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  • TEC10: What kind of data and records are needed to monitor the use of IVIG ?
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What kind of data and records are needed to monitor the use of IVIG ?

Authors: Jesús González-Enríquez, Nadine Berndt, Houria Mouas

Internal reviewers: Romana Tandara Haček, Mirjana Huic, Anna-Theresa Renner

Refer to domain search and domain methodology section.

Detailed documentation of IVIG infusions should include the patient’s current health status and any changes in this status in the period between IVIG infusions; the name, dose and the lot numbers of the product; any pre-medications which were given; time duration of the infusion and specific rate titrations which were made; and any problems or adverse reactions  the patient experienced during the infusion and how they were managed.

Prior to the first administration { NZ Clinical Immunology Group, 2013; ACT Health, 2013; Octapharma 2014; Baxter 2011;Younger, 2012 }{32,33,36,37}:

- Serological testing for prior exposure to or infection with known blood pathogens (such as EBV, CMV, HBV, HCV, HIV) and appropriate vaccinations should be considered

Prior to each administration:

- A signed informed and written consent should be obtained from the patient, who should have received full information on the description of IVIG, their nature of blood product, the associated risks and benefits as well as alternatives to this treatment.

- The prescription from the physician for

•          the IVIG with the date, the identification of the patient, the particular IVIG product, the dose based on the patient weight, rate and duration of infusion

•          a premedication if needed.

•          specific instructions must be in place in case adverse events occur (headache, flu-like symptom, allergic reaction, malaise, nausea).

- Record of brand and assessment that it matches the physician prescription, the manufacturer, lot number, expiry date, dose of the product and identification of the patient.

For each administration:

- The integrity and quality of the IVIG should be assessed prior to the use, all refrigerated products should be at room temperature, the reconstitution of the product should be done per manufacturer’s guidelines, prescriber’s orders and following aseptic technique.

- The health status and the body weight of the patient prior to the infusion should be assessed and recorded. The dosage of the product should be adapted in case of any significant change of the body weight.

- The administration of the product should be carefully monitored and observed for any symptoms or alteration of vital signs throughout the infusion period and for at least 20 minutes after administration. In addition, a monitoring of the renal function and of the diuresis is required as well as a good hydration of the patient. As certain adverse reactions are more frequent in case of a high rate of infusion, during the first administration of IVIG, in case of switch between specific products and /or re-challenge infusion, or depending on patient medical condition and pre-existing risk factors, a low initial rate of infusion - which depends of each product - should be respected and may be gradually increased if the infusion is well tolerated by the patient. Should an adverse reaction happening (e.g. hypersensitivity with anaphylactic reaction, hyperviscosity complications such as thromboembolic events, acute renal failure, aseptic meningitis syndrome, haemolysis), then the vital signs should be checked and documented, the rate of infusion should be decreased or stopped and standard medical treatment should be implemented.

After the administration:

- Records of the infusion and declaration of any adverse reaction.

- Assess and record the need for a premedication for future infusions and ensure its prescription and availability for the next infusion.

- Records of the discard of any remaining product.

- Every 6 to 12 months:

-           Long term complications of IVIG such as renal impairment, hemolytic anemia.

-           Blood-borne infections.

Important
Partially
González-Enríquez J et al. Result Card TEC10 In: González-Enríquez J et al. Description and technical characteristics of technology In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 24 October 2020]. Available from: http://corehta.info/ViewCover.aspx?id=267

References