OBJECTIVE PSYCHOLOGICAL MEASUREMENT AND CLINICAL ASSESSMENT OF ANXIETY IN ADVERSE DRUG REACTIONS
Main Article Content
Keywords
adverse drug reaction, anxiety, idiopathic environmental intolerance, psychogenic reactions, trauma symptom checklist-40
Abstract
Background
A confounding factor in the diagnosis of adverse drug reactions (ADRs) is the psychological state of the patient. Patients with underlying anxiety and related disorders may present with psychogenic reactions, which involve physiologic responses originating from psychological, rather than organic factors.
Objective
To examine the contribution of anxiety and related disorders to adverse drug events.
Methods
Participants from an adverse drug reaction clinic completed the Trauma Symptom Checklist-40 (TSC-40), a 40-item questionnaire consisting of six subscales: anxiety, depression, dissociation, sexual abuse trauma index (SATI), sexual problems, and sleep disturbance. Physicians assessed the likelihood that adverse events were due to anxiety or drug(s) by providing an anxiety score (0 to 10) and an ADR score (0 to 10), respectively, for each participant.
Results
Patients clinically assessed as having “high anxiety” (anxiety score 7-10 and ADR score 0-3; n = 11) scored higher than patients clinically assessed as having a “true ADR” (anxiety score 0-3 and ADR score 7-10; n = 19) on the TSC-40 total (P = 0.006) as well as anxiety (P = 0.012), depression (P = 0.007), and SATI subscales (P = 0.016).
Conclusion
This study is the first to use a validated psychological measurement to indicate that a substantial percentage of reported adverse drug events may in fact be a manifestation of underlying anxiety and/or related disorders. We suggest that mechanisms of symptom generation may be analogous to those operative in idiopathic environmental intolerance.
References
2. Miller R. Drug surveillance utilizing epidemiologic methods. A report form the Boston Collaborative Drug Surveillance Program. Am J Hosp Pharm 1973;30:584-92.
3. Lakshmanan M, Hershey C, Breslau D. Hospital admissions caused by iatrogenic disease. Arch Intern Med 1986;146:1931-4.
4. Edwards I, Aronson J. Adverse drug reactions: definitions, diagnosis and management. Lancet 2000;356:1255-9.
5. Haber J, Knowles S, Knight A. Allergy to local anaesthetics. Allergy Asthma 2000;12:27-34.
6. Fiset L, Milgrom P, Weinstein P, Getz T, Glassman P. Psychophysiological responses to dental injections. J Am Dent Assoc 1985;111:578-83.
7. Staudenmayer H. Environmental illness: myth and reality. Boca Raton: Lewis Publishers; 1999.
8. American Academy of Allergy Asthma and Immunology. Idiopathic, enironmental intolerances (position statement). J Allergy Clin Immunol 1999;103:36-40.
9. Sparks P. Idiopathic environmental intolerances: overview. In: Sparks P, editor. Multiple Chemical Sensitivity/Idiopathic Environmental Intolerance. Philadelphia: Hanley & Belfus; 2000. p. 497-510.
10. Binkley K, King N, Poonai N, Seeman P, Ulpian C, Kennedy J. Idiopathic environmental intolerance: increased prevalence of panic disorder-associated cholecystokinin B receptor allele seven. J Allergy Clin Immunol 2001;107:887-90.
11. Giardino N, Lehrer P. Behavioral conditioning and idiopathic environmental intolerance. In: Sparks P, editor. Multiple Chemical Sensitivity/Idiopathic Environmental Intolerance. Philadelphia: Hanley & Belfus; 2000. p. 519-28.
12. Leznoff A, Binkley K. Idiopathic environmental intolerances: results of challenge studies. In: Sparks P, editor. Multiple Chemical Sensitivity/Idiopathic Environmental Intolerance. Philadelphia: Hanley & Belfus; 2000. p. 529-37.
13. Dalton P, Hummel T. Chemosensor function and response in idiopathic environmental intolerance. In: Sparks P, editor. Multiple Chemical Sensitivity/Idiopathic ENvironmental Intolerance. Philadelphia: Hanley & Belfus; 2000. p. 539-56.
14. Black D. The relationship of mental disorders and idiopathic environmental intolerance. In: Sparks P, editor. Multiple Chemical Sensitivity/Idiopathic environmental Intolerance. Philadelphia: Hanley & Belfus; 2000. p. 557-70.
15. Staudenmayer H. Psychological treatmnet of psychogenic idiopathic environmental intolerance. In: Sparks P, editor. Multiple Chemical Sensitivity/Idiopathic Environmental Intolerance. Philadelphia: Hanley & Belfus; 2000. p. 627-46.
16. Poonai N, Antony M, Binkley K, et al. Carbon dioxide inhalation challenges in idiopathic environmental intolerance. J Allergy Clin Immunol 2000;105:358-63.
17. Leznoff A. Provocative challenges in patients with multiple chemical sensitivity. J Allergy Clin Immunol 1997;99:438-42.
18. Binkley K, Kutcher S. Panic response to sodium lactate infusion in patients with multiple chemical sensitivity syndrome. J Allergy Clin Immunol 1997;99:570-4.
19. Staudenmayer H, Camazine M. Sensing type personality, projection and universal allergic reactivity. J Psychol Type 1989;18:59-62.
20. Black D, Rathe A, Goldstein R. Environmental illness: a controlled study of 26 subjects with "20th century disease". JAMA 1990;264:3166-70.
21. Rosenberg S, Freedman M, Schmaling K, Rose C. Personality styles of patients asserting environmental illness. J Occup Med 1990;32:678-81.
22. Selner J, Staudenmayer H. Neuropsychophysiologic observations in patients presenting with environmental illness. Toxicol In Health 1992;8:145-55.
23. Staudenmayer H, Selner M, Selner J. Adult sequelae of childhood abuse presenting as environmental illness. Ann Allergy 1993;711:538-46.
24. Briere J, Runtz M. The trauma symptom checklist (TSC-33): early data on a new scale. J Interpersonal Violence 1989;4:151-63.
25. Elliott D, Briere J. Sexual abuse trauma among professional women: validating the Trauma Symptom Checklist-40 (TSC-40). Child Abuse Negl 1992;16:391-8.
26. Gold S, Milan L, Mayall A, Johnson A. A crossvalidation study of the Trauma Symptom Checklist: the role of mediating variables. J Interpersonal Violence 1994;9:12-16.
27. Zlotnick C, Shear M, Begin A, Pearlstein T, SImpson E, Costello E. The validation of the Trauma Symtpom Checklist-40 (TSC-40) in a sample of inpatinets. Child Abuse Negl 1996;20:503-10.
28. Whiffen V, Benazon N, Bradshaw C. Discriminant validity of the TSC-40 in an outpatient setting. Child Abuse Negl 1997;21:107-15.
29. Gold J, Cardena E. Convergent validity of three posttraumatic symptoms inventories among adult sexual abuse survivors. J Trauma Stress 1998;11:173- 80.
30. Briere J. Psychometric review of the Trauma Symptom Checklist-40. In: Stamm B, editor. Measurement of stress, trauma, and adaptation. Lutherville: Sidran Press; 1996.
31. Naranjo C, U, Sellers E, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45.
32. Kreutzer R, Neutra R, Lashuay N. Prevalence of people reporting sensitivities to chemicals in a population-based survey. Am J Epidemiol 1999;150:1- 12.
33. Tran C, Knowles S, Liu B, NH. Gender differences in adverse drug reactions. J Clin Pharmacol 1998;38:1003-9.