Table 2.
Frequency of Safety Information Provision in the Four Sites
| Van/Mon N = 841 | Sac N = 445 | Toul N = 406 | Total N = 1692 | Toul vs. Van/Mon Adjusted OR (95 % CI) | Toul vs. Sac Adjusted OR (95 % CI) | Sac vs. Van/Mon Adjusted OR (95 % CI) | |
|---|---|---|---|---|---|---|---|
| Minimally adequate safety information* | 12 (1.4 %) | 4 (0.9 %) | 12 (3.0 %) | 28 (1.7 %) | 2.9 (1.0–8.8) NS | 7.3 (1.2–44) p = 0.03 | 0.2 (0.04–1.3) NS |
| Any harm information† | 282 (34 %) | 173 (39 %) | 246 (61 %) | 701 (41 %) | 4.0 (2.8–5.6) p < 0.001 | 2.4 (1.7–3.6) p < 0.001 | 1.4 (1.0–2.0) p = 0.04 |
| Written prescribing information | 391 (46 %) | 207 (47 %) | 293 (72 %) | 891 (53 %) | 2.7 (1.9–3.9) p < 0.001 | 3.7 (2.4–5.6) p < 0.001 | 1.1 (0.8–1.5) NS |
| No oral or written harm information | 334 (40 %) | 162 (36 %) | 43 (11 %) | 539 (32 %) | 0.15 (0.1–0.2) p < 0.001 | 0.20 (0.1–0.3) p < 0.001 | 0.8 (0.6–1.8) NS |
| Specific safety information | |||||||
| Serious adverse events§ | 45/830 (5 %) | 26/439 (6 %) | 22/383 (6 %) | 93/1652 (6 %) | 1.1 (0.5–2.3) NS | 0.8 (0.3–1.8) NS | 1.1 (0.5–2.2) NS |
| Contraindications§ | 117/831 (14 %) | 69/404 (17 %) | 155/391 (40 %) | 341/1626 (21 %) | 4.6 (3.0–7.1) p < 0.001 | 4.0 (2.4–6.7) p < 0.001 | 1.1 (0.7–1.8) NS |
| Non-serious adverse events | 185 (22 %) | 113 (25 %) | 146 (36 %) | 444 (26 %) | 2.2 (1.5–3.3) p < 0.001 | 1.2 (0.8–1.8) NS | 1.6 (1.1–2.3) p < 0.001 |
| Potential to compromise safety | |||||||
| Unapproved indications | 109 (13 %) | 44 (10 %) | 65 (16 %) | 218 (13 %) | 1.3 (0.9–2.1) NS | 2.0 (1.1–3.5) p = 0.02 | 0.8 (0.5–1.3) NS |
| Unqualified safety claims | 60 (7 %) | 21 (5 %) | 59 (15 %) | 140 (8 %) | 2.5 (1.4–4.2) p = 0.001 | 3.5 (1.7–7.1) p < 0.001 | 0.6 (0.3–1.3) NS |
All odds ratios are adjusted for physician sex, # years in practice, remuneration, practice size, frequency of PSR visits, industry funding, medical faculty affiliation, sales visit duration, one-to-one or group, if drug was previously prescribed, and drug safety warnings. Results not adjusted for multiple comparisons
Van/Mon combined results of Vancouver and Montreal sites; Sac Sacramento; Toul Toulouse
*Minimally adequate safety information is defined as: at least one approved indication AND at least one non serious adverse event AND at least one serious adverse event (among drugs with SAE) AND at least one contraindication (among drugs with contraindications) AND no unqualified safety claims or unapproved indications
†Any harm information is defined as at least one mention of either a serious adverse event, a non-serious adverse event or a contraindication
‡Defined as promotions without a single mention of harm reported and with no written prescribing information (approved product information or alternative)
§Denominators are promotions of drugs with at least one serious adverse event in labeling (for serious adverse events) or at least one contraindication in labeling (for contraindications)