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Drug Utilization

Safety and usage pattern of an over-the-counter ambroxol cough syrup: a community pharmacy-based cohort study

M. Schulz, A. Hämmerlein, U. Hinkel, G. Weis and A. Gillissen

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Volume 44 p. 409 - 421

Abstract

M. Schulz¹,², A. Hämmerlein¹, U. Hinkel³, G. Weis³ and A. Gillissen⁴

¹Center for Drug Information and Pharmacy Practice, ABDA – Federal Union of German Associations of Pharmacists, Berlin, ²Institute of Pharmacology, Johann Wolfgang Goethe University, Biocenter N²⁶⁰, Frankfurt, ³Medical Science Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, and ⁴St. George Medical Center, Robert Koch Hospital, Leipzig, Germany
Introduction: Mucoactive substances such as ambroxol, available in several countries as over-the-counter (OTC) medicines, are used for the treatment of acute and chronic bronchitis. Objective: This study was designed to evaluate the “real life” behavior of consumers with non-prescription access to an ambroxol cough syrup with special focus on tolerability and the pattern of product usage. Methods: Customers who bought the ambroxol syrup were recruited in 300 community pharmacies in Germany. Baseline data were collected from the participants in the pharmacy. Completing a self-administered questionnaire, participants provided information on tolerability, self-perceived effectiveness and usage pattern. Results: 2,707 participants were recruited in 266 pharmacies. 2,664 questionnaires were evaluable. At baseline, the respondents reported a complex pattern of symptoms. Productive cough, congested airways, dry cough, cough irritation in the throat and soreness in the throat were the most common ones. 67 patients (2.5%) reported a total of 81 adverse events (AE) which were usually mild in nature and mostly affecting the gastrointestinal tract (n = 53) followed by skin and subcutaneous tissue disorders (n = 9). No serious or unknown AE were reported. In general, 97% of the participants assessed the safety as “very good” (51%) or “good” (46%). Overall, the respondents complied with the indications for use and the recommended dosages, with only 0.7% of the participants using the maximum daily dose. 92% of the patients assessed the self-perceived effectiveness as “very good” (29%) or “good” (63%) and 89% were willing to purchase this ambroxol cough syrup again. Conclusions: This study confirms that ambroxol is used according to the advice given in the patients’ leaflet and supports the already established safety and efficacy of this product in acute bronchitis. It also demonstrates that the use of an OTC cough medication can be successfully monitored in a pharmacy-based cohort study.Correspondence to:
Prof. M. Schulz
Center for Drug Information and Pharmacy Practice (ZAPP), ABDA
Jägerstraße 49/50
10117 Berlin, Germany
Email: [email protected]

Drug Utilization

OTC laxative use of sodium picosulfate – results of a pharmacy-based patient survey (cohort study)

U. Hinkel, C. Schuijt and J.F. Erckenbrecht

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42.00 $

Volume 46 p. 89 - 95

Abstract

U. Hinkel, C. Schuijt and J.F. Erckenbrecht

¹Boehringer Ingelheim GmbH, Ingelheim and ²Florence Nightingale Hospital, Düsseldorf-Kaiserswerth, Germany
Objectives: Constipation is one of the most frequent gastrointestinal symptoms. Traditionally, drug therapy for constipation is not prescribed and controlled by physicians. Instead, laxatives are sold by pharmacists as over-the-counter (OTC) medication. The aim of this study was to explore the safety and usage pattern of the OTC laxative sodium picosulfate use by collecting data from patients at their pharmacies. The study describes how self-treatment of constipation is practiced. In addition, the characteristics of patients buying the contact laxative, sodium picosulfate, for self-treatment of constipation were analyzed. Methods: The survey was a pharmacy-based observational study (PHOBS) in community pharmacies in Germany. Participating pharmacists asked customers requesting a specific contact laxative to participate in the study. Customers gave verbal informed consent to study participation before receiving a structured questionnaire to be completed at home and then returned to the pharmacy. Results: Data from 1,845 patients recruited by 243 pharmacies were collected. Compliance with the recommended dosage of 5 – 10 mg/day was 96%, compliance with the indication of constipation was 99%. More than 90% rated the efficacy as “very good” to “good”. There was no weakening of the efficacy rating with increasing duration of use. 8% of patients reported mild-to-moderate adverse events. Nearly 60% of respondents reported to be satisfied with less than 1 bowel movement per day. Therefore, users appear to have a rational way of using OTC laxatives. Conclusions: Self-medication of constipation with sodium picosulfate is efficacious and considered to be safe.Correspondence to:
U. Hinkel, RPh, Medicine CHC, Boehringer Ingelheim GmbH, Bingerstraße, 55216 Ingelheim, Germany
Email: [email protected]

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