In: Nursing
Research the National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) and discuss how this act modifies the "standard of care" that might otherwise apply to a drug manufacturer.
http://www.cdc.gov/vaccinesafety/Vaccine_Monitoring/history.html
National Childhood Vaccine Injury Act(NCVIA) of 1986
The law acknowledged that deaths and injuries because
of vaccine for that family should be aware of safety protection and
they should be finanacially supported..
The federal vaccine injury compensation program has
some legal requirements for those who are giving vaccine;
-Prior information to parents about benefits and
risk about the vaccine to parents is important..(VIS) vaccine
information statement distributes that to state and local health
departments..
-Manufacturer names and lot numbers of vaccination
must be intered properly..
-Notify previous child health problem before vaccination..
-Report to federal Vaccine adverse Events Reporting system(VAERS)
if there is any serious health problems during vaccination..
U.S government provided nearly 4 billion dollar to those who are
injured with vaccination..To be against with infectious disease
vaccination is iportant..To improve and respond to public health
concerns,congress passed many ways through NCVIA..
FDA requires all vaccines from manufacturers to submit the vaccine
before they use for public..This must be tested before
administration due to high temperature and contamination there will
be some sensitivity reaction to public..
Standard of care:
The safety of vaccines are important for public
health..manufacturers are responsible for anu issues and damages
with vaccinations..The standard of products by manufacturers must
be safe and good for peoples..Vaccines and drugs are required
different components it can provide serious adverse effects..The
principles helps from unavoidably unsafe products avoided by public
before they getting it..Manufacturers about childhood vaccination
they need some cost insurance coverage for this proper maintenance
program..There are only few vaccine suppliers and risk of shortages
if company leave the field..
NCVIA provided lot of vaccine design..FDA
checking that and reporting of any adverse events..NCVIA need
additional regulatory support to operate the system in a safety
way..