Payment for Services, Pain Management Needs, OTC Confusion

The concept that pharmacists should provide services to patients on a self-pay basis rather than relying on third party payers for reimbursement, as discussed in the commentary by Ganther1.Ganther J.M. Third party reimbursement for pharmacist services: why has it been so difficult to obtain and is it really the answer for pharmacy?.J Am Pharm Assoc. 2002; 42: 875-879Abstract Full Text Full Text PDF Scopus (3) Google Scholar and the Viewpoint by Winckler2.Winckler S.C. Pharmacist services: insurance need not be the only answer.J Am Pharm Assoc. 2002; 42: 826Abstract Full Text Full Text PDF Scopus (1) Google Scholar in the November/December 2002 JAPhA, is an interesting one. My own experience over the last few years has taught me that having patients pay out-of-pocket for services is not only realistic in practice but can be a much better financial approach for pharmacists to take. In my community pharmacy setting in Chino Hills, Calif., most of the standard prescriptions and some of the durable medical equipment prescriptions are paid for by third party payers. All of the other pharmacy services are self-pay. Patients pay the full amount for compounded prescription services; clinical laboratory services (i.e., lipid profiles, INR, ALT screening); immunization services (adult and pediatric); intramuscular drug administration (i.e., contraceptive agents); weight reduction program; drug therapy review, evaluation, and consulting; physical assessment (i.e., blood pressure monitoring, body composition measurement); and wound care. We post a list of the services and their costs. Most of the nonprescription services are billed at a fixed amount, although we charge an hourly rate for drug therapy review, evaluation, and consulting. The fee for the initial consultative services visit is based on the concept that the initial visit will take half an hour of the pharmacist's time, with fees for follow-up visits based on a quarter hour of the pharmacist's time. If less time is needed, profit increases, but if the visit exceeds the allocated or estimated time, profit is lower. Both patient and referrer know exactly what the service will cost. A written consult with recommendation is given to the patient and sent to his or her physician, and this document serves as a medical- legal document, as well as billing documentation. Our pharmacokinetic consult fee is based on a 1-hour visit. This approach can be used in any pharmacy since one can determine the cost for 1 hour of time and, thus, what the hourly fee should be. Immunization fees are determined by the average wholesale price of the vaccine plus an administration fee based on the fact that it takes about 5 minutes to administer a vaccine. The administration time includes the time to review the history form we require for each new patient. In one instance, we agreed to bill a patient's insurance carrier directly for his INRs because the physician had requested INRs be done as needed and this patient needed to be seen every 3 to 4 weeks. This patient had a triple bypass and an artificial mitral valve implanted, so it was critical to maintain his INR in the 3.0 to 3.5 range to prevent clot formation. I billed $65 per visit because, along with determining INR, I also evaluated his dose and present status and sent a written progress note to his cardiologist. The payer treated this service as a laboratory test and reimbursed $22.50 for each test. The company would not pay for the pharmacist consultation, so, obviously, I was losing money on each test. In addition, it took anywhere from 3 to 6 months to get paid for each test. I also needed personnel to do the proper billing based on the particular payers' requirements. As a result of this experience, I decided to never again bill third party payers. So, all of the nonprescription services, as well as compounding, are done on a cash basis at my pharmacy. This strategy eliminates cash flow problems and the need for personnel dedicated to billing and collection. We always provide patients with a receipt and recommend that they submit it to their payer. Unfortunately, I hear many stories from my patients about how poorly insurance companies pay. Our experience shows that patients are willing to pay for pharmacist services themselves once they perceive and understand a service's value and as long as the fees are reasonable. My visit fees are similar to those for a typical nonspecialist physician office visit. The strategy Ganther1.Ganther J.M. Third party reimbursement for pharmacist services: why has it been so difficult to obtain and is it really the answer for pharmacy?.J Am Pharm Assoc. 2002; 42: 875-879Abstract Full Text Full Text PDF Scopus (3) Google Scholar discussed in her commentary is neither unrealistic nor overly idealistic but practical and marketable for any ambulatory pharmacy. I hope that other pharmacists will learn from this article and maybe take a chance on offering services without payer reimbursement. I have actually found offering self-pay services to be simpler and easier than struggling for reimbursement from third party payers. Let Us Hear From You!We invite your comments on issues of interest to pharmacists or your responses to material in the journal. Send your letters of 250 words or less to: Editor, Journal of the American Pharmacists Association, 2215 Constitution Ave., NW, Washington, DC 20037-2985.Letters are edited and published at the editor's discretion. We invite your comments on issues of interest to pharmacists or your responses to material in the journal. Send your letters of 250 words or less to: Editor, Journal of the American Pharmacists Association, 2215 Constitution Ave., NW, Washington, DC 20037-2985. Letters are edited and published at the editor's discretion. I wholeheartedly agree with the conclusions of the authors of “Pain Management Content in Curricula of U.S. Schools of Pharmacy” (January/February 2003 JAPhA) that “the topic of pain management is poorly presented and inadequately developed” in pharmacy school curricula.1.Singh R.M. Wyant S.L. Pain management content in curricula of U.S. schools of pharmacy.J Am Pharm Assoc. 2003; 43: 34-40Abstract Full Text Full Text PDF Scopus (27) Google Scholar I chose to supplement my bachelor's degree in pharmacy with a master's in pain research, education, and policy because the nontraditional PharmD program did not adequately cover the area of pain management in which I wished to specialize. As part of my internship, in 2001 I investigated territory similar to that studied by the authors of the above article but on a smaller scale, covering only the four pharmacy schools in New England. My principal findings were as follows. I downloaded curricula from the schools' Web sites and contacted deans or curriculum chairs to estimate the number of hours devoted to pain management and policy in each school's program and to ask whether content specifically related to pain had recently been added to the curriculum. All four replied. I found that none of the schools offered stand-alone courses in the subject, the hours devoted to pain within other courses varied from 2 to 27, and none of the schools had recently added pain content to the pharmacy curriculum. I conducted an extensive literature search to evaluate and compare pharmacists' and other health care professionals' perceptions of pharmacists' roles in pain management and to determine what roles were actually being carried out by pharmacists. The results demonstrated a paucity of writings on the subject and, often, a discordance between the roles described in pharmacy-related journals and in other clinical literature.2.Joranson D.E. Berger J.W. Regulatory issues in pain management.J Am Pharm Assoc. 2000; 40: S60-S61Google Scholar43.Davis W.M. A pharmacist's guide to anti-inflammatories.Drug Topics. 7 December 1998; Google Scholar Next, I interviewed health care clinicians to obtain their views of pharmacists' actual or potential roles. These interviews confirmed the discordance noted above. Pharmacists envisaged a wide range of contributions, encompassing education, patient assessment and counseling, policy making, drug information, dosage conversion of analgesics, and compounding and dispensing of medication. Other clinicians, however, viewed pharmacists' roles in a narrower context, even to the extent that they sometimes perceived pharmacists as hindering patients' access to pain medication. I investigated pharmacists' contributions to pain policies, including those made in preparation for meeting the new Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards for assessing and treating pain. The recent JCAHO guidelines,44.Pain Standards for 2001. Joint Commission on Accreditation of Healthcare Organizations Web site.24 April 2001www.jcaho.org/standards_frm.htmlGoogle Scholar46.Joint Commission Resources. Design, education and change programs to manage pain consistently.Jt Comm Benchmark. 1999; 3: 4-5Google Scholar for example, do not stipulate that a pharmacist needs to be part of a multidisciplinary pain team. In addition, I examined pain medication policies and regulations introduced by the departments of public health (DPH) and the boards of pharmacy in New England states and the extent to which these policies and regulations affect access to medications and information. In 2001 the pain policies of the majority of DPHs and boards of pharmacy in New England had not been recently reviewed, and it seemed that access to medication and pain education was not at the forefront of their priorities. New policies were needed to ensure that pharmacists would be perceived to be enablers, rather than impeders, of good pain management. Finally, I conducted a study of the procedures involved in obtaining approval for the creation of a pain management pharmacist position. In spite of a nationwide shortage of pharmacists, the current health care environment dictates that such dedicated positions are cost-effective. Health care systems need to be persuaded that the creation of pharmacist positions dedicated to pain management is justified. The publication of high-impact articles similar to those submitted by pharmacists working in the intensive care setting would go a long way toward making the case for such positions.47.Montazeri M. Cook D.J. Impact of a clinical pharmacist in a multidisciplinary intensive care unit.Crit Care Med. 1994; 22: 1044-1048Crossref PubMed Scopus (132) Google Scholar48.Leape L.L. Cullen D.J. Clapp M.D. et al.Pharmacist participation on physician rounds and adverse drug events in the intensive care unit.JAMA. 1999; 282: 267-270Crossref PubMed Scopus (1242) Google Scholar My professional experience indicates that pharmacists can be actively involved in many aspects of patient care and policy, but that to do so it may be necessary to change other health professionals' perceptions. The extent of coverage devoted to pain in the current pharmacy curricula, however, may be inadequate for pharmacists to fulfill this role. The International Association for the Study of Pain has prepared and disseminated an Outline Curriculum on Pain for Schools of Pharmacy.49.International Association for the Study of Pain. Outline Curriculum on Pain for Schools of Pharmacy. International Association for the Study of Pain, Seattle, Wash10 April 2003www.iasp-pain.org/pharmacy_toc.htmlGoogle Scholar Clearly, we are a long way from meeting these guidelines. Since Claritin (loratadine— Schering-Plough) was approved for over-the-counter (OTC) marketing on November 27, 2002, three brands of loratadine have been marketed, and consumers will soon need to choose among those and many more generic equivalents that are set to follow. This rapid influx of multiple products with different names but similar ingredients may cause confusion among Americans seeking to relieve springtime allergy symptoms. At this time, consumers can choose among OTC Claritin, Alavert (Wyeth Consumer), and Tavist ND (Novartis) for products containing the active ingredient loratadine. The fact that three loratadine products came onto the market almost simultaneously with a barrage of advertisements could make differentiating one from the other difficult for prospective users, and this confusion could lead to possible medication overdose. Some of the statements in the ads, especially the TV and the Internet versions of the Alavert advertisements, may cause confusion for certain consumers. Before it was switched to OTC status, loratadine was the highest selling prescription drug. OTC availability of Claritin was long-awaited news for consumers with seasonal allergic rhinitis, associated with sneezing, runny nose, and itchy, watery eyes. In announcing this Rx-to-OTC switch, FDA Commissioner Mark McClellan, MD, PhD, said, “This approval reflects FDA's commitment to bringing prescription drugs to OTC when they can be safely used without a prescription.”1.FDA approves OTC Claritin. FDA Consumer. January-February 2003; : 3Google Scholar FDA indicated that it is a potentially safer replacement for older OTC antihistamines that might contribute to driving impairment, especially if there is overdosing.1.FDA approves OTC Claritin. FDA Consumer. January-February 2003; : 3Google Scholar However, a recent study reporting a meta-analysis comparing the use of diphenhydramine and second-generation antihistamines indicated that there is no clear and consistent distinction between sedating and nonsedating antihistamines.2.Bender B. Berning S. Dudden R. et al.Sedation and performance impairment of diphenhydramine and second-generation antihistamines: a meta-analysis.J Allergy Clin Immunol. 2003; 111: 770-776Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar Furthermore, the same study indicated that although some newer antihistamines may claim to have a lower sedating effect, it was mainly dose-dependent, and the lower sedation effect claimed was significantly different from that of a placebo. The researchers concluded that second-generation antihistamines, including products containing loratadine, were not nonsedating.2.Bender B. Berning S. Dudden R. et al.Sedation and performance impairment of diphenhydramine and second-generation antihistamines: a meta-analysis.J Allergy Clin Immunol. 2003; 111: 770-776Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar As competition increased, several advertisements were launched by manufacturers of diverse brands of loratadine. The Internet and print advertisements for Claritin compare several allergy medications with each other.3.Claritin vs. other brands. 7 April 2003; (Available at, Accessed)www.claritin.com/content/learn_about/claritin_products/claritin_tablets_chart.htmlGoogle Scholar These advertisements clearly state that consumers need not restrict their driving or operation of machinery when using Claritin.3.Claritin vs. other brands. 7 April 2003; (Available at, Accessed)www.claritin.com/content/learn_about/claritin_products/claritin_tablets_chart.htmlGoogle Scholar However, when referring to warnings about driving and operating machinery, the advertisement just indicates “no restriction” without clarifying the dose requirements.3.Claritin vs. other brands. 7 April 2003; (Available at, Accessed)www.claritin.com/content/learn_about/claritin_products/claritin_tablets_chart.htmlGoogle Scholar This statement may be misleading for some consumers who may take higher doses of the drug, advertently or inadvertently. Higher doses of loratadine may cause sedation.2.Bender B. Berning S. Dudden R. et al.Sedation and performance impairment of diphenhydramine and second-generation antihistamines: a meta-analysis.J Allergy Clin Immunol. 2003; 111: 770-776Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar4.OTC Loratadine. Med Lett Drugs Ther. 2003; 45: 3--4Google Scholar FDA requires that advertisements for these products present balanced reporting of risks and benefits and that all the potential risks be stated clearly. The advertisements for these products, especially those that were recently switched from Rx to OTC status, should necessarily promote product safety and inform about adverse events because of the nonprescription nature of these drugs. In addition, the advertisements for Alavert (both Internet and TV) claim that it is a “new” non-drowsy product for seasonal allergies, without any statements mentioning the dosage.5.The Alavert advantage. Alavert Web site.7 April 2002www.alavert.com/chart/index.aspGoogle Scholar6.Introducing Alavert. 7 April 2002; (Available at, Accessed)www.alavert.comGoogle Scholar Furthermore, the same advertisements assert that Alavert provides 24-hour nondrowsy relief, which “even Claritin can't beat.”6.Introducing Alavert. 7 April 2002; (Available at, Accessed)www.alavert.comGoogle Scholar Consumers with severe allergies who may be taking Claritin may misconstrue this ad, thinking that Alavert is truly a different medication from Claritin with a different active ingredient. This could lead to either product replacement (switching from Claritin to Alavert) or overdosing (taking Alavert along with Claritin). Pharmacists should be aware of these possibilities and counsel patients accordingly, as opportunities arise. Although FDA insists that broadcast ads for medications should be neither false nor misleading,7.FDA finalizes guidance on DTC ads.Am J Health Syst Pharm. 1999; 56: 1815Google Scholar the agency rarely evaluates the effects of these ads on consumers' understanding and perceptions. Notification is usually given to the manufacturers for broadcasting ads that may be misleading in some aspect or do not comply with FDA guidance. However, this usually happens after the ads have already been broadcast. FDA should look into the matter and try to be proactive, because any delay in action may adversely affect certain consumers. FDA should monitor ads for loratadine products aggressively, especially since Claritin was the highest selling prescription product. We were quite surprised to find that liquid Kaopectate and Children's Kaopectate, brand-name antidiarrheals marketed by Pfizer, were recently reformulated to contain bismuth subsalicylate, and we wanted to share important information about this change with other clinicians. Prior to their reformulations, these products contained attapulgite, a magnesium aluminum silicate compound capable of adsorbing up to eight times its weight in water. However, in the absence of controlled trials, the U.S. Food and Drug Administration's (FDA) Nonprescription Drugs and Gastrointestinal Drugs Advisory Committees in 1993 deemed the efficacy of attapulgite for adult diarrhea to be unproven.1.Attapulgite to lose monograph status as antidiarrheal ingredient. Nonprescription Pharmaceuticals and Nutritionals. 1993; 4 (October): 1-2Google Scholar2.Antidiarrheal drug products for over-the-counter human use: tentative final monograph, 51.Federal Register. 1986; 16138Google Scholar At the time of this writing, a final ruling on the safety and efficacy of non-prescription antidiarrheal agents was expected to be issued by FDA in April 2003. At that time, manufacturers may be obligated to reformulate antidiarrheal products containing ingredients not accepted as safe or efficacious for their labeled indications. Of note, Children's Kaopectate continues to be labeled for use in children 3 years and older, despite the salicylate content (87 mg bismuth subsalicylate/5 mL). The label does contain a warning about the potential for Reye's syndrome, stating that Children's Kaopectate should not be used in children or adolescents who have or are recovering from influenza or chicken pox. However, knowledge of the active ingredient is also important since Kaopectate and Children's Kaopectate should be avoided in patients with allergies to aspirin or other salicylates and in those taking medications that may interact with salicylates (e.g., warfarin). In addition, toxicity is possible in patients receiving salicylates from other sources, or even following prolonged therapy using the manufacturer's recommended dosage regimens.3.Safety briefs. ISMP Medication Safety Alert!. 6 March 2003; Google Scholar Consumers or clinicians who are unaware of the bismuth content of the new products may suspect upper gastrointestinal bleeding, as bismuth salts may darken the stool. Bottles of attapulgite-containing Kaopectate liquid may still be found on pharmacy shelves as the new formulations are phased in. The new bottles may be identified by the “New & Improved” flag on the front label. Confusing matters further, Kaopectate caplets will not be reformulated until later this year and kaolin-pectin suspension continues to be marketed by several manufacturers. Pharmacists and other clinicians need to be aware of this change in formulation and to counsel consumers regarding the bismuth subsalicylate content in the new Kaopectate product line. We recognize that pharmaceutical manufacturers periodically change the active ingredients of their nonprescription products. However, we believe that when such changes occur, the manufacturer should publicize these changes widely to clinicians in order to prevent potential drug-related problems. Although information regarding this formulation change is now available at the Pfizer Web site and at www.kaopectate.com, it was not located by others3.Safety briefs. ISMP Medication Safety Alert!. 6 March 2003; Google Scholar or by us in an initial search. I am a registered pharmacist, a graduate of Ohio State University College of Pharmacy Class of 1952, and a continuous member of the American Pharmaceutical Association since 1954. The article “Pharmaceutical Sciences in America 1952— 2002”1.Feldmann E.G. The Pharmaceutical Sciences in American, 1952-2002.J Am Pharm Assoc. 2002; 42: 828-830Abstract Full Text Full Text PDF Scopus (2) Google Scholar by Dr. Ed Feldmann, in the November-December 2002 JAPhA, was of particular interest to me personally since my professional career has been primarily in industrial pharmacy. In 19541 started in research and development (R&D), working on dosage form development for Sterling Winthrop Research Institute. Longer term, I served as R&D vice president for two major pharmaceutical corporations before retiring to my consultant practice in New Jersey. During the period prior to 1986, the APhA Scientific Section and Academy of Sciences provided an invaluable forum at APhA meetings for pharmacists in industry to explore new technologies. Many important contributions to innovative new drug products were developed as a result of the interactions and communications at this forum. Since the formation of the separate American Association of Pharmaceutical Scientists (AAPS) in 1986, such a forum has existed only within AAPS, and there has been minimal contact between pharmacists in industry and pharmacists in other areas of practice. I continue to maintain memberships in both the APhA Academy of Pharmaceutical Research and Science (APhA-APRS) and AAPS. I encourage other pharmacists in industry to join APhA and APhA-APRS; presently APhA-APRS counts few pharmacists involved in industry among its members. It would be valuable to have a forum for this group to interact with the many practitioners represented by the renamed American Pharmacists Association.