Dataset Information

Vaccine safety surveillance informs public health policy beyond immunization: A case-series on bleeding following vaccination, Nepal, 2016-2018.

ABSTRACT: BACKGROUND:Surveillance for adverse events following immunization (AEFI) is important to monitor vaccine safety and should lead to appropriate responses to improve health and immunization program. Bleeding following vaccination is not recognized as an important AEFI. Without policy of vitamin K (VK) prophylaxis at birth, vitamin K deficiency bleeding (VKDB) could be an important cause of bleeding in young infants and may manifest as AEFI. METHODS:We retrospectively analysed all serious AEFI cases that presented with external or internal bleeding reported to Nepal's AEFI surveillance system during 2016-2018. The cases were classified as VKDB, suspected VKDB or non-VKDB. RESULTS:During the period, 16 serious AEFI with symptom or sign of bleeding were reported representing 21.3% of all serious AEFI reported. Cases were between 40 and 94 days of age. The National AEFI Investigation Committee classified all cases as coincidental. Fourteen cases (87.5%) had bleeding from injection site. Median time from vaccination to injection site bleeding was 4.3 h (interquartile range: 2.1-11.6 h). Six cases (37.5%) had intra-cranial haemorrhage. Only one case had confirmed history of receiving VK at birth. Ten cases (62.5%) received appropriate treatment (VK injection; blood transfusion if needed). Based on limited laboratory investigations available, three cases (18.75%) could be classified as late onset VKDB and 11 cases (68.75%) as suspected late onset VKDB. CONCLUSION:VKDB should be suspected in young infants presenting with bleeding including following vaccination, and prompt treatment should be initiated. Bleeding following vaccination should be recognized as an important AEFI as even a small amount of blood loss in young infants can be catastrophic. We posit that this series is a small subset of VKDB cases in Nepal detected through AEFI surveillance system. In countries without policy of VK prophylaxis at birth including Nepal, the policy should be introduced.

SUBMITTER: Pradhan R

PROVIDER: S-EPMC7482439 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Vaccine safety surveillance informs public health policy beyond immunization: A case-series on bleeding following vaccination, Nepal, 2016-2018.

Pradhan Rahul R Sharma Gautam Jhalak J Tinkari Bhim Singh BS Adhikari Neelam N Bose Anindya Sekhar AS

Vaccine 20200809 40

<h4>Background</h4>Surveillance for adverse events following immunization (AEFI) is important to monitor vaccine safety and should lead to appropriate responses to improve health and immunization program. Bleeding following vaccination is not recognized as an important AEFI. Without policy of vitamin K (VK) prophylaxis at birth, vitamin K deficiency bleeding (VKDB) could be an important cause of bleeding in young infants and may manifest as AEFI.<h4>Methods</h4>We retrospectively analysed all se ...[more]

PMID: 32788134

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Project description:IntroductionNepal passed a comprehensive tobacco control law in 2011. Tobacco control advocates successfully countered tobacco industry (TI) interference to force implementation of law.Aims and methodsPolicy documents, news stories, and key informant interviews were triangulated and interpreted using the Policy Dystopia Model (PDM).ResultsThe TI tried to block and weaken the law after Parliament passed it. Tobacco control advocates used litigation to force implementation of the law while the TI used litigation in an effort to block implementation. The TI argued that tobacco was socially and economically important, and used front groups to weaken the law. Tobacco control advocates mobilized the media, launched public awareness campaigns, educated the legislature, utilized lawsuits, and monitored TI activities to successfully counter TI opposition.ConclusionsBoth tobacco control advocates and the industry used the discursive and instrumental strategies described in the PDM. The model was helpful for understanding TI activities in Nepal and could be applied to other low- and middle-income countries. Civil society, with the help of international health groups, should continue to track TI interference and learn the lessons from other countries to proactively to counter it.ImplicationsThe PDM provides an effective framework to understand battles over implementation of a strong tobacco control law in Nepal, a low- and middle-income country. The TI applied discursive and instrumental strategies in Nepal in its efforts to weaken and delay the implementation of the law at every stage of implementation. It is important to continuously monitor TI activities and learn lessons from other countries, as the industry often employ the same strategies globally. Tobacco control advocates utilized domestic litigation, media advocacy, and engaged with legislators, politicians, and other stakeholders to implement a strong tobacco control law. Other low- and middle-income countries can adapt these lessons from Nepal to achieve effective implementation of their laws.

Project description:ObjectiveThe aim of this study was to measure the impact of zero-mark-up drug policy (ZMDP) on drug-related expenditures and use in urban hospitals.DesignThis was a retrospective observational study of trends in drug expenses and use in the context of the ZMDP using an interrupted time series analysis.SettingTwelve hospitals (three tertiary hospitals and nine secondary hospitals) in Xi'an, which is the capital of Shaanxi Province in Western China.Data and participantsThe prescription information for all outpatients and inpatients in the study hospitals from January 2016 to April 2018 was used in this study.InterventionsThe Chinese government announced the policy intervention measure of the ZMDP, which was implemented in all public hospitals as of 1 April 2017.Primary measuresMonthly drug expenditures, monthly medical expenditures, the percentage of drug expenditures among total medical expenditures, the average outpatient drug expenditure per visit, the percentage of prescriptions that include an injection and the percentage of prescriptions that include an antibiotic.ResultsMonthly total medical expenses increased in both tertiary and secondary hospitals after the ZMDP was implemented. In tertiary hospitals, the average outpatient drug expenditures per visit showed a slow decreasing trend before the intervention and an increasing trend after the intervention, with statistically significant changes in both the level (p<0.001) and the trend (p=0.02). Secondary hospitals showed a slow increasing trend both before and after the policy implementation, with no significant change in the trend (p=0.205). The proportion of prescriptions, including injections, was over 20% in secondary hospitals and less than 20% in tertiary hospitals, with no significant changes to this indicator observed after implementation of ZMDP.ConclusionsThe effect of the ZMDP on drug-related expenditures and use in Chinese public hospitals was not substantially evident. Future pharmaceutical reform measures should give more consideration to physician prescription behaviours.

Dataset Information

Vaccine safety surveillance informs public health policy beyond immunization: A case-series on bleeding following vaccination, Nepal, 2016-2018.

Publications

Vaccine safety surveillance informs public health policy beyond immunization: A case-series on bleeding following vaccination, Nepal, 2016-2018.

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