Chapter 19: Drug Information in Ambulatory Care

After completing this chapter, the reader will be able to

• Describe the importance of drug information provided by the health care professional in the ambulatory care setting.

• Discuss the importance of access to up-to-date formulary information in the provision of care in the ambulatory setting.

• Identify sources with links to full-text evidence-based practice guidelines.

• Describe desired characteristics of drug information resources specific to the ambulatory environment.

• Describe reputable drug information sources geared toward the health care professional that are also useful in providing drug information to patients.

• List ways that practitioners may address concerns regarding access to information.

• Discuss importance of providing drug information regarding disposal of unused, unwanted, or expired medications and immunizations.

• Identify resources providing quality-assurance indicators for optimal provision of ambulatory care.

1. The clinician in the ambulatory care setting routinely utilizes multiple drug information skills on a daily basis to not only provide drug information to patients and other health care providers, but to function competently and efficiently within this practice setting.

2. The ambulatory care practitioner is the person with the greatest opportunity to fill the role of medication information provider and interpreter to the lay public.

3. Knowledge of formulary status of medications is only one part of the prescription decision-making process. Whenever they exist, evidence-based clinical practice guidelines should guide prescriptive decision making.

4. Ambulatory practitioners have the responsibility to remain up-to-date regarding current practice guidelines.

5. Increasingly more medical literature, including tertiary references, is being provided in the electronic or Internet-based format, and such databases are attractive to utilize in ambulatory care for multiple reasons.

6. Ambulatory care clinicians bear a responsibility to educate patients on the proper disposal of unused and unwanted medications and should, therefore, be aware of pertinent sites for information.

7. While ambulatory clinicians (in particular, pharmacists) typically recommend and/or dispense most medications, immunizations are medications that are administered in the ambulatory care setting. Those practitioners immunizing in this setting have the obligation to not only provide these services safely, but to serve as immediate sources of information (i.e., drug information) regarding the medications they are administering.

8. Health care professionals involved in the provision of care in the ambulatory care setting should familiarize themselves with the pertinent established quality measures.

This textbook covers a long list of drug information topics and skills, although not every clinician will use all of these skills on a daily basis. ❶ The clinician in the ambulatory care setting routinely utilizes multiple drug information skills on a daily basis to not only provide drug information to patients and other health care providers, but to function competently and efficiently within this practice setting.

The ambulatory care practitioner is required to use a variety of drug information skills and resources during routine encounters with patients to provide information at a personalized and appropriate level. Before doing so, the practitioner must know where to look for appropriate information, and how to interpret and practically apply this information to a specific patient or population. This is where many practitioners may be challenged.

This chapter discusses the resources and skills commonly needed by the ambulatory care provider in order to provide appropriate drug information. Topics covered will include (a) commonly used references for prescription formularies and for obtaining evidence-based guidelines, (b) desired characteristics of drug information resources and examples of those particularly useful to the ambulatory care clinician, (c) information resources pertinent to the current trends in ambulatory care, such as the proper disposal of unused or unwanted or expired medications, (d) preventive health information (specifically regarding immunizations), and (e) quality-assurance measures in ambulatory care.

Ambulatory care encompasses a variety of settings. For example, an ambulatory care practitioner may be a clinician who practices in a community pharmacy (including persons in medication-dispensing roles), a community-based clinic or office, an outpatient setting of an institutional care facility, or someone who provides on-site services within an employer-provided wellness and disease management program. As such, the case scenarios within this chapter include scenarios where the provider is in a medication-dispensing role as well as where the provider is in a nondispensing role.

Although the provision of health care takes place in a variety of settings, ranging from hospital and long-term care facilities to patients’ homes, the emphasis in today’s patient care environment is to provide as much health care as possible in the outpatient, ambulatory setting. This may or may not be a setting that dispenses medications. It is also commonly recognized that patients are increasingly technologically savvy and utilize the Internet and news media to provide self-care in the outpatient setting. The quality of the medical and drug information patients obtain themselves varies widely, depending on the source (see Chapters 4 and 5 for drug literature evaluation); however, even when quality information is obtained by a patient or family member, someone with clinical expertise and drug information training is necessary to explain medical information and to provide guidance in the decision-making process.

Finally, with increasing numbers of team-based patient care models such as patient-centered medical homes (PCMHs) being established across the country, the provision of accurate, comprehensive drug information in the ambulatory setting is growing exponentially, as it is crucial to (a) researching appropriate medical treatment, especially of chronic conditions, (b) bridging the gap between data provided from health information technology and how to most effectively use these data to treat patients on an individual and population-based basis, and (c) educating patients regarding their treatment.

“I CAN JUST GOOGLE® IT MYSELF”

Given the name of a medication, the average lay person may well be able to Google^® the name of the drug, and would very likely find general information regarding its use and side effects. Blogs regarding the experiences of other people with that particular medication may also be easily found, as well as anecdotal comments about the drug and the condition being treated, including outdated information. The average patient is, in fact, able to access a plethora of information via Web sites and blogs; however, the reliability, accuracy, and timeliness of this information can vary widely, as discussed in Chapter 3. While some of these sources of drug information may be reputable, they are impersonal and can only offer general information to the reader. Such sites typically advise patients to talk with their practitioners for specific personal questions.

WHAT SHOULD THE PUBLIC (OR OTHER HEALTH CARE PROVIDERS) KNOW ABOUT UTILIZING CLINICIANS TRAINED IN DRUG INFORMATION VERSUS PERFORMING THEIR OWN SEARCHES?

Health care providers fill an important role in the provision, interpretation, perspective on clinical application, and, perhaps most importantly, providing patient-specific application of drug information that is often targeted toward the layperson by the media. While there is an ever-increasing trend toward patient empowerment, self-care, and self-education, the lay public is often unaware that the health care provider has access not only to the same Web sites as the patient, but also to professional literature and databases (see Chapter 3) that expand and often provide critical analysis of the information the public accesses. The lay person is unable to access and/or interpret such information. Depending on their clinical training, even certain health care providers may also lack knowledge regarding available resources and how to best interpret health information data.

Although in some cases, individuals may be able to personally access secondary or even primary literature, interpreting this information and putting it into context with their personal health conditions as well as with current evidence-based guidelines (see Chapter 7) require a health care professional trained in drug information. Interpreting and evaluating primary literature (see Chapters 4 and 5) as well as locating and interpreting evidence-based guidelines are skills that require training and practice. These activities call for an individual trained in drug evaluation and with expertise in these areas (see Chapters 3, 4, 5, 7, and 8).

❷ The ambulatory care practitioner is the person with the greatest opportunity to fill the role of medication information provider and interpreter to the lay public. The definition of the ambulatory care practitioner is changing, with a growing number of health care settings (e.g., particular PCMHs) lending themselves to providing streamlined, comprehensive outpatient care. Any medical care delivered on an outpatient basis is considered ambulatory care. For example, an ambulatory care practitioner may be a clinician who practices in a community pharmacy (including persons in medication-dispensing roles), a community-based clinic or office, an outpatient setting of an institutional care facility, or someone who provides on-site services within an employer-provided wellness and disease management program.

Although proficiently providing drug information is a skill which requires training and practice, often the biggest challenge for ambulatory care practitioners is not providing the needed drug information skills proficiently, but convincing the public that they offer a unique skill in drug information beyond the Internet.

Unfortunately, many practitioners place too little emphasis on the need for their involvement in interpretation of drug information, assuming that other health care professionals and even the public itself, with adequate access to information databases, can research and answer their own questions. In 2001, it was reported that in 1 year, approximately nine million hospital admissions and over 18 million emergency room visits in the United States (U.S.) were caused by incorrect use of medications.¹ Although these data were published several years ago, this is an issue that has not resolved. Consider a study conducted in Vancouver, Canada, published in 2008, which reported pharmaceuticals were the cause of 12% of emergency room visits and resulted in significantly longer length of stays for those patients admitted.² In a 2011 study published by Budnitz and associates, of over 100,000 medication-related emergency room visits, only 1.2% of medication-related emergency room visits were attributed to what were classified as high-risk medications.³ Finally, according to a 2012 update from the Centers for Disease Control and Prevention (CDC), over 700,000 emergency room visits are made in the United States every year as a result of what are often preventable adverse drug events.⁴ The circumstances behind these statistics are certainly multifactorial, and may include nonadherence or misuse of medications, lack of communication between patients and health care providers, and clinically inappropriate prescribing patterns. Paramount to correcting each of these factors is the research, interpretation and communication of drug-related information to all parties.

In today’s environment, with direct-to-consumer advertising (see Chapter 23) and increasing numbers of nonprescription medications that were formerly available only by prescription, the decision to use a medication is not made solely by prescribers, but also by patients themselves. It is evident that all decision makers need guidance. Who guides these decision makers? Unfortunately, the answer is often no one.

There is certainly not a lack of available drug information, nor is there, for many individuals, a lack of accessibility. What is lacking, however, is the provision of quality drug information provided by a practitioner trained to do so for not only patients, but for other health care providers.

The emphasis placed on drug information in the curricula for different types of health care professionals vary widely; however, it can be said that pharmacists are the health care professionals with the greatest amount of time devoted to this topic in their professional training. As such, this profession bears the responsibility to educate both the public and fellow health care providers. Examples of this type of education in the ambulatory setting may include (a) whenever possible, ensuring that biased sources such as pharmaceutical salespersons are not the main source of new product education for prescribers, (b) leading or facilitating discussions with prescribers regarding newly published studies, meta-analyses, and clinical guidelines, with emphasis on an understanding of limitations of these publications and how they apply specifically to those prescribers’ patient populations, (c) researching and answering drug information questions (which may or may not be patient-specific), (d) writing newsletters regarding topics pertinent in the media, and/or in the condition-specific clinic(s) in which the pharmacist works, (e) “debunking” misperceptions that may arise from direct-to-consumer advertising regarding exaggerated efficacy or risk associated with treatments, (f) providing basic statistical training including terms such as relative risk versus actual risk of treatments, and how to determine them. In addition, it is worth mentioning that in order to provide patient-specific drug information, complete medication profiles must be obtained, and this often involves communication between not only outpatient/ambulatory care clinics, but one or more pharmacies to get the full picture regarding all pertinent medical conditions and medications. Regardless of which method(s) are used to educate fellow clinicians, it is vital that pharmacists are prepared to explain the vital role they play in assisting others to understand and use medications in the safest and most effective way possible.

In today’s busy society, the case for the pharmacist (and subsequent pharmacist-provided drug information) needs to be concise and to the point. Until that case is made to the public and other payers for health care, including both employers and legislators, it is likely that pharmaceuticals will continue to have the unintended effect of increasing, rather than decreasing morbidity and mortality, and contributing to rising health care expenditures.

The following section discusses resources integral to the provision of drug information in ambulatory care.

Integral drug information-related responsibilities of the ambulatory care clinician are many. Several key responsibilities include (1) assisting prescribers and consumers to find the most cost-effective drug to treat a given condition, (2) ensuring a prescribed medication is appropriate and follows current treatment guidelines, (3) ensuring a patient’s understanding of the appropriate use of their medications (see Chapter 20), (4) guiding others regarding the proper disposal of unused or unwanted medications, (5) delivering preventive health information, and (6) incorporating quality-assurance indicators into daily practice.

Practitioners who may not be the initial prescribers of medications (e.g., those who work under consult agreement, collaborative practice agreement, or who work with supervisory physicians or collaborating physicians) must be familiar with this information. Regardless of the U.S. state in which a clinician practices, and regardless of health care provider degree (e.g., PharmD, Physician Assistant, Nurse Practitioner), sound recommendations regarding modifications in drug therapy, drug therapy renewal, and initial drug therapy recommendations all hinge upon a solid understanding of drug formularies, appropriate practice guidelines, and drug information database considerations.

DRUG FORMULARY INFORMATION

Key to assisting prescribers and consumers in finding the most cost-effective treatment is familiarity with drug formularies. Whether a clinician is prescribing or filling a prescription order, formulary restrictions increasingly influence medication usage patterns.

A formulary is a list of medications that are approved to be paid for or provided at a discounted rate through prescription insurance plans. It is important to note that even if a medication is not included on a formulary (i.e., is considered “nonformulary”), or is not listed as a preferred option by the payer for a patient’s prescription drugs, the prescriber is not bound to this when deciding whether to prescribe that medication and nothing prohibits the pharmacist from filling an appropriate medication for a patient, regardless of its formulary status.

Additionally, there are some medications that, while on formulary, may require prior authorization from the insurance company before it will be paid for. That does not mean it cannot be dispensed—it only means that if the patient wants the insurance company to pay for the medication, additional information must be provided in advance regarding the medical need. The pharmacist plays an integral role in working with the prescriber on a patient’s behalf to obtain an insurance company’s authorization to fill a prescription for such a medication.

What formulary status ultimately affects is the amount the patient will personally pay for a medication. Several useful tools exist to assist in determining formulary restrictions and then making decisions as to risks versus benefits of abiding by these restrictions.

Center for Medicaid and Medicare Services

The Center for Medicaid and Medicare Services (CMS) is a government agency within the U.S. Department of Health and Human Services that is responsible for the administration of this country’s Medicare and Medicaid services, through which medical and prescription benefits are derived for select components of the populations, traditionally for the poor, elderly, and disabled. Historically, private insurances have modeled reimbursement structures for medical and medicine-related costs after the CMS model. Current health care reform in the United States is anticipated to result in increasing numbers of persons who were either uninsured or underinsured (without adequate prescription insurance to cover medical-related costs) to now being insured through either Medicaid or other government mandated programs. In other words, the landscape of prescription coverage will change, and many patients’ prescription constraints will shift from those related to personal finance to those related to formulary restrictions.

In addition, it remains a fact that the largest proportion of the population taking prescription medications are already Medicare recipients. These persons’ drug coverage is provided through a component of Medicare called Medicare Part D. Through this program, various insurances provide government-funded prescription coverage for Medicare recipients. Each insurance company has a different formulary, or list of drugs that are provided at a reduced price to Medicare recipients. As such, understanding formularies and their restrictions, as well as the ability to access to Medicare drug plan (i.e., Medicare Part D) formulary information is paramount. Although many patients may select their own Medicare drug provider and plan, others often look to their pharmacist to assist them in this decision. Drug plan selection is done largely online and is based on a patient’s prescription profile as well as geographic location. A pharmacist is an ideal person to assist with this process as this is the provider likely to be most familiar with various drug classes listed on drug plan formularies as well as acceptable over-the-counter and generic alternatives to specific medications. Information to guide selection is available at http://www.medicare.gov and clicking on the link to “Find health and drug plans,” https://www.medicare.gov/find-a-plan/questions/home.aspx. Users choose their state of residence and enter their prescription drug profile (i.e., the list of prescriptions the patient takes). The program will then provide a list of Medicare Part D plans that include some or all of the medications the patient takes, as well as information regarding the status of each drug in a particular plan, and the number of pharmacies that participate with a plan in a given state. Users, including prescribers, can also download complete formularies, as well as appeals and exceptions forms. These are forms that may be completed, usually by the prescriber on behalf of the patient asking for consideration of payment for a drug due to extenuative circumstances or a situation specific to that patient. This Web site can be used by patients alone or may be used by a provider on behalf of the patient. Additionally, it is useful for the provider needing to complete necessary forms for patients requiring a medication not covered on their formulary plan. Finally, although not required to prescribe for medications on a patient’s specific drug plan, providers may use the site to determine if a drug will be paid for, and if not, if there are acceptable therapeutic alternatives that will be covered.

An additional method for obtaining formulary information via the Internet is by typing the name of the prescription insurance provider+formulary+the calendar year you desire (e.g., 2015) in the Internet search engine (e.g., Google^®, Bing™). Most prescription insurance providers will have Web pages that include a full formulary guide, a list of covered medications listed by drug or by drug class, medications tier status in which participants are subject to varying levels of copayment options for a given drug (depending on its formulary status) links to suggested alternatives to a medication if it is not covered, and links for forms necessary for prior approval, appeals, and exceptions. An advantage to using these Web sites is immediate access to information and necessary forms. Each prescription insurance provider, however, will have a different Web page design and there is often not consistency as to where the user will find information.

Epocrates®

Many clinicians may be familiar with Epocrates^®, Inc., software programs (http://www.epocrates.com/). Epocrates^®, Inc., markets programs with a variety of content areas including calculations, continuing medical education, diagnostics, a medical dictionary, disease state information, drugs, pill identification, medical news, and tables. These content areas are bundled into various data packages, some of which are free. All Epocrates^® programs, including those that are available at no cost, include both national and regional formulary information, including Medicare Part D. Users can access formulary status and restrictions for over 3300 brand and generic medications. Users of these programs select the formulary or formularies they desire to include in their searches. Epocrates^®, Inc., updates formulary information at least once per week.⁵

Epocrates^® accounts may be established on the Internet, but for those practitioners who work without Internet access; these programs are downloadable to handheld electronic devices (e.g., iPhone/iPad and Android). This program may prove the most practical solution for providers who require timely formulary information and who operate without full Internet access. It is strongly recommended, however, in light of increasing amounts of current drug information available exclusively online, or for which online access provides regularly updated information not otherwise available, that all providers of drug information and direct patient care insist on Internet access in order to ethically and competently perform their responsibilities.

Electronic Prescribing (e-Prescribing) Platforms

Clinicians with prescribing privileges should also note that electronic prescribing (e-prescribing) platforms provide drug and formulary information at the point of care. In a 2008 study conducted by the Agency for Healthcare Research and Quality (AHRQ) and published in the Archives of Internal Medicine, prescribers utilizing e-prescribing platforms with formulary decision supports (FDS) were significantly more likely to prescribe tier 1 (least expensive) medications, with resulting significant potential cost savings.⁶ Chang and associates evaluated over 21,000 prescriptions for just over 1 year, and reported in 2010 that generic drug use was 6% higher, formulary drug use was 3% higher, and cost savings for the payer and prescription drug member was over 17% higher for those prescriptions electronically prescribed.⁷

Lexicomp®

Finally, as outlined later in this chapter, Lexicomp^® online drug information, http://lexi.com, also contains useful formulary information.

It is important to note, however, that ❸ knowledge of formulary status of medications is only one part of the prescription decision-making process. Whenever they exist, evidence-based clinical practice guidelines should guide prescriptive decision making.

Current Practice Guideline Information

It is beyond the scope of this chapter to discuss in depth the development and the interpretation of evidence-based clinical practice guideline recommendations (see Chapter 7). It is important to note, however, that ❹ ambulatory practitioners have the responsibility to remain up-to-date regarding current practice guidelines. No individual can be expected to know the current treatment guidelines for every condition; however, clinicians can and should be expected to be able to retrieve this information quickly and efficiently. The following outlines several sources for such retrieval.

Perhaps most useful to the ambulatory care clinician may be the databases that include mobile applications. The Centers for Disease Control and Prevention Web site includes free mobile apps (compatible with iPhone/iPad, Android, and Microsoft Windows 8) for a variety of medical conditions, available at http://www.cdc.gov/mobile/mobileapp.html.

Clinicians searching for current practice guidelines may also wish to visit the National Guideline Clearinghouse (NGC), http://www.guidelines.gov. This compilation of evidence-based clinical practice guidelines is a project of the American Health Insurance Plan (AHIP) and the AHRQ, and is a public resource for evidence-based clinical practice guidelines. The NGC includes links to full-text current treatment guidelines, guidelines in process, as well as archived guidelines. Side-by-side comparison of two or more treatment guidelines for a given condition is also available. Users may search this site by disease/condition, treatment/intervention, or organization.⁸ If Internet or wireless Internet access (depending on practice location) is not readily available, users can download guidelines, often at no cost, in HTML format to their personal handheld devices for quick reference. Clinicians in this situation may wish to consider downloading treatment guidelines they most commonly refer to in their particular practice, checking regularly for updates. For example, a general practitioner may wish to download the current American Diabetes Association (ADA) guidelines, the current American College of Cardiology and American Heart Association guideline for the treatment of hypercholesterolemia, and the current Joint National Committee (JNC) guidelines for the treatment of hypertension. Clinicians who may work primarily with a specialized population may wish to tailor downloads to those pertinent to their area of practice. The NCG Web site also provides links to the Web sites of various guideline developers (e.g., American Academy of Dermatology, American Academy of Family Physicians, etc.) for those that have mobile-device-friendly formats of their guidelines.

The Iowa Drug Information Service (IDIS) database also provides an efficient method for locating treatment guidelines.⁹ Users may narrow the type of journal article the database retrieves by utilizing the descriptor practice guidelines, and then typing the disease state they are researching in the appropriate text box. Users have online full-text access to articles published after 1988. This database requires a subscription, however, and is not freely available to the public.

Many additional search engines and Internet sites, including sites for the organizations such as the American Heart Association and the American Diabetes Association include links to current full-text, pertinent practice guidelines. Those sites that may be particularly useful to the ambulatory care practitioner because they (a) are available without a subscription and (b) provide links to full-text guidelines for a large number of medical conditions include Health Services Technology Assessment Texts (HSTAT), http://www.ncbi.nlm.nih.gov/books/NBK16710/; the Turning Research Into Practice (TRIP) Database, http://www.tripdatabase.com/; and PubMed^®, http://www.pubmed.com; PubMed does allow the user to establish (for free) a user account and allow the viewer to filter searches to include review articles (which may include clinical practice guidelines). Some, but not all, search results within PubMed^® provide links to full-text articles. Those that do not provide full-text article links provide full citations.¹⁰

The American Society of Health-Systems Pharmacists (ASHP) also provides links to what it has deemed Best Practice policies and treatment guidelines (http://www.ashp.org/bestpractices). The American Pharmacists Association (APhA), while it does not endorse guidelines as ASHP does, also provides links from its Web site to select practice guidelines (http://www.pharmacist.com).

This list is not all inclusive. For example, MEDLINE^® (which is partially available via PubMed), EMBASE, and the Cochrane Database of Systematic Reviews indexing systems are excellent resources for retrieving clinical practice guidelines; however, they require subscriptions and familiarity with the search techniques in order to yield optimal results. The reader should refer to Chapters 3 and 7 for a more detailed description of each of these, as well as other databases that may be utilized when searching for clinical practice guidelines. Of note, the most effective search term may be practice guideline in the publication-type field of various search pages. An additional useful search term may be treatment guideline.

DESIRED CHARACTERISTICS OF DRUG INFORMATION RESOURCES IN THE AMBULATORY SETTING

❺ Increasingly more medical literature, including tertiary references, is being provided in the electronic or Internet-based format, and such databases are attractive to utilize in ambulatory care for multiple reasons.

• Electronic databases are easily accessible, which is of utmost importance, as ambulatory care may take place in clinics or pharmacies that are part of the same health system, but located in multiple locations.

• Electronic databases tend to be updated more easily and frequently, with new drug updates and pertinent changes in patient and disease management versus print copies of drug information that may outdate quickly.

• Electronic drug information databases are more quickly and easily searched for specific topics pertinent to a given patient, and often utilize hyperlinks or search functions. Recall that, as reviewed in Chapter 3, regardless of the format (electronic versus print), patient education materials should contain language that is directed either toward the patient, parent, or caregiver, and be written at an appropriate reading level. It is recommended that databases specify the reading level of patient education material.

Examples of particularly useful databases are provided below.

A REVIEW OF SELECTED DRUG INFORMATION RESOURCES FOR THE AMBULATORY CLINICIAN

Many of the following tertiary resources are also mentioned in Chapter 3, however, rather than focusing solely on the appropriate resource for a specific drug information request, the following is a brief overview of selected resources that (a) are available electronically, (b) are primarily geared toward the health care professional and are also particularly useful to the ambulatory care practitioner, (c) provide in-depth drug and alternative product monographs, and (d) provide useful patient-oriented material.

Clinical Pharmacology®

Gold Standard, http://www.clinicalpharmacology.com. This database includes MedCounselor^® Consumer Drug Information Sheets that are available in both English and Spanish, and includes the date of last revision of any given patient education sheet. MedCounselor^® Sheets are available via hyperlinks from drug monographs or by searching by drug product under a patient education tab within the site. This product includes patient education materials written at a sixth- to eighth-grade reading level regarding prescription, nonprescription, and some herbal medications.

In addition to this information geared toward the consumer, this database also includes clinical calculators, manufacturer contact information, normal laboratory reference values, drug class overviews, clinical comparison reports, and convenience charts (e.g., meds that should not be split, that interact with grapefruit juice, etc.). Information on complementary and alternative medicine (CAM) is also found in this database. This may of particular value in the ambulatory setting as these patients are most likely to be concurrently taking or inquiring about CAM in addition to their prescription medications.

Drug Facts and Comparisons®

Wolters Kluwer Health, Inc., http://www.factsandcomparisons.com. The electronic version of this database, utilizes MedFacts Patient Information^®, which provides customizable patient information in both English and Spanish for over 4000 brand and generic drugs, and includes some herbal medication patient education materials. The reading level is written at the eighth-grade level or below, with the date of last issue clearly provided on each education sheet.

In addition, the ambulatory care clinician can find within this database clinical calculators, comparative data tables, and comparative efficacy tables within drug classes, a “don’t crush/chew” list of medications, a drug identifier tool, drug interactions tool, immunization schedules, and even information regarding patient assistance programs for those patients experiencing difficulty affording their medication(s). Additional information on pregnancy and lactation with medications, natural medicines, and toxicology treatment guidelines (e.g., for overdose treatment or for reversal of effects of medications) is also available within this database.

Apps from this database are available for the iPhone/iPad as well as Android devices.

Lexicomp® Online

Available as an online subscription through Lexicomp, http://www.lexi.com, Lexicomp^® Online incorporates an Internet-based platform to provide not only the electronic version of information found in Lexicomp’s Drug Information Handbook, but, depending on the subscription purchased, may also include information from AHFS^® Drug Information reference, and prescription drug plans including information regarding pricing, formulary status, and prior authorization status. Of particular interest to the ambulatory clinician, this resource includes links within drug monographs to Patient Education Modules (PEM).

PEM deliver patient-specific education regarding a particular medication or a disease, condition, or procedure. Condition and procedure information is available in either English or Spanish, with medication leaflets available in up to 19 different languages. PEM are also available for select natural products. Patient information is written at a fifth- to sixth-grade reading level, and may be personalized and printed for distribution to the patient.¹¹ The practitioner specifies whether a PEM is for an adult or pediatric patient, with pediatric information written toward the parent or caregiver.

The Lexicomp platform is also available for handheld apps (e.g., on the iPhone/iPad, Android, Blackberry).

Micromedex® Healthcare Series’ Detailed Drug Information for the Consumer™

Available as an online subscription through Truven Health Analytics, http://www. micromedex.com, the Micromedex Patient Connect Suite^® includes educational resources written at third- to seventh-grade reading level in up to 15 languages and that may be delivered in multiple media formats (e.g., written, video, interactive tools, a 3D avatar, and more). This suite of resources is intended for use by not only retail and hospital pharmacists, physicians, and nurses, but also patient education program coordinators.¹²

Separate tabs contain information within this database regarding drug interactions, drug identification, calculators, and toxicology/drug effect reversal. The toxicology section may be of particular interest to clinicians in ambulatory setting who work with high-risk medications such as anticoagulants (e.g., warfarin) or insulin products.

CareNotes™ System

Also available via a subscription, by Truven Health Analytics, http://www.micromedex.com, the CareNotes^® System enables the clinician to provide customizable patient education documents (in 15 different languages, confirmed to be written at a sixth- to eighth-grade reading level in English and Spanish). These documents may address general health condition information, preprocedure or presurgical information, and information regarding inpatient and discharge care for patients, laboratory test information, and a section titled DrugNotes, which includes patient-directed drug information for both prescription and nonprescription medications.¹³

In addition, of use to the ambulatory care provider in particular, this database includes drug identification, toxicology management, drug comparison tables, clinical calculators, and even pricing and manufacturing information in medical devices and select diagnostic equipment (e.g., blood glucose monitors).

Apps from this database are compatible with iPhone/iPad and Android devices, but not with Palm and Pocket PC/Windows Mobile Classic platforms.

Natural Medicines Comprehensive Database®, Pharmacist’s Letter®, and Prescriber’s Letter®

All published by Therapeutic Research Center, subscriptions to each of these publications are available electronically, may be downloaded to electronic handheld devices, and may be of great value, especially in the ambulatory care setting.

The Natural Medicines Comprehensive Database®

The Natural Medicines Comprehensive Database^® (NMCD), http://naturaldatabase.therapeuticresearch.com (subscription required), provides evidence-based information regarding complementary, alternative, integrative medicine, and natural medicines. The database provides full monographs with evidence-based ratings, safety ratings, and interaction ratings based on currently available literature. NMCD includes a useful natural product/drug interaction checker and patient handouts written in both English and Spanish.¹⁴

Of use to the ambulatory clinician, enabling frank discussion of the risk versus benefit of complementary or natural medicines is an “efficacy” rating, which rates each natural medication on the likelihood of its being effective for a given condition, coined the NMBER^TM+ (Natural Medicines Brand Evidence-based Rating). Information regarding perioperative use of natural medications is also available.

Pharmacist’s Letter® and Prescriber’s Letter®

Pharmacist’s Letter^®, http://pharmacistsletter.com, and Prescriber’s Letter, http://prescribersletter.com (subscription required), provide detailed information regarding traditional prescription and nonprescription medication, including full monographs with evidence-based ratings, safety rating, and interactions based on currently available literature. The main difference between these two databases is the target audience. These publications cover new developments in drug therapy and trends in pharmacy practice, concise updates, and advice regarding current therapeutic issues with links to a detail document with a more in-depth explanation of the topic. These publications also include very useful comprehensive disease-, medication-, and practice-related charts. For example, ambulatory care clinicians may find comparison charts for statins, insulin products, injectable anticoagulants, anticipated availability of first-time generics, etc. Links for treatment guidelines for a variety of commonly treated conditions are also available (e.g., cardiology, diabetes, gastroenterological conditions, asthma, COPD). A “Rumor vs. Truth” section may also be of use for quick reference when fielding questions from the public on misstated facts or exaggerated efficacy claims in the media, for example.

Apps from this database are available for the iPhone/iPad as well as Android devices.

Drug Information Web Sites

Particularly useful Web sites include those of the (a) Food and Drug Administration (FDA), http://www.fda.gov, as it provides recent drug-related news, drug approvals, recalls and safety warnings, therapeutic equivalency codes, and MedWatch adverse event reporting data; (b) Centers for Disease Control and Prevention (CDC), http://www.cdc.gov, as it provides useful information regarding infectious disease treatment and prevention, immunization information, treatment guidelines for infectious disease, and even traveler’s health information, some of which may be available in more than one language; and (c) Medscape, http://www.medscape.com, which provides free access to continuing education, select health-related journals, evidence-based information, and pertinent review articles.

ACCESS CONSIDERATIONS

For the reasons outlined above, the electronic version of each of these databases and publications is the preferred format. Whenever possible, databases that are available for downloading to a smart phone or alternate handheld device are included; however, even these will require intermittent Internet access for synchronizing and updating information. Responsible provision of up-to-date drug information requires Internet access. Health care providers and employers should ensure that this is available to those providing medical information to others.

Practitioners may also note that by partnering with colleges of pharmacy or medicine to provide experiential education to students, they may expand their access to drug information databases to which the college subscribes, depending on subscription limitations.

Drug information centers, also referred to as medication information centers, may be a viable source of information, particularly when in-depth research of a topic is not feasible due to either a lack of access to appropriate databases, paucity of individuals trained in drug information, or lack of time.

PATIENT EDUCATION

The preceding sections (e.g., practice guidelines, desired characteristics of databases, and other drug information resources) address the role of the ambulatory care provider in researching appropriate medical treatment and using this data to treat patients on an individual basis. This section focuses on yet another important aspect to ambulatory drug information: educating patients on the appropriate use of their medications. Certainly documents generated from the databases outlined above, manufacturer-provided patient information leaflets, and direct patient counseling at the pharmacy, all serve to educate patients on intended use(s), cautions, possible side effects, and required monitoring for each medication, but this is not enough. Ambulatory care clinicians fill an important role in educating patients regarding the proper administration of certain medications (e.g., insulin, inhalers, injectable anticoagulants), the management of adverse reactions (e.g., hypoglycemia, bleeding), and dosing adjustments that may be required such as during perioperative periods or during periods of illness. While most of this information may be found within the individual drug information databases (e.g., how to reverse the effects of hypoglycemia caused by excess insulin or how to reverse the effects of warfarin), it is not always included in patient education materials, and must be taught to the patient. Additionally, for those medications that require specific administration technique, providing patients with written instructions is not enough.

Hands-on demonstration and teach-back communication are vital to ensuring medications are used optimally. Manufacturers of drug products that require special administration typically provide patient handouts for this purpose. The Centers for Disease Control Web site (http://cdc.gov) also has useful videos as well as tutorial sheets (e.g., asthma inhaler use, how to check blood glucose), which may be modified or used “as is.” Finally, for the condition of interest, there are often topic-specific patient education materials available from a national Web site for the disorder being treated. For example, the American Diabetes Association (http://www.diabetes.org/) Web site includes links for recognizing and treating hypoglycemia, testing blood glucose, and “sick-day” management. Information obtained from any of these places, however, must be explained, tailored to the patient and the situation, and even demonstrated (e.g., glucose monitor, insulin pen); ambulatory clinicians fill an important in the provision of this type of drug information.

While health care providers may know that they cannot legally accept medications that have previously been dispensed, they must also be able to take the next step and provide drug information to the inquirer regarding the legal, safe, and appropriate disposal of these medications.

More often than in any other setting, ambulatory care practitioners are asked about disposal of unused or unwanted medications. While there no specific laws regarding personal disposal of medications by patients, disposal of unused or unwanted pharmaceuticals (both prescription and nonprescription) is becoming an emerging and complex environmental issue. In a 2006 survey published in the Journal of the American Board of Family Medicine, of 301 patients surveyed at an outpatient pharmacy, 50% reported storing unused or expired medication and another 50% report they have flushed such medications down the toilet. Less than 20% of respondents reported having been counseled by a health care provider about the appropriate means of medication disposal.¹⁵ Drug information is often considered (among other things) the provision of information to patients or health care providers about safe and appropriate use about medications, but it also includes serving as a resource for information about the proper storage and disposal of medications when they are not in use. ❻ Ambulatory care clinicians bear a responsibility to educate patients on the proper disposal of unused and unwanted medications and should, therefore, be aware of pertinent sites for finding this information. The Pharmaceutical Research and Manufacturers of America (PhRMA), the American Pharmacists Association (APhA), and the U.S. Fish and Wildlife Service (FWS) have joined forces to educate the public on the importance of appropriate medication disposal via the SMARxT DISPOSAL^tm campaign, http://www.smarxtdisposal.net/. Their key message to consumers: do not flush medications down the toilet and do not pour them down a sink or drain. The campaign actively promotes people to participate in medication take-back collection days, and provides a hyperlink to the U.S. Department of Justice and Drug Enforcement Administration’s Web page regarding the national drug take-back initiative.¹⁶

The FDA, http://www.fda.gov, provides consumer health information regarding the disposal of unused medicines, and has worked with the White House Office of National Drug Control Policy (ONDCP) to develop consumer guidance regarding this topic. Documents developed by these organizations are available online at the FDA and ONDCP Web sites.^17,18 In addition, disposal information for some, but not all, medications may be found in DailyMed, http://dailymed.nlm.nih.gov/dailymed/about.cfm, by searching within monographs in one or more of the following fields: Information for Patients and Caregivers, Patient Information, Patient Counseling Information, Safety and Handling Instructions, or Medication Guide.

Additional useful online resources with information on the safe disposal of medications include those of the Pharmacist’s Letter, http://www.pharmacistsletter.com, and the Institute for Safe Medical Practice (ISMP), http://www.ismp.org. Finally, the Community Medical Foundation for Patient Safety, http://www.communityofcompetence.com, has developed a very useful document, the National Directory of Drug Take-Back and Disposal Programs. The first edition, published in 2008, detailed the rationale, federal laws, state laws, published resources, useful Web sites, and practice guidelines for handling unused and expired medications. The second edition, published in 2011, listed just under 500 drug take-back programs, including locations and contact information for each and was available for purchase through the Community Medical Foundation for Patient Safety.¹⁹ Local and state drug take-back initiative sites may be listed on a case-by-case basis online; however, one site attempts to centralize drug take-back information on a national basis. The Product Stewardship Institute (PSI) addresses appropriate disposal of multiple types of products, including pharmaceuticals, and visitors to the PSI Web site may research take-back efforts and activities on a state-by-state basis.²⁰

There are a select few medications for which flushing medications down the toilet is the FDA-recommended method of disposal. For these medications, the sentiment of FDA officials is that in order to best protect persons and animals that could inappropriately use these medications, prompt flushing of unused or unwanted medication down the toilet is the preferred method of disposal. The drugs are listed in Table 19–1.²¹

DRUG REPOSITORY PROGRAMS

Drug repository programs (which allow nursing homes, long-term care pharmacies, and wholesalers to donate unused medication for redistribution to those patients who meet prespecified criteria) may exist in certain states. While patients understandably may be reluctant to throw away their personal unused or unwanted medications, these medications, once dispensed and in patients’ homes, are not eligible for donation to drug repository programs, as these drugs have left the custody and controlled environment of a pharmacy or institution. Practitioners should refer to their respective state’s Board of Pharmacy Web site for information regarding drug repository programs.

Formerly provided primarily in the traditional clinician’s office or in county or city health departments, immunizations are increasingly being delivered by pharmacists and other health care providers in ambulatory care settings, including pharmacies and retail groceries. ❼ While ambulatory clinicians (in particular, pharmacists) typically recommend and/or dispense most medications, immunizations are medications that are administered in the ambulatory care setting. Those practitioners immunizing in this setting have the obligation to not only provide these services safely, but to serve as immediate sources of information (i.e., drug information) regarding the medications they are administering.

SOURCES OF IMMUNIZATION INFORMATION

Centers for Disease Control and Prevention

While multiple texts exist regarding immunization and vaccine-preventable disease, the Department of Health and Human Services Centers for Disease Control and Prevention Web site, http://www.cdc.gov, provides the most comprehensive, regularly updated information regarding immunizations. Links are available from the CDC Web page titled Vaccines and Immunizations, http://www.cdc.gov/vaccines, for both the health care provider and patients, that provide up-to-date information regarding vaccine-preventable disease, as well as safety, adverse events, administration schedule, and dosing recommendations for immunizations. Also available from this site are Vaccine Information Statements (VISs), which must be distributed with their respective immunizations.

Epidemiology and Prevention of Vaccine-Preventable Disease

This textbook, commonly referred to as the Pink Book, is published annually by the National Center for Immunization and Respiratory Diseases (part of CDC) (http://www.cdc.gov/vaccines/pubs/pinkbook/index.html).²² It provides physicians, nurses, nurse practitioners, physician assistants, and pharmacists with comprehensive information regarding the vaccine-preventable diseases. The textbook is available for purchase in print; however, PDFs of each chapter are available fully formatted for download from the CDC Web site. While this text does not provide vaccine specific information, it provides detailed information regarding respective vaccine-preventable disease, including epidemiology, prevalence, and prevention recommendations.

Immunization Training for the Pharmacist

The prerequisites for pharmacists to administer immunizations vary from state to state, and pharmacists are advised to refer to their state’s laws and confer with their state board of pharmacy regarding specific questions; however, in each state that allows for pharmacist-administered vaccines, a training program approved by the state pharmacy board is required. The most widely recognized training program, Pharmacy-Based Immunization Delivery, is offered nationally by the American Pharmacists Association, http://www.pharmacist.com. Other programs do exist that may be recognized nationally or within specific states only. Pharmacists may wish to inquire with their specific state board of pharmacy regarding recognized and approved training programs. Regardless of the training program initially utilized, it is expected that pharmacists, as well as all other providers of health care, maintain and document appropriate continuing education for the immunizations and the associated drug information they deliver.

This chapter has thus far covered a variety of drug information topics pertinent to ambulatory care practice and the case has been made that efficiently accessing and interpreting a variety of types of information is necessary for functional competence in ambulatory care. A final drug information consideration for safe and competent function in the ambulatory setting is quality-assurance.

While facilities that are under the umbrella of a health care facility generally consider the standards set forth by The Joint Commission (TJC) (see Chapter 14) as a primary source of quality-assurance guidelines, several other organizations provide quality- assurance guidelines that may be applied to a variety of care settings, and will be discussed in the following paragraphs.

Via a variety of initiatives, including the Accountable Care Organizations (ACOs) model, The Department of Health and Human Services Centers for Medicaid and Medicare Services (CMS) has specified 33 required quality measures that are evaluated in order to determine payment structure for patient care networks, which are inclusive of ambulatory care settings. The quality measures themselves are standards set forth that evaluate efficiency (or resource use), structure, process, intermediate outcome, long-term outcome, and patient centeredness (which includes patient reports of satisfaction).²³

The Department of Health and Human Services Center for Medicaid and Medicare Services (CMS) has also contracted with Florida Medical Quality Assurance, Inc. (FMQAI) in a project particularly pertinent to quality-assurance in the ambulatory care setting. The project, Medication Measure Special Innovation Project, is tasked with maintaining the current 33 quality measures and expanding them to include new measures focused on medication-related patient safety (e.g., detecting/preventing medication errors, adverse drug reactions). The project specifically includes a portfolio of six National Quality Forum (NQF)-endorsed measures for the ambulatory care setting, including measures related to patient adherence to specific medication classes, adherence to regular monitoring for warfarin (both routine and when on antibiotics), and adherence of patients with schizophrenia to antipsychotic therapy.

❽ Health care professionals involved in the provision of care in the ambulatory care setting should familiarize themselves with the pertinent established quality measures.

The Patient Safety and Clinical Pharmacy Services (PSPC) Collaborative is one of the newest nation-wide initiatives to improve quality of care. Launched in 2008, PSPC is sponsored by the U.S. Health Resources and Service Administration (HRSA). The initiative focuses on cutting medication-related patient errors and improving the quality of health care in the United States by incorporating clinical pharmacy services into the provision of primary care. Each of the participating organizations in this initiative is focused on incorporating evidence-based clinical pharmacy services into the care of patients with chronic diseases. More information about the PSPC may be found at http://www.hrsa.gov/publichealth/clinical/patientsafety/index.html.²⁴

Ensuring patient safety is a crucial component of quality care, and the ISMP is an important resource for health care providers in any setting. The ISMP publishes four distinct newsletters, each geared toward practitioners in a different health care setting. The ISMP Medication Safety Alert! Community/Ambulatory Care edition is targeted toward pharmacists, pharmacy technicians, nurses, physicians, and other community health professionals. This newsletter is sent monthly as an e-mail, and provides up-to-date information about medication-related errors, adverse drug reactions, and their implications for community practice sites. Finally, the newsletter includes recommendations on how to improve medication safety within the community setting (http://www.ismp.org/Newsletters/default.asp). A subscription to this newsletter is recommended for all ambulatory care providers (ISMP Medication Safety Alert! Community/Ambulatory Care edition). More information regarding ISMP as well as its newsletters can be found at http://www.ismp.org/.²⁵

Finally, the tracking, reporting, and prevention of not only medication errors, but of near misses, is paramount to assuring quality in any health care setting, including ambulatory care. ISMP is one organization dedicated to this task. The reader should refer to Chapter 16 for a complete discussion on organizations and programs devoted to assuring quality by reporting and prevention of medication errors.

The American Pharmacists Association Web site, http://www.pharmacist.com, has a Patient Safety and Quality Assurance page that provides links to AHRQ, ISMP, the National Patient Safety Foundation (NPSF), the United States Pharmacopeia (USP) Medication Errors Reporting Form, and the PSPC Collaborative.

As health professionals committed to optimal patient care, the provision of drug information goes far beyond providing patient information leaflets with medications. Application of drug information is performed routinely in the ambulatory care setting in a variety of manners, and it is in this setting that the clinician pulls it all together and takes the most important step—imparting this information not only to patients and their caregivers, but to other health care providers in a understandable, personalized, and practical format that will serve to improve health care.