u. r...__.___. ‘\ 1 l. r 1‘ r‘ I'f‘ "’Y’ ' ‘~ " ‘ 1 \_' -"! ‘1 ‘7 q lth-afi\/ I '. ‘ ' ‘ k . Unimrs‘if‘v PLACE IN RETURN BOX to remove this checkout from your record. To AVOID FINES return on or before date due. MAY BE RECALLED with earlier due date if requested. DATE DUE DATE DUE DATE DUE 6/01 c:/C|RC/DateDue.p65-p. 15 A Clinical Protocol For Assessing Compliance And Identifying Risk For Drug Interactions In Elderly Clients by Dale Haaksma A Scholarly Project Submitted To Michigan State University College of Nursing in partial fulfillment of the requirements for the degree of Master Of Science College of Nursing 1 995 LIBRARY Michigan State University Abstract A Clinical Protocol For Assessing Compliance And Identifying Risk For Drug Interactions In Elderly Clients by Dale Haaksma Drug induced illness is the leading cause of preventibie illness in the elderly. Morbidity and mortality is increasing related to increased medication consumption due, in part, to increased treatment of disease with prescription medications and availability of over-the-counter medications. Any client has the potential for adverse drug reactions when taking three or more medications, including over-the-counter drugs. The elderly client is at significantly increased risk because of normal changes in physiology of the body, and is at further risk related to non-compliance in taking medications, whether intentional or unintentional. The focus of this project was the development of a protocol, to be used in primary care, to assess the elderly client for risk of adverse drug reactions. The background and scape of the problem is discussed and a protocol is presented, describing one way a client can be assessed for risk of developing adverse drug reactions. Acknowledgments I would like to extend my sincere gratitude to the members of my committee who were of such encouragement to me in the process of completing this project. Thanks to Sharon King Ph. 0., RN, who was supportive of my idea for this project from the beginning and thanks also to my other committee members. Brigid Warren M.S.N., Ft.N., and Patty Peek M.S.N., R.N., who have provided insight and been quick with a cheerful word throughout the process. I would also like to express my appreciation to my wife. Lin, for her encouraging words and support of my abilities to finish this project. Thanks also to my daughters Gina and Cameo for being part of an encouraging family. TABLE OF CONTENTS The Problem ......................................... 5 Introduction ..................................... 5 Problem Statement ............................... 8 Purpose ........................................ 8 Conceptual Definitions .................................. 9 Polymedicine .................................... 9 Compliance ..................................... 10 Self-medication .................................. 10 Adverse Drug Reactions ........................... 11 Review of Literature ..................................... 18 Project Development .................................... 23 Implications for Advanced Nursing Practice and Primary Care. . . .27 References ............................................ 32 Appendix ............................................. 37 A Clinical Protocol For Assessing Compliance And Identifying Risk For Drug Interactions In Elderly Clients The Problem 1mm Drug induced illness is the leading cause of preventable disease in older people. Each year there are approximately 61,000 older adults diagnosed with drug-induced parkinsonism, 32,000 older adults with hip fractures including 1,500 deaths attributable to drug-induced falls, 16,000 injurious car crashes caused by adverse drug reactions, 163,000 with drug-induced or drug worsened memory loss, 659,000 who have to be hospitalized because of adverse drug reactions, including 41,000 hospitalizations (3,300 deaths) from ulcers caused by nonsteroidal anti-inflammatory drugs, usually for arthritis, and hundreds of thousands of older adults with drug-induced dizziness or fainting. Over half (50.5%) of the Food and Drug Administration adverse reaction reports of deaths and 39% of hospitalizations related to adverse drug reactions are in older adults. All told, 9.6 million older adults suffer an adverse drug reaction each year (Wolfe, 1993) . It is estimated that 10% to 31% of geriatric hospital admissions are due to adverse drug reactions (ADRs) (Lamy. 1990; Nolan & O'Malley, 1988). A Boston Collaborative Drug Surveillance Program estimated a total annual number of deaths at 29,000 related to adverse drug reactions (Davidson et. al., 1987). In terms of morbidity it has been estimated that up to 18.4% of hospital 6 admissions in this country are the result of drug related events, the financial costs of which are estimated to be up to 4.5 billion dollars in hospital charges each year, in 1974 dollars (Silverrnan 8 Lee, 1974)! Older adults (60 and older) in the United States represent one-sixth of the population but use almost 40% of the prescription drugs, an average of 15.4 prescriptions for each person. Thirty seven percent of older adults are using five or more different prescription drugs and 19% use seven or more (Wolfe, 1993). In addition older adults are major users of over the counter (OTC) drugs. Physicians are not always aware of which OTC drugs their patients are taking; only about 50% ask about such use (Pal, 1986). It is estimated that 65% to 85% of all medical care in the United States is self-care (Heller, 1984). In one survey, 35% of all health problems experienced by Americans were treated with OTC preparations (Holden, 1992). Evidence suggests that some 40% of people over the age of 60 use OTC medications every day, a consumption pattern seven times greater than that of younger adults. Additional risk occurs when an estimated 80% of older OTC users also use alcohol, prescribed drugs or both (Kofoed, 1985). Studies of drug use in patients who attended a general medical clinic associated with a teaching hospital revealed that the average number of medications used per person was 3.3 and the number increased to 5.0 for patients over age 65 (Stewart & Cluff, 1971). In 1977 research showed that patients in the United States received 4.3 new and refill prescriptions, and that number rose to 10.7 for patients over age 65 (Kasper, 1982). Obviously, the reason elderly patients take so many drugs is not hard to understand. The elderly are more likely than other age groups to have one or more chronic illnesses, including heart disease, high blood pressure, diabetes and arthritis. Few of these such diseases can be treated with just one medication, and 7 medication for chronic illnesses usually must be taken over a long period of time, frequently until the end of the life span. Polymedicine, (the taking of multiple medications), occurs because of the facts just stated. The fact that the elderly are now taking so many medications naturally increases the chances that they will experience adverse reactions, a chance three times greater than that of the younger person (Braude, 1986). The reactions that elderly patients may experience include stupor, confusion or ’ paradoxical over stimulation from sedatives, intestinal bleeding from aspirin or other nonsteroidal anti-inflammatories, lowered blood pressure from antipsychotics such as chlorpromazine, and fainting following the use of antidepressants, diuretics, sedatives, tranquilizers and some high blood pressure medications (Braude, 1986). Women are at an increased risk since they use many of the previously mentioned medications at a rate of two and one half times that of elderly men. It has been shown that the potential for an interaction when two medications are used in combination is 5.6%. This potential increases dramatically to 50% for five medications and 100% when eight medications are used concurrently (Sloan, 1986). The statistics cited generally indicate the potential for adverse reactions in elderly patients taking prescribed medications, in the manner prescribed. This problem is often greatly compounded when the patient fails to take the medications as prescribed, (i.e. noncompliance, whether intentional or unintentional), combines them with OTC medicines, uses alcohol, or begins to treat him/her self with previously prescribed medications that were discontinued, i.e. self-medication. The elderly population (age 65 and older) is expected to grow substantially by the year 2000. The Census Bureau projects a population of 31.7 million elders by that time (Braude, 1986). New advances in diagnostic techniques will 8 increase the number of detectable diseases in the elderly, and physicians will feel compelled to treat those conditions. New drugs will become available through traditional pharrnacologic research and new biotechnological breakthroughs. Considering the prevalence of potentially treatable disease in the elderly, polypharrnacy (polymedicine) will become the rule, not the exception (Stewart & Hale 1992). Emblemflatemem Unwanted side effects of medication administration, especially polymedicine, are often preventable, and the morbidity and mortality of the elderly population can be significantly affected by interventions of health care workers in the primary care setting. Often side effects occur because of misinformation, lack of information given to the patients, or the lack of information given to the provider that the patient is taking medications for other problems. Advanced practice nurses (APNs) play a unique role in the care and management of elderly patients on drug therapy, and must be cognizant of the effects of polymedicine on the elderly and must monitor them for adverse effects and protect them from harm (Alford, 1982). There is a need for a concise and efficient tool that can be used in the primary care setting to assist in evaluating the efficacy of a patients medication administration. Bum The purpose of this scholarly project is to develop a protocol that can be used to clearly document what medications a patient is taking and to determine whether a patient is at risk for adverse effects of medication administration. The tool developed will (1) assist the health care provider to determine more comprehensively what drugs a patient is taking, whether prescription, OTC, or 9 those not traditionally thought of such as alcohol, caffeine, nicotine, mega vitamins etc. (2) identify the types of questions to ask to illicit information on compliance of medication administration to determine if misuse of their medications is resulting in unwanted side effects. E | IDE'T P I l' . Polymedicine is the use of multiple medications concurrently. Another term used in the literature is polypharmacy and most authors agree that the two terms refer to the same phenomenon. The term polymedicine will be used in this document because it more closely specifies the actual problem; the potential for side effects when taking multiple medications. Many elderly clients are using multiple drugs to adequately treat a variety of medical conditions including congestive heart failure, chronic obstructive pulmonary disease, hypertension and arthritis, to name a few. Obviously the use of multiple medications is often necessary to treat one illness and even more important for a client suffering J multiple illnesses. Polymedicine can occur for a number of different reasons, including appropriate prescribing of medications to treat various illnesses. Polymedicine becomes a problem when several providers prescribe medications for the same client unknowingly; when the client self-medicates with left over medicines; when the client mixes alcohol with the medications (whether knowingly or not) or through various forms of noncompliance which will be discussed in more detail later. Care given to the client is often fragmented between subspecialties and the opportunity exhists for multiple medications of the same class to be given 1 O concurrently. Providers prescribing medications can include physicians of multiple specialties, including ophthalmologists, dentists, podiatrists and nurse practitioners, to name a few. Using one pharmacy for obtaining all of ones medications will help if that pharmacy has a computer system that is able to track prescriptions and alert the pharmacist of the potential for interactions, but another potential problem is that so little is known about appropriate dosages for elderly clients. Adding to the potential problem are the enormous variety of OTC medications available to the public. Advertising to the public and recommendations from friends on how to treat a problem compound the potential for adverse drug reactions. QQIIIDllamfi Compliance as related to medication administration can be defined as the degree to which a client follows through on an agreed upon schedule for taking a prescribed medication. A client can become noncompliant by purposely or inadvertently neglecting to take medications appropriately, too much, too little, or not at all. Issues to consider are; does the client understand the directions for taking the medication; can the client afford the financial cost; does helshe have transportation to obtain the medicine; does the client have visual problems in reading the label; can the client open the container; and does the client fear possible side effects of the medication. 5 |[_ l' I' Sometimes there is a basic misunderstanding of what constitutes a medication. For instance, when asked what medications a client takes the client may not report OTCs, such as analgesics, laxatives, vitamins, antacids etc. because they do not consider them to be medications. Ostrom, Hammarlund, 1 1 Chriastiansen, Plain, and Kethley, (1985), in a study of 183 elderly residents, found that respondents often did not consider non-prescription drugs to be medications and frequently omitted mention of them until asked to produce the containers. Some clients experiencing symptoms may remember medications taken in the past and assume that those medications may help treat the current illness not realizing that the medicine may be out of date and whose chemical composition may have changed. Some clients may follow the old adage that if a little (medication) is good, then a lot will be better. Advertising in the media encourages self treatment of physical problems without regard to other medications the patient may be taking. Some of the OTC medicines have a large percentage of alcohol and can affect the elderly client adversely. Even mega dose vitamin therapy can result in side effects which the client may then try to treat with yet another medication. WW Adverse drug reactions (ADR) are defined by the World Health Organization as “any noxious or unintended response to a drug that occurs at doses usually used for prophylaxis, diagnosis, or therapy of disease or for the modification of psychological function" (Lamy,1990, p 293). An ADR may also be defined as “any adverse event associated with a dmg as normally used or in abuse, overdosage, or on withdrawal of the drug“ (Lamy, 1990, p 293). The Federal Drug Administration (FDA) has proposed the following definition. 'An ADR may also be due to a drug interaction defined as a pharmacologic response that cannot be explained by the action of a simple drug but is due to two or more drugs acting simultaneously. (Lamy, 1990). 1 2 As stated before, the potential for medication interactions increases exponentially as the number of medications is increased. Some of these interactions can lead to hypotension, cognitive impairment, bleeding (primarily gastrointestinal), potentiation of diabetes and other life threatening complications such as cardiac arrhythmia's. It is known that at least half of the most commonly used drugs in the elderly have the potential to interact with alcohol (Lamy,1990). In addition to alcohol being drunk as a beverage it is present in many OTC medications potentiating the central nervous system depressant effects of tranquilizers, narcotics, sedatives and antihistamines. It also decreases the half- life of tolbutamide and may enhance the potential toxicity of acetaminophen (Holden, 1992). Older adults are obviously at greater risk for ADRs because they generally have a mixture of both chronic and acute illnesses, putting them at risk for multi- drug treatment. Coupled with the fact that the older client is undergoing physiologic changes, specifically changes in the distribution, metabolism, and excretion of medications, his/her risk for ADRs is compounded. Distribution of medications is affected by changes in body composition. The elderly experience an increase in total proportion of fat related to lean body mass and total body water. Since some medications are highly fat soluble, they may be stored longer in fat and thereby prolong their effect. Other water soluble medications may be more highly concentrated because of less total body water, and therefor need to have their dosages reduced. Liver size and kidney function decrease with age resulting in decreased clearance of the medications processed here, and increased half-life of some medications. Because of these changes it is estimated that 70% to 80% of drug reactions are dose related (Nolan & O'Malley, 1988). 1 3 Maintaining perspective it should be noted that medications have had an extremely positive effect on the elderly clients in alleviating symptoms, and curing potentially life threatening infections. Conversely as depicted (Figure 1), selfmedicating, noncompliance, and multiple providers all may contribute to polymedicine which in turn may lead to ADRs with unwanted side effects. Excessive drug use may also result in a decrease in the quality of life of many elderly clients and contribute to excessive medical costs (Stewart 8 Cooper, 1994). Adverse drug reactions are a fact of life. The drugs most likely to cause ADR's are well documented. There are texts written on the topic and computer programs are available and being continuously updated to alert pharmacists of the potential for ADR's in their patients. This project will focus on the issue of determining risk as it relates to compliance in medication administration in the primary care setting. The issue of compliance and related concepts leading to the potential for ADR's fits well into the framework of a general theory of nursing presented by theorist Dorothea Orem. Orem's theory broadly described is a self- care deficit theory. The term deficit was chosen by Orem because it ”describes and explains a relationship between abilities of individuals to care for themselves and the self-care needs or demands of the individual, their children, or the adults for whom they care. The notion of 'deficit' does not refer to a specific type of limitation, but to the relationship between the capabilities of the individual and the need for action" (Orem, 1991, pg. 9). Orem's theory provides the basis for this project. Orem describes her theory as one comprising three “articulating“ or interrelated theories: the theory of self-care, the theory of self-care deficit, and the theory of nursing systems. 14 T MORTALITY 1 MORBIDITY ADR’S l SELF CARE DEFICIT POLY I NON MEDICINE l COMPLIANCE SELF MULTIPLE MEDICATION PROVIDERS EjguILL Model For Risk of Adverse Drug Reactions The central theme in Orem's theory is that occasionally individuals are limited in their abilities to meet their self-care needs. The limitations can be a medical condition such as an accident, hypertension, or diabetes, or because of other factors such as age; referred to as an internal factor. A geriatric client may have limitations because of age and need nursing care. An external factor may be a life experience such as a death in the family. W Two important ideas that Orem focuses on here are identified as: self-care as learned behavior and self-care that is deliberate action. It is presumed that as this behavior is learned from communication and interaction in larger social groups that action will vary because of cultural and social experiences of the individual. Self-care is not instinctive but performed rationally in response to a known need. All individuals have the potential ability and motivation necessary to care for themselves but not all individuals will take action, according to Orem. mm The third component of Orem's theory of nursing, the theory of “nursing system“ incorporates the theory of self-care deficit. Orem calls this the "unifying theory.“ This unifying theory explains the relationship between nursings actions and roles and the patients actions and roles. The central idea is that nurses have abilities that they use to determine if help is necessary. The process involves the nurse determining whether self-care is possible or if a deficit exhists, the development of a plan of care that is mutually acceptable, and identifying what is to be done and by whom. The actions of the nurse, the patient and/or the 1 6 dependent care giver are collectively called the nursing system. The goal of the nursing system is to increase the patient's capabilities to meet a need. Orem describes three types of nursing systems: wholly compensatory, when the patient is totally incapacitated and the nurse performs all necessary actions; partially compensatory, when the nurse must at least assist the patient when health deviation occurs; and finally the supportive-educative nursing system (Orem, 1991, p. 287). It is within the supportive-educative nursing system that the APN is most able to assist the client in a primary care setting, especially in relation to the concepts identified for this project. It is here that compliance can be determined partially by assessing poly-medicine and self-medicating and potentially reducing ADR's. Orem identified five general methods that persons use to help others: acting or doing for another; guiding or directing another; providing support, both physical and psychological; environmental support; and teaching (Orem 1991, p. 286). These are all appropriate roles for the APN in primary care. Many patients are able to accomplish self-care, (Figure 2), without intervention of the APN. When a patient presents with symptoms of illness or is seeking assistance in appropriate health care maintenance activities, the opportunity exhists to evaluate, among other things, the medications helshe is taking to determine whether potential exhists for ADR's. With an appropriate tool the APN can use the above identified roles that Orem has suggested and assess the patient for current or potential ADR's and support and educate the patient toward reducing that potential for ADR's. Orem said "Together with other 17 FClient at risk for ADR Nurse Action Regulates self-care agency Performs some ‘ _ self-care measures Patient Acfion Accepts care and assistance from nurse Partly compensatory system Accomplishes self-care Patient Action Regulates the exercise and development of Nurse Action self-care agency Supportive-educative system 591.13.?“ Orem's View of a General Theory of Nursing 1 8 health professionals nurses focus on the quality of the physical environment and material resources, on what members of a population should or should not do in order to protect themselves and their dependents, and on preventive health care in a way that brings benefit to all (Orem, 1984, p. 46)". E . I I 'l | ADR's can occur in any patient of any age but the physiologic changes occurring in the elderly increase the occurrence. A review of the literature produces numerous articles devoted to describing the potential for ADRs in the elderly. Nolan and O’Malley (1988), found that 30% of hospital outpatients experienced ADRs. Ostrom, et al (1985), related that adverse reactions to medications are more common in the elderly and found that Often, if unrecognized, the ADRs would lead to additional prescriptions to treat the reactions. This of course had the potential of a chain reaction of additional ADRs Gray (1990), Beers and Ouslander (1989), Campion, Avom, Radar, and Olins (1987), and Coons and Chandler (1990), all describe those changes that occur, such as replacement of lean muscle mass with fat, decreased renal function and hepatic function with a resultant decrease in the ability of the body to excrete or detoxify drugs. Coons and Chandler (1990), placed the mechanisms of drug interactions into four categories; absorption, distribution, metabolism and excretion, and related how aging effects the ability of the human body to accomplish these tasks, usually negatively with respect to ADRs Multiple providers also contribute to the potential for ADRs but to a lesser extent. LeSage (1991) pointed out that because of specialization of physicians and multiple problems in the elderly that older adults are likely to have multiple care providers, including seeking advice from pharmacists and nurses. Lamy 1 9 (1990) who has written extensively on the subject and Coons and Chandler (1990), agree that in some cases the patient is seeing other health care providers without the knowledge of the primary physician. Poly-medicine remains a key factor with respect to ADRs as documented by a literature review by Nolan and O'Malley (1988). LeSage (1991) in a study of geriatric clients demonstrated that the total number of drugs given, the number of prescription drugs, and the number of medical problems had a strong relationship with the number of potential drug related problems. Some of the potential causes of poly-medicine are reviewed by Montamat and Cusack (1992), (Table 1). Polymedicine was cited in ”Healthy People 2000 “(1990), as the principal drug safety issue of the coming years. Shimp, Ascione, Glazer, and Atwood (1985), Stewart and Comer (1994), and Lamy (1982), all discuss the problems associated with polymedicine but emphasize that it is often self-medicating with OTC drugs that contributes to the problem. Self-medicating either with prescription drugs or OTCs contributes to poly- medicine. Some people believe that they need a 'pill for every ill', (LeSage, 1991). This is encouraged by the media. Gray (1990), Montamat and Cusack (1992), LeSage and Zwygert-Stauffacher (1988), and Coons and Chandler (1990), remind us that OTC drugs may not be reported without prompting and in fact are often thought of as medications. Up to 60% of all OTC drugs taken by the elderly are not reported to a physician or nurse even when a careful history is taken (Everitt & Avom, 1986). The potential for ADRs is quantified by Gardner and Hall (1982), in estimating that 65-85% of all illness episodes are managed by an individual or a family member. Americans have over 100,000 OTC products to choose to self- prescribe and self-medicate. Gardner and Hall (1982), further suggest that 85% 20 Patient-related factors 1.E)¢)ectationofphysiclantoprescrbemedication 2.Inadeqt.iatereportingofcmentmedications 3. Failtretocomplainabwtsymptormmspeciallyifreiatedto medication 4. Useofnwltipleautornatfcrefillswidroutvbltingphysician 5.UseofmulIIpIe pharmaciesormultble physicians 6. Hoadingpriormedications 7.9orrowingmedicationstromramiiymemhersortnends 8.SeIf-medicationwithover-the-counterdrugs 9. htpai'edcognltiona'vision 10. Economicfactorssuchashlghd’ugcosts Physician-related factors 1.Presumlngthatpatientsexpectpreecriptionofmedication 2.Omgireaunentotsyrnptornswimoutsurnciemctnicaievaruation 3.1'reatingconditionswithoutsettlngooalsofW 4. Communicating instructions In unclear, complex, or incorrplete manner 5. Failuemreviewmedicafionsandmetpossbleadmeefleasatmgula'm 6.Useofautomaticr6fills 7.Lw(ofhwbdgeofgamdhbalph8maoGOQy,badngminbing 8. lnadequateswervlsionofmedicationslnlong-tmncare 9. Failuetosimplifyctugreginensasoftenaspossble 2 1 of persons taking OTC medications do not follow the instructions on the label or fully comprehend their significance. Reviewing the previous discussion, it is obvious that ADRs are an unwanted potential side effect of well meaning and often appropriate treatment provided by health care workers. The physiologic changes inherent in aging are inevitable. Given the specialization of medicine and likely multiple disease states prevalent in the elderly patient, multiple providers and poly-medicine are a fact of life. Additionally the availability of OTC drugs and strong media encouragement to treat oneself, not altogether inappropriate, will not alter the incidence of self- medicating with OTC drugs. APNs encourage patients to take on more responsibility for self-care when appropriate. The danger is when patients do not understand the potential for ADRs when multiple drugs are taken or the increased potential for ADRs in a debilitated patient undergoing the physiologic changes of age. The issue of compliance is the area that has the most potential for improved outcomes regarding medication administration, the elderly patient, and the APN in primary care. There are many references to compliance issues in the literature. Non- compliance as defined by Gryfe and Gryfe (1984), is failure of the patient to take the specified dmg in the specified manner. This can exhibit itself as overuse, underuse, erratic, or contraindicated use of medication (Montamat & Cusack, 1992). Lamy (1990), Gryfe and Gryfe (1984), and Young (1986), estimate that up to 60% of patients make compliance errors in the taking of medications whether intentionally or unintentionally. The reasons for noncompliance are many and varied. Alford and Moll (1982),.Montamat and Cusack (1992), LeSage and Zwygart-Stauffacher (1988), Harper, Newton, and Walsh (1989), Shimp et al (1985), Powell-Jackson and 22 Swift (1987), and LeSage, Beck, and Johnson (1979), show how decreased mental competence and changes in sensory and cognitive ability lead to noncompliance. Decreased vision alters the ability to read the label on the medication container and alters the patients ability to discern color and size of the pills. Mental competence may effect memory related to when to take medications. A knowledge deficit regarding illness and reasons for taking the medications can effect compliance as outlined by LeSage and Zwygart- Stauffacher (1988), Martin and Mead (1982), Stewart and Cooper (1994), and Lamy (1980). LeSage (1991), Lamy (1980), and Powell-Jackson and Swift (1987) all point to the physical disability that can come with increasing age that decreases the ability to open containers of medications. The complexity of a medication regimen, the increased number of medications prescribed and length of medicinal therapy can lead to increased noncompliance as identified by LeSage (1991), Coons and Chandler (1990), Gryfe and Gryfe (1984), Young (1987), and Stewart and Cooper (1994). Some elderly patients, in an effort to maintain control of their own lives, will self- medicate by increasing or decreasing amounts of prescription drugs, or by taking OTC drugs to avoid seeing their health care provider, Powell-Jackson and Swift (1987),and Lamy (1982). Patients take some medications incorrectly simply because they forget instructions, (Shimp et. al., 1985; Martin and Mead, 1982; and Lamy, 1980); are feeling well and think they must not need the medication anymore, (Coons and Chandler, 1988; and Young, 1987); or are financially unable to pay for more medications, Harper, Newton, and Walsh (1989). 23 BMW Since there are many resources that specify which drugs are likely to cause interactions, the focus of this project was to develop a protocol (Appendix), to determine the level of risk of the patient for an ADR. A tool which elicits complete information and is not overly time consuming to administer can be valuable in assessing a patient for current or potential risk of ADRs. Determination of level of compliance is one area that the APN in primary care can have a significant effect in reducing the potential for ADRs and enhance the goals of treatment with prescribed and OTC medications. It is expected that this tool can be administered in the primary care setting by any registered nurse. Demographic data is an important first step. Age gives us a first clue as to what physiological changes may be occurring. The older the patient, the more likely there are multiple medical problems requiring treatment and the more likely there are multiple medications from multiple providers being taken. The educational level of the patient may alert us to a potential limited ability of understanding instructions, although that is not necessarily the case. Marital status should be broadened to include a significant other, the importance of which would be the availability of another person to help with medication administration, or someone from whom medicines may be borrowed. A patient may resist taking a diuretic because of the increased frequency of urination, especially if the bathroom is on another level of the house from where the patient spends most of his/her time. This potential variant in their regimen makes the living arrangement another important piece of information. The problem list should be a part of every patients chart alerting the APN to what medications a patient may be taking. Occasionally, problems thought to 24 be associated with growing old, such as confusion, may in fact be signs of ADRs. Looking at the problem list in association with the medications being taken may alert the care provider to a possible ADR. When identifying the medications being taken it is important to ask very specific questions including whether the patient uses ointments, eyedrops, or patch medications in addition to the pill forms. Eyedrops, for instance, are often not thought of as a medication but have the potential for interaction with other medications. If the medication bottles are available for the APN to look at, the original prescription can be obtained from them and then through further questioning determine if and how the medication is currently being taken. If the patient tells the APN that the medication is taken twice a day, then more detail is required as to when exactly it is taken. A prime example is the patient who when asked how she took her medication, which was scheduled twice a day, said "I take one pill at 9 am and one at 10 am“. This satisfied the twice a day direction but was obviously an inappropriate way to take the medication. Hahn and Wietor (1992), from whom some of the portions of this tool have been adapted, found in their study that 50.7% of their stbjects did not take all prescribed medications correctly further emphasizing the need for periodic medication screening. WW ‘ This protocol is intended to be administered to ambulatory, independent elderly clients who are cognitively intact. Most of the information requested on the first two pages of the protocol can be filled out by the client without taking the time of the APN. or with minimal assisstance from office personnel. The first two pages of the protocol (demographics, problem list, prescription and nonprescription medication information, and social drug data) 25 should be part of every clients chart and continuously updated. A quick review of the information contained here will alert the care provider of clients 65 years of age or older or one taking more than three medications. These two pieces of information will serve as ”red flags“ to identify individuals who ' should be considered for evaluation. Prior to a scheduled appointment at the primary care setting the client should be instructed to bring all of their medications with them. A quick review of the information may elicit questions which then can be addressed. The narrative questions are meant to bring out information that might not otherwise be heard using typical yes or no response questions. Hahn and Motor (1992), found that most elderly clients gave better information if asked specific questions about common drugs such as sleeping aids, laxatives, aspirin, etc., and that 75% of elderly persons use nonprescription drugs. Ellor and Kurz (1982), also suggest a “directed and focused interview exploring the use of these drugs [OTC] specifically. Questions about a person's treatment of pain, headaches, sleep, common colds, constipation, diarrhea, or heartburn are likely to elicit answers of OTC drug usage“ (p. 325). The final physical assessment questions are self explanatory related to the determinations of physical abilities. With the completion of these questions the care provider should be able to assess whether the client is at high or low risk for ADRs, and be able to take appropriate action. It is intended that this tool will take a maximum often minutes to complete if the initial questions are answered by the client or clinic personnel prior to the actual visit. This tool should be completed on an annual basis to provide consistant follow-up. On interim visits the APN can ask if any changes have 26 been made on any medications since the last visit, and if any new providers have been seen. WW Evaluation of this protocol could be accomplished initially by having several experienced APNs review it to determine whether it is a workable tool. The length of the tool appears manageable but could be better evaluated by APNs currently working in the primary care setting. Criteria that could be used to determine efficacy would be a chart review of 100 elderly clients. The review would determine if the protocols are being filled out; if ADRs have been documented to have occurred; if hospitalizations have occurred related to the ADRs; and if teaching about expected medication reactions is being taught and documented. Also a comparison could be made of how many charts had up to date drug lists before and after the protocol was instituted. E I I. I B' I Taking more than three medications and certain questions in the protocol serve as indicators for increased risk of ADRs. These questions have been printed in bold type and should be reviewed following the interview. Any answers in the affirmative indicate an increased risk for ADRs, and the greater the number of questions answered 'yes', the greater the risk. A red check marking those questions answered affirmatively will help in final evaluation. It is at this point that the care provider needs to decide on how to proceed, based on the level of risk determined. If the client is at high risk the chart should be flagged with a bright orange sticker that states “DRUGS”, which would alert the care provider to an increased risk for ADRs and to take 27 appropriate action now and at future visits. If low risk, document any teaching and reinforce good drug taking habits. ADRs are present in every care providers practice. Some are not preventable due to the necessary medications a client must take to control a disease process. Many ADRs are preventable and the first step in preventing them is to evaluate the client for risk of being noncompliant, or encountering difficulties in medication administration, leading to potential ADRs. This tool can provide the first step in that direction. While the tool is being administered an opportunity exhists to assess the knowledge level of the client regarding their medications. Ellor and Kurz, (1982), state that ”patients should be educated in the following areas...: the reason for a specific drug prescription, the effects expected, which side effects indicate a need for further medical intervention, the action to be taken when side effects appear or when the expected therapeutic effect does not occur, and specific actions to be taken if a dose of prescribed medication is missed“ (p. 325). Ellor and Kurz, (1982), further discuss how the role of the professional nurse to be a patient advocate, as it relates to drug taking behavior among the elderly, goes beyond acting on behalf of the client. '1’ he professional nurse must also ensure that the elderly person recognizes the need to be his own advocate and to act constructively on his own behalf” (p. 325). On the occasions when the client dOes not have the proper knowledge of possible side effects of medications, or know what to do when the side effects occur, the APN must intervene and provide supportive, educative nurse action as in Orem's theory. The same action by the APN is required when other patient limitations interfere with the therapeutic administration of medications. The 28 APN takes apprOpriate action and assists the client in returing to accomplishing self care. The APN can play a significant role as an educator in helping the client to understand the reasons why certain medications need to be taken and why the client should take them on a specific schedule. Montamat and Cusack (1992), list as one of their guidelines for effective prescribing to educate the patient about the drug therapy. Hussar (1986), asserts that communication is the key. We as care providers must tell our clients what to expect from drug therapy and the patient, in turn, must tell the care giver how helshe is feeling and whether helshe thinks the drug is working. The client must agree that a partnership must exhist between the client and the care giver in an effort to move the client toward wellness. Alford and Moll (1982), provide some “dos and don'ts' to clients based on a booklet by Roche Laboratories: Never exchange medications with a relative or friend. Avoid alcoholic beverages when taking medications. Keep a list of all medicines you take for use when consulting your physician and primary nurse. Take your medicines as directed for as long as directed. Write out and follow a schedule of when your medicines should be taken. Know what to do if a dose of medicine is missed. Know what to do if your medicine causes unpleasant symptoms. The patient also should be encouraged to seek the help of their pharmacist when choosing OTC medications. 29 l l' ' i It is important that we assure that all health care providers, physicians and nurses, receive information in their respective curricula which alerts the providers that ADRs are a major health problem. Education of nurses and physicians in primary care sites is especially critical because this is the first line of defense in preventing ADRs. The use of the pharmacist as a resourse is essential. Requiring a pharmaceutical course beyond what is typically taught in nursing school would help in understanding the potent consequences of certain medication combinations. In educating the staff in primary care delivery sites there are several principles to remember. Dilts (1994), Gray (1990), Montamat and Cusack (1992), and Harper, Newton, and Walsh (1989), all discuss the importance of keeping the drug regimen simple, providing verbal and written instructions, and suggesting use of assistive devices in remembering to take medications. Medications taken once a day are more convenient, easier for the patient to remember, and usually more economical (Gray, 1990). Begin therapy with a low dose and increase slowly, watching for reactions (Dilts, 1994). LeSage (1991), suggests that care providers ask themselves some important questions prior to prescribing any new medications. Is this new drug or dose increase absolutely necessary? Can this new drug replace other drugs currently being taken? Will this new drug interact with other drugs? Will this drug or its side effects have an adverse effect on the patient's coexhisting health problems? What specific therapeutic effects will this drug achieve? Can this drug be discontinued in the future? (p. 285) The care provider should also take Into consideration whether nutrition, exercise, or stress reduction could replace a planned prescription. 30 i i r h Studies on ADRs in nonhospitalized patients are rare even though their relevance to everyday primary care is great. Few studies address the special considerations of age of elderly patients (Nolan 8 O'Malley, 1988). The continued documentation of ADRs highlights the need for further research into improved methods to assess for risk of ADRs and of the need to determine what characteristics of the aging body interact with various drugs (Montamat 8r Cusack, 1992). Follow, Stoller, Forster, and Duniho (1994), point to a need for more research on “drug-specific data collection protocols“ which could help researchers in developing a ”drug risk profile”, followed by tailoring interventions to the level of risk identified. Another important focus of research should be in determining effective prescribing practices for care providers of the elderly, and in promoting cooperation among health care providers to enhance compliance in medication taking. We, as providers of health care, also should strive to form partnerships with our patients in the Optimal goal of taking medications responsibly. QQIIQIIEIQEI Medications can serve the elderly client to great benefit. Misapplication and misuse of medications may result in undesirable outcomes, ranging from lack of maximum efficacy, annoying nuisance side effects, diminishing quality-of-Iife, and even life-threatning adverse outcomes. By careful attention to the principles of good prescribing and a sensitive approach to the need for bidirectional communication and even more careful assessment of the need for, type of, and outcomes of pharmacologic intervention in the elderly, prescribers can enhance 3 1 their patient's appropriate compliance, achieving maximum benefit (Weintraub, 1990, p. 451). 32 References Alford, D. M., & Moll, J. A. (1982). Helping elderly patients in ambulatory settings cope with drug therapy. WWW, 11(2), 275- 282. Braude, M. (1986). Drugs and drug interactions in the elderly woman. Beers, M. H., 81 Ouslander, J. G. (1989). Risk factors in geriatric drug prescribing. Drugs, 31(1), 105-112. Campion, E. W., Avorn, J., Reder, V. A., 8 Olins, N. J. (1987). Overmedication of the low-weight elderly. W441, May, 945-947. Coons, S. J., & Chandler, M. H. H. (1990). Drug interactions in older adults. MW, 88, May, 130-133. Davidson, K., Khan, A., & Price, R. (1987). Reduction of adverse drug reactions by computerized drug interaction screening. Wail! M99. 25(4), 371 -375. . Dilts, P. V. (1994). Drug interactions and reactions in postmenopausal and elderly patients. W 1(2), 80-82. Ellor, J. R., at Kurz, D. J. (1982). Misuse and abuse of prescription and nonprescription drugs by the elderly. Wm 11(2), 319-329. Everitt, D. E. & Avorn, J. (1986). Drug prescribing for the elderly. AmbbresetlntemaLMedicine. 1Q. Dec. 2393-2396. 33 Gardner, E. R., 8 Hall, R. C. W. (1982). Psychiatric symptoms produced by over-the-counter drugs. Wigs, 23(2), 186-190. Gray, M. W., (1990). Polypharrnacy in the elderly: Implications for nursing. W 9(6). 49-54- Gryfe, C. l., & Gryfe, B. M. (1984). Drug therapy of the aged: The problem of compliance and the roles of physicians and pharmacists. Mamas Am r' n ri i ' , 32(4), 301 -307. Hahn, K. & Wietor, G. (1992). Helpful tools for medication screening. Gea‘atticflutsing May-June. 160-166. Harper, C. M., Newton, P. A., & Walsh J. R. (1989). Drug-induced illness in the elderly. W, 55(2), 245-256. Harry Heller Research Corp. Health care practices and perceptions. (Survey) Washington, DC: The Proprietary Association, 1984: 1552. Healthy People 2000: National health promotion and disease prevention objectives, US Dept of Health and Human Services 91-50212, p. 67, Washington DC, 1990. Holden, M. (1992). Over-the-counter medications. W Medians, 91(8), 191 -202. Hussar, D. A. (1986). Drug interactions. W, 16(8), 34-39. Kasper, J. A., (1982). Prescribed medicines: Use, expenditures, and source of payment (data preview 9, National Health Care Expenditures Study), Washington DC: US Dep. Health and Human Services Pub. No. (PHS) 82:3320. Kofoed L., (1985). OTC dnJg overuse in the elderly: What to watch for. Genetics 5900). 55-60- Lamy, P. (1982). Effects of diet and nutrition on drug therapy. mm W 3.001). 99-112- 34 Lamy, P. (1982). Over-the-counter medication: The drug interactions we overlook. WW 3901). 69-75- Lamy, P. (1984). Hazards of drug use in the elderly. W MM, 15(1), 51 -53. Lamy, P. (1986). The elderly and drug interactions. JQIILDBLQLILIQ WWI! 3.518). 586-592. Lamy, P. (1990). Adverse drug effects. WWII. 6(2), 293- 306. LeSage, J., Beck, 0., 8 Johnson, M. (1979). Nursing diagnosis of drug incompatibility: A conceptual process. MW, 1(2), 63-77. LeSage, J. (1991). Polypharmacy in geriatric clients. mm mm. 26(2). 273-289- LeSage, J. & Zwygart-Stauffacher, M. (1988). Detection of medication misuse in elders. MW Summer, 32-36. Montamat, S. C., & Cusack, B. (1992). Overcoming problems with polypharmacy and drug misuse in the elderly. W, 8 (1), 143-158. Martin, D. C., & Mead, K. (1982). Reducing medication errors in a geriatric population. WW, 30(4), 258-260. Nolan, L. & O'Malley, K. (1988). Prescribing for the elderly, Part 1: Sensitivity of the elderly to adverse drug reactions. Wan W, 36(2), 142-149. Orem, D. E. (1991). W (4th ed.). St. Louis: Mosby. Ostrom, J. R., Hammarlund, E. R., Christensen, D. B., Plein, J. B... & Kethley, A. J. (1985). Medication usage in an elderly population. mm, 23(2), 157-164. 35 Pal, B. (1986). General practitioners' awareness of availability of NASAIDS without a prescription. Emetitjenei, 230(Jan), 75-78. Pollow, R. L., Stoller, E. P., Forster, L. E., and Duniho, T. S. (1994). Drug combinations and potential for risk of adverse drug reaction among community- dwelling elderly. W 53(1), 44-49. Powell-Jackson, P. R., 8 Swift, C. G. (1987). Drug treatment in the elderly. W, 231, June, 877-881. Shimp, L. A, Ascione, F. J., Glazer, H. M., & Atwood, B. F. (1985). Potential medication-related problems in noninstitutionalized elderly. Qnig W 19. Oct. 766-772. Silverman, M. & Lee, P., (1974) W Berkely, Ca: University of California Press. Sloan, R. W., (1986) WWW Oradell, N. J.: Medical Economics Books. Stewart, R. B. & Cluff, L. E., (1971). Studies on the epidemiology of adverse drug reactions. VI: Utilization and interactions of prescription and non prescription drugs in outpatients. WM 129, 319-331. Stewart, R. B., 8. COOper, J. W. (1994). Polypharmacy in the aged. Qnige ansLAoing. 4(6). 449-461. Stewart, R. B. at Hale, W. E. (1992). Acute confusional states in older adults and the '0'9 01‘ POWDMNTIECY- WM. 13. 415- 430. Weintraub, M. (1990). Compliance in the elderly. QflnjeaLEneimeeejegy 5(2), 445-451. Wolfe, S. (1993). W. Washington DC, Public Citizens Health Research Group. 36 Young, F. E. (1986). Clinical evaluation of medicines used by the elderly. Wes 52(6). 666-669. 37 APPENDix NAME BIRTH DATE SEx PHONE PHARMACY ALLERGIES PHONE MARITAL STATUS EMPLOYMENT EDUCATION LIVING ARRANGMENT INSURANCE PROBLEM LIST RESOLVED DATE ODQ‘I-hGDRD-lL PRESCRIPTION MEDICATION: liquids, pills, ointments, patches, and eyedrops Name Dose Freq Sched Who R; Date How take QNQU'I-hODN-fi 38 NONPRESCRIPT ION DRUG LIST PROBLEM OTC USE? PRODUCT NAME FREQ PAIN SLEEP COLD STOMACH CONSTIPATION DIARRHEA VITAMINS OTHER SOCIAL DRUGS AMOUNT FREQUENCY COFFEE/T EA ALCOHOL TOBACCO STREET Rx Adapted from Sample Drug Questionaire Ellor and Kurz (1982) and Medication Taking Profile Hahn and Wietor (1992) 39 ADR RISK QUESTIONNAIRE Are these all of your medications? What medications did you leave at home? Which of these medications are you currently taking? PPN?‘ Describe how and when you take your medications. 9‘ Do you use any special reminders to help you remember your medications? 6. When you miss a dose, what do you do? 7. How often do you forget to take your medications?_Day__Vlleek. 8. Do you take your pills when you go away for the day or a longer trip? 9. What do you do when you run out of medications? 10. Are there any prescribed pills you cannot afford?Yes__ No 11. How often do you skip medications you have difficulty paying for? 12. Where do you store your medications? 13. Do you keep medications in the original containers? Yes____No 14. Does anyone help you with your medications? Who helps? What involvement? 15. Do you ever share medications with or from anyone? Yes _No__ 16. When instructed to stop a medication, what do you do with the remaining supply? 17. Do you have trouble swallowing pills? 18. Do you ever crush pills or take capsules apart? 19. How do you get your pills? Clinic visit? Delivered? Drug store, self? Dmg store, one ?_Multiple? 20. Do any of your medications cause problems like diarrhea, constipation, or frequent urination? 21. Have you ever had what you consider to be a side effect of medication?— What was it? What did you do? 40 W 1. Please read this label to me. Able to read? YES__NO_DIFFICULT_ 2. What color isthis pill? Correct Incorrect 3. Please open these containers. Twist top. Able Unable Child proof. Able Unable ”DIE: Client taking greater than 3 medications and unsatisfactory answer to one or more bold face questions or inability to complete physical assessment satisfactorily is at We. ASEESSMENI Risk for ADR. High low Plan: Goals: 2429337” é 293 02219 7838