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Presentations

DRUG SAFETY IN AMBULATORY CARE

Dan Budnitz, M.D., M.P.H.

Centers for Disease Control and Prevention


Adverse drug events (ADEs) are responsible for 3.6 million office visits a year, 700,000 emergency room visits, and 117,000 hospitalizations, according to Dan Budnitz at the Centers for Disease Control and Prevention (Budnitz et al., 2006; Zhan et al., 2005). Dosing mistakes appear to cause a disproportionate number of the most severe ADEs, with over half of the hospitalizations caused by unintended overdoses or supra-therapeutic drug levels. An examination of emergency visits for ADEs shows that patient age is a risk factor, with those ages under 5 and over 65 at greater risk than others.

Interventions to prevent ADEs have been implemented primarily in hospitals and have focused on preventing medication errors1 through computerization and systems changes. In the hospital environment, health professionals prescribe and monitor the use of medications and have extensive support systems.

In the ambulatory setting, however, patients play a key role in drug safety since medications may be prescribed by a health professional or may be self-prescribed by the patient, and patients or other laypersons

1

Medication error is defined as any preventable event that may lead to inappropriate medication use or patient harm.



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2 Presentations DRug SAFETy IN AMbuLATORy CARE dan Budnitz, M.d., M.P.H. Centers for disease Control and Preention Adverse drug events (ADEs) are responsible for 3.6 million office visits a year, 700,000 emergency room visits, and 117,000 hospitalizations, according to Dan Budnitz at the Centers for Disease Control and Preven- tion (Budnitz et al., 2006; Zhan et al., 2005). Dosing mistakes appear to Budnitz . cause a disproportionate number of the most severe ADEs, with over half of the hospitalizations caused by unintended overdoses or supra- therapeutic drug levels. An examination of emergency visits for ADEs shows that patient age is a risk factor, with those ages under 5 and over 65 at greater risk than others. Interventions to prevent ADEs have been implemented primarily in hospitals and have focused on preventing medication errors1 through computerization and systems changes. In the hospital environment, health professionals prescribe and monitor the use of medications and have extensive support systems. In the ambulatory setting, however, patients play a key role in drug safety since medications may be prescribed by a health professional or may be self-prescribed by the patient, and patients or other laypersons 1 Medication error is defined as any preventable event that may lead to inappropriate medication use or patient harm. 

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 stAndARdizing MediCAtion lABels are the ones responsible for administering, storing, and monitoring the use of medications. Support systems for the patient are minimal in the ambulatory setting, and in some instances the medication container label may be the only source of information for the patient. Although medication injuries often result from a complex interaction of agent, host, and environment, the most appropriate basis for identify- ing safety interventions may be patient-focused approaches such as those used in the injury-prevention field. The first step in an injury-prevention approach uses a heuristic called a phase–factor matrix (originally devel- oped by Haddon) (Figure 2-1) to identify plausible interventions. In this matrix the three phases of the injury process appear in the left-hand column: pre-event, event (or the injury), and post-event. Across the top of the matrix are the three entities among which the interactions traditionally occur to cause an injury or disease: the host or patient, the agent or drug, and the environment. When the phase–factor matrix was used to identify interventions for ADEs from Warfarin, the first two environmental changes identified were standardized naming and dos- ing conventions and improved medication label readability for patients (Budnitz and Layde, 2007). Once interventions are identified, the second step in the injury- prevention approach is to consider implementation strategies since different strategies require different actions on the part of individuals, stakeholders, and society, and each strategy has different strengths, weak- nesses, costs, and feasibility. Strategies include education, enforcement (e.g., laws mandating use of seat belts), and engineering (e.g., better medi- cation label design). Injury-prevention strategies are typically classified as Factor Host Agent Environment (Patient) (Drug) Phase Pre-Event Event Post-Event FIguRE 2-1 Phase–factor matrix for identifying plausible intervention. SOURCE: Budnitz (2007). fig 2-1 New

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 PResentAtions either active or passive. Active approaches require action on the part of an individual (e.g., actively disposing of needles and sharps containers), whereas passive approaches do not require action by the individual (e.g., the use of needleless IV connectors throughout a hospital). Typically pas- sive approaches are more sustainable. Finally, it is critical to evaluate the impact of these interventions. Budnitz concluded that drug safety for ambulatory patients is an important public health problem that offers an opportunity to develop and implement patient-centered drug safety measures such as standard- ized naming and dosing instructions. THE ROLE OF HEALTH LITERACy IN PATIENT CARE terry C. dais, Ph.d. louisiana state Uniersity Health sciences Center Ninety million Americans have trouble understanding and acting on health information, reported Terry Davis of the Louisiana State University Health Sciences Center. How well people understand medication con- tainer labels is a function of both the clarity of the labels and the degree of people’s health literacy. When there is a gap between the complex- ity of health information and a person’s ability to understand and use that information, misunderstandings occur. The National Assessment of Health Literacy identifies four levels of health literacy: below basic, basic, intermediate, and proficient. Only two-thirds of those who fall into the below basic level are even able to circle the date on a doctor’s appoint- ment slip. In 2003, the National Assessment of Health Literacy found that only 12 percent of adults scored in the proficient category. Twenty-two percent of Medicare beneficiaries scored in the basic range, Davis observed, yet the elderly, on average, fill 27 prescriptions a year and see 8 different physicians. Fifty-three percent of high school graduates scored in the very low intermediate range. Only two-thirds of those in the intermediate range—53 percent of the population—are able to determine what time to take a prescription medicine based on the label. Patients are not taught to read labels, yet it is assumed that patients who receive medicines will be able to understand instructions for proper use (NAAL, 2005). Medication errors are the most common medical mistake, said Davis. While labeling instructions and auxiliary warnings appear simple, accord- ing to a study of 395 patients by Davis and colleagues (2007), they are often misunderstood. For example, the auxiliary label instructing “take with food” (see Figure 2-2) appears straightforward. It is written at a first- grade level. Yet 16 percent of patients did not understand this label.

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 stAndARdizing MediCAtion lABels FIguRE 2-2 Auxiliary warning labels. SOURCE: Davis et al. (2007). fig 2-2 new Another auxiliary label in Figure 2-2 above states “medication should and revised be taken with plenty of water.” However, the label does not say how much is plenty; only 59 percent of patients understood that label. Fur- thermore, unfamiliar, multistep instructions such as “do not take dairy products, antacids, or iron preparations within one hour of this medica- tion” are even more confusing. Only 8 percent understood this instruction (Davis et al., 2007). In response to a question, Wolf observed that the problem of auxiliary warning labels is compounded when the patient is not fluent in English. Of the 114 auxiliary labels, few have been translated into Spanish and none into other languages. The Walgreen Company is implementing a program that provides translations of medication information in several languages, but the effectiveness of the program has not yet been evaluated. Using icons does not necessarily make instructions clearer, Davis said. For example, in Figure 2-2 the warning label stating “do not chew or crush, swallow whole” includes an icon intended to show a whole pill heading into the stomach, but the meaning of the icon was not clear. Some patients interpreted the icon to mean “someone swallowed a nickel,” while others thought it indicated “indigestion” or “a bladder” or said that “it looks like a ghost—Casper.” Nor did adding words to the icon help clarify instructions. Various patients interpreted the words to mean “chew pill and crush before swallowing,” “chew it up so it will dissolve,”

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 PResentAtions “don’t swallow whole or you might choke,” and “just for your stomach” (Davis et al., 2007). In a study by Davis and colleagues (2006a), patients were given five pill bottles with instructions on the label. They were then asked how they would take the medication. Nearly half the patients (46 percent) did not understand at least one of the labels, and even among those with adequate literacy, more than a third (38 percent) missed at least one of the labels. When asked specifically how many pills they would take if the instructions (written at a sixth-grade level) were “take two tablets by mouth twice daily,” 71 percent said they would take two pills two times a day but only about a third could demonstrate what that meant—that is, actually count out four pills. The study authors then measured comprehension of the instructions “take two pills in the morning and two pills in the evening” (seventh- grade level writing), and “take two pills by mouth at 8:00 a.m. and two pills at 6:00 p.m.” (eighth-grade level writing). The results, shown in Figure 2-3, demonstrate that the instructions written at the higher grade levels—seventh and eighth—were actually understood by more people than those written at the sixth-grade level. The comprehension also increased, despite the increased reading level, because instructions were more precise. Davis also commented that the problem of misunderstand- Comprehension of Glyburide Instructions by Literacy Rx Dose Instructions Literacy High Low Take 2 tablets by mouth twice daily. 71 33* (6th grade level) 76 ‡ 92 Take 2 pills in the morning and 2 pills in the evening. (7th grade level) 90 76 Take 2 pills by mouth at 8 am and 2 pills at 6 pm. (8th grade level) *p < 0.001, ‡ p < 0.01 FIguRE 2-3 Readability does not equal clarity. SOURCE: Davis et al. (2007). fig 2-3 NEW

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 stAndARdizing MediCAtion lABels ing medication labels is not confined to the United States, but is rather a worldwide problem. While many might assume that misunderstanding medication label instructions is confined to those with low health literacy, in fact the prob- lem is more widespread. As a patient who underwent mitral valve surgery herself, Davis reported experiencing several problems in understanding, even though she is a professor of medicine. First, instructions were not clear for the medications she was given. For example, Davis was given the prescription medication Coumadin. However, the Coumadin bottles had different instructions on them. One label read “take 1 and ½ tabs (7.5 mg) by mouth Tues, Thurs, Sat, and Sun and 2 tabs (10 mg) Mon, Wed, Fri,” while another labeled bottle of Coumadin stated “take one (1) tablet by mouth or as directed.” In addition to the confusing medication instruc- tions, the drug names of numerous medications were strange and not use- ful, Davis’s provider was unaware that she was going too fast with unfa- miliar routine discharge instructions, and Davis was too overwhelmed and embarrassed to ask all the questions that needed to be asked. While medication container labels appear simple, they are not neces- sarily clear and mistakes are common. There is a tremendous amount of variability in the wording of the instructions, in the icons used, and in the colors of auxiliary medication labels. An ability to read the label does not guarantee correct interpretation. Furthermore, mistakes are more likely as the number of medications a patient is taking increases, and the vari- ability of dosing instructions is a source of confusion. Instructions need to be tested with patients, Davis concluded. THE AMERICAN COLLEgE OF PHySICIANS FOuNDATION WHITE PAPER ON DRug LAbELINg: FINDINgS Michael wolf, Ph.d., M.P.H. Feinberg school of Medicine, northwestern Uniersity The charge to the Medication Labeling Technical Advisory Board of the American College of Physicians (ACP) Foundation was to examine the current evidence about patients’ ability to understand and successfully use medication labels, to identify barriers to labeling reform, and to engage stakeholders in planning how to improve medication labels for patients. Ideally, when a drug is prescribed for a patient, the prescribing phy- sician provides adequate counseling about the drug’s purpose and how to administer it. Several studies demonstrate, however, that there is actu- ally little communication with patients at the point of prescribing new medicines and that patients often leave the doctor’s office with very little information about what drugs they are taking, what they are used

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 PResentAtions for, and how they should be taken. An audience member questioned whether physicians had time available for adequate counseling, given the constraints of practice, especially in poorer communities. Wolf responded that effective counseling can be provided in the limited time available as demonstrated with studies on such topics as colon cancer screening and other preventive services. However, such effective counseling requires provider training that, to date, has not been undertaken. Wolf pointed out that patients who have been given an explanation of why they are taking a drug take the drug most effectively. Few patients are given any sort of printed material about their medica- tions other than the written prescription forms. Those forms are intended primarily for the purpose of communicating with the pharmacist and usu- ally contain Latin abbreviations that, while useful to the pharmacist, are of little value to patients. Ideally, when the patient obtains medication from the pharmacist, the pharmacist will counsel the patient, answering ques- tions and making sure that the patient understands how to use the drug. Studies show, however, that there is little such verbal communication. The patient receives his or her medication in a bag with accompanying written material such as the consumer medication information (CMI)2 sheet and appropriate package inserts. These documents are of great length and are difficult to comprehend. One study appearing in the 2006 issue of Patient Education Counseling showed that less than a third of patients attend to information stapled to the bag and that patients frequently discard these sheets, especially patients with low literacy skills (Wolf et al., 2006b). Because there is so little actual communication between the prescrib- ing physician and the patient and between the pharmacist and the patient, the patient’s primary guide for medication use ends up being the medica- tion container label. Patients with high health literacy may turn to infor- mal sources such as the Food and Drug Administration (FDA) website or the AARP guide to Pills; however, those with low literacy skills are less likely to seek out health information beyond what they are told by their primary care providers. Studies dating back to the late 1980s have found high rates of patient misunderstanding of both dose instructions and auxiliary warnings on medication labels. For example, a recent study examined patients’ under- standing of label instructions and found that 46 percent of all patients misunderstood one or more dosage instructions. Furthermore, fewer than 10 percent of patients actually read auxiliary warning labels, and of those, 54 percent misunderstood one or more auxiliary warnings (Davis et al., 2 CMI is written information about prescription drugs developed by organizations or individuals other than a drug’s manufacturer that is intended for distribution to consumers at the time the drug is dispensed (FDA, 2006).

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0 stAndARdizing MediCAtion lABels 2006a; Wolf et al., 2006a). It is also the case that older adults and those taking multiple medication regimens are at significantly greater risk for misunderstanding and misuse of medications. Therefore, finding number one of the ACP Foundation white paper is that “Inadequate patient understanding of prescription dosing instruc- tions and warnings is prevalent and a significant safety concern.” (See Appendix C.) In addition to the problem of misunderstanding of label instructions, variability in medication labels leads to another problem. For prescription medications the FDA requires that certain information appear on the drug container label: drug name, pharmacy name and address, serial/lot num- ber of the prescription, prescribing physician name, patient name, and instructions for use. The assumption is that prescription medications are used under the guidance of a physician (the learned intermediary) who will be communicating necessary information regarding use. Beyond the FDA requirements, state boards of pharmacy are responsible for establish- ing further standards. In response to such regulations, national pharmacy chains have developed 31 different label styles, resulting in variability in the clarity and complexity of medication use instructions (ACPF, 2007). Finding number two of the white paper is that “Lack of universal standards and regulations for medication labeling is a root cause for medication error.” The ACP Foundation white paper concludes that there is value in attempting to improve prescription labels since they are the most tan- gible source of information patients receive, they are brief, and they are repeatedly used. The question then is, How can the medication label be improved? Wolf observed that there are three decades of research and hundreds of studies that have examined variability in medication labels and how drug labels can be improved. For example, a study appearing in the Sep- tember 2007 issue of the Archies of internal Medicine (Shrank et al., 2007) examined variability in label content and format when identical prescrip- tions were dispensed at 85 different pharmacies in four cities in the United States. The study found that the current labeling system emphasized information important to the provider (e.g., pharmacy logo and prescrip- tion number) rather than information that supports understanding and use of the medication. These studies point to the need for standards that address what content should be on the drug label, the formatting and font size to use, the best types of icons to support auxiliary instructions, how better to present dosage instructions on the label, and how to be more explicit and concise when telling people how to take their medicine. Finding number three of the ACP Foundation white paper states that “An evidence-based set of practices should guide all label content and

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 PResentAtions format.” The existing evidence base for label standards supports the fol- lowing practices: 1. Use explicit text to describe dosage and interval in instructions. 2. Use a recognizable visual aid to convey dosage and use instructions. 3. Simplify language, avoiding unfamiliar words and medical jargon. 4. When possible, include indication for use. 5. Include distinguishable front and back sides to the label. 6. Organize the label in a patient-centered manner. 7. Improve typography: use larger, sans serif font. 8. When applicable, use numeric instead of alphabetic characters. 9. Use typographic cues (bolding and highlighting) for patient con- tent only. 10. Use horizontal text only. 11. Use a standard icon system for signaling and organizing. Beyond the content and format, one of the most important things on the prescription drug label is the “sig line” or dosage instruction. This information also causes the most difficulties. It is the information that patients are looking for, yet there are high levels of variability in how such information is presented. Furthermore, while instructions are seem- ingly simple, they are often unclear and require patient interpretation. For example, health literacy best practices indicated that the instruction “take 2 tablets by mouth twice daily” would be clearer if it read “take 2 tables in the morning and 2 tablets at bedtime” (Davis et al., 2006b). Finding number four of the white paper states that “Instructions for use on the container label are especially important for patients and should be written in the most clear, concise manner. Language should be standardized to improve patient understanding for safe and effective use.” While the drug label is of primary importance, it is only one part of a larger system of written material on medication use that includes such things as patient information leaflets, package inserts, and CMI sheets. These materials do not meet acceptable standards for the design of health information, Wolf observed. Additionally, they are not well integrated into the pharmacy dispensing system. For example, in the study of 85 pharmacies mentioned above (Shrank et al., 2007), one of the drugs pre- scribed required an FDA-approved and mandated medication guide to be distributed with the prescriptions. Of the 85 pharmacies, none distributed the medication guide. Why not? In order to distribute the FDA-mandated medication guide, the pharmacist has to identify the medication as one that requires a guide, then has to find a copy of the guide. These guides are not integrated into the pharmacy system. However, pharmacy soft-

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 stAndARdizing MediCAtion lABels ware systems automatically generate a patient information leaflet to accompany each prescription. Finding number five of the white paper states that “Drug label- ing should be viewed as an integrated system of patient information. Improvements are needed beyond the container label, and other sources of consumer medication information should be targeted.” Medication labeling changes cannot and should not replace provider counseling. The physician is the learned intermediary, that is, the person who is legally responsible for communicating important information about prescription drugs to patients. Moreover, health communication research has shown that physicians are the most important and trusted source of health information. Pharmacists also have a mandate to provide basic information and to counsel patients about proper drug use. Additionally, pharmacists have a tremendous knowledge base about medications. Drug labeling should be a complementary link to physician and pharmacist counseling. However, as demonstrated earlier, health care providers have missed opportunities to counsel patients on the proper use of prescription medications. Finding number six of the white paper states that “Health care pro- viders are not adequately communicating to patients, either orally or in print, for prescribed medicines. More training is needed to promote best practices for writing prescriptions and counseling patients.” What is needed is an evidence-based approach to drug labeling that includes testing of a new, standard drug label and identification of best practices that are then communicated to physicians and pharmacists. Furthermore, research that incorporates known best practices is needed to determine whether the proposed changes result in improved patient understanding, behaviors, and ultimately health outcomes. Finally, it is crucial that systems of prescribing and dispensing be integrated to pro- vide the best information. The final finding of the ACP Foundation white paper states that “Research support is necessary to advance the science of drug labeling and identify best practices for patient medication information.” Wolf concluded that variability is most likely a major cause of medi- cation error and that there is evidence to support the conclusion that the way we currently communicate information on prescription medications leads to a variety of problems. The white paper focused on medication container labeling because it may be the most important, most tangible information about use of prescription medications that is actually used by patients. There is an opportunity for improvement through setting evidence-based standards for drug labels. It is also important, Wolf observed, to view drug labeling as a system of patient information that

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 PResentAtions should be integrated into the entire process of prescription, dispensing, and use of prescription medications. SIMPLIFICATION OF DRug DOSINg TIMES: CAN WE CONFuSE PATIENTS LESS? Alastair J. J. wood, M.d., F.A.C.P. symphony Capital llC Successful drug therapy is dependent upon completing a number of steps accurately. First, a physician must choose the correct drug, make the correct decision about drug dosage, and then correctly write the prescrip- tion. A pharmacist must then correctly understand the written prescription, accurately transcribe the prescription to the drug label, and correctly transmit information to the patient. Patients have their own requirements for proper drug use. They must first have access to the medicines, and they must then use the medicines correctly. From the patient’s perspective, correct medica- tion use involves both accurately understanding the instructions and know- ing how to implement the instructions. Additionally, a patient must be able to integrate taking multiple medicines into a daily schedule and, finally, actually take the medicine. While there are a number of steps in the process at which interven- tions to reduce medication errors could be made, the focus of this work- shop was on improving medication container labels. To take medicines properly, one needs to know what to take, how many pills to take, and when to take them. What appears simple is actually quite complicated. As discussed earlier, there is tremendous variation in labeling instruc- tions. For example, a written survey examined how the instruction “take one pill a day” is written by prescribers and found that it was written 44 different ways. Even the same prescriber wrote the same instruction in different ways throughout the day. Similarly, variation at the level of the pharmacist’s transcription may arise in a number of ways. A single pharmacist may transcribe the same instruction in different ways at different times, there may be variation across pharmacists in one pharmacy, and there may be variation across different pharmacies (see Figure 2-4). While each of the labels in Figure 2-4 may appear reasonable, they can produce very different outcomes. With Fosomax, for example, if the pill stays in the esophagus it causes irritation, so it is very important after taking Fosomax to remain upright and take fluids so that the pill travels to the stomach and doesn’t lodge in the esophagus. Therefore, it is appropriate to place on the label the warning, “do not lie down for at least 30 minutes after taking.” However,

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 Prescription Examples of Pharmacy “Sig” Interpretations Lipitor 10 mg tabs - “Take one tablet daily.” Take one tab QD - “Take 1 tablet by mouth for high cholesterol.” Dispense #30 - “Take one (1) tablet(s) by mouth once a day.” Indication: for high cholesterol No refills - “Take one tablet by mouth every day for high cholesterol.” Fosamax 5 mg tabs - “Take 1 tablet by mouth daily.” Take one tab QD - “Take one tablet by mouth every day for osteoporosis prevention. Do not lie down for at least Dispense #30 30 minutes after taking.” Indication: osteoporosis prevention - “Take 1 tablet every day, 30 minutes before breakfast with a glass of water. Do not lie down.” Do not lie down for at least 30 minutes - “Take one tablet every day.” Bactrim DS tabs - “Take one tablet by mouth twice daily for UTI” Take one tab BID - “Take one tablet by mouth twice daily for urinary tract infection.” Dispense #6 - “Take 1 tablet by mouth 2 times a day.” Indication: UTI No refills - “Take 1 tablet twice daily for 3 days.” Ibuprofen 200 mg tabs - “Take 1 to 2 tablets by mouth as needed for pain.” Take 1-2 tabs TID PRN pain - “Take 1 to 2 tablets by mouth three times daily as needed for pain.” Dispense #30 - “Take 1 to 2 tablets by mouth as needed for pain. **Not to exceed 4 times a day” No refills - “Take 1 to 2 tablets 3 times a day as needed for pain.” FIguRE 2-4 Transcription of Rx to label imperfect and variable. SOURCE: ACPF (2007).

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 PResentAtions two of the four pharmacy labels shown in Figure 2-4 did not provide any instruction at all about remaining upright. And of the two that did, one said simply, “do not lie down.” But do not lie down for how long— 5 minutes, 30 minutes, 2 hours? While drug labels vary by pharmacy, an examination of those labels does reveal similarities. For example, the most prominent item on a drug bottle label is the pharmacy name, the second most prominent is the pharmacy telephone number, and the third is the number of refills, Wood stated. Less prominent and less clear are the patient’s instructions for use. As Wolf reported previously, 46 percent of patients misinterpret at least one instruction on a prescription bottle label. Table 2-1 provides examples, taken from a 2007 study by Wolf and colleagues, of how patients misinterpret instructions. The situation becomes even more complicated with multiple medica- tions. For example, assume a patient must take three medications daily, one medication three times a day (TID), a second medication four times a day (QID), and a third medication twice daily (BID). The schedule for taking such medications might look as shown in Table 2-2. A universal medication schedule (UMS), where patients take all their medications at breakfast, lunch, dinner, and/or bedtime would simplify drug labeling and make directions more understandable for the patient. If such a schedule were followed for the example illustrated in Table 2-2, rather than taking medication eight times a day, the patient would take medication four times a day at the times shown in Table 2-3. With such a schedule, there would be less likelihood of forgetting to take one’s medicines. TAbLE 2-1 Patient Misunderstanding of Medication Instructions Dosage Instruction Patient Interpretation Take one teaspoonful by mouth three Take three teaspoons daily times daily Take three tablespoons every day Drink it three times a day Take one tablet by mouth twice daily for Take two pills a day 7 days Take it for 7 days Take one every day for a week I’d take a pill every day for a week Take two tablets by mouth twice daily Take it every 8 hours Take it every day Take one every 12 hours SOURCE: Wolf et al. (2007).

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 stAndARdizing MediCAtion lABels TAbLE 2-2 Schedule for Taking Medications TID, QID, and BID Time Med Taken Time Med Taken 7:00 a.m. TID med 4:00 p.m. 8:00 a.m. QID med 5:00 p.m. 9:00 a.m. BID med 6:00 p.m. 10:00 a.m. 7:00 p.m. QID med 11:00 a.m. 8:00 p.m. Noon 9:00 p.m. BID med 1:00 p.m. QID med 10:00 p.m. 2:00 p.m. 11:00 p.m. TID and QID med 3:00 p.m. TID med SOURCE: Wood (2007). TAbLE 2-3 Simplified Medication Schedule for TID, QID, and BID Time of Day TID QID bID Breakfast X X X Lunch X X Dinner X X Bedtime X X SOURCE: Wood (2007). Wood reported that a study by Wolf demonstrated that 77 percent of prescriptions could be easily accommodated by the UMS (personal com- munication, Michael Wolf, Northwestern University Feinberg School of Medicine, October 2007). Of the 346,000 oral prescriptions examined, the study found the following: • 51 percent were once a day. • 19 percent were twice a day. • 5 percent were three times a day. • 2 percent were four times a day. If one included prescriptions for medications that were not timed at all—for example, those with instructions to take as directed or as needed—92 percent of all prescriptions could be accommodated with the proposed UMS. Audience members asked why not specify time intervals (e.g., “take every 6 hours”) or specific times a day (e.g., 8:00 a.m. and 8:00 p.m.) rather than using the UMS. In response, Wolf pointed out that studies have shown that hourly intervals are less well understood by patients

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 PResentAtions than directions to take a medication a certain number of times a day. Furthermore, studies using a medication bottle with a chip in the cap that registers when a patient opens the bottle demonstrate that even with specific timed directions for taking a drug, patients do not follow those instructions. One question is whether a UMS would improve understanding. In a study of 500 patients in two sites in Chicago and Shreveport, Louisiana, Wolf and colleagues compared patients’ understanding of instructions for the standard labels for BID, TID, and QID with the UMS (personal com- munication, Michael Wolf, Northwestern University Feinberg School of Medicine, October 2007). They found that the UMS produced five times better comprehension than the standard labels with a p < 0.001. However, as stated in response to a question from the audience, further studies are needed to test the UMS effect on patient understanding. The UMS also produces an additional benefit: the ability to move to a standard prescription form that would have a schedule that includes breakfast, lunch, dinner, and bedtime (see Figure 2-5). For each prescrip- tion medicine, the prescriber could fill in the number of tablets to be Alastair Wood, MD 1234 Springfield Drive Nashville, TN 54321 (302) 432-1234 1. ___________________ 2. ___________________ 3. ___________________ Dose: ____________________ Dose: ____________________ Dose: ____________________ Take for: __________________ Take for: __________________ Take for: __________________ Schedule Schedule Schedule Breakfast Lunch Dinner Bedtime Breakfast Lunch Dinner Bedtime Bedtime Breakfast Lunch Dinner Bedtime Additional Instructions Additional Instructions Additional Instructions _ Take with a meal _ Take with a meal _ Take with a meal _ Swallow whole _ Swallow whole _ Swallow whole _ Do not drink alcohol _ Do not drink alcohol _ Do not drink alcohol _ Limit your time in the sun _ Limit your time in the sun _ Limit your time in the sun _ Other __________________ _ Other __________________ _ Other __________________ FIguRE 2-5 Standard dosing times on prescriptions. SOURCE: Wood (2007). new fig 2-5

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 stAndARdizing MediCAtion lABels taken on the standardized label as well as fill out additional instructions needed. The standardized prescriptions could then be translated readily onto a standard label on the prescription bottle. Patients, pharmacists, and physicians would all use the same schedule. Variability in prescription writing and transcribing would be reduced substantially, and patients’ understanding improved. It is important to note, however, that studies have not been conducted on whether patients’ adherence or outcomes would be improved with the UMS. Additionally, if such a system were adopted, clinical trials of drugs could use UMSs in pivotal clinical trials for FDA approval. Currently, different trials may have different times when drugs are administered as long as the studies adhere to a defined schedule for administration. A potential objection to use of the UMS is that such a schedule would cause drug concentrations in the body to vary more than would be the case if the patient took the medication at equal intervals—exactly every 8 hours, for example, or exactly every 12 hours. Wood observed that there is greater variation between approved generic drugs and their brand name counterparts than would be the case with administering drugs using the UMS since the FDA requirement for brand/generic equivalence requires only that the 90 percent confidence intervals for peak and average con- centrations (AUC) must lie within 80 percent to 125 percent of those of the branded product. Furthermore, concentrations vary enormously among individuals because of biological variability and metabolizing activity. Concentrations can also vary within the same individual because of dietary intake. In response to questions from the audience, Wood emphasized that the UMS does not remove the need to provide warnings such as can be found on auxiliary labels. It is a system for standardizing the times at which one takes medicine. There are some instances when, for example, taking the medication with certain foods or juices can vastly change the effect of the medication. For those medications, additional instructions should specify which foods to avoid. Wood concluded that, as data presented in this workshop show, the current situation of drug labeling is unsatisfactory. Prescriptions are unclear. Transcription of a prescription to the label is imperfect. Patients frequently misunderstand the drug label. Finally, variability and complex- ity of labels are excessive. The potential advantages of the UMS include a simplified dosing schedule with no loss of efficiency, improved patient understanding and patient adherence, reduced errors, reduced variability, and improved therapeutic outcomes.