Octapharma News August 15th, 2003

August 15th, 2003

Self-Sufficiency Symposium Brazil: rationale for National Plasma Derivatives programme (Part 1)

Sat 9th August, São Paulo, Brazil

More than 500 key clinicians and government officials attended an Octapharma sponsored satellite symposium entitled: “The Role of Plasma in transfusion medicine and self-sufficiency programmes.”

The symposium was held as part of the 26th Congress of the Brazilian Society of Haematology and Haemotherapy (SBHH) which was held in São Paulo from 6th-9th August.

Opening the symposium, SBHH President, Dr. Dante Mário Langhi, acknowledged the enormous importance of the ongoing Brazilian plasma self-sufficiency project both in terms of potential economic savings and as a step towards achieving greater access and equality of health care.

Dr. Eva Fontes, Head of the Haemostasis Deparment, Hemorio (Rio de Janeiro) gave a fascinating overview of the world market for plasma derivatives.
By comparing plasma with petroleum, she clearly demonstrated the value of the precious “liquid gold” used as the starting material for plasma fractionation.

	Petroleum	Plasma
Fractionationed:	into diverse sub-products	into diverse sub-products
Annual production:	16 Billion barrels (1 barrel=200 litres)	61 Million litres
Major Producer:	OPEC	USA
Annual World Market:	US$ 500 Billion	US$ 20 Billon
Value of fractionated derivatives from 1 barrel:	US$ 45	US$ 70,000

Dr. Eva Fontes

In addition, Dr. Fontes described the history of plasma product manufacturing from the development of Cohn fractionation in the 1940´s through to the exponential growth of intravenous immunoglobulins (IVIG) in the 21st century. She then went on to explain that although there had previously been some production of haemoderivatives in Brazil, all facilities have now closed with the exception of a small pilot scale manufacturing plant for albumin in the state of Pernambuco.

Brazil collects approximately 3 million units of plasma per year, of which, close to 1.8 million (356,000 litres) should be available for fractionation either in Brazil or by foreign contract manufacturers, such as Octapharma. However, due to the large number of units that are discarded due to positive serology or other donor risk factors, inadequate freezing and storage facilities, non-accreditation of some blood banks and a nationwide abuse of fresh frozen plasma (FFP) for transfusion -the volume of plasma delivered for fractionation between January 2002 and April 2003 was only 130,000 litres.

In order to address this situation a national plan has been launched, to increase quality, safety and availability of blood and plasma derivatives.

Key objectives of the Brazilian national plasma derivatives programme include:

Supply the country with haemoderivatives produced from Brazilian plasma
Rationalise use of Brazilian donations & maintain ethical respect for donors
Eliminate the wastage of plasma in blood banks
External contract fractionation of excess Brazilian plasma
Construction of a plasma fractionation facility in Brazil
Achieve self-sufficiency

Currently, Brazil has achieved self-sufficiency for FIX and IVIG (although the latter is due to the fact consumption of IVIG is <15% of the theoretical demand and <5% of usage in more developed countries). 25% of Brazil´s albumin requirements and 15% of FVIII demand are currently met through self-sufficiency.

Fundamental to increasing these percentages and achieving self-sufficiency will be a significant reduction in the volume of FFP used for transfusion. Brazilian data from 1990 (Amorim & Lopes) showed that only 25% of FFP transfusions were for justified indications:

FFP use in Brazil 1990

Indication	%
Hypovolemia with hypoalbuminaemia	36%
Hypovolemia without hypoalbuminaemia	30%
Bleeding without coagulopathy	6%
Nutritional use	25%
Haemorrhage with coagulopathy	25%

By 1998 the situation was even worse!

FFP Usage in Brazil 1998 (Lopes & Amorim)

Correct Indications	Possibly Justified Indications	Unjustified Indications
7.8%	15.4%	74.7%

Coming next week… part 2 of this symposium report will cover the second speakers presentation in which practical suggestions were offered to reduce the abuse of FFP and to increase the overall availability of plasma for the Brazilian self-sufficiency project.

To view the original presentation from Dr Eva Fontes (in Portuguese) please click here

© Octapharma AG, 2003