METHODS: In this economic evaluation study, 22 primary healthcare centers were randomly selected in Malaysia between December 2019 and July 2020. The baseline immunization schedule includes switching from Pentaxim® (four doses) and hepatitis B (three doses) to Hexaxim® (four doses), whereas the alternative scheme includes switching from Pentaxim® (four doses) and hepatitis B (three doses) to Hexaxim® (four doses) and hepatitis B (one dose) administered at birth. Direct medical costs were extracted using a costing questionnaire and an observational time and motion chart. Direct non-medical (cost for transportation) and indirect costs (loss of productivity) were derived from parents'/caregivers' questionnaire. Also, HCPs' and parent's/caregivers' perceptions were investigated using structured questionnaires.
RESULTS: The cost per dose of Pentaxim® plus hepatitis B vs. Hexaxim® for the baseline scheme was Malaysian ringgit (RM) 31.90 (7.7 United States dollar [USD]) vs. 17.10 (4.1 USD) for direct medical cost, RM 54.40 (13.1 USD) vs. RM 27.20 (6.6 USD) for direct non-medical cost, RM 221.33 (53.3 USD) vs. RM 110.66 (26.7 USD) for indirect cost, and RM 307.63 (74.2 USD) vs. RM 155.00 (37.4 USD) for societal (total) cost. A similar trend was observed for the alternative scheme. Compared with Pentaxim® plus hepatitis B, total cost savings per dose of Hexaxim® were RM 137.20 (33.1 USD) and RM 104.70 (25.2 USD) in the baseline and alternative scheme, respectively. Eighty-four percent of physicians and 95% of nurses supported the use of Hexaxim® in the NIP. The majority of parents/caregivers had a positive perception regarding Hexaxim® vaccine in various aspects.
CONCLUSIONS: Incorporation of Hexaxim® within Malaysian NIP is highly recommended because the use of Hexaxim® has demonstrated substantial direct and indirect cost savings for healthcare providers and parents/caregivers with a high percentage of positive perceptions, compared with Pentaxim® plus hepatitis B.
TRIAL REGISTRATION: Not applicable.
Objective: This research aimed to investigate the prevalence of adverse events following immunization (AEFI) with/without PCM to be prescribed post infants' vaccination in Malaysia (possible associated factors: age, types and stages of vaccination, concomitant vaccines and drugs, and/vitamins).
Materials and Methods: A retrospective cross-sectional study was conducted from 2011 to 2017. The AEFI was extracted from Quests 2, 3, and 3+ System of National Pharmaceutical Regulatory Agency (NPRA). The population of vaccinated infants was obtained from the Ministry of Health (MOH) Malaysia official website. The AEFI data were further categorized into (i) AEFI with possibility for PCM to be prescribed, and (ii) AEFI with no possibility for PCM to be prescribed. The data were analyzed using Microsoft Excel 2013, Portland, USA simple and multiple logistic regression tests, Statistical Package for the Social Sciences (SPSS) software programme, version 22.0 (IBM), New York, USA.
Result: Various AEFI cases (359 infants) were reported. DTaP/Hib/IPV and measles-mumps-rubella (MMR) showed higher prevalence of AEFI with/without PCM to be prescribed post infants' vaccination cases per 100,000 population (2.07 and 2.21, respectively) than other types of vaccinations. DTaP/Hib/IPV (2 months) vaccination showed the highest value (3.00) among other age groups. Backward elimination presented DTaP/Hib/IPV (3-4 months) (95%CI; 0.231, 0.899%; P = 0.023) was the possible associated factor. Hepatitis B (1-5 months), DTaP/Hib/IPV (3-4 months), DTaP/Hib/IPV (5-12 months), concomitant vaccines as well as concomitant drugs and/ vitamins were the identified potential cofounders.
Conclusion: Prescribing and dispensing of PCM post infants' vaccination may be confined to DTaP/Hib/IPV (2-4 months) and 12 months MMR groups.