All pharmacists must be effective medication information providers regardless of their practice. As defined by the New Mexico Conference, an effective provider perceives, assesses, and evaluates medication information needs and retrieves, evaluates, communicates, and applies data from the published literature and other sources as an integral component of patient care. If the profession is to be successful in accepting patient care responsibilities, all pharmacists must have a certain minimum level of skill to survive in the changing practice environment. Developing the skills of an effective medication information provider is the foundation for the pharmacist to be a lifelong learner and problem solver. The literature is a valuable component of both of these processes and will allow the individual pharmacist to adapt to the needs of a continually changing health care system.
Opportunities abound for pharmacists to use medication information skills in all practice settings either as a generalist or a specialist practitioner. There is still the need for the practitioner to have support from drug information centers to meet special information needs, to serve as a resource on effective medication use, and to assist pharmacy practitioners as well as others in solving medication therapy situations. Individuals with special training as medication information specialists will still be needed to operate the centers and to provide leadership in the area of drug informatics, institutional drug policy, poison control, pharmaceutical industry, and in academia.
References
1. Parker PF. The University of Kentucky drug information center. Am J Hosp Pharm. 1965;22:42–7.
2. Amerson AB, Wallingford DM. Twenty years' experience with drug information centers. J Hosp Pharm. 1983;40:1172–8.[PMID: 6881155]
3. Walton CA. The problem of communicating clinical drug information. J Hosp Pharm. 1965;22:458–63.
4. Lowe HJ, Barnett GO. Understanding and using the medical subject headings (MESH) vocabulary to perform literature searches. JAMA. 1994;271:1103–18.[PMID: 8151853]
5. Institute of Medicine. Health professions education: a bridge to quality. Washington, DC: National Academy Press; 2003.
6. Mehnert RB. A world of knowledge for the nation's health: The U.S. National Library of Medicine. J Hosp Pharm. 1986;43:2991–7.[PMID: 3544826]
7. Walton CA. Education and training of the drug information specialist. Drug Intell. 1967;1:133–7.
8. Francke DE. The role of the pharmacist as a drug information specialist. J Hosp Pharm. 1966;23:49.[PMID: 5907110]
9. Koumis T, Cicero LA, Nathan JP, Rosenberg JM. Directory of pharmacist-operated drug information centers in the United States—2003. J Health Syst Pharm. 2004;61:2033–42.[PMID: 15509126]
10. Rosenberg JM, Koumis T, Nathan JP, Cicero LA, McGuire H. Current status of pharmacist-operated drug information centers in the United States. J Health Syst Pharm. 2004;61:2023–32.[PMID: 15509125]
11. Drug topics red book. Montvale(NJ). Medical Economics; 2004.
12. Kinky DE, Erush SC, Laskin MS, Gibson GA. Economic impact of a drug information service. Ann Pharmacother. 1999;33:11–6.[PMID: 9972378]
13. LaFleur J, Tyler LS, Sharma RR. Economic benefits of investigational drug services at an academic institution. Am J Health Syst Pharm. 2004;61:27–32.[PMID: 14725117]
14. Study Commission on Pharmacy. Pharmacists for the future. Ann Arbor (MI): Health Administration Press; 1975. p. 139.
15. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990;47:533–50.[PMID: 2316538]
16. American Society of Health-System Pharmacists. ASHP guidelines on the provision of medication information by pharmacists. Am J Health Syst Pharm. 1996;53:1843–5.
17. Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health care system. Washington, DC: National Academy Press; 1999.
18. Vioxx (rofecoxib) information [monograph on the Internet]. Washington: Food and Drug Administration; 2005 [accessed 2007 Jan 18]. Available from: http://www.fda.gov/cder/drug/infopage/vioxx/default.htm
19. Stricker BH, Psaty BM. Detection, verification, and quantification of adverse drug reactions. BMJ. 2004;329:44–7.[PMID: 15231627]
20. Landis NT. ADE rate uncertain, reporting systems inadequate, GAO tells legislators. Am J Health Syst Pharm. 2000;57:515–9.[PMID: 10754757]
21. Grissinger M. Adverse drug reactions: documentation is important, but communication is critical. P&T. 2004;29:5.
22. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health Syst Pharm. 1995;52:417–9.
23. Fink JL, Vivian JC, Keller RK, editors. Pharmacy law digest. St Louis (MO): Facts and Comparisons; 1999.
24. FDA issues regulation prohibiting sale of dietary supplements containing ephedrine alkaloids and reiterates its advice that consumers stop using these products [monograph on the Internet]. Washington: Food and Drug Administration; 2004 Feb 6 [accessed 2007 Jan 18]. Available from: http://www.fda.gov/bbs/topics/NEWS/2004/NEW01021.html
25. FDA letter warning health care professionals about kava. Available from: http://www.fda.gov/medwatch/safety/2001/kava.htm
26. Ansani NT, Ciliberto NC, Freedy T. Hospital policies regarding herbal medicines. Am J Health Syst Pharm. 2003;60:367–70.[PMID: 12625219]
27. Wachter RM. The end of the beginning: patient safety five years after "To Err Is Human." Health Aff [serial on the Internet]. 2004 Nov 30 [accessed 2007 Jan 18]: [about 9 p.]. Available from: http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.534/DC1.
28. Johnson ST, Wordell CJ. Internet utilization among medical information specialists in the pharmaceutical industry and academia. Drug Inf J. 1998;32:547–54.
29. Malone PM, Young WW, Malesker MA. Wide area network connecting a hospital drug informatics center with a university. Am J Health Syst Pharm. 1998;55:1146–50.[PMID: 9626377]
30. Berland GK, Elliott MN, Morales LS, Algazy JL, Kravitz RL. Health information on the Internet: accessibility, quality, and readability in English and Spanish. JAMA. 2001;285:2612–21.[PMID: 11368735]
31. Kim P, Eng TR, Deering MJ, Maxfield A. Published criteria for evaluating health related websites: review. BMJ. 1999;318:647–9.[PMID: 10066209]
32. Murray E, Pollack L, Donelan K, Catania J, Lee K. The impact of health information on the Internet on health care and the physician-patient relationship: national U.S. survey among 1050 U.S. physicians. J Med Internet Res. 2003;5:e17.
33. Belgado BS. Drug information centers on the Internet. J Am Pharm Assoc. 2001;41:631–2.[PMID: 11486993]
34. Dugas M, Weinzierl S, Pecar A, Hasford J. Am J Health Syst Pharm. 2001;58:799–802.[PMID: 11351921]
35. Ruppelt SC, Vann R. Marketing a hospital-based drug information center. 2001;58;1040.
36. Erbele SM, Heck AM, Blankenship CS. Survey of computerized documentation system use in drug information centers. Am J Health Syst Pharm. 2001;58:695–7.[PMID: 11329762]
37. McCreadie SR, Stevenson JG, Sweet BV, Kramer M. Using personal digital assistants to access drug information. Am J Health Syst Pharm. 2002;59:1340–3.[PMID: 12132560]
38. Brody JA, Camamo JM, Maloney ME. Implementing a personal digital assistant to document clinical interventions by pharmacy residents. Am J Health Syst Pharm. 2001;58:1520–2.[PMID: 11515349]
39. Barrons R. Evaluation of personal digital assistant software for drug interactions. Am J Health Syst Pharm. 2004;61:380–5.[PMID: 15011766]
40. Silva MA, Tataronis GR, Maas B. Using personal digital assistants to document pharmacist cognitive services and estimate potential reimbursement. Am J Health Syst Pharm. 2003;60:911–5.[PMID: 12756942]
41. Reilly JC, Wallace M, Campbell MM. Tracking pharmacist interventions with a hand-held computer. Am J Health Syst Pharm. 2001;58:158–61.[PMID: 11202540]
42. Lau A, Balen RM, Lam R, Malyuk DL. Using a personal digital assistant to document clinical pharmacy services in an intensive care unit. Am J Health Syst Pharm. 2001;58:1229–32.[PMID: 11449881]
43. Lynx DH, Brockmiller HR, Connelly RT, Crawford SY. Use of PDA-based pharmacist intervention system. Am J Health Syst Pharm. 2003;60:2341–4.[PMID: 14652983]
44. Grasso BC, Genest R, Yung K, Arnold C. Reducing errors in discharge medication lists by using personal digital assistants. Psychiatr Serv. 2002;53:1325–6.[PMID: 12364687]
45. Clark JS, Klauck JA. Recording pharmacists' interventions with a personal digital assistant. Am J Health Syst Pharm. 2003;60:1772–4.[PMID: 14503114]
46. Clauson KA, Seamon MJ, Clauson AS, Van TB. Evaluation of drug information databases for personal digital assistants. Am J Health Syst Pharm. 2004;61:1015–24.[PMID: 15160777]
47. Lowry CM, Kkostka-Rokosz MD, McCloskey WW. Evaluation of personal digital assistant drug information databases for the managed care pharmacist. J Manag Care Pharm. 2003;9:441–8.[PMID: 14613442]
48. Elson RB, Connelly DP. Computerized medical records in primary care and their role in mediating guideline-driven physician behavior change. Arch Fam Med. 1995;4:698–705.[PMID: 7620600]
49. Evans RS, Pestotnik SL, Classen DC, Clemmer TP, Weaver LK, Orme JF, Jr. et al. A computer-assisted management program for antibiotics and other anti-infective agents. N Engl J Med. 1998;338:232–8.[PMID: 9435330]
50. Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based clinical support systems on physician performance and patient outcomes: a systematic review. JAMA. 1998;280:1339–46.[PMID: 9794315]
51. Rind DM, Kohane IS, Szolovits P, et al. Maintaining the confidentiality of medical records shared over the Internet and world wide web. Ann Intern Med. 1997;127:138–44.[PMID: 9230004]
52. Frisse ME. What is the Internet learning about you while you are learning about the Internet? Acad Med. 1996;71:1064–107.[PMID: 9177639]
53. Giacalone RP, Cacciatore GG. HIPAA and its impact on pharmacy practice. Am J Health Syst Pharm. 2003;60:433–45.[PMID: 12635449]
54. Blank C. Spending on pharmaceuticals will pass $180 billion by 2008. Hosp Pharma Rep. 1998;12:54.
55. Hoffman JM, Shah ND, Vermeulen LC, Hunkler RJ, Hontz KM. Projecting future expenditures—2005. Am J Health Syst Pharm. 2005;62:149–67.[PMID: 15700889]
56. Altman DE. The new medicare prescription drug legislation. N Engl J Med. 350:1:9–10.
57. Institute of Medicine. Insuring America's health: principles and recommendations. Washington, DC; 2004.
58. Opportunities for the community pharmacist in managed care. Special Report. Washington, DC: American Pharmaceutical Association; 1994.
59. Ellrodt G, Cook DJ, Lee J, Cho M, Hunt D, Weingarten S. Evidence-based disease management. JAMA. 1997;278:1687–92.[PMID: 9388089]
60. Vermeulen LC, Beis SJ, Cano SB. Applying outcomes research in improving the medication-use process. Am J Health Syst Pharm. 2000;57:2277–82.[PMID: 11146972]
61. Top 10 areas of research: report on the most popular fields of drug development. Med Ad News. 2003;137:22:S22.
62. Emilien G, Ponchon M, Caldas C, et al. Impact of genomics on drug discovery and clinical medicine. Q J Med. 2000;93:391–423.[PMID: 10874050]
63. Epler GR, Laskaris LL. Individualization health care and the pharmaceutical industry. Am J Health Syst Pharm. 2001;58:1042.[PMID: 11402480]
64. Special feature: direct-to-consumer advertising. Med Mark Media. 1996;15:8.
65. Piturro M. D-T-C thrives. Managed Health Care News. 1998;14:1.
66. Young D. FDA examines direct-to-consumer advertising data. Am J Health Syst Pharm. 2003;60:2420–1.[PMID: 14686217]
67. Basara LR. The impact of a direct-to-consumer prescription medication advertising campaign on new prescription volume. Drug Inf J. 1996;30:715–29
68. Larner AJ. Use of Internet medical websites and of NHS direct by neurology outpatients before consultation [abstract]. J Neurol Neurosurg Psychiatry. 2002;72:140.
69. Silberg W, Lundberg GD, Musacchio RA. Assessing, controlling, and assuring the quality of medical information on the Internet. JAMA. 1997;277:1244–5.[PMID: 9103351]
70. Wyatt J. Measuring quality and impact on the world wide web. BMJ. 1997;314:1879–81.[PMID: 9224133]
71. Practice and Policy Guidelines Panel, National Institutes of Health Office of Alternative Medicine. Clinical practice guidelines in complementary and alternative medicine an analysis of opportunities and obstacles. Arch Fam Med. 1997;6:149–54.
72. McQueen CE, Shields KM, Generali JA. Motivations for dietary supplement use. Am J Health Syst Pharm. 2003;60:655.[PMID: 12701546]
73. Pal S. Herbal sales reach mainstream market. US Pharm. 1999;24:12.
74. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990–1997: results of a national survey. JAMA. 1998:280:1569–75.
75. Shields KM, McQueen CE, Bryant PJ. National survey of dietary supplement resources at drug information centers. J Am Pharm Assoc. 2004;44:36–40.[PMID: 14965151]
76. West PM, Lodolce AE, Johnston AK. Telephone service for providing consumers with information on herbal supplements. Am J Health Syst Pharm. 2001;58:1842–6.[PMID: 11596701]
77. Meade V. Patient medication information hotlines multiply. Am Pharm. 1991;NS31:569–71.
78. Troutman WG. Consensus-derived objectives for drug information education. Drug Inf J. 1994;28:791–6.
79. Ferrill MJ, Norton LL. Drug information to biomedical informatics: a three tier approach to building a university system for the twenty-first century. Am J Pharm Edu. 1997;61:81–6.
80. Gora-Harper ML, Brandt B. An educational design to teach drug information across the curriculum. Am J Pharm Educ. 1997;61:296–302.
81. Miller S, Clarke A. Impact of postdoctoral specialty residencies in drug information on graduates' career paths. Am J Health Syst Pharm. 2002;59:961–3.[PMID: 12040736]
82. Forrester LP, Scoggin JA, Valle RD. Pharmacy management company-negotiated contract for drug information services. Am J Health Syst Pharm. 1995;52:1074–7.[PMID: 7656096]
83. Fox ER, Tyler LS. Managing drug shortages: seven years' experience at one health-system. Am J Health Syst Pharm. 2003;60:245–53.[PMID: 12613233]
84. Woodruff AE, Hunt CA. Involvement in medical informatics may enable pharmacists to expand their consultation potential and improve the quality of health care. Ann Pharmacother. 1992;26:100–4.[PMID: 1606329]
85. Vanscoy GJ, Gajewski LK, Tyler LS, Gora-Harper ML, Grant KL, May JR. The future of medication information practices: a consensus. Ann Pharmacother. 1996;30:876–81.[PMID: 8826577]
86. Warren PN. Pharmacists to the fore. Managed Health Care News. 1997;13:20H–20I.
87. Zinberg S. Practice guidelines—a continuing debate. Clin Obstet Gynecol. 1998;41:343–7.[PMID: 9646966]
88. Field JM, Lohr KN, editors. Guidelines for clinical practice: from development to use. Washington, DC: National Academy Press; 1992.
89. Harrison MAJ, Draugalis JR, Slack MK, Langley PC. Cost-effectiveness of regional poison control centers. Arch Intern Med. 1996;156:2601–8.[PMID: 8951304]
90. Gong SD, Millares M, VanRiper KB. Drug information pharmacists at health-care facilities, universities, and pharmaceutical companies. Am J Hosp Pharm. 1992;49:1121–30.[PMID: 1595739]
91. Riggins JL. Pharmaceutical industry as a career choice. Am J Health Syst Pharm. 2002;59:2097–8.[PMID: 12434723]
92. Overstreet KM. Medical education and communication companies: career options for pharmacists. Am J Health Syst Pharm. 2003;60:1896–7.[PMID: 14521042]
93. Moghadam RG. Scientific writing: a career for pharmacists. Am J Health Syst Pharm. 2003;60:1899–1900.[PMID: 14521044]
Copyright ©2007 The McGraw-Hill Companies. All rights reserved.
Privacy Notice. Any use is subject to the Terms of Use and Notice. Additional Credits and Copyright Information.
Wednesday, March 26, 2008
Pharmaceutical Industry
The pharmaceutical industry provides many career opportunities for pharmacists in a variety of areas including drug discovery, product development, information technology, training and development, scientific communications, health outcomes research, regulatory affairs, professional affairs, medical information services, and clinical research. Within the area of medical information services, the pharmacist participates in typical types of activities such as answering drug information questions, reporting and monitoring ADRs, and providing information support to other departments. Other positions in medication information services include disease specialist, health outcomes associate, labeling associate, and medical or scientific writer. Pharmacists providing medication information in the pharmaceutical industry may also provide support for individuals responsible for drug formularies or participate in quality improvement efforts with the medication use process. In addition to providing written information on the drug product produced by the manufacturer, there are opportunities to provide additional information at pharmacy and therapeutics committees or state drug use review (DUR) boards. Pharmaceutical companies have extensive scientific data on their products; some of which are not available through other published sources or may require a formal FOI (freedom of information) request. Medication information specialists may also serve as reviewers for journal articles, evidence-based guidelines, and published drug monographs. Medication information specialists may interact with sales and marketing, participate with regulatory affairs issues, and handle product complaints.
Pharmacists with specialized training can take a leadership role in evaluating current research, helping to manage ongoing research, or designing studies to help answer questions about new indications for future use of the product. The impact of new medications on the health care environment is also felt within the pharmaceutical industry. The area of health outcomes research is fairly new and growing and offers tremendous opportunity for pharmacists to share their knowledge of the health care environment, research design, technology, and economics from the perspective of the pharmaceutical industry. As the sophistication of drug products and information management (e.g., electronic new drug applications [NDAs]) has increased, so have the opportunities for pharmacists to practice in the pharmaceutical industry and focus on using the skills of a medication information specialist.
Pharmacists with specialized training can take a leadership role in evaluating current research, helping to manage ongoing research, or designing studies to help answer questions about new indications for future use of the product. The impact of new medications on the health care environment is also felt within the pharmaceutical industry. The area of health outcomes research is fairly new and growing and offers tremendous opportunity for pharmacists to share their knowledge of the health care environment, research design, technology, and economics from the perspective of the pharmaceutical industry. As the sophistication of drug products and information management (e.g., electronic new drug applications [NDAs]) has increased, so have the opportunities for pharmacists to practice in the pharmaceutical industry and focus on using the skills of a medication information specialist.
Poison Control
Poison information is a specialized area of medication information with the practitioner typically practicing in an accredited poison information center or an emergency room. Similar to the mission of traditional drug information centers, poison information centers exist to provide accurate and timely information to enhance the quality of care of patients. There are, however, several differences between a traditional drug information center and poison control center. Health professionals generate most consultations received in drug information centers, whereas, in a poison control center, most are generated from the public. Poison information centers must be prepared to provide information on the management of any poison situation, including household products, poisonous plants and animals, medications, and other chemicals. Because of the type of information that the specialist provides, nearly all requests for information to a poison control center are urgent, with an average response time of 5-minutes, compared to anywhere from 30 minutes to days for drug information centers depending on the urgency of the call and complexity of information required. A specialist in poison information therefore requires expertise in clinical toxicology, as well as an ability to obtain a complete history that correctly assesses the potential severity of exposure, an understanding of where to search for this type of information, and the ability to communicate the information and plan in a comprehensive, concise, and accurate manner to consumers with varied levels of education. Because of the unique expertise of this type of specialist, a national certification examination is offered through the American Association of Poison Control Centers (AAPCC, http://www.aapcc.org/). In addition to a poison control center providing information regarding individual patients, centers in the United States also contribute data to a larger program through the Toxic Exposure Surveillance System (TESS), which is coordinated by the AAPCC. These data can be used to compare safety profiles for similar products, to develop risk assessment guidelines for specific substances, to target national prevention programs, and to conduct postmarketing surveillance on products (e.g., chemicals).
Despite the impact that regional poison control centers have on reducing morbidity and mortality with poison exposures, they are also facing increasing emphasis on economic justification. One study used decision analysis to compare the cost-effectiveness of treatment of poison exposures with the services of a regional poison control center to treatment without access to any poison control center. The average cost per patient treated with the services of a poison control center was almost half of that achieved without services of a poison control center. These results were consistent regardless of exposure type, average inpatient and emergency department costs, and clinical outcome probabilities.
Despite the impact that regional poison control centers have on reducing morbidity and mortality with poison exposures, they are also facing increasing emphasis on economic justification. One study used decision analysis to compare the cost-effectiveness of treatment of poison exposures with the services of a regional poison control center to treatment without access to any poison control center. The average cost per patient treated with the services of a poison control center was almost half of that achieved without services of a poison control center. These results were consistent regardless of exposure type, average inpatient and emergency department costs, and clinical outcome probabilities.
Health Maintenance Organizations (HMOs)/Pharmacy Benefit Management Organizations (PBMs)/Managed Care Organizations (MCOs)
A key opportunity identified in a strategic planning meeting in 1994 by the Consortium for the Advancement of Medication Information, Policy and Research (CAMIPR) was the growing role for medication information specialists in the area of medication policy development/research and technology. Since pharmaceuticals account for approximately 10% of health care dollars, which is up from 7% 5 years earlier, this offers tremendous opportunities for the medication information specialist to provide leadership in the development and implementation of mechanisms to support the cost-effective selection and use of medications in HMOs, PBMs, and managed care organizations. The specialist may coordinate activities relating to formulary development and implementation, ADE reporting and analysis, and therapeutic guideline development. Medical and pharmaceutical outcomes research has been an increasing interest among health care providers, payers, and regulatory agencies. With appropriate training (e.g., specialized residency in medication information practice or managed care experience) and expertise, opportunities are growing for the medication information specialist in the insurance industry, HMOs, managed care organizations, pharmacy benefits management companies, state and national government agencies (e.g., Medicaid and Medicare), as well as other groups interested in the cost-efficient use of medications.
A pharmacist in any of these organizations has the opportunity to evaluate new information for medications on the market and assess its true value in a target group of patients. Prior to approval by the FDA, drugs undergo testing in a limited number of patients. Once approved, experience in patients escalates and previously unrecognized, rare adverse events may be identified. The drug may also be found to be useful for conditions not described in the labeling. Perhaps one of the most important functions of postmarketing surveillance is in the area of ADR reporting. This type of analysis can answer questions about drug interactions, identify potential new indications for the product, and study patients in a broader population. Organizations with a relatively large patient population offer opportunities to study these issues under the leadership of a medication information specialist.
Opportunities also exist to establish guidelines for selected disease states (e.g., management of patients with diabetes mellitus) or classes of drugs (e.g., selection of appropriate antibiotic for surgical prophylaxis). Practice guidelines are becoming an increasingly important part of the biomedical literature. These clinical guidelines are systematically developed to assist practitioners and patients with decisions about health care in an effort to improve the quality and consistency of health care while minimizing costs and liability. Evidence-based practice guidelines are developed through systematic reviews of the literature appropriately adapted to local circumstances and values. Key questions to consider when reviewing a practice guideline have been proposed. These questions primarily rely on how accurately the guideline reflects the research used to produce it. More information on therapeutic guidelines can be found in .
A pharmacist in any of these organizations has the opportunity to evaluate new information for medications on the market and assess its true value in a target group of patients. Prior to approval by the FDA, drugs undergo testing in a limited number of patients. Once approved, experience in patients escalates and previously unrecognized, rare adverse events may be identified. The drug may also be found to be useful for conditions not described in the labeling. Perhaps one of the most important functions of postmarketing surveillance is in the area of ADR reporting. This type of analysis can answer questions about drug interactions, identify potential new indications for the product, and study patients in a broader population. Organizations with a relatively large patient population offer opportunities to study these issues under the leadership of a medication information specialist.
Opportunities also exist to establish guidelines for selected disease states (e.g., management of patients with diabetes mellitus) or classes of drugs (e.g., selection of appropriate antibiotic for surgical prophylaxis). Practice guidelines are becoming an increasingly important part of the biomedical literature. These clinical guidelines are systematically developed to assist practitioners and patients with decisions about health care in an effort to improve the quality and consistency of health care while minimizing costs and liability. Evidence-based practice guidelines are developed through systematic reviews of the literature appropriately adapted to local circumstances and values. Key questions to consider when reviewing a practice guideline have been proposed. These questions primarily rely on how accurately the guideline reflects the research used to produce it. More information on therapeutic guidelines can be found in .
Medical Informatics in a Health System
With the growth and development of new technologies (e.g., information systems), there are tremendous opportunities for an informatics specialist—an individual who has advanced medication information skills with a keen understanding of computer and information technology. This individual can help support the concepts of pharmaceutical care by improving the efficiency of workflow and increasing access to patient-specific information and the medical literature through technology by remote-site availability. This individual may also be involved in the area of institutional drug policy management. As more information is computerized (e.g., medical records), data that were accessible only through a paper record will be available for those professionals who understand the type of data that are needed for quality improvement efforts, and are able to get information efficiently out of the system. As database designs evolve and become user friendly and computer systems become more sophisticated, there are increasing opportunities for applying computer technology using clinical decision support systems to enhance many aspects of the medication use process. Clinical decision support systems can integrate patient-specific information, perform complex evaluations, and present this information to a clinician in a timely manner. These systems can be used to support initiatives with ADR reporting and analysis programs, formulary management, and continuous quality improvement efforts.
Opportunities in Specialty Practice
As the role of the practicing pharmacist changed regarding medication information activities, so has the role of the specialist. The role of the medication information specialist has changed from an individual who specifically answers questions to one who focuses on the development of medication policies and provides information on complex medication information questions. A specialist in medication information can provide leadership in a contract drug information center, medical informatics, health maintenance organizations (HMOs) and pharmacy benefit management organizations (PBMs), managed care organizations, scientific writing and medical communications, poison control, pharmaceutical industry, and academia. In a recent survey that examined the career paths of pharmacists who completed a drug information specialty residency in 2000 and 2001, the types of careers were diverse. However, the most common positions were in industry (32%), academia (21%), medical writing (12%), and as a specialist in an institution (9%). A specialist in medication information can be involved in multiple activities in establishments listed in the following section.
Contract Drug Information Center (Fee-for-Service)
The need for accurate information pertaining to drug therapy is more acute today than ever before in the history of health care. One estimate suggests that prescription drug expenditures will increase at an average rate of 11.1% between 2002 and 2012. Within the next decade health care costs will increase at an alarming rate, with total expenditures reaching the $2.1 trillion mark. A majority of these costs will be shouldered by the private sector with a significant increase in prescription drug costs. Drug information practitioners are in an enviable position to provide a service that will improve patient outcomes and decrease health care costs through the provision of unbiased information that supports rational, cost-effective, patient- and disease-specific drug therapy. One of the best ways to deliver such information is by contracting with a drug information service with formally trained health care professionals. Potential clients include managed care groups, contract pharmacy services, pharmacy benefits managers, buying groups, small rural hospitals, chain pharmacies, and independent pharmacies. Several different fee structures have been used. A client may be charged a simple fee per question, or may be offered a detailed menu of services (written medication evaluations, continuing education programs, guideline development for particular diseases) with the final cost dependent on the number and types of services chosen by the contracting party.
Services provided within these contracts may include providing answers to drug information requests, preparation of new drug evaluation monographs, formulary drug class reviews, development of MUE criteria, providing journal reprints, pharmacoeconomics evaluations, writing a pharmacotherapy newsletter, and providing continuing education programming. Additional services the center may make available are access to online resources, access to in-house question files for sharing information on commonly asked questions, and direct access to the center's Internet home page for review of medical use evaluations, formulary reviews, and newsletters. One center reports providing information on drug shortages to the American Society of Health-System Pharmacists through a grant. Frequently, the contracting drug information center also has responsibilities for pharmacy services (drug information, drug policy) as part of an entire health system.
Contract Drug Information Center (Fee-for-Service)
The need for accurate information pertaining to drug therapy is more acute today than ever before in the history of health care. One estimate suggests that prescription drug expenditures will increase at an average rate of 11.1% between 2002 and 2012. Within the next decade health care costs will increase at an alarming rate, with total expenditures reaching the $2.1 trillion mark. A majority of these costs will be shouldered by the private sector with a significant increase in prescription drug costs. Drug information practitioners are in an enviable position to provide a service that will improve patient outcomes and decrease health care costs through the provision of unbiased information that supports rational, cost-effective, patient- and disease-specific drug therapy. One of the best ways to deliver such information is by contracting with a drug information service with formally trained health care professionals. Potential clients include managed care groups, contract pharmacy services, pharmacy benefits managers, buying groups, small rural hospitals, chain pharmacies, and independent pharmacies. Several different fee structures have been used. A client may be charged a simple fee per question, or may be offered a detailed menu of services (written medication evaluations, continuing education programs, guideline development for particular diseases) with the final cost dependent on the number and types of services chosen by the contracting party.
Services provided within these contracts may include providing answers to drug information requests, preparation of new drug evaluation monographs, formulary drug class reviews, development of MUE criteria, providing journal reprints, pharmacoeconomics evaluations, writing a pharmacotherapy newsletter, and providing continuing education programming. Additional services the center may make available are access to online resources, access to in-house question files for sharing information on commonly asked questions, and direct access to the center's Internet home page for review of medical use evaluations, formulary reviews, and newsletters. One center reports providing information on drug shortages to the American Society of Health-System Pharmacists through a grant. Frequently, the contracting drug information center also has responsibilities for pharmacy services (drug information, drug policy) as part of an entire health system.
Educating for the Need
The education of pharmacists continues to evolve in scope and depth. Many areas identified as needed by the drug (medication) information specialist are now incorporated into pharmacy curricula and taught to all pharmacists. In 1991, a consensus conference in New Mexico was held to define a set of objectives for didactic and experiential training in drug information for the year 2000. Twenty-three educators and practitioners participated in the conference. There were several key concepts that were developed including (1) drug information should be a required component of the pharmacy curriculum and include both didactic and competency-based experiential components (2) drug information concepts and skills should be spread throughout the curriculum, beginning the day students enter pharmacy school and (3) problem solving should be a major technique in drug information education, with the goal of developing self-directed learners. Developing these skills should provide the foundation for the pharmacist to be a lifelong learner and problem solver. Based on the work of this conference, as well as changes in the health care system, and the movement toward outcome-based education, colleges of pharmacy are redesigning their curricula to provide a more comprehensive and integrated approach to teaching medication information concepts and skills. Communication skills are taught formally to facilitate the pharmacist's ability to transmit information to both health professionals and patients. Medication information and policy development are integrated throughout the three goal areas addressed in the pharmacy practice residency standards. Specialty practice residencies in medication information are also available in a variety of practice sites at (http://www.ashp.org/directories/residency/).
The Self-Care Movement
Finally, consumers have a continually growing desire for information about their medications. The growth of the self-care movement, the increase in focus on health care costs, and the improved accessibility of health information are some of the factors that have influenced patients to participate more fully in health care decisions, including the selection and use of medications. Based on these needs, direct-to-consumer advertising (DTCA) campaigns have appeared in virtually all media including magazines, television ads, and radio reports. In 1996, for the first time ever, the amount spent on DTCA exceeded the amount spent on direct advertising to physicians. In 1997, the pharmaceutical industry spent over $1 billion on DTCA, which is up 61% from 1996. Today, it is estimated that pharmaceutical companies spend about $3 billion per year. This increase in spending for DTCA may be in response to the increase in sales for these drugs.
Likewise, there is a growing use of e-mail and the web by the public. A recent survey found that approximately 25% of individuals with home access to the Internet searched medical websites prior to arrival at a neurology clinic. Unfortunately, 60% of the information was considered to be inappropriate. Because a single individual is able to serve as author, editor, and publisher of information on the Internet, there is no safeguard on the quality of information provided. The end result is a potentially misinformed consumer. When patients find information about medications that they are either considering to start taking or are currently taking, from the Internet, through the lay press, or by DTCA, a pharmacist can help consumers critically assess the medication information and add to the information based on specific patient-related needs.
The need to critically assess information regarding complementary and alternative medicine has become increasingly important, with an estimated one of three Americans choosing to use this option. The use of dietary supplements continues to grow in popularity. This area presents a challenging situation for pharmacists because of the lack of relevant outcomes data from well-designed clinical trials. Consumers are increasingly interested in finding reliable information regarding these products; pharmacists are in an excellent position to help provide such information. One drug information center describes its experience with a devoted telephone line to provide information regarding herbal supplements., There was an increased demand for the service over time based on a higher call volume. This is consistent with the growing use of complementary and alternative medicine nationally. They also described the challenges and limitations of finding reliable information on herbal products. Several resources are available that have information on herbal products. It is just as important that the pharmacist provides information from reliable sources, as well as identify information that is lacking, in regard to a particular product.
Groups like the National Council on Patient Information and Education (NCPIE) encourage patients to seek information when they have questions. The experience with some medication information hotlines that have been established for public access has indicated public desire and need for information. Such hotlines, often established by pharmacists, are intended to enhance the relationships between pharmacists, physicians, and patients.
The changing environment affords the pharmacist many opportunities to use the full spectrum of medication information skills. Factors such as the integration of new technologies, the focus on evidence-based medicine and drug policy development, the sophistication of medication therapy, and the advent of consumerism require that all pharmacists have a strong foundation in medication information concepts.
Likewise, there is a growing use of e-mail and the web by the public. A recent survey found that approximately 25% of individuals with home access to the Internet searched medical websites prior to arrival at a neurology clinic. Unfortunately, 60% of the information was considered to be inappropriate. Because a single individual is able to serve as author, editor, and publisher of information on the Internet, there is no safeguard on the quality of information provided. The end result is a potentially misinformed consumer. When patients find information about medications that they are either considering to start taking or are currently taking, from the Internet, through the lay press, or by DTCA, a pharmacist can help consumers critically assess the medication information and add to the information based on specific patient-related needs.
The need to critically assess information regarding complementary and alternative medicine has become increasingly important, with an estimated one of three Americans choosing to use this option. The use of dietary supplements continues to grow in popularity. This area presents a challenging situation for pharmacists because of the lack of relevant outcomes data from well-designed clinical trials. Consumers are increasingly interested in finding reliable information regarding these products; pharmacists are in an excellent position to help provide such information. One drug information center describes its experience with a devoted telephone line to provide information regarding herbal supplements., There was an increased demand for the service over time based on a higher call volume. This is consistent with the growing use of complementary and alternative medicine nationally. They also described the challenges and limitations of finding reliable information on herbal products. Several resources are available that have information on herbal products. It is just as important that the pharmacist provides information from reliable sources, as well as identify information that is lacking, in regard to a particular product.
Groups like the National Council on Patient Information and Education (NCPIE) encourage patients to seek information when they have questions. The experience with some medication information hotlines that have been established for public access has indicated public desire and need for information. Such hotlines, often established by pharmacists, are intended to enhance the relationships between pharmacists, physicians, and patients.
The changing environment affords the pharmacist many opportunities to use the full spectrum of medication information skills. Factors such as the integration of new technologies, the focus on evidence-based medicine and drug policy development, the sophistication of medication therapy, and the advent of consumerism require that all pharmacists have a strong foundation in medication information concepts.
Sophistication of Medication Therapy
The sophisticated level of medication therapy that occurs today provides pharmacists much more opportunity to lend their expertise in assessing medication information needs of professionals, patients, or family members, and providing literature to help choose the best medication to use within a class, to convey the appropriate information to help patients correctly and safely use the more potent medications, and to address administration and delivery problems. It is increasingly difficult for physicians and other health professionals to keep up with all of the developments in medication therapy, as well as keep abreast of the other information required for their practice. It is estimated that over 1600 compounds are in various stages of drug development. Several of these drugs could have a substantial impact on clinical practice and drug expenditures once they are commercially available. For instance, it is anticipated that at least 560 of these medications are anticancer agents, which could have an impact on life expectancy, quality of life, and the related expenses associated with the potential need for increased ancillary care, additional physician office visits, or hospitalization. It is important that drugs in the pipeline be monitored by pharmacists to provide adequate time to identify the patient population that will most benefit from the new drug and to help anticipate the cost of treating these patients compared to traditional therapy.,
There is also a trend toward individualization of health care using DNA profiling to determine potential drug effectiveness. Patients may be tested for genomic patterns and their drug therapy will be altered accordingly. There are several potential benefits of using this pharmacogenomic technique: new effective treatments for a variety of medical conditions could be identified faster and in smaller samples, computer modeling can help eliminate the medications that do not work, and because this technique can help identify the best candidates for a particular drug, it can help patients become more productive sooner.
There is also a trend toward individualization of health care using DNA profiling to determine potential drug effectiveness. Patients may be tested for genomic patterns and their drug therapy will be altered accordingly. There are several potential benefits of using this pharmacogenomic technique: new effective treatments for a variety of medical conditions could be identified faster and in smaller samples, computer modeling can help eliminate the medications that do not work, and because this technique can help identify the best candidates for a particular drug, it can help patients become more productive sooner.
Focus on Evidence-Based Medicine and Drug Policy Development
The pharmacist's ability to apply medication information skills to drug policy decisions will be of growing importance in this changing health care environment. This can be done by identifying trends of inappropriate medication use in a group of patients and providing supporting scientific evidence to help change behavior. Continued growth in national health expenditures has raised the concern of government, insurance agencies, health care providers, and the public in identifying strategies to control spending while maintaining access to quality health care. With $216 billion spent on pharmaceuticals in 2003 (increased from $194 billion in 2002), inevitably, questions arise about the value of services received. These increases in pharmaceutical costs are of particular concern especially in light of the recent approval of the Medicare drug benefit. The Medicare Prescription Drug Improvement and Modernization Act has several provisions that will affect pharmacy practice including one that requires participating in health plans to create medication therapy management programs to ensure that the covered medications are used appropriately by high-risk patients. Likewise, the IOM recently completed a 3-year study of the uninsured with a recommendation that universal health insurance coverage be available in the United States by 2010. In 2001, uninsured Americans received $35 billion in uncompensated medical care; $30 billion was ultimately paid for with tax dollars. Although a list of insurance benefits has not been defined, they will be created based on evidence of improved patient care.
In recent years, there has been a shift from a fee-for-service, inpatient focus, to a capitated, managed care, ambulatory focus. Managed care—a process seeking to manage the delivery of high-quality health care in order to improve cost effectiveness—is consuming an ever-increasing portion of health care delivery. Today, providers are relying less on impressions of what may be happening in a practice setting and more on data that are actually being collected in that same group of patients (e.g., number of patients receiving appropriate dose of drugs). Goals are set for a particular group of patients (e.g., all patients receive beta-blocker therapy after a myocardial infarction) based on evidence found in the scientific literature. This connection of applying the scientific information to the patient care setting is made through evidence-based medicine. Evidence-based medicine is an approach to practice and teaching that integrates current clinical research evidence with pathophysiologic rationale, professional expertise, and patient preferences to make decisions for a population. This has strengthened the need for pharmacists to have a solid understanding of medication information concepts and skills. Pharmacists need to be able to evaluate the medication use issues for a group of patients; search, retrieve, and critically evaluate the scientific literature; and apply the information to the targeted group of patients. Evidence-based medicine techniques are used in health care organizations in the development and implementation of a variety of quality assurance tools (e.g., therapeutic guidelines, clinical pathways, MUEs, and disease state management) in an effort to improve patient outcomes and decrease costs. All of these situations require pharmacists to use medication information skills and to have various kinds of medication information support at the practice site or easily accessible at a remote site. The process of evidence-based medicine requires that systems be developed to measure and report processes and outcomes that can be used to drive quality improvement efforts. Data can be collected and analyzed by a medication information specialist using scientific methods to support the decision-making process in a managed care organization. Outcomes research can be used to identify the effectiveness of pharmaceutical products and services in achieving desired health outcomes. Likewise, the branch of outcomes research, pharmacoeconomics, provides tools to assess cost, consequences, and efficiency. This will be discussed more fully in .
In recent years, there has been a shift from a fee-for-service, inpatient focus, to a capitated, managed care, ambulatory focus. Managed care—a process seeking to manage the delivery of high-quality health care in order to improve cost effectiveness—is consuming an ever-increasing portion of health care delivery. Today, providers are relying less on impressions of what may be happening in a practice setting and more on data that are actually being collected in that same group of patients (e.g., number of patients receiving appropriate dose of drugs). Goals are set for a particular group of patients (e.g., all patients receive beta-blocker therapy after a myocardial infarction) based on evidence found in the scientific literature. This connection of applying the scientific information to the patient care setting is made through evidence-based medicine. Evidence-based medicine is an approach to practice and teaching that integrates current clinical research evidence with pathophysiologic rationale, professional expertise, and patient preferences to make decisions for a population. This has strengthened the need for pharmacists to have a solid understanding of medication information concepts and skills. Pharmacists need to be able to evaluate the medication use issues for a group of patients; search, retrieve, and critically evaluate the scientific literature; and apply the information to the targeted group of patients. Evidence-based medicine techniques are used in health care organizations in the development and implementation of a variety of quality assurance tools (e.g., therapeutic guidelines, clinical pathways, MUEs, and disease state management) in an effort to improve patient outcomes and decrease costs. All of these situations require pharmacists to use medication information skills and to have various kinds of medication information support at the practice site or easily accessible at a remote site. The process of evidence-based medicine requires that systems be developed to measure and report processes and outcomes that can be used to drive quality improvement efforts. Data can be collected and analyzed by a medication information specialist using scientific methods to support the decision-making process in a managed care organization. Outcomes research can be used to identify the effectiveness of pharmaceutical products and services in achieving desired health outcomes. Likewise, the branch of outcomes research, pharmacoeconomics, provides tools to assess cost, consequences, and efficiency. This will be discussed more fully in .
Integration of New Technologies
Computer technology has changed drastically, but positively, the ability to store and access information. Even though the amount of literature is much larger today than earlier, it is more manageable. The Internet has grown into a vast network of computers that millions of users can access in most countries. The World Wide Web (WWW), a method of sharing information over the Internet, allows the user to easily access the scientific literature, government publications, items in the news, and many other things. The information may be purely in textual form, or include graphics (e.g., GIF, JPEG), video (e.g., MPEG), or sound (e.g., WAV, MP3). Patients and health care practitioners can find information on nearly every disease and treatment, and virtual health communities and forums provide a mutually supportive environment for patients, family, and friends. A pharmacist in a local community pharmacy or rural hospital can communicate with health care professionals or their patients locally or can obtain information about a medication found only in another country. Although drug information centers have ready access to the Internet, and specialists use information from this resource on a daily basis, businesses have yet to take full advantage of this technology. This is likely to change in the near future. Local area networks are frequently used to interconnect computers within a drug information center, building, or neighboring areas. The use of wide area networks will grow as institutions merge and interconnect data management functions.
There is an increasing need by health professionals, as well as consumers, to get more information about medications sooner. Information is needed quickly when a new medication becomes commercially available because of the potential for health and cost implications, when a product is withdrawn from the market for safety reasons, or when data from a new study are released that could have an impact on how common ailments are treated. The lag time that occurs with the print format may not be acceptable for many direct patient care issues. The Internet allows medical information to be available sooner to both health care professionals and the public. Online repositories for articles, such as BioMed Central (http://www.biomedcentral.com) and PubMed® (http://www.pubmedcentral.nih.gov) have allowed individuals to access millions of articles quickly, easily, and free of charge. The site http://www.freemedicaljournals.com provides a comprehensive list of medical journals that are free of charge. The availability of e-journals has helped speed up the publication process to allow articles to be available electronically sooner than the print version. Hypertext links between reference lists from an article in one online journal to the original article eliminate the need to travel to a library. When the journals e-mail a table of contents (TOC) or provide an automatic alert about articles on a particular topic, this results in a more effective method of keeping up to date. E-textbooks are also available on the World Wide Web; however, the majority of printed medical textbooks with an online version require a subscription. For instance, Harrison's Principles of Internal Medicine (http://www.harrisonsonline.com) is a continually updated and expanded version of the printed text. Other textbooks are available for purchase as a CD-ROM.
Registries of ongoing clinical trials, such as http://www.ClinicalTrials.gov, provide information on the purpose and criteria for participation in these trials. This has allowed pharmacists to anticipate new therapies, and perhaps help their patients receive medications not yet FDA approved through enrollment in a clinical trial.
There are a variety of websites sponsored by different companies and individuals. In a recent survey, 85% of physician respondents had experienced a patient bringing Internet information to a visit. Ninety percent of respondents perceived that the majority of these patients had brought them information because they wanted to ask their opinion. Wide availability of this information should be tempered with the need to evaluate the validity of information obtained, especially for the public. Information is many times incomplete or inaccurate. Because misinformation may result in harmful behavior (e.g., discontinuing medication, increasing the doses), the availability of quality information is important. There is currently no valid instrument available to assess the quality of a website, although there are many proposed methods. However, there are some common sense criteria that can be used to examine the quality of information (accurate, up to date, authoritative authorship) on a website. One site that may be helpful in providing patients with information on a range of medical conditions and management is http://www.healthfinder.gov. However, if misinformation or inaccurate information is shared, organizations exist to monitor fraud on the World Wide Web (e.g., http://www.quackwatch.com).
Mailing lists, newsgroups, bulletin boards, web forums, and chat rooms have simplified the way in which peers can exchange news and share opinions. E-mail has been an effective method to keep up to date with a journal's e-mailed table of contents (eTOC), which are often sent before print publication. Several professional organizations (e.g., American Society of Health-System Pharmacists, http://www.ashp.org) have websites that offer e-mail alert services to maintain awareness of important news affecting pharmacy, drug shortages, and awareness of their meetings.
Drug information centers have created their own sites to post information about their center and services, provide links to related sites considered to be of acceptable quality, and as a convenient means of receiving and answering drug information questions. The advantage of having a request form for answering drug information questions on the web is that physicians, pharmacists, or other health professionals can access computers at their practice site. Many times, this is accessible only through an institution's Intranet. An Intranet is a network that belongs to an organization and is designed to be accessible only by the organization's members, employees, or others with authorization. The website looks and acts just like other sites, but has a firewall surrounding it, and therefore the center can provide easy access to their primary patrons without receiving extraneous questions from people outside their defined clientele.
Likewise, the use of personal digital assistants (PDAs) has grown. A PDA offers the convenience of collecting and accessing information from a unit that can be carried in a user's pocket. There are several examples of the use of PDAs in pharmacy practice. In certain situations, these systems can be used more conveniently than a desktop computer for online searching, to provide medication profiles, to set appointments, as a time-management tool, and to search drug information databases (e.g., general drug information text and drug interaction resources). The PDA can provide access to the formulary, order entry and verification, medication error and ADR reporting, and medication use guidelines. One area where several institutions have found PDAs to be a valuable tool in their facility is in the documentation of clinical interventions by pharmacists. One study compared the efficiency of using a PDA for documentation of clinical interventions compared to paper. The number of new interventions performed by pharmacists was divided by the number of new orders written during a 6-month period. When the PDA was used to document interventions, there was consistently more complete information and more interventions documented than when data were collected on paper (7.43% [697 PDA-documented interventions/15,979 new orders written] vs. 4.36% [919 paper-documented interventions/13,184 new orders; P < 0.001]). An additional advantage of using a PDA for documentation of clinical interventions is that it decreases the time needed to aggregate the data into a database, rather than retrospectively entering data into the database. This may have some advantages in documenting reimbursement for services. In another study, authors calculated their potential claims using their Medicaid reimbursement rate for pharmacists' cognitive services documented with PDAs. The amount was more than $1 million in 6 months, assuming a 100% reimbursement rate. This cost reflects total reimbursement and was not compared to paper documentation. There are some limitations to PDAs. In general, they are not considered to be secure at this time and, therefore, may not protect proprietary or confidential information. Also, the unit may compromise usability by trying to present too much information on a small screen. The advantage, however, is that this system offers a convenient and, in many cases easily updated, information tool at the bedside. Frequently, in a clinical setting, the use of a mix of desktop, laptop, or hand-held devices is optimal based on the particular clinical scenario.
Although technology affords remote-site access to medication information sources, it is critical that pharmacists have the skills to perceive, assess, and evaluate the information, and apply the information to the situation. One of the most rapidly changing technologies in health care is information technology. It is important that pharmacists not only keep up with medication use concepts, but that they also stay abreast of developments in the area of information technology in an effort to integrate new and valuable systems in a timely and efficient manner. The need for this type of training is emphasized in a recent IOM report.
Future technology developments are likely to further enhance access and use of information. The medical record, including administrative information, laboratory data, and pharmaceutical information are becoming more commonly accessible in patient care areas. A properly configured medical record provides decision support, facilitates workflow, and enables the routine collection of data for performance feedback. This offers opportunities for pharmacists, and in particular medication information specialists, to take a leadership role in planning and implementing computerized intervention programs that automatically educate at the point of prescribing. The use of computer-based clinical support systems that provide patient information with recommendations based on the best evidence has shown to be valuable in the patient care setting, including a reported decrease in length of hospital stay. In one study that examined the value of using a decision support program to assist physicians in using anti-infective agents, the length of hospital stay of patients who used the recommendations was compared with a group of patients who did not always use the recommendations, and compared against a group of patients who were admitted to the unit 2 years before the intervention program. The length of hospital stay was statistically different with an average of 10, 16.7, and 12.9 days, respectively.
Although the Internet has been used to transfer information instantaneously to clinicians and researchers, its value as a patient care resource and professional education tool is only starting to be tested. One of the concerns in using the Internet for transfer of patient information is patient confidentiality. Virtual private networks (VPNs) are used to eliminate many of the technical issues surrounding security of information. Confidentiality has been addressed with new legislation referred to as the Health Insurance Portability and Accountability Act (HIPAA) to make sure that covered entities (e.g., health plans, health care providers, and health care clearing houses) limit disclosure of an individual's protected health information. Once the legislation has been implemented for several years, the implications of this legislation will be more clear.
There is an increasing need by health professionals, as well as consumers, to get more information about medications sooner. Information is needed quickly when a new medication becomes commercially available because of the potential for health and cost implications, when a product is withdrawn from the market for safety reasons, or when data from a new study are released that could have an impact on how common ailments are treated. The lag time that occurs with the print format may not be acceptable for many direct patient care issues. The Internet allows medical information to be available sooner to both health care professionals and the public. Online repositories for articles, such as BioMed Central (http://www.biomedcentral.com) and PubMed® (http://www.pubmedcentral.nih.gov) have allowed individuals to access millions of articles quickly, easily, and free of charge. The site http://www.freemedicaljournals.com provides a comprehensive list of medical journals that are free of charge. The availability of e-journals has helped speed up the publication process to allow articles to be available electronically sooner than the print version. Hypertext links between reference lists from an article in one online journal to the original article eliminate the need to travel to a library. When the journals e-mail a table of contents (TOC) or provide an automatic alert about articles on a particular topic, this results in a more effective method of keeping up to date. E-textbooks are also available on the World Wide Web; however, the majority of printed medical textbooks with an online version require a subscription. For instance, Harrison's Principles of Internal Medicine (http://www.harrisonsonline.com) is a continually updated and expanded version of the printed text. Other textbooks are available for purchase as a CD-ROM.
Registries of ongoing clinical trials, such as http://www.ClinicalTrials.gov, provide information on the purpose and criteria for participation in these trials. This has allowed pharmacists to anticipate new therapies, and perhaps help their patients receive medications not yet FDA approved through enrollment in a clinical trial.
There are a variety of websites sponsored by different companies and individuals. In a recent survey, 85% of physician respondents had experienced a patient bringing Internet information to a visit. Ninety percent of respondents perceived that the majority of these patients had brought them information because they wanted to ask their opinion. Wide availability of this information should be tempered with the need to evaluate the validity of information obtained, especially for the public. Information is many times incomplete or inaccurate. Because misinformation may result in harmful behavior (e.g., discontinuing medication, increasing the doses), the availability of quality information is important. There is currently no valid instrument available to assess the quality of a website, although there are many proposed methods. However, there are some common sense criteria that can be used to examine the quality of information (accurate, up to date, authoritative authorship) on a website. One site that may be helpful in providing patients with information on a range of medical conditions and management is http://www.healthfinder.gov. However, if misinformation or inaccurate information is shared, organizations exist to monitor fraud on the World Wide Web (e.g., http://www.quackwatch.com).
Mailing lists, newsgroups, bulletin boards, web forums, and chat rooms have simplified the way in which peers can exchange news and share opinions. E-mail has been an effective method to keep up to date with a journal's e-mailed table of contents (eTOC), which are often sent before print publication. Several professional organizations (e.g., American Society of Health-System Pharmacists, http://www.ashp.org) have websites that offer e-mail alert services to maintain awareness of important news affecting pharmacy, drug shortages, and awareness of their meetings.
Drug information centers have created their own sites to post information about their center and services, provide links to related sites considered to be of acceptable quality, and as a convenient means of receiving and answering drug information questions. The advantage of having a request form for answering drug information questions on the web is that physicians, pharmacists, or other health professionals can access computers at their practice site. Many times, this is accessible only through an institution's Intranet. An Intranet is a network that belongs to an organization and is designed to be accessible only by the organization's members, employees, or others with authorization. The website looks and acts just like other sites, but has a firewall surrounding it, and therefore the center can provide easy access to their primary patrons without receiving extraneous questions from people outside their defined clientele.
Likewise, the use of personal digital assistants (PDAs) has grown. A PDA offers the convenience of collecting and accessing information from a unit that can be carried in a user's pocket. There are several examples of the use of PDAs in pharmacy practice. In certain situations, these systems can be used more conveniently than a desktop computer for online searching, to provide medication profiles, to set appointments, as a time-management tool, and to search drug information databases (e.g., general drug information text and drug interaction resources). The PDA can provide access to the formulary, order entry and verification, medication error and ADR reporting, and medication use guidelines. One area where several institutions have found PDAs to be a valuable tool in their facility is in the documentation of clinical interventions by pharmacists. One study compared the efficiency of using a PDA for documentation of clinical interventions compared to paper. The number of new interventions performed by pharmacists was divided by the number of new orders written during a 6-month period. When the PDA was used to document interventions, there was consistently more complete information and more interventions documented than when data were collected on paper (7.43% [697 PDA-documented interventions/15,979 new orders written] vs. 4.36% [919 paper-documented interventions/13,184 new orders; P < 0.001]). An additional advantage of using a PDA for documentation of clinical interventions is that it decreases the time needed to aggregate the data into a database, rather than retrospectively entering data into the database. This may have some advantages in documenting reimbursement for services. In another study, authors calculated their potential claims using their Medicaid reimbursement rate for pharmacists' cognitive services documented with PDAs. The amount was more than $1 million in 6 months, assuming a 100% reimbursement rate. This cost reflects total reimbursement and was not compared to paper documentation. There are some limitations to PDAs. In general, they are not considered to be secure at this time and, therefore, may not protect proprietary or confidential information. Also, the unit may compromise usability by trying to present too much information on a small screen. The advantage, however, is that this system offers a convenient and, in many cases easily updated, information tool at the bedside. Frequently, in a clinical setting, the use of a mix of desktop, laptop, or hand-held devices is optimal based on the particular clinical scenario.
Although technology affords remote-site access to medication information sources, it is critical that pharmacists have the skills to perceive, assess, and evaluate the information, and apply the information to the situation. One of the most rapidly changing technologies in health care is information technology. It is important that pharmacists not only keep up with medication use concepts, but that they also stay abreast of developments in the area of information technology in an effort to integrate new and valuable systems in a timely and efficient manner. The need for this type of training is emphasized in a recent IOM report.
Future technology developments are likely to further enhance access and use of information. The medical record, including administrative information, laboratory data, and pharmaceutical information are becoming more commonly accessible in patient care areas. A properly configured medical record provides decision support, facilitates workflow, and enables the routine collection of data for performance feedback. This offers opportunities for pharmacists, and in particular medication information specialists, to take a leadership role in planning and implementing computerized intervention programs that automatically educate at the point of prescribing. The use of computer-based clinical support systems that provide patient information with recommendations based on the best evidence has shown to be valuable in the patient care setting, including a reported decrease in length of hospital stay. In one study that examined the value of using a decision support program to assist physicians in using anti-infective agents, the length of hospital stay of patients who used the recommendations was compared with a group of patients who did not always use the recommendations, and compared against a group of patients who were admitted to the unit 2 years before the intervention program. The length of hospital stay was statistically different with an average of 10, 16.7, and 12.9 days, respectively.
Although the Internet has been used to transfer information instantaneously to clinicians and researchers, its value as a patient care resource and professional education tool is only starting to be tested. One of the concerns in using the Internet for transfer of patient information is patient confidentiality. Virtual private networks (VPNs) are used to eliminate many of the technical issues surrounding security of information. Confidentiality has been addressed with new legislation referred to as the Health Insurance Portability and Accountability Act (HIPAA) to make sure that covered entities (e.g., health plans, health care providers, and health care clearing houses) limit disclosure of an individual's protected health information. Once the legislation has been implemented for several years, the implications of this legislation will be more clear.
Adverse Drug Events
The 1999 IOM report To Err is Human: Building a Safer Health Care System has generated a great deal of discussion in the medical community and legislature because of the impact of ADEs on patient health and well-being, and because of economic implications. IOM analysts estimate that prescription medications are responsible for up to 7000 American deaths per year, with the cost of drug-related morbidity and mortality being nearly U.S. $77 billion per year. Their definition of ADEs includes both medication errors and adverse drug reactions (ADRs). Accurate statistics of the frequency of ADRs are difficult to assess for a particular drug since phase I–III of clinical research includes too small a sample size and frequently medications are taken for a short duration. For instance, rofecoxib (Vioxx) was a drug approved in 1999 as a safer alternative to first-generation nonsteroidal anti-inflammatory agents for elderly patients with pain. The drug was recalled on October 1, 2004 in the largest prescription drug withdrawal in history. The withdrawal was prompted after a new study examining the drug's impact on bowel cancer found that the drug caused an almost twofold increase in heart attacks and strokes. Although the Adenomatous Polyp Prevention on Vioxx® (APPROVe) trial began enrollment in 2000 and was being monitored by an independent data safety monitoring board, it was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events with Vioxx®. The actual number of ADRs nationally reported is probably underestimated because the full range of patients likely to use the medications postmarketing are not included in premarketing studies. Frequently, these studies include patients with only one disease and exclude children, pregnant women, and the elderly. If a report is identified by a health professional or consumer, the Food and Drug Administration (FDA) has a voluntary reporting program to help identify and address these issues once the medication has become commercially available. However, it is estimated that the spontaneous reporting system captures only 1 to 10% of all adverse events., Therefore, this can be used only as a flag to stimulate further research in postmarketing surveillance studies. Communication and coordination among patients, physicians, pharmacists, and other health care professionals can help avoid these dangerous incidents., Pharmacists should cautiously recommend newly approved therapy by weighing the risk versus benefit, with an understanding that all information regarding adverse effects may not be available yet on a newly approved product. When a product is newly approved with claims of decreased frequency of side effects, these claims need to be tempered with the understanding that the depth of information that is available regarding these products is not as good as products that have been available for many years.
There may also be ADR implications when selecting medications for a formulary. When a new medication becomes commercially available, clinicians supporting a proactive formulary system will review and decide if that medication will be available for routine use for patients immediately. Because information regarding new medications is frequently limited, it may be wise to collect data on patients in a clinical setting and compare this use against a standard of how the drug should be used once the product becomes available in an institution. This can be accomplished through a medication use evaluation (MUE) program. Because the product is new, physicians and other health professionals need to know how to prescribe (select appropriate patient population and dose), administer, and monitor the drug to avoid ADEs and provide effective therapy. Many times, adverse effects of newly approved medications do not appear until a medication is used in a group of patients with multiple medical problems who are taking several other medications. Data acquired from this MUE will verify that the medication is indeed being used as recommended, and that it has been used safely.
Adverse events associated with dietary supplements provide an additional concern, because the manufacturers do not need to submit safety or efficacy data to the FDA prior to availability. Consumers and health practitioners have limited information to help them make decisions on safety. Large-scale studies that frequently include several thousand patients are required for a drug to be approved, but are not available with these products. Therefore, it is necessary to rely on reporting to the FDA after the supplement has become available to determine if there are safety concerns. In addition to having limited information on adverse effects, information is also limited in other areas such as appropriate dose, efficacy, and pharmacokinetics. Adverse effects that are reported to the FDA may be evaluated, and action may be taken. For instance, in 2004, the FDA prohibited sale of dietary supplements containing ephedrine alkaloids (ephedra) because of the limited data available on efficacy, and because of the risk of adverse health outcomes including myocardial infarction and stroke. In other cases, a communication to health care professionals may alert them to a particular side effect. For instance, recently the FDA issued a warning citing 25 reports of hepatotoxicity worldwide with kava, a dietary supplement used for several indications including insomnia. This product is still available in the United States. Because of these and other issues, most hospitals have policies regarding herbal product use.
Information on ADRs in patients receiving either medications or dietary supplements is frequently coordinated through an ADR program in a hospital. The ADR program for an institution has many components including identification of suspected side effects, assessment of probability, dissemination of information (documentation in the medical record and submission to a larger database of information), and monitoring of outcomes. In health care systems (e.g., hospitals), this initiative is performed by pharmacists, physicians, and other health professionals in a coordinated fashion. The ADR program is most often coordinated by the pharmacy department, and specifically, the drug information center, if available. Both medications as well as dietary supplements used for medicinal purposes are submitted to the coordinating group and evaluated in an ADR program. More information on ADEs can be found in .
Despite efforts to decrease the frequency of medical errors after the 1999 IOM report To Err is Human: Building a Safer Health System, many consumers are still dissatisfied with the quality of health care in the United States. In a recent survey, 40% of respondents believed that the quality of health care has gotten worse in the past 5 years, while only 17% said that it has improved. Thirty-four percent of respondents said that they or a family member had experienced a medical error at some point in their life. Efforts are ongoing to lobby for additional funding for initiatives to decrease the risk of medical errors in the United States. Because of the pharmacists' role in helping to identify and prevent ADEs in patients, this could have future implications.
There may also be ADR implications when selecting medications for a formulary. When a new medication becomes commercially available, clinicians supporting a proactive formulary system will review and decide if that medication will be available for routine use for patients immediately. Because information regarding new medications is frequently limited, it may be wise to collect data on patients in a clinical setting and compare this use against a standard of how the drug should be used once the product becomes available in an institution. This can be accomplished through a medication use evaluation (MUE) program. Because the product is new, physicians and other health professionals need to know how to prescribe (select appropriate patient population and dose), administer, and monitor the drug to avoid ADEs and provide effective therapy. Many times, adverse effects of newly approved medications do not appear until a medication is used in a group of patients with multiple medical problems who are taking several other medications. Data acquired from this MUE will verify that the medication is indeed being used as recommended, and that it has been used safely.
Adverse events associated with dietary supplements provide an additional concern, because the manufacturers do not need to submit safety or efficacy data to the FDA prior to availability. Consumers and health practitioners have limited information to help them make decisions on safety. Large-scale studies that frequently include several thousand patients are required for a drug to be approved, but are not available with these products. Therefore, it is necessary to rely on reporting to the FDA after the supplement has become available to determine if there are safety concerns. In addition to having limited information on adverse effects, information is also limited in other areas such as appropriate dose, efficacy, and pharmacokinetics. Adverse effects that are reported to the FDA may be evaluated, and action may be taken. For instance, in 2004, the FDA prohibited sale of dietary supplements containing ephedrine alkaloids (ephedra) because of the limited data available on efficacy, and because of the risk of adverse health outcomes including myocardial infarction and stroke. In other cases, a communication to health care professionals may alert them to a particular side effect. For instance, recently the FDA issued a warning citing 25 reports of hepatotoxicity worldwide with kava, a dietary supplement used for several indications including insomnia. This product is still available in the United States. Because of these and other issues, most hospitals have policies regarding herbal product use.
Information on ADRs in patients receiving either medications or dietary supplements is frequently coordinated through an ADR program in a hospital. The ADR program for an institution has many components including identification of suspected side effects, assessment of probability, dissemination of information (documentation in the medical record and submission to a larger database of information), and monitoring of outcomes. In health care systems (e.g., hospitals), this initiative is performed by pharmacists, physicians, and other health professionals in a coordinated fashion. The ADR program is most often coordinated by the pharmacy department, and specifically, the drug information center, if available. Both medications as well as dietary supplements used for medicinal purposes are submitted to the coordinating group and evaluated in an ADR program. More information on ADEs can be found in .
Despite efforts to decrease the frequency of medical errors after the 1999 IOM report To Err is Human: Building a Safer Health System, many consumers are still dissatisfied with the quality of health care in the United States. In a recent survey, 40% of respondents believed that the quality of health care has gotten worse in the past 5 years, while only 17% said that it has improved. Thirty-four percent of respondents said that they or a family member had experienced a medical error at some point in their life. Efforts are ongoing to lobby for additional funding for initiatives to decrease the risk of medical errors in the United States. Because of the pharmacists' role in helping to identify and prevent ADEs in patients, this could have future implications.
Drug Information—from Centers to Practitioners
The responsibilities of individual pharmacists regarding the provision of medication information have changed substantially over the years. Impetus for this change was provided not only by the development of drug information centers and the clinical pharmacy concept, but also by the Study Commission on Pharmacy. This external group was established to review the state of the practice and education of pharmacists and report its findings. One of the findings and recommendations stated that:
. . .among deficiencies in the health care system, one is the unavailability of adequate information for those who consume, prescribe, dispense and administer drugs. This deficiency has resulted in inappropriate drug use and an unacceptable frequency of drug-induced disease. Pharmacists are seen as health professionals who could make an important contribution to the health care system of the future by providing information about drugs to consumers and health professionals. Education and training of pharmacists now and in the future must be developed to meet these important responsibilities.
The report of the Commission was issued in 1975 and since that time drug information practice has changed both for drug information centers and individual pharmacists. The development of clinical pharmacy has helped move pharmacy forward in recognizing its capabilities to contribute to the care of patients. Clinical pharmacy was primarily thought of as an institutional patient care process and did not gain widespread acceptance outside of hospitals. Over time, the activity of the pharmacist as a medication expert for patients has gained acceptance in a variety of practice settings including community pharmacies, nursing homes, and primary and specialty practices in medicine. Pharmacists who provide patient-specific information with a goal of improving patient outcomes use the medical literature to support their choices.,
Pharmacists involved in patient care areas (e.g., hospitals, clinics, long-term care, and home health care) now frequently answer drug information questions, participate in evaluating a patient's drug therapy, and conduct medication usage evaluation activities. The provision of medication information may be on a one-on-one basis or may occur using a more structured approach, such as a presentation to a class of diabetic patients or a group of nurses in the practice facility. In either case, the pharmacist educates those who are the beneficiaries of the medication information. Pharmacists may also participate in precepting students in patient care or pharmacy environments. In any of these roles, the pharmacist must use appropriate information retrieval and evaluation skills to ensure that the most current and accurate information is provided to make decisions about medication use for those they are serving. There is a well-described systematic approach to answering drug information questions ( and ). It is important to obtain the important background information including pertinent patient factors, disease factors, and medication-related factors to determine the true question. Good problem-solving skills are required to fully assess the situation, develop a search strategy, evaluate the information, and formulate a response. It is equally important for the pharmacist to develop good communication skills to respond in a clear and concise manner, using terminology that is consistent with the patients', caregivers', or health professionals' level of understanding. lists the medication information skills a pharmacist needs.
. . .among deficiencies in the health care system, one is the unavailability of adequate information for those who consume, prescribe, dispense and administer drugs. This deficiency has resulted in inappropriate drug use and an unacceptable frequency of drug-induced disease. Pharmacists are seen as health professionals who could make an important contribution to the health care system of the future by providing information about drugs to consumers and health professionals. Education and training of pharmacists now and in the future must be developed to meet these important responsibilities.
The report of the Commission was issued in 1975 and since that time drug information practice has changed both for drug information centers and individual pharmacists. The development of clinical pharmacy has helped move pharmacy forward in recognizing its capabilities to contribute to the care of patients. Clinical pharmacy was primarily thought of as an institutional patient care process and did not gain widespread acceptance outside of hospitals. Over time, the activity of the pharmacist as a medication expert for patients has gained acceptance in a variety of practice settings including community pharmacies, nursing homes, and primary and specialty practices in medicine. Pharmacists who provide patient-specific information with a goal of improving patient outcomes use the medical literature to support their choices.,
Pharmacists involved in patient care areas (e.g., hospitals, clinics, long-term care, and home health care) now frequently answer drug information questions, participate in evaluating a patient's drug therapy, and conduct medication usage evaluation activities. The provision of medication information may be on a one-on-one basis or may occur using a more structured approach, such as a presentation to a class of diabetic patients or a group of nurses in the practice facility. In either case, the pharmacist educates those who are the beneficiaries of the medication information. Pharmacists may also participate in precepting students in patient care or pharmacy environments. In any of these roles, the pharmacist must use appropriate information retrieval and evaluation skills to ensure that the most current and accurate information is provided to make decisions about medication use for those they are serving. There is a well-described systematic approach to answering drug information questions ( and ). It is important to obtain the important background information including pertinent patient factors, disease factors, and medication-related factors to determine the true question. Good problem-solving skills are required to fully assess the situation, develop a search strategy, evaluate the information, and formulate a response. It is equally important for the pharmacist to develop good communication skills to respond in a clear and concise manner, using terminology that is consistent with the patients', caregivers', or health professionals' level of understanding. lists the medication information skills a pharmacist needs.
The Evolution
It is useful to look at the evolution of drug information practice from the perspective of drug information centers and of practicing pharmacists. One report describes the decline in number of drug information centers nationally with the number of drug information pharmacists and other personnel being the lowest in 30 years., A total of 81 drug information centers were identified in this survey, although there are some existing centers missing from this list and there has been some controversy at meetings of drug information practitioners regarding some centers being excluded because of the definition of drug information centers that is used. Another source of drug information center locations, the 2004 Red Book, lists a total of 112 drug information centers nationally. Determining the accurate number is difficult. The centers are identified for these two sources through various listings that have developed over the years, but no agency or organization is responsible for maintaining a list. Well-defined criteria are not established for using the titles of drug information center/service. Some centers have specialized in a particular area of drug information and their name may reflect that specific function (e.g., Center of Drug Policy). Likewise, these lists only address drug information centers listed in the United States or Puerto Rico, and not those that have been created internationally. They also exclude centers/services provided by the pharmaceutical industry. Therefore, depending on how one would define a drug information center, the number may actually be higher.
A recent survey (2003) describes the current status of drug information centers compared to past years. For several years, funding for drug information centers has been provided primarily by hospitals or medical centers (73% in 2003, 82% in 1992, and 88% in 1986), or colleges or universities (37% in 2003, 35% in 1992, and 32% in 1986). However, there was a statistically significant decrease in the percentage of drug information centers funded by hospitals between 1986 and 2003. This decrease could be attributed to the economic constraints faced by the health care system in the last several years.
Drug information pharmacists working in centers appear to be better trained than those in the past and a larger percentage have a doctor of pharmacy degree (71% in 2003, and 42% in 1986 and 1992). The number of individuals who have completed a drug information residency, fellowship, or MS degree program has also increased in recent years (29% in 2003 and 11% in 1992).
In addition to the responsibility of answering questions, the most commonly reported services in 2003 were preparation of newsletters (80%) and participation in pharmacy and therapeutics committee activities (79%). Education appears to be a growing area of responsibility. Forty-one percent of respondents considered education to be their primary goal. There was an increase in the percentage of drug information centers that participated in any type of residency program training (83% in 2003) compared to 1976, 1980, 1986, and 1992, in which the number of centers that participated in any residency program ranged from 54 to 66%. There was also a larger number of drug information centers used for experiential training as part of a doctor of pharmacy program (95% in 2003 compared to 59% in 1992). outlines several services that are typically provided by drug information centers.
There have been a few studies that have described the economic benefit of maintaining a drug information center or related activity in an academic institution or hospital. One such study examined the economic impact of drug information services responding to patient-specific requests. The resultant benefit/cost ratio was found to be 2.9:1 to 13.2:1. Most of the cost savings resulted from decreased need for monitoring (e.g., laboratory tests) or decreased need for additional treatment related to an adverse effect. Another study examined the drug cost avoidance and revenue associated with the provision of investigational drug services, which are many times a responsibility of a drug information center. The annualized drug cost avoidance plus revenue was $2.6 million. Although the cost avoidance varied with the type of study and disease category involved, overall, the investigational drug service accounted for substantial drug cost avoidance. These types of studies are becoming increasingly important in an era of cost containment.
A recent survey (2003) describes the current status of drug information centers compared to past years. For several years, funding for drug information centers has been provided primarily by hospitals or medical centers (73% in 2003, 82% in 1992, and 88% in 1986), or colleges or universities (37% in 2003, 35% in 1992, and 32% in 1986). However, there was a statistically significant decrease in the percentage of drug information centers funded by hospitals between 1986 and 2003. This decrease could be attributed to the economic constraints faced by the health care system in the last several years.
Drug information pharmacists working in centers appear to be better trained than those in the past and a larger percentage have a doctor of pharmacy degree (71% in 2003, and 42% in 1986 and 1992). The number of individuals who have completed a drug information residency, fellowship, or MS degree program has also increased in recent years (29% in 2003 and 11% in 1992).
In addition to the responsibility of answering questions, the most commonly reported services in 2003 were preparation of newsletters (80%) and participation in pharmacy and therapeutics committee activities (79%). Education appears to be a growing area of responsibility. Forty-one percent of respondents considered education to be their primary goal. There was an increase in the percentage of drug information centers that participated in any type of residency program training (83% in 2003) compared to 1976, 1980, 1986, and 1992, in which the number of centers that participated in any residency program ranged from 54 to 66%. There was also a larger number of drug information centers used for experiential training as part of a doctor of pharmacy program (95% in 2003 compared to 59% in 1992). outlines several services that are typically provided by drug information centers.
There have been a few studies that have described the economic benefit of maintaining a drug information center or related activity in an academic institution or hospital. One such study examined the economic impact of drug information services responding to patient-specific requests. The resultant benefit/cost ratio was found to be 2.9:1 to 13.2:1. Most of the cost savings resulted from decreased need for monitoring (e.g., laboratory tests) or decreased need for additional treatment related to an adverse effect. Another study examined the drug cost avoidance and revenue associated with the provision of investigational drug services, which are many times a responsibility of a drug information center. The annualized drug cost avoidance plus revenue was $2.6 million. Although the cost avoidance varied with the type of study and disease category involved, overall, the investigational drug service accounted for substantial drug cost avoidance. These types of studies are becoming increasingly important in an era of cost containment.
Medication Information Services
To develop some perspective for the reader on why the development of drug information centers and specialists was important, consider 4 of the 15 summary points in a congressional review of a survey by the National Library of Medicine on The Nature and Magnitude of Drug Literature published in 1963.
"Drug literature is vast and complex. The very problem of defining what constitutes the literature is difficult."
"Drug literature is growing rapidly in size. It is also increasingly complex, i.e., interdisciplinary and interprofessional in nature. Thus, drug information 'sprawls across' many professional journals of the most varied types."
"Literature on clinical experience with drugs is sizable and is growing. Its effective use by the practitioner offers many difficulties."
"Competent evaluation of masses of drug information is particularly necessary."
Interestingly, these statements still seem applicable even today when given the figures of more than 20,000 biomedical journals and approximately 17,000 new biomedical books published annually are considered. Many journals are now published both in print and on the Internet (i.e., e-journal or electronic journal). Training in computer and information technology was considered one of the five core areas of focus for health professionals' education in an Institute of Medicine (IOM) report published in April 2003. Drug information specialists can provide leadership in this area.
In the 1960s, the availability of new drugs (e.g., neuromuscular blockers and first-generation cephalosporins) was providing challenges for practitioners to keep abreast and make appropriate decisions for their patients. Part of the problem was finding a way to effectively communicate the wealth of information to those needing it. The information environment relied heavily on the print medium for storage, retrieval, and dissemination of information. The Medical Literature Retrieval and Analysis System (MEDLARS) was developed by the National Library of Medicine in the early 1960s. While it provided a computerized form of searching, requests for searches were submitted by mail and results returned by mail. The ability to transmit such information over telephone lines (online technology) was not available until 1971 when MEDLINE® was introduced and was limited to libraries. During this time, the drug information specialist was viewed as a person who could bridge the gap and effectively communicate drug information.
In describing the training required for a drug information specialist, the following areas were identified to either need strengthening or addition to pharmacy school curricula: biochemistry, anatomy, physiology, pathology, and biostatistics and experimental design (with some histology, embryology, and endocrinology incorporated into other courses). Such topics were either not incorporated or emphasized in curricula of the 1960s. In today's pharmacy curricula, most of these topics receive considerable emphasis. Pharmacists today use knowledge and skills to make clinical decisions about medication use in specific patients or a group of patients in conjunction with other health professionals. Pharmacists may be principal investigators or coinvestigators in research involving a variety of therapeutic topics including medication use, optimal dose, drug interactions, or adverse effects of new or existing medications. Likewise, publications in the area of therapeutic guidelines or other drug policy initiatives are frequently authored by a pharmacist, sometimes with support of the pharmacy professional organizations.
The development of drug information centers and drug information specialists was the beginning of the clinical pharmacy concept. It laid the groundwork for pharmacists to demonstrate the ability to assume more responsibility in providing input on patient drug therapy. Pharmacists were provided the opportunity to extend their patient care contribution by taking a more active role in the clinical aspects of the decision-making process as it related to medication therapy. By using their extensive drug knowledge and expanding their background in certain areas, pharmacists could offer their expertise as consultants on medication therapy. The tool the pharmacist would use to function in this capacity was the clinical drug literature. This role of consultant has expanded for all pharmacists and is discussed in more detail later.
"Drug literature is vast and complex. The very problem of defining what constitutes the literature is difficult."
"Drug literature is growing rapidly in size. It is also increasingly complex, i.e., interdisciplinary and interprofessional in nature. Thus, drug information 'sprawls across' many professional journals of the most varied types."
"Literature on clinical experience with drugs is sizable and is growing. Its effective use by the practitioner offers many difficulties."
"Competent evaluation of masses of drug information is particularly necessary."
Interestingly, these statements still seem applicable even today when given the figures of more than 20,000 biomedical journals and approximately 17,000 new biomedical books published annually are considered. Many journals are now published both in print and on the Internet (i.e., e-journal or electronic journal). Training in computer and information technology was considered one of the five core areas of focus for health professionals' education in an Institute of Medicine (IOM) report published in April 2003. Drug information specialists can provide leadership in this area.
In the 1960s, the availability of new drugs (e.g., neuromuscular blockers and first-generation cephalosporins) was providing challenges for practitioners to keep abreast and make appropriate decisions for their patients. Part of the problem was finding a way to effectively communicate the wealth of information to those needing it. The information environment relied heavily on the print medium for storage, retrieval, and dissemination of information. The Medical Literature Retrieval and Analysis System (MEDLARS) was developed by the National Library of Medicine in the early 1960s. While it provided a computerized form of searching, requests for searches were submitted by mail and results returned by mail. The ability to transmit such information over telephone lines (online technology) was not available until 1971 when MEDLINE® was introduced and was limited to libraries. During this time, the drug information specialist was viewed as a person who could bridge the gap and effectively communicate drug information.
In describing the training required for a drug information specialist, the following areas were identified to either need strengthening or addition to pharmacy school curricula: biochemistry, anatomy, physiology, pathology, and biostatistics and experimental design (with some histology, embryology, and endocrinology incorporated into other courses). Such topics were either not incorporated or emphasized in curricula of the 1960s. In today's pharmacy curricula, most of these topics receive considerable emphasis. Pharmacists today use knowledge and skills to make clinical decisions about medication use in specific patients or a group of patients in conjunction with other health professionals. Pharmacists may be principal investigators or coinvestigators in research involving a variety of therapeutic topics including medication use, optimal dose, drug interactions, or adverse effects of new or existing medications. Likewise, publications in the area of therapeutic guidelines or other drug policy initiatives are frequently authored by a pharmacist, sometimes with support of the pharmacy professional organizations.
The development of drug information centers and drug information specialists was the beginning of the clinical pharmacy concept. It laid the groundwork for pharmacists to demonstrate the ability to assume more responsibility in providing input on patient drug therapy. Pharmacists were provided the opportunity to extend their patient care contribution by taking a more active role in the clinical aspects of the decision-making process as it related to medication therapy. By using their extensive drug knowledge and expanding their background in certain areas, pharmacists could offer their expertise as consultants on medication therapy. The tool the pharmacist would use to function in this capacity was the clinical drug literature. This role of consultant has expanded for all pharmacists and is discussed in more detail later.
Definition of Efflux and Influx Transporters
Drug transporters can be categorized as efflux or influx transporters according to the
direction in which they transport substrate across the cell membranes. This classification
is often observed in the literature where drug transport studies are performed
at the cellular level. With this definition, transporters that pump the substrates out of
the cells are called efflux transporters, whereas transporters that transfer substrates
into cells are called influx transporters.
direction in which they transport substrate across the cell membranes. This classification
is often observed in the literature where drug transport studies are performed
at the cellular level. With this definition, transporters that pump the substrates out of
the cells are called efflux transporters, whereas transporters that transfer substrates
into cells are called influx transporters.
CLASSIFICATIONS OF DRUG TRANSPORTERS
Drug transporters can be classified in a number of different manners, including as efflux transporters versus influx transporters, secretory transporters versus absorptive
transporters, andATP-binding cassette (ABC) transporters versus solute carrier (SLC)
transporters.
transporters, andATP-binding cassette (ABC) transporters versus solute carrier (SLC)
transporters.
POLARIZED EXPRESSION OF DRUG TRANSPORTERS
Most drug transporters are expressed in tissues with barrier functions such as the
liver, kidney, intestine, placenta, and brain. Cells at the border of these barriers are
usually polarized. For example, enterocytes of intestine and proximal tubule cells of
kidney have an apical domain facing the lumen and a basolateral domain facing the
blood circulation; hepatocytes polarize into a canalicular membrane facing the bile
duct and a sinusoidal membrane facing the blood circulation; syncytiotrophoblasts of
placenta have an apical domain facing maternal blood and a basolateral domain facing
the fetus. Brain capillary endothelial cells, which function as the blood–brain barrier,
also polarize into apical and basolateral membranes. In most cases, the expression of
drug transporters is highly restricted to one side (i.e., apical or basolateral domain)
of polarized cells. Such polarized expression of the transporters is essential for the
concerted transport of drugs in the same direction. One of the best studied examples of
concerted transport is the kidney. Kidney proximal tubule cells play a critical role in the
body clearance of drugs. These drugs are first taken up from the blood into the proximal
tubule cells by transporters at the basolateral membrane. Once inside the cells, these
drugs are then transported out of the cells into the tubule lumen by transporters at
the apical membrane and subsequently eliminated in the urine. The alliance between
transporters at both the basolateral membrane and the apical membrane of the kidney
proximal tubule cells ensures clearance of the drugs from the body.
liver, kidney, intestine, placenta, and brain. Cells at the border of these barriers are
usually polarized. For example, enterocytes of intestine and proximal tubule cells of
kidney have an apical domain facing the lumen and a basolateral domain facing the
blood circulation; hepatocytes polarize into a canalicular membrane facing the bile
duct and a sinusoidal membrane facing the blood circulation; syncytiotrophoblasts of
placenta have an apical domain facing maternal blood and a basolateral domain facing
the fetus. Brain capillary endothelial cells, which function as the blood–brain barrier,
also polarize into apical and basolateral membranes. In most cases, the expression of
drug transporters is highly restricted to one side (i.e., apical or basolateral domain)
of polarized cells. Such polarized expression of the transporters is essential for the
concerted transport of drugs in the same direction. One of the best studied examples of
concerted transport is the kidney. Kidney proximal tubule cells play a critical role in the
body clearance of drugs. These drugs are first taken up from the blood into the proximal
tubule cells by transporters at the basolateral membrane. Once inside the cells, these
drugs are then transported out of the cells into the tubule lumen by transporters at
the apical membrane and subsequently eliminated in the urine. The alliance between
transporters at both the basolateral membrane and the apical membrane of the kidney
proximal tubule cells ensures clearance of the drugs from the body.
TRANSPORT MECHANISMS
Not only do different transporters reside in the membrane with different threedimensional
structures, but they also transport their substrates through different transport mechanisms. According to their transport mechanisms, transporters can be divided into passive and active transporters: passive transporters, also called facilitated transporters, allow molecules to move across cell membrane down their electrochemical gradients. Such a spontaneous process decreases free energy and increases
entropy in a system and therefore does not consume any chemical energy.
In contrast to facilitated transporters, active transporters typically move molecules
against their electrochemical gradients; such a process is entropically unfavorable
and therefore needs coupling of the hydrolysis of adenosine triphosphate (ATP) as an
energy source. This coupling can be either primary or secondary. In primary active
transport, transporters that move molecules against their electrical or chemical gradient,
hydrolyzeATP. In the secondary active transport, transporters utilize ion gradients,
such as sodium or proton gradients, across the membrane produced by the primary
active transporters and transport substrates against an electrochemical difference.
STRUCTURE AND MODEL OF DRUG TRANSPORTERS
Because of the involvement of transporters in all facets of drug absorption, excretion,
and toxicity, characterization of transporter structure can provide a scientific basis for
understanding drug delivery and disposition, as well as the molecular mechanisms of
drug interactions and interindividual and interspecies differences.However, compared
to soluble proteins, the atomic resolution crystal structures of membrane transporters
have been extremely difficult to obtain, for several reasons. First is the amphipathic
nature of the surface of the transporters, with a hydrophobic area in contact with
membrane phospholipids and polar surface areas in contact with the aqueous phases
on both sides of the membrane; second is the low abundance of many transporters in
the membrane, making it impossible to overexpress them, a prerequisite for structural
studies; and third is the inherent conformational flexibility of the transporters, making
it difficult to obtain stable crystals.
Due to these difficulties, high-resolution three-dimensional structures have been
obtained for only a limited number of transporters. For other transporters, threedimensional
structures have been achieved through homology modeling. In this approach,
similar folding patterns between any protein and one for which the crystal
structure is known enable the construction of a fairly accurate three-dimensional protein
model of the unknown structure using the related crystal structure as a template
and modern computational techniques. Three-dimensional structures have revealed
that transporters have α-helical structures of the membrane-spanning domains, and
some of the helices have irregular shapes with kinks and bends. Certain transporters
undergo substantial movements during the substrate translocation process. Construction
of three-dimensional transporter models have provided insight into functional
mechanisms and molecular structures and enabled formulation of new hypotheses
regarding transporter structure and function, which may be validated experimentally.
and toxicity, characterization of transporter structure can provide a scientific basis for
understanding drug delivery and disposition, as well as the molecular mechanisms of
drug interactions and interindividual and interspecies differences.However, compared
to soluble proteins, the atomic resolution crystal structures of membrane transporters
have been extremely difficult to obtain, for several reasons. First is the amphipathic
nature of the surface of the transporters, with a hydrophobic area in contact with
membrane phospholipids and polar surface areas in contact with the aqueous phases
on both sides of the membrane; second is the low abundance of many transporters in
the membrane, making it impossible to overexpress them, a prerequisite for structural
studies; and third is the inherent conformational flexibility of the transporters, making
it difficult to obtain stable crystals.
Due to these difficulties, high-resolution three-dimensional structures have been
obtained for only a limited number of transporters. For other transporters, threedimensional
structures have been achieved through homology modeling. In this approach,
similar folding patterns between any protein and one for which the crystal
structure is known enable the construction of a fairly accurate three-dimensional protein
model of the unknown structure using the related crystal structure as a template
and modern computational techniques. Three-dimensional structures have revealed
that transporters have α-helical structures of the membrane-spanning domains, and
some of the helices have irregular shapes with kinks and bends. Certain transporters
undergo substantial movements during the substrate translocation process. Construction
of three-dimensional transporter models have provided insight into functional
mechanisms and molecular structures and enabled formulation of new hypotheses
regarding transporter structure and function, which may be validated experimentally.
WHAT ARE DRUG TRANSPORTERS?
Transporters are membrane proteins whose primary function is to facilitate the flux of
molecules into and out of cells. Drug transporters did not evolve to transport specific drugs. Instead, their primary functions are to transport nutrients or endogenous
substrates, such as sugars, amino acids, nucleotides, and vitamins, or to protect the
body from dietary and environmental toxins. However, the specificity of these transporters
is not strictly restricted to their physiological substrates. Drugs that bear
significant structural similarity to the physiological substrates have the potential to be
recognized and transported by these transporters. As a consequence, these transporters
also play significant roles in determining the bioavailability, therapeutic efficacy, and
pharmacokinetics of a variety of drugs. Nevertheless, because drugs may compete
with the physiological substrates of these transporters, they are also likely to interfere
with the transport of endogenous substrates and consequently produce deleterious
effects on body homeostasis.
molecules into and out of cells. Drug transporters did not evolve to transport specific drugs. Instead, their primary functions are to transport nutrients or endogenous
substrates, such as sugars, amino acids, nucleotides, and vitamins, or to protect the
body from dietary and environmental toxins. However, the specificity of these transporters
is not strictly restricted to their physiological substrates. Drugs that bear
significant structural similarity to the physiological substrates have the potential to be
recognized and transported by these transporters. As a consequence, these transporters
also play significant roles in determining the bioavailability, therapeutic efficacy, and
pharmacokinetics of a variety of drugs. Nevertheless, because drugs may compete
with the physiological substrates of these transporters, they are also likely to interfere
with the transport of endogenous substrates and consequently produce deleterious
effects on body homeostasis.
Sunday, March 23, 2008
Free Drug Bank Is Back...
Hi everyone, after a few years we are back again to share all our experiences with you.We would like to help to you and all the people about the drugs.As you know we are not doctors or something else.We'll just find the good informations about drugs and post it here so we don't accept any responsibilities about the posts that we sent.Thank you again...
Subscribe to:
Posts (Atom)