Table 1.
Reasons for ADR underreporting based on Inman´s ‘seven deadly sins’ and others identified in other systematic reviews and included studies
| Reasons | Explanation | No. of studies | |
|---|---|---|---|
| Total [N (%)] | 50% with more qualitya [N (%)] | ||
| Professional activities | |||
| Ambitionb | To publish personal case series | 2 (3.1) | 1 (3.1) |
| Financial reimbursementb | Belief that there should be financial incentives or a reward for reporting | 14 (21.5) | 8 (25.0) |
| Legal aspectsb | Fear of possible involvement in a lawsuit | 19 (29.2) | 9 (28.1) |
| Knowledge and attitudes | |||
| Fearb |
Fear of harming the patient Fear of damaging relationships and negative impact on the company that produced or marketed the drug Fear of confidentiality issues |
7 (10.8) | 2 (6.3) |
| Complacencyb | Conviction that only well tolerated drugs are on the market and that serious ADRs are well documented when the drug is marketed | 30 (46.2) | 14 (43.8) |
| Ignoranceb |
Lack of knowledge to recognize the ADR and its importance Lack of knowledge about the requirements needed to report, where to report, how to describe the notification, and how the information is further used; belief that only serious or unexpected ADRs should be reported |
56 (86.2) | 29 (90.6) |
| Indifferenceb | Belief that one case could not contribute to medical knowledge | 18 (27.7) | 11 (34.4) |
| Diffidenceb |
Lack of confidence and fear of appearing ridiculous for making a report of ADRs merely based on a suspicion Only reports if it is sure that it was drug-related |
29 (44.6) | 13 (40.6) |
| Insecurityc | The belief that it is nearly impossible to be certain that a particular drug was responsible for causing a specific adverse reaction | 22 (33.8) | 11 (34.4) |
| Unavailability of the reporting formc |
Do not have access to the report form Reporting forms are not available when needed |
22 (33.8) | 8 (25.0) |
| Excuses | |||
| Lethargyb |
Procrastination and postponing the notification Lack of time or motivation, effort, or interest to report Need for an easier method The report will generate extra work Forgetfulness |
55 (84.6) | 26 (81.3) |
| Othersb | Lack of feedback on the report submitted (Feedback) | 6 (9.2) | 2 (6.3) |
| Stopped taking the medicine | 38 (58.5) | 21 (65.6) | |
| ADR resolved | |||
| Lack of clinical training | |||
| Lack of communication | |||
| Lack of enough information about the patient for making a report (Information) | 13 (20.0) | 5 (15.6) | |
| Not their responsibility for reporting (Obligation) | 12 (18.5) | 8 (25.0) | |
|
Lack of confidence in the regulatory authority Reporting of ADR affects patient confidentiality issues (Confidentiality) |
6 (9.2) | 4 (12.5) | |
ADRs adverse drug reactions
aDefined by the number of AXIS criteria met by each paper
bProposed by Inman
cDescribe in the literature