PHP31 - What's New in the Guidelines for Submission of Dossier for Listing into the Ministry of Health Medicines Formulary (Mohmf) ?

Abstract

Based on a previous study of formulary listing process conducted in 2012-2013, several gaps were identified in the MOHMF submission process. These include insufficient coordination and poor communication, inadequate guidance and standard procedures, lack of resources, lack of transparency, possible influences of pharmaceutical companies, unpredictable process duration and delays, unbalance mix of the committee’s membership and unstandardized management of the local/hospital formularies. As a result, a new submission guideline was introduced in January 2016 to overcome these gaps. The aim of this study is to review changes made to the submission guideline and to determine if the gaps identified have been successfully addressed. Document reviews of the previous edition of the submission guideline (2012) and the new submission guideline (2016) were conducted. The differences in terms of proposer eligibility, medicines listing criteria, submission document and workflow were compared and assessed to determine if the gaps have been addressed. The new submission guideline allows direct submission of dossiers by pharmaceutical companies to the MOHMF Secretariat as opposed to submission by MOH personnel only (specialists) previously. This could improve the coordination and communication with pharmaceutical companies, enhance transparency and overcome delays in processing of submissions. The possible influences of pharmaceutical companies on clinicians could also be minimised. The new submission guidelines was found to provide more detailed guidance in preparing submission documents. The timeline of each process (submission and resubmission) and criteria for listing were clearly specified. Pre-submission consultation with the MOHMF Secretariat is allowed to discuss submission related issues. Procedure for listing drugs into the local/hospital formulary was also introduced in new submission guidelines to standardize the management of local/hospital formularies. The new submission guideline was more refined and detailed. Most of the gaps identified in the previous submission guidelines were addressed in the new submission guidelines.