lawceA Pharmacist-Only Class of Drugs:
An Idea Whose Time Has Come?

Release Date: December 1, 2012

Expiration Date: December 31, 2014

FACULTY:

Gerald Gianutsos, PhD, JD
Associate Professor of Pharmacology
University of Connecticut School of Pharmacy
Storrs, Connecticut

FACULTY DISCLOSURE STATEMENTS:

Dr. Gianutsos has no actual or potential conflict of interest in relation to this activity.

Postgraduate Healthcare Education, LLC does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced, objective, and scientifically rigorous. Occasionally, authors may express opinions that represent their own viewpoint. Conclusions drawn by participants should be derived from objective analysis of scientific data.

ACCREDITATION STATEMENT:

Pharmacy acpe
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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Credits: 2.0 hours (0.20 ceu)
Type of Activity: Knowledge

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Payment of $6.50 required for exam to be graded.

TARGET AUDIENCE:

This accredited activity is targeted to pharmacists. Estimated time to complete this activity is 120 minutes.

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DISCLAIMER:

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

GOAL:

To provide pharmacists with information on the potential implementation of a third class of drugs (behind-the-counter or pharmacist-only drugs) and to discuss how this may affect pharmacy practice.

OBJECTIVES:

After completing this activity, the participant should be able to:

  1. Review the criteria for classifying drugs as OTC or prescription only.
  2. Identify the drug classes that are most likely to be included in a new third classification.
  3. Recognize the potential for increased counseling and liability.
  4. Explain the role of the FDA in this process and describe the roadblocks to its implementation.
  5. Describe the risks and benefits to pharmacists and patients if such a program is implemented.
  6. Discuss the positions taken by pharmacy and other health care organizations.


ABSTRACT: The FDA is exploring the creation of a third class of drugs (behind-the-counter) to complement prescription and OTC drugs. This controversial measure has the capability of expanding the role of pharmacists in patient care and creating a new niche in the health care system. In one model, these drugs would only be available in a pharmacy under the supervision of a pharmacist. Alternatively, pharmacists could find themselves excluded from the program. This "new paradigm" has the potential to both lead to new opportunities for pharmacists as well as create additional burdens and challenges.

Traditionally, drugs have been available to patients through one of two means: prescription or nonprescription (i.e., OTC). However, there have been numerous efforts to designate a third class of drugs, known as behind-the-counter (BTC) or pharmacist-only drugs. BTC drugs would also be available without a prescription but would differ from OTC drugs that are routinely obtainable in any retail outlet and require no supervision or preapproval. In contrast, it is likely that BTC drugs would be available only within a health care setting, most likely a pharmacy, and would require intervention by a health care professional, most likely a pharmacist, before they could be purchased by the ultimate user. However, several alternative models are also being considered.

Efforts to create a third class of drugs began in the 1970s, and the FDA has considered enacting appropriate regulations at least four times.1 Yet, almost 40 years have elapsed with no visible progress in creating a viable third class of drugs. Nevertheless, the FDA is once again taking up the possibility of establishing what it describes as a "new paradigm," which has the potential of radically changing the pharmacy practice environment.2

This article will review the background for approving drugs in different classifications by the FDA and present some of the advantages and disadvantages to pharmacists and patients if a third class is created. This "new paradigm" has the potential to create new opportunities as well as additional burdens and challenges for pharmacists.

Rx or OTC?

Before considering the possible third class of drugs, it is necessary to first distinguish between the two existing categories of drugs. In 1951, the Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) established a statutory framework to differentiate prescription and nonprescription drugs.3 (It is noteworthy that both sponsors of this congressional amendment had a background in pharmacy.) Prior to 1951, there was no formal distinction between Rx and OTC drugs, and the same drug was often marketed as both an OTC and Rx drug.4 Under the 1951 framework, if a drug's safe use requires the supervision of a health care practitioner, it can only be available by prescription.3

The FDA makes the determination whether a drug will be marketed as Rx-only or OTC at the time of approval of the New Drug Application (NDA). Prior to 1951, the manufacturer made the determination.3 The FDA is given considerable latitude in making its decision. The Durham-Humphrey Amendment also prohibited a drug from being marketed as both an OTC and Rx drug at the same dosage and indication, although there can be both an OTC and Rx version of a drug if they have different dosages or indications.3

There are also differences in the requirements for OTC and Rx labeling. Prior to the Durham-Humphrey Amendment, there was no distinction between Rx and OTC labeling under the FDCA. The amendment changed the nature of the labeling so that today, information on an Rx drug is directed to the prescriber and pharmacist, while information on an OTC drug label is for the benefit of the consumer.3 The OTC label must contain "adequate directions for use,"5 and these must be conspicuous and capable of being understood by the ordinary person under customary conditions of purchase and use.3 In other words, the information on an OTC label must be sufficient so that the consumer can use it appropriately without professional supervision.

In essence, the differentiation between drug classes is based upon potential toxicity and degree of supervision needed to safely use the drug (see TABLE 1 for details).6 Specifically, the FDCA states that a drug must be dispensed by prescription if, ''because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, [it] is not safe for use except under the supervision of a practitioner licensed by law to administer such drug.''7 Collateral measures include the risk if the patient misdiagnoses his or her illness, misinterprets the improvement in symptoms produced by the drug, or delays treatment in reliance on the drug. The toxicity of the drug, while important, is not the only criterion for its classification. A drug may be sold as an OTC medication if such a level of supervision is not required and where the patient may be entrusted to adequately self-diagnose and self-treat.


table 1

The FDA may also change the status of a drug from Rx to OTC or from OTC to Rx after the drug has been marketed. In fact, more than 700 products available as OTC today use ingredients or dosages that were available only by prescription less than 30 years ago.8 While the FDA can initiate the change on its own, almost all Rx-to-OTC changes have been initiated by the manufacturer.8 In one unusual case, the petition for switching loratadine (Claritin) and other Rx antihistamines to OTC status was initiated by a managed care group looking to reduce its reimbursement costs and was enacted without the approval of the manufacturer.9

In order to change a drug from Rx to OTC, the sponsor submits an abbreviated new drug application (ANDA) for an existing drug that is reviewed by the FDA. The review can take several years to complete and may require the sponsor to undertake costly and complicated studies of safety, efficacy, label comprehension, and consumer use.9

The FDA is required to make a two-fold finding before switching a drug product.3 First, the FDA must find that the prescription dispensing requirements are not necessary for the protection of the public health and that the drug is safe and effective if used for self-medication. In other words, it must fulfill the initial criteria for an OTC drug. The second issue for the FDA is whether patients acting alone can achieve the desired medical result without endangering their safety.10 Manufacturers submit data to the FDA showing that the drug is appropriate for self-administration, and they may be required to include studies showing that the labeling can be read, understood, and followed by the consumer without the guidance of a health care provider. The FDA reviews the new data, along with any information known about the drug from its prescription use. Usually, if the drug being submitted is the first in a new category, the FDA seeks a recommendation from a joint advisory committee made up of members of the agency's Nonprescription Drugs Advisory Committee and another committee with expertise in the type of drug being considered. The FDA is not bound by the advisory committee's recommendation but usually follows it.10

An additional benefit to the manufacturer for switching a drug from Rx to OTC is that the Drug Price Competition and Patent Restoration Act of 1984 (more commonly known as the Hatch-Waxman Act) provides for a patent extension of 3 years for drugs switched from prescription to OTC status if the company has been required to provide additional clinical trials for the switch to be evaluated.3 It is not a coincidence that most switches occur around the time the Rx product is about to go off patent.

Some drugs have consistently failed to gain approval for an Rx-to-OTC switch. The statins provide a relevant example. An FDA advisory panel has rejected applications for OTC statins on at least three occasions. In its effort to gain OTC status for lovastatin (Mevacor), Merck & Co. attempted to argue that elevated cholesterol is inadequately managed, increasing the risk of heart disease, and that an OTC statin would provide a valuable alternative for consumers who resort to unproven food and dietary remedies to lower cholesterol.11 Furthermore, they argued that the safety and efficacy of the drugs has been established over many years of use and that they can be safely used by consumers. However, the advisory panel rejected the application, most recently in 2008 by a wide margin, citing concerns about inappropriate self-selection, toxicity concerns (liver and muscle), and the need to monitor liver enzymes. They also noted that OTC statins could have a negative impact on efforts to promote preventive lifestyle measures such as diet and exercise.11

Could the statins then be ideal candidates for a BTC drug? Could intervention by a pharmacist alleviate some of the concerns raised by the advisory panel? It is worth noting that statins have been available without an Rx in the United Kingdom (UK) since 2004.12 Before dispensing the drugs, the pharmacist is expected to carry out cardiovascular risk assessment, although measurements of cholesterol or blood pressure are not required. Instead, pharmacists focus on risk factors like age, smoking, family history, weight, and race and are encouraged to assist patients in determining whether they are eligible for statins. Analysis of data from the UK indicates that few patients taking advantage of OTC accessibility are within the at-risk targeted population.13 However, a survey of pharmacists in the UK found that most felt they needed full access to clinical information (e.g., cholesterol levels), which they did not have, in order to properly assess the sale of a statin, and that those patients inquiring about OTC simvastatin were those least likely to benefit from its use.14 The study also found a very low rate of requests for OTC simvastatin. These lessons from the UK should help guide decisions made in the United States.

While the process and criteria for approving an OTC or Rx drug and for an Rx-to-OTC switch are well established and largely codified into FDA regulations, any procedures and criteria for approving BTC drugs are unknown at this time. Similarly, the role for pharmacists and the criteria that will be used to ensure pharmacist compliance with the FDA's intent are also unknown.

In 1982, the National Association of Retail Druggists (NARD) passed a resolution proposing a significant change in the two-tier system, the establishment of a "pharmacist legend" class of drugs, which could be dispensed only under the supervision of a pharmacist, as an intermediate class for drugs moving from prescription to OTC status.15 Two years later the NARD petitioned the FDA to restrict ibuprofen—which at the time was available only by Rx—to sales by pharmacists. The FDA concluded that such a move was unnecessary since there was no demonstrated public health need.15 In 2003, a citizen's petition was filed requesting that the Nicotrol inhaler become the first "pharmacist only" OTC drug (i.e., BTC). The petition was denied by the FDA on the basis that there was not enough data to support the finding that this unique delivery device was safe and effective for use as a self-medication.16 These decisions illustrate the historical reluctance of the FDA to establish a BTC class. However, they provide little guidance for future directions the FDA may take.

Background

In a report issued in 1995, the U.S. General Accounting Office (now Government Accountability Office [GAO]) reported on the drug distribution system in 10 countries (Australia, Canada, Denmark, France, Germany, Italy, the Netherlands, Sweden, Switzerland, UK) and the U.S. In all of the countries except the U.S., there was an intermediate class of drugs.15 However, the GAO concluded that the "available evidence shows that there are no major benefits from establishing a class of pharmacist-controlled nonprescription drugs" and that "the countries' safeguards to prevent drug misuse and abuse are easily circumvented and pharmacist counseling is infrequent and incomplete."15 The GAO report is frequently cited by medical and other organizations opposed to establishing a BTC class.

The report also commented on a program in the U.S., the former Florida Pharmacist Self-Care Consultant Law, enacted in 1985, which permitted pharmacists to prescribe specific medications without the supervision of a physician. Eventually 42 different drugs were included in the formulary and included oral and otic analgesics, antihistamines, decongestants, topical anti-inflammatories, antifungals, and keratolytic agents. Pharmacists were expected to maintain separate files for prescription drugs dispensed under the program and were to include, at a minimum, the patient's chief complaint, including onset, duration and frequency of the problem, and a medical history.15

However, the GAO report pointed out that pharmacists rarely used this authority and, when they did, they seldom followed the law's record-keeping requirements. The GAO concluded that Florida pharmacists "often gather[ed] incomplete information and spent little time in assessing and responding to their patients' medical complaints."15 Thus, when given the opportunity to demonstrate the value of pharmacist intervention, the experiment was a failure. Florida pharmacists maintain that the infrequent use of BTC drugs is primarily attributable to the availability of OTC drugs that are just as effective.17

So Why Consider a Third Class?

Issues: In the past, in addition to a lack of demonstrated need, the FDA has maintained that it does not have the statutory authority to create a third class of drugs because the Durham-Humphrey Amendment places drugs into only two categories, a position reinforced by the American Medical Association (AMA) in its opposition to creating BTC drugs.12 The FDA has also maintained that restricting the sale of exempt drugs (i.e., nonprescription) to pharmacies would limit competition and access and was not justified unless a significant safety issue could be demonstrated.18 However, the FDA appears to be softening its position,2,12 and the likelihood of a third class becoming a reality is perhaps greater than ever.

Proponents and opponents of a third class of drugs have raised a number of relevant issues that need to be resolved before such a program can become a reality. As a general overview, these are access, costs, and pharmacist responsibility.15,17,19

Access to drugs could increase if a prescription were no longer necessary, since patients could more easily obtain drugs at a local pharmacy instead of being required to first schedule a visit with a physician. This could be particularly relevant on weekends or late at night when finding an open pharmacy is much easier than contacting a physician.

In its most recent comments in considering making fewer drugs Rx-only (although not necessarily pharmacist-only), the FDA stated that "undertreatment of many common diseases or conditions in the United States is a well recognized public health problem" and noted that the requirement to first obtain a prescription may be a contributing factor to the undertreatment.2 The FDA further noted that health outcomes could be improved if there were processes to increase the number of first-time medication users and simplify the continuation of necessary drug therapy (e.g., not requiring a prescription to initiate a drug or, alternatively, requiring an Rx for the initial dispensing but not for refills in order to continue ongoing therapy). The FDA also remarked that freeing physicians from routine tasks associated with prescription refills could free up time to attend to more seriously ill patients and reduce the burdens on the health care system.

However, BTC opponents have argued that a BTC default could reduce accessibility to drugs that would otherwise be eligible for an Rx-to-OTC switch, since OTC drugs can be obtained at any retail outlet. In a direct Rx-to-OTC switch model, more drugs would be available for self-selection by consumers but would not necessitate a pharmacist intervention or a visit to a pharmacy.

Health care costs could decrease if fewer physician visits were required and also if BTC drugs were priced at a level below their corresponding prescription costs, an as-yet untested assumption.19 BTC drugs could also reduce the number of emergency room visits if self-help were more easily accessible. BTC drugs could also reduce the amount of time that physicians spend dealing with more routine illnesses and allow them to focus on more serious conditions. However, out-of-pocket expenses could rise if insurance coverage were denied for BTC drugs, similar to what is the norm for OTC drugs. Compensation to pharmacists, if provided for cognitive services, could offset much of the direct savings; the AMA calls this "cost-shifting" instead of cost savings.20 In its analysis, the Rand organization concluded that any cost savings would likely be on a drug-by-drug basis rather than uniform.19

BTC drugs would also increase the utilization of pharmacists' expertise and potentially provide improvements in public health. However, opponents have argued that pharmacists may not have adequate preparation to provide a suitable level of service and that the infrastructure (e.g., time, reimbursement, facilities) for providing improved service may be lacking. Further consideration of pharmacist-related issues will be addressed below.

Drugs: In addition to asking what potential risks and benefits are associated with a third class of drugs, another relevant question is, Which drugs might be appropriate candidates for such a move? (See TABLE 2.) In earlier discussions, pharmacy organizations, which have largely been supportive of establishing a BTC class, have enumerated criteria including whether the drug is suited to treat a disease requiring limited physical assessment, has easily interpretable laboratory tests, and can be reliably self-diagnosed.21


table 2

The GAO has noted that potential candidates include drugs that treat chronic conditions such as elevated cholesterol, asthma, hypertension, diabetes, osteoporosis, and urinary incontinence.17 Also mentioned are vaccines (most states permit pharmacists to administer flu and other vaccines), epinephrine auto-injectors, and oseltamivir in the event of an influenza pandemic. Classes of drugs currently under consideration by the FDA include drugs for hyperlipidemia, hypertension, migraine, and asthma.2 Others include topical antifungals and drugs for gastrointestinal (GI) conditions and pain.21

Drawing from the experience in Canada where BTC drugs have been available since 1995, some drugs that have achieved BTC status include EpiPens, Polysporin eye or ear drops, some lice shampoos, and Tylenol No. 1 with codeine.22

Pharmacists surveyed in a research study identified the following drugs as most appropriate to be added to a BTC category: prescription prenatal vitamins (1 mg folic acid), triamcinolone cream, silver sulfadiazine cream, mometasone nasal inhalation, fluconazole, epinephrine injection, promethazine, and mebendazole. Medications receiving much less support for dispensing as BTC candidates include sildenafil, drospirenone/ ethinyl estradiol, atorvastatin, and glipizide.23

Models

Several distribution models that resemble a BTC-like program already exist and are discussed below.

Collaborative Practice: Most pharmacists are familiar with collaborative practice arrangements, which are formal agreements between pharmacists and prescribers to facilitate management of individual or groups of patients. The nature of these arrangements varies from state to state and site to site.24 Generally, they grant the pharmacist, in at least some practice settings, the authority to implement or modify drug therapy as described in a written protocol and agreement and may also permit ordering of laboratory tests. These arrangements more closely resemble a limited prescriptive authority applying to drugs that are still legally considered Rx drugs. A BTC proposal would differ in being a less formal and structured arrangement where a pharmacist could provide service to any patient, not just those being managed by a particular physician who is a party to the agreement, and where patients could seek out a larger number of pharmacies, not just those participating in the agreement with their physician.

On the other hand, collaborative practice agreements would generally cover a larger spectrum of drugs and disease states than a BTC program, which would be expected to be more limited in scope. At this time, the responsibilities of the pharmacist under a BTC program are still unresolved, making further comparisons difficult.

Emergency Contraception (Plan B): The dispensing of Plan B, available under a novel, hybrid regulatory framework, comes closer to the concept of a BTC program. The pharmacist serves as a gatekeeper for patients who want to purchase the drug, and a patient who wants it may do so at any pharmacy without a prescription, so long as she (or he) meets certain criteria (e.g., be 17 years of age or older, provide proof of age, etc.).25 The drug is not available from a retail outlet that does not have a licensed pharmacist, and therefore differs from an OTC drug. Likewise, the pharmacist may dispense the drug to any eligible patient without having to be expressly granted that authority by a prescriber. The pharmacist may not dispense the drug to a consumer who does not meet the criteria, except on the presentation of a valid prescription. However, Plan B differs from what might be expected in an OTC program since there is no mandate for counseling nor drug selection among alternatives. Although the final structure of a BTC program is still unknown, the pharmacist, the drug, and/or the patient may all have to meet certain criteria or characteristics to be part of the program, and this may not be uniform for all drugs.

Pseudoephedrine (PSE): PSE is also sold "behind the counter" but is not an example of a true BTC program. The goal with PSE is to limit its diversion into the illicit manufacture of methamphetamine and is not intended to promote a patient-pharmacist conversation that could lead to modified and improved drug therapy, although opportunities for counseling do exist.

Exempt Narcotics: In many states, certain Schedule V controlled drugs are available without a prescription. The characteristics closely resemble PSE sales. The consumer obtains these drugs from a pharmacist who must record information about the sale. The intent is to control sales and reduce abuse, not to improve health outcomes.

Alternative Models: The 2009 GAO report looked at several alternative methods that are used for drug distribution worldwide.17 In addition to the familiar Rx or unrestricted OTC dichotomy, some other models that exist internationally include BTC with pharmacist contact required, BTC without necessity for pharmacist contact, and self-selection only from a retail outlet that has a pharmacist present.

The FDA is also considering a program where the initial dispensing of a drug may require a prescription, but refills could be more liberally handled, citing as examples asthma rescue inhalers and epinephrine for allergies.2 Finally, two different models of BTC drugs are being considered; one is a fixed BTC class and the second is a transitional class where an Rx drug would have an intermediate life as a BTC during which its suitability for general sale could be assessed before potentially becoming a true OTC drug.2

Attitudes Towards BTC

According to testimony by the National Community Pharmacists Association (NCPA), independent pharmacists overwhelmingly support BTC services, citing the results of a member survey that found that 97% of pharmacists felt positively about the prospect of being able to offer a BTC drug after clinical evaluation by and consultation with a pharmacist.26 The NCPA survey also showed strong pharmacist support for involvement in patient screening, laboratory testing, additional counseling, follow-up, and monitoring.26

Surveys by other pharmacists' associations have also indicated support for the idea of BTC drugs, but this is usually contingent upon some form of reimbursement beyond the dispensing fee.22 This has led to some physicians' groups to claim that shoppers in a BTC program will not interact with pharmacists, but rather with pharmacy technicians or other support personnel.22

A recent survey conducted in Ohio showed that pharmacists moderately agreed (5.65 on a 7-point scale) that they would participate in providing BTC medications at their current practice site and also moderately agreed that introducing a BTC category would create more pharmacist-directed patient care that would advance the profession.23 These pharmacists felt that the added amount of time spent with patients would be the greatest barrier to implementation (greater than reimbursement or education), but also agreed that patient counseling should be mandatory before providing any medications in a BTC category. They also said that they would be willing to take the extra time.

Consumer groups have expressed mixed opinions about a BTC program, with some favoring it and others being more skeptical.12 The NCPA cites another survey that shows that roughly two-thirds of consumers 18 years and older support giving a pharmacist the authority to dispense both OTC and Rx drugs.26 The support is even higher in consumers who have children under 18 years of age in their household. Consumers also believe that OTC drugs that were previously available only by prescription are more effective than products that have always been available OTC.4

The Consumer Healthcare Products Association (CHPA), an OTC industry trade group, opposes such a program, citing the GAO reports, and advocates instead for the Rx-to-OTC switch, claiming better access and affordability under a two-tier system.27 Most medical societies also oppose the introduction of a BTC class. The AMA, for example, claims that there is no demonstrated need for a BTC category and that there is the potential to jeopardize patient health, adding that BTC would remove the physician from the vital step of diagnosis and treatment and place it in the hands of pharmacists who are not trained for these activities.28 Likewise, the American Academy of Family Physicians (AAFP), commenting on the most recent FDA proposal, while acknowledging the role of pharmacists in the health care system especially with respect to OTC drugs, nevertheless stated that "allowing the pharmacist authority to dispense medication without consulting with the patient's physician first could seriously compromise the physician's ability to coordinate the care of multiple problems of many patients."29

In addition, the Endocrine Society, commenting on the proposal specifically as it applies to diabetes, said: "Diabetes rarely exists as an isolated medical condition in any patient. Evaluating, assessing and making decisions about the most effective medication regimen in these patients are exceptionally difficult. The ability to make well reasoned and well informed decisions about which medications are most appropriate to use in these patients and how they should be adjusted should rest with the primary care physician or endocrinologist to ensure that patients are optimally managed and serious complications are avoided."30

Issues for the Pharmacist

Clearly, the introduction of a BTC class would create an opportunity for pharmacists to improve public health and to better utilize their knowledge and expertise. However, pharmacists need to consider some of the potential issues that could affect them.

Foremost, pharmacists have to think about the need to devote resources to counseling and to do so without the safety net provided by the patient's prior contact with a prescriber. Pharmacists are currently encouraged to counsel for OTC drugs, and there are certain federal and state mandates for counseling for Rx drugs (e.g., the Omnibus Budget Reconciliation Act of 1990 [OBRA]). However, patients can opt out of Rx counseling and unwilling pharmacists can encourage opting out. A BTC category may afford another opportunity for counseling. The 1995 GAO report noted that most countries did not have a counseling requirement for BTC drugs, despite the fact that many of them restricted sales to an outlet that had a pharmacist present.15 However, the 2009 report noted that their experts recommended that counseling be mandatory.17

It is reasonable to expect that this advice will be followed. If counseling is mandated, it could be more burdensome on the pharmacist than the OBRA mandates, since the pharmacist may be the only provider of information to the patient. The FDA suggests that "potential roles for the pharmacist include assessing whether the consumer has any conditions or other risk factors that would indicate that the drug should not be used, or assisting the consumer in choosing between various drug products."2 Moreover, BTC drugs will likely be more risky drugs than OTC products, with more side effects and lower safety margins. BTC drug users are also likely to be sicker patients, with more complicated medical conditions and more potential interactions than users of OTC drugs. Recall that pharmacists participating in a research survey identified the extra time spent with patients as potentially the biggest barrier to implementation.23 In order to adequately counsel, pharmacists will also need access to medical records and could benefit from improved and simplified diagnostic tools. In fact, the FDA anticipates the development of diagnostic agents suitable for use by the patient or pharmacist,2 while the American Pharmacists Association (APhA) considers access to electronic health records to be "essential" in the new paradigm.31

If pharmacists will be required to counsel, the issue of reimbursement becomes relevant. Pharmacists surveyed were strongly supportive of being paid for professional services when providing BTC medications.23 The APhA believes that appropriate, standardized mechanisms for payment must be developed and that manufacturers might include these costs in the price of the product, although how this would take place is unknown.31 If some pharmacists refuse to take on the added duties inherent in counseling patients, it could reduce the access of patients to these drugs, which is contrary to the intent of a BTC program. The infrastructure for providing counseling and privacy may also have to be modified, and documentation and record-keeping will likely become more onerous.

Counseling also raises concerns about the skills that will be necessary. A survey of pharmacists found that most of them were unsure about their educational preparation and the need for further education for BTC drugs.23 Experts providing advice to the GAO concluded that additional training would be necessary for at least some pharmacists, particularly those educated prior to the current emphasis on patient care, in order for them to appropriately dispense BTC drugs.17 The nature of these programs, if any, is unknown, but credentialing of pharmacists has been considered. For example, one option proposed to the GAO by a retail chain is for each pharmacy to have the discretion to designate only certain pharmacies or pharmacists as BTC sources.17 The GAO has pointed out that this would create consumer confusion and would further reduce consumer access. Moreover, three classes of drugs with different requirements for counseling could further overburden pharmacists.17

Possible solutions include the development of practice algorithms or pathways for screening, assessment, consultation, and referral, which would aid pharmacists working with other clinicians.2,31 The APhA's expectation is that the sponsor of the drug destined for BTC status will help in the initial development of the appropriate pathways and provide educational material.31 Others have noted that educational material developed by manufacturers—similar to those provided for smoking cessation products—may improve patient compliance.4

Another issue of concern to pharmacists is a potential for increased liability.15 If pharmacists are recommending and monitoring a product, the onus for poor outcomes, including side effects and other adverse drug reactions, becomes more serious. For prescription drugs, the pharmacist has traditionally been shielded by the legal duty placed on the physician to warn and monitor the patient, although this protection has gradually been eroding.18 However, if the physician is no longer prescribing the drug, the entire burden and responsibility will logically be placed on the pharmacist.

The GAO report pointed out that consumers would also have to adjust if a BTC program were implemented.17 Consumers would need to understand protocols that might be used for BTC drugs (e.g., a requirement for counseling, need for laboratory tests, etc.) and would also need to understand that a pharmacist could refuse to provide a BTC drug. Finally, pharmacists would also have to overcome resistance from other health practitioners.

One Cautionary Note for Pharmacists: The FDA is considering several new paradigms for implementing increased access to prescription drugs. However, not all of them would involve the pharmacist. The new distribution system could rely on technology rather than the pharmacist. For example, the FDA is "aware" of new technologies such as kiosks or the Internet that could guide a consumer through a self-screening process using an algorithm that would determine whether a particular medication is appropriate and safe for the condition wherein treatment is sought.2 The algorithm could consist of a series of questions that help in the self-diagnosis of a disease state and provide medication warnings and contraindications to consider before deciding to use a specific drug. The FDA has also commented on expanded use of diagnostic tests and agents that may be directly geared to consumers. Clearly these approaches could eliminate or at least substantially limit the need for the pharmacist.

Conclusion

The FDA is once again considering the establishment of a BTC/pharmacist-only drug system. It is still an open question whether a BTC category will become a reality and, if so, how far it will reach and what the pharmacist's role will be, if any. If a BTC category is created, it offers an exceptional opportunity for pharmacists to engage in patient care and create a valuable niche in the health care system. On the other hand, it will increase the burden on pharmacists, and it is a virtual certainty that some will reject the opportunity, while others will embrace the idea only if adequate reimbursement mechanisms are put into place. Pharmacists should watch with great interest to see how this situation unfolds and whether it is indeed a "new paradigm" or whether another decade will elapse without a change in the existing two-tier system.

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