Codificação da injeção de imnunoglobulina Anti-D (Rh)

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Codificação da injeção de imnunoglobulina Anti-D (Rh)

Mensagem por amaral bernardo em Seg 16 Jul 2018, 10:12

"Eu tenho codificado a injecção de imunoglobulina como 30233S1, ou o Coding Clinic indica outro código?"


(Responde Fernando Lopes)
 
O Coding Clinic do 4Q 2014 p.16 diz "Assign 3E0234Z, Introduction of serum, toxoid and vaccine into muscle, percutaneous approach, for the intramuscular administration of Rh (D) immune (anti-D immune globulin)."
 
Temos, então:
30233S1 Transfusion of Nonautologous Globulin into Peripheral Vein, Percutaneous Approach
3E0234Z Introduction of Serum, Toxoid and Vaccine into Muscle, Percutaneous Approach
Qual utilizar?
 
Para responder a esta questão é necessário saber se a imunoglobulina administrada é um 'medicamento' ou uma 'transfusão'.
 
"Manufacturing and safety
Rho(D) immune globulin is a derivative of human plasma. The most common way anti-D products are manufactured is by a form of the Cohn cold ethanol fractionation method developed in the 1950s. Variations of the Cohn method developed in the 1950s may not completely clear aggregates of immunoglobulins, which can cause problems for patients if administered intravenously, and is a primary reason why most anti-Ds are for intramuscular use only. A non-Cohn manufacturing variation is ChromaPlus process approved by the U.S. Food and Drug Administration (FDA) that is used to make Rhophylac.[22] Rho(D) immune globulin may trigger an allergic reaction. Steps are taken in the plasma-donor screening process and the manufacturing process to eliminate bacterial and viral contamination, although a small, residual risk may remain for contamination with small viruses. There is also a theoretical possibility of transmission of the prion responsible for Creutzfeldt–Jakob disease, or of other, unknown infectious agents." (Wikipedia: Rho(D) immune globulin)
 
"OCTAGAM®️ 10% is a sterile liquid preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. It is prepared by cold-ethanol fractionation of donated human fresh frozen plasma. Viral inactivation is accomplished by a solvent detergent (S/D) method and a specific pH 4 treatment. The pH 4 treatment also reduces anti-complementary activity and aggregation of the IgG polymers. Residual S/D reagents are removed by extraction and chromatography before sterile filtration. Residual ethanol is removed via ultra-/diafiltration. The whole manufacturing process is carried out at a low pH in order to maintain the nativity of the IgG molecules. After addition of maltose the 10% IgG solution is sterile filtered and filled into siliconized glass vials. The final product is salt free and no dilution with saline solution is needed prior to its administration. This product is prepared from large pools of human plasma, which may contain the causative agents of hepatitis and other viral diseases (see WARNINGS AND PRECAUTIONS section)." (Octafarma: OCTAGAM®️ 10%Immune Globulin Intravenous (Human)Solution for Infusion, 100 mg/mL)
 
Parece não restarem dúvidas de que a imunoglobulina anti-D é produzida a partir de grandes quantidades de plasma humano.
A sua purificação/fabrico transformá-la-á num 'medicamento'/'soro' para que a sua administração se considere uma 'injeção'?
Deixo a questão à consideração da comunidade.
Quem puder não deixe de se pronunciar.
 
Obrigado.
Fernando Lo
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amaral bernardo

Mensagens : 57
Data de inscrição : 19/12/2016

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