlier this year, FMI committed significant resources to develop the Pharmacy Services Department to provide our members with a clinical perspective in identifying and developing federal policy impacting retail pharmacy.
First, I’d like to address patient access to pharmaceuticals. As noted by the FDA in the October 4th Federal Register notice, some groups have asserted that a BTC category could increase patient access to medications, particularly those patients without health insurance. FMI believes strongly in affordable access to medications and actively works to ensure that its members’ customers have convenient access to needed healthcare products and medication. However, FMI cautions that if product selection criteria are not narrowly defined and strictly applied, a BTC category may actually decrease patient access to needed medications especially in rural and underserved markets.
Many individuals living in rural areas do not have convenient access to a pharmacy and instead rely on FMI member stores not all of which have pharmacies as their only convenience store is a pharmaceutical and healthcare products. Classifying certain over-the-counter medications as BTC would limit the products available in these stores which would necessarily limit the access these individuals have to the products they depend on for their health and wellbeing. We support maintaining consumer access to those medications that can be taken safely and effectively without a prescription. Such products should remain over-the-counter medications available to consumers through various retail outlets.
As the FDA explores the possibility of behind the counter availability of drugs, we remind the agency that criteria used to identify products for inclusion in this potential category should address the concern associated with the substantial self-diagnosis and/or self-medication role of the patients. The approval process should be carefully developed and they’re early defined and should allow for input from drug manufacturers, pharmacists and other health professionals, citizens and the FDA. Likewise, the criteria used to determine acceptability in the BT class must be based upon sound scientific evidence with a strong emphasis on safety concerns. FMI believes strongly in increasing consumers’ access to the products and medications but not at the expense of patient safety.
We also caution the FDA to only use the BTC category as a means to increase patient access to drugs that require intervention from the pharmacist but that do not have the safety concerns that warrant physician supervision. The BTC category must not be used as a means to enforce age limits, quantity of product purchase or other drug enforcement concerns. Pharmacists are trained as healthcare professionals with the expertise, education and experience to assist patients with their healthcare and pharmaceuticals needs. As has been shown with pseudo-ephedrine, pharmacists are not needed to enforce quantity limits and ensure that patients’ purchasing particular products meet minimum age requirements. FMI urges the FDA to limit the scope of any BTC class to those situations where the intervention of a pharmacist can expand access to pharmaceuticals that would otherwise only be available by prescription.
Next, I would like to address the pharmacists’ liability concerns. Every day, pharmacists help patients self-manage the medication therapy and improve the medication through appropriate drug selection monitoring and education. While our pharmacists are eager to help patients access the pharmaceutical care they need, the medications must be safe and effective for their intended use and they must be properly labeled for their intended audience. Drugs should not be placed behind the counter simply to transfer liability from manufacturers to pharmacists or pharmacies because the products themselves are not properly labeled for consumers to purchase in an OTC setting or because manufacturers have not adequately established the safety or efficacy of the drug. If FDA decides to proceed in the development of a BTC class of drugs, it might be appropriate to seek legislation to ensure that liability is fairly apportioned.
With regards to a pharmacist’s reimbursement for services, the creation of a BTC class of drugs will means that the pharmacist will have to spend greater amounts of time on patient assessment, counseling and dispensing and documentation services for these new drugs. FMI strongly believes that pharmacists must be compensated for these cognitive services. In designing a BTC class it will be important to consider how payers respond. For instance, will BTC drugs be treated as analogous to prescription drugs which they are typically covered by insurance, or as OTCs which generally are cash and carry products? Given the products currently being discussed for BTC status, FMI would argue that treatment closer to prescription status would be more appropriate. The status could provide a mechanism for pharmacists to be compensated for their services, the legislation might be required to accomplish this goal particularly in the case of Medicare.
Depending of the number and type of drugs placed in the BTC category, pharmacies may face considerable logistical challenges in transitioning to this new class of drugs. Behind the counter shelves space already at a premium in most stores will become even more cramped and sought after. As pharmacists take a more active role in patient diagnosis and care, they will need to communicate and coordinate care with labs, physicians and other healthcare providers. This increased level of communication will also present new challenges, and if pharmacists are required to interview and examine patients, pharmacies will need to rethink and redesign their space in order to provide a private space for the pharmacists to consult with the patient, draw blood, et cetera.
A standardized documentation system will be required beyond the simple registry of the sale to include the BTC medication dispense and the related services. Communication back to the patient’s primary care provider, if known, with patient consent must also be addressed. Given the considerable logistical challenge, changes that will be required, FDA should continue to include the pharmacy community and discussions about the possible creations of the BTC class.
Finally, given the complexity of this issue and the wide array of stakeholders affected, we ask that the agency consider extending the comment period to ensure all stakeholders have the opportunity to be heard. Again, FMI credits FDA for accepting public comment on the possible creation of a BTC class. We look forward to working with the FDA as they continue to explore behind the counter availability of certain drugs. Thank you.
MR. LUTTER: Thank you very much, Ms. Harley. Our next speaker is Dr. Joseph Cranston from the American Medical Association. Welcome.
JOSEPH CRANSTON: Good morning. My name is Joseph Cranston. I’m a pharmacologist by training, and I currently serve as the director of science research and technology at the American Medical Association. I’m speaking on behalf of the AMA at this FDA public meeting on behind the counter or BTC availability of drugs.
The first question posed by the FDA in its Federal Registry Notice was should there be BTC availability of certain drug products? The focus of my comments today is to express the AMA opposition to the establishment of a BTC class of drugs in the United States. The BTC class also has been referred to third class, transitional class or pharmacy or pharmacists’ only class of drugs and for the purpose of this presentation, the terms should be considered interchangeable.
The AMA has a number of reasons for opposing a BTC class of drugs. First, the AMA does not believe the FDA has the statutory authority to establish a BTC class. The Durham-Humphrey amendments to the Federal Food Drug and Cosmetic Act clearly establish two classes of drugs in the United States: prescription and over the counter. For the past half century no one, including a number of past FDA commissioners has argued that the FDA has the authority to establish additional classes of drugs such as the BTC class by regulation or guidance. Thus, it is somewhat perplexing for the AMA that this meeting is even being held today.
We are aware of at least one former high level FDA official who’s publicly commented that restricted distribution provisions on the FDA Amendments Act of 2007 or FDAAA provides the authority for FDA to establish a BTC class of drugs. The AMA strongly disagrees with that interpretation of this provision of the new law. If you read the title of the section in restricted distribution in FDAAA states and I quote, “providing safe access for patients to drugs with no serious risk that would otherwise be unavailable.” The purpose of the restricted distribution provision is to allow drugs with really serious risks such as thalidiomide and isotretionin to remain on the market as prescription drugs.
However, if an over-the-counter drug is found to have significant new risks, it could be moved to the current prescription-only class and would still be available. There’s no need to establish a new BTC classification. There’s not a scintilla of support in the statutory literature FDAAA or in the congressional record that confers the FDA the dramatic new authorities to create a whole new class of drugs. Furthermore, the AMA is unaware of any discussions within Congress about a BTC class of drugs during its deliberations on the restricted distribution or for that matter any other provision of FDAAA. If Congress wanted to establish a BTC class regarding this major new law that so profoundly affects FDA, Congress would have clearly, unequivocally done so.
Even if the FDA could make a case that it has a legal authority to establish a BTC class of drugs, the AMA is unaware of any good evidence that supports the need for such a new classification. To the contrary, the most definitive report on this subject published the U.S. General Accountability Office in 1995 concluded and I quote, “little evidence supports the establishment of a pharmacy or pharmacist class of drug in the United States as either a fixed or transitional class. The evidence that is available tends to undermine the contention that major benefits are being obtained in the countries that have such a class.” Although the GAO report was written over a decade ago, there is little or no evidence to suggest that its inclusion should be disregarded today.
Many questions about the impact of a BTC class of drugs remain unanswered. For example, it is unclear what the impact of a BTC class would have on access to drugs or on their cost. If a drug that is currently available over the counter will move to a BTC class, access to the drug undoubtedly would decrease because the number of retail settings that sell the product would be lowered by at least an order of magnitude. Furthermore, the cost of the drug most likely would increase substantially because of reduced competition in the market place.
On the other hand, for drugs currently available by prescription only to move to a BTC class access to the product probably would increase. However, the cost of the patient also could increase if a third-party payer refuses provide coverage for nonprescription drugs. Currently, this is a relatively common practice among third-party payers. Of greater concern, what if a third-party payer force the patients to use a BTC class drug before paying for a visit to the patient’s physician in some form of step therapy program where is the cost of removing physician oversight from the process, and I’m going to address that issue in greater detail later in the presentation.
Also, what would be the added cost to patients for pharmacist services if a BTC class of drugs is established? Pharmacists have had the authority to counsel patients about their prescription medicines since the early 1990s. And the AMA generally has been supportive of pharmacist counseling. However, pharmacists really counsel patients and overall it is routine for the pharmacy to ask you to sign a waiver that you declined counseling. The reason most likely is that pharmacists are not paid for this service. So what would be the added cost to the healthcare system for pharmacist related services that would be associated with the dispensing of BTC drugs?
The last question in the Federal Register notice for this meeting was what impact would BTC availability of drugs have on the practice of medicine? I’d like to spend the remainder of my time addressing this question. The AMA’s position is that when a drug is not safe for use by consumers without supervision whether due to its toxicity, its method of use or the quality (?) measures necessary for its use, then a physician who is adequately trained to evaluate and diagnose disease and is licensed to prescribe drugs should be responsible for supervising the use of that drug. This is our interpretation of current federal law and it should not be changed by adding new BTC class of drugs. While pharmacists are very knowledgeable about drugs, they lack the necessary education and experience in patient evaluation, clinical diagnosis and prescribing for individual patients to make the types of patient management decisions that physicians do on a routine basis every day.
The AMA is especially concerned that the FDA might consider moving a number of prescription drugs used to treat various chronic conditions to BTC status. In the 2000 Federal Registry Notice seeking comments on the regulation of OTC drug products, the FDA listed antihypertensive drugs, cholesterol lowering drugs, anti-diabetic drugs, treatments for osteoporosis, treatments for asthma and contraceptives as possible candidates for Rx-to-OTC switch. One can only presume that some of these classes of drugs might be considered seriously for Rx-to-BTC switch.
For example, the manufacture of lovastatin, the cholesterol lowering medication in the statin class submitted an NVA for OTC status about three years ago for the sale of the product could only be in pharmacies. That application was rejected, but as I understand that this drug would be considered for OTC status by an FDA advisory committee next month.
The AMA opposes switching these types of products from prescription only to a BTC class. The benefits of a physician doing a thorough history and clinical examination, including for other preexisting conditions as well as performing the necessary laboratory tests to make the correct differential diagnosis and direct them in the best treatment strategy to monitor the patient for clinical response is critically important for patient with chronic diseases. Some of these diseases have poorly recognizable symptoms that only a physician can evaluate it appropriately. Also many patients have multiple chronic conditions and they require a number of drugs. Only a physician is capable of managing these complex cases. Pharmacists certainly do not have the necessary education and training to perform these critical functions. The patients lose these benefits of physician supervision by switching drug products to a BTC class that in the AMA’s view will be detrimental to the health of many individuals and for the public.
In conclusion, the AMA opposes the establishment of a BTC class of drugs. We do not believe the FDA has a statutory authority to create a third class of drugs by either regulation or guidance. If this question needs to be addressed, it should be done so legislatively at the level of Congress. However, even if the FDA disagrees in that point, the AMA has identified a number of reasons why the FDA should not move forward. The need for a BTC class has not been clearly shown, and in the fact, most thorough evaluation of this subject reaches the opposite conclusion. Many questions remain unanswered about the impact of a BTC class including issues of access to drugs and cost of drugs.
Finally, removing the physician to the patient takes away an important step in determining whether the patient is properly diagnosed and being treated optimally and this can negatively impact the patient’s outcome. The AMA appreciates the opportunity to presents its views on this important issue. I’d be happy to entertain any questions.
MR. LUTTER: Dr. Cranston, thank you very much for your comments. Our next speaker is Dr. Daniel Hussar from the Philadelphia College of Pharmacy, the University of the Sciences in Philadelphia.
DANIEL HUSSAR: Thank you very much. I wish to commend the FDA for convening this meeting of what I consider to be a very important opportunity that will have multiple benefits. The perspectives and the opinions that I share are based on my responsibilities as a faculty member. One of my responsibilities is the nonprescription drug therapy course. What I would like to do in my comments is to address some of the general issues that were identified in the FDA notification announcement in the Federal Register, and then I’ll also mention several specific examples of medications that I consider to be excellent candidates to be transferred from prescription only to behind the counter availability in pharmacies.
The first FDA general issue identified in the Federal Register reads: should there be BTC availability of certain drug products? If so why? If not, why? My response to that question is an unequivocal yes, that certain drug products should be available without prescription behind the counter in pharmacies. I recognize that over the years there have been questions as to whether the FDA has the authority to establish such a groups or medications. I feel that that question was conclusively answered in late 2006 when the Food and Drug Administration approved the transfer of levonorgestrel or plan B to over the counter – I’m sorry – nonprescription availability behind the counter. That decision was made without any additional legislative authority or any other measure of authority that was granted to the FDA at that time.
I’ll address some of the specific reason in support of my “yes” response to this question when I discuss the individual drugs. The second question that I would like to address, what might the impact of BTC be on patient access? The access of patients to medications from which they can benefit will be markedly increased by such decisions.
For various reasons, many individuals rarely, if ever, see a physician unless there is some emergency for which they need treatment. The BTC availability of certain medications from a pharmacist will not only be of value in the treatment of conditions for which physician consultation is not necessary, but it will also facilitate and increase the referral by pharmacist of patients with potentially serious problems to physicians. Those individuals may not otherwise have gotten into the healthcare system.
Indeed, the interaction with the pharmacist regarding a BTC medication will, for many individuals, represent the first step into the healthcare system and their subsequent evaluation and appropriate treatment.
General issue five that the FDA listed: please comment on the following criteria for what roles the pharmacists or rather health professionals might play. Pharmacists are well prepared and strategically positioned to review clinical laboratory test results, identify contraindications, drug interactions and other drug-related problems, counsel patients on the appropriate and safe use of medications and monitor for the continued safe and effective use. Some pharmacists have additional credentials and authorization to prepare them for added responsibilities.
General issue 11 that the FDA identified: would BTC availability be cost effective to patients? Please explain. The increase in the number of nonprescription BTC pharmacy available medications will make them available on a more cost effective basis than if they were only available on prescription. The nonprescription marketplace is very competitive, whether it’s OTC or BTC. Although it is available over the counter rather than BTC, one example would be the Prilosec OTC. The cost of Prilosec OTC is a small fraction of what the other proton pump inhibitors cost on a prescription-only basis.
At the present time, most insurance company drug benefit programs provide coverage only for prescription medications and not for nonprescription medications. As medications are transferred from prescription only to BTC status, the employers and other organizations that pay the insurance companies to provide these programs should not only expect, but should insist, on continued coverage of these medications.
In my opinion, there are numerous medications that are excellent candidates for a transfer to BTC availability in pharmacies. I’ve selected four particular examples to illustrate different reasons for which I consider it to be in the interest of patients, society and the healthcare system in general to transfer these agents from prescription only to BTC status.
The first group that I would mention are medications that will help individuals stop smoking. Varenicline, also known by the brand name Chantix, nicotine nasal spray, also known by the brand name Nicotrol, a nicotine inhalation system. These three products now are only available on prescription. We don’t need to recite the statistics of the number of deaths due to smoking related causes each year. Some individuals have not been successful with the use of the nonprescription products available to help them stop smoking, and other strategies are not readily available to them.
Some of these individuals will not take the next step and go to a physician so that the prescription options for helping them to stop smoking can be considered. There are many smokers who want to quit. but don’t take that step to see a physician. For these individuals, the nonprescription availability of varenicline, nicotine nasal spray and nicotine inhalation system will provide a pharmacist-monitored opportunity for a successful effort to stop smoking.
I realize that there have been some recent reports of some occasional adverse events with varenicline and some will say that there has not been enough experience yet with this relatively new drug. However, of all the medications that have been approved in recent years for prescription use, varenicline has one of, if not the, cleanest safety profile with regard to its labeling.
It is an unacceptable irony that the only – that proof of age is the only requirement for which individuals can purchase a dangerous product like cigarettes, whereas a prescription is required to obtain the products that will help the individuals to stop smoking. Effective and safe smoking cessation age should be conveniently accessible for individuals, for smokers who choose not to visit a physician and barriers to such access must be reduced.
The second medication I would mention is the epinephrine auto-injector. Some individuals experience very serious and even life-threatening reactions following insect bites or stings or exposure to other allergens. Epinephrine is the drug of choice for these emergency situations and the administration of a product like Epipen can be a life-saving intervention. Epipen requires a prescription. Many individuals who have had that experience of a serious allergic reaction carry an Epipen with them, but they may not have it on every occasion. They may not have had occasions to use it and when the time arises, when it is needed, they’d note that it’s well passed the expiration date.
Emergencies such as anaphylactic reactions seldom occur in a convenient location such as a block away from a hospital in which needed treatment can be quickly provided. Often these events occur in an area and/or at a time in which the local pharmacy is more quickly accessible than a physician or a hospital. The nonprescription BTC pharmacy availability of Epipen, or a similar product, can be lifesaving.
The third drug I would mention is oseltamivir, Tamiflu. In recent years, there has been considerable publicity about the possibility of an influenza pandemic. Osiltamivir or Tamiflu is one of a very small number of antiviral agents that is effective in the treatment of influenza. However, for this drug to be optimally effective, it is very important that treatment be initiated as soon as possible designated as within two days following the onset of symptoms. Patients who experience influenza symptoms should be provided the fastest access possible to medications that might be of significant benefit, and even the delay in seeing a physician who can be expected to be even busier than usual during the flu season, waiting that delay or for the delay in receiving the prescription, may compromise the effectiveness of therapy.
And the last group of agents that I would mention are the statins. The statins are among the most widely prescribed of all therapeutic agents. They are the most effective medications in lowering cholesterol concentrations and are well tolerated by most patients, notwithstanding the potential for musculo-skeletal adverse events. You heard earlier about request to transfer Lovastatin and also Pravastatin to nonprescription status.
The primary concern voiced by those who oppose nonprescription status for the statins is that patients will have difficulty determining their need for a medication and subsequent monitoring of a statin, particularly because hypercholesterolemia is not associated with symptoms. Although this is a valid concern, it must also be recognized that many individuals, rather than seeing a physician and receiving prescribed medications, are purchasing herbal products and dietary and nutritional supplements for the purpose of decreasing their cholesterol and deriving the suggested accompanying benefits. Just the other night, I was half listening to a television advertisement for new, Centrum Cardio; it lowers cholesterol. This is made by one of the major pharmaceutical companies that contains phytosterols. Now, to what extent have they been tested?
These products, such as the herbal products and so forth, have not been evaluated in clinical studies and I think in this context, a strong case can be made for the nonprescription BTC pharmacy availability of statins that have been extensively studied, have a known safety profile and can be monitored by a pharmacist. There are also other examples. Time does not permit me to address these individually.
The increase in number of nonprescription BTC pharmacy available medications will not only result in increased patient access to helpful medications, but will also make them available on a more cost-effective basis. The opportunity that the FDA is providing is one in which all participants can win, individual patients, society in general, the healthcare system, pharmacists, pharmaceutical companies and the FDA. Thank you for this opportunity to participate in this forum.
MR. LUTTER: Thank you very much, Dr. Hussar. At this point, we have approximately 10 minutes for questions from the FDA panel, and the questions may be posed to the most recent speakers collectively or individually. It might be beneficial if they were identified with respect to who they’re aimed at and – are there questions? Yes. Jane?
MS. AXELRAD: Yes. I have some questions. The first question I’d like to address to the pharmacy members of the panel, pharmacist members of the panel. I was wondering if you could address what type of training you think pharmacists would need to be able to conduct the clinical assessments that you have all, I think, indicated are a key part of being able to dispense a drug safely behind-the-counter? Anyone, I guess can address it.
MR. HUSSAR: At the Philadelphia College of Pharmacy, and I am confident that this is the experience at all colleges of pharmacy, we provide comprehensive didactic training that includes a review of case studies in which individuals, students, meet in small groups with their clinical instructors. And then there is one entire year of experience in which – in different practice sites and rotations, students are given the responsibilities in a setting in which their performance and recommendations are monitored by the pharmacist, by physicians and other members of the healthcare team.
There is a primary focus in many of the educational programs on chronic disease, conditions like hypercholesterolemia, conditions like diabetes and asthma, so that the pharmacist, the pharmacy students, are prepared to recognize the symptoms. They know what questions to ask to distinguish between one condition and another. They are also strongly encouraged, as I do in my nonprescription drug therapy course, in the discussion of every topic, we identify the types of symptoms and situations and patients that can be appropriately treated with nonprescription drugs. We also identify the circumstances in which the best advice the pharmacist will give is to refer that individual to a physician or to an emergency department.
I don’t think there is a concern about pharmacists overstepping their expertise or the boundaries. Indeed, earlier, a question was raised about liability and that shouldn’t be the primary parameter by which we fulfill responsibilities to the patients, but I think pharmacists are well prepared, I think that the FDA will be discrete in determining what medications they will switch into such a category and that they will have the confidence that pharmacists will be well prepared to provide the appropriate assessment and guidance.
MS. AXELRAD: Thank you.
MR. LUTTER: Is there another response to that same question?
MR. WEBB: Yes. I think it’s fair to say that a pharmacist is not a pharmacist is not a pharmacist, and I think there is – you need to appreciate the substantial changes in curriculum and education that have occurred in the last decade in terms of the movement to the doctor of pharmacy degree as the sole professional degree. And I think, clearly, the current curriculum prepares our new graduates to be very effective in this role. There are pharmacists in practice now who have graduated 15, 20, 25 years ago for whom this set of activities and skills will not necessarily be second nature, but that doesn’t mean that they can’t be prepared and educated to assist in this process.
We believe that – I agree with Dan. I think the greater challenge for the public and for the profession sometimes is getting pharmacists to step up to these responsibilities, not be overanxious to do things for which they are not prepared. So we believe that pharmacists are well prepared to do this and those who seek to do this will be more than prepared to accomplish it.
MR. LUTTER: Other questions from the panel?
MS. MALONEY: I had a question for Dr. Moné with regard to the survey. I think you said 80 percent supported BTC. I would be interested in knowing what the 20 percent, if there were big issues that they were raising, why they were not in support of it.
MR. MONÉ: Actually, the 20 percent that didn’t show support – it was not a question of not showing support for it. They just said that there were so many more questions that they needed to see answered, which is essentially the 25 or so items that were in the notice. They said, well, we need to see what it looks like before we can say that we’re in support of it. So it wasn’t really a rejection of the concept. It probably would be more accurate to say that 100 percent of them were okay with the concept, 80 percent showed significant favorability toward what was already existent in the fact that FDA was talking about doing this initiative.
MR. LUTTER: Thank you, Dr. Moné. Other questions?
MS. MALONEY: I had another question for Dr. Webb. I’m really not that familiar with the category CPT codes, and are these payment codes that you talked about the initial 15 minute consultation for new and established patient? And where I’m going with this is trying to understand more what is happening out there in the real world. Right now, if you go to the pharmacist and pick up a prescription it says, do you want to consult a pharmacist? You can do that and there’s no fee. So I didn’t know if this involves a charge and if you see a difference between people getting consultation or not when there’s a fee involved.
MR. WEBB: I’m not sure we have data to answer that question necessarily. The newly approved CPT codes, which are now category one, go into effect in January of 2008. The CPT editorial panel approved category three temporary codes two and a half years ago for the purpose of evaluating the approach and possibility of using codes such as this for pharmacist intervention with patients. And the data presented to the CPT panel earlier this year from the profession to document more than three million patient encounters using the temporary codes convinced the AMA to move forward with changing the category to category one status.
Clearly, having a CPT code available doesn’t mean payment occurs. Payment policy is a different issue than the availability and the structure of a payment code, that the code system exists and now, particularly for medication therapy management services under Part D as a Medicare benefit, for example, many of the PBMs are beginning to use this code structure for purposes of payment for medication therapy management services under Part D. We’re clearly a generation or two behind medicine in its coding and billing capabilities, but that doesn’t mean the structure shouldn’t be there to accomplish it and we believe it’s the perfect model and venue reflective of the interaction of pharmacists face-to-face with patients.
MR. LUTTER: Thank you. Other questions, Jane?
MS. AXELRAD: Yes. I believe a number of members of the panel discussed the need for substantially increased access to patient records to be able to effectively implement a behind-the-counter system. And I was wondering how the community would address concerns about patient privacy if sensitive health records beyond just the list of the medications that the patient was taking, laboratory results and other parts of the record would become more widely available outside of the controlled system of their physician.
MR. LUTTER: Who would like to volunteer to take that?
MR. HUSSAR: I’ll make one comment. One of my responsibilities is to provide the ethics topics and the confidentiality of the patient information, as well as other information that should remain confidential, is one of the specific topics to which we give a strong emphasis. The pharmacists, to practice optimally, should have access to pertinent information. Indeed, there’s a lot of information available to pharmacists. In fact, sometimes, pharmacists have a more complete medication history for patients than some of the prescribing physicians do, when individuals are seeing an internal medicine physician or a family practitioner and also seeing a number of specialists.
And usually, at least in many situations, those patients will go to the same pharmacies and pharmacists are in a position to identify those problems, but I can assure you that this is a responsibility that pharmacists take very seriously. I guess, in large chain store operations, where databases, information bases are huge, there are added security precautions that would need to be taken. My understanding is that those organizations have done that in a way that does protect patient confidentiality.
MR. LUTTER: Mr. Zellmer, would you like to (ever in it also?
MR. ZELLMER: Yes. Just to add briefly to Dr. Hussar’s comments. You know, in the hospital outpatient pharmacy setting, ambulatory care setting, this commonly happens, where the pharmacist has complete access to the patient’s health record in that institution. And I think it’s well ingrained in our profession to respect that information and to use it for healthcare purposes. So there’s at least one model out there in that environment where this has been going on for a long time and has done quite successfully.
MR. LUTTER: Thank you. Question from Lisa Bernstein?
MS. BERNSTEIN: Many of the pharmacy speakers talked about how it’s important for the record keeping and to document the patient encounter, and then we heard from Dr. Cranston a concern that the pharmacist may not know the full background of the patient and that pharmacists aren’t diagnosticians. I’m just wondering if you could elaborate a little bit about the opportunities that pharmacists have for accessing patient information and medical records or history, and the collaborations that pharmacists might have with doctors to make this more of a partnership to address some of the concerns that Dr. Cranston had.
MR. WEBB: I think access to the patients’ other healthcare records is obviously, very practice site-specific in terms of pharmacy practice sites and the availability, the extremes, but it runs the gamut. In 41 or 42 states, collaborative practice agreements between pharmacists and physicians allow essentially, full information exchange and access back and forth between pharmacists and physician in the collaborative care of patients.
In other settings, that access would have to be more reengineered and structured than it is in those kinds of settings, but clearly, there are practice models where that kind of information and exchange is doable and possible. I would just reemphasize what Dr. Hussar and Mr. Zellmer said. This access to patient medical records issues, in terms of privacy issues, is really – HIPAA is about – treatment approaches under HIPAA essentially require that patient privacy be maintained. And the interaction between physicians and pharmacists in the collaboration and care of patient is basically a HIPAA covered transaction, so I think the rules and regulations in most pharmacy practice settings clearly adhere to those standards.
MR. HUSSAR: There’s no question that there are many situations now in which pharmacists do not have access to as much information as would be desirable for them to practice optimally, but I look at what we’re considering today as an opportunity for the pharmacists to take a more active role and be more accessible with regard to these medications for those individuals who are not served at all by the healthcare system now. I look at this as an opportunity to – I don’t feel this will be one that will have pharmacists and physicians in conflict or working against each other. Indeed, I feel that there are synergies to be achieved.
And one of the comments I had made earlier was that I think that there will be some individuals who will take the initiative to speak with the pharmacist about a product they hear is available from a pharmacist, and that can be the first step in which an individuals gets into the healthcare system, often with the next step being a referral to a physician who can provide the more comprehensive evaluation. But the individuals, the patients, who are well served now by the physicians and other individuals within the healthcare community, these are the individuals who will probably need the least attention, the least follow-up from pharmacists.
MR. LUTTER: Thank you very much. I think I’ve benefited greatly from the comments from this first group of speakers, and please join me in giving them a round of applause for their contributions. (Applause.)
Our next group of speaker consists of six representatives of boards of pharmacies, schools of pharmacy, the Medical Center and the Consumer Healthcare Products Association. And our first speaker in this group will be Dr. Carmen Catizone from the National Association of Boards of Pharmacy.
CARMEN CATIZONE: Good morning, Randy, and others of the FDA and stakeholders. Thank you very much for the opportunity to allow the National Association of Boards of Pharmacy to share our view on the consideration of behind-the-counter availability of drugs. NABP commends the Food and Drug Administration for opening a dialogue on this issue and bringing together key stakeholders.
Since 1993, NABP has advocated for a change in the Food, Drug and Cosmetic Act to establish a new third class of drugs. A resolution adopted by all member boards of NABP called for the establishment of a third class of drugs to be dispensed by a pharmacist and address patient safety issues that occur when some prescription-only drugs are reclassified into over-the-counter status. The resolution explained that drugs classified in this third class would require appropriate patient counseling and monitoring by the pharmacist.
Continuing to push for the a third class of drugs, NABP’s member state boards of pharmacy adopted a similar resolution in 1995 and again emphasized the critical patient need that exists, when drugs with serious side effects or special monitoring requirements, are allowed to move to over-the-counter status and bypass patient counseling and monitoring.
It is NABP’s position that such a class, that is a transitional class of drugs, would provide significant benefits to patients without decreasing access to such medications. A transitional class of drugs would allow the FDA and manufacturers to collect additional data on drugs similar to phase four clinical trials and provide valuable data about the side effects and safety of the drug, what the long-term risk and benefits are and how well the drug works when it’s used more widely than at clinical trials.
A transitional class of drugs could also be used to provide medications to those patients for when a drug is not safe to be dispensed over the counter without supervision, but does not warrant prescription-only status, or requires special monitoring such as routine blood tests. With such a third class in place, drugs that might not be brought to patients because of risk management concerns would now be available to patients who could benefit from them.
In both instances, NABP believes that pharmacists should be central to the transitional class of drugs as part of the effective provision of medication therapy management and patient care. The decision on whether a drug is categorized into the transitional class would rest with the FDA and the manufacturer, based upon the evaluation of critical data. National standards would need to be established, but the dispensing of the medication and delivery of medication therapy management would rest with, and be regulated by, the state boards of pharmacy.
Again, NABP appreciates the opportunity to present our view on this important topic. We’ll be submitting more detailed comments in response to the notice and we offer any assistance we can provide to the FDA as you move through this issue. Thank you.
MR. LUTTER: Thank you. Our next speaker is Dr. William Soller from UCSF School of Pharmacy.
WILLIAM SOLLER: Thank you, Mr. Chairman, members of the panel. I’m Bill Soller. I’m professor at the University of California, San Francisco School of Pharmacy and the executive director for the Center for Consumer Self-Care. And I’m here to provide our support for a behind-the-counter status for selected prescription drugs based on several significant health trends that I’ll talk about, as well as provide recommendations on criteria for BTCness.
In 1974 in the Federal Register, FDA provided comment administrative aspects of the OTC review and stated no controlled studies, rather, adequate research data had been supplied to support a third class of drugs, and that essentially set forth FDA’s policy that a public health need must be demonstrated before such a class would be formed. In that same Federal Register, FDA said that the Food, Drug, Cosmetic Act permits imposition of whatever limitations or restrictions are necessary to assure the safe use of any drug, including restrictions on channels of distribution.
Since that time, most recently in fact, BTC access of nonprescription medicines exists. It focuses mainly on potential risks, managing age restrictions, for example, in Plan B, or managing distribution to avoid misuse, and we think that BTC access should be expanded to enhance potential benefits of intended use. Our reasons for this focus on major public health needs relating to gaps in consumer use and understanding of essential drug information, as well as medication non-adherence.
Many consumers do not read the OTC or Rx drug information when they get their medicines. From two recent surveys, one at Harris Interactive online survey through NCPI, and supported by industry and about 1,000 people and studies that we’ve undertaken at the center, label comprehension studies funded by target pharmacy at about the same number of individuals.
In the Harris Interactive study, when asked what do you read when buying or taking a new OTC medicine the first time, you see the numbers there, all of the label, none of it about 5 percent, translates to a lot of people, side effects, warnings and alcohol interactions. People are not looking at these when they buy their OTC meds. From our studies on target clear Rx system, we ask, do you read the retail drug monograph, which is the information that is stapled to the dispensing bag before using a prescription drug the first time, or do you keep this information?
And this slide showing all study participants, about 45 percent, read or keep Rx drug information 50 percent or less of the time. This is similar across ethnic, socio-economic and age groups, and here, a category of recent interest to FDA mothers of children two to nine-years-old showing about the same pattern of distribution.
Now, in physician communication, when prescribing new medications, (TARN?) looked at audio-taped patient-physician encounters in terms of scripts for new Rx meds in 185 outpatient visits, 44 physicians covering 243 new meds, and what physicians conveyed about drugs that they prescribed, over 75 percent or so on medication name and purpose of meds, but as you get to adverse effects, and how long to take the med, the amount of information that’s conveyed drops off significantly. Physicians fulfill the mean of 3.1 of five expected elements of drug information. So I think we have a national risk communication gap on medicines, OTC drug, Rx drug and health professional counseling information.
The second major trend is medication non-adherence, and I only bring up one study, but this, as I’m sure you know, is an area that has been amply studied and lots and lots of publications in this area. This was a study by Ho et al on the effect of medication non-adherence and hospitalization and mortality among patients with diabetes meletis, a retrospective cohort study from Kaiser, Colorado, in about 11,000 patients, where non-adherence was less than 80 percent of days covered.
And just to give a summary, although they found that the non-adherent patients' category was about 20 to 25 percent, which is about half of what most studies show about 50 percent after a year and a half on therapy, medication non-adherence increases the risk of all caused hospitalization, all caused mortality and is a consistent across hypoglycemics, oral hypoglycemics and the hypertensives and statins.
This is a general phenomenon across a number of disease cases and I’ve listed them in my bibliography to these slides but diabetes, statin therapy and our hypertensives and so on. So along with this significant gap in risk communication, we have a significant gap in medication adherence.
And the third general trend is what is something that is beyond the tipping point. We are an event cascade in relation to pharmacist care services. This was initiated in clinical pharmacy curriculum at UCSF in the ’70s and then with an evolution of the pharmacy education curriculum and the Pharm.D. degree has expanded to all schools. This expansion of community pharmacy services as a result has occurred with medication therapy management, disease state management, screening, preventive care reminders and providing education that is seen routinely in the community setting. And in the box to the right, I just show some of the things that pharmacists are involved in today.
Looking back at one of the early demonstration projects here, the Asheville experiment, which was an employer-based diabetes disease management program by pharmacists, you’ll see the claims data here. And if you look at the blue, which is the lower set of boxes, the insurance claims for hospitalizations and ER visits, you see that the costs go down dramatically; diabetes prescriptions and other prescriptions go up because there’s more adherence and actually, physician visits go up. In fact, the pharmacist is a coach, a facilitator of the health team in the community and this is something that physicians should actually support as opposed to oppose.
The Medicare Modernization Act 2003 really put, I think, a boost in the arm in this particular area. It identified the pharmacist as a provider of medication therapy management, particularly for benefits in this area for seniors under Part D and these are basically medication reviews, doses, side effects, other essential information and adherence counseling, which is what you might expect for a statin that would go behind-the-counter. This is national in scope and must be provided by insurance providers.
So an interim summary here, we think the time is right to consider BTCness to improve the transfer of essential drug information to consumers at the time of drug product selection, to help medication adherence and to help improve disease outcomes.
I’d like to turn to the second topic here on Rx to BTC switch criteria, and in 2002, I published a study called “Rx to OTC Switch” in the Drug Information Journal. It was developed from presentations to the industry by past CDER director Carl Peck and OTC office Director Robert DeLap, and essentially, represented the collective wisdom of over 15 years of Rx to OTC switching, and it was published with the approval of the Consumer Healthcare Products Association Scientific Affairs Committee.
In that, I list 12 questions that provide the conceptual framework for switch, and I think with very limited addition, that the same kind of framing can be put together to really frame the discussion around what kind of research you would like to see, what kind of evidence you would like to see in terms of demonstrating safe and effective BTC status. As an example, can the condition be adequately self-diagnosed with the help of a pharmacist in a retail setting? Can the condition be successfully self-treated under BTC conditions of use?
The yellow font there shows the additions, the white font shows what was published in the study. And then as you get into consumer understanding of expected benefit or other consumer understanding of the use of the product, the general rubric, after pharmacist counseling, these same questions apply as were applied for a well proven program in Rx to OTC switch.
So other criteria. Well, criteria for – (unintelligible) – grey for the OTC review obviously don’t apply here, but we think that the OTC drug facts, labeling requirement, should apply since BTC is essentially a form of nonprescription status. And as to material time and extent, considering the kinds of side effects, the unexpected side effects, that appear within the year and a half to two year post-marketing of a new drug, probably something in the range of three to five years, that is, you need a sufficient material time and extent on the Rx market before you can consider either OTC or BTC.
So main conclusions. The time is right to consider BTC access to nonprescription medicines. Risk communication gap and drug information exist; there’s a gap in medication adherence, and we are in the midst of an event cascade of rapidly growing pharmacist care services throughout the country.
We have the scientific tools for demonstrating BTCness, actual use studies, label comprehensions, selection studies, as well as the studies that are emerging on pharmacist care services that, for example, we’re doing in the Northern California region. And we’re not the only center or school that is engaging in these kinds of demonstration projects.
BTCness should be viewed as a testable hypothesis undertaken on a case-by-case evidence basis, using modest refinements to Rx to OTC switch criteria. We don’t advocate legislation, we don’t advocate wholesale creation of a category and switching of many, many drugs, but to do this in an incremental basis, so that there is experience gained. Each one will likely be very different than the other one if Rx to OTC switch is anything to take lessons from. FDA has the authority to impose limitations on OTCness through BTC access and should expand this approach to selected Rx drugs incrementally. Thank you very much.
MR. LUTTER: Thank you very much for the presentation. Our next speaker is Dr. Maria Marzella Sulli. Welcome.
MS. MARIA MARZELLA SULLI: Good morning. Thank you for this opportunity to address the panel. I’m Dr. Sulli. I’m a faculty member at St. John’s University College of Pharmacy and I’m here today to represent myself and three of my colleagues from the Department of Clinical Pharmacy Practice.
We’re here really to highlight the education of a pharmacist, to highlight the facts that pharmacists are trained to meet this need for behind-the-counter access of certain medications. We’d like to first address the question posed: should there be behind-the-counter availability of certain drug products? And we’d like to say we are in favor of behind-the-counter availability of certain medications. This class should be available without a prescription, only upon discussion with the registered pharmacist or by prescription from a prescriber, as several of the presenters this morning have already discussed.
We do believe the discussion should include an assessment of the patient’s condition for appropriateness of therapy and counseling on the proper use of medication, and I’ll highlight later how pharmacists are trained and prepared to do this. We think the discussion could be patient or pharmacist-initiated, and that a system for compensation for these services needs to be explored in order to ensure adequate participation and quality. We believe this behind-the-counter class should not just serve as a transitional stage for medications moving from Rx to OTC status, but may serve as a permanent status for certain medications where deemed appropriate.
We’d also like to highlight just briefly some of the criteria or standards for a drug to be treated as behind the counter, and many of these have already been presented this morning. Medications with overall safety, but complicated dosing instructions and administration, would likely benefit patients to be in this behind-the-counter class, so that pharmacists would be able to adequately counsel them on appropriate use and this would in turn improve patient safety. Medications with acute need in chronic previously diagnosed conditions and medications where the outcome of the treatment is dependent on prompt administration, and this also has been discussed previously.
We also feel that certain over-the-counter medications may benefit from moving into this behind-the-counter class, over-the-counter medications that have significant drug-drug interactions, drug-food interactions or drug-supplement interactions that again, moving to behind-the-counter would add a layer of patient safety.
Over-the-counter medications with a high incidence of reported abuse or misuse, serious adverse drug events or deaths, and we also support that this class would not simply serve as a class that the pharmacists would need to simply check age, identification and so forth, not be a policing of a commodity, more of a class that would involve clinical interaction between the pharmacist and the patient for use.
We also point out the recent controversies with over-the-counter medications for cough and cold in children, and believe that over-the-counter products currently approved for the use in children under the age of six should be required to have some pharmacist consultation and intervention prior to dispensing these medications to ensure that the parents are capable of administering the medication safely to a child.
Any drug for a condition that does not require extensive physical examination or laboratory monitoring that is not clear waived in many states under collaborative drug therapy management agreements, pharmacists are able to perform clear waive laboratory testing and are trained appropriately to do so. Also current prescription medications for symptomatic treatment of common and previously diagnosed conditions and the examples are there for you.
As I said earlier, we want to focus our presentation on the training because the question number seven under the logistics portion of the document was, would special training be needed for pharmacists to participate in dispensing behind-the-counter medications? We’d like to say that pharmacist graduates are trained and equipped to meet the public’s need for this behind-the-counter class. I’m going to reference the standards for the Pharm.D. program put forth by the Accreditation Council for Pharmacy Education, which is the national agency responsible for the accreditation of professional degree programs in pharmacy.
I want to highlight several standards that I believe reinforce what I’m about to say about pharmacists receiving the training and the education necessary in order to provide this crucial service to the public. ACPE standard number 10 involves development of the curriculum and the delivery and the improvement, continuous quality improvement, of curriculum in colleges of pharmacy. Quoted right out of this standard, the professional portion of the degree program must be a minimum of four academic years or the equivalent, 30 percent of the curriculum of which is dedicated to professional practice experiences.
Standard number 14, which outlines the composition of those practice experiences, states that the pharmacy practice experiences must include direct interaction with the diverse patient population and involve collaboration with healthcare professionals. And as my colleagues before me have stated, we do feel that this behind-the-counter class of medications would only serve to improve communication between pharmacists and other healthcare providers that prescribe medications and maintain patient records. Our pharmacists, during their training, do receive adequate training in order to communicate with other healthcare professionals, and do strongly feel that it is important and necessary in order to provide the best care for patients.
ACPE standard number 12 mandates that graduates of a doctor of pharmacy program be competent to provide patient-centered care by being able to design, implement, monitor and evaluate patient medication use, again, in cooperation with patients, prescribers and other members of the healthcare team. It also states that pharmacists should be competent to promote health, provide, assess and coordinate safe, accurate and time-sensitive medication distribution to improve the therapeutic outcomes of medication use, and pharmacists, of course, we believe, are trained to do so.
I would like to comment here, as the question was brought up earlier regarding training of pharmacists who have not graduated recently under the standards and under the new doctor of pharmacy program that was required as of 2004. Pharmacists in all states require continuing education in order to maintain licensure and there are many certificate programs and credentialing programs available for currently practicing pharmacists who want to expand their knowledge and enhance their skills, and kind of keep up with the times in order to be able to interact with patients and perform these services. So we believe from the educational standpoint, that the current graduates are prepared and the pharmacists out there who would be interested in performing these services have adequate resources in order to gain the training required to do this well.
And just lastly, the expanding roles of the pharmacists that we have seen, since the implementation of these new guidelines, have also been highlighted today, medication therapy management under the Medicare Part D program, pharmacists are now recognized as providers under Medicare. And I think that’s a testament to the training and expertise that pharmacists can provide in terms of medication management.
Collaborative drug therapy agreements, pharmacists providing immunizations, pharmacists participating in the institutional setting on committees such as the Pharmacy and Therapeutics Committee and institutional review boards also highlight how pharmacists are viewed by their colleagues, other healthcare professionals and recognized widely in the healthcare market as the medication experts.
So in conclusion, my colleagues and I support the creation of this behind-the-counter class of medications. We feel it would enhance the current system for the delivery of medications, and believe it would improve the quality and care that patients receive by improving safety, improving communication between pharmacists and other healthcare providers and improving patient satisfaction. Thank you.
MR. LUTTER: Thank you very much, Dr. Sulli. Our next speaker is Dr. Michael Hogue from the Institute for Public Health and Pharmacy.
MICHAEL HOGUE: Good morning. My name is Michael Hogue and I am the assistant director for the Institute for Public Health and Pharmacy, or IPHP. IPHP is a part of the McWhorter School of Pharmacy at Samford University in Birmingham, Alabama, where I hold the appointment of assistant professor of pharmacy practice. I am also the coordinator and primary instructor in our self-care therapeutics course.
In addition to being an academic pharmacist, I also practice clinical pharmacy in an outpatient adult medicine indigent clinic of the Jefferson County Alabama Department of Public Health. The role of our Institute of Public Health and Pharmacy is to study and teach about the relationship between the professions of pharmacy and public health and specifically, how this relationship impacts the health status of our communities.
Thank you for allowing the Institute of Public Health and Pharmacy the opportunity to comment on the proposed creation of a behind-the-counter category of drugs. Our comments are focused on the public health implications of the creation of a BTC category of drugs, and this may be a somewhat unique perspective that you hear today. I am going to focus on what we think are the most central questions that have been asked by the agency, and I have provided a more extensive comment list to you in advance.
The first question was: should there be BTC availability of certain drug products? We support the creation of a BTC category of drugs, but we issue such support with an important caveat. The BTC category, in our view, will improve access by underserved populations to important pharmacotherapy preventative services and treatments, access the poorest and most vulnerable in our population desperately need. However, making products available in a BTC category must be accompanied by the availability of professional pharmacist services to help ensure that patients will be able to use those drugs appropriately.
It may sound strange to suggest that even though a pharmacist must be available to dispense the BTC medicine, that the professional services of the pharmacist might not be available. We believe that this could, in reality, be the case. It is very important to recognize that the creation of a BTC drug category should create substantial changes, could create substantial changes, in the current practice of pharmacy. Of course, the reason to place certain drugs in the BTC category is to require interaction between a pharmacist and a patient for that drug to be dispensed.
However, simply creating a category of drug that requires that interaction does not ensure adequate care. The current economic incentives in community pharmacy practice appear to strongly favor the dispensing portion of pharmacy practice, and hence, may limit the time available for assessing and advising a patient in relation to the dispensing judgment and BTC selection.
A study published in 2002 entitled “Pharmacist Time Requirements for Counseling in an Outpatient Pharmacy,” the authors came to a simple and very straightforward conclusion, and I quote, “Patient counseling in the community pharmacy setting will suffer unless community pharmacies and managed care organizations develop a method for reimbursing pharmacists for this service.”
Thankfully, managed care organizations, employers, Medicare Part D and a few Medicaid agencies are beginning to realize the importance of compensating pharmacists for their medication therapy interventions. As a result, we’re beginning to see some practice changes happen with regard to prescription product interventions, and there’s a higher value being placed on assisting patients with ensuring appropriate medication therapy outcomes.
These remuneration changes are beginning to also change the number of pharmacists who are actively engaging in direct patient care services. Prescription medication misuse is among the greatest public health issues of our time, and we are hopeful that this trend of pharmacists being more engaged in a patient assessment and drug therapy outcome monitoring will continue, as it’s in the best interest of our nation’s health.
Second question that we’re addressing is: what might the impact of BTC be on patient access? Patient access to care is also a major public health issue. Many would say that we have an access to care crisis in this country. Patient access to drugs themselves is a similar but separate issue. The nation’s uninsured population has been estimated at over 40 million individuals. Health disparities among minorities, immigrants, children and the elderly persist, despite what seems to be very good efforts in many communities.
Even though drug therapy often represents the most cost effective disease process intervention, the cost of these life-saving therapies are often out of reach of many in our population. Thus, in our opinion, the real question is two-fold: what might the impact of BTC be on patient access to patient care, and then secondly, what might the impact of BTC be on patient access to pharmaceuticals?
First, from a public health perspective, the most vulnerable in our population tend to have the greatest difficulty with access to healthcare services. The availability and cost of transportation alone severely restrict access to even basic primary care. Faced with limited financial resources, lack of transportation and lack of educational resources, many of our most vulnerable find themselves in their inner city and rural communities with few or no available healthcare resources, except for their local community pharmacist.
Pharmacists are well trained to perform patient interview and limited physical assessment, and help many of our nation’s underserved through recommendation for use of available over-the-counter products. It is for all these reasons that we believe the availability of a broader group of products and a BTC category could greatly enhance the access to care for our most vulnerable citizens.
Secondly, related to access to pharmaceuticals, many of the issues are the same. For many of the 40-million-plus uninsured in our population, access to pharmaceuticals is a choice between putting food on the table or paying rent and having the availability of medicines. The first step in having access to medicines is the ability to afford to be seen by a physician or other provider legally permitted to provide medications. The cost of a visit to one of these professionals can be significant and cost can escalate rapidly with laboratory testing. Sometimes, this is necessary.
However, a BTC category of drugs will not resolve the situation entirely and there will be a need for some compensation of the pharmacists’ services at this time. We do know that data published in the American Pharmacist Association and gathered by the Lewin Group show that pharmacists are reimbursed at a rate of approximately 80 percent of the physician compensation rate for similar time-based services.
So therefore, we believe that while there will be some costs associated with BTC provided services, we believe that these costs will be much more manageable. We also agree with the previous speakers that the average cost of the medication is likely to decrease substantially, as we’ve seen the move of Rx to OTC products have cost reductions as much as 90 percent after coming to the OTC market.
Finally, related to access, perhaps the most extensive data on access to pharmaceutical product exist in the area of vaccines. Access to vaccines in some parts of our country is abysmal at best, particularly for adults. Vaccines represent one of the most cost effective interventions available for prevention of disease and are vital to protection of the health of the entire community, not just the individual who receives the vaccine.
Pharmacists in 46 states have the authority to administer medications including, vaccines, and do so under prescription standing orders with physicians. We would argue, from a public health perspective, that should the FDA decide to create a BTC category of pharmaceuticals, that vaccines should become the very first group of Rx-only products granted the status, so that these life-saving products are more readily available to susceptible patients.
The last thing I will comment on is, what should the criteria or standards be for a drug to be treated as BTC? The public health profession serves, in part, as a social safety network. Issues of safety which affect the health of the population are monitored on the local level by state and county departments of health. Any standards which are created for a BTC category must consider the public health implications of such actions. We believe that at least one of the following two criteria must be met for any drug to be given BTC status.
The first criteria: drugs to treat a condition which can be easily accessed and diagnosed using primarily patient interview with limited physical assessment and only point-of-care laboratory testing. Exampled conditions here could include allergic rhinitis, contact dermatitis, head lice, scabies, otitis media, and hyperlipidemia.
Our second criteria suggestion is drugs to treat or prevent conditions which have the potential to impact the health or well being of the community or a population; for example: vaccines, malaria prophylaxis, antidiarrheal preparations, topical antiinfectives and oral antivirals when used for secondary prophylaxis during influenza outbreaks.
As time is running short, I will move straight to my summary. We believe that the creation of this BTC category is in the best interest and health and welfare of the public. We believe that the category can improve access to both needed pharmaceuticals and to the patient care services of a pharmacist. Today’s doctorally trained pharmacists are fully prepared to deliver the services required to successfully implement this new and very important BTC drug category.
The creation of this category will likely have significant impact on the overall practice of pharmacy and will have impact on employers and insurers. However, we believe these impacts will overall be very positive and again will be in the best interest of the health of the population broadly.
We have one final recommendation to make. We would urge the FDA to carefully word the media-related messaging put forth by the agency, should this category be decided to move forward, and also require manufacturers who have drugs approved into this category to carefully word their promotional advertising and consumer material to emphasize the fact that an assessment by a pharmacist is necessary. We do not want the public to have inappropriate expectations.
Again, thank you for allowing our institute at Samford University to testify at the hearing. I look forward to opportunity to answer your questions.
MR. LUTTER: Thank you very much, Dr. Hogue. Our next speaker is Dr. Eric Brass from the Harbor-UCLA Medical Center.
ERIC BRASS: Thank you. I am Eric Brass, director of the Harbor-UCLA Center for Clinical Pharmacology and professor of medicine at UCLA School of Medicine. I am past chair of the Nonprescription Drugs Advisory Committee and have served as a consultant to industry on issues related to OTC drug development. Expenses for my appearance today have been partially paid by the Consumer Healthcare Products Association.
It is clear that we all share the goal of improving public health by increasing access to safe and effective medicines. It is deciding where the balance lies between imposing barriers designed to protect consumers, versus limiting access to safe and effective medicines that provide the challenge. The factors that influence this balance create a natural tension and vary for each individual drug considered.
I appreciate this opportunity to share my thoughts on when additional barriers to access might be appropriate for nonprescription drugs and how we can continue to make decisions on OTC drug access in an evidence-based way.
I believe it is important to understand where we are today in the evolution of clinical research with respect to moving drugs from prescription to OTC status. As regulators have made explicit the requirement that sponsors demonstrate that consumers themselves manage the condition using only the OTC label, the research community has responded with increasingly sophisticated research tools for assessing consumer behaviors. These include iterative label comprehension testing to develop a label that could be understood by the typical U.S. consumer.
Self-selection and actual use studies are designed to assess consumer behaviors, when they are provided the opportunity to use the proposed OTC drug in an unsupervised setting. These research programs define whether the consumer can use the drug safely and effectively in an unsupervised setting and also define any limitations in consumer decision making with respect to the drugs use.
These specific limitations can then be addressed with supplemental methods, such as non-display package labeling tools or marketing restrictions. Using this approach, we have seen the ability of industry and regulators to use research and making evidence-based, case-specific regulatory decisions.
Data made clear that barriers to access in the marketplace may be substantial, even within the universe of nonprescription drugs. We have seen this in the United States in the response of consumers, to moving pseudo-ephedrine containing drugs to behind-the-counter status.
Data on this transition were recently presented by Steve Johnson of IRI. Prior to being moved behind the counter, pseudo-ephedrine-containing products accounted for 49 percent of sales in the OTC respiratory drug category. However, once pseudo-ephedrine was moved behind the counter in 2004, sales fell rapidly. By March of 2007, sales of pseudo-ephedrine containing products were only approximately 40 percent of their pre-transition sales, despite continued growth in the overall respiratory drug category.
This fall in sales cannot be accounted for by decreased diversion of pseudo-ephedrine containing products. Consumer studies of users of one specific branded pseudo-ephedrine containing product indicated that only 30 percent continued to use this product post-transition to behind-the-counter status. The barrier of behind-the-counter status was sufficient for consumers to disrupt their established normal self-treatment paradigms.
I believe Dr. Shiffman will share with you this afternoon the experience in other countries where behind-the-counter status of nicotine replacement products limited access to these drugs. Also this afternoon, Dr. Mann will share with you how pharmacist-consumer interactions in the U.K. create artificial barriers to how – to accessing statins for consumers interested in lowering the cardiovascular risk and for whom statins were appropriate.
Thus, it is evident to me that the decision to restrict a drug to behind-the-counter status must not be a default, but must be justified on the basis of data demonstrating that it is the optimal strategy to achieve the balance between access and proper use.
What data do we need to make a generalized conclusion that behind-the-counter status is optimal for any drug, much less as a rigid component of a tripartite drug access model? It has always been of interest to me that for prescription drugs, we write drug labels based on research data, and assume that prescribers will use these labels to optimize therapeutic decision making, despite considerable evidence that the label is quite ineffective in modifying prescriber behavior. In contrast, for OTC drugs, we write labels and assume that consumers cannot use the drug until we provide research data establishing that, in fact, they can.
It is unclear to me what standard would be used to assess behind-the-counter access during drug development and regulatory review.
Making the assumption that the U.S. pharmacy environment, the typical U.S. pharmacy environment, will result in an idealized consumer-pharmacist interactions, where the pharmacist precisely follows decision algorithms, is not only without experimental foundation, but also, quite frankly, defies common sense.
Based on what we have seen, a default behind-the-counter status for new prescription to OTC switches will inevitably result in barriers to access. But as we sit here today, we cannot cite any offsetting improvement in outcome in public health. Thus, we have demonstrable cost, both financial, which has been well established this morning, and in terms of decreased access without demonstrable benefit, meaning that some consumers may not have access to new safe and effective OTC drugs, potentially using inferior products in their place.
Having served on the Nonprescription Drugs Advisory Committee, it is easy to visualize the committee retreating to behind-the-counter option as the safe option, and avoiding the perceived risk of endorsing a more expanded access decision, even when the expanded access may improve public health. Thus, in any behind-the-counter consideration, we must ask explicitly what the role of the pharmacist will be, provide data that the proposed pharmacist role can, in fact, be achieved in a typical pharmacy environment and demonstrate the incremental value of the pharmacist over consumer self management.
Addressing these issues will require entirely new research methodologies. How well we can model the behavior and skill sets of the typical U.S. pharmacist working in a typical U.S. pharmacy environment to conclude that any higher order decision-making role can be completed with sufficient quality. For a specific proposed OTC drug, how do we quantify the public health value of a required pharmacist-consumer interaction, as compared with consumer self-management in order to justify the added restriction to access?
I know of no data which supports any conclusion to these questions, nor of validated research models to even address these questions.
As noted, research methodologies to ensure the effectiveness of OTC labels have evolved tremendously over the past 15 years and increasingly support a spectrum of evidence-based drug-specific marketing restrictions. This decisionmaking, based on research data along a spectrum of marketing models, has worked successfully in the current OTC environment, and has the highest potential to ensure that the balance between access and proper consumer use is optimized.
While some form of marketing restriction similar to behind-the-counter status may be the right solution for some drugs, both available data and the law of unintentional consequences suggest that creating three discrete bins of marketing classes will result in many drugs that can be used safely and effectively by consumers, in fact, being made less available to them.
In conclusion, I believe that meeting our goal of improving public health by maximizing consumer access to safe and effective medicines is dependent on evidence-based decision-making. Each potential prescription to OTC switch presents unique challenges and raises unique questions. Clinical research is, and should be, required to inform regulatory decision-making on OTC switches. Our regulatory mechanisms can function best when they use the learnings from this research to create drug-specific approvals across a spectrum of post-approval marketing restrictions.
I thank you for the opportunity to share my thoughts on these important issues.
MR. LUTTER: Thank you very much, Dr. Brass. Our next speaker is Mr. David Spangler from the Consumer Healthcare Products Association.
DAVID SPANGLER: Good morning. I’m David Spangler with the Consumer Healthcare Products Association. We represent manufacturers of OTC medicines and dietary supplements.
OTC access empowers consumers and allows them to take control of their health. It provides them a choice with convenience, and in a competitive environment that keeps cost down. The existing system provides sufficient flexibility to handle specific challenges to specific switches through a range of mechanisms and methods. This might include pharmacists. It could include distribution restrictions. It could include post-approval study commitments or other measures.
Fed by innovations and prescription to OTC switch, the existing system works and it works well. It works well for consumers; it works well for the public health. As a result, we don’t need the law to change to expand access and we don’t need a new class of medicines.
Before we get into the existing two-class system, let’s step back for a moment and talk about some of the things that Dr. Throckmorton addressed earlier, and that’s consumer interest. As you can see on the slide, about three out of four consumers agreed that they prefer to treat conditions themselves, rather than having to go to see a doctor. Roughly three out of five say that in the future, they want to diagnose and treat more of their conditions, rather than going to see a doctor. Another example of this consumer interest, roughly four out of five Americans turn to the Internet for health information.
Now, one way they take action on this interest, just one way, is through the use of OTC medicines. Access to OTC medicines provides an important cost effective, convenient benefit to consumers. Let’s look at three examples around the power of access.
Thanks to the prescription to OTC switch of a number of antihistamines and decongestants through the mid to late 1970s and into the 1980s, we saw a decrease in doctor visits for the common cold of roughly 100,000 a year according to a study done by MIT economist Peter Temin. Dr. Temin also calculated roughly a three quarter billion dollar gain to society, thanks to the switches through this period.
Second example. Medical school dean Dr. Martin Lipsky found a 15 percent decline in doctor visits for vaginitis in the first four years after the switch of these proven safe and effective medicines for this condition. And we should add that the sponsors of these switches conducted studies that found that women were just as good as their doctors in recognizing the recurrence of this condition, recurrence in the OTC indication.
A final example. A number of authors have looked at nicotine replacement therapies. In one study, there was somewhere between 150 to 200 percent increase in their use in the first year following their switch to OTC status. That’s because consumers had access to them. That access results in tens of thousands of new former smokers every year. That’s longer, healthier lives. That’s a $2 billion social benefit every year. Access provides tremendous power to consumers and that’s why we continue to advocate for the switch of safe and effective medicines for direct consumer use.
Now, let’s switch gears. Let’s think about OTC approvals kind of with a blank slate. Every switch has its challenge, but in thinking about those challenges,