Responding to the rise of adverse drug events, one organization developed a successful strategy to make patient self medication safer.

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s incidents of adverse drug events (ADEs) increase, it is imperative for healthcare providers, particularly home care professionals, to find a way to conquer the problem. To do this, healthcare providers must fully understand the circumstances that lead to ADEs, examine the root causes, and try to create an atmosphere in which ADEs can be reduced if not eliminated. Carilion Home Care Services, Roanoke, Va, accepted this challenge and created a medication management plan that cut its ADEs in half.

Adverse Drug Events

       The National Coordinating Council on Medication Error Reporting and Prevention defines an adverse drug event as “any preventable event that may cause or lead to inappropriate use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer.”¹ This dry definition belies the often tragic personal impact of ADEs on patients’ lives every year.
       In its 1999 report,² To Err is Human: Building a Safer Health System, the Institute of Medicine’s Committee on Quality of Health Care in America estimated that more than 2 million serious medical errors, causing from 44,000 to 98,000 deaths, occur every year. Medical errors are the 4th-leading cause of death, ahead of pulmonary disease, diabetes, acquired immune deficiency syndrome (AIDS), and auto accidents. Of these medical errors, ADEs cause 7,000. While these statistics have been disputed over the past 5 years, they have also served to bring the critical topic of medication safety to the forefront and elevated public awareness of the issue.
       In the minds of most of the general public, ADEs are often attributed solely to the acute care setting. This is largely due to the intense media attention they tend to receive there. However, if we look again at the definition, it includes preventable events that occur when medication is in the hands of the patient, as well as the healthcare professional. This is of particular importance to home care providers. Establishing the root causes of the ADEs is essential if there is to be any progress in reducing the number.

Causes of the Common ADEs

       Western medicine relies heavily on both prescription and over-the-counter medications. The huge growth of mass media and the vast quantity of information available to people, even through very passive avenues like television, creates a very high degree of confidence in the ability of drugs to alleviate symptoms and cure nearly every condition. Americans visit their doctors’ offices expecting to leave with a prescription—little wonder, because nearly 66% of physician visits result in a prescription.³ The propensity of physicians to pull out the prescription pad, coupled with the increased number of both prescription and over-the-counter medicines, is a major contributor to ADEs and is exacerbated by the fact that the occurrences of ADEs increase exponentially when a patient takes 4 or more medications. In 2000, 2.8 billion outpatient prescriptions were filled. That amounts to 10 per person in the United States.⁴
       This is especially troubling to home healthcare professionals, because most home care patients are elderly and take multiple prescriptions, often prescribed by more than 1 physician.⁵ And, by definition, the home care setting is highly informal, often with a variety of family or friends who serve as caregivers and who very likely do not fully understand the patient’s medications or how to identify the symptoms of adverse reactions. This greatly increases the home care patient’s vulnerability to ADEs.

Types of ADEs

       The most common ADEs include heart-rhythm disturbances, diarrhea, fever, nausea and vomiting, kidney failure, mental confusion, rashes and itching, low blood pressure, bleeding, and, in some instances, death. Adverse drug events can be attributed to several causes, including medicine-to-medicine and medication-to-disease interactions.
       Medication-to-medication interactions. By far, the most pervasive cause of ADEs is medication-to-medication interactions. These interactions are often triggered by the decrease or increase of the presence of a medication in the blood where other medications are already present. The results can range from an increase in 1 or more of the drug’s known side effects, to a higher risk of falls or injuries due to blurred vision or dizziness, to a more serious, aforementioned adverse event.
       It is imperative for caregivers to take over-the-counter (OTC) drugs into consideration when assessing medication safety. Over-the-counter products contribute to ADEs and are often not fully reported to caregivers by the patient. According to a recent study, the elderly use 40% of all nonprescription medication and feel they are safe. It is highly likely that when asked what medications they are taking, they will overlook these products unless asked specifically—and possibly not even then.⁶
       The following lists contain the 7 most common prescription and OTC products responsible for medication-to-medication interactions. It is easy to understand why most patients would not think to mention the nonprescription drugs that fall into these categories, but all of them appear at least once on the list of contraindicated drugs for the prescription medications.
Prescription Medications:
• Aspirin
• Digoxin
• Furosemide
• Nifedipine
• Phenytoin
• Prednisone
• Theophyllin
Over-the-Counter Medications:
• Analgesics/nonsteroidal anti-inflammatory drugs (NSAIDs)
• Antacids
• Cold remedies
• Decongestants
• Fluid pills
• Laxatives
• Sleeping aids.
       On a pharmacokinetic level, drug-drug interactions impair medication efficacy by altering how the body processes each drug, namely by altering rates of absorption, distribution, excretion, and metabolism. This occurs because interactions can impair renal function, reduce muscle mass, and retard gastrointestinal (GI) motility and absorption. For example, a decrease in GI motility caused by a drug-drug interaction results in malabsorption, which leads to higher blood levels of water-soluble drugs; whereas a decrease in medication binding impedes drug distribution, resulting in lower blood levels of fat-soluble drugs. Similarly, decreases in liver and kidney function slow the metabolism, which can increase drug toxicity.
       Additionally, the occurrence of ADEs increases exponentially when a patient is taking 4 or more medications.⁷ Often in these cases, the resulting side effects mimic disease conditions, which could be misdiagnosed and treated with even more medications.
Medication-to-disease interactions. A second cause of ADEs is medication-to-disease interaction. This occurs when a medication has an adverse effect on another disease for which it was not prescribed. Usually, these effects include exacerbating symptoms or inducing a new disease state. For example, beta blockers prescribed for cardiovascular disease may increase respiratory disease or heart failure in people with asthma or chronic obstructive pulmonary disease. Likewise, the long-term prescription of NSAIDs to treat osteoarthritis may increase the risk of gastrointestinal bleeding or worsen renal failure, among other things.⁸

The Implications For Home Care

       What does this mean for home care? Home care patients are especially vulnerable to ADEs. The population is largely comprised of elderly people who take multiple prescriptions, often provided by several different physicians. Many live alone and are cared for by multiple, perhaps untrained caregivers, which makes ADEs even more likely. Studies conducted in the past several years have affirmed this hypothesis. One such study, published in the Journal of the American Medical Association, documented the inappropriate use of medication among the community-dwelling elderly in 12% to 40% of the studied population.⁹ A separate study similarly concluded that the usage patterns of between 17% and 30% of homebound patients could result in medication error.⁵ Finally, a study by consultant pharmacists estimated that ADEs account for a quarter of the hospitalizations among the elderly. Looked at from a financial, emotional, and physical perspective, the costs are enormous.¹⁰
       The causes of ADEs in home care are much the same as for the rest of the population and range from simple patient noncompliance to a breakdown in processes on the provider side related to ordering medications, monitoring their use, education, and communication.

Patient Noncompliance

       The reasons for patient noncompliance will be familiar to any caregiver. Patients often forget to take medication; failing eyesight can make small print on prescription bottles or handwritten instructions difficult to read. Often, patients lack the basic information and education about what, how, and why they are taking certain medications. Perhaps the most prevalent reason for noncompliance today, though, is the high cost of medications. It is very common for patients to ration a month’s supply to make it stretch over several months.

Provider Errors

       The potential for errors on the provider side is even greater, because there are often so many people involved in a single prescription, from ordering to monitoring, educating, and administering the medication. During the ordering process, ADEs can be attributed to 4 types of errors: transcription, interpretation, abbreviation, and decimal point misplacement.
       Transcription errors occur when the pharmacist inputs an illegible prescription. Interpretation errors occur when the pharmacist substitutes the wrong drug, particularly in the case of a sound-alike drug. Decimal point errors may occur when a “0” is omitted before the decimal point—for doses less than 1, this can increase or decrease the dosage 10-fold. Abbreviation errors contribute to misinterpretation of the prescription.
       Factors that complicate the monitoring process include comorbidities and complex medical regimes, which can make it difficult to determine how well individual drugs are working and which drugs, if any, are causing adverse reactions. And, of course, the home environment makes it more difficult to monitor drug efficacy than in the hospital, because as mentioned earlier, it is often difficult to verify that the patient is taking all medications as they were prescribed.
       Too often, caregivers assume that patients understand the medications they receive. Caregivers need to be aware that patients have widely varying learning requirements, and though they may have received education previously, the extent to which they have processed and retained that information depends on mental agility and the availability of family or other support to help reinforce compliance, answer questions, and watch for interactions.
Additionally, for complex medical regimes, the list of possible medication interactions can be long and overwhelming—even for seasoned professional clinicians. Ensuring that caregivers stay up to date on current interaction information is essential.
       Finally, communication about the patient’s care plan and all medication must be clear, prompt, and thorough and must include all members of the care team: physician, clinician, and pharmacist.
       After looking at all of the factors that can lead to an ADE, how can a home care organization go about ensuring that what can possibly go wrong will not go wrong?

Carilion Medication Management Strategy

       Carilion Home Care Services has served southwestern Virginia for 20 years, providing home care services, such as nursing, intravenous (IV) therapy, physical, occupational, and speech therapies, home health aides, and medical social workers. We developed a plan that encompasses every aspect of the organization to maximize medication management for reduced instances of ADEs.
       Before developing our medication management strategy, we compared our outcome-based quality improvement (OBQI) data with other similar agencies to establish the percentage of our patients that showed a decline in ability to manage their oral medications over a given period of time. In September 2003, 1.06% of our patients showed a decline compared to 0.82% in the reference agencies.
       Carilion took a systemic approach to managing medication. We recognized that in order to maximize efficiency and control ADEs, we could not simply look at only 1 aspect of our organization, such as education. We had to implement a system that permeated the entire culture to achieve our goals.

Staff Competency Evaluation

       The first target of Carilion’s medication management plan focused on those closest to the home care patients—our clinicians. We asked each clinician to participate in a staff competency evaluation. In this evaluation, caregivers were required to complete a quiz based on a typical prescription label. The quiz required them to identify each part of the label and explain the agency’s processes for completing order sheets and administering medications or treatments.
       Each clinician had to identify the “DO NOT USE” abbreviations on the label. If a staff member could not identify Carilion’s DO NOT USE abbreviations, even though the prohibited abbreviation requirement from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has been in place for 2 years, we knew that more education and reinforcement were needed.

Clinical Information Technology

       The more people with unique ways of doing things that handle a file vastly increases the potential for errors and, therefore, increases the possibility of ADEs. Carilion found that implementing clinical information technology was by far the best way to reduce ADEs. Our field clinicians used laptop computers to carry an electronic copy of the patient’s chart into the home and document the visit interactively. This created a standardized documentation process and eliminated the need to enter data manually later, decreasing the likelihood of errors.
       Using clinical information technology, clinicians could automatically check medication orders against the patient’s full drug regimen for potential drug interactions. This allowed the clinician to send the complete updated electronic medical record to a common database, where it was readily available to the other members of the care team for more coordinated care and less potential for errors.

Education

       Regardless of how much technology an organization provides to its clinicians, it cannot take the place of good old-fashioned education. Carilion created a forum for discussing medication safety and developed specialized educational materials for both clinicians and patients. Carilion instituted regular in-service education sessions that specifically addressed medication safety. This served not only to educate staff members about the mechanics of medication management but also to reinforce the importance of the issue to the culture of the organization and, therefore, reinforce its importance in the minds of clinicians.
       In order to help improve process standardization, we developed a Medication Administration Teaching Guide that fully delineated our organization’s medication administration processes. The guide was available in a traditional book form or could be accessed electronically, along with extensive teaching instructions, from the clinician’s laptop computer. By making the guide and instructions available at all times, clinicians had a resource to support their medication administration and decision making, which helped avoid mistakes.
       Carilion also developed and implemented a detailed patient-to-clinician review process designed to help the clinician probe patients’ understanding and use of the medications they take. This helped the clinician determine that the patient understood how to properly take each medication and ensured the patient was aware of the possible side effects and interactions that could occur while taking the medication. If the clinician noticed a deficiency, he or she could take immediate steps to provide the information to the patient. By providing a structured evaluation and education process, Carilion helped patients avoid physically and emotionally damaging ADEs.

Communication

       Open communication between all members of the care team is vital to the success of any program. If any member of the team is excluded, the system cannot function at full efficiency. Carilion’s medication management plan extended beyond the walls of the organization to include physicians as well as pharmacists.
       To strengthen communication with physicians, Carilion developed a process by which clinicians could seek clarification about why a medication had been prescribed or recommended.
       Carilion provided its pharmacists with better access to information instructing them in the electronic medical record used by the clinicians. Additionally, we worked closely with pharmacists to establish pain medication titration standards that enabled our nurses to alter pain medication as the patient’s pain increased. This helped ensure our clinicians could more accurately control and administer the patient’s medications.

Results

       Less than 1 year after the initial implementation of our medication management strategy, Carilion saw the percentage of our patients who showed a decline in the ability to manage their oral medications cut almost in half. In May 2004, only 0.55% of Carilion’s patients showed a decline, putting us well below the 0.77% demonstrated by the OBQI reference group.
       Carilion Health System still has room for improvement, but with our medication management strategy in place, we are well positioned to comply with industry standards and our own high standards of patient safety.