Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class
Published: 2009-02-20T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: In the United States, most nonprescription drugs are available over-the-counter (OTC) in pharmacies and other stores. Experts have suggested that drug availability could be increased by establishing an additional class of nonprescription drugs that would be held behind the counter (BTC) but would require the intervention of a pharmacist before being dispensed; a similar class of drugs exists in many other countries. Although the Food and Drug Administration (FDA) has not developed a detailed proposal for a BTC drug class, it held a public meeting in 2007 to explore the public health implications of BTC drug availability. GAO was asked to update its 1995 report, Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated (GAO/PEMD-95-12). Specifically, GAO is reporting on (1) arguments supporting and opposing a U.S. BTC drug class, (2) changes in drug availability in five countries since 1995 and the impact of restricted nonprescription classes on availability, and (3) issues important to the establishment of a BTC drug class. GAO reviewed documents and consulted with pharmaceutical experts. To examine drug availability across countries, GAO studied five countries it had reported on in 1995 (Australia, Italy, the Netherlands, the United Kingdom, and the United States) and determined how 86 drugs available in all five countries were classified in each country.
section_title: What GAO Found
paragraphs: Arguments supporting and opposing a BTC drug class in the United States have been based on public health and health care cost considerations, and reflect general disagreement on the likely consequences of establishing such a class. Proponents of a BTC drug class suggest it would lead to improved public health through increased availability of nonprescription drugs and greater use of pharmacists' expertise. Opponents are concerned that a BTC drug class might become the default for drugs switching from prescription to nonprescription status, thus reducing consumers' access to drugs that would otherwise have become available OTC, and argue that pharmacists might not be able to provide high quality BTC services. Proponents of a BTC drug class point to potentially reduced costs through a decrease in the number of physician visits and a decline in drug prices that might result from switches of drugs from prescription to nonprescription status. However, opponents argue that out-of-pocket costs for many consumers could rise if third-party payers elect not to cover BTC drugs. All five countries GAO studied have increased nonprescription drug availability since 1995 by altering nonprescription classes or reclassifying some drugs into less restrictive classes. Italy and the Netherlands, which previously allowed nonprescription drugs to be sold only at specialized drug outlets, made some or all of these drugs available for OTC sale. Australia, the United Kingdom, and the United States switched certain drugs from more restrictive to less restrictive drug classes, increasing these drugs' availability. However, the impact of restricted nonprescription drug classes on availability is unclear. When we examined the classification of 86 selected drugs in the five countries, we found that the United States required a prescription for more of those drugs than did Australia or the United Kingdom--the study countries using a BTC drug class. However, the United States classified more of the 86 drugs as OTC--the option that provides greatest access to these drugs for consumers--than all four of the other study countries. Pharmacist-, infrastructure-, and cost-related issues would have to be addressed before a BTC drug class could be established in the United States. For example, ensuring that pharmacists provide BTC counseling and that pharmacies have the infrastructure to protect consumer privacy would be important. Issues related to the cost of BTC drugs would also require consideration. For example, the availability of third-party coverage for BTC drugs would affect consumers' out-of-pocket expenditures and pharmacists' compensation for providing BTC services would need to be examined. In commenting on a draft of this report, the Department of Health and Human Services (HHS) agreed that cost-related issues would have to be addressed before implementing a BTC drug class and also provided technical comments. The Department of Veterans Affairs (VA) also reviewed the report and provided technical comments. We have incorporated HHS and VA technical comments as appropriate.

section_title: Letter
paragraphs: The United States has a two-tier system for the classification of drugs:  The United States has a two-tier system for the classification of drugs:  prescription and nonprescription. Prescription drugs can be dispensed  prescription and nonprescription. Prescription drugs can be dispensed  only with written or oral orders (i.e., a prescription) from a licensed  only with written or oral orders (i.e., a prescription) from a licensed  prescriber—such as a doctor, nurse practitioner, or physician’s assistant— prescriber—such as a doctor, nurse practitioner, or physician’s assistant— to a pharmacist or other licensed dispenser. Most nonprescription drugs  to a pharmacist or other licensed dispenser. Most nonprescription drugs  are available for sale over the counter (OTC) by self-service in pharmacies  are available for sale over the counter (OTC) by self-service in pharmacies  and in nonpharmacy outlets such as grocery stores, mass merchandisers,  and in nonpharmacy outlets such as grocery stores, mass merchandisers,  and gas stations. The two-tier system in the United States is distinct from  and gas stations. The two-tier system in the United States is distinct from  other countries that have more or different categories of nonprescription  other countries that have more or different categories of nonprescription  drugs. In other countries, levels of restriction on where and by whom a  drugs. In other countries, levels of restriction on where and by whom a  nonprescription drug can be sold vary. For example, certain  nonprescription drug can be sold vary. For example, certain  nonprescription drugs may be sold only under the supervision of a  nonprescription drugs may be sold only under the supervision of a  pharmacist.  pharmacist.
Pharmacists, academics, and other experts have suggested that an  Pharmacists, academics, and other experts have suggested that an  additional class of nonprescription drugs could increase drug availability,  additional class of nonprescription drugs could increase drug availability,  because more drugs could be made available without the need to obtain a  because more drugs could be made available without the need to obtain a  prescription. In the United States, the Food and Drug Administration  prescription. In the United States, the Food and Drug Administration  (FDA), an agency within the Department of Health and Human Services  (FDA), an agency within the Department of Health and Human Services  (HHS), has authority to approve drugs prior to their marketing, to ensure  (HHS), has authority to approve drugs prior to their marketing, to ensure  that they are safe and effective, and to determine their prescription or  that they are safe and effective, and to determine their prescription or  nonprescription status. Although FDA has not developed a specific  nonprescription status. Although FDA has not developed a specific  proposal, in November 2007, it held a public meeting to explore the public  proposal, in November 2007, it held a public meeting to explore the public  health implications of behind-the-counter (BTC) availability of certain  health implications of behind-the-counter (BTC) availability of certain  drugs. BTC drugs would be held behind a pharmacy counter and available  without a prescription, but dispensed only after intervention by a  pharmacist. The primary purpose of a BTC class would be to increase  access to drugs to promote public health by making drugs available  without a prescription when intervention by a pharmacist or other means  can help ensure the safe and effective use of such drugs. Similar proposals  have been considered in the past and, in 1995, GAO issued a report titled  Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet  to Be Demonstrated (GAO/PEMD-95-12). In that report, we stated that  there was little evidence to support the establishment of a BTC or similar  class of drugs in the United States. The evidence at the time tended to  show that countries with a BTC or similar drug class were not obtaining  major benefits from that class.
In light of the FDA hearing on BTC drugs and the fundamental change that  a BTC drug class would represent in the U.S. drug classification system,  you asked us to update 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.
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-OTC  switches, and the transcript of and docket submissions for the November  2007 FDA meeting on BTC drugs. 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 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 it affects drug availability in three of our study  countries. We reviewed published literature, reports, and agency  documents on drug classification and prescription-to-nonprescription  switches in our study countries. We also interviewed agency officials,  industry representatives, and others knowledgeable about pharmaceutical  practices in the United States and the other study countries. 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. Additionally, we  determined the classification of selected drugs in our study countries. We  chose a sample of drugs using World Self-Medication Industry data on the  classification of more than 200 drugs in 36 countries and identified 86 of  these drugs as available in all five study countries. 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. We then used drug  classification documents published by the regulatory agencies in each of  the study countries and information from agency officials to determine  how each of the 86 drugs was classified in each country. The data in these  reference documents are standard data sources published by each  country’s regulatory authority and were sufficiently reliable for our  purposes.
To identify issues that would be important to the establishment of a BTC  drug class in the United States, we reviewed published literature and  reports. We interviewed officials at FDA, the Centers for Medicare &  Medicaid Services (CMS), the Department of Veterans Affairs (VA), the  Indian Health Service (IHS), pharmacy associations, drug manufacturers,  consumer groups, industry associations, and drug regulatory agencies in  other countries. We also interviewed academics and other experts— including individuals who have testified before FDA on the possible  creation of a BTC drug class in the United States—knowledgeable about  pharmacists’ prescribing authority. Appendix I provides a more detailed  explanation of the scope and methodology for this report. 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.
subsections: section_title: Background
paragraphs: 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.
subsections: section_title: Use of a BTC Drug Class
paragraphs: 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.
section_title: Nonprescription Drug Classes in Other Countries
paragraphs: 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.
section_title: Arguments Made Supporting and Opposing a BTC Drug Class Reflect Disagreement on Its Impact on Health Care and Health Care Costs
paragraphs: 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.
subsections: section_title: Some Proponents of a BTC Drug Class Argue It Will Improve Public Health
paragraphs: 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.
section_title: Some Opponents of a BTC Drug Class Raise Concerns about Potential Harm to Public Health
paragraphs: 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.
section_title: Some Proponents of a BTC Drug Class Argue that It Would Reduce Costs
paragraphs: 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.
section_title: Some Opponents of a BTC Drug Class Cite the Potential for Increased Costs
paragraphs: 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.
section_title: All Study Countries Have Increased Nonprescription Drug Availability, but the Impact of Restricted Nonprescription Drug Classes on Availability Is Unclear
paragraphs: 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.
subsections: section_title: All the Study Countries Have Increased Nonprescription Drug Availability Since 1995 by Changing Drug Classes or Switching Drugs
paragraphs: 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.
section_title: The Impact of Restricted Nonprescription Drug Classes on Drug Availability Is Unclear
paragraphs: 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.
section_title: Pharmacist-, Infrastructure-, and Cost-Related Issues Would Be Important Considerations if a BTC Drug Class Were Established
paragraphs: 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.
subsections: section_title: Issues Related to Pharmacists’ Roles and Responsibilities Would Be Important to Consider if a BTC Drug Class Were Established
paragraphs: 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.
section_title: Infrastructure Issues Would Be Important Considerations in the Establishment of a BTC Drug Class
paragraphs: 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.
section_title: Cost-Related Issues for Drugs, Pharmacists’ Services, and Drug Switches Would Be Important Considerations in Establishing a BTC Drug Class
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
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section_title: Appendix I: Objectives, Scope, and Methodology
subsections: section_title: Objectives
paragraphs: 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.
section_title: Scope and Methodology
paragraphs: 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.
section_title: Appendix II: Description of Drug Classification Systems in the Five Study Countries and the European Union
paragraphs: 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).
subsections: section_title: Australia
paragraphs: 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).
section_title: Italy
paragraphs: 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.
section_title: Netherlands
paragraphs: 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).
section_title: United Kingdom
paragraphs: 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.
section_title: United States
paragraphs: 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.
section_title: European Union
paragraphs: 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.
section_title: Appendix III: Classification of 86 Drugs in Australia, Italy, the Netherlands, the United Kingdom, and the United States
subsections: section_title: Epinephrine (not for asthma) (adrenaline)
paragraphs: Rx  Rx  Legend: Rx = prescription; BTC = behind-the-counter; P = pharmacy; D = drugstore; OTC/P = over- the-counter (pharmacist reuired); OTC = over-the-counter.
section_title: Appendix IV: Comments from the Department of Health and Human Services
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: 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.