Current Drug Safety - Volume 10, Issue 1, 2015

It has been a long journey starting from the beginnings of variolation [3] leading up to the greatest success in the history of immunization: the eradication of smallpox [39]. Today, vaccines are an acknowledged important medical advance [40]. Nevertheless, immunization has been the subject of public controversy on several occasions [15, 24, 31]. This article shall provide a short overview of some aspects of the early stages of immunization in Western countries, including some examples of vaccine safety controversies in the past.

Highly publicised vaccine scares and recent debates about the risks suggest that public trust in immunisation programmes is fragile. For instance, the recent outbreak of Measles in Wales was the direct result of almost fifteen years of distrust for the MMR vaccine in the UK. This article shows how the latest science on risk communication will help critical actors, especially policy-makers, to build trust when they communicate risks to citizens and patients. The article offers policy advice on risk communication based on the results of three vaccines case studies. Five procedural principles which were developed for the UK government – the so-called “five As” of public risk communication are used to structure the discussion. Conclusions and recommendations suggest ways to move forward and build a two-way proactive risk communication practice.

In times of declining immunization rates among children in many countries and an increasing threat of potentially vaccine-preventable diseases, there is a strong need for new strategies to improve trust in vaccinations and acceptance of recommendations, especially in parents of infants and children. A survey to evaluate vaccination acceptance has been conducted in Vienna, Austria, based on a US CDC survey, applying a cross-sectional approach with districts and public as well as private kindergartens and preschools as selection base. The survey aimed to investigate the impact of parent satisfaction with, and overall trust in the physician on vaccine acceptance, as well as the impact of quality and completeness of safety information delivered during the vaccination consultation. Overall 1101 parents, predominantly (84.2%) mothers, participated in the survey. The majority (82.7%) of participants had a generally positive view concerning childhood vaccination. However, 25.1% refused at least one of the recommended vaccinations. In multivariate analysis, confidence in vaccinations was significantly influenced by education (lower confidence at higher levels of education), gender (higher confidence in females), and positively associated with trust in physician, smooth vaccination procedure, and information about vaccine risks. Similar results were obtained for compliance with recommended vaccinations with information about vaccine benefits being the most important predictor. This large survey indicates an important role of the physician in communicating balanced information about benefits and risks associated with childhood vaccinations. A trustworthy parent-physician relationship is crucial for vaccination decisions of parents.

Not only the general public, but also those studying to become health professionals, are struggling to keep up with a growing body of evidence and increasingly complex information about the many different types of vaccines available to date. At the same time, a number of increasingly complex subjects of study are competing for their attention during undergraduate and graduate education. In many medical school curricula in German-speaking countries, the subject of vaccines has been entirely omitted, or is regarded a minor subtopic. During the studies, most medical school curricula in German-speaking countries do not offer obligatory courses and/ or hands-on training vaccinology in vaccination. In Germany, private pediatricians administer the majority of immunizations. Even during postgraduate training programs in pediatrics, which are largely hospital-based, vaccinations are rarely a topic, and vaccinology remains a “hobby” and a “field without lobby” lacking specific certification requirements. Studies of acceptance of vaccines among health professionals and medical students have shown that many may still have their own doubts and uncertainties about vaccines revealing a number of unanswered questions during their studies and postgraduate training.

When reporting adverse events following immunisation, information about which vaccine was given, how it was administered, and if it was administered within the expiry date is often incomplete. To improve immunisation practice, a standardised uniform procedure is needed. Examples are given, where immunisations were given beyond the expiry date or were wrongly administered. These examples include proposals to avoid misleading documentation in the immunisation card.

The highly complex and controversial topic of vaccine safety communication warrants innovative, user-centered solutions that would start with gaining mutual respect while taking into account the needs, concerns and underlying motives of patients, parents and physicians. To this end, a non-profit collaborative project was conducted by The Vienna Vaccine Safety Initiative, an international think tank aiming to promote vaccine safety research and communication, and the School of Design Thinking in Potsdam, Germany, the first school for innovation in Europe. The revolutionary concept of the Design Thinking approach is to group students in small multi-disciplinary teams. As a result they can generate ground-breaking ideas by combining their expertise and different points of view. The team agreed to address the following design challenge question: “How might we enable physicians to encourage parents and children to prevent infectious diseases?” The current article describes, step-by step, the ideation and innovation process as well as first tangible outcomes of the project.

Any ambiguity in texts used in the communication about vaccines can not only interfere with comprehension, but also generate safety and liability issues. Within a survey on the quality of written protocols for at-risk interventional procedures and sanitary crises, we analyzed documents relating to vaccination, and among them, the “package-leaflet” of an anti-H1N1 influenza vaccine, widely disseminated to the public in 2009-2010. Among the most common mistakes, we observed that 1) language was not always adjusted to the non-specialist’s level of knowledge; 2) chronology, logic, consistency, and homogeneity were often missing; 3) crucial pieces of information were disseminated all over the text, 4) use of the passive voice did not distinguish between instructions and information; 5) use of synonyms could be misleading and impair translation. We propose the use of “Controlled language” (CL) to improve the situation. By constraining lexicon, grammar and syntax, CL is a way to write documents that are clear, accurate and devoid of ambiguity. However, the set of rules necessary to write in CL is difficult to memorize. We thus developed authoring software (Rédacticiel Prolipsia) to make the creation of a CL by linguists and its use by health professionals easy and adapted to any domain. It may considerably improve the writing of vaccine package inserts/leaflets. It could be used to write information documents about vaccines and their safety, and operating procedures for professionals to prepare, store, and administer vaccines, decide upon proper indication of vaccines, and follow patients after vaccine injection.

The risk of severe disease outcomes and complications of infectious diseases remains markedly increased in children and adolescents with chronic conditions. Specialized pediatric healthcare aims to improve quality of life in this high-risk group. One of the most important measures to achieve this goal is to improve immunization rates in this vulnerable population. This article aims to provide insight into models for the integration of infectious disease prevention into specialized healthcare for children with chronic conditions, by the example of the Department of Vaccines and Disease Prevention in Children with Chronic Conditions in Moscow, Russian Federation. The article highlights the importance of vaccine safety and effectiveness research in children with chronic conditions. Useful strategies for the optimization of vaccination rates in this population are presented, along with suggestions for the development of individual immunization schedules for different disease conditions.

Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

Vaccines are effective in preventing infectious diseases and their complications, hence reducing morbidity and infectious disease mortaity. Successful immunization programs, however, depend on high vaccine acceptance and coverage rates. In recent years there has been an increased level of public concern towards real or perceived adverse events associated with immunizations, leading to many people in high- as well as low-resource settings to refuse vaccines. Health care workers therefore must be able to provide parents and guardians of children with the most current and accurate information about the benefits and risks of vaccination. Communicating vaccine safety using appropriate channels plays a crucial role in maintaining public trust and confidence in vaccination programs. Several factors render this endeavor especially challenging in low-resource settings where literacy rates are low and access to information is often limited. Many languages are spoken in most countries in low-resource settings, making the provision of appropriate information difficult. Poor infrastructure often results in inadequate logistics. Recently, some concerned consumer groups have been able to propagate misinformation and rumors. To successfully communicate vaccine safety in a resource limited setting it is crucial to use a mix of communication channels that are both culturally acceptable and effective. Social mobilization through cultural, administrative and political leaders, the media or text messages (SMS) as well as the adoption of the Village Health Team (VHT) strategy whereby trained community members (Community Health Workers (CHWs)) are providing primary healthcare, can all be effective in increasing the demand for immunization.

Vaccination has been shown to be the most successful measure in preventing millions of mortalities and morbidities related to infectious diseases. Higher rates of vaccination lead to a greater number of protected individuals in the community. While vaccine safety is a primary concern, misinformation accessed through various communication channels can lead to misconceptions about vaccination that are often hard to address. When the public collects information, they usually do not check for accuracy. To overcome the problem, the most effective way is to disseminate information through teaching facts about vaccine benefits and harms to the public and the authorities in advance. To encourage the public to participate and support vaccination programs, basic scientists and public health officials must be trained and updated about vaccines and vaccination benefits and harms to be able to inform the public.

Vaccines are among the most effective measures to control and prevent infectious diseases. Yet, the topic of vaccination is difficult to communicate, as it bears upon individual versus common good. The efficacy and safety of vaccines can only be shown by the absence of undesired events, such as vaccine-preventable diseases or adverse events following immunization. The authors of this paper view accurate, transparent and timely vaccine-safety communication to the media and general public as a core responsibility of healthcare providers. The authors wish to explore potential difficulties faced by immunization specialists when talking to the media, and suggest how to successfully convey vaccination messages to the general public.

Modern health protection generally affords vaccination against infectious diseases along with other environmental health threats. However, with the increase both in development of new vaccines and in making more and more vaccines available to the general public comes an increase in health scares, mainly in the media. In the wake of health scares, we often find government and health organizations launching campaigns to restore faith in current vaccine policies. But health scares are hard to quell and seem to have messages that “speak better” to those unconvinced about the safety of vaccines. This paper seeks to review recent studies on the health messages prevalent in various news outlets and on the internet. Equal focus has been given to messages originating from government and health organizations as well as those that stem from lay organizations, such as parent communities and anti-vaccination groups. Particular emphasis was placed on studies that did not simply look at the content of the message, but which explored the rhetoric of the message. This review revealed that there is a shortage of studies, and that a comprehensive study of health messages and communication outlets across a much wider range of vaccines is urgently warranted. Based on current research, lay-based/lay-oriented dissemination approaches seem to have a greater effect on lay perceptions of vaccines, and potentially parent behavior. In terms of content, these approaches rely heavily on parent stories around adverse effects, and in terms of rhetoric, the language used tends towards dread words.

We report a case of isoniazid induced convulsions in 35 years old male alcoholic and smoker patient receiving intensive phase therapy for pulmonary tuberculosis. A case was confirmed by accidental positive de-challenge and rechallenge as well as ruled out other conditions. Use of isoniazid in alcoholic and smoker patient required a caution for prevention of neurological adverse reactions. Pyridoxine should always be prescribed to such patients for the prevention of such adverse reaction.