Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class
Released: 2009-03-23T00:00:00

Letter

Background

In the United States, although drugs are classified as prescription or nonprescription at the federal level by FDA, the practice of pharmacy is typically regulated by states. For example, states license pharmacists and enforce pharmacists’ continuing education requirements.

The 1951 Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act provided the statutory basis for the two-tier drug classification system that currently exists in the United States. Since that time, there have been a number of proposals to introduce a third category of drugs in the United States. This category has been called by a number of names, including pharmacist-legend, pharmacist-only, third class of drugs, and BTC. Although there is some variation between proposals, the basic idea is the same: a class of drugs would be established that would be available without a prescription, but only in pharmacies. The BTC idea that FDA sought comment on would require that these drugs be sold only in pharmacies, and that a pharmacist’s intervention with a consumer occur before the drug could be dispensed.

Use of a BTC Drug Class

There are two general views on how a BTC class of drugs would be used in the United States. The first is that BTC would be a permanent class. It would be similar to the current prescription and OTC classes, in that drugs would be placed in the BTC class with no expectation that they would eventually switch to the prescription or OTC class. Drugs in the BTC class would be those determined by FDA to be nonprescription but would require the intervention of a pharmacist. Drugs in the BTC class could come from the current prescription and OTC classes or new drugs could be classified as BTC, although proposals for a BTC drug class generally seek to increase access to medications by switching drugs out of the prescription class.

The second view is that the BTC drug class could function as a transition class for some drugs and a permanent class for others. A drug being switched from prescription to nonprescription would spend time in the transition class, during which the suitability of the drug for OTC status could be assessed. In addition to studies specifically designed for such an assessment, consumer use of the drug as a prescription drug and as a BTC drug could be examined. The argument is that this would provide a better picture of how the drug would be used by the public if it were available as an OTC product. Information that could be gathered while the drug was in the transition class includes types and levels of misuse among the general public, incidents of adverse drug reactions, and interactions with other medications. At some point after the product has been BTC, a decision might be made based on the available data to switch the drug to OTC, return the drug to prescription status, keep the drug in the BTC class for future study, or keep the drug in the BTC class with no expectation that it would eventually be switched to the prescription or OTC class.

FDA has not indicated which drugs might be classified as BTC in the United States. However, among the drugs suggested by some proponents are certain drugs that treat chronic conditions such as high cholesterol, asthma, high blood pressure, diabetes, urinary incontinence, and osteoporosis. Vaccines; the epinephrine auto-injector used in emergency situations following insect bites, stings, or exposure to other allergens; and oseltamivir—which is used to treat influenza and might be effective in the event of an influenza pandemic—have also been suggested as possible BTC products. More generally, drugs that are subject to abuse and drugs that are to be sold only to consumers of a minimum age have been mentioned as possible candidates for a BTC class.

Nonprescription Drug Classes in Other Countries

Figure 1 defines the terms we use to describe the drug classes in the United States and other countries and how the levels of restriction vary among classes based on the conditions under which drugs are sold. As discussed in our previous report, varying levels of restriction on nonprescription drugs already exist in other countries. Among the criteria foreign countries have used for switching a drug from prescription to a less restrictive nonprescription drug class are: (1) the symptoms or circumstances for use of the drug are suitable for self-medication, including self-diagnosis, with the intervention of a pharmacist; and (2) the drug has a low potential for side effects or overdose, and intervention by a pharmacist could minimize these risks. In contrast, nonprescription drugs in the United States generally have these characteristics: (1) their benefits outweigh their risks; (2) consumers can use them for self-diagnosed conditions; (3) they can be adequately labeled for self-medication; and (4) a prescription by a licensed prescriber is not needed for the consumer to safely and effectively use the drug and the conditions or symptoms are generally self-limiting. Appendix II provides details on the drug classification systems in each study country and the European Union (EU).

While Figure 1 indicates how the levels of restriction for prescription and nonprescription drug classes affect drug availability, there are other factors that can also affect availability including cost, patient participation in health decisions, and purchase site convenience. For example, the number of pharmacies in a country affects the availability of BTC drugs. The more pharmacies there are, the greater the availability of BTC drugs and the smaller the difference in availability between BTC and OTC drugs. Also, the distribution of pharmacies can affect availability. Areas without a local pharmacy but with outlets that sell OTC drugs, would be more affected by not having drugs available OTC than would areas with nearby pharmacies.

Arguments Made Supporting and Opposing a BTC Drug Class Reflect Disagreement on Its Impact on Health Care and Health Care Costs

Arguments that have been made supporting and opposing a BTC drug class are generally based on public health or cost considerations and reflect disagreement on the likely consequences of the establishment of such a class. Many of the arguments are concerned with how a BTC drug class might affect consumers’ access to medications, pharmacist involvement in selecting drugs, the costs of drugs, and payment policies.

Some Proponents of a BTC Drug Class Argue It Will Improve Public Health

Some of those who support a BTC drug class, including representatives of pharmacist associations and some academics, suggest that such a class would lead to improved public health through increased availability of nonprescription drugs. Proponents of a BTC drug class argue that such a class would increase access because drugs that might not otherwise be suitable for general OTC use could be available without a prescription. The switching of a drug from prescription to OTC represents a large change in the distribution of the drug, from requiring a prescription to requiring no medical intervention at all. Proponents argue that pharmacists could help bridge this gap if there were a BTC drug class. By providing a new avenue for switches from prescription to nonprescription, a BTC drug class would give consumers access to more drugs that could benefit their health. Pharmacists could counsel consumers on BTC medications and, consequently, some drugs that were unsuitable for OTC availability could be made available as BTC drugs. Proponents argue that this would be particularly important for underserved populations, such as the uninsured, underinsured, or those with limited access to a primary care provider and, thus, to prescription drugs. Moreover, an FDA official told us that many of the drugs that could be switched to OTC under the current two-tier drug classification system have already been reclassified and that a BTC drug class might allow additional drugs to be switched out of prescription status.. The convenience of acquiring BTC drugs at a pharmacy could improve consumer adherence to drug regimens by eliminating the need for a visit to a physician to obtain refill prescriptions. Additionally, FDA has noted that people are now taking a larger role in managing their health. Experts have stated that increased access to drugs through a BTC class could give them even more tools to do so, thus potentially improving their health.

Other arguments in favor of a BTC drug class focus on the expanded role of pharmacists under such a class, suggesting that greater use of pharmacist expertise would improve health outcomes. Proponents of a BTC drug class note that pharmacists are successfully engaging in activities beyond their traditional role of dispensing drugs, such as prescribing drugs under certain circumstances or reviewing individuals’ drug regimens if they participate as providers of medication therapy management (MTM) in programs where they are authorized to perform such reviews. Proponents also point out that pharmacists are well trained in medication therapy, and a BTC drug class would make better use of pharmacists’ knowledge of drug use, drug interactions, and other factors. Additionally, pharmacy schools are becoming more patient focused, integrating training on counseling, physical assessments of patients, and interpretation of lab results into their curricula. Because pharmacists might be more accessible than physicians, better health outcomes could result from the greater consumer interaction with pharmacists brought on by a BTC drug class. During such interactions, pharmacists might also refer individuals with potentially serious medical conditions to a physician; these individuals might not have otherwise entered the health care system. Moreover, proponents of a BTC class note that numerous studies have demonstrated that expanded pharmacist roles in individuals’ care can result in health improvements. They note that the pharmacy practice literature generally supports the ability of community pharmacists to reduce adverse reactions and improve clinical outcomes for conditions such as asthma, diabetes, hypertension, and high cholesterol.

Proponents also argue that a BTC drug class would improve public health by permitting additional data to be obtained that would better indicate when a drug would be appropriate for OTC availability. For example, BTC availability might allow consumer–pharmacist interactions to be studied to determine if consumers really need the pharmacist’s input. Additionally, information might be collected from pharmacists about whether consumers could understand product information and appropriately assess their suitability for a medication without pharmacist prompting. This could affect the labeling if the drug were switched to OTC availability. Depending on a drug’s safety and usage profile in a BTC class, a drug could either remain permanently in the BTC class or subsequently transition to OTC.

Some Opponents of a BTC Drug Class Raise Concerns about Potential Harm to Public Health

Opponents of a BTC drug class, including some academics and representatives of drug manufacturers, raise concerns that such a class could harm public health by decreasing the availability of nonprescription drugs. Overall, opponents believe that the current two-tier drug classification system works well and provides consumers with an appropriate level of drug availability. Opponents of a BTC drug class argue that such a class could become the default option for drugs being switched from prescription status due to the cautious approach of regulators. Prescription drugs that could have switched to OTC might instead be placed into a BTC drug class, resulting in decreased consumer access compared to OTC availability. Drugs might also remain in a BTC drug class even if suitable for OTC use. Concerns have also been raised that current OTC products could be moved into a BTC class, thereby reducing availability. Additionally, depending on how well information is communicated to consumers about a BTC drug class, both in public campaigns and within pharmacies, consumers could be unaware of available BTC drugs. Underserved and rural communities with few or no pharmacies might also experience barriers to accessing BTC drugs, which would only be available through pharmacies.

Opponents also raise concerns about the potential harm that might be done to consumers if pharmacists are not able to provide high-quality, reliable BTC services. Physician association representatives and others have stated that pharmacists lack adequate clinical training to properly diagnose and treat illnesses, skills which might be required when dispensing BTC drugs. Opponents also raise the concern that pharmacists are very busy and might not have enough time to provide individualized counseling to consumers regarding BTC drugs. Additionally, pharmacists might not have access to relevant information (e.g., a complete medical record, laboratory results, and a complete list of medications taken by the individual) necessary to make an optimal and safe BTC drug recommendation. Opponents also argue that, currently, pharmacists counsel infrequently and sometimes incorrectly. Beyond concerns over inadequate service, opponents suggest that a lack of private confidential areas in pharmacies for consumer–pharmacist interactions could discourage individuals from seeking care for sensitive matters.

Some opponents of a BTC drug class assert that adverse health outcomes could result from improper use of BTC drugs. Individuals who use BTC drugs without consulting a physician might treat symptoms but not the underlying cause of the illness, thus delaying appropriate therapy. Readily available BTC drugs could also encourage individuals with chronic conditions to seek pharmaceutical remedies instead of lifestyle changes that could alleviate the conditions. Additionally, an individual’s personal physician might not be aware when a person begins a pharmacist- recommended BTC drug regimen and thus might not be able to monitor the individual appropriately. Experts told us this uncoordinated care could further fragment the provision of health care.

Some Proponents of a BTC Drug Class Argue that It Would Reduce Costs

Proponents of a BTC class have argued that establishment of such a class would likely reduce costs. In the past, the price of a drug has decreased when it was switched from prescription to OTC. Consequently, if a BTC drug class permits increased switching of drugs and pricing follows this pattern, it could reduce costs to consumers and to the overall health care system. Cost savings could also result from a decrease in the number of physicians’ visits. The availability of BTC drugs that previously had prescription status could result in fewer physician office visits for patients seeking prescriptions and, accordingly, fewer co-payments and third-party reimbursements to physicians. This would reduce costs for both consumers and insurers, as well as overall health care system expenditures. The pharmacy practice literature also supports the ability of community pharmacists to provide cost-effective interventions and reduce the cost of drug therapy.

Additionally, because third-party payers do not typically reimburse consumers for nonprescription drugs and thus might not provide coverage for BTC drugs, drug expenditures for third-party payers could decrease if prescription drugs were switched to a BTC class. Cost reductions for insurers could also be realized in the area of compensation for professional services. Although pharmacist associations maintain that pharmacists would need to be compensated for health care services provided under a BTC paradigm, health services provided by pharmacists are less expensive than those provided by physicians—pharmacists are reimbursed at approximately 80 percent of physician rates for similar time- based services.

Some Opponents of a BTC Drug Class Cite the Potential for Increased Costs

Many arguments against a BTC drug class are based on the potential increased costs to individuals, third-party payers, and the overall health care system that such a class might cause. For instance, because insurers do not typically reimburse consumers for OTC drugs and thus might not provide coverage for BTC drugs, out-of-pocket expenses for consumers could increase if prescription drugs were switched to a BTC drug class and if the cost of the BTC product were greater than the previous copay. Opponents of a BTC drug class have argued also that costs could increase as the result of the pharmacy services required for establishing such a class. Compensation for pharmacists providing BTC services could result in greater costs for consumers and third-party payers than if the drugs had been made OTC in the current two-tier system. Furthermore, restricted competition could also increase costs. It has been noted that there would be fewer outlets for BTC drugs than for OTC products because BTC products could not be sold at retail outlets other than pharmacies. This reduced availability could adversely affect retail competition and, as a result, drive up prices.

Additionally, improper use of BTC drugs and the absence of physician consultations in the BTC process could result in expensive adverse health outcomes. For example, without a physician’s diagnosis, a pharmacist might recommend a BTC drug to treat stomach pain. However, potentially serious gastrointestinal problems might underlie this symptom, and delays in obtaining appropriate treatment could have serious and expensive consequences to the consumer and the health care system as a whole.

All Study Countries Have Increased Nonprescription Drug Availability, but the Impact of Restricted Nonprescription Drug Classes on Availability Is Unclear

All five study countries have increased nonprescription drug availability since 1995; however, the impact of restricted nonprescription drug classes on availability is unclear. The five study countries increased drug availability in two ways: by changing nonprescription drug classes or by switching some drugs into less restrictive classes. Italy and the Netherlands established new OTC classes by making some or all nonprescription drugs available for sale at nonpharmacy outlets, while Australia, the United Kingdom, and the United States switched a number of drugs from more restrictive to less restrictive drug classes. When we compared the classification of 86 selected drugs in the five study countries, we found that the impact of restricted nonprescription drug classes on availability is unclear. The United States required a prescription for more of the selected drugs than did the two study countries (Australia and the United Kingdom) with a BTC drug class but also had more of these drugs classified as OTC—the option that provides greatest availability— than the other four study countries.

All the Study Countries Have Increased Nonprescription Drug Availability Since 1995 by Changing Drug Classes or Switching Drugs

Consumers in all five study countries have experienced an increase in nonprescription drug availability compared to 1995 due to changes in drug classes or reclassification of drugs into less restrictive classes. Two countries changed their drug classes. The Netherlands added an OTC class in 2007; previously, all nonprescription drugs in the Netherlands were restricted to pharmacy or drugstore sales. As a result, the Netherlands now has three nonprescription drug classes: pharmacy, drugstore, and OTC. Italy also relaxed nonprescription drug sale restrictions in 2006 by making all nonprescription drugs available in nonpharmacy outlets; previously, nonprescription drugs could be sold only in pharmacies. Italy requires that a pharmacist be on the premises in any outlet that sells nonprescription drugs. As a result, Italy’s single nonprescription drug class has changed from a pharmacy class to an OTC/pharmacist class. The presence of a pharmacist is not a requirement for the OTC class in any of the other countries we examined. Due to the changes made by Italy and the Netherlands, all five of the study countries now have some form of OTC availability of drugs. The other three study countries made no changes to their drug distribution categories since 1995. Australia has three nonprescription drug classes: BTC, pharmacy, and OTC. The United Kingdom has two nonprescription classes: BTC and OTC. The United States has one nonprescription class: OTC. (Table 1 summarizes the drug classes in use in the study countries in 2008. Appendix II provides more details on the drug classification systems in each of the study countries.)

Australia, the United Kingdom, and the United States have increased drug availability since 1995 by switching certain drugs from more restrictive to less restrictive drug classes. For example, the United States switched 31 drugs—including nonsedating antihistamines, orlistat (a weight-loss aid), and levonorgestrel (an emergency contraceptive switched for consumers aged 18 and above)—from prescription to nonprescription status during this period; there were no switches from nonprescription to prescription status. Australia approved more than six times as many drug switches as the United States—193—to less restrictive classes in the same period. Australia does not require drugs to switch in a stepwise manner; for example, 28 percent of switches approved from 1995 to 2008—54 out of 193 switches—bypassed an intermediate class in favor of a less restrictive class (e.g., bypassing BTC when switching from prescription to pharmacy status). During this same period, an additional 67 drug switches resulted in more restrictive classification (e.g., from pharmacy to prescription).

The United Kingdom also switched drugs from more restrictive to less restrictive classes, approving more than 50 switches from prescription to BTC or BTC to OTC between 1995 and 2008. Among the switches approved were two that were the first of their kind for any country: the 2004 switch of a cholesterol-lowering statin—simvastatin—from prescription to BTC status and the 2008 switch of an antibiotic— azithromycin for treatment of chlamydia—to BTC status. In 2002, the United Kingdom began exploring ways to increase the number of drugs available without a prescription. As part of this process, the United Kingdom has changed its approach to nonprescription switches from a focus on switching drugs for short-term conditions to include drugs for chronic conditions. The United Kingdom uses a stepwise process in which drugs leaving prescription status are given BTC status for several years before they are considered for OTC sale. Thus the BTC drug class in the United Kingdom can serve as a transition class.

The Impact of Restricted Nonprescription Drug Classes on Drug Availability Is Unclear

It is unclear whether the presence of restricted nonprescription drug classes increases drug availability. The United States required a prescription for more of the drugs we examined than did the two study countries—Australia and the United Kingdom—using a BTC drug class in addition to other nonprescription drug classes. When we compared the classification status of 86 selected drugs in the five study countries, the United States required a prescription for 42 drugs while Australia and the United Kingdom each required a prescription for 23 of the drugs (see table 2). The United States had slightly more of the selected drugs available without a prescription than the two study countries—Italy and the Netherlands—that did not use a BTC drug class. (See app. III for further details on classification of these 86 drugs in the study countries.)

However, the United States had more of the 86 selected drugs classified as OTC—the option that provides greatest availability of these drugs for consumers—than all other study countries. With the exception of levonorgestrel (an emergency contraceptive), all nonprescription drugs (43 drugs, or 98 percent) were OTC in the United States without any restrictions. In contrast, 54 to 100 percent of nonprescription drugs in the other four study countries had conditions placed on their sale that restricted their availability. These restrictions included limiting sale to pharmacies and requiring pharmacist involvement in the sale (Australia and the United Kingdom), limiting sales to pharmacies and drugstores (the Netherlands), or requiring a pharmacist to be on the premises at any retail outlet selling nonprescription drugs (Italy).

Therefore, an assessment of the restrictiveness of the drug distribution system in the United States compared to the other countries studied depends on the definition of availability. If availability is defined by the number of drugs available for OTC sale, the United States appears to have the least restrictive system, because more of the 86 drugs are available for OTC sale than in any of the other countries. However, if availability is defined by the number of drugs for nonprescription sale regardless of any other restriction on their sale, the United States is more restrictive than Australia and the United Kingdom but slightly less restrictive than Italy and the Netherlands.

The classification of drugs in other countries and the existence of other classes provide little insight into the likely effect of a BTC drug class on nonprescription drug availability in the United States. It is unclear whether establishing a BTC drug class in the United States would allow more drugs to be switched out of the prescription class. We did not find a consistent association between the classification of particular drugs in our sample by a given country and the drug classification system in that country. For example, the United States gave less restrictive classification to some drugs and more restrictive classification to other drugs when compared to the other four study countries. Twelve drugs (14 percent) in the sample had OTC status in the United States but a more restrictive status in all of the other study countries, including two drugs with OTC status in the United States but prescription status in all of the other study countries (see table 3).

Conversely, we found that seven drugs (8 percent) in the sample had prescription status in the United States and nonprescription status in all other study countries (see table 4).

Additionally, we found that seven drugs (8 percent) in the sample had prescription status in the United States, Italy, and the Netherlands but had nonprescription status in Australia and the United Kingdom, the two countries with a BTC drug class (see table 5). Study countries without a BTC drug class, therefore, had reduced availability of a small percentage of drugs when compared with the study countries using a BTC drug class.

Pharmacist-, Infrastructure-, and Cost-Related Issues Would Be Important Considerations if a BTC Drug Class Were Established

Pharmacist-, infrastructure-, and cost-related issues would have to be addressed before a BTC drug class could be established in the United States. Several issues involved with implementing a BTC drug class pertain to the roles and responsibilities of pharmacists, such as defining their BTC dispensing responsibilities and training needs. Infrastructure issues, such as establishing systems for the transfer of patient information and private consultation areas, would also be important if a BTC drug class were established. In addition, cost-related issues, such as the availability of third-party coverage for BTC drugs and counseling, would also be important considerations.

Issues Related to Pharmacists’ Roles and Responsibilities Would Be Important to Consider if a BTC Drug Class Were Established

If the United States were to establish a BTC drug class, it would be important to establish pharmacists’ responsibilities for dispensing BTC drugs. According to FDA, pharmacists’ responsibilities for dispensing BTC drugs could include but are not limited to reviewing or conducting an initial screening for clinical laboratory results, contraindications, or drug interactions; advising consumers on safe drug use; and monitoring for continued safe or effective use. Additionally, a pharmacist could be required to document interventions with consumers when dispensing BTC drugs. Experts told us that dispensing procedures could vary depending on the product and disease. Determining whether a standard set of BTC dispensing requirements would apply to all pharmacies and pharmacists across the country would also be important. Determining whether BTC drugs could be sold through mail-order and Internet pharmacies—where physical observation of the consumer would not be possible—would be important, as well as determining whether pharmacists in these settings would need to fulfill additional dispensing requirements, such as using screening questions designed for remote counseling to ensure appropriate drug use.

Ensuring that pharmacists meet their responsibilities for dispensing BTC drugs, including providing necessary counseling, would be an important issue to resolve. One potential purpose of classifying drugs as BTC is for pharmacists to ensure that consumers meet specified criteria for using these drugs and then to provide education on the proper use of these drugs. Failure to ensure that such counseling occurs would diminish the value of a BTC drug class. In Australia, one of our study countries with a BTC drug class, a 2000 government-sponsored review of the drug classification system found that pharmacist counseling did not occur to the intended extent and called for an enhancement of professional standards for pharmacists. Australian agency officials told us that since the time of this report, pharmacists’ provision of counseling for BTC drugs has improved with the development of counseling standards and clarification of legislative controls which regulate these professional standards. Professional associations have also played a role in monitoring the quality of pharmacist counseling in Australia. A study examining the Quality Care Pharmacy Support Centre’s “mystery shopper” visits—used to monitor and provide feedback on Australian pharmacies’ performance since 2002—found that repeated mystery shopper visits led to notable improvement in pharmacists’ handling of nonprescription drugs.

FDA officials told us that, if a BTC drug class were created in the United States, FDA would need to work with the states to determine the mechanisms through which oversight would be provided. An official from the National Association of Boards of Pharmacy told us that, if a BTC drug class were created, the state boards of pharmacy would need to establish national standards for a number of issues, including the types of data systems, consumer interactions, documentation, and expertise required for a BTC practice. This official noted that it could be challenging for the state boards of pharmacy to provide oversight for a BTC drug class because of resource constraints. Pharmacy practice experts and others have also raised concerns that BTC verbal counseling requirements would need to be more stringent than the counseling requirements associated with the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90). Under OBRA ‘90, consumers are allowed to waive their right to speak with a pharmacist, and according to pharmacy practice experts and others, many consumers do so. These experts told us that verbal counseling for a BTC drug class should be mandatory.

Another consideration in the establishment of a BTC drug class would be determining if additional training would be needed for pharmacists and pharmacy staff and assessing whether all pharmacists and pharmacy staff would need to undergo this training. In pharmacist education today, more emphasis is being placed on patient care and assessment than was the case in earlier years. To fulfill degree requirements, pharmacy students must now earn a Doctor of Pharmacy degree, for which they are required to complete a minimum of 4 academic years, with at least 30 percent of the program spent in clinical training in settings such as community pharmacy, hospital pharmacy, ambulatory care, and acute care general medicine to develop advanced professional practice skills. However, one study found significant variation in courses used to teach patient assessment skills—which have been mentioned as potentially important for pharmacists providing BTC counseling. Further, pharmacists who received their education prior to the current shift toward patient care and assessment might not have the same skills and abilities as recent graduates. Consequently, several experts told us that additional training would be necessary for at least some pharmacists in order for them to appropriately dispense BTC drugs. At VA and IHS, where some pharmacists have expanded dispensing responsibilities and have been authorized to prescribe drugs, credentialing programs are used to assess pharmacists’ competencies before they are granted expanded privileges. Pharmacy associations have indicated that they could design and administer training for a BTC drug class. It would also be necessary to determine whether all pharmacists and pharmacy staff would be required to be trained in BTC-related skills. For example, one retail chain we spoke with suggested that each pharmacy should have the discretion to designate certain pharmacies or pharmacists who would be responsible for dispensing BTC drugs. However, if BTC drugs were only dispensed at certain pharmacies or by BTC-accredited pharmacists, confusion about how to access BTC drugs could result.

To implement a BTC drug class, it would be important to evaluate whether a sufficient pharmacist workforce would be available to make such a program viable. Pharmacy practice experts told us that there is currently a pharmacist shortage that will continue for some time. The Health Resources and Services Administration found that pharmacists have experienced increasing demand for their time in part because of an increase in prescription volume and in part because of the increased amount of time needed to address insurance coverage problems for prescriptions. In addition, experts we interviewed raised the possibility that some pharmacists might not want to take on the additional duties associated with dispensing BTC drugs, which could further reduce the number of pharmacists available to participate. In other countries, pharmacists have been unwilling at times to dispense BTC products. For example, a survey of 1,156 community pharmacists regarding their views and early experiences with BTC simvastatin (a cholesterol-lowering drug) in Great Britain revealed that pharmacists had a number of concerns and infrequently sold simvastatin. Despite feeling well prepared to counsel on BTC simvastatin, pharmacists were still reluctant to dispense the drug without cholesterol or blood pressure testing—which was not required by the drug’s protocol—and therefore infrequently sold it.

Another example of this can be seen in Florida, which in 1985 authorized pharmacists to independently prescribe certain drugs. Experts have stated that despite having this authority, pharmacists in Florida have rarely done so. Florida pharmacists’ rare use of their prescribing authority is primarily attributable to drugs being available without a prescription that are just as effective as those they are allowed to prescribe. Pharmacists were also concerned that they would increase their liability risk if they prescribed and they considered the recordkeeping requirements associated with prescribing a drug to be excessively time consuming. Having an inadequate number of pharmacists willing to carry out BTC functions could reduce the value of such a class.

Communicating pharmacists’ new role to the public could influence demand for products and services and would be an important issue for the implementation and viability of a BTC drug class. Experts have stated that consumers would need to understand protocols for obtaining BTC drugs, such as the necessity of consulting with a pharmacist before obtaining a BTC drug. Consumers would also need to be aware that, after a consultation, the pharmacist could decide that a BTC drug is not appropriate for the consumer or that a physician visit is necessary. If a BTC drug class were established in the United States, consumers might need time to adjust to pharmacists’ new role under such a class. For example, in the United Kingdom, which has had a BTC drug class since 1968, pharmacists have expressed concerns that consumers have a poor understanding of the pharmacist’s role. Researchers have suggested that marketing pharmacists’ professional services could help to create a demand for these services. Officials with the United Kingdom Department of Health consider increasing the public’s awareness of pharmacist services to be a goal. According to these officials, while some consumers are comfortable obtaining health advice through a pharmacy, very few use a pharmacy’s full range of services.

In implementing a BTC drug class, it would be important to determine whether restrictions on the size of a BTC drug class are necessary. Experts raised concerns that if a BTC drug class were too large or if whole categories of drugs switched to BTC at once, it could overwhelm pharmacies because of the time burden involved in dispensing these drugs and the need to train pharmacists and pharmacy staff on new procedures associated with BTC drugs. As a consequence, this situation could create unintended gaps in care by disrupting pharmacies’ regular prescription dispensing duties or interfering with their ability to provide BTC drugs. For instance, pharmacists in the United Kingdom found following different dispensing procedures for multiple drugs to be burdensome. Their ability to make appropriate recommendations was hampered by the time involved in following these procedures. However, some pharmacy officials we spoke with told us that restricting the size of a BTC drug class would not be necessary because pharmacists are accustomed to managing a large number of drugs for various individuals.

Infrastructure Issues Would Be Important Considerations in the Establishment of a BTC Drug Class

An assessment of infrastructure needs would be important to the establishment of a BTC drug class in the United States. Implementing a BTC drug class could entail infrastructure changes for pharmacies so that pharmacists could have better patient information on which to base dispensing decisions. For example, data infrastructure enhancements would be necessary for some pharmacies to meet the possible record- keeping requirements of a BTC drug class and to facilitate communication between pharmacists and physicians. Other countries consider information-sharing systems important for supporting physician– pharmacist communication. For example, in the Netherlands, physicians and pharmacists communicate regularly through electronic prescribing systems, and health officials are developing a system that physicians and pharmacists can use to share patient-specific drug data. Electronic patient health information, such as laboratory results and diagnoses, could also help U.S. pharmacists make better decisions when dispensing BTC drugs. Although commentators note that most state regulations require that a patient drug profile be maintained at the pharmacy and reviewed prior to dispensing a drug, pharmacies currently have limited access to electronic patient health information. For example, a study of Nebraska pharmacists found that 6 percent of surveyed pharmacists had access to electronic patient health information from other providers. Additionally, a 2003 survey of community pharmacies from across the United States found that 54 percent of the respondent pharmacies were using a paper documentation system. Researchers have found several challenges associated with a paper system, all of which could impact implementation of a BTC drug class; these challenges include documentation time, retrieval of patient data, tracking consumer outcomes, and storage. Improving pharmacists’ access to patient information has been shown to improve decision-making. One study found that pharmacists performing drug utilization reviews made better decisions when they had access to more complete patient information on which to base decisions.

The need for private pharmacy consultation areas is another important infrastructure issue that would require consideration if a BTC drug class were implemented. Several groups have identified a need to establish private counseling areas in pharmacies to ensure consumer privacy. Consumers might be reluctant to receive counseling from pharmacists if they have concerns about privacy. A study of Dutch pharmacies indicated that if individuals are aware that a pharmacy has a separate consultation room, they might be more likely to seek a private consultation with a pharmacist. Similarly, researchers have found that enclosed counseling areas in Australian pharmacies increase the likelihood that screening activities and other enhanced pharmacy services occur. One pharmacy practice expert told us that the majority of Australian pharmacies are including private consultation areas when updating their infrastructure. If private consultation rooms were required as part of a BTC drug class, U.S. pharmacies could incur costs to remodel their facilities. Although the National Association of Boards of Pharmacy currently recommends that U.S. pharmacies have a private area for confidential conversations, states have varied in requiring these areas.

Cost-Related Issues for Drugs, Pharmacists’ Services, and Drug Switches Would Be Important Considerations in Establishing a BTC Drug Class

Several cost-related issues would be important for the establishment of a BTC drug class. One consideration would be the availability of third-party coverage of BTC drugs. Pharmacy association and consumer group officials we spoke with told us that the effect of a BTC drug class on consumers’ out-of-pocket drug expenses would depend on the reimbursement decisions of third-party payers such as health insurers, who often pay all or most of the cost of prescription drugs but generally do not pay for OTC products. A 1999 review of insurance plan benefits reported that less than one-third of plans covered selected OTC products and that less than one-third of plans continued to cover products switched from prescription to OTC status. A 2003 study found that although 39 of 43 state Medicaid programs reporting in 2003 covered some OTC drugs when ordered by a prescriber, only 12 provided coverage for OTC drugs that switched from prescription to OTC. HHS officials told us that legislative changes might be necessary to allow for Medicare Part D coverage of BTC drugs. A similar consideration concerns drugs now covered under the Medicaid program. If third-party payers do not reimburse consumers for drugs that were switched from prescription to BTC, consumers’ out-of-pocket expenditures could increase.

The cost of nonreimbursable BTC drugs could also affect the extent to which consumers use BTC drugs. Evidence from other countries suggests that drug costs can be prohibitive to consumers. In the view of pharmacists in Great Britain, the high cost of BTC drugs such as omeprazole, especially relative to prescription or OTC alternatives, might deter consumers from using the drug. Another expensive BTC drug in the United Kingdom is simvastatin, which is intended for use by individuals who do not qualify for National Health Service coverage of statin treatment. However, according to pharmacists, the high cost of the drug could discourage some consumers from using it. Officials with the Medicines Evaluation Board of the Netherlands told us that consumers often oppose switches of drugs from prescription to pharmacy status because they lose insurance coverage when a drug becomes nonprescription. Therefore, in the Netherlands, prescription drugs that are not already covered by insurance are more likely to be considered viable switch candidates for pharmacy class status. A survey of individuals with indigestion or hypertension found that about half of all Italian respondents—regardless of their ability to pay for drugs—had obtained prescriptions for drugs that were available OTC in order to obtain insurance coverage because they considered the OTC products too expensive.

The availability of third-party coverage for BTC counseling could influence pharmacists’ involvement in a BTC drug class and the quality of pharmacists’ services, and third-party coverage for BTC counseling could also increase drug prices. Officials from the American Pharmacists Association have raised concerns about whether it would be financially feasible for pharmacies to carry BTC drugs unless pharmacists were able to bill and be fully paid for the clinical services that might be required for a BTC drug class. In addition to influencing pharmacists’ willingness to participate in a BTC drug class, whether or not pharmacists are compensated might also affect their performance. One study of the factors that increase the prevalence of patient care services in community pharmacies found that paying pharmacists increased their detection of drug-related problems. Another study found that providing pharmacists with a financial incentive was associated with significantly higher documentation levels and higher advanced service levels. A counseling fee could lead to higher drug prices if pharmacist compensation were included in the price of BTC drugs. However, consumers might be willing to pay more for BTC drugs if they consider pharmacist services valuable. A survey of 2,500 adults in the United States found that the majority of respondents were willing to pay an out-of-pocket fee for pharmaceutical care services, even if they were not currently receiving such services. Third-party payers might also be willing to cover pharmacist services. In one diabetes management study, self-insured employers reimbursed pharmacists for consultation services, and based on the clinical improvements and financial savings associated with the diabetes management program, decided to retain the program as a permanent component of their health plan benefit.

Compensation for BTC services might be necessary to offset increased liability. Additional liability could be incurred by pharmacists and pharmacies as a result of their participation in BTC counseling. Pharmacy officials raised the possibility that pharmacists participating in the implementation of a BTC drug class could have a greater exposure to liability because they would dispense drugs without a physician’s order. Concerns about liability might deter pharmacists from dispensing BTC drugs. For instance, such concerns were cited by pharmacists in Florida who were hesitant to use their prescribing authority.

Costs might also be affected by new incentives necessary to encourage drug manufacturers to invest funds in a two-stage switch process (from prescription to BTC and then from BTC to OTC). Clinical trials, including actual use studies, are often conducted to help determine whether a drug could be switched from prescription to OTC, and an FDA official indicated that these trials may also be needed to determine if a product could be switched from prescription to BTC and from BTC to OTC. Currently, drug manufacturers may receive 3 additional years of exclusive marketing rights for drugs switched from prescription to OTC status if the switch requires additional clinical trials. Some FDA officials and manufacturers we spoke with believe it might be necessary to provide manufacturers with exclusive marketing rights for drugs switching from prescription to BTC status and also for BTC-to-OTC switches. It is unclear what period of exclusivity would make drug manufacturers’ investment in clinical studies for prescription-to-BTC and BTC-to-OTC switches worthwhile. However, FDA noted that granting this additional period of market exclusivity could reduce competition.

Agency Comments and Our Evaluation

HHS provided comments on a draft of this report. The comments are reproduced in appendix IV. In its comments HHS agreed that cost-related issues would have to be addressed before implementing a BTC drug class.

HHS recommended that GAO add a discussion regarding the statutory authority to provide reimbursement under Medicare Part D for drugs that would be included in a BTC drug class if it were to be created. Such discussion is beyond the scope of this report, but we noted in the report that the ramifications for Medicare, as well as Medicaid, would need to be considered before establishment of a BTC drug class.

HHS also suggested that a footnote in the report could mislead the reader to believe that the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires pharmacists to review Medicare beneficiaries’ prescription drug regimens as a component of MTM under Medicare Part D. While pharmacists are required to participate in the development of such programs, we added text to the main body of the report to clarify that MMA does not require that pharmacists furnish the services provided in MTM programs but also does not prohibit them from doing so.

HHS stated that while MMA required Part D sponsors to implement MTM programs, the Part D program does not establish any payment schedules for either physicians or pharmacists performing MTM. HHS was concerned that a footnote in the report might be read to mean that MMA specified such a payment schedule. We have revised the text to clarify that MMA does not specify a payment schedule but that CMS often uses a rate that is 80 percent of the physician rate to determine their payments under Medicare.

In addition, HHS and VA provided technical comments on the report draft, which we have incorporated as appropriate.

As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies to the Secretary of Health and Human Services, the Commissioner of the Food and Drug Administration, committees, and others. The report also will be available at no charge on the GAO’s Web site at http://www.gao.gov.

If you or your staff have questions about this report, please contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made major contributions to this report are listed in appendix V.

Appendix I: Objectives, Scope, and Methodology

Objectives

In light of the November 2007 Food and Drug Administration (FDA) public meeting to explore the public health implications of behind-the-counter (BTC) availability of certain drugs in the United States and the fundamental change that BTC availability would represent in the U.S. drug classification system, we are updating information we first presented in our 1995 report. Specifically, we are reporting on (1) the arguments that have been made supporting and opposing the creation of a BTC drug class in the United States; (2) changes in drug availability in our five study countries since 1995 and the impact of restricted nonprescription drug classes on drug availability; and (3) issues that would be important to the establishment of a BTC drug class.

Scope and Methodology

To describe the arguments that have been made supporting and opposing a BTC drug class in the United States, we reviewed published literature, reports, and meeting minutes of FDA hearings on prescription-to-over-the- counter (OTC) switches, and the transcript of and docket submissions for the November 2007 FDA meeting on BTC drug availability. We interviewed officials at FDA, pharmacy associations, drug manufacturers, consumer groups, and industry associations in the United States. We also interviewed academics and other officials knowledgeable about pharmaceutical practice.

To determine the impact of restricted nonprescription drug classes on drug availability, we interviewed experts to ask them to help us identify countries that had evaluated drug classification in their countries since our 1995 report. Based on this information, we selected 5 of the 11 countries covered in our previous report. We also examined drug classification in the European Union (EU) because these factors affect drug availability in three of our study countries. We reviewed published literature, reports, and agency documents on drug classification and prescription-to-nonprescription switches. We also interviewed agency officials, industry representatives, and others knowledgeable about pharmaceutical practices and the relevant laws and regulations in our study countries. Although some countries—including the United States— place additional restrictions on certain prescription drugs, a complete analysis of prescription drug classification was beyond the scope of this report. For our analysis, all prescription drugs were placed in the same class. We examined changes since 1995 in the drug classification systems in two study countries (Italy and the Netherlands) that changed the number or type of nonprescription drug classes in use. We also determined the number of drugs switched from one drug class to another (e.g., prescription to BTC) between 1995 and 2008 for the three study countries—Australia, the United Kingdom, and the United States—that maintained the same number and type of nonprescription drug classes during that time. We examined relevant documents and interviewed knowledgeable officials in those countries. We counted the first switch of a particular drug (e.g., ibuprofen) from one drug class to another that occurred after January 1, 1995, but did not count subsequent switches of additional products containing the same drug between the same two drug classes (except in the case of different nicotine dosage forms such as gum and patches) in order to achieve consistency with the World Self- Medication Industry (WSMI) data discussed below. We also did not count switches that changed only the allowable dosage, pack size, or indications for a drug that had previously been switched. In some cases, a switch in one country may have involved a drug that was not approved for use in one of the other countries or was not subject to regulation as a drug in another country.

Additionally, we determined the classification of selected drugs in the United States and the other study countries. We selected a sample of drugs using the WSMI databases that describe the classification status— prescription or nonprescription—of more than 200 drugs in 36 countries. We used the February 1, 2007, tables; these were the most recent tables available at the time we were conducting our study. We excluded from the list any drugs listed as “not registered” or with a blank entry for Australia, the Netherlands, the United Kingdom, or the United States; a sample of 110 drugs resulted. We examined the survey format used to collect information on drug classification and response rates from the most recent survey, and determined that the data were sufficiently reliable for our purposes. After drawing the initial sample from the WSMI tables, we added Italy to our scope. We then determined the classification status of the sample drugs in each of the study countries using agency information including information from knowledgeable agency officials and an examination of the Standard for the Uniform Scheduling of Drugs and Poisons No. 22 (Australia); the Prontuario Farmaceutico Nazionale and the Elenco indicativo dei farmaci SOP e OTC in commercio con prezzo in vigore al 31/12/2006 ai sensi del comma 802 dell’art. 1 Legge 27 dicembre 2006, n. 296 (Italy); the Medicines Evaluation Board Database Human Medicines (Netherlands); List A: Consolidated list of substances which are present in prescription only medicines (POM), with exemptions for pharmacy sale or supply (P), List B: Consolidated list of substances which are present in authorised medicines for general sale, and List C: Consolidated list of substances which are present in authorised products which have been reclassified since 1 April 2002 (United Kingdom); the list of Approved Drug Products with Therapeutic Equivalence Evaluations, 28th Edition (i.e., the Orange Book) (United States); and other agency documents. The data in these reference documents are standard data sources published by each country’s regulatory authority and were sufficiently reliable for our purposes. We found that 24 of the 110 drugs in our initial sample were not approved in one or more of the five study countries and eliminated these drugs from our sample, resulting in a final sample of 86 drugs. We then compared the classification of these drugs across the five study countries in order to determine the least restrictive class to which each drug was assigned regardless of pack size, dosage, or combination ingredients.

To identify issues that would be important to the establishment of a BTC drug class in the United States, we interviewed officials at FDA, the Centers for Medicare & Medicaid Services (CMS), the Department of Veterans Affairs (VA), the Indian Health Service (IHS), pharmacist associations, drug manufacturers, consumer groups, and industry associations. We interviewed academics and other experts knowledgeable about pharmacists’ prescribing authority, including individuals who have testified to FDA on the possible creation of a BTC drug class in the United States. We also interviewed agency officials, industry representatives, pharmacist association representatives, and others knowledgeable about pharmacy practices in our other study countries. We reviewed reports and the transcript of and docket submissions for the November 2007 FDA meeting on BTC drugs. We also reviewed published, peer-reviewed pharmacy practice literature, focusing on articles published since our 1995 report and relating to the United States or our other study countries. For this literature review, we searched 67 databases, including International Pharmaceutical Abstracts, EMBASE, Pharmaceutical News Index, Gale Group Health & Wellness Database, Pharm-Line, Science Citation Index, and MEDLINE. Key search terms used were pharmacy practice, pharmacist counseling, pharmacist intervention, pharmacist prescribing authority, pharmaceutical care, collaborative practice, medication therapy management, drug classification, and drug reclassification. We also reviewed literature cited in these studies and studies recommended to us by those we interviewed.

We conducted our work from March 2008 through February 2009 in accordance with all sections of GAO’s quality assurance framework that are relevant to our objectives. The framework requires that we plan and perform the engagement to obtain sufficient and appropriate evidence to meet our stated objectives and to discuss any limitations in our work. We believe that the information and data obtained, and the analysis conducted, provide a reasonable basis for any findings and conclusions.

Appendix II: Description of Drug Classification Systems in the Five Study Countries and the European Union

In this appendix, we describe the drug classification systems in our five study countries—Australia, Italy, the Netherlands, the United Kingdom, and the United States. We also describe drug classification in the EU because it affects drug availability in three of our study countries. Although the terms used for different drug classes are included for each country, a standardized set of terminology is also used to facilitate comparisons (see fig. 2).

Australia

The Therapeutic Goods Administration within the Department of Health and Ageing is responsible for the evaluation and approval of new drugs in Australia. The National Drugs and Poisons Schedule Committee makes recommendations on the appropriate classification of drugs and is also responsible for all decisions to switch a drug from one class to another. Generally, the committee requires that a drug be marketed for 2 years before it will consider allowing it to move to a less restrictive classification; applications that do not meet this requirement may be considered when sufficient evidence is presented. While each state or territory has the authority to determine drug classification independently, all states and territories agreed in 2005 to adopt the national scheduling committee’s decisions in full in order to reduce barriers to commerce in Australia.

Australia has a complex, multilevel classification system for drugs that includes Schedule 2 (equivalent to pharmacy), Schedule 3 (equivalent to BTC), Schedule 4 (equivalent to prescription), Schedules 5 and 6 (certain essential oils for human therapeutic use, as well as household and agricultural chemicals); available without a prescription at nonpharmacy outlets, and Schedule 8 (controlled substances for which restrictions on availability are necessary to reduce abuse, misuse, or dependence; e.g., opioids and amphetamines).

Additionally, if a substance does not appear in a schedule, it is referred to as unscheduled; unscheduled drugs can be supplied to the public from any retail outlet (i.e., these are OTC drugs). Schedule 1 (formerly containing a number of toxic volatile oils) is not currently in use; Schedule 7 contains dangerous agricultural and industrial poisons; and Schedule 9 contains substances whose manufacture, possession, sale, or use is prohibited except under specific circumstances (e.g., heroin and cannabis).

Italy

The Italian Pharmaceutical Agency (l’Agenzia Italiana del farmaco), an autonomous agency under the oversight of the Ministry of Health, authorizes the marketing of drugs in Italy. The agency is assisted by the Scientific and Technical Committee which evaluates and issues opinions on marketing applications. Italy currently has the following drug classes: nonprescription.

All nonprescription drugs in Italy are available for sale in nonpharmacy outlets such as supermarkets as long as a pharmacist is on the premises. The requirement that a pharmacist be present wherever nonprescription drugs are sold means that nonprescription drugs in Italy are in an OTC/pharmacist class. However, Italian officials are evaluating the possibility of making small packs of some drugs available in nonpharmacy outlets without the presence of a pharmacist.

The agency is also responsible for the decision to switch drugs from one classification to another. Switches from prescription to nonprescription status are generally initiated by the manufacturer; switches from nonprescription to prescription status are much less frequent. Drugs can also be switched from prescription to more restrictive classification on rare occasions for safety reasons.

Netherlands

The Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) is responsible for drug approval and classification in the Netherlands. The Medicines Evaluation Board is also responsible for approving requests to switch a drug; requests for OTC classification must be initiated by the company holding the marketing authorization.

The drug classification system in the Netherlands includes four categories: pharmacy only (equivalent to pharmacy), pharmacy and drugstore (equivalent to drugstore), and general sale (equivalent to OTC).

The last three categories are all nonprescription and differ primarily in the locations at which the drugs are available for sale. OTC classification in the Netherlands is based, in part, on a determination of public benefit and the risk–benefit profile of the drug. The drugstore class is the default class for all nonprescription drugs that do not meet the criteria for pharmacy or OTC sale. In the Netherlands, the distinction between drugstore and OTC classification is often based on the dosage or pack size; large pack sizes or higher dosages of a drug might be restricted to pharmacies and drugstores even when smaller pack sizes or lower dosages are available for OTC sale. The pharmacy class in the Netherlands is reserved for drugs requiring interaction with pharmacy staff although not necessarily a pharmacist; agency officials told us that they do not expect to place many drugs into this class. At the time of our analysis, six drugs were assigned to the pharmacy class: domperidone (to suppress nausea), orlistat (weight loss aid), aliskiren (treatment of hypertension), clotrimazole (antifungal agent), hexamidine, and dextromethorphan (cough suppressant).

United Kingdom

The Medicines and Healthcare products Regulatory Agency (MHRA) within the Department of Health is responsible for drug approval and classification in the United Kingdom. The United Kingdom continues to use the three-tier drug classification system that was in place in 1995. This system includes prescription only (equivalent to prescription), pharmacy (equivalent to BTC), and general sale list (equivalent to OTC).

The presumption under law is that all drugs are restricted to the BTC drug class unless they meet the criteria for prescription or OTC status.

MHRA encourages wider availability of drugs as soon as there is adequate evidence of safety in use. Manufacturers or other interested parties can initiate switches, which proceed in a stepwise manner (prescription to BTC, then BTC to OTC). Experience gained at one level is used to inform the decision to switch the drug to the next level. For example, MHRA guidelines indicate that substances suitable for OTC classification will have been in widespread use in BTC products for many years. Switching to more restrictive classes can also occur when warranted; this was done for large pack sizes of paracetamol in 1998 in an attempt to reduce adverse events associated with this drug.

United States

In the United States, FDA has authority to approve drugs before they are marketed, to ensure that they are safe and effective, and to determine whether they will be available only by prescription. The United States uses a two-class drug system—prescription and nonprescription—established by the 1951 Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act. Prescription drugs can be dispensed only with written or oral orders (i.e., a prescription) from a licensed prescriber—such as a doctor, nurse practitioner, or physician’s assistant—to a pharmacist or other licensed dispenser, while nonprescription drugs do not require a prescription. Although most nonprescription drugs in the United States are publicly available without any restrictions, a few are stored behind the counter due to refrigeration requirements (e.g., insulin), to monitor quantity of purchase (e.g., pseudoephedrine), or are restricted to pharmacy sale in order to monitor consumer age (e.g., levonorgestrel). Nonprescription drugs are often referred to in the United States as OTC drugs.

Between 1995 and 2007, FDA assigned 99.7 percent (1233 out of 1237) of newly approved drugs to the prescription class, with four new drugs—a topical herpes simplex treatment, a sunscreen product, a nicotine lozenge, and a product to block contact with poison ivy—classified as nonprescription. Drugs can be switched from prescription to OTC status in a number of ways, including through rulemaking or submission of a supplemental new drug application to FDA by the sponsor. In making switch decisions, FDA may seek advice from the Nonprescription Drugs Advisory Committee, often in conjunction with an appropriate specialty committee (e.g., the Pediatric Advisory Committee or the Gastrointestinal Drugs Advisory Committee). Although not bound by the advisory committee’s advice, FDA follows the committee’s recommendation most of the time.

European Union

The Pharmaceuticals Unit of the European Commission Directorate General for Enterprise and Industry is responsible for approving new drugs submitted for marketing throughout the EU, and the European Medicines Agency makes a recommendation on whether the new drug should receive prescription or nonprescription status. The EU leaves to each member state the decision on whether to use subcategories within the prescription and nonprescription classes. Pharmacy experts told us that European countries have a long tradition of restricting drug sales to pharmacies and that about 60 percent of EU countries do not have an OTC drug class.

There are four primary methods to receive marketing approval for a drug in the EU. These include national authorization procedures that allow a drug to be marketed in a specific country based on an individual application and for which the classification decision is made by the appropriate national authority, plus three methods that are handled at the EU level: The centralized approval procedure allows applicants to market an approved product throughout the EU with a single application.

The mutual recognition procedure can be used to request that a drug approval from one EU country be recognized as valid in one or more other EU countries.

The decentralized procedure allows a company to apply for simultaneous approval in multiple EU countries for a drug that is not yet approved in any EU country.

Centralized approval is required for certain categories of drugs, including all drugs developed through biotechnology; drugs for the treatment of certain diseases, including acquired immunodeficiency syndrome (AIDS), cancer, neurodegenerative diseases, diabetes, and autoimmune diseases; and orphan drugs. Although most drugs currently on the market in the EU were originally approved through national authorization procedures prior to the development of a centralized approval process, about 95 percent of new drugs brought to market are now approved through the centralized procedures. The first-ever application for the centralized switch of a drug (orlistat) from prescription to nonprescription status, which will make orlistat available without a prescription in all EU countries, was recently approved. Orlistat was granted centralized approval as a prescription drug in 1998.

Appendix III: Classification of 86 Drugs in Australia, Italy, the Netherlands, the United Kingdom, and the United States

Epinephrine (not for asthma) (adrenaline)

Rx Rx Legend: Rx = prescription; BTC = behind-the-counter; P = pharmacy; D = drugstore; OTC/P = over- the-counter (pharmacist reuired); OTC = over-the-counter.

Appendix IV: Comments from the Department of Health and Human Services

Appendix V: GAO Contact and Staff Acknowledgments

Acknowledgments

In addition to the contact above, Thomas Conahan, Assistant Director; Robert Copeland; Cathy Hamann; Karen Howard; Kristen Jones; Marisa Lee; and Julian Klazkin made key contributions to this report.