Measuring quality of care for universal health coverage in the Western Pacific.

To deliver on the promise of universal health coverage, regions and countries need to invest in high-quality health systems and put quality of care at the forefront of priority setting and agenda. The Western Pacific Region and its member countries should establish measurements and standards to ensure delivery of high-quality services. In order to effectively do so, individual and system capacities to measure and use quality-of-care data should be strengthened, localized initiatives to develop quality-of-care measures of practice and policy relevance need to be carried out, accountability mechanisms should be in place, and the role of quality as a driver of better health outcomes and economic benefits should be emphasized among all stakeholders. Such initiatives will ensure that quality-of-care measures are "measurements for action" toward quality improvement and reform.

Implementation strategies for the first licensed dengue vaccine: A meeting report.

Dengue vaccination would enhance the control of dengue, one of the most frequent vector-borne viral diseases globally. CYD-TDV is the first dengue vaccine to be licensed, but global uptake has been hampered due to its use being limited to seropositive persons aged 9 years and above, and the need for a 3-dose schedule. The Partnership for Dengue Control (PDC) organized a meeting with key opinion leaders and stakeholders to deliberate on implementation strategies for the use of CYD-TDV. New data have emerged that support the shortening of the primary schedule from a 3 to 2 dose schedule, extending the age range below 9 to 6 years of age, and expanding the indication from endemic populations to also include travelers to endemic areas. Cost-effectiveness may improve with the modified 2-dose regimen and with multiple testing. Strategies to implement a dengue vaccination program have been developed, in particular school-based strategies. A range of delivery scenarios can then be considered, using various settings for each step of the intervention. However, several challenges remain, including communication about limiting the use of this vaccine to seropositive individuals only. Affordability will vary from country to country, as will government commitment and community acceptance. Well-tailored communication strategies that target key stakeholders are expected to make up a significant part of any future dengue vaccination program.

The politics of Covid-19 vaccine confidence.

In the context of emerging COVID-19 virus variants, trends of vaccine nationalism, and multiple vaccine supply challenges, COVID-19 vaccine related uncertainties and challenges continue. Additionally, confidence in new COVID-19 vaccines is highly variable, with minority communities generally less trusting of not only the new vaccines, but also those who produce them and the governments buying and recommending them. How governments handle the COVID-19 response will be a key influencer of public confidence in and acceptance of COVID vaccination.

Novel vaccine safety issues and areas that would benefit from further research.

Vaccine licensure requires a very high safety standard and vaccines routinely used are very safe. Vaccine safety monitoring prelicensure and postlicensure enables continual assessment to ensure the benefits outweigh the risks and, when safety problems arise, they are quickly identified, characterised and further problems prevented when possible. We review five vaccine safety case studies: (1) dengue vaccine and enhanced dengue disease, (2) pandemic influenza vaccine and narcolepsy, (3) rotavirus vaccine and intussusception, (4) human papillomavirus vaccine and postural orthostatic tachycardia syndrome and complex regional pain syndrome, and (5) RTS,S/adjuvant system 01 malaria vaccine and meningitis, cerebral malaria, female mortality and rebound severe malaria. These case studies were selected because they are recent and varied in the vaccine safety challenges they elucidate. Bringing these case studies together, we develop lessons learned that can be useful for addressing some of the potential safety issues that will inevitably arise with new vaccines.

Vaccine confidence plummets in the Philippines following dengue vaccine scare: why it matters to pandemic preparedness.

In November 2017, it was announced that the new dengue vaccine ("Dengvaxia") had risks for those not previously exposed to dengue. While some countries proceeded with adjusting guidance accordingly, the Philippines reacted with outrage and political turmoil with naming and shaming of government officials involved in purchasing the vaccine, as well as scientists involved in the vaccine trials and assessment. The result was broken public trust around the dengue vaccine as well heightened anxiety around vaccines in general. The Vaccine Confidence ProjectTM measured the impact of this crisis, comparing confidence levels in 2015, before the incident, with levels in 2018. The findings reflect a dramatic drop in vaccine confidence from 93% "strongly agreeing" that vaccines are important in 2015 to 32% in 2018. There was a drop in confidence in those strongly agreeing that vaccines are safe from 82% in 2015 to only 21% in 2018; similarly confidence in the effectiveness of vaccines dropped from 82% in 2015 to only 22%. This article highlights the importance of routinely identifying gaps or breakdowns in public confidence in order to rebuild trust, before a pandemic threat, when societal and political cooperation with be key to an effective response.

Consumption of barracuda in the Caribbean Sea linked to ciguatera fish poisoning among Filipino seafarers.

INTRODUCTION: Ciguatera fish poisoning (CFP) is common in tropical and subtropical waters. On 13 November 2015, eight Filipino seafarers from a cargo ship sailing in the Caribbean Sea experienced a range of symptoms after consuming a barracuda. Upon their return to the Philippines, an investigation was conducted to describe the cases. METHODS: A case-series was conducted. A CFP case was defined as a previously well individual on the ship who developed at least one gastrointestinal symptom and at least one neurologic manifestation after eating barracuda on 13 November 2015. All cases were admitted to hospital in Manila, Philippines and were interviewed using a standard questionnaire. Urine and serum samples of cases were collected for ciguatoxin (CTX) testing by radiological and receptor-binding assay. RESULTS: Eight of the 25 seafarers on the ship ate the barracuda; all eight met the CFP case definition. The age of cases ranged from 37 to 58 years (median: 47 years) and all were males. Onset of symptoms ranged from 1 to 3 hours (median: 2 hours) from the time of ingestion of the barracuda. All cases experienced gastrointestinal (nausea, vomiting, diarrhoea) and neurologic (temperature allodynia, itchiness) symptoms but no cardiovascular manifestations. Urine and serum specimens of all eight cases showed CTX below the detection limit. DISCUSSION: The Philippines Epidemiology Bureau recommended that the Philippine Maritime Authority include CTX poisoning and its health risks in seafarers' training to prevent future cases of CFP. The Event-based Surveillance and Response system will continue to provide a mechanism for the reporting and appropriate management of CFP cases.

Epidemic hysteria following the National School Deworming Day, Zamboanga Peninsula, Philippines, 2015.

INTRODUCTION: In July 2015, the Philippines conducted a school-based mass drug administration using albendazole for soil-transmitted helminths infection. Reports of adverse events were subsequently made through the event-based surveillance system, mostly from the Zamboanga Peninsula on the island of Mindanao. A team from the Epidemiology Bureau investigated the reports of adverse events following mass drug administration (AEFMDA). METHODS: Five schools were identified for the investigation which comprised an unmatched case-control study, key informant interviews and laboratory examinations. AEFMDA cases were students who had sudden onset of abdominal pain, vomiting, diarrhoea, loss of consciousness, headache or dizziness within 24 hours after intake of deworming tablet; controls were healthy students who did not develop signs and symptoms after deworming. RESULTS: Most (85%) of the 7313 AEFMDA cases reported nationwide were from Zamboanga Peninsula. Most reports were made after rumours of deaths following deworming and of the use of expired drug were spread through the region. Many parents sent their children to hospital, even if asymptomatic. The case-control study found that being an AEFMDA case was associated with no history of previous deworming (odds ratio = 4.08, 95% confidence interval: 1.77-9.42). DISCUSSION: The investigation concluded that epidemic hysteria was the cause of the increased number of AEFMDA cases in the Zamboanga Peninsula. The false information, aggravated by social media, caused panic and an increase in reporting. Some cases had no history of deworming, and they may not have been aware that albendazole is safe and that side-effects are expected. Risk communication before, during and after future national deworming programmes are recommended to prevent unnecessary reporting of AEFMDA.

Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery.

The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product. We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations conducted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine 'democratic' approach to sharing educational material to a wider community and an openness for access.

Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years.

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally.

Empowering consumers as contributors for health product safety: lessons from the Philippines.

Empowering consumers to contribute to adverse drug reaction reporting seems a sensible innovation, particularly when traditional reports emanating from healthcare professionals are neither increasing nor improving. This work, inspired by an EU-FP7-funded project, describes an attempt by the Philippines to introduce a consumer reporting system through education and an online platform for reporting, and the lessons that were captured in the process. While participating consumers did not contribute to the adverse drug reporting process in the traditional sense as originally expected, the reports received by the drug regulatory agency revealed consumers' concerns regarding health product legitimacy, quality and market claims, as well as the lack of available and accessible information. These reports led regulators to take action. Initial insights on consumer behavior are proposed for regulators and industry to consider in greater depth and how this may impact on consumers providing valued information that will promote other aspects of product safety.

Challenges of drug risk communications in the Philippines.

Risk communication in the context of patient care is about conveying balanced information on benefit and risk of medical products and procedures and developments in health. It is an integral part of pharmacovigilance and healthcare communications and involves stakeholders such as regulators, industry, health professionals and patients. In the Philippines, many factors can interfere with effective risk communication and affect the safety of patients when medicinal products are used: poverty, literacy, age, social media, practice and behaviour of health professionals, industry marketing, patient expectations and product quality. These factors must be taken into consideration when formulating effective risk communications to ensure patient safety.

Presenting evidence for the court.

The medical doctor is sometimes called upon to serve in the courts as expert witness. The work is challenging and has serious implications for the legal and justice system. The outcome of a case may adversely affect the lives of real people when the evidence is not presented appropriately. However, there is reluctance from doctors to participate in the court process. The health professional may not be trained in the art of being a court witness and while scientifically qualified, may not provide the due diligence in explaining the issues properly to the members of the court. Some of the issues that may affect the outcome of a legal case include late discovery of conflicts of interest, inability to communicate well and stick to scientific facts, the inefficiencies of the legal system, and testifying against a medical colleague. There is merit to recommend that all medical doctors must undergo theoretical and practical training when presented as expert witness in courts. Five cases are presented here as illustrations of doctors involved in court cases.