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ANALYZING MEDICINES INFORMATION OF OVER-THE-COUNTER MEDICINES LEAFLETS IN SLOVENIA

Akademija MM, 2016-12, Vol.13 (26), p.9-22

ISSN: 1408-1652

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  • Title:
    ANALYZING MEDICINES INFORMATION OF OVER-THE-COUNTER MEDICINES LEAFLETS IN SLOVENIA
  • Author: Kasesnik, Karin ; Kline, Mihael ; Gammie, Todd ; Babar, Zaheer-Ud-Din
  • Subjects: Consumer advertising ; Infectious diseases ; Nonprescription drugs ; Prescription drugs ; Side effects
  • Is Part Of: Akademija MM, 2016-12, Vol.13 (26), p.9-22
  • Description: Appropriate information on over-thecounter (OTC) medicines is provided by pharmacies in the form of written medicines information and by pharmacist's advice. In Slovenia, prescription medicines and OTC medicines patient information leaflets (PILs) and summaries of product characteristics (SmPCs) are regulated by the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices. Promotional leaflets must include two obligatory sentences required by Slovene legislation. But we consider these legislative requirements on medicine information insufficient and establish a need for adequate balance of information regarding benefits and risks. Therefore benefit and risk claims within OTC medicine leaflets related to three therapeutic groups - infectious diseases, allergies, and osteoporosis treatment - were targeted. We aimed to determine their ratio, and one- or two-sidedness of the messages. Two-sided messages are considered to be more advantageous. Fair, balanced promotion and advertising and rational medicine use is suggested by the World Health Organization (WHO). The Food and Drug Administration requires a fair balance between information relating to side effects and contraindications, and information relating to effectiveness of the medicine, in terms of scope, depth, and detail. Risks and benefits should be properly presented within the medicine information. Medicine information should have a positive impact on the public health. 30 leaflets with OTC medicines were analyzed, 10 for each selected therapeutic group. The collected leaflets were obtained from the representative sample derived from Slovene pharmacies. At selecting a sample of leaflets we considered regional equivalency. Therapeutic groups for treatment of viral diseases, allergies, and osteoporosis were chosen. The texts were coded by two researchers. Besides determining frequencies, a t-test and a chisquared test were used as statistical methods. A majority of the analyzed leaflets seem to be twosided, with a smaller share of two-sided leaflets in the osteoporosis treatment group. However, generally there is an imbalance between the benefits and the risks observed. Only in one leaflet do risk claims exceed benefit claims in terms of scope, depth, and detail. There are 353 benefit claims and 79 risk claims in the OTC medicine leaflets related to infectious diseases and 77 benefit claims and 18 risk claims in the OTC medicine leaflets related to allergies. The messages are mainly two-sided, with benefit and risk claims included. There are 265 benefit claims and 22 risk claims in OTC medicine leaflets related to osteoporosis; six leaflets include two sided-messages. A fair-balance criterion is not confirmed. We concluded that benefit claims exceed risk claims in the analyzed leaflets not only in scope but also in depth and detail. Only one company is estimated to be socially responsible and to respect treatment safety. Two-sided messages do not always exist, thereby establishing a need for educating manufacturers and patients. The companies' strategies include a larger share of two-sided messages. An association between a preventive OTC treatment and a prevalence of benefits is shown in our research study. Stricter legislation regarding the scope, depth, and detail of both the benefits and risks contained in medicine information packs and leaflets is needed. Also educating the leaflets' creators and patients should take place.
  • Publisher: Ljubljana: Drustvo za Marketing Slovenije - DMS
  • Language: Slovenian
  • Identifier: ISSN: 1408-1652
  • Source: ProQuest Central
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