Development and Validation of a Questionnaire to Evaluate the Knowledge on Registered Medicinal Products Among Healthcare Personnel in Perlis

Abstract

Introduction: 

In Malaysia, all medicinal products must be registered with the Ministry of Health (MOH). However, unregistered products continue to circulate, posing a risk to public health. Healthcare personnel play a vital role in ensuring only registered medicinal products are used in clinical practice. This study aimed to develop and validate a questionnaire to assess the knowledge of registered medicinal products among healthcare personnel in Perlis.

Methods: 

The study employed a four-phase process: (1) item generation through literature review and expert consultation; (2) content validity assessment by six experts; (3) pilot testing by healthcare personnel; and (4) construct validity and reliability testing.

Results: 

An initial 30-item knowledge questionnaire was developed in English and Malay. Language accuracy was reviewed by two local experts. Content validation led to the removal of two items, while the pilot study incorporating face validation retained the remaining 28 items. One item was excluded prior to factor analysis. Exploratory factor analysis removed 15 items and identified five domains: Product Registration in Malaysia, Registration Numbers & Requirements for Product Registration, Hologram Security Label, Current Requirements for SIRIM and Halal Labels, and Product Registration Categories. The final validated questionnaire consisted of 12 items.

Conclusion:

The 12-item questionnaire demonstrated a validated structure for future research and initiatives aimed at enhancing healthcare personnel’s knowledge on registered medicinal products in Malaysia. However, domains 2 (Registration Number and Requirements for Product Registration), 3 (Hologram Security Label), and 5 (Product Registration Categories) showed inadequate internal consistency, indicating the potential for further refinement.