In the United States, there are essentially two categories of drugs for distribution: prescription and nonprescription. Nonprescription drugs are often referred to as over-the-counter (OTC) medications (the terms are used interchangeably in this report). The term “prescription” has several meanings but generally refers to the order of a physician to a pharmacist for the delivery of certain medications to a patient. A prescription drug may be dispensed to a patient only on the basis of such an order. Nonprescription drugs are available for general sale without a prescription by self-service in pharmacies and in nonpharmacy outlets such as grocery stores, mass merchandisers, gas stations, and restaurants. The principal factors used to determine the prescription or nonprescription status of drugs are the margin of safety, method of use and collateral measures necessary to use, benefit-to-risk ratio, and adequacy of labeling for self-medication. Nonprescription drug sales were over $13 billion in 1992 and may reach $18 billion by the end of 1995 or 1996 (Covington, 1993, p. xxv). The importance of these medicines is growing, partly as a result of the reclassification of some commonly used drugs from prescription to nonprescription status. The two-tier system in the United States is unusual. Other countries typically have either more or different categories. There can be limitations on where and by whom a nonprescription drug can be sold. In some countries, the sale of some or all nonprescription drugs is restricted to pharmacies. Additionally, in some countries, certain nonprescription products have to be dispensed personally by a pharmacist. The 1951 Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act of 1938 provided the statutory basis for the two-tier drug classification system 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. These proposals have been called by a number of names, including pharmacist-legend, pharmacist-only, third class of drugs, and transition class. Although there is some variation between them, the basic idea is the same: a class of drugs would be established that would be available only in pharmacies but no prescription would be needed. One variation is that the pharmacist would have to be personally involved in the sale of a drug in this class; a sales clerk could not sell the drug without the permission of the pharmacist. (For additional information on the history of this issue in the United States, see appendix I.) There are two general views on how an additional class of drugs would be used in the United States. The first, and the one advocated in the past by various pharmacist organizations such as the American Pharmaceutical Association (APhA) and the California Pharmacists Association, sees it as a permanent class. It would be similar to the current classes in that drugs would be placed in the class with no expectation that they would eventually be moved to the prescription or nonprescription class. Drugs in the new class would be thought not to be appropriate for use without some supervision by a health professional but a physician’s oversight would not be necessary. Drugs in this middle class could come from either the prescription or nonprescription classes, although it is generally believed that they should come from the prescription class. Opponents of this proposal have included the Nonprescription Drug Manufacturers Association (NDMA) and the American Medical Association (AMA). The second, advocated first in 1982 by the National Association of Retail Druggists (NARD) and currently supported by such groups as APhA and the National Consumers League, sees the intermediate class as a transition class. A drug that was being switched from prescription to nonprescription status would spend a period of time in the transition class, during which the suitability of the drug for general sale could be assessed. The assessment could be based not only on experiences with the drug as a prescription product (as is currently done) but also on experiences with the drug in the transition class, where it would not be limited to prescription sale. The argument is that this would give a better picture of how the drug would be used if it were available for general sale (that is, without a prescription and outside of pharmacies). 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 the end of a specified period, the Food and Drug Administration (FDA) would decide to switch the drug to the general sale class, return the drug to prescription status, or keep the drug in the transition class for further study. This proposal has also been opposed by, among others, NDMA and AMA. The effect of an intermediate class of drugs in the United States would depend on whether the drugs in it would come from the prescription or general sale class. Figure 1.1 illustrates the several ways an intermediate drug class might function in the United States. Arguments for and against an intermediate class of drugs fall into two general (but sometimes related) categories: health and economic. Table 1.1 lists some of the arguments that have been put forth in support of and opposition to an intermediate class of drugs. Most of the arguments are relevant for both a fixed and a transition class. The principal difference between a fixed and a transition class is not the benefits and costs that would ensue but their goals. The goal of a transition class in the United States would be to facilitate the movement of drugs into the general sale category. The goal of a fixed class would be to place drugs permanently in the class. Many of the arguments for an intermediate class of drugs suggest that the quality of health care would improve if pharmacists’ involvement were greater. Proponents such as APhA argue that pharmacists are well trained in pharmacology and that their expertise is underused. They could play an important role in improving drug use. It is argued further that making use of this expertise is especially important for recently switched drugs whose potential for widespread abuse and toxicity is great. In the case of a transition class, Penna (1985) writes that pharmacists would be in a position to aid FDA in its switch decisions by maintaining records of the medications they dispense and by providing access to them to researchers assessing the safety and efficacy of these drugs. They might also be encouraged or required to report adverse drug reactions and be involved in postmarketing evaluation studies. Currently, FDA derives this information only from the use of drugs as prescription products. Some arguments against an intermediate class of drugs come from industry officials who have argued that while pharmacists have useful information to pass on to consumers, an intermediate class is not necessary for tapping into it. If customers are interested in getting advice from pharmacists, they can go to a pharmacy and ask for it but are not forced to do so. They also note some difficulties with an increased role for pharmacists. Counseling for nonprescription products is infrequent and sometimes inappropriate, and they argue that this would not change with the establishment of an intermediate class of drugs. In addition, consumers use nonprescription drugs responsibly. They read and understand drug labels. There is nothing for the pharmacist to add. NDMA agrees that pharmacists are well-trained in pharmaceuticals but believes that they are not trained in other roles—in particular, diagnosing illnesses (NDMA, 1992). Only physicians have this training and should be performing this role. Improper diagnosis could lead to treating symptoms rather than the underlying cause of an illness. Finally, opponents argue that the current two-tier system works well (NDMA, 1992). It is simple and effective. Either a drug is safe enough to be taken without medical supervision or it is not. There is no need for an intermediate class of drugs. To find out whether there would be significant advantages to creating an additional class of drugs, the Ranking Minority Member of the House Committee on Commerce asked us to examine the operation of drug distribution systems in 10 countries that have a pharmacist or pharmacy class of drugs and to compare these systems with that in the United States. To respond to this request, we posed specific evaluation questions: 1. What conclusions can be drawn from studies or reports on the development, operation, and consequences of different multiple-classification drug distribution systems? 2. What are the drug distribution systems for the 10 countries? 3. What drug distribution will be implemented in the European Union? 4. How does access to nonprescription drugs vary between the study countries and the United States? 5. How do pharmacists ensure the proper use of nonprescription drugs? 6. What is the U.S. experience with dispensing drugs without a physician’s prescription but only by pharmacists? Our purpose was to learn generally about factors that affect drug distribution in other countries and, in particular, about the perceived costs and benefits of a pharmacist or pharmacy class of drugs. This can raise important issues about the desirability or usefulness of such a class of drugs in the United States. By studying other countries, it is possible to bring empirical data to the debate. We examined the drug distribution systems in Australia, Canada, Denmark, France, Germany, Italy, the Netherlands, Sweden, Switzerland, and the United Kingdom. (See appendix II.) As requested, we also studied the harmonized system for the members of the European Union (EU). We examined the classification of the following 14 drugs: aspirin, cimetidine, codeine, diclofenac, diflunisal, ibuprofen, indomethacin, naproxen, phenylpropanolamine, promethazine, ranitidine, sulindac, terfenadine, and theophylline. (See appendix III and IV.) We chose these drugs because they either are past switches or have been suggested as candidates for switching in the United States or another country. We focused on an intermediate class of drugs as it has generally been discussed in the United States and practiced in other countries—that is, a class of nonprescription drugs available only in pharmacies or from a pharmacist. We did not assess the more general notion of pharmaceutical care, although we discuss it briefly in chapters 4 and 5. An intermediate class of drugs might be considered one form of pharmaceutical care. While some arguments and evidence regarding pharmaceutical care are therefore relevant for an intermediate class of drugs, a complete evaluation of pharmaceutical care was beyond our scope. To determine what is known about the operation of drug distribution systems that include a pharmacist or pharmacy class of drugs, we examined extant information and gathered expert opinion on six general issues. (1) The findings of studies on the health and economic effects of a pharmacist or pharmacy class. (2) The experiences of other countries and the European Union with a pharmacist or pharmacy class, including its use to move a drug to a general sale class, its usefulness in preventing drug abuse, and its effect on drug expenditures. (3) The effect on consumers’ access to nonprescription drugs of restricting their sale to pharmacies or personal sale by pharmacists. (4) The role of pharmacists in the study countries and the United States and the findings of studies on pharmacist counseling for nonprescription drugs. (5) The limited experience in the United States of pharmacists prescribing drugs without a physician’s involvement and of restricting some nonprescription drugs to sale only by pharmacists. We gathered information from a number of sources and used several data collection methods. We did not do independent analyses of data bases. We conducted computerized literature searches on the following topics: (1) drug distribution systems in the study countries, (2) the behavior of pharmacists, (3) the classification of the 14 drugs, (4) the advantages and disadvantages of an intermediate class of drugs, and (5) assessments of the health and economic effects of different drug distribution systems. We conducted interviews with officials of FDA involved in the regulation of prescription and nonprescription drugs, pharmacy associations, drug manufacturers, consumer groups, and drug manufacturer associations. We also interviewed academics who have written on this subject. In addition, we met with officials and academics in Florida to discuss their experiences with the Florida Pharmacist Self-Care Consultant Law (see appendix V). We requested information from government and pharmacy association officials in the 10 study countries. Because Canada’s individual provinces have a great deal of power over drug distribution, we also requested information from officials in Ontario. We sought to gather descriptive information on the drug distribution system in each country, including criteria for drug classification, the classification of the 14 drugs, requirements for pharmacist counseling, and liability issues. To obtain more in-depth information about the systems and experiences of particular countries, we traveled to Australia, Canada, Germany, the Netherlands, Switzerland, and the United Kingdom. We chose these countries because each allows the sale of some drugs outside pharmacies. The extensiveness of this general sale class varies greatly between countries; however, it was important to assess the experiences of countries where at least some drugs are available in the same manner as in the United States. We met with government officials, industry and pharmacy representatives, and other individuals knowledgeable about drug distribution in each country. The trips also allowed us to gather the views of a wider range of people than we contacted by mail, such as consumer groups, physicians’ associations, drug manufacturers, and academics. We also visited officials in Brussels, Belgium, to understand the rationale behind the decisions of the European Union regarding drug distribution in the member countries. We conducted our evaluation between February 1993 and December 1994 in accordance with generally accepted government auditing standards. Although studies have examined individual drug distribution systems, we found that little effort has been made to systematically compare systems. Our study brings together information about the drug distribution systems in 11 countries (including the United States), Ontario, Canada, and the European Union. In addition to describing the systems, we examine the accessibility of nonprescription drugs in the study countries and the United States, describe the role of pharmacists in the countries, and assess evidence for implementing a class of nonprescription drugs available only from pharmacies (or personally from a pharmacist) in the United States. This information allows the assessment of the operation of a pharmacist or pharmacy class of drugs in the study countries as well as raises issues that would have to be addressed if such a class of drugs were considered in the United States. One important difference between the United States and the other countries limits the lessons that can be learned. In all the countries other than the United States, there is some government provision of health care to the general public or universal health insurance through the private sector but regulated by the government. Thus, the context in which drugs are acquired, sold, and paid for can be quite different in these countries from that in the United States. If the barriers to obtaining a prescription drug in these countries are smaller than in the United States because individuals do not directly pay for physician visits and drugs prescribed in them, there may be less incentive there to purchase nonprescription products. Another limitation is that the available data did not allow us to directly assess the effect of a pharmacy or pharmacist class on adverse drug effects, quality of care, and cost of drugs to the consumer and health care system. Instead, we had to rely on the assessments of government officials, association representatives, and other experts in each country. We also did not examine in great detail the individual drug classification decisions made in each country. That is, we did not examine the documentation that supports particular classification decisions to assess how decisionmaking varies between countries. Additionally, because of cost and resource limitations, we did not visit every country included in the study. (We did not travel to Denmark, France, Italy, and Sweden.) Finally, because our focus is on the experiences of other countries and what can be learned from them, we did not assess the principal reason FDA has given for not establishing an intermediate class of drugs—namely, that a public health need for such a class in the United States has not been demonstrated. Consequently, we did not address issues such as the frequency of adverse effects for nonprescription drugs in general and, more specifically, for recently switched drugs in the United States. Officials from FDA reviewed a draft of this report and provided written comments (see appendix VI). They stated that the report does not consider certain additional requirements establishing an intermediate class of drugs would impose upon FDA, drug manufacturers, or pharmacists such as new FDA labeling requirements and additional training of pharmacists. The report discusses other potential additional requirements for pharmacists in chapters 2, 3, and 5. However, we did not attempt to address all additional requirements because a comprehensive assessment was beyond the scope and objectives of our report. An assessment of the additional requirements for FDA and drug manufacturers was also beyond our scope. The following chapters address each of the five evaluation questions. Chapter 2 summarizes studies that have assessed the effects of different drug distribution systems and describes the drug distribution systems in the 10 countries as well as officials’ views on the operation of their systems. It also describes the system in the European Union. Chapter 3 presents information on access to nonprescription drugs in the study countries, including the classification of the 14 drugs. Chapter 4 summarizes the role of pharmacists in each country and examines studies of pharmacists’ behavior in the study countries and the United States. Chapter 5 examines the U.S. experience, focusing on Florida with its Pharmacist Self-Care Consultant Law. Chapter 6 summarizes our findings and presents conclusions. Drug distribution systems differ from country to country. In this chapter, we summarize information from studies on the consequences of the different systems. To show how the United States differs, we describe the drug distribution systems for the 10 countries and the European Union. Our purpose is to identify the countries that have a pharmacist or pharmacy class of drugs and examine possible benefits that the United States does not receive because they have such a class and the United States does not. Specifically, we answer the following questions: 1. What conclusions can be drawn from studies or reports on the development, operation, and consequences of different drug distribution systems? 2. What is the structure of the drug distribution system in each country? 3. What are the criteria for the initial classification, and subsequent classification changes, of a given drug product in each country? 4. To what extent is the pharmacist or pharmacy drug class used as a transition class for drugs being moved from prescription to general sale? 5. How effective is a pharmacist or pharmacy class in preventing the abuse of drugs? 6. What is the effect on expenditures on a drug when the drug is switched from prescription to nonprescription status? 7. What drug distribution system will be implemented in the European Union? Little or no analysis has been done to show the advantages and disadvantages of different drug distribution systems. For example, as of March 1995, researchers had not attempted to determine how differences in drug distribution systems may affect health care costs. A number of studies have found significant differences in prescription drug prices across countries, both at the retail and manufacturers’ level. However, as the costs of production and distribution make up only a small share of the total cost of any prescription drug, it is unlikely that differences in distribution systems are major sources of country-by-country differences in drugs prices (GAO, 1994a, p. 29). The effect of different drug distribution systems on nonprescription drug prices has not been assessed. Similarly, no studies have attempted to link the type of drug distribution system in a country to the frequency of adverse drug reactions or have attempted to relate different drug distribution systems to the quality of health care. The studies that have been done focus on the experiences of a single country when switching specific drugs and do not attempt to assess the merits of alternative drug distribution systems (Andersen and Schou, 1993; Bytzer, Hansen, and Schaffalitzky de Muckadell, 1991; Halpern, Fitzpatrick, and Volans, 1993; Hansen, Bytzer, and Schaffalitzky de Muckadell, 1991; Hopf, 1989; Perry, Streete, and Volans, 1987; Ryan and Yule, 1990; and Temin, 1992). While some researchers have found health and economic benefits to switching specific drugs in a particular country, no attempt has been made to determine what the effects would have been under a different drug classification system. For instance, would cough and cold remedies have been switched earlier in the United States if an intermediate-drug class had been available? If so, what would the benefits have been? If not, are there costs (for instance, adverse drug reactions) that would have been avoided if they had been switched into an intermediate class? There are also no studies that explicitly attempt to link the drug distribution system with the switching of specific drugs. In sum, it is necessary to examine other data to assess how a new class of drugs in the United States might operate. Table 2.1 summarizes the drug classes in the 10 countries, Ontario, and the United States. Note that in the Netherlands and Switzerland, a distinction is made between pharmacies and drugstores. Pharmacies are run by professionals with university degrees in pharmacy. All nonprescription drugs can be sold in pharmacies and prescriptions can be dispensed. Conversely, in drugstores, the principal “drug expert” is the druggist. Although some training is required to become a druggist, it is not university-based and is not as extensive as that for a pharmacist. In contrast to pharmacies, prescription drugs cannot be dispensed in drugstores, nor can all nonprescription drugs be sold there. In Australia, Canada, and Switzerland, some of or all the power for classifying drugs for distribution rests with the states, provinces, or cantons rather than the national government. For our purposes, it is sufficient to note that drug classification is rather uniform throughout Australia and Switzerland and, therefore, we categorize these systems as being national rather than local. In Canada, since the number of drug classes and classification decisions varies greatly between provinces, we present information on Ontario as well as the national government. As table 2.1 shows, the two-tier system in the United States is unique. All the other countries restrict the sale of at least some nonprescription drugs to pharmacies. France, Italy, and the Netherlands do not allow the sale of any drugs outside pharmacies or drugstores. Although some drugs are available for sale outside pharmacies in Denmark, Germany, Sweden, and Switzerland, this general sale class is quite small. In Australia, Canada (including Ontario), and the United Kingdom, the general sale class is larger than in these 4 countries but smaller than in the United States. The general rationale for restricting the sale of nonprescription drugs is the same in all the countries. Drugs are not typical consumer products. The dangerous aspects to them means they should be treated accordingly. A pharmacist can help provide guidance to patients on the proper use of the drugs and, thereby, reduce the possibility of adverse effects. All 10 countries and the United States generally use a drug’s safety, efficacy, and quality for approving it. Each country then uses related criteria for determining the drug’s distribution class. For instance, among the criteria the United Kingdom uses when switching a drug from prescription to pharmacist class is that the medicine has an acceptable margin of safety during unsupervised use, including safety in overdose or following accidental misdiagnosis. Officials in the United Kingdom also told us that when making classification decisions, they take into account the role that pharmacists are expected to play. Among the criteria Denmark uses is that the drug should be available by prescription for 2 years without problems before it is switched. (A detailed comparison of the specific classification criteria was beyond our scope.) Over the last 15 years, the number of drugs switched from prescription to nonprescription status has increased in the United States. In fact, this is a worldwide trend. Despite arguments for a transition class in the United States, an intermediate class is not frequently used as a transition class in the study countries. It is operative only in Australia (and there was some support for it by government officials in Ontario and by Canadian national pharmacy association officials). In the Australian state of Victoria, after a drug is switched from prescription class to pharmacist class, officials watch for reports of adverse drug effects (they do not actively track users of the drug). If reports do not materialize, they consider switching the drug from pharmacist to pharmacy class. It is important to emphasize that even when the class is considered a transition class, the goal is not to allow the drug to be sold outside pharmacies. One Australian official told us that she could remember only paracetemol (acetaminophen in the United States) being moved into the general sale category. In Canada, although some government and pharmacy officials told us they support the general idea of a transition class, the intermediate class is not generally used in this manner. Some manufacturers’ officials were concerned that drugs could get “stuck” in a transition class. They said that ibuprofen was switched in the provinces in 1989 out of prescription class into pharmacist class, where it was supposed to remain for only a short time, but it still remains there today, 6 years later. More generally, a Canadian official questioned the idea of whether a transition class would allow drugs to be switched from prescription status faster if the data package for switching remained the same. Only by altering the package could the process be made faster: either fewer or shorter tests would be required or drugs would have to be switched before the tests were completed. The same official raised the issue of the usefulness of the data that might be gathered through a transition class. There would be no controls in the studies. The official thought that because of the lack of controls, the studies would provide little useful information. A U.S. manufacturer echoed this idea and stated that FDA responds to randomized, double-blind studies in which the experimental drugs are compared to placebos. (In a double-blind medical experiment, neither the patients nor the persons administering the treatment and recording the results know which subjects are receiving the drug and which are receiving the placebo.) This allows the effectiveness and adverse effects to be accurately assessed. A transition class would not provide this type of study. An official in the United Kingdom stated that, theoretically, new adverse reactions could be found when a drug is switched to a pharmacist or pharmacy class but that, as a practical matter, the adverse-effect profile for a drug is established by the time a drug is switched. In the other countries we visited, the intermediate classes were not transition but permanent. There was no certainty that the drugs would be assessed for reclassification after a period of time. Thus, little helpful information is available from other countries as to whether or how a transition class might speed the switching of drugs. If a transition class is to play a role in speeding approval of a change from prescription to nonprescription status, it must regularly employ a system to track adverse effects. Without this information, the class could not aid FDA in assessing a drug for general sale. Tracking studies would help link drug use (or at least purchases) to adverse effects. They could also give some indication of the pattern of use in the population. Two difficulties with such a recordkeeping requirement are the time burden it places on pharmacists and the likelihood of increased costs. Proponents for an intermediate class of nonprescription drugs argue that limiting the availability of certain drugs to pharmacies would impede abuse. For example, the pharmacist would be expected to intervene if a customer wanted to purchase inordinate amounts of a drug (either at one time or over a period of time) or if the customer appeared to have no medical need for it. The class could be used in two ways. First, for drugs being switched from prescription to nonprescription status, abuse could be studied and a decision made at a later time on appropriate classification. Second, nonprescription products that were being abused could be moved back to the intermediate class for some safeguards. The advantage of moving a drug from general sale to an intermediate class is that it would still be available to customers for legitimate uses. Although access would be restricted to pharmacies, the added impediment of a prescription would not be required. Currently, if access is to be restricted, the drug must be moved to prescription class. The usefulness of an intermediate class to prevent drug abuse has not been demonstrated. We identified no studies that addressed the general issue of using an intermediate class to deter drug abuse. Few government and pharmacy officials whom we spoke with in the United States and abroad thought that an intermediate class would be completely successful in doing so. They agreed that it would be quite easy for an individual who wanted a large amount of a drug simply to visit several pharmacies and buy what appears to be a reasonable amount in each one, thereby avoiding potential surveillance. Having to deal with a pharmacist might be an impediment, as would the necessity of visiting several pharmacies; however, it would not be overly difficult to get around the system. The difficulties in using a pharmacist class to prevent abuse can be illustrated by experience in New South Wales, where Australian truck drivers were taking ephedrine to try to stay awake. At the time, the drug was restricted to sale by pharmacists. New South Wales officials decided to move the drug back to prescription status, and eventually the other Australian states followed their lead. In this case, since restricting the sale of ephedrine to pharmacists did not prevent abuse, officials thought it necessary to put tighter controls on the product. Similarly, a study in Germany indicated the difficulty of preventing the sale of nonprescription drugs even when they are restricted to pharmacies (Product Testing Foundation, 1991). Children between the ages of 10 and 14 were sent to pharmacies to see how easily they could purchase nonprescription medications containing alcohol. In all 54 pharmacies the children visited, they were allowed to purchase the drugs. In only one case was the purchaser questioned intensively. The consumer association that did the study criticized the pharmacists, and the pharmacy association called the results “lamentable.” Much of the discussion about the proposed roles for an intermediate drug class has centered on public health issues. For example, a primary concern has been the effect of an intermediate class on consumers’ ability to use pharmaceuticals safely and effectively. In addition, an intermediate class of drugs would also have an economic effect. Establishing a pharmacy or pharmacist class could affect the price and availability of drugs to consumers and might also alter the revenues or profits of both manufacturers and retailers. Pharmacy experts in the United States told us that drugs cost less as nonprescription than prescription medicines, although initially the nonprescription cost may be higher than was the prescription price. Ibuprofen is an example. However, the experiences of other countries do not clarify what the economic effect of establishing an intermediate class of drugs would be in the United States. The few studies that have been done focus on the switching of particular drugs in particular countries. The studies do not generalize beyond the study country and do not attempt to determine the effect of the presence or absence of a pharmacist or pharmacy class. Ryan and Yule (1990), examining the economic benefits of switching loperamide (an antidiarrheal) and topical hydrocortisone from “prescription only medicines” to “pharmacy medicines” in the United Kingdom, found that the costs of obtaining each drug decreased after the products were switched. However, in the United Kingdom (and all the study countries), prescription drug prices are controlled in some manner by the government. Nonprescription drug prices generally are not, although some are controlled if the drugs are purchased with a prescription. Therefore, a comparison of drug prices before and after a switch is not a comparison of two free markets. Because there is no U.S. government price control, a comparison of drug prices in the study countries before and after switching would not yield useful insights for the United States. (Thus, the Ryan and Yule findings do not necessarily indicate what would occur in the United States if a drug were switched to an intermediate class.) When Temin (1992) studied the costs and benefits of switching cough-and-cold medicines in the United States, he found that visits to doctors for common colds fell by 110,000 per year (from 4.4 million) from 1976 to 1989, coinciding with the switching of the medicines. After ruling out other possibilities, he concluded that the decrease in physicians’ visits was attributable to the switching of these drugs. He estimated this to be a saving of $70 million per year. Although there is thus some evidence of cost savings from switching drugs, the effect of an intermediate class of drugs has not been assessed. Ryan and Yule did not assess what the savings would have been if loperamide and topical hydrocortisone had been sold outside pharmacies. Temin did not study how the savings would have been different if cough-and-cold medications had been restricted to sale by pharmacists.Therefore, while the studies do indicate potential savings from switching drugs, we cannot use them to assess empirically the relative savings from different drug distribution systems. Our interviews with officials in the study countries indicated that the cost savings from fewer physicians’ visits may not be as great as expected. They said that many patients do not pay the full price for a prescribed drug. For instance, an insured patient might have only a $5.00 copayment for a prescription drug while having to pay the full price for a nonprescription product. Patients might thus have an incentive to go to doctors for a prescription. It could be for either a different but therapeutically equivalent product or the original drug if insurance covers it. The latter has occurred in Denmark with antiulcer medications that were switched in 1989. Bytzer, Hansen, and Schaffalitzky de Muckadell (1991) estimated that only 3 percent of the sales of cimetidine and ranitidine were made without some medical assessment or control. In Germany, approximately half of nonprescription drug sales are prescribed and reimbursed. A somewhat similar situation exists in the Netherlands with respect to acetaminophen. This drug can be purchased without a prescription as a general pain reliever; however, it is also commonly used as a pain killer for cancer patients and, in fact, is the most prescribed drug in the country. When it is prescribed, it is reimbursable. An official told us that this results in consumers being able to get their headache remedy free of charge. The economic effects of an intermediate class of drugs depend on several different factors and the current literature does not provide a comprehensive analysis of them. A complete treatment of economic issues was outside our scope. In the remainder of this section, however, we briefly illustrate some of the unresolved economic issues in assessing proposals for an intermediate class of drugs. The economic effect of an intermediate class of drugs would largely depend on how this class were structured and used—that is, whether it was a transition or a permanent class and, if the latter, whether the drugs in this class were coming largely from the prescription or the nonprescription category. For example, if drugs were moved to pharmacy or pharmacist class from prescription status, then the drug choices available to consumers without a prescription would increase. However, if drugs were largely moved to the intermediate class from the general sale category, then these drugs would be less widely available to consumers because fewer retail outlets could sell them (although they would still be available without a prescription). A major unresolved question is how the availability of a pharmacist or pharmacy class would affect pharmaceutical prices. Depending on the structure of the new class, several factors might strengthen or soften its effect. The following four examples provide an illustrative, but not comprehensive, list of scenarios that could play out if the United States adopted an intermediate class of drugs. The availability of an intermediate class of drugs might prompt a change in manufacturers’ pricing patterns. For example, if the introduction of an intermediate class permitted a drug to be switched from prescription status, the price might decline. If drugs were switched from general sale to the intermediate class, they would be available in fewer retail outlets. It is possible that the decrease in the number of retailers selling these drugs could adversely affect retail competition and, as a result, drive up prices. However, the availability of mail-order pharmacies and other outlets (provided they sold the drugs in the intermediate class), and the likelihood of new pharmacies opening, could mitigate or eliminate this effect. If drugs were moved to the intermediate class from the general sale category, the greater role of pharmacists might lead to higher prices if a counseling fee were implemented. The effect of an intermediate class of drugs on consumers’ out-of-pocket drug expenses would depend on the behavior of third-party payers such as health insurers, which often pay all or most of the cost of prescription drugs but generally do not pay for over-the-counter products. If insurers elected not to reimburse consumers for drugs that were moved from prescription status to an intermediate class, consumers’ out-of-pocket expenditures would increase. However, if fewer drugs were reimbursed, health insurance costs might decrease and partially or fully offset consumers’ greater out-of-pocket drug expenditures. An intermediate class of drugs could also produce savings in other health care costs. The cost of obtaining a prescription drug includes not only the cost of the drug itself but also the cost of the visit to a physician. Patients would be saved the cost of the visit to the physician for a pharmacy- or pharmacist-class drug. While this is potentially true for new prescriptions, cost savings for refilling prescriptions is less clear, since refills are often ordered on the telephone. The 15 member countries of the European Union are moving toward the creation of a single international market, without barriers to the free movement of goods, services, persons, or capital. One aspect of this is the harmonization of requirements governing the manufacturing and marketing of pharmaceuticals.Regulatory authority rests with Directorate General III “Industry.” Section III-E-3 deals with pharmaceutical products. Decisions of the European Union must be approved by a vote of the member countries. “Medicinal products shall be subject to medical prescription where they: —are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or —are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or —contain substances or preparations thereof the activity and/or side effects of which require further investigation, or —are normally prescribed by a doctor to be established parenterally.” The directive goes on to state that “Medicinal products not subject to prescription shall be those which do not meet the criteria established in Article 3.” Despite this directive, the member countries will retain the authority for classifying drugs into prescription and nonprescription classes. This power will not be transferred to the European Union. Nonetheless, the expectation is that because of the EU classification criteria, drugs will be increasingly classified as prescription or nonprescription throughout the union. It is expected that classification into prescription and nonprescription classes will become harmonized throughout the European Union in the next 15 to 20 years. However, the European Union has decided not to impose a particular drug distribution system on the member countries. It will be up to each country to determine the number and nature of nonprescription drug classes in it. If a country decides that it wants to restrict the sale of nonprescription drugs to pharmacies, this will be allowed. Similarly, if a country wants to allow the sale of some or all nonprescription drugs outside pharmacies, it may do so. Thus, despite the European Union’s developing criteria to distinguish prescription from nonprescription products, member countries can have more than two drug distribution classes. An EU official with major responsibilities for and involvement in the directive told us that the reason the European Union decided not to require a particular drug distribution system was that sufficient evidence did not exist to recommend one system over another. EU officials were not convinced that restricting drug sales to pharmacies was a commercial barrier to trade. Conversely, they were not convinced that allowing the sale of drugs outside pharmacies would increase health concerns. We were told that as long as a country’s requirements are the same for both domestic and foreign entities, the European Union will accept its drug distribution system. Drug distribution systems are seen, in part, as a function of tradition. Member countries were unwilling to give up their current systems. In general, the northern European countries are less restrictive on the sale of medications than are the southern countries. The northern countries did not want to restrict the sale of all nonprescription drugs to pharmacies, while the southern countries did not want to allow their sale outside pharmacies. In the absence of sound evidence to support one system as superior to the other, the European Union decided to allow the countries to determine their own individual systems. While there will be no required changes in the number and type of drug classes in a country, officials in the Netherlands told us that they are planning to adapt to EU guidelines by moving from a three-tier to a two-tier system. Their plan is to combine the pharmacist and drugstore classes into one class and allow the drugs to be sold in both locations. It was noted that some nonprescription drugs currently restricted to sale by pharmacists will be moved back to prescription status. Officials of the Netherlands indicated that they perceived no major, consistent benefit from requiring that a large category of nonprescription drugs be available only from pharmacists. Proponents of an intermediate drug class argue that access to pharmaceuticals would increase in the United States if an additional nonprescription drug class, either fixed or transition, were established. Opponents argue that access would decrease. The actual change in access would depend on how the intermediate class were used. In general, access would decrease if (1) drugs that are currently available without a prescription were to be moved into the intermediate class or (2) drugs that would have been switched to general sale were instead placed into the intermediate class. However, access would increase if (1) drugs that would have been moved back to prescription status were placed in the intermediate category or (2) the effect of an intermediate class were to allow drugs to move into it that could not be moved into the general sale class. While the number of outlets (54,000 pharmacies) selling the product would not change, accessibility would increase because a prescription would not be necessary. Beyond these general observations, it is unclear exactly how access would change. No studies have assessed this issue and, moreover, it would be very difficult to do so. A complete understanding of how access would be affected would require assessing a number of factors, including the number of drug outlets that would sell the drugs, how the class would be used, and the number and nature of drugs that would be placed in it. None of these can be precisely predicted. In this chapter, we report our comparison of access to nonprescription drugs in the United States with that in the study countries. Making this comparison helped us understand what the effects of an intermediate class might be in the United States regardless of whether a fixed or transition class were established. We focused on the following three aspects of access: the number of community pharmacies and drugstores in each country, the availability of nonprescription drugs by self-selection, and, more generally, the classification of particular drugs as either prescription or nonprescription products. In particular, we answer the following questions: 1. How many pharmacies and drugstores are there in each of the study countries and the United States? 2. In the study countries, can consumers select nonprescription drugs themselves, or must they request such drugs from a pharmacist? 3. How does the classification of the 14 drugs we selected vary between the study countries and the United States? The drugs include a number of pain relievers, antiulcer medications, and allergy medicines (see appendix IV). Their classification varies from country to country, and all have been either switched or mentioned as candidates for switching in the United States or another country. Private sector officials in the United States indicated that the 14 are a good list for getting a general indication of the access to nonprescription drugs in a country. However, it is not possible to generalize from this list about drug classification in a country—that is, the classification of these drugs does not necessarily indicate the overall availability of nonprescription drugs in a country. Instead, the drugs should be viewed as examples of differences between countries. The number of community pharmacies can give some indication of how available intermediate-class drugs would be in the United States. However, there are a number of other drug outlets that could increase the availability of these products, including government, managed care, and mail-order pharmacies. If these outlets were to sell intermediate class drugs, consumers would not have to go to a community pharmacy to purchase them. However, we cannot be certain that all or any of these potential outlets would choose to sell the drugs. Thus, any analysis of how accessible intermediate class drugs would be is limited by uncertainty over the number of outlets. Similarly, any comparison between countries of the number of drug outlets must note that in some countries physicians are permitted to dispense drugs where there is no convenient pharmacy. For example, in France and Italy physicians are allowed to dispense nonprescription drugs in rural areas where no pharmacy is available. The effect is to increase the number of drug outlets for nonprescription drugs and, hence, their accessibility. For countries that have more specialized drug outlets than the United States, physicians’ dispensing would increase the difference between the countries while narrowing the difference for countries that have fewer pharmacies than the United States. If the United States were to allow physicians to dispense intermediate-class drugs where no pharmacy was available, this would also reduce inconvenience but negate one rationale (not having to visit a physician to receive the drug) for such a class of drugs. To get some indication of how many U.S. outlets would be able to sell these drugs and how similar this is to other countries, we compared the number of community pharmacies per capita in the United States with a comparable measure in other countries. We found that the United States has considerably fewer community pharmacies or drugstores per capita than 6 of the countries. (See table 3.1.) However, only Denmark, with one pharmacy for every 17,500 residents, and Sweden, with one for every 10,200 residents, have substantially fewer pharmacies per capita than the United States, which has one for every 4,800 residents. The United Kingdom, Canada, and Ontario have a similar number per capita to the United States. This gives some indication that restricting nonprescription drugs to sale in pharmacies might be more of an inconvenience in the United States than it is in 6 of the countries we studied. If drugs in the intermediate class were to come from the general sale rather than prescription class, change in access to these products would depend on not only the number of community pharmacies but also their distribution. In some parts of the country, the nearest pharmacy can be 100 or more miles away. Even within a city, the number of pharmacies varies between neighborhoods, and nonpharmacy drug outlets generally sell fewer products than do pharmacies. Therefore, people with a nearby pharmacy already have an advantage in the number of nonprescription products readily available to them. Moving drugs from the general sale class to an intermediate class could make this difference somewhat larger. The number of outlets selling the drugs would decrease, and individuals with easy access to pharmacies would find these drugs readily available to them while those without accessible pharmacies would not. However, moving drugs from the prescription class to an intermediate class would not change the number of outlets (that is, pharmacies) selling them (assuming noncommunity pharmacies chose to sell the products), and, therefore, the difference in access for individuals with readily available pharmacies and those without would remain the same. It would still be necessary to go to a pharmacy to purchase the drug. The difference would be that a prescription would not be required. Moreover, introducing an intermediate class of drugs in the United States would constitute a large change in nonprescription drug distribution since the more than 690,000 nonpharmacy drug outlets would not be allowed to sell these products. Consumers would have to learn that not all nonprescription drugs could be sold in all retail outlets. Individuals who wanted to purchase a drug in the intermediate class would need to know that it was necessary to purchase the drug at a pharmacy. This would affect all residents, regardless of location. In the United States, nonprescription products (except for controlled substances available without a prescription and insulin) are generally available by self-service—that is, consumers can select their nonprescription products from the shelves personally. Consumers have the power to choose their own nonprescription drug regimen by comparing different products on such items as dosing, side-effects, and price. Of course, if they are in a pharmacy, they can always ask the pharmacist for information or advice. In other countries, self-selection of pharmaceuticals is limited to certain drug classes or not allowed at all. Table 3.2 summarizes the direct availability of nonprescription drugs to consumers. The table shows that the ability to choose one’s own drugs is limited, except for drugs available outside pharmacies (in countries where this is allowed). Only in Australia, Canada (as determined by the individual provinces such as Ontario), and Sweden is self-service allowed for some or all pharmacist or pharmacy drugs. If the United States were to follow the general pattern in other countries of not permitting self-service for pharmacist- or pharmacy-class products (as is done for controlled substances available without a prescription and insulin in some states), purchasing these products would be much different from purchasing other nonprescription drugs. Consumers would not only be unable to buy the products in outlets such as convenience stores and gas stations but would also find it more difficult to compare products if they could not select pharmacist- or pharmacy-class drugs directly from the shelf. One of the principal benefits cited by proponents of an intermediate class is that the number of products available without a prescription would increase because FDA would have the option of putting drugs in a class that provides for consumer counseling (National Consumers League, 1991). To see if there is a pattern of greater nonprescription availability in countries that have a pharmacist or pharmacy class, we examined the classification of 14 drugs in the study countries and the United States. (See appendixes III and IV.) These drugs have either been switched or mentioned as candidates for switching in the United States or in another country, but they are only examples meant to illustrate differences between the countries. It is not possible to generalize from them to the entire drug classification system in a country. Our analysis shows only that the presence or absence of a pharmacist or pharmacy class has no consistent effect on drug classification. It is unclear what effect establishing an intermediate class in the United States would have on the classification of drugs as prescription or nonprescription products. Specific examples illustrate how classification varies between countries. Ibuprofen is available for general sale in the United States but, although it is a nonprescription product in 10 other countries, its distribution is limited to specialized drug outlets in all of them. Naproxen is also available for general sale in the United States but as a nonprescription product in only 2 of the 10 countries. For these two drugs, the United States clearly has the most open system and the lack of an intermediate class has not prevented their being switched here. In fact, the United States was among the first to classify ibuprofen (1984) and naproxen (1994) as nonprescription products. However, for other drugs the United States is more restrictive. For the 10 countries studied, only France, Italy, and Sweden, like the United States, do not allow nonprescription sale of the antihistamine terfenadine. Similarly, only Germany, Sweden, and the United States do not allow the nonprescription sale of promethazine, another antihistamine. In the seven countries, these drugs are available in either a pharmacist or pharmacy class; the U.S. system is less open than theirs are. It is unclear whether the theoretical safeguards associated with a pharmacist or pharmacy class would be sufficient for regulators to switch these drugs from prescription to nonprescription. It is thus unclear whether establishing an intermediate class of drugs in the United States would allow more drugs to be switched, since the United States already classifies some drugs as nonprescription that other countries that have a pharmacist or pharmacy class still restrict to prescription class. What is clear is that other factors in addition to or instead of the existence of a pharmacist or pharmacy class account for differences in drug classification between the study countries. An assessment of the relative openness of the current drug distribution system in the United States compared to the other countries studied depends on one’s definition of “access.” If access is defined by the availability of drugs for general sale, the United States appears to have the most open system, since more of the 14 drugs are available for sale outside pharmacies than in any of the other countries. However, if access is defined by the availability of drugs for nonprescription sale regardless of where they can be sold, the United States falls somewhere in the middle. Some countries have more of the 14 drugs available without a prescription than the United States does, but others have fewer. Many of the theoretical benefits associated with a pharmacist or pharmacy class of drugs (whether a fixed or transition class) involve improving drug use or, conversely, reducing misuse. The assumption is that pharmacists will pass on to consumers the information they need to take a drug properly. Critics of an intermediate class in the United States do not question the potential value of pharmacists’ relaying information to consumers but do not believe that it is necessary to have an additional drug class to do this. In this chapter, we describe the role pharmacists play in monitoring the use of pharmacist- and pharmacy-class drugs in the study countries. We focus on pharmacist practices that would have to be engaged in for a fixed or transition class to be effective. We also report on selected aspects of pharmacy practice in the United States, including counseling on nonprescription drugs. Specifically, we answer the following questions: 1. Are pharmacists in the 10 countries required by law to counsel consumers on the proper use of nonprescription drugs? 2. What are the legal sanctions for failing to provide counseling? 3. What studies show whether pharmacists in the study countries and the United States counsel purchasers of nonprescription drugs, and what is the quality of that counseling? 4. What are the requirements and practices of pharmacists in monitoring adverse drug reactions and maintaining patient profiles? 5. How might recent developments in the practice of pharmacy affect the counseling behavior of pharmacists in the United States? One reason proponents commonly give for limiting nonprescription drugs to sale in pharmacies (even if no counseling is required) is that it allows customers to ask for advice if they want it. Table 4.1 summarizes the counseling requirements for nonprescription drugs in the 10 study countries and Ontario. Only in Australia, Denmark, Germany, and Italy are pharmacists required to provide information to patients on the use of nonprescription drugs. In Australia, these requirements vary by state: some states require counseling on pharmacist class drugs but others do not. For instance, in Victoria, the pharmacist is required to speak with the patient every time a pharmacist-class drug is sold. In Denmark, Germany, and Italy, the pharmacist is required to provide information to patients on their medications; however, there are no specific counseling requirements. In Ontario and the United Kingdom, nothing is required beyond the pharmacists’ supervision of sales. In France, the Netherlands, and Switzerland, pharmacists need merely be physically present on the premises of the pharmacy. In Sweden, while the pharmacist is expected to promote proper drug usage, there is no requirement that a pharmacist be present when a nonprescription drug is sold. There are no national counseling requirements in Canada. In the 6 countries we visited—Australia, Canada, Germany, the Netherlands, Switzerland, and the United Kingdom—and Ontario, there is some enforcement of the requirements for pharmacists selling nonprescription drugs, but it is somewhat limited. Enforcement is sometimes by a professional association and is sometimes focused on physical aspects of the pharmacy rather than the counseling of patients. The number of inspectors is sometimes small and nonprescription drugs can be less emphasized than prescription products. Counseling requirements are set by the states in Australia. Officials in the state of Victoria told us that enforcement is done primarily through three pharmacy inspectors of the Pharmacy Board of Victoria on the basis of professional standards. One reason for the board’s enforcing the law rather than the state is that the board’s standard of proof is less stringent, thereby making it easier to discipline recalcitrant pharmacists. The state standard of proof, “beyond a reasonable doubt,” has been replaced by the less strict “balance of probabilities.” The pharmacy board brings its case before pharmacy representatives who may impose penalties ranging from letters of admonition and fines to temporary suspension or permanent cancellation of a pharmacist’s registration. There are three or four suspensions or cancellations per year. We were told that generally there is not a great deal of enforcement in Australia unless there are complaints or drug abuse concerns. Enforcement of pharmacist requirements is done at the state and regional level in Germany and focuses on the physical aspect of the pharmacy rather than the behavior of pharmacists. Inspectors check such items as cleanliness of the pharmacy, proper storage of medicines, size of the laboratory, availability of instruments, and orderliness of records. In the Netherlands, the State Public Health Inspectorate supervises all matters relating to the sale of drugs. Pharmacists must give access at any time to inspectors to examine the pharmacy and everything in it. If inspectors find that the pharmacy is not operating in accordance with the law, they inform the pharmacist and stipulate a time within which the problem must be corrected. We were unable to determine the amount of effort put forth in identifying violations of counseling requirements for nonprescription products. In Switzerland, each canton has a pharmacist organization that conducts inspections. Inspectors examine the shop and laboratory to determine if they are in accordance with regulations. They also check to see if the pharmacist is present when the pharmacy is open, as required by law. In the United Kingdom, pharmacy medicines are to be sold only under the supervision of a pharmacist. This is normally defined as being present, aware of the transaction, and in a position to intervene. Enforcement of the law is not by the government but by the Royal Pharmaceutical Society of Great Britain. The society has 18 pharmacy inspectors and 2 inspectors for nonpharmacy drug outlets. This works out to about 650 to 700 pharmacies per inspector. We were told that a large number of cases are brought to the attention of the Royal Pharmaceutical Society every year by competitors and consumers. After the society visits the pharmacy to meet with the pharmacist, it decides whether to handle the case informally or to take formal evidence. Often it sends only a warning letter. Approximately 15 cases a year are prosecuted. Additional cases (6 in 1993) are dealt with through the pharmacy code of ethics. However, we were told that the society is unlikely to base action on the sale of pharmacy-class drugs (for instance, selling a pharmacy medicine without appropriate counseling). Overall, Royal Pharmaceutical Society officials thought that a great deal of effort was put into identifying violations of laws and regulations concerning purchases of nonprescription drugs. Government officials told us that enforcement of pharmacy practice requirements is successful mainly as a deterrent. Pharmacists are aware of the law and try to stay within it. In Ontario, pharmacists (or an intern) must make the “decision to sell” a pharmacist-class drug. This is generally defined as the pharmacist’s being “aware of the sale.” There is no requirement that pharmacists actually speak with the patients. Enforcement is done by the Ontario College of Pharmacists, a professional and regulatory association. Officials told us that compliance with the law is minimal. There is no method for monitoring pharmacist interventions other than through consumer complaints to the college, which are then investigated. We asked pharmacy officials in the countries we did not visit how much effort is put forth in enforcing nonprescription drug counseling requirements. Officials in France and Denmark told us that “moderate” effort is put into enforcing counseling requirements in those countries; Swedish officials said that there is “some” effort. In Italy, there are no sanctions against pharmacists who do not counsel patients on the use of nonprescription drugs. Officials noted that the enforcement of counseling requirements can be problematic. It is difficult to determine what is or is not appropriate counseling behavior. Appropriateness needs to be assessed case by case. What appears to be a lack of counseling might reflect a legitimate judgment by the pharmacist, such as that a particular customer regularly uses the drug and does not need counseling on it. This makes enforcement of counseling requirements quite difficult. Various academics, consumer groups, and pharmacy associations have conducted studies of the behavior of pharmacists when they sell nonprescription drugs. Typically, participants in a study go to a pharmacy and attempt to purchase a particular nonprescription product or describe their symptoms (or those of the person for whom they are buying the product), seeking advice from the pharmacist on what drug to purchase. Each shopper has been trained by the investigators to act in accordance with a script developed for the study. The pharmacist’s advice is recorded and compared to what the pharmacist should have done according to criteria determined by a group of experts. We refer to these investigations as trained shopper studies. Other common study designs are investigators’ observation of pharmacists’ behavior and pharmacists’ completion of a questionnaire on their counseling activities. Table 4.2 lists the pharmacist counseling studies, their methodologies, and what they assessed. Studies have not been conducted in all the countries. While the studies vary considerably in design and objective, a number of common themes are evident. Despite differences in the law and regulations across countries, counseling is generally incomplete and infrequent. Estimates of the frequency of pharmacists’ counseling on nonprescription products (that is, the percentage of patients receiving advice) ranged from 11.1 percent in Sweden (Marklund, Karlsson, and Bengtsson, 1990) and 12.3 percent in Canada (Taylor and Suveges, 1992a) to 93.75 percent in Germany (Product Testing Foundation, 1991). Germany’s was by far the highest estimate. The second highest, based on self-reports of pharmacists, was 37.6 percent in the United Kingdom for single proprietor pharmacies (Phelan and Jepson, 1980). (The lowest estimate for the United Kingdom was 21 percent for chain pharmacies, also found by Phelan and Jepson.) However, even in Germany, the researchers generally thought that too little counseling was being done. In one third of the cases in Germany, only one piece of information was being passed to the consumer. An Australian study found that the vast majority of pharmacists thought that they should counsel for both prescription and nonprescription medications (Ortiz et al., 1984b). However, pharmacists gave a number of reasons for not counseling. The three most important were lack of adequate medical histories, lack of feedback from the person counseled, and the belief that counseling may not be necessary. Another reason counseling may not occur is that customers may not want it. In Canada, Taylor and Suveges (1992a) found that 195 of 207 customers who did not receive advice on a nonprescription product indicated that they did not want counseling. The main reasons they gave were that they had “used medicine before with good results” and “had already received advice elsewhere on what to buy.” Regarding the quantity of counseling (that is, the availability of pharmacists to counsel, the number of counseling events per day, and the time spent counseling), a Canadian study found that pharmacists responded to requests from patients for advice on nonprescription drugs an average of 2.8 times a day (Poston, Kennedy, and Waruszynski, 1994). The range between pharmacies was from 0.07 to 38.64 counseling events per day. A study in Australia found that 23 percent of pharmacist counseling activities involved OTC medications (Ortiz, Thomas, and Walker, 1989). (This was the second most frequent counseling activity behind giving advice on prescribed medications.) Patients initiated the counseling in 259 of 438 cases. In 394 of the cases, counseling took 2 minutes or less. The quality of counseling was somewhat mixed. Recommended products and advice (when given) were generally found to be appropriate. Willison and Muzzin (1992) found that in Canada the quality of advice varied by ailment, with patients receiving better advice on less complex problems. For three of four scenarios in which the use of a prescription medication was not involved, the percentage of patients receiving totally safe and appropriate advice ranged from 62 to 77 percent. For the fourth scenario, only 17 percent received such advice. In Germany, the Product Testing Foundation (1991) found that pharmacists’ explanations tended to be accurate for preparations requiring special explanations (for instance, appetite suppressants and iron preparations) and that performance had improved since 1984. There are also examples of inappropriate advice being given. For instance, Goodburn et al. (1991) found that pharmacists in the United Kingdom gave inappropriate advice for the treatment of childhood diarrhea 70 percent of the time. In Germany, Glaeske (1989) found that 61 percent of all nonprescription products sold were ineffective or presented dangers to the uninformed user. In all the countries where studies have been conducted, researchers found that information-gathering and advice were often incomplete (that is, the information given was appropriate but not everything that should have been covered was discussed). In Australia, Feehan (1981) found a lack of information-gathering on patients’ characteristics. For instance, 25 of 43 pharmacists were prepared to sell a weight-reduction product without checking on the patient’s health or to see whether she was taking other medications. Glaeske (1989) reported that in Germany no pharmacist asked all the questions considered to be essential. For instance, not one trained shopper who was a woman was asked if she was pregnant or lactating. Consultation on side effects was unsatisfactory—for example, such simplistic statements as “every medication has side effects” and “there are no side effects” were sometimes made. In a 1991 study, the Consumers Association (1991) of the United Kingdom found that customers were not adequately questioned. Only 10 percent of pharmacists asked the trained shoppers what other medications they were taking. Studies in Australia (Harris et al., 1985), Canada (Willison and Muzzin, 1992), and the United Kingdom (Smith, Salkind, and Jolly, 1990) found a wide range of skills and performance between pharmacists. Feehan (1981) in Australia and Willison and Muzzin (1992) in Canada thought that this could indicate a shortcoming in pharmacists’ education for dealing with patients and that there is a need to strengthen their clinical interviewing skills. Interestingly, Smith, Salkind, and Jolly (1990) in the United Kingdom found that pharmacists’ counseling was either very good or very poor. Few pharmacists were in the middle. The studies generally found that pharmacy practice has improved as more and better counseling has been given. This is so when the same organization collected the same data at different times (Product Testing Foundation, 1984 and 1991) as well as when the results of different studies over time were compared (Willison and Muzzin, 1992). The results of studies in the United States of pharmacist counseling on nonprescription drug use are quite similar to the findings in other countries. However, no studies in the United States have assessed the frequency of pharmacy counseling on these products. Three studies assessed some aspect of the quantity of counseling. In a mail survey, Carroll and Gagnon (1983) found that 96 percent of households said the pharmacist was available to answer questions about nonprescription medications half the time or more. Meade (1992), reporting on a study conducted for APhA, noted that 69 percent of pharmacists said they counsel patients 10 or more times per day on nonprescription products, well within the range reported in Canadian pharmacies. Another survey conducted for APhA (Market Facts, 1994) indicates that pharmacist counseling for nonprescription drugs is increasing. The 1993 National Prescription Buyers Survey found that the percentage of respondents who had ever asked a pharmacist for advice about a nonprescription drug had increased from 37 percent in 1979 to 64 percent in 1993. (There was evidence that interactions with pharmacists for prescription advice had increased as well.) The other U.S. studies in table 4.2 examined the quality of counseling. In the 1960’s and early 1970’s, two studies examined pharmacists’ counseling regarding nonprescription drugs in U.S. pharmacies (Knapp et al., 1969, and Wertheimer, Shefter, and Cooper, 1973). The conclusions of both studies were generally negative. Insufficient inquiries of patients were made, counseling was infrequent, and inappropriate drugs were sold. Jang, Knapp, and Knapp (1975), while finding some positive aspects of pharmacists’ counseling, also had criticisms, including poor performance on drug monitoring and controlling OTC drug use. The Wertheimer, Shefter, and Cooper (1973) study was replicated by Vanderveen and colleagues (Vanderveen, Adams, and Sanborn, 1978; Vanderveen and Jirak, 1990). In the 1978 study, the authors concluded that the pharmacy “profession has not made any great strides in the area of OTC product counseling.” The only question asked by more than one fourth of the pharmacists was the age of the child for whom the medicine was being purchased. The 1990 study found some improvement, with a majority of pharmacists asking about both the age of the child and the duration of the illness. However, no other issue was raised by more than half the pharmacists. The general conclusion was that while pharmacists’ counseling had improved, it could still be better. Barnett, Nykamp, and Hopkins (1992) found that the majority of pharmacists questioned customers before making OTC recommendations and gave directions on their use. For one scenario, an average of 2.81 out of 5 pertinent questions were asked; for a second, an average of 1.58 questions out of 5 were asked. Combining results from the two scenarios, they found that 68.2 percent of product recommendations by pharmacists younger than 30 were appropriate while 42.4 percent by pharmacists 30 and older were appropriate. Overall, the authors concluded in 1992 that pharmacists had made strides in OTC counseling since the earlier studies. In a study of pharmacist counseling for prescription drugs in Wisconsin, where there is a requirement that pharmacists provide appropriate consultation for a prescription, Pitting and Hammel (1983) sent trained shoppers to 84 pharmacies. (The number of trained shoppers and the selection method for the pharmacies was not given.) They found that 61.5 percent of pharmacists did not consult with the patient when a prefabricated drug was dispensed, although 87.5 percent did consult on compounded products. Thus, even when pharmacists were legally required to counsel patients, not all pharmacists did so. The results of the studies in the United States are rather similar to those in countries where the sale of at least some nonprescription drugs is restricted to pharmacies. In general, the theory of pharmacy practice diverges from the reality. The advice of pharmacists is often appropriate but not universally given. In addition, it is often incomplete, with little information being given to customers on such items as possible side effects. In other words, what information is given is accurate, but not enough was passed on to consumers. Researchers consistently found a lack of information-gathering on the part of pharmacists. For instance, information is often not gathered on symptoms and other medications. More positively, within a range of pharmacists’ behavior, many pharmacists do a good job. In addition pharmacists’ performance, while still often deficient, has improved over time. One argument for an intermediate class of drugs is that pharmacists would be in a position to monitor patients for adverse drug reactions to medications in this class. In the case of a transition class, this information could be passed on to FDA and aid in its decision whether to allow the sale of a drug outside pharmacies. However, in Italy and the United Kingdom, adverse drug reaction reports from pharmacists are not accepted. In the other countries, reports from pharmacists are accepted but not required. This is the same as in the United States. Government, pharmacy, and manufacturers’ officials stated that pharmacists rarely submit adverse drug reaction reports. Thus, the experiences of the 10 other countries do not allow us to assess the benefits from or costs of requiring pharmacists to report adverse drug reactions. However, there is some limited information from the United States that suggests that community pharmacists can, at least in some situations, successfully monitor patients for adverse drug reactions. Meade (1994a and b) gives examples of pharmacists who have successfully done this. She reported on a pharmacist in Minnesota who, through consultation with a patient, detected that a prescription drug was causing the patient dizziness, chest pain, and swelling and tingling in the hands. When the prescribing physician took the patient off the drug, the symptoms disappeared. Meade also reported on a pharmacist in Tennessee who discovered from a patient’s reaction to a prescribed drug that the patient had diabetes. One potential role for pharmacists is to record prescription and nonprescription drug sales in patient profiles. This information could help link drug use with adverse drug reactions and other complications. Other uses for profiles would be prospective. For instance, a patient profile could alert a pharmacist to medical conditions that might be affected by a prescribed drug’s side effects. The pharmacist could alert the physician to the problem and, if it were appropriate, the physician or pharmacist could select a different drug without these side effects. Similarly, a profile could alert the pharmacist to possible adverse interactions with other drugs that a patient was currently taking. It is not possible to judge the usefulness of such a procedure for nonprescription products. Only in Australia are pharmacists ever required to include nonprescription drug use in patient profiles. These requirements are determined by the individual Australian states and exist only in certain states and for particular pharmacist-class drugs. The drugs for which sales must be recorded vary from state to state. There are no requirements in any of the states for recording sales of pharmacy-class drugs or drugs available outside pharmacies. Officials in Victoria told us that there has been some difficulty in getting pharmacists to comply with recording requirements. They attributed this to the requirements’ covering too many drugs and, consequently, they have reduced the list of nonprescription drugs for which the sale must be recorded to those for which they believe recording is most important. The situation in Victoria is similar to one in the state of Washington in the United States for prescription drugs. Washington has mandatory regulations governing pharmacy practice that include a requirement that pharmacists maintain and use patient profiles. In a trained shopper study, Campbell et al. (1989) found that 67 percent maintained these profiles. While this was an increase from 54 percent in 1974 (when the law was enacted), it was considerably below the law’s 100 percent. The authors speculated that it was doubtful that maintaining and using patient profiles was significantly greater in Washington than it was in states that did not have the same requirements. In 1987, the National Association of Retail Druggists surveyed pharmacists through the NARD Newsletter (The NARD Survey, 1988). More than 1,300 pharmacists responded. While 92 percent of the pharmacists reported that they maintain patient profiles, only 15 percent said that they record OTC drug sales in them. The views of many of the government officials in the countries we visited (Australia, Canada, Germany, the Netherlands, Switzerland, and the United Kingdom) were consistent with the results of the studies discussed above. There was agreement that pharmacists have done a rather poor job of passing their knowledge on to consumers. Many officials questioned the frequency of pharmacists’ counseling and thought that not enough counseling was being done. Pharmacists were selling drugs and providing little or no advice on their use. Officials gave several possible explanations for this, including time constraints and a lack of counseling skills. Nonetheless, the officials thought that pharmacists had the potential to improve drug use if they passed their knowledge on to patients. There was general agreement that pharmacists are knowledgeable and have a great deal to offer patients on the proper use of medications. This position was held even by those who opposed or questioned the usefulness of restricting the sale of some nonprescription drugs to pharmacies. Pharmacists could ask key questions about other drugs a patient is currently taking and about underlying medical conditions and could monitor compliance and report adverse drug reactions. Professional pharmacist associations in these countries are taking criticisms seriously, and many have initiated various programs to address them. They have instituted continuing education courses to give pharmacists the skills necessary to better perform their counseling role. A number of officials noted that pharmacy education has changed a great deal in the past 10 or so years. There is currently more of an emphasis on clinical pharmacy with its focus on patient service. Pharmacists who received their training before this change are often described as not having the “people skills” to be good counselors. In this section, we briefly describe some recent developments in the practice of pharmacy that are relevant to our assessment of an intermediate class of drugs. Our purpose is not to evaluate these changes but to make the reader aware of them. The idea of pharmaceutical care constitutes a major change in the practice of pharmacy. It moves pharmacists away from their traditional role of dispensing drug products and involves them more in selecting and monitoring drug therapies. The idea has been advocated in the United States by academics in university-based pharmacy schools and pharmacy organizations and has spread to other countries (the initiatives mentioned above have often been undertaken under the name of pharmaceutical care). Hepler defined pharmaceutical care as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that increase a patient’s quality of life” (1991, pp. 141-42). It involves “designing, implementing, and monitoring a therapeutic plan, in cooperation with the patient and other health professionals, that will produce specific therapeutic outcomes” (Klein-Schwartz and Hoopes, 1993, p. 11). The proponents of pharmaceutical care point to various studies (most of them in institutional settings where complete patient information exists) that show the benefits that pharmacists can have on health care. For instance, one hospital study showed shorter length of stay, smaller total cost per admission, and smaller pharmacy cost per admission for patients who received either of two programs involving pharmaceutical care (Clapham et al., 1988). In another study, elderly apartment residents were instructed in drug use and given access to drug counseling by pharmacists (Hammarlund, Ostrom, and Kethley, 1985). After 1 year, the residents who initially had the greatest number of medication problems (and were available for follow-up interviews) were found to have had an 11-percent decrease in the number of prescriptions taken and a 39-percent decrease in the number of medication problems. There is some evidence of the value of pharmaceutical care in community pharmacies. McKenney et al. (1973) examined the effect of a clinical pharmacist’s counseling hypertensive patients in three community pharmacies. Throughout the study, the pharmacist maintained close contact with the patients’ physicians. The patients who received the counseling were more likely than those who did not receive it to show an increased knowledge of hypertension and its treatment, comply more often with their prescribed therapy, and maintain their blood pressure within the normal range. In a later study, pharmacists in six community pharmacies in Virginia were trained to provide similar services (McKenney et al., 1978). Results showed improved compliance and better blood pressure control in patients receiving counseling than in those not receiving it. Pharmacists also detected 38 instances of adverse drug reactions. Rupp (1992) estimated the value of community pharmacists intervening to correct prescribing errors. Of 33,011 prescriptions that were examined, 623 (1.9 percent) were found to be problematic. The estimated value of these interventions was $76,615. Nichols et al. (1992) examined the effect of counseling on nonprescription drug purchasing decisions. They found that 25.4 percent of patients purchased a different product than they had intended after receiving counseling, 13.4 percent did not purchase a drug, and 1.3 percent were referred to their physician. However, the study did not measure the importance of these decisions (for instance, how much of an improvement was brought by changing medications). More research is being conducted on the effect of pharmaceutical care in community pharmacies. Studies are focusing on the effect of drug use reviews by pharmacists, the use of protocols by pharmacists in managing and monitoring diseases, and a pharmaceutical care program for pediatric and adolescent patients with asthma. In addition, there appears to be at least some movement among community pharmacists to implement pharmaceutical care. Training courses are offered on how to implement pharmaceutical care (Martin, 1994) and articles have been written on pharmacies where it has been established (Meade, 1994a and b). For our purposes, it is important to note that the methods and goals of pharmaceutical care are consistent with those of an intermediate drug class. The general idea of both is that pharmacists would be more involved in a patient’s drug therapy by such actions as consulting with patients. The evaluation of pharmaceutical care in community pharmacies would give some indication of the potential value of a greater role for pharmacists and, consequently, would provide some information on the value of an intermediate class of drugs. However, even if a positive value were established, or at least indicated, a number of the difficulties we have identified in this report would still have to be addressed. For nonprescription drugs, pharmacists would need to counsel patients, monitor and report adverse drug reactions, refer patients to physicians when necessary, and perform many other activities. This has not been the norm. Other issues would also need to be addressed. For instance, pharmaceutical care can take a great deal of time. Pharmacists would probably have to delegate more responsibility to technicians. The appropriate role for technicians would have to be determined. Pharmacists’ compensation for pharmaceutical care activities may be especially important. Many pharmacies now charge a fee for pharmaceutical care services. (Some pharmacies have different fees depending on the level of services offered.) However, some insurance companies have been reluctant to pay for the services (Martin, 1994). It should be clear that pharmaceutical care regarding nonprescription drugs can be given without an intermediate class of drugs. When and if pharmaceutical care is established in community pharmacies, the need for an intermediate class will still need to be established. It will still be unclear what benefits would accrue from establishing such a class of drugs. Arguments such as we hear now will still be heard (for instance, more drugs would be switched and health care costs would be reduced). The difference would be that, at least in some areas, pharmacists would be doing what is necessary for an intermediate-drug class to be successful. How much, if anything, would be gained by establishing an intermediate class of drugs, even under these circumstances, is unclear. Within the Omnibus Budget Reconciliation Act of 1990 are new requirements for the practice of pharmacy that went into effect on January 1, 1993, and that mandate prospective drug use reviews, counseling of patients, and maintenance of patient profiles for Medicaid recipients. Although these requirements cover only Medicaid beneficiaries, most (44) state boards of pharmacy have extended them to cover other patients receiving prescriptions. The goal, of course, is to improve health care through helping patients understand and follow medication directions better. Success is being evaluated by several studies funded by the Health Care Financing Administration. The applicable regulations require prospective drug use reviews before each Medicaid prescription is filled. Prescriptions are to be screened for potential problems from therapeutic duplication, drug-disease interactions, drug-drug interactions, incorrect dosage or duration of treatment, drug-allergy interactions, and clinical abuse or misuse. The pharmacist is to intervene, if necessary, before the prescription is dispensed. Additionally, in drug use reviews pharmacists must offer to counsel patients about their prescription medications. Exact counseling requirements are defined by each state. Information that might be passed on includes the name and description of the medication, the dosage, special directions and precautions, common severe side or adverse effects, interactions, therapeutic contraindications, and proper storage. Pharmacists must also make a “reasonable effort” to obtain, record, and maintain at least the following information: the patient’s name, address, telephone number, date of birth or age, and gender; the patient’s individual history, where significant, including disease states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; the pharmacist’s comments relevant to the patient’s drug therapy. The reaction of practicing pharmacists to the new requirements has been mixed. Some see it as an opportunity while others are wary. While the law requires pharmacists to perform additional duties, it does not stipulate that they should be compensated for them, despite some pharmacies’ having had to hire new employees and buy new computer software. Pharmacists are also concerned that lawsuits against them will increase. A 1994 survey conducted for the National Association of Boards of Pharmacy found that only 38 percent of all customers stated that someone in the pharmacy offered to have a pharmacist discuss their prescription medications with them. The president of the association stated that the results “clearly indicate that too few patients and caregivers are being counseled on their prescription medications.” However, the same study found that pharmacist counseling is perceived positively by the public. Seventy-one percent of offers to counsel were accepted, and the same percentage of patients thought that counseling was very important. The counseling that was done also appears to have been of a high quality, with 99 percent of respondents believing that the pharmacist had clearly presented the information and with pharmacists telling patients how and how often to use their medications at least 93 percent of the time. A large majority of patients were also told the dosage amount, the name (along with a description) of the medication, how long it should be taken, special directions or precautions, and any side effects. However, less than half of the pharmacists told patients how to monitor the effects of their medications and what they should do in the event of a missed dose. Pharmacists’ liability is becoming a concern throughout the United States.Data from the Chicago Insurance Company show that claims against pharmacists rose 22 percent from 1987 to 1990. Recent court rulings have expanded a pharmacist’s liability under some circumstances. Pharmacists in some states may now be held liable if they fail to instruct a patient about the maximum safe dosage or fail to identify a potential adverse drug interaction for a prescribed drug. (Chapter 5 discusses pharmacists’ liability in prescribing drugs in Florida.) A 1994 ruling by an Arizona appellate court also indicates that pharmacists’ liability might be increasing. According to one source, a majority of court decisions involving pharmacy liability between 1986 and 1994 had concluded that pharmacists generally did not have a responsibility to warn patients of potential adverse effects of their drug regimen. However, in Lasley v. Shrake (880 P.2d 1129 (1994)), the appellate court ruled that pharmacists have a general duty of “reasonable care” that could include a duty to warn. The case was sent back to the trial court to determine what constitutes reasonable care. In addition, some pharmacists have speculated that requirements of the Omnibus Budget Reconciliation Act of 1990 will also increase pharmacists’ potential liability, as could pharmaceutical care. While the United States has essentially only two classes of drugs (prescription and general sale, the latter commonly referred to as OTCs), there are situations in which a pharmacist may supply a prescription drug to a patient without a physician’s prescription and instances in which nonprescription drugs are not available for general sale. These include dispensing a small number of controlled substances (for instance, particular amounts of codeine) regulated under the Controlled Substances Act (Public Law 91-513, title II) and insulin. Similarly, in Florida pharmacists have been given the independent authority to dispense a limited number of prescription drugs without a doctor’s prescription. Federal law requires that prescriptions be dispensed by “practitioners” but allows individual states to determine who is a “practitioner.” In Florida, this group includes pharmacists. Finally, in some states pharmacists have been given dependent prescribing authority—that is, they may prescribe under the supervision of a physician. In this chapter, we describe these situations. The lessons that can be learned from them are relevant for both a fixed and transition class since, as with an intermediate class, pharmacists are expected to do more than simply dispense medications. Under the Controlled Substances Act of 1970, the manufacturing, distribution, and dispensing of controlled substances (that is, psychoactive drugs) is regulated. The act’s purpose, among other things, is to prevent drug abuse and dependence and strengthen law enforcement authority in the field of drug abuse. These drugs are placed into one of five categories (referred to as schedules) based on three criteria: currently accepted medical use, abuse potential, and human safety. Schedule V drugs have the fewest restrictions and may be made available by FDA without a prescription. They are defined as drugs having a low abuse potential relative to drugs or other substances in schedule IV, having a currently accepted medical use in treatment in the United States, and leading to limited physical or psychological dependence when abused relative to drugs or other substances in schedule IV. Schedule V drugs are classified as prescription or nonprescription products as determined under the Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act of 1938. Some schedule V drugs classified as nonprescription under this act are available without a prescription in some states but not all. However, even when a prescription is not required, schedule V drugs are still available only from a pharmacist. Schedule V products are few. They are the narcotic buprenorphine, the stimulant pyrovalerone, and products containing specific amounts of the narcotics codeine, dihydrocodeine, ethylmorphine, diphenoxylate with atropine sulfate, opium, or difenoxin with atropine sulfate. Larger doses of these products (when available) are in a more restricted schedule. Sellers of schedule V products must follow federal and state requirements. For instance, in Connecticut the seller must keep a record containing “the full name and address of the person purchasing the medicinal preparation, in the handwriting of the purchaser, the name and quantity of the preparation sold and the time and date of sale.” Federal regulations state more generally that the purchaser must be 18 years old or older and furnish suitable identification and that all transactions must be recorded by the dispensing pharmacist. While one purpose of the Controlled Substances Act is to improve public health, the requirements for selling a product differ from what is typically discussed for an intermediate class of drugs. Under the act, the focus is on recordkeeping; in an intermediate class of drugs, activities such as counseling and monitoring patients would be stressed. Nonetheless, the two are somewhat similar in that the pharmacist is involved in the sale and that reducing drug abuse is a goal. Any information on how successful the establishment of schedule V has been in reducing drug abuse would be helpful in evaluating the potential value of an intermediate class of drugs. However, we were unable to locate any studies evaluating the usefulness of schedule V in preventing abuse or monitoring the use of the products.Therefore, while it would be useful to know how successful schedule V has been, we have no data with which to find out. Insulin is also available without a prescription but restricted to dispensing by pharmacists in most states. However, a physician must first determine the patient’s insulin needs and provide instructions for controlling diabetes. As with schedule V products, we located no studies that evaluated the effect of this restriction. The Florida Pharmacist Self-Care Consultant Law (sometimes referred to as the Florida Pharmacist Prescribing Law), which went into effect on October 1, 1985, is unique in the United States. It allows pharmacists to independently prescribe specific categories of medications that under federal law may be dispensed only upon the prescription of a licensed practitioner; in Florida, this includes pharmacists. Perhaps the most important point about the law is that pharmacists are able to independently prescribe medicines—that is, they are not operating under the supervision of a physician. Despite this independence, the law does limit what pharmacists can do. Pharmacists are not allowed to order injectable products, treat a pregnant patient or nursing mother, order more than a 34-day supply of the drug, prescribe refills unless specifically authorized to do so in the formulary, or order and dispense anyplace but in a pharmacy. Pharmacists recommending a drug must advise patients to see a physician if their condition does not improve at the end of the drug regimen. When the law went into effect, there were 35 drugs in the formulary. Since then, 7 drugs have been added, bringing the total to 42. Responsibility for the original list, as well as for adding and deleting drugs, rests with a seven-member committee. The law states that any drug sold as an OTC product under federal law may not be included in the formulary. Among the categories of drugs in the formulary are oral analgesics, antinausea preparations, and antihistamines and decongestants. Under the law, pharmacists are not required to perform the prescribing role. However, if they choose to do so, a number of requirements pertain, including the labeling of products, creating prescriptions, and maintaining patients’ profiles. (More detail on the products in the formulary and the requirements for pharmacists is in appendix V.) In 1990, a group of researchers from the College of Pharmacy at the University of Florida reported on the effect of Florida’s Pharmacist Self-Care Consultant Law during its second and third years of operation (Eng et al., 1990). Four methods were used in the study: a survey of pharmacists, pharmacy audits, shopper visits, and a survey of consumers. The following four subsections summarize the results that are most relevant to our report. In a mail survey of pharmacists, Eng and colleagues found that pharmacists infrequently prescribed drugs from the formulary. Thirty-three percent of community pharmacists had prescribed a drug at least once. Of this group, 60 percent had prescribed less than one drug per month. The principal reasons given for not prescribing were that drugs in the formulary offered no advantages over nonprescription drugs, prescribing increased the risk of liability, and time was too short. Conversely, the main reasons for prescribing were that it helped the patient maximize self-care, used the pharmacist’s knowledge, and saved the patient money. No differences were found between the prescribers and nonprescribers with respect to gender, professional degree, position (for instance, prescription department manager and pharmacy owner), and prescription volume. The study authors did find that pharmacists with fewer years of practice were more likely to prescribe than those with more years of practice, and independent community pharmacists were more likely to prescribe than chain pharmacists. The law requires that if a pharmacist prescribes a drug, the pharmacy must maintain a profile of the patient. Of 19 pharmacies that reported that their pharmacists prescribed drugs, only 9 maintained the required profiles. The audits showed that pharmacists’ prescriptions made up a small proportion of the total number of prescriptions: less than 0.25 percent of all the medications that were prescribed in the 9 pharmacies. These prescriptions were primarily limited to topical pediculicides (lindane shampoo), oral analgesics, and otic (ear) analgesics. These categories constituted 82 percent of all pharmacists’ prescriptions. Trained shoppers found that the quality of the pharmacists’ performance in 21 community pharmacies was high in two areas: (1) following the law’s labeling and quantity limitation requirements and (2) practicing the art of communication. In more than 70 percent of the cases, the shoppers found that the pharmacist was friendly, provided some privacy, and appeared to be interested. However, the pharmacists spent very little time in assessing and responding to medical complaints presented by patients. Less than 17 percent of the 62 pharmacists asked about chronic medical conditions, medication allergies, and current prescription and nonprescription drugs that the patients were taking. Only 5 percent of the pharmacists asked about the onset, duration, and frequency of the medical problem while 13 percent asked if they had tried other medications. In less than 40 percent of the visits, pharmacists provided information on topics such as the number of doses to be taken per day, the duration of the treatment, and side effects. The authors noted that when counseling was provided, the information was generally accurate but incomplete. The performance of the 21 pharmacists in three scenarios was mixed. In a scenario leading to the recommendation of an OTC product, all 21 pharmacists recommended the correct product. However, for a scenario that should have led to referral to a physician, only 1 pharmacist made the referral. In a scenario leading to the pharmacist’s prescribing a product, the patient asked for a specific shampoo that was in the formulary; only 5 pharmacists prescribed it. The four reasons given for not prescribing were that liability insurance did not cover the pharmacist’s prescribing, it is against company policy to prescribe, a prescription is needed, and the particular pharmacist does not prescribe. Consumers in the pharmacies were surveyed to determine their attitudes toward receiving advice from pharmacists. Three principal reasons were given for seeking advice from pharmacists: confidence in their abilities, convenience, and the problem’s not being serious enough to consult a physician. All 149 of the patients who answered the question on how pleased they were with the pharmacist’s actions indicated that they were satisfied. Ninety percent of consumers said that they would follow the pharmacists’ advice regarding seeing their physician or taking a recommended OTC product or pharmacist prescribed drug. A small majority (52.3 percent) also indicated a willingness to pay a fee for a pharmacist’s services if a drug were prescribed by the pharmacist but not if the pharmacist only provided advice, recommended a nonprescription product, or referred the patient to a doctor. Of those willing to pay a separate fee, one third were willing to pay more than $5.00. Officials we met with in Florida invariably thought that the effect of the law had been minimal because few pharmacists were using their prescribing authority. One official who had previously done pharmacy inspections in Florida estimated that 1 in 50 pharmacists actually prescribed drugs. The officials’ reasons for the lack of prescribing mirrored those given by the pharmacists themselves. The first involved the drugs in the formulary. There is a belief that the drug categories available to the pharmacists and the specific drugs in them are not very useful because some OTC products work just as well. Therefore, there is no incentive for a pharmacist to use one of the drugs in the formulary to treat patients. The second explanation involved the liability issue. Individual pharmacists were concerned that they would increase their liability risk if they prescribed. Insurance companies did not want to insure individuals who prescribed drugs. The policies of some pharmacists who prescribed were canceled while others had riders attached. At one point, there was an insurance surcharge if a pharmacist wanted to prescribe. The third common reason given for pharmacists’ not prescribing was the presence of time constraints. As shown in appendix V, a number of recordkeeping requirements are associated with prescribing a drug. They take time (one official estimated 10 minutes per prescription). One official tied the recordkeeping requirements to the liability issue, noting that the paperwork involved with prescribing brings pharmacists into the spotlight and makes them more fearful of liability. In chapter 4, we discussed the practice of pharmacy in the study countries, including reports on pharmacists’ counseling on nonprescription drugs. The experiences in Florida are generally similar to those in the other countries. For example, Florida is similar to Australia—the one country where pharmacists are ever required to maintain patient profiles on nonprescription drug use—in that pharmacists often did not maintain the required profiles. Recordkeeping requirements were seen in both places as being excessive. In Florida, this was attributed to the requirements taking too much time, while in Australia the requirements were viewed as covering too many drugs. Similarly, in counseling their patients, pharmacists in other countries and Florida did not gather sufficient information from them on such items as medical conditions and other medications being taken. In many cases, counseling was more incomplete than inappropriate. Consumers’ views toward pharmacist counseling were also quite similar. Customers in Florida were generally positive toward pharmacists’ counseling, but they were less willing to pay for advice from pharmacists if only a nonprescription drug was involved. A study in Canada also found that most customers did not want advice on nonprescription drugs. While pharmacists in Florida have been given independent (although limited) prescribing authority, some pharmacists elsewhere in the United States have been given dependent prescribing authority. Typically, the pharmacists are constrained by protocols established by supervisory physicians. Dependent prescribing has not normally been discussed in terms of an intermediate class of drugs, but it does indicate roles that pharmacists have played in addition to the traditional one of dispensing medications. Because these activities are outside the scope of this report, we do not evaluate them here. Instead, we only describe alternative roles that pharmacists sometime have in the United States. The Indian Health Service (IHS), part of the U.S. Public Health Service in the Department of Health and Human Services, provides health services to American Indians and Alaskan Natives, including hospital and ambulatory medical care. IHS pharmacists are authorized to provide certain prescription drugs directly to patients without a physician’s authorization. At the outset of the program, the pharmacists could modify doses, dosage forms, and quantities of medicines and make therapeutic substitution of medicines. Later, their responsibilities were expanded to include treating minor acute illness and monitoring patients receiving chronic drug therapy between physician visits. The activities of pharmacists are defined by approved protocols that indicate their functions, responsibilities, and prescribing privileges. The protocols are organized by disease and include such elements as the criteria for inclusion in pharmacy-based care, specific definitions of the role of the referring physician or nurse and the pharmacist, criteria for periodic visits by physicians to review a patient’s status and the quality of care the pharmacist delivers, and drug therapy. In March 1995, the Department of Veterans Affairs (VA) issued a directive establishing medication prescribing authority for, among others, clinical pharmacy specialists. The directive defines inpatient and outpatient prescribing authority for clinical pharmacy specialists and other professionals, it lists the requirements for pharmacists to be given prescription authority, and it notes that each professional given the prescription authority will be limited by “a locally-determined scope of practice” that indicates his or her authority. Prescriptions written within the scope of practice do not require a physician’s signature, but those outside the scope of practice do. Nine states have established dependent prescribing privileges for pharmacists. In California, Nevada, and North Dakota, pharmacists are allowed to prescribe only in institutional settings; there are no such restrictions in the six other states. Only in New Mexico is special training required for pharmacists to prescribe. In these nine states, prescribing is done by a protocol that involves a voluntary agreement between the pharmacist and the physician. The pharmacist is responsible for initiating, monitoring, and modifying drug therapy while the physician supervises the process and overall patient care. For example, in Washington, all practicing pharmacists are eligible to initiate and modify drug therapy by protocol, but a written agreement must be developed between the pharmacist and an authorized prescriber. The agreement must be sent to the Washington State Board of Pharmacy for review. It must include, among other items, the type of prescribing authority to be exercised (including types of medical conditions and drugs or drug categories), documentation of prescriptive activities to be performed, and a mechanism for communicating with the authorizing practitioner. North Dakota recently gave pharmacists the right to prescribe but only in institutional settings (a hospital, skilled nursing facility, or swing bed facility) in which a patient’s medical records are readily available to the physician. Following diagnosis and initial patient assessment by a licensed physician, pharmacists in these settings (under the supervision of the same licensed physician) can initiate or modify drug therapy. The purpose of this report was to examine the structure and operation of drug distribution systems in other countries in order to better understand the potential advantages and disadvantages of establishing an intermediate class of drugs in the United States. The assumption is that while the experiences of other countries might not be models for the United States, they might provide a useful starting point for discussion. This chapter summarizes our findings and presents our conclusions. The two-tier U.S. drug distribution system with its prescription and general sale classes is unique among the 10 countries we studied. These countries restrict the sale of at least some nonprescription drugs to pharmacies or personal sale by a pharmacist. However, their drug distribution systems differ, and no efforts have been made to study systematically the consequences of the different systems. We found no systematic evidence to support the superiority of one drug distribution system over another. It is unclear how some of the benefits of a transition class would be realized in the United States. The experiences of other countries cannot be used to assess its usefulness because their intermediate classes are not used in this manner. Instead, they are generally viewed as fixed classes into which drugs are placed permanently. The intermediate classes are used solely to restrict access to drugs, not to facilitate their movement to general sale. It is unclear whether a transition class could be effective in monitoring adverse drug reactions while a drug is being considered for general sale. Several officials, questioning the usefulness of the data that would be collected, argued that toxicity profiles are well established through clinical research and experience with drugs as prescription products. Additionally, the data that would be collected when a drug was in the transition class would not be from well-controlled studies. The conclusions that could be drawn from the data would not be as well supported as conclusions from other types of studies. If an intermediate class were used to increase knowledge to better assess drugs for switching, pharmacists would have to keep records on patients’ drug purchases. This would allow the purchase of a drug to be linked with adverse outcomes. Pharmacists would have to record symptoms, other medical conditions, the practitioners who recommended the product, and the amount purchased. They would also have to follow up, recording experiences with a product such as efficacy, side effects, and interactions with food, drugs, and medical conditions. These recordkeeping requirements would take time and add costs; much less demanding recordkeeping requirements deter pharmacists in Florida from prescribing such drugs. Similarly, in the Australian state of Victoria, we found that pharmacists often did not maintain records of patients’ use of pharmacist-class drugs, despite being required to do so. Officials in the United States and abroad thought that an intermediate class, whether fixed or transition, would do little to prevent drug abuse. While having to buy drugs in pharmacies rather than in other outlets would be a deterrent (for instance, a consumer would have to talk to the pharmacist or would be able to buy only a small amount of the drug), this safeguard would be relatively easy to circumvent. Consumers could visit the same pharmacy on numerous occasions or go to several pharmacies to purchase the drug. Experiences in Australia and Germany in which pharmacist-controlled nonprescription drugs were either used or purchased improperly are consistent with these conclusions. All 10 countries control the prices of prescription drugs but not necessarily nonprescription products. Consequently, we could not draw useful lessons for the United States (where neither prescription nor nonprescription prices are controlled) on how prices change when a drug is switched. We did find some evidence from the United States and the United Kingdom that the price of a drug decreases when it is switched from prescription to nonprescription status. However, the effect on price of the presence or absence of an intermediate drug class has not been assessed. We also found that moving a drug to nonprescription status did not necessarily reduce health care costs. An incentive is created to obtain a drug with a prescription when such drugs remain reimbursable if they are prescribed but not if bought without a prescription. This can occur if patients have less out-of-pocket costs (for instance, because of a small copayment) for a prescription drug than for a nonprescription product, even if the nonprescription product is less expensive. The European Union has decided not to require that the member countries establish a particular drug distribution system. The European Union was not convinced of the superiority of any particular system. Each member country will be allowed to establish whatever drug distribution it wants, provided the requirements for domestic producers and importers are the same. The European Union has established criteria for distinguishing prescription from nonprescription drugs in the hope that drugs in these categories will become consistent from country to country. There are approximately 54,000 community pharmacies in the United States. This is substantially less per capita than 6 of the countries studied (if drugstores are included), while 2 other countries and the Canadian province of Ontario have approximately the same number as the United States. Only Denmark and Sweden have many fewer community pharmacies per capita than the United States. This suggests that limiting the sale of some nonprescription drugs to pharmacies in the United States would create somewhat greater access problems than in 6 of the countries. However, this is complicated by the number of other outlets such as mail-order and managed care pharmacies that might choose to sell these drugs. If such outlets chose to sell these products, the reduced access to these drugs from limiting them to sale in pharmacies could be offset. While the number of pharmacies gives some indication of access, the distance to a pharmacy is also very important. The distance that people live from pharmacies varies greatly in the United States. The nearest pharmacy can be 100 or more miles away. Restricting the sale of some nonprescription drugs to pharmacies would give individuals who have ready access to a pharmacy a greater number of nonprescription drugs from which to choose. However, if the drugs were to come from the prescription class, relative access between customers with and without ready access to a pharmacy would remain the same. The drugs would still be available for sale only in pharmacies; the difference would be that a prescription would not be required. Of the countries studied, only the United States allows self-selection of all nonprescription drugs. Denmark, France, and Italy do not allow self-service for any drugs, while the remaining countries allow it for some but not all nonprescription products. If the United States were to establish an intermediate class of drugs (whether fixed or transition), it might not allow the self-selection of these products, since the theoretical benefits associated with the class would be difficult to achieve without some control on their distribution in pharmacies. This could change the way nonprescription drug purchases are made, since comparisons between products would be more difficult for consumers to make, not being able to select intermediate-class products from the shelf personally. Our examination of the classification of 14 selected drugs in the study countries indicated no clear pattern of increased nonprescription drug availability because of the existence of a pharmacist or pharmacy class. It appears that other factors in addition to or instead of the existence of a pharmacist or pharmacy class account for differences in drug classification between the countries. Despite the absence of an intermediate class, the United States allows the sale of some of the 14 drugs without a prescription that many other countries restrict to prescription sale. Conversely, the United States restricts to prescription sale some drugs that other countries allow to be sold without a prescription but only in a pharmacist or pharmacy class. It also appears that access in one country relative to another depends in part on how access is defined. More of the 14 drugs were available for sale outside pharmacies in the United States than in any of the other countries. However, the United States restricts the sale of more of these drugs to prescription status than do 5 of the countries. These drugs, while available for sale without a prescription, are restricted to a pharmacist class. Thus, if the criterion used for defining access is the number of drugs available for general sale, the United States has the most accessible system. However, if the criterion is the number of drugs available without a prescription, the United States is somewhere in the middle in terms of accessibility. Officials in the countries we visited and the literature on pharmacist counseling generally agree that the theory of pharmacy practice diverges from the reality. The theory of pharmacy practice involves (and the success of a fixed-intermediate or transition class requires), for example, the complete and appropriate counseling of patients on such issues as dosing instructions and potential adverse drug reactions, as well as maintaining patient profiles. However, pharmacists have often not performed these roles (especially for nonprescription drugs), either in the United States or abroad, even when doing so is expected and, in some cases, required. Pharmacist counseling, as practiced, is less frequent and less thorough than desired, although it has improved over time. In efforts in the United States and elsewhere to increase the role of pharmacists, professional associations and academics are advocating the idea of “pharmaceutical care,” with its emphasis on monitoring a patient’s drug therapy rather than on dispensing the drugs. There is evidence that in institutional settings such as hospitals, there are benefits from pharmaceutical care. However, pharmaceutical care is only now being implemented in community pharmacies and its value has yet to be established. Improved drug use is often cited as a justification for an intermediate drug class, and evidence for it gives support for expanding the role of pharmacists in general. Such an expansion does not necessitate creating an additional drug class. Indeed, the current system would benefit from an improvement in pharmacist counseling. The Florida Pharmacist Self-Care Consultant Law has had very little effect on the practice of pharmacy. Pharmacists rarely prescribe drugs in the formulary. This is attributed to (1) drugs being available without a prescription that are just as effective as the ones in the formulary, (2) the perception of increased liability, and (3) burdensome recordkeeping requirements. Other countries’ and Florida’s experiences do not support a fundamental change in the drug distribution system of the United States such as creating an intermediate class of drugs, whether fixed or transition, at this time. Its benefits are unclear. No evidence at this time shows the overall superiority of a drug distribution system that restricts the sale of at least some nonprescription drugs to pharmacies. However, it should also be clear that there is no evidence that systems that do this are necessarily inferior to drug distribution systems that allow some or all nonprescription drugs to be sold outside pharmacies. The evidence that does exist tends to undermine the contention that major benefits are being obtained in countries with a pharmacist or pharmacy class. Such a class is not being used to facilitate the movement of drugs to sale outside pharmacies. Also, pharmacist counseling as it is currently practiced does not support the goals of either a fixed or a transition class. Pharmacists are not regularly counseling patients, maintaining patient profiles, or monitoring for adverse drug effects. Thus, there is no evidence to show that the role that U.S. pharmacists would have to play to support the appropriate use of an intermediate class of drugs (either fixed or transition) would be fulfilled reliably and effectively. The evidence indicates that at this time major improvements in nonprescription drug use are unlikely to result from restricting the sale of some OTCs to pharmacies or by pharmacists, nor are the safeguards for pharmacy- or pharmacist-class drugs that would have otherwise remained in the prescription class likely to be sufficient.

Summary: Pursuant to a congressional request, GAO reviewed the creation of a drug class that would be available only through pharmacies, but would not require a physician's prescription, focusing on: (1) studies and reports on the development, operation, and consequences of different drug distribution systems; (2) the drug distribution systems in 10 selected countries; (3) how access to nonprescription drugs varies between the selected countries and the United States; (4) how pharmacists ensure the proper use of nonprescription drugs; and (5) the U.S. experience with pharmacists dispensing drugs without a prescription. GAO found that: (1) available evidence shows that there are no major benefits from establishing a class of pharmacist-controlled nonprescription drugs; (2) studies have not attempted to link different drug distribution systems with differences between the countries' health care costs, adverse drug reactions, and quality of care; (3) the two-tier system in the United States is unique, since all other countries have at least one intermediate class of drugs; (4) although all 10 countries restrict some or all sales of nonprescription drugs, they do not use the pharmacy or pharmacist drug class to assess the drugs' suitability for sale outside of pharmacies; (5) the European Union has decided not to impose any particular drug distribution system on its members, since no system has proved to be superior; (6) there is no clear pattern of increased or decreased access to nonprescription drugs where an intermediate class of drugs exists; (7) the countries' safeguards to prevent drug misuse and abuse are easily circumvented and pharmacist counseling is infrequent and incomplete; (8) pharmacists are rarely required to keep records on drug use and none are required to report adverse reactions; and (9) Florida's unsuccessful experience with a similar class of drugs was due to pharmacists' failure to regularly prescribe these drugs, give patients adequate counseling, or follow recordkeeping requirements.