Communication Of Adverse Events Research Articles

Active surveillance of adverse events after immunization (AEFI) from the Local Health Unitof Ferrara, Italy.

SummaryIntroductionVaccine vigilance implies the collection, evaluation, analysis and communication of adverse events following immunization (AEFI) and is a useful tool for vaccine monitoring allowing, even after approval and marketing, to check its safety/tolerability. The multiregional project “Active surveillance of adverse vaccine reactions”, joined by the AUSL of Ferrara, is aimed at making parents of children, who have undergone at least one vaccination provided by the regional vaccination calendar in the first 24 months of life, aware of the reporting of any AEFI via mobile phone-SMS.MethodsAn analysis of the project data, collected in the period March 2018 - May 2019, was carried out, to evaluate the effectiveness of the reporting tool and the type and frequency of AEFI. Anonymized data were analyzed by number, gender, distribution by age, type of vaccine, adverse event, severity and outcome.ResultsA total of 1,494 consents and 983 SMS messages were obtained from parents. The vaccine doses carried out were 1,984 (28.3% hexavalent, 28% PCV13, 17% anti-rotavirus, 14.3% Men-B). Almost all (99.5%) AEFI were classified as “not serious”. Based on the Organ System Class (SOC), most reports are related to “General Disorders and Administration Site Conditions” (52.3%), followed by “Psychiatric Disorders” (26.5%) and “Metabolic and nutrition disorders” (12.5%).ConclusionsThe reported AEFI are in line with the ones reported in the literature. Reporting via SMS is a valid vaccine surveillance tool contributing to the qualitative and quantitative improvement of the information transmitted.

The Impact on Healthcare Workers of Italian Law n. 24/2017 "Gelli-Bianco" on Patient Safety and Medical Liability: A National Survey.

Italian “Gelli–Bianco” law (law n. 24 enacted by the Italian Government on 8 March 2017) introduced innovative changes and regulations regarding patient safety and healthcare workers’ (HCWs) liability. We promoted a national survey to evaluate the effect of the law on HCWs. The questionnaire was edited and distributed using the free online tool “Google Forms” (Google LLC). The mode of administration chosen for the questionnaire was telematic self-completion. In particular, the questionnaire was sent to several portals of information, websites, in the scientific and medical sectors. Four hundred forty-five subjects participated in the survey. The differences in categorical variables for Gelli–Bianco Law reading with professional variables were analyzed in a univariate analysis using the Chi-square test and Fisher’s exact test. Reading the law is significantly and positively related to knowledge and communication of adverse events and sentinel events, checklist adoption, and participation in educational activities on risk management. The law’s implementation and promotion is a reliable educational tool for increasing patient safety culture and involving HCWs in risk management activities. Knowledge of the law, related education, and understanding of its application are still inadequate; therefore, educational programs regarding patient safety, risk management, and the contents of the law itself must be vigorously promoted to achieve clinical governance goals.

Disclosure of Adverse Events: A Guide for Clinicians.

Children's Hospitals' Solutions for Patient Safety (SPS) acknowledged a recommendation from the American Academy of Pediatrics to develop education programs on the communication of adverse events with patients and families. SPS set out to create a guide that would outline a standardized disclosure process and provide a training curriculum and tools so that providers would feel better prepared to have effective disclosure conversations. SPS disclosure work began with the development of a project team made up of 9 network hospitals. The team utilized key driver diagrams and process maps to show the relationship between the project aims, key drivers, and specific interventions. The team developed a training curriculum, guide, and tools for each area of improvement. To ensure these were effective, they were tested using case studies and plan-do-study-act cycles. One of the cohort hospitals piloted the curriculum and tools, training 48 physicians, nurses, executives, and other allied health professionals. Pretest to posttest scores improved from an average of 82.7% to 90.2%. Survey feedback was favorable with 100% of respondents noting that they strongly agree or agree that attending this educational activity increased or improved their competency, performance, and patient outcomes. Initial testing suggests that the developed curriculum is empowering for frontline clinicians. Materials are available in an electronic format on the SPS external website. As member hospitals implement these materials, they will be evaluating learner satisfaction and provider usage. SPS will seek out feedback from these hospitals to further develop the materials and support clinicians.

Communication in health care - legal aspects

This paper is focusing on the legal aspects of communication in health care, especially on doctor-patient relationship, responsibility for information, communication of adverse events, and legal declarations.

Analysis of the communication of adverse events from the perspective of the nurses directly involved in patient care

This descriptive study aimed to analyze the process of communicating adverse events in the hospital context, from the nurses’ perspective. Data was collected in January 2013 in a public hospital in Fortaleza, Ceará, Brazil. A semi-structured interview was held with 37 nurses, covering guiding questions regarding the communication/recording of adverse events. It was found that communication of adverse events exists in the service, but that cases are under-reported and inadequately analyzed; the nurses were not unanimous in identifying the documents indicated for recording events; and a punitive culture predominates in the situations which generate adverse events, evidenced by reports of practices of reprimanding and punishment of the professionals. It is concluded that encouraging appropriate communication of adverse events in the service is necessary, considering recording as indispensable in the organizational communication process, as this is the source of data for analyzing the occurrence of adverse events and ensures patient safety.

Adverse Events Following Immunisation and Global Scenario in Vaccine Pharmacovigilance

The safety of vaccines is a high priority for vaccine manufacturers and drug regulatory bodies. Adverse event following immunization (AEFI) is an untoward, temporally associated event following immunization process which does not necessarily have a causal relationship with administration of vaccine. Vaccine pharmacovigilance relates to detection, assessment, understanding, prevention and communication of adverse events following immunization, or of any other vaccine - or immunization- related issues. AEFI aggravate public opposition to immunisation and jeopardize the effectiveness of immunisation campaigns. AEFI are of various types and may be due to programmatic errors, vaccine-induced or potentiated errors. Global vaccine pharmacovigilance systems focus on passive, active or hybrid systems, record linkage and rapid cycle analyses. The global advisory committee on vaccine safety also plays an important advisory role to WHO in vaccine pharmacovigilance. Majority of the population are however exposed to non-functional systems. Thus, a global vaccine safety data network can be useful in solving this problem. WHO AEFI reporting system contains a checklist and causality assessment criteria. It can be made more effective by acting on results of assessment tools. AEFI reporting in India is an elaborate process under the charge of the CDSCO, Ministry of Health and Family Welfare. However, capacity to detect and respond to AEFI needs improvement. A multipronged approach by WHO involving national authorities, multilateral agencies, nongovernmental and professional organizations, academia, healthcare institutions, pharmaceutical industry, lay public and media is the key to ensuring effective vaccine safety monitoring worldwide.

Brazilian registered nurses’ perceptions and attitudes towards adverse events in nursing care: a phenomenological study

To describe the perceptions and attitudes of registered nurses (RNs) towards adverse events (AEs) in nursing care. The professionals' subjective perspectives should be taken into account for the prevention of AEs in care settings. Schütz's social phenomenology was developed. Interviews were conducted with nine Intensive Care Unit RNs. The following five descriptive categories emerged: (1) the occurrence of AEs is inherent to the human condition but provokes a feeling of insecurity, (2) the occurrence of AEs indicates the existence of failures in health care systematization, (3) the professionals' attitudes towards AEs should be permeated by ethical principles; (4) the priority regarding AEs should be the mitigation of harm to patients, and (5) decisions regarding the communication of AEs were determined by the severity of the error. The various subjective perspectives related to the occurrence of AEs requires a health care systematization with a focus on prevention. Ethical behaviour is essential for the patients' safety. Activities aimed at the prevention of AEs should be integrated jointly with both the professionals and the health care institution. A culture of safety, not punishment, and improvement in the quality of care provided to patients should be priorities.

Pharmacovigilance in vaccines.

Sir, Vaccines are among the safest tools of modern medicine that help in protecting against disease by inducing immunity. In all countries, routine immunization represents fundamental service of the public health system, offering one of the most cost-effective methods of reducing morbidity and mortality among children less than five. A lack of complete vaccine coverage increases the risk of disease for the entire population. Pharmacovigilance is the science related to the safety of drugs and it helps prevent harmful effects of the drugs in population. It originated with thalidomide tragedy that caused 10000 birth defects in children. Regulatory systems were established soon to bring an improvement in post-marketing surveillance for the safer medicines.[1] Since the majority of vaccines are administered to vulnerable (children) as well as healthy population, strict safety supervision of vaccines is essential. Safety issues in vaccines may lead to rumors and undermine general confidence in vaccination and, ultimately, have dramatic consequences on immunization coverage and disease incidence.[2] Safety of vaccines, therefore, must be excellent to make it acceptable, since it usually has deferred individual benefit, but immediate adverse drug reactions (ADRs). Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization, or of any other vaccine- or immunization-related issues. The WHO defines an adverse event following immunization (AEFI) as a medical incident that takes place after an immunization causes concern, and is believed to be caused by the immunization. The goal of vaccine pharmacovigilance is the early detection and timely response to adverse events following immunization, in order to minimize negative effects to the health of individuals and lessen the potential negative impact on immunization of population. Although vaccines are considered to be medicines with anti-infective activity that work by immunological action and administered for prophylaxis, pharmacovigilance for vaccines should be different from other drugs because of the following reasons. Information to be captured is complex and different from other drugs. Vaccines are complex biological products, which may include multiple antigens, live organisms, adjuvants, and preservatives. ADRs may be due to administration of live wild viruses e.g. lymphocyte meningitis after anti-mumps vaccine or may be non-specific, related to component different from the antigen (aluminum hydroxide involved in the macrophagic myofasciitis, allergic reactions to neomycin, latex, egg, or gelatin).[3] So, each component has unique safety implications, which require different information to capture as compared to other drugs. In vaccination campaign, the vaccine is administered to large population over short period of time, which may result in administration error and hence has to be dealt with differently. Different modes of causality assessment There are some issues, which make evaluation of vaccines different from other drugs. Local or immediate adverse reactions, which occur due to administrative error and attenuated virus, can be attributed with degree of confidence but delayed events are difficult to correlate. They have immunological considerations in addition to pharmacological action and take long time to respond.[4] Criteria commonly used to determine causality such as resolution of the event following treatment discontinuation and the result of re-challenge cannot be used to assess causality of an event occurring after vaccination.[5] Reporters and reporting chain Vaccines are part of national health plan and physicians involved in primary health care conduct the immunization en masse. So, reporter and reporting chain are different, especially in developing countries where physicians involved in primary health care are not exposed to technology (internet, etc) and pharmacovigilance sensitization. Although pharmacovigilance of vaccines is important, yet it is given much less attention. There are no different systems and regulatory guidelines in most of the countries for this activity. Lot of research is going on for vaccine development in infectious diseases e.g. HIV, malaria, H1N1, etc that have high patient load. For the last two decades, pharmacovigilance has been gaining an increasing attention. It is now, high time that vaccines also receive their due attention.