Compliance Towards Dispensed Medication Labelling Standards: A Cross-Sectional Study in the State of Penang, Malaysia

Abstract

Good medicine labelling practice is vital to ensure safe use of medicines. Non-compliance to labelling standards is a potential source of medication errors. This study was intended to evaluate and compare compliance towards labelling standard for dispensed medications between community pharmacists and general practitioners in Penang, Malaysia. A total of 128 community pharmacies and 26 general practitioners' clinics were visited. Using 'Simulated Client Method' (SCM), data were collected on the medications dispensed upon presentation of hypothetical common cold symptoms. The medications dispensed were evaluated for labelling adequacy. Result revealed that majority of the dispensed medications obtained were not labelled according to regulatory requirements. However, general practitioners complied better than community pharmacists in terms of labelling for: name of patient (p<0.001), details of supplier (p<0.001), dosage of medication (p=0.023), frequency to take medication (p=0.023), patient's reference number (p<0.001), date of supply (p<0.001), special instructions for medication (p=0.008), storage requirements (p=0.002), and indication for medication (p<0.001). Conversely, community pharmacists labelled dispensed medications with the words "Controlled Medicine" more often than did general practitioners (p<0.001). Although laws for labelling dispensed medicines are in place, most community pharmacists and general practitioners did not comply accordingly, thereby putting patients' safety at risks of medication errors.

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“…This will protect practitioners from making fatal mistakes and medication errors [7]. According to regulations 12 (1) and 12 (2) of the Malaysian Poisons Law, the container of any dispensed medicines shall be clearly labeled by writing the name and address of the supplier, patient's or customer's name, date of dispensing and writing the word "Controlled Medicine".…”

“…The survey finding also showed that GPs adhered to labeling standards better than CPs, reflecting a serious need for a vital reform in labeling practices to comply with the health requirements of patients and consumers. The study also paved the way for a more comprehensive study in this essential field [7].…”

“…All details were documented on an observation form developed by the first author from literature [3,7,8]. This form was developed before the pilot case study and amended later after the case study by deleting some items from the counseling standard sections given that it was too long.…”

“…This method showed a useful and adaptable evaluating style with a coherent costeffectiveness [17]. Using simulated patients and common cold symptoms, the findings from a similar pilot survey conducted in Penang by Neoh et al 2009, to study labeling standards revealed that CPs and GPs provided deficient and confusing information of the dispensed medication labels and did not comply with the current regulatory legislations [Table/ Fig-1]. The survey finding also showed that GPs adhered to labeling standards better than CPs, reflecting a serious need for a vital reform in labeling practices to comply with the health requirements of patients and consumers.…”

“…Doctors and pharmacists may assume that their patient can read, understand or act on short directions found in the label of medicines, but this possibly will not be true [6]. Good labeling is very important to guarantee safe use of medicines and inappropriate labeling of medicines will lead to medication errors [7]. The third practice is the responsibility of patient assessment www.jcdr.net Alamin Hassan M. A. Alabid et al, Medicine Labeling, Patient's Counseling and Symptomatic Diagnosis medicines besides the rationale for doctors to increase income [14].…”