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.
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
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.
Case Study 19–1
Consider the following scenario:
Sue Granger, PharmD, is working in an outpatient anticoagulation clinic, when TH, a Hispanic woman in her mid-30s who takes warfarin for a mechanical heart valve, stops by to report a new medication and to confirm it is “okay” to take with her warfarin. TH says, “My doctor says I can just take it as needed, but I’m always nervous about any new medication! I just filled the prescription and it was really expensive—they told me it ‘wasn’t on formulary,’ whatever that means. I wish there was something I could do instead of taking this medication.” After some discussion, Sue discovers that TH has been experiencing a burning feeling in her chest for the last month, saw her family doctor today, and was told it was “just heartburn.”
• In addition to asking Sue to check for a drug interaction between warfarin and esomeprazole, what drug information questions has TH either requested or implied she needs to know?
• How might Sue begin to answer each of these questions?
The patient (TH) requires the ambulatory care pharmacist to assist with several drug information queries. Before leaving the clinic, TH now asks for any information available (in addition to the leaflet stapled to the prescription bag she got at the pharmacy) regarding her new prescription and what to expect with gastroesphageal reflux disease (GERD). TH further requests that, if possible, she would like information in Spanish, as it is easier for her to read health-related information in her first language.
• What resource database(s) could Sue refer to with patient information written at an appropriate level? Are there databases that are useful for traditional drug information geared toward the health care professional and that also have information geared toward patient education?
• Do any of these databases provide patient information in multiple languages?
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.
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.
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.
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 NMBERTM+ (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.
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.
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.