ASSOCIATED EVENTS FOLLOWING IMMUNIZATION (KIPI)

Definition KIPI

For operational purposes, the Commission determines that the Commission Kipi-occurring post-immunization as an adverse reaction is known as co-occurring post-immunization (Kipi) or adverse events following Immunization (AEFI) is a medical events associated with immunization in the form of a vaccine effect or side effects, toxicity, sensitivity reactions, pharmacological effect, or program error, coincidence, injection site reaction, or a causal relationship can not be determined.


In certain circumstances the old Kipi observations could achieve 42 days (chronic arthritis after rubella vaccination), or even up to 6 months (infection of vaccine-strain measles virus in immunodeficient patients after vaccination against measles and polio and paralytic polio vaccine virus infection in the recipient strains non immunodeficiency or immunodeficiency recipients post-polio vaccination).

In general, reactions to drugs and vaccines may constitute adverse reactions (adverse events), or other events that are not caused by the direct effects of the vaccine. Vaccine Adverse reactions may include and pharmacological effects, side effects (side-effects), drug interactions, intolerance, idiosyncratic reactions, and allergic reactions are generally clinically difficult to distinguish from one another. Pharmacological effects, side effects, and idiosyncratic reactions usually occur because of a potential vaccine alone, whereas the sensitivity of a person's allergic reaction to a vaccine component to the genetic background. Allergic reactions can occur to egg proteins (a vaccine against measles, mumps, influenza, and yellow fever), antibiotics, preservatives material (neomycin, mercury), or other elements contained in the vaccine.

Genesis is not due to a direct effect of the vaccine may occur due to technical problems the manufacture, supply and distribution and storage of vaccines, error procedures and techniques of immunization, or merely events that arise by chance.

Lay perceptions of health workers and also usually assume all abnormalities and events associated with immunization as an allergic reaction to the vaccine. However, the study report by the Vaccine Safety Comittee Kipi, the Institute of Medicine (IOM) stated that most of the USA Kipi occur by chance alone (coincidence). The incident was a result of immunization is the most common due to improper procedures and technical implementation (programmatic errors).

Epidemiology Kipi

The incidence of post-immunization follow-up will occur after administration of the vaccine in large quantities. Study the efficacy and safety of vaccines produced through the usual phases of clinical trials, the phase 1, 2, 3, and 4. Phase 1 clinical trials conducted on laboratory animals to humans, while the next phase. Phase 2 clinical trials to determine the safety of the vaccine (reactogenicity and safety), while in the third phase also tests other than security effectiveness (immunogenicity) vaccine.

In a limited number of vaccine recipients may Kipi is not visible, then it need the Kipi to assess the phase 4 clinical trials with large samples, known as post-marketing surveillance (PMS), PMS objective is to monitor and determine the safety of vaccines after the use of a fairly widespread in the community (in this case the immunization program). PMS data can provide benefits to the program if all Kipi (especially Kipi weight) were reported, and the problem resolved soon. Instead it will hurt if the program did not immediately respond to the problems that arise Kipi causing public unrest against the side effects of the vaccine with all its consequences.

According to the National Childhood Vaccine Injury of the Committee of the Institute of Medicine (IOM) in the USA is very difficult to obtain because the data Kipi by:

     Biological mechanisms are less understood phenomenon Kipi
     Kipi Data reported less detailed and accurate
     Kipi surveillance has not been extensive and thorough
     Kipi yet dilakukari surveillance for long-term
     Publication Kipi in a large number of cases are still lacking.

In view of the above it is very difficult to determine the actual number of cases Kipi. Co-occurring post-immunization can be mild to severe, especially in mass immunization or after the use of more than 10,000 doses.

etiology

Not all events are caused by immunization Kipi because most did not have anything to do with immunization. Therefore fatherly determine Kipi necessary information on:

     Kipi on a large frequency of occurrence of certain vaccine
     The nature of local or systemic disorders
     the degree of pain the recipient
     if the cause can be confirmed, suspected, or proven
     whether it can be concluded that Kipi associated with the vaccine, production errors, or errors procedure

KN PP Kipi Kipi divides the causes into five groups according to the classification by aetiological factor WHO Western Pacific (1999), namely:

     Error program / ​​technical implementation (programmic errors)

Most cases of Kipi-related problems and technical implementation of the immunization program which includes a program error storage, management, and administration of the vaccine. Errors can occur at different levels of immunization procedures, for example:

         Antigen dose (too much)
         Location and how to inject
         Sterilization of syringes and needles
         Used needles
         Aseptic and antiseptic action
         Contamination of vaccines and injecting equipment
         vaccine storage
         Use leftover vaccine
         The type and amount of solvent vaccine
         Do not pay attention to the manufacturer's instructions

Suspicion of errors governance need to be considered if there is a trend repeated in the case of Kipi same officer.

     reaction injection

All the clinical symptoms caused by trauma puncture needles either directly or indirectly, should be recorded as a reaction Kipi. Reaction injection directly eg pain, swelling and redness at the injection site, whereas indirect injection reactions such as fear, dizziness, nausea, until syncope.

     Induction vaccine (vaccine reactions)

Kipi symptoms caused by the induction of general vaccine could have been predicted in advance because it is a vaccine adverse reactions are usually mild and clinically. Nevertheless, the clinical symptoms can occur is superb as a systemic anaphylactic reaction with the risk of death. These adverse reactions have been well identified and listed in the user guide is written by the manufacturer as a contra indications, specific indications, special attention, and attention atauberbagai other specific actions, including potential drug interactions or other vaccines. These instructions must be considered and responded well by implementing immunization.

     Coincidence (coincidence)

As already mentioned above, the incident arose due to chance alone after being immunized. Indicator coincidence is marked by the discovery of the same events at the same time the local population groups with similar characteristics but not immunized.

     The cause is not known

If the reported incident or problem can not be grouped into one cause it to temporarily put into this group while waiting for more information. Usually denagn completeness of such information will be determined groups of causes of Kipi.

classification Kipi

Kipi Assessment and Management Commission (Commission Regulation Kipi) classify the etiology of Kipi in 2 classifications are:

     According to the WHO classification by Western Pacific (1999) for health workers in the field.
     Classification of causality according to the IOM in 1991 and 1994 to study the PP Kipi Commission.
     Classification field (WHOWestern Pacific 1999)

In accordance with the value in the field, the National Commission for PP-Kipi wearing Western Pacific WHO criteria for sorting out the cause of Kipi in five groups, namely the error program, injection site reaction, vaccine reactions, coincident, and the cause is unknown. Classification of this field can be used for recording and reporting Kipi.

     Error program / ​​technical implementation (programmatic errors)

Most cases of Kipi-related problems and technical implementation of the immunization program which includes a program error storage, management, and administration of the vaccine. Errors can occur at different levels of immunization procedures, for example:

     antigen dose (too much)
     location and injecting
     sterilization of syringes and needles
     used needles
     aseptic and antiseptic action
     contamination of vaccines and injection equipment
     vaccine storage
     use the rest of the vaccine
     the type and amount of solvent vaccine
     do not pay attention to the manufacturer's instructions (user guide, contra indications and others)

Suspicion of errors governance need to be considered if there is a trend repeated in the case of Kipi same officer.

Prevent a program error

     For each syringe injections
     · Solvent vaccine that has been provided by the manufacturers of the vaccine
     Vaccines that have been dissolved immediately discarded after 6 hours
     the refrigerator should not be any drugs other than vaccines
     Training vaccinations and supervision that good
     Program errors are tracked, so as not to repeat the same mistakes

     reaction injection

All the clinical symptoms caused by trauma puncture needles either directly or indirectly, and should be recorded as a reaction Kipi. Reaction injection directly eg pain, swelling and redness at the injection site, whereas indirect injection reactions such as fear, dizziness, nausea, until syncope. This reaction is not related to the content contained in the vaccine, mass vaccination pd common are:

     Syncope / fainting
         Often in children> 5 years,
         Occurred a few minutes post immunization,
         No need special handling.
         Avoid stress when the child is waiting,
         Avoid the trauma of the fall / positions should be seated.
     Hyperventilation due to fears
         Some small children vomiting, breath holding spell,
         Sometimes screaming, running and even reactions such as seizures (patients need to be examined)
     Some children are afraid of needles, trembling, hysteria.
     Important explanations and appeasement

Prevention Kipi reaction injection reaction with:

- Correct injection technique

- Quiet atmosphere injection site

- Overcome the fear that a child who appears larger pd

     Induction vaccine (vaccine reactions)

Kipi symptoms caused by the induction of general vaccine could have been predicted in advance because it is a vaccine adverse reactions are usually mild and clinically. Nevertheless, the clinical symptoms can occur is superb as a systemic anaphylactic reaction to the risk of death. These adverse reactions have been well identified and listed in the user guide is written by the manufacturer as a contra indications, specific indications, special attention, or a variety of other actions and specific attention, including possible interactions with other drugs or vaccines. These instructions must be considered and responded well by implementing immunization.Vaccine reactions consisted of:

     Local reactions:

     Pain at the injection site.
     Swelling, redness around the injection place 10%
     Swelling of the DPT and tetanus injections about 50%
     BCGscar occur after a minimum of 2 weeks later ulcerated and healed after a few months.

      Systemic reactions:

o Heat at about 10%, except DPT nearly 50%, are also others such as irritable reactions, malaise, systemic symptoms.

o MMR and measles, systemic reactions caused by infection with the vaccine virus. Heat and or rash occurs and conjunctivitis at 5-15% and milder than measles infection but in patients with severe immunodeficiency.

o At the mumps vaccine reaction parotid gland swelling, joint pain rubella occurred 15% and lymph node swelling.

o OPV is less than 1% diarrhea, headache and muscle aches.

     Severe vaccine reactions:
     convulsions
          thrombocytopenia
     Hypotonic hyporesponsive episodes / HHE
     Persistent inconsolable screaming is self-imiting and do not constitute long-term problems
     Anaphylaxis, the potential to be fatal but can disembuhan without long-term effects
     Encephalopathy due to measles or DTP immunization

Prevention of vaccine reactions:

     Note the contra indications.
     Live vaccines are not given to children with immune deficiency.
     Parents are taught to handle mild vaccine reactions and recommended immediate reply back if there is a reaction that worried.
     Paracetamol can be given 4 times a day to reduce fever and pain.
     Know and be able to cope anaphylactic reactions.
     Others adapted to the mild reaction / weight that occur or should be referred to the hospital with full facilities.

       Coincidence (coincidence)

Incidents arising out of this happened by chance alone after immunization. Indicators of chance discovery characterized by the same event at the same time the local population groups with similar characteristics but not immunized.

     The cause is not known

If the reported incident or problem can not be grouped into one cause it to temporarily put into this keiompok sambi! wait for Informat [further. Usually the completeness of the information would cause Kipi groups can be determined.

World Health Organization in 1991 meialui expanded program on Immunisation (EPI) has recommended that reporting Kipi made ​​by each country. For developing countries the most important is how to control and reduce programmatic errors vaccine, including how to use the syringe properly, tool disposable or reusable syringes, and injecting the correct way so that the transmission of blood-borne pathogens can be avoided. It also stressed that in order to minimize the occurrence of Kipi should always endeavor to increase the accuracy of immunization during the immunization program implemented.

     classification of causality

Vaccine Safety Committee in 1994 made ​​a slightly different classification Kipi Comittee reports the Institute of Medicine (1991) and became the basis of the current classification, namely:

     There is no evidence of a causal relationship (unrelated)
     Not enough evidence to accept or reject a causal relationship (unlikely)
     Evidence of a causal relationship strengthens rejection (possible)
     Proof of receipt strengthen the causal relationship (probable)
     Evidence ensure causal relationship (very like / on certain)Table 1: Kipi on vaccines DT / Td / TT, measles, OPV / IPV, DPT. Hepatitis B and Hib based causality.