Hosa Biomedical Debate 2020 Updated Exam Multiple Choices And Questions Fully Solved

Coincidental event - correct answers An AEFI that is caused by something other than the vaccine product, immunization error or immunization anxiety. Ex: A fever occurs at the time of the vaccination (temporal association) but is in fact caused by Malaria. Coincidental events reflect the natural occurrence of health problems in the community with common problems being frequently reported. An AEFI will be considered serious, if it: - correct answers results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. It is important to note that 'serious' and 'severe' are often used as interchangeable terms but they are not. A vaccine reaction - correct answers an individual's response to the inherent properties of the vaccine, even when the vaccine has been prepared, handled and administered correctly. Minor Reaction - correct answers usually occur within a few hours of injection. Resolve after short period of time and pose little danger. Local Minor Reaction - correct answers includes pain, swelling or redness at the site of injection. Systemic Minor Reaction - correct answers includes fever, malaise, muscle pain, headache or loss of appetite. Severe Reaction - correct answers usually do not result in long-term problems. Can be disabling. Are rarely life threatening. Include seizures and allergic reactions caused by the body's reaction to a particular component in a vaccine. Severe reactions is a term including serious reactions but also including other severe reactions. How does a vaccination induce immunity? - correct answers by causing the recipient's immune system to react to antigens contained in the vaccine. Local and systemic reactions such as pain or fever can occur as part of the immune response. In addition, other vaccine components (e.g. adjuvants, stabilizers, and preservatives) can trigger reactions. What does a successful vaccine do? - correct answers keeps even minor reactions to a minimum while producing the best possible immune response." what do severe vaccine reactions include? - correct answers seizures, thrombocytopenia, hypotonic hypo responsive episodes (HHE), and prolonged crying, which all need to be reported. Most severe vaccine reactions do not lead to long-term problems. Anaphylaxis, while potentially fatal, is treatable without leaving any long-term effects. What do immunization errors result from? - correct answers errors in vaccine preparation, handling, storage or administration. They are preventable and detract from the overall benefit of the immunization programme. The identification and correction of these incorrect immunization practices are of great importance. Individuals can react in anticipation to and as a result of an injection of any kind. These reactions are not related to the vaccine, but to fear of the injection. What are the four reactions you may encounter? - correct answers fainting, hyperventilation, vomiting, and convulsions. When do coincidental events occur? - correct answers after a vaccination has been given, but they are not caused by the vaccine or its administration. Vaccinations are normally scheduled in infancy and early childhood, when illnesses are common and congenital or early neurological conditions become apparent. Coincidental events are inevitable when vaccinating children in these age groups, especially during a mass campaign. Immediate investigation of a severe adverse event attributed to a vaccine, but not causally related to it, is critical in order to: (1) (2) - correct answers(1) respond to a community's concern about vaccine safety (2) maintain public confidence in immunization. Common safety issues in vaccination campaigns - correct answers It involves administration of vaccine doses to a large population over a short period of time. As a result, adverse events may be more noticeable to staff and to the public. Factors in Calculating AEFI's - correct answers-Vaccines (different companies produce the same vaccine with different compositions) -Age (Same vaccinations to different age groups can cause different reactions) -Vaccine Doses (primary dose vs booster dose) -Case Definitions (research studies that do not stick to the same definitions) -Surveillance Methods (how data is collected might change) -Background Rate (statistics that already exist) What are common results of mass vaccination campaigns? - correct answers an increase in immunization errors because of staff inexperience in vaccinating a wider age group, and the spread of unfounded rumours that may damage the campaign. Drug Pharmacovigilance Definition - correct answers the practice of detecting, assessing, understanding, responding and preventing adverse drug reactions, including reactions to vaccines. It is now an integral part of the regulation of drug and vaccine safety. Surveillance systems exist at national and international levels to ensure effective monitoring and prompt actions in response to AEFIs. NRA's (National Regulatory Authorities) are responsible for ensuring that every pharmaceutical product - including vaccines - used within the country is: - correct answers Of good quality, Of known potency, Safe for the purpose or purposes for which it is proposed. Immunization Safety Definition - correct answers the process of ensuring and monitoring the safety of all aspects of immunization, including: vaccine quality, adverse events, vaccine storage and handling, vaccine administration, disposal of sharps, management of waste. Vaccine Pharmacovigilance Definition - correct answers the science and activities relating to the: Detection, Assessment, Understanding and Communication of adverse events following immunization and other vaccine or immunization-related issues, and to the prevention of untoward effects of the vaccine or immunization. What does vaccine pharmacovigilance depend on? (1) (2) (3) - correct answers(1) Signal Detection (2) Development of Causality Hypothesis (3) Testing of Causality Hypothesis. Who monitors vaccines? - correct answers The National Regulatory Authority is usually the only agency with the mandate to ensure the safety, efficacy and quality of vaccines. While AEFI surveillance is a key function of National Regulatory Authorities, monitoring the safety of vaccines requires the involvement of both the National Immunization Programme and the National Regulatory Authority. Their good collaboration should be supported by clearly distinguishing their roles and responsibilities. A cluster of AEFIs definition - correct answers Two or more cases of the same adverse event related in time, place or the vaccine administrated. Apart from checking on these three factors (e.g. checking vaccine batch), the investigator should check for AEFIs occurring in similar age groups and populations with genetic predisposition or disease. Cluster investigation begins by establishing the case definition and identifying all cases that meet the case definition. The immunization programme manager should then take two actions. (1) Identify the immunization history of the cluster cases including details of when, where and which vaccines were given, by collecting and recording (2) Identify any common exposures among the cases, for example What do causality assessment outcomes do? - correct answers they help raise awareness of vaccine associated risks among healthcare workers. This, combined with knowledge of benefits of immunization, forms the basis of vaccine information for parents and/or vaccines. What are the general principles of AEFI surveillance? - correct answers-Detection, correction and prevention of immunization errors, -Identification of potential problems with specific vaccine lots, -Prevention of false blame from coincidental events, -Maintenance of confidence in the programme by properly responding to parent/community concerns, -Identification of signals for unexpected adverse events and generation of hypotheses to be tested by controlled studies, -Estimation of AEFI rates in local populations, -Support to formulate and adjust contraindications, risk/benefit equations, and provider and patient information. What are mass vaccination campaigns? - correct answers an area of specific need; during campaigns, a large number of doses are administered over a short period. There is a high probability of coincidental adverse events. Immunization errors may occur if vaccines are not being given by those who regularly administer vaccine. During campaigns there is also often increased awareness towards an apparent rise in reported adverse events, which can undermine the confidence in the vaccine being used and can have a major impact on the success of the campaign. What is the difference between vaccine and immunization safety? - correct answers-Vaccine Safety is concerned with ensuring and monitoring the safety of vaccines -Immunization Safety refers to ensuring and monitoring the safety of all aspects of immunization, including vaccine storage, handling, administration, and waste management. Why should all countries have a National regulatory authority? - correct answers to ensure that all medicines, including vaccines, used within the country are safe, effective and of good quality. NRAs function within the framework of national medicines policy and overall health policy, and as with any public entity, must abide by principles of transparency, fairness and accountability." What is the function of the NRA? - correct answers The NRA is usually the main institution mandated to regulate drugs, including vaccines. It has the aim of ensuring the quality, efficacy and safety of the product. NRAs function within the framework of national medicines policy and overall health policy. As with any public body, NRAs must have principles of transparency, fairness and accountability. How many different vaccine types are there compared to how many drugs? - correct answers There are only about 30 different vaccine types (but many more product formulations) compared with approximately 20,000 drugs. Why should NRAs test vaccines? - correct answers Because vaccines are biological products and quality can vary from lot to lot, NRAs should conduct tests before a vaccine lot is released for public use. NRAs often delegate testing to a national control laboratory. NRAs are not responsible for testing vaccine lots when the vaccine is procured through a United Nations organization i.e. is prequalified, which takes responsibility for the testing. What is the function of the NIP? - correct answers A national immunization programme (NIP) is the organizational component of Ministries of Health charged with preventing disease, disability, and death from vaccine-preventable diseases in children and adults. A NIP is a government programme that operates within the framework of overall health policy. Like the NRA, the NIP is responsible for the delivery to the population of safe, effective vaccines of high quality. The NRA releases vaccines for public use (lot release). Who are AEFI First Responders? - correct answers When an adverse event following immunization (AEFI) happens, it is the health staff administering vaccines that often are the first responders. They assess and treat the adverse event, reporting it, and may be called to contribute to an AEFI investigation. The national immunization program is responsible for assuring that health staff respond to adverse events, and act to minimize the risk of AEFIs in the future. How does one avoid immunization errors? - correct answers-Train immunization workers adequately, provide refresher updates and ensure close supervision so that proper procedures are being followed. -Do not store other drugs or substances in the refrigerator of the immunization center. This will avoid mix-up between vaccine vials and other drug containers and minimize immunization errors. If stored together, a drug risks being given instead of a vaccine or an inappropriate diluent. -Use sterile, preferably single-use, auto-disable syringes for all injections. If only multi-use syringes are available, sterilize them adequately after each use. -Reconstitute the vaccine only with its specific diluent supplied by its manufacturer. -Discard reconstituted vaccines within 6 hours or at the end of each immunization session (whichever comes sooner). -Carefully conduct epidemiological investigation of an AEFI to pinpoint the cause and how to improve immunization practices where necessary. -Monitor persons receiving vaccines for 20 minutes after vaccination. What are the responsibilities of the AEFI review committee? - correct answers-Review individual serious and unusual AEFIs and other AEFIs referred to it by expert groups -Assess potential causal links between AEFIs and a vaccine (or vaccine lot), -Monitor reported AEFI data for potential signals of previously unrecognized vaccine-related adverse events, -Provide recommendations for further investigation, education, corrective action and communication with interested parties, including the media, -Record its deliberations and decisions and feedback on each reviewed case to all relevant stakeholders. Challenges that countries need to address in differing priorities depending on their local contexts include: - correct answers-Continued prevalence of unsafe injections and injection practices, -Mishandling of rumours and adverse events, -Lack of access to new, safer technologies such as auto-disable syringes, -Growing anti-immunization movements, including anti-vaccination websites, -Inadequate AEFI surveillance, -Globalization and the internet (greater impact of misinformation raising public concerns about harm from vaccines) The Brighton Collaboration Definition - correct answers an international voluntary collaboration of scientific experts, launched in 2000. It facilitates the development, evaluation and dissemination of high-quality information about the safety of human vaccines. The Brighton Collaboration provides globally accepted, standard case definitions for assessing AEFIs so that safety data across trials and surveillance systems can be compared. The Council for International Organizations of Medical Sciences (CIOMS) Definition - correct answers an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949 to serve the scientific interests of the international biomedical community. The Council for the International Organizations of Medical Sciences (CIOMS) and WHO established a joint working group on vaccine pharmacovigilance in 2005, recognizing that vaccines represent a special group of medicinal products with issues specific to the monitoring and assessment of vaccine safety. A country that does not produce its own vaccines acquires them from providers outside. It is strongly recommend