Adverse Drug Reactions: Implications for Providers of Health Care Marie J. Bourgeoid, RN, PhD Hyattsville, Maryland

Adverse drug reactions are defined and examples are given. Four areas of concern are addressed, namely, defining drug reactions, identifying some of the factors contributing to the adverse drug reactions, implications of adverse drug reactions for health-care providers, and preventive measures which impact on the occurrence of adverse drug reactions. It is implied that increased knowledge and research are important factors in the control of these problems.

Adverse drug reactions or drug-

induced illness is a formidable health problem. Two major consequences are involved: the patient's welfare and the overwhelming cost resulting from hospitalization. Tile use of drugs, which represents one-tenth of the nation's enormous health care expenditures, is one of the most important and certainly the most widely practiced form of therapy. To quote from Silverman's book Pills, Profits, and Politics:

Requests for reprints should be addressed to Dr. Marie J. Bourgeois, Research Training Section, Nursing Research Branch, Division of Nursing, Department of Health, Education, and Welfare, Hyattsville, MD 20782.

"Each year, roughly one half of all patients visiting a physician's office receive a prescription. On the average, each hospitalized patient gets eight prescriptions during his hospital stay. Even though drug expenditures are now many billions of dollars a year, the use of drugs is one of the least expensive types of treatment. When used rationally, drugs can minimize far more costly alternatives-needless (and sometimes dangerous) surgery, needless hospitalization, and needless office visits. It is all too evident that the use or misuse of drugs can injure or kill, but it is equally apparent that the harm caused by drugs is far outweighed by their benefits."'

In the current literature, considerable attention has focused on the problem of adverse drug reactions. In particular, complex key problems related to adverse drug reactions have been reported. For example, hazards of hospitalization; errors in the administration of medications; monitoring, assessing, and reporting such reactions; problems with multiple drugs; the role of

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hospital personnel as to adverse drug reactions; medication errors by the patient in the home; admissions to hospitals due to bad reactions; and drug and diet interactions. Four areas which will be addressed in this article are (1) defining of adverse drug reactions, (2) identification of some of the factors contributing to these reactions, (3) implications of this health problem for health providers, and (4) some preventive measures that may impact on the occurrences of such reactions.

Defining Adverse Drug Reactions Adverse (as defined in Webster's Collegiate Dictionary) applies to that which is unfavorable, harmful, or detrimental. An adverse drug reaction is a reaction to a drug which causes unfavorable or 725

harmful effects. Usually the individual becomes ill, the illness being an undesirable consequence of taking the drug. Melmon's definition of drug reaction states, "a drug reaction includes all unwanted consequences of drug administration, including administration of the wrong drug (or drugs) to the wrong patient in the wrong dosage (form, amount, route, or interval) at the wrong time and for the wrong disease. Any single wrong may result in unwanted consequences and may therefore cause a reaction."2 Melmon indicates that classic drug reactions include symptoms related to the subject's immunologic response to standard doses of drugs (hypersensitivity reactions), his response to usual or less than usual doses (idiosyncrasy or hyperreactivity), or his predictable responses to an overdose of the drug or a drug combination.2 In addition to reactions per se, Melmon gives examples of adverse consequences of drug administration. He states, "for example, prescription of drugs for symptoms only may delay diagnosis of a disease, possibly preventing appropriate therapy for a serious but curable disorder. In addition, the inappropriate drug may, because of toxicity, cause a disorder to which a patient would otherwise not be subject: ulceration of the bowel may develop from potassium chloride; intramural intestinal hemorrhage from anticoagulants; retinal disorders from phenothiazines; cardiac failure from propranolol; changes in carbohydrate tolerance from diuretics; liver damage from many drugs; renal tubular acidosis from antibiotics; neuropathies from anticancer agents; and aseptic necrosis of bone from corticosteroids."2

Factors Contributing to the Occurrence of Adverse Drug Reactions American culture, oriented as it is to a time frame of speed and haste, has placed great value on the efficacy of pills to serve as instant cure-alls. Pills are valued as quick and easy problem solvers. For example, many individuals believe that ingesting pills ensures quick weight loss; that pills pep them up rapidly; that pills can make you feel 726

calm and tranquil quickly; and that pills ease aches and pains instantly. In addition, Americans have quick access to drugs. Melmon believes the availability of drugs without prescription and the availability of illicit preparations contribute to adverse drug reactions.2 Increased use of drugs may well result in an increased number of adverse drug reactions. Seidel reports that from 18 to 20 percent of all hospitalized patients double their hospital stay due to drug reactions.3 Further, he indicates that from three to five percent of patients admitted to hospitals are admitted primarily for drug reaction.3 The Task Force on Prescription Drugs reports that one-seventh of all hospital days is devoted to the care of drug toxicity at an estimated yearly cost of $3 billion.4 Among the many forms of medical therapy, the most widely applied is probably drug therapy. In 45 percent of all office visits, the physician prescribes or recommends the use of one or more products. For hospital inpatients, it appears that an average of one prescription is written for each day of hospitalization-or about eight prescriptions for a typical hospital stay.5 The use of prescription drugs has continued to climb year after year. For out-of-hospital drugs dispensed by community pharmacies alone, the number of prescriptions rose from approximately 363 million in 1950 to 634 million in 1960 and 1.2 billion in 1970. At the retail level, these products represented expenditures of about $736 million in 1950, $2 billion in 1960, and $4.8 billion in 1970.5 Although, according to the most recent National Prescription Audit, the number of prescriptions dispensed annually by retail pharmacies dropped from 1,505 million in 1974 to 1,490 million in 1975 and 1,461 million in 1976, the decrease was attributed to such factors as a drop in the number of prescription refills, the increased number of dosage units per prescription, the increased number of prescriptions filled by hospital pharmacies for outpatients, and the impact of the recession. The average prescription price rose from about $4.65 in 1974 to $5.20 in 1975 and $5.60 in 1976.6 The increase in adverse drug reactions is related also to an increase in total population, the increase in the proportion of women and of the elderly

in the population, the increase in the number of patient-physician visits each year, and the development of important new drug categories.

Implications of Adverse Drug Reactions for Health Providers Nurses, physicians, and pharmacists have important roles in the preventive aspects of adverse drug reactions in five major areas which are not mutually exclusive. These are planned observation, communication, documentation and reporting, patient education, and increased knowledge.

Planned Observation Well-laid plans for observation of drug effect should be made before its administration. The nurse should be made aware of the therapeutic effects the physician believes the drug will accomplish. Whenever the medication fails to produce the expected results, alteration in its absorption, metabolism, or elimination should be considered and appropriate steps taken.2'7 Nurses and physicians must be sensitive to and more suspicious of new symptoms or laboratory data which do not fit into the anticipated course of the disease.2 Further, the nurse and the physician must be more "tuned in" to the patient's complaints about the medication and his/her reaction to it.

Communication Excellent communication must exist between the physician and the nurse since the nurse has an important function in the administration of medications: observation of the patient before and after the administration of medications; recording on the patient's record of the medications given; noting observations, complaints, and symptoms reported by the patient. The patient in the hospital setting is usually under the continuous observation and care of the nurse. Hence, it is the nurse who is often the first to recognlize symptoms of drug reactions and

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who may observe new symptoms which are related to adverse reactions. Consequently, the nurse and the physician must confer frequently concerning all aspects of drug administration. Any questions the nurse may have about the patient's medication, especially when multiple drugs are being administered, should be discussed thoroughly with the physician and may include the pharmacist. In addition, informed communication is required between the physician and nurse when the patient is receiving drugs which have the same action and drugs which are antagonistic to one another. The physician and nurse should confer whenever there is a change in the dosage-for instance, an increase or decrease in the dosage. Further, the nurse is obligated to keep the physician informed of the patient's compliance with taking the medication as scheduled. Members of the health team, in addition to promoting informed communication, should be continuously suspicious of any symptoms the patient presents, particularly new symptoms. The pharmacist may be responsible for the maintenance and use of adequate patient drug profiles showing all drugs sold to the patient and members of the patient's family and any known allergies and incidents of drug reactions. He may also alert the physician that the prescription calls for a drug to which the patient is believed to be allergic, whether the patient is taking other drugs which may cause a drug reaction, or if the patient is stockpiling for suicide.

Patient Education In carrying out health teaching, the nurse should encourage the patient to report all symptoms. The nurse may obtain information that the patient has not shared with the physician about nonprescription and over-the-counter drugs he/she is taking. In some instances, it may be "root" medicinemedicine made from tree barks, roots, and leaves.8 The physician, nurse, and pharmacist may participate in teaching the patient about the hazards involved in the use of alcoholic beverages when driving, occupational hazards when certain drugs are administered, and the hazards of mixing drugs without a physician's advice. It is most important for the patient to understand that no drug is too insignificant to report to the physician when he questions what medicines a patient is taking.

Increased Knowledge Nurses and physicians with comprehensive knowledge of pharmacology, pharmacokinetics, and chemistry of the drugs prescribed will provide some assurance in the prevention of adverse reactions. In addition, it is important for physicians and nurses to increase their knowledge of physiologic factors in health and disease that predispose individuals to drug reactions and adverse drug reactions.

be established and maintained to ensure the benefits of quick retrieval of information about adverse drug reactions. Rigorous research on the frequency and causes of adverse drug reactions should be conducted, taking into consideration age, race, sex, cultural and social factors, and health and illness beliefs and practices of the patient. Finally, rational prescribingthe use of the right drug for the right patient at the right time and in the right amounts-may ensure the prevention of adverse drug reactions.

Conclusion It is clearly evident that a successful program of prevention of adverse drug reactions is highly dependent upon cooperation among members of the health team; their strong commitment to quality health care and to the patient; their dedication to excellence in the practice of their respective professions; and a full realization of the importance of generating, through research, new theories and scientific information about adverse drug reactions.

Literature Cited

Preventive Measures Documentation and Reporting Physicians and nurses should document new symptoms on the patient's record, especially all symptoms recognized as an adverse drug reaction. The nurse must bring to the doctor's attention the patient's complaints about the medications he/she is receiving and any

significant observations she has made about the patient, and record them on the patient's record. Reporting and documenting, in writing, adverse drug reactions is a major and important responsibility of the members of the health team and provides a data base of information that may be used to study patterns of such problems.

Prevention of adverse drug reactions requires immediate research and strengthening of the abilities of health care providers. It is important to recognize drug reactions which are not clear-cut cause and effect events; for instance, certain drugs may have longterm effects which will not manifest themselves until a generation later. The administration of drugs in the hospital must be done under quality supervision and high-level management in order to prevent errors. Excellent communication must be established and maintained among the patient, physician, nurse, and pharmacist. Effective monitoring systems of patients and sophisticated reporting systems must

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1. Silverman M, Lee PR: Pills, Profits, and Politics. Berkeley, California, University of California Press, 1974, p 258-281 2. Melmon KL: Preventable drug reactions--Causes and cures. N EngI J Med 284:1361-1362, 1971 3. Seidel LG, Thornton GT, Smith JW, et al: Studies on the epidemiology of adverse drug reactions: III: Reactions in patients on a general medical service. Bull Johns Hopkins Hosp 119:299-315, 1966 4. US Department of Health, Education, and Welfare, Office of the Secretary, Task Force on Prescription Drugs: The Drug Users, Final Report. Washington, DC, US Government Printing Office, 1969 5. US Department of Health, Education, and Welfare, National Center for Health Services Research Report Series: Drug Coverage Under National Health Insurance: The Policy Options. DHEW Publication No. (HRA) 77-3189. Washington, DC, US Government Printing Office, 1977, p 5 6. Pharmacy Times, April 1977 7. US Department of Health, Education, and Welfare: Larkin T: Mixing Medicines? Have a care! FDA Consumer, March 1976, DHEW

publication No. (FDA) 76-3020, Washington, DC, US Government Printing Office 8. Williams RA: Textbook of Black Related Diseases. New York, McGraw-Hill, 1975

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Adverse drug reaction: implications for providers of health care.

Adverse Drug Reactions: Implications for Providers of Health Care Marie J. Bourgeoid, RN, PhD Hyattsville, Maryland Adverse drug reactions are define...
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