Reducing Adverse Drug Events From Physician Error John Caccavale, Ph.D., ABMP
During the calendar year ending 2001, more than 3 billion prescriptions for medications were written in
the United States at a cost of more than $132 billion dollars.32-34 Estimates project this cost to rise to
more than $400 billion by the year 2014. The passage of the prescription benefit bill during the Bush II
administration greatly increased these costs. The growing use and reliance on prescription medications
presents American society with major health, public safety, and public policy dilemmas. The
helpfulness and efficacy of many prescribed medications is unarguable. When used appropriately for
the conditions indicated, pharmaceuticals can contribute to the quality of life. On the other hand,
Estimates of the annual cost due to increased harm from medication related injuries ranges from a low
of $72 billion to a high of $172 billion.32 The fact that the increased harm and costs from medications
may actually exceed the total annual cost of medications themselves begs for further study. Fatalities
from adverse drug events in the United States are estimated to exceed 100,000 people on a yearly
basis.35 Annual non-fatal injuries from Adverse Drug Events (ADEs) are estimated to be about
650,000.35,36 These statistics are alarming, but they only represent fatalities and harm to those patients in
hospital settings. Data for ambulatory patients is sorely lacking due to an absence of an enforceable
policy for systematically reporting ambulatory ADEs.
It is important for all healthcare providers to be knowledgeable regarding adverse drug events
associated with prescription medications. Psychology, as a health care profession, is no exception.
Knowledge of ADEs is particularly important for those psychologists seeking prescriptive authority.
Knowledge on the types and incidence rates of ADEs also can shed light on whether medical school
training is a necessary prerequisite to safely prescribe medications as argued by opponents of non-
physician prescribers. Medical studies have long been concerned with patient safety related to the use
of medications.37, 38 The Harvard School of Public Health conducted one of the first studies to look at
ADEs associated with prescription medications.39 This Harvard benchmark study was a first attempt at
trying to quantify the types and incident rates of medication errors in a large population of hospitalized
patients. In a sample of more than 30,000 hospitalized patients, they concluded that medication errors
were associated with serious outcomes that negatively affected patient safety. Overall, they found that
adverse events from medications comprised about 20% of total errors.
All prescription medications approved by the US Food and Drug Administration (FDA) are for specific
purposes. Most medications are of little use outside their stated purpose, although many medications
are used “off label” with little or no data to support their use.40 Cardiovascular, gastrointestinal,
endocrinological, antibacterial and hematological drugs are examples of medications that have little or
no use for conditions other than purposes for which they are approved. These classes of medications
comprise the greater share of fatalities and serious ADEs.41-43
The FDA delineates two types of drug related adverse events. Type A ADEs are harms resulting from
prescription medication errors and other avoidable errors. Harms can range from a simple and minor
rash to death. Type B ADEs are harms not related to errors but to the unique response of the patient to
the drug, e.g., anaphylactic shock. “Undetected hypersensitivity or unknown inherited response to a
medication” comprise this category of ADEs. The types of errors described in studies reporting on
ADEs seem to change very little from year to year.44, 45
Prescribing of the wrong dose or the wrong medication, even when known allergies to a medication
exist, is a major problem. Overdosing is another serious problem. When errors such as these occur
time and again, chance occurrence is not a viable explanation.46 In response to the escalating ADE
problem, many hospitals have implemented ADE reduction programs such as using pharmacists to
A review of physician orders by pharmacists in order to provide medication counseling on all new
prescriptions is now required by Medicare. This federal requirement has resulted in pharmacists being
granted limited prescriptive authority in more than 40 states. Many of these prescription review
programs have reduced ADEs associated with the types of errors presented in the cited studies.47,48
There are many variables that can explain ADEs, e.g., physician distraction, workload, unfamiliarity
with a specific medication. Specific training on ADE pitfalls in all pharmacological training is
The Institute of Medicine (IOM) of the National Academies of Sciences performed a comprehensive
investigation of medical errors and published this landmark study as To Err Is Human (2000).34 One of
the major findings of that study was that annual fatalities from medication errors surpassed deaths from
motor vehicle accidents (43,458), breast cancer (42,297), and AIDS (16,516). Many of the findings and
conclusions of this study, however, have been challenged.49,50 Generally, these studies dispute both the
incident rate and seriousness of ADEs cited in the IOM study. Acknowledging that some of the
findings on ADEs may be overstated, the IOM study sheds much light on the risks associated with
Classes Of Medicines Most Related To Injury And Harm To Patients
Opiate and cardiac medications contribute the greater share of all ADEs and fatalities.51,52 Available
data suggests that the risks of ADEs associated with psychotropic medications may be far less than
those of drugs used for other disorders but nonetheless potentially dangereous.53,54 Although the data
cited in many studies is more than 10 years old, the more recent studies generally are consistent with
In the year ending 2000, more than 16,000 deaths from gastrointestinal complications were attributed
to non-steroidal anti-inflammatory drugs.43 In addition, several thousand more deaths involving
cardiovascular complications also were attributed to this same class of medication, which is used to
treat common inflammation.48 Increasingly, we see psychotropics being used for conditions for which
they are not approved and with populations never intended. Psychotropic drugs are often used by
managed care organizations as a less costly substitute for psychotherapy. Weight loss, dermatological
problems, student behavioral control, autism, inappropriate behavioral restraint, podiatry, pain
management, and in dentistry, are examples of applications not indicated by research or, in many cases,
by logic. Antidepressant medications are being prescribed for an ever- expanding catalog of newly
created problems.55,56 Uses of these medications, like many medications, go beyond those initially
indicated and their use becomes more questionable.
Newer atypical antipsychotic medications, for example, are finding even greater use for non-psychotic
conditions such as insomnia, and with children57, who are populations generally excluded from drug
trials. The incidence rates of injury and hepatotoxicity from psychotropic drugs are an area that
physicians need to be concerned and remain alert about when prescribing these drugs. The standard of
care requires baseline blood tests, which should be repeated to insure against liver and kidney damage.
However, few primary care physicians follow these requirements. Greater risk to patients from
psychotropic medications occurs when these types of medications are prescribed by medical
professionals who are not specifically trained in clinical psychopharmacology, and in the diagnosis and
treatmentof behavioral disorders.
An analysis of ADE studies, including fatalities, associated with psychotropic medications shows that
psychotropic medications need strict monitoring when prescribed alongside other drugs.58-60 These
studies show that opiates, cardiovascular and non-steroidal anti-inflammatory drugs (NSAID)
medications comprise the greatest share of serious ADEs. Clozaril, a drug used to treat schizophrenia
in a population of treatment resistant patients, registers about 10-15 fatalities for every 10,000 patient
years.58 This is why behavioral healthcare requires that patients be seen for follow-up care while on
psychotropic medications. Primary care physicians do not have the time or inclinationto provide this
The intention here is not to scare, but to warn of the potential harms that can result from the
inappropriate use of psychotropic medications. When ADEs do arise from the use of psychotropics,
they can be attributed to prescribing the drug for the wrong populations, errors in the prescriptions31
and to the inherent uniqueness in response of the patients receiving them. A few studies have provided
some insight into the classes of drugs most associated with ADEs in hospitalized and outpatient
Medical School Is Not The Most Effective Way To Reduce Prescribing Errors
Steel 61 argues that many ADEs are related to limited medical training in pharmacology and calls for
physicians to be licensed to prescribe medications only in their specialty. Wiggins & Cummings62
reported 1 million episodes of mental health care where psychologists with documented training in
psychopharmacology managed both the combined use of psychotherapy and psychotropic medications
without patients’ complaints of how psychologists dealt with their medications. Several studies of the
effectiveness of prescribing psychologists in the military show that they perform safely and with high
standards.63 These data suggest that the greatest danger to patients may not be a function of who
prescribes but the content and quality of training one gets to learn how to prescribe.64,48,39 Thus, the
available data does not support the broad assertion that medical school education can fully prepare
Physicians need to go beyond medical schools’ more limited training experiences in pharmacology by
focusing greater attention on preventable ADEs. Given what we know about many of the causes of
ADEs, specific training recommendations can easily be implemented to significantly reduce Type A
ADEs. One positive recommendation would be to provide training in drug-drug interactions between
drug classes. With more than 8,`000 medications now in general use, it is almost impossible to recall
specific drug-drug interactions between single medications. Since most medications in a class behave
similarly, this could reduce ADEs. For example, generally, non-steroidal medications (NSAIDS) can
have serious drug-drug interactions with anti-hypertensives. Knowing this can alert physicians to this
interaction and would require a more detailed look into specific drugs that are being considered in these
classes. Conversely, a more thorough understanding of the patient would reduce errors resulting from
polymorphisms and other significant pharmacodynamics.
We now have available very detailed, but easy to use, computerized pharmacology. These programs are
easy to update and take very little time to master. In cases in which multiple medications are being
used, performing a simultaneous drug-drug interaction search can take seconds. Pharmacology
programs should train in their use and require students to acquire and use this technology. Yet, many
physicians resist newer technology and still use written prescriptions which are difficult to read and
Many ADEs occur due to prescribers writing an incorrect dose of a medication. For example,
medications, such as Levoxyl, a thyroid hormone substitute, must be prescribed in microgram doses.
This drug is responsible for a significant number of ADEs with serious consequences simply because
the prescriber writes the dose as milligrams. Reducing this type of ADE can be accomplished simply
by providing training in dosing arithmetic similar to that required of nurses and physician assistants.
Along this line, ADEs related to writing errors, which bad handwriting is the cause, can be significantly
reduced by eliminating hand written prescriptions. Students who are trained from the beginning to
order prescriptions in type will tend to use this method when they gain authority to prescribe.
Clearly, prescribing medications requires skills that must start with early training. As in many
professions, there are those who may lack the skills needed to correctly and competently perform
tasks.65 Training that addresses ADEs is not prominent and included in the core subject matter of the
majority of medical schools.66 While this type of training may not guarantee the competence of any one
prescriber, without specific training in ADEs, we may invite only more ADEs and their consequences.
Medical psychologists are in the unique position of being a positive factor in reducing ADEs while at
the same time providing behavioral health services effectively and efficiently. General practitioners and
other non-psychiatric physicians are neither mental health specialists nor psychopharmacologists.
Commenting on a recent study on ADEs, Steel,61 in his article, advocates that non-physicians and
sophisticated computer systems need to be part of the prescribing process if ADEs are to effectively be
Concluding Statements
Collaboration between psychologists and physicians can result in more effective and safer treatment for
behavioral health patients by reducing ADEs. Their knowledge of ADEs, pharmacological training, and
the practice by psychologists to spend as much time with patients to develop working differential
diagnoses,allow them to promote higher-quality behavioral healthcare, while being a conduit to
physicians about their patients condition. With better treatment comes efficiency and a significant
reduction in overall health care costs.72-74 The Therapy in America Survey 71 reports that an estimated 59
million people received some form of mental health treatment in the two years reported on in the study.
However, an estimated 24 million people received no treatment, even though they reported having
symptoms severe enough to warrant a diagnosis and treatment.
Patients experiencing depression and seeing a general practitioner are often undiagnosed or
misdiagnosed. McGynn3 reports that only 53% of patients with depression receive an adequate
standard of care; their symptoms go untreated or they are given medications for something they may
not even need. Misdiagnosis, inappropriate medications, insufficient training in mental disorders, and
poor pharmacology skills can all increase the likelihood of ADEs. Suicide rates among people who are
not being seen by a mental health professional are several times greater than those patients receiving
treatment.75,76 Psychologists can fill a significant gap in behavioral healthcare by prescribing
psychotropic medications, when appropriately indicated, and providing related psychological services.
RISPERDAL CONSTA INTRAMUSCULAR INJECTION Risperidone Consumer Medicine Information (CMI) if the packaging is torn or shows signs of having What is in this leaflet to treat any other complaints unless your doctor This leaflet contains important information about RISPERDAL CONSTA. It does not contain all of the available information. It does not take the place of Before yo
Knowledge Engineering (CM3016) Coursework A Medical Diagnosis Expert System 1. Administrative Issues Lecturers/Examiners: Dr. K. Hui & Dr. N. WiratungaCoursework Part:This coursework examines the students’ ability to construct an expert system using the CLIPS expert system shell. 3. The Problem Domain The application problem is to build an expert system that performs medical di