Understanding adverse drug reactions in package leaflets – an exploratory survey among health care professionals

Table 2 Responses to questionnaire on standard format package leaflet (statins without placebo comparison)

Extract of questionnaire
CRESTOR® 10 mg film-coated tablets
Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):
• Headache
• Stomach pain
• Constipation
• Feeling sick
• Muscle pain
• Feeling weak
• Dizziness
Question 1: If 100 patients take this statin – in how many of them does the intake of this statin cause muscle pain?^a
Responses (No)	0	1	>1	>10	No response
Format multiple choice	0	1	>1	>10	No response
Group 4 (n = 124) Diabetes experts			75^b (60 %)
Group 5 (n = 39) Medical students	0	0	37 (95 %)	2 (5 %)	0
Group 6 (n = 87) Pharmacy group	2 (2 %)	9 (10 %)	57 (66 %)	19 (22 %)	0
Question 2: If 100 patients do not take this statin – in how many of them does muscle pain occur?^c
Responses (No)	0	1	>1	>10	No response
Format multiple choice	0	1	>1	>10	No response
Group 4 (n = 124) Diabetes experts	16 (13 %)	11 (9 %)	64 (51 %)	17 (14 %)	16 (13 %)
Group 5 (n = 39) Medical students	24 (62 %)	5 (13 %)	4 (10 %)	5 (13 %)	1 (2 %)
Group 6 (n = 87) Pharmacy group	18 (21 %)	8 (9 %)	35 (40 %)	25 (29 %)	1 (1 %)

^aSince the exact value cannot be known from the information provided, any value lower than given in the package leaflet including no response would be accepted. The frequency given in the package leaflet or higher would definitely be wrong
^bExact data lost due to technical problems, but the value was confirmed independently by two other lecturers
^cPossible answers: Since the exact value cannot be known from the information provided, any value except “none” and “more than 10” including no response would be accepted

ISSN: 1472-6963