Tips and Information

January, 2000

New OBRA Investigative Protocols: Adverse Drug Reactions

The OBRA regulations state that residents should not receive "unnecessary" drugs, which are defined as those given without adequate justification, in an inappropriate dose, for an inappropriate duration, or which cause preventable side effects and complications. The survey process has always included substantial, but mostly general, medication review. Existing criteria used to evaluate for possible unnecessary drugs include appropriate indications or reason for use, dose, presence of monitoring for effectiveness and harmful effects, and the presence of duplicate therapy. Surveyors have used the guidelines for reviewing psychoactive medications, based on this provision, for many years. Two principal portions of the regulations covering medication review are Tag F329, Unnecessary Drugs, and Tag F428/429, Drug Regimen Review.

This portion of the survey process now includes additional guidelines related to the occurrence of adverse drug reactions (ADRs). Surveyors will continue to review medications taken by selected residents/patients. They are expected to use observations, the clinical record, and interviews with a resident/patient or interested parties, and are supposed to correlate the review of the drugs with a resident/patient’s clinical condition and any extenuating circumstances such as recent admission, a change in the individual’s environment, or recent hospitalization.

Some general principles underlying the OBRA ‘87 regulations apply to the medication guidelines, as follows. While abnormalities and symptoms are very common in the frail elderly population, neither of these necessarily implies that a problem requiring a health-care intervention exists. Providers and practitioners are responsible for using their knowledge and skills to identify the significance of these abnormalities and symptoms. When a symptom or abnormality is determined to be problematic, medications are only one form of intervention. Furthermore, many negative things happen to frail, elderly individuals. They get sick, they die, need hospitalization, decline functionally, get depressed, and so on. Many of these negative outcomes are unavoidable, while others may result at least partially from care process failures. When a negative outcome occurs, a facility must show that a care process was directed towards avoiding a predictable negative outcome, or that a negative outcome was not predictable or avoidable. It must also demonstrate that reasonable efforts were made to identify and correct symptoms and problems that were probably or definitely related to medications.

It is well known that medical treatments may help produce positive outcomes, may cause or contribute to negative ones, or may do some of each [Darchy B, Le Miere E, Figueredo B, Bavoux E, Domart Y. Iatrogenic diseases as a reason for admission to the intensive care unit: Incidence, causes, and consequences. Arch Intern Med 1999; 159:71-78.]. For several decades, medications have been identified as a major cause of morbidity and mortality in the elderly. Therefore, it is felt to be reasonable to request evidence that efforts were made to minimize the known risks and maximize the benefits of those treatments –especially, medications.

Medications may be more likely to cause undesired effect in those with significant underlying risks. The frail elderly already have a number of risk factors, such as age-related changes in drug metabolism and excretion, the need to take many different medications, and the inability of many of them to identify their own condition, to recognize their own significant condition changes, or to give a detailed history about new symptoms.

The treatment of any at-risk population always requires balancing risks and benefits. When treatments with a known risk potential are rendered to individuals known to have a higher than average risk for adverse consequences, the provider must try to anticipate a possible ADR, try to reduce the possibility of its occurring, identify its occurrence in a timely fashion, and act appropriately if it occurs. Not all risk situations can be predicted accurately. Therefore, it is appropriate to try to stratify risk categories (for example, high, moderate, and low or marginal likelihood) and to concentrate preventive efforts on residents/patients or medications with high or moderate risk, or to indicate why preventive measures are not indicated.

A literature review and expert consensus led to the publication of a list of medications that are known to either have a high likelihood of causing ADRs in the elderly or are more likely to cause severe ADRs, or both [Beers, Mark. Explicit criteria for determining potentially inappropriate medication use by the elderly. Archives of Internal Medicine. July 28, 1997]. This list was then used as the primary basis for creating the new ADR guidelines. However, facilities are responsible for the appropriate use of all medications. These new ADR guidelines are only a supplement to existing ones (for example, the psychotropic drug guidelines), and thus are not exclusive.

The varieties of ADRs may include:

- Drug-drug interaction (e.g., Bactrim displaces Coumadin from protein binding and increases bleeding risk)

- Hypersensitivity (allergic) reaction (e.g., Individual develops rash to an antibiotic)

- Drug side effect (e.g., Antihistamine causes drowsiness while used to treat allergies; Rogaine grows hair while used to treat hypertension or lowers BP while used to grow hair)

- Drug toxicity (e.g., Normal doses of digoxin may accumulate to toxic levels in a patient with acute renal failure)

- Idiosyncratic reaction (e.g., Individual has a non-specific intolerance for a particular analgesic)

- Complication (e.g., Diuretics and ACE inhibitors lead to dehydration and hypernatremia; NSAID causes GI bleeding)

Identifying an ADR. Surveyors will use at least two sources of information (observation, interview, or record review) to confirm that a resident/patient has had an adverse drug reaction possibly related to one of the listed medications. If the surveyor confirms that the resident/patient has apparently experienced an ADR, this will trigger a further review for whether that ADR (a "negative outcome") was medically unavoidable or may have been related to a process problem. An appropriate process related to these medications involves 1) consideration of alternatives to a medication likely to lead to an ADR, 2) reasonable and prudent efforts to anticipate and try to prevent ADRs, and 3) the appropriate, timely detection and management of an ADR when it occurs.

Anticipation and prevention of ADRs. ADRs may be prevented by either not using a potentially hazardous medication or by using it judiciously. The simplest –and often medically most appropriate– route is to choose a non-medication approach to managing a problem or to use a less risky medication. But if a potentially hazardous medication is felt to be needed, then it should be used in the lowest possible dose for the shortest possible time, and with appropriate caution and concern at all times.

If an ADR is detected, and the patient is taking one or more medications with a high potential to cause an ADR or the potential to cause a severe ADR, surveyors are expected to look for evidence justifying the use of such medications. Such evidence would include some or all of the following: 1)evaluation of the risks and benefits of the drug in a specific individual, 2)explanation that other less problematic medications were tried unsuccessfully, 3)evidence that the individual cannot or should not take those other medications, and 4)evidence that the condition or problem has been defined and its cause identified sufficiently to show that the individual can potentially benefit from the medication. Sources of such evidence may include progress notes, kardexes, monitoring tools, physician orders, consultant pharmacist reviews, or other parts of the clinical record; direct discussion with nurses, other staff, physicians, or the medical director, etc. This evaluation does not necessarily have to be written by the physician, but the physician may need to demonstrate involvement to try to sort out these various concerns; for example, evaluating the relative risks and benefits of a medication in a specific patient.

Detection and management of ADRs. Any medication may cause an ADR, although some are much more likely than others to do so in the elderly. Medications should be considered as a potential cause or contributing factor in the presence of: 1) a significant condition change, as defined under OBRA, 2) the new onset and persistence of a symptom or problem or the worsening of an existing one, 3) an otherwise unexplained decline in function or cognition, or 4) a non-specific symptom that is not otherwise clearly attributable to a specific underlying physical or functional cause.

Various medications are strongly or frequently associated with predictable symptoms or syndromes (collections or patterns of signs and symptoms). For example, medications such as amitriptyline, doxepin, and others with high anticholinergic properties are prone to cause syndromes that may include dry eyes, dry mouth, dry skin, constipation, lethargy, orthostatic hypotension, and increasing confusion. Facilities are responsible for the timely, appropriate detection and management of possible or definite ADRs. The anticipation of a possible ADR, and the level of suspicion in the presence of a symptom or condition change, should be greater for medications known to cause such problems more often or with greater severity.

An acceptable approach to detecting and managing ADRs involves 1) a level of suspicion when a symptom or condition change could represent an ADR, 2) reasonable and prudent efforts to try to determine if a symptom or condition change is reflecting an ADR, and 3) the appropriate, timely management of an ADR when it occurs. Evidence of appropriate process related to #1 and #2 includes assessing causes of symptoms and condition changes, incorporating a review of the existing medications. Evidence of appropriate process related to #3 includes the reduction or discontinuation of a medication which is, or should be, suspected as a possible cause of the ADR, relevant explanation if the medication is continued despite its likely contribution to, or cause of the symptoms, and appropriate corrective action to try to reverse the medication’s adverse effects.

Sources of evidence to support the appropriate monitoring and timely recognition of an ADR may include some or all of the following: 1)nursing or physician progress notes that list pertinent positives and negatives (for example, notation of the absence of severe or progressive constipation, attention to the cause of a fall, or the measurement of positional blood pressures), 2)physician orders to reduce or discontinue a medication in the presence of a possible ADR, 3)evidence of a physician’s response to a consultant pharmacist’s identification of a symptom, explaining why that symptom may or may not be due to a medication, 4)timely interventions to manage the ADR, or 5)a medically relevant explanation of why it is felt necessary to continue or to not reduce a potentially problematic medication in the face of a possible or probable ADR. Other sources of such evidence may include kardexes, monitoring tools, direct discussion with nurses, other staff, physicians, or the medical director. While these evaluations do not necessarily have to be written by the physician, the physician may need to demonstrate involvement to help sort out these various concerns; for example, determining the significance of non-specific symptoms such as lethargy or dizziness and their possible relationship to a medication, a chronic condition, a new acute illness, or some combination thereof. Overall, a facility should show that it has an appropriate process to detect and assess new symptoms and condition changes in a timely fashion, depending on the specificity of symptoms and other abnormalities. The process for detecting and managing ADRs is just one variation of this overall approach.

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