title: Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance.
abstract: OBJECTIVE
  Using a patient targeted survey, we sought to assess patient representations of how physicians responded when patients presented with possible adverse drug reactions (ADRs). As a demonstration case, we took one widely prescribed drug class, the HMG-CoA reductase inhibitors ('statins'). This information was used to assess whether a patient-targeted ADR surveillance approach may complement provider reporting, potentially fostering identification of additional patients with possible or probable ADRs.
  
  
  METHODS
  A total of 650 adult patients taking statins with self-reported ADRs completed a survey. Depending on the problems reported, some patients completed additional surveys specific to the most commonly cited statin ADRs: muscle, cognitive or neuropathy related. Patients were asked to report drug, dose, ADR character, time course of onset with drug, recovery with discontinuation, recurrence with rechallenge, quality-of-life impact, and interactions with their physician in relation to the perceived ADR. This paper focuses on patients' representation of the doctor-patient interaction and physicians' attribution, when patients report perceived ADRs.
  
  
  RESULTS
  Eighty-seven percent of patients reportedly spoke to their physician about the possible connection between statin use and their symptom. Patients reported that they and not the doctor most commonly initiated the discussion regarding the possible connection of drug to symptom (98% vs 2% cognition survey, 96% vs 4% neuropathy survey, 86% vs 14% muscle survey; p < 10(-8) for each). Physicians were reportedly more likely to deny than affirm the possibility of a connection. Rejection of a possible connection was reported to occur even for symptoms with strong literature support for a drug connection, and even in patients for whom the symptom met presumptive literature-based criteria for probable or definite drug-adverse effect causality. Assuming that physicians would not likely report ADRs in these instances, these patient-submitted ADR reports suggest that targeting patients may boost the yield of ADR reporting systems.
  
  
  CONCLUSIONS
  Since low reporting rates are considered to contribute to delays in identification of ADRs, findings from this study suggest that additional putative cases may be identified by targeting patients as reporters, potentially speeding recognition of ADRs.
authors: Department of Medicine, University of California San Diego, La Jolla, CA 92093-0995, USA. bgolomb@ucsd.edu
authors: Beatrice A
authors: BA
authors: Golomb
authors: John J
authors: JJ
authors: McGraw
authors: Marcella A
authors: MA
authors: Evans
authors: Joel E
authors: JE
authors: Dimsdale
mesh_terms: D003625:Data Collection; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010361:Patients; D010819:Physician's Role; D010817:Physician-Patient Relations; D010820:Physicians; D011358:Product Surveillance, Postmarketing
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
references: Am J Med. 2004 Dec 1;117(11):823-9
references: 15589485
references: Am Fam Physician. 1997 Nov 1;56(7):1718, 1721
references: 9371003
references: Pharmacoepidemiol Drug Saf. 1998 Mar;7(2):79-90
references: 15073731
references: Postgrad Med. 1998 Mar;103(3):13-6
references: 9519028
references: Med J Aust. 1999 Mar 15;170(6):270-3
references: 10212650
references: JAMA. 2002 May 1;287(17):2215-20
references: 11980521
references: Ann Pharmacother. 2003 Feb;37(2):274-8
references: 12549960
references: Pharmacoepidemiol Drug Saf. 2001 Dec;10(7):663-7
references: 11980258
references: JAMA. 2004 Dec 1;292(21):2622-31
references: 15572720
references: Neurology. 2002 May 14;58(9):1333-7
references: 12011277
references: Am J Med. 2000 May;108(7):538-46
references: 10806282
references: Eur J Clin Pharmacol. 2001 Apr;57(1):89-91
references: 11372600
references: JAMA. 1984 Aug 24-31;252(8):1030-3
references: 6748207
references: Postgrad Med. 1997 Apr;101(4):13-6
references: 9126202
references: Drug Saf. 2003;26(4):211-7
references: 12608885
references: J Neurol Neurosurg Psychiatry. 1995 May;58(5):625-8
references: 7745415
references: Clin Pharmacol Ther. 1981 Aug;30(2):239-45
references: 7249508
references: N Z Med J. 1991 Nov 27;104(924):493-5
references: 1745460
references: N Engl J Med. 2004 Sep 30;351(14):1385-7
references: 15459298
references: QJM. 2004 Apr;97(4):229-35
references: 15028853
references: J Clin Pharm Ther. 2001 Aug;26(4):303-10
references: 11493374
references: Arch Intern Med. 2005 Jan 24;165(2):158-60
references: 15668360
references: Pharmacotherapy. 2003 Jul;23(7):871-80
references: 12885101
references: Ann Intern Med. 2002 Oct 1;137(7):581-5
references: 12353945
references: JAMA. 2004 Dec 1;292(21):2647-50
references: 15572723
references: Clin Ther. 1998;20 Suppl C:C40-4
references: 9915089