[Presence of excipients in pharmaceutical products in 3 sources of therapeutic information].

OBJECTIVE

To evaluate the level of agreement between information compiled from the Vademecum, the Pharmaceutical Catalogue and instruction leaflets on the four excipients most commonly used to prepare pharmaceutical products (saccharin, saccharose, lactose and ethanol).

DESIGN

Descriptive study.

SETTING

Primary care.

PATIENTS AND OTHER PARTICIPANTS

658 orally administered preparations of pharmaceutical products were chosen. Their composition formulas in the Vademecum, Pharmaceutical Catalogue and instruction leaflets were compared with a theoretical model constructed as the most reliable source of information on excipients.

RESULTS

Saccharin and saccharose were the most frequently described and quantified excipients, and lactose the least. Saccharin was quantified in 97.3% of cases in which it was used as an excipient, saccharose in 95%, ethanol in 91.4% and lactose in 17.5%. Saccharin is also the excipient which coincided most in the three sources examined, followed by saccharose, lactose and ethanol. The Vademecum did not state the presence of saccharose in 62% of preparations and of lactose in 39.7%. Instruction leaflets were the source with the lowest rate of failing to state the excipients.

CONCLUSIONS

Saccharose and lactose are excipients frequently omitted from the composition of orally taken pharmaceutical products in the Vademecum. Instruction leaflets provide the most reliable source out of the three analysed. The need to make available for doctors simple texts, contributing more reliable and up-to-date information, is underlined.