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.
Wednesday, March 26, 2008
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.
Subscribe to:
Posts (Atom)
