Octapharma News August 22th, 2003

August 22th, 2003

Plasma Self-Sufficiency Symposium Brazil: (Part 2)

Sat 9th August, São Paulo, Brazil

As reported last week, Octapharma recently sponsored a satellite symposium on: “The Role of Plasma in transfusion medicine and self-sufficiency programmes.” during the 26th Congress of the Brazilian Society of Haematology and Haemotherapy (SBHH).

The first speaker, Dr Eva Fontes described the current situation with regard to the national haemoderivative self-sufficiency project in Brazil (more…)

Product	Quantity
FVIII (Octavi SDOptimum)	> 10 M IU
FIX (Octanyne)	> 23 M IU
VIG (Octagam)	> 2,000 kg
Albumin	> 350 kg

From January 2002- April 2003, >130 litres of Brazilian plasma have been contract fractionated by Octapharma in our Lingolsheim production facility. As of April 2003, the following products have been returned to Brazil.

Whilst self-sufficiency has been achieved for both FIX and IVIG, there is an urgent need for more plasma in order to increase the availability of Brazilian plasma derived FVIII and albumin.

Judi Miller

This issue was addressed by the second speaker – Judi Miller, Scientific Director of Octapharma.

Increasing the volume of plasma available for self-sufficiency fractionation can be achieved by:

1. increasing donor numbers
2. improving donor retention and motivation
3. increasing donation frequency
4. increasing donation volume
5. reducing donation rejection / wastage
6. optimising collection and freezing procedures
7. decreasing the use of whole blood and cryoprecipitate
8. decreasing the use of FFP for transfusion

Judi Miller began by reminding the audience that Fresh Frozen Plasma (FFP) is the most common blood component to be used inappropriately in clinical practice. Over-use of FFP not only exposes patients to unnecessary risk but reduces the volume of plasma available for fractionation and thus increases the costs for plasma derivatives as finished goods must be imported to bridge the self-sufficiency gap.

Potential risks associated with FFP transfusion include:

Pathogen transmission
Allergic reactions
Anaphylactoid reactions
Reaction to leukocyte & platelet antibodies
- Febrile Non-Haemolytic Transfusion Reaction (FNHTR)
- Post Transfusion Purpura (PTP)
- Transfusion Related Acute Lung Injury (TRALI)
- Graft-Vesus-Host-Disease (GVHD)
Allo-immunisation
Fluid overload
Citrate Toxicity

Given the above risks, many countries have produced guidelines for the use of FFP. Although such guidelines are not identical most agree that FFP should only be used in the following clinical circumstances:

Indication	Consideration
Warfarin Effect	Use specific factors if available
Acute DIC	Indicated for bleeding & abnormal coagulation
TTP	Accepted treatment
Coagulation Inhibitor deficiencies	May be appropriate in patients undergoing high-risk procedures
Massive Transfusion	Appropriate in the presence of bleeding & abnormal coagulation
Cardiac Bypass	Appropriate in the presence of bleeding & abnormal coagulation
Liver disease & transplantation	Appropriate in the presence of bleeding & abnormal coagulation

Contraindications include: hypovolaemia, plasma exchange procedures (except in TTP), bleeding in the absence of coagulopathy, treatment of immunodeficiency states & nutritional use.

Despite the presence of guidelines, a number of retrospective audits have shown the continued abuse of FFP. A 1999 evaluation of FFP transfusion over a 6 month period in one Mexican hospital, for example, revealed that 96.23% was inadequately indicated Rev Med Hosp Gen Mex 1999; 51(2): 89-92

The audience were then offered a number of practical suggestions for reducing FFP use:

	Perform national prospective study to identify the current patterns of use of FFP
	Obtain national commitment to reduce inappropriate use of plasma
	Introduction of national guidelines for FFP
	Introduction of informed consent for recipients of labile blood products
	Increase use of blood and plasma salvage during surgery
	Substitution of FFP with a virus inactivated plasma such as Octaplas®
	Appointment of transfusion teams or coordinators with a remit for education, monitoring and audit.
	Review of all requests for FFP manually or using computer algorithm
	Use of an FFP dose/weight chart is recommended to eliminate over and under-dosage
	Reduce the use of FFP for immediate reversal of Warfarin anticoagulation by: better availability of Prothrombin Complex Concentrate for the treatment of life-threatening bleeding judicious use of Vitamin K better planning of elective procedures

Introduction of such measures can be extremely effective in reducing FFP usage. Judi Miller went on to describe the effect of introducing computerised audits of all blood requests in Italy
Marconi M. Tumori, 2001;87:S14-S16

	N° Requests	Compliance (%)
1995	1112	60
1996	1010	71
1997	1040	64
1998	967	70
1999	1098	86.5
2000 (Jan-Jun)	366	95.5

In parallel with a national commitment to reducing the use of FFP, Brazil should also concentrate on programmes to increase the number of donations, increase the volume of plasma/ donation, expand the number of accredited blood banks authorised to supply plasma to the national fractionation project, and optimise freezing and storage temperatures of plasma.

If such measures are undertaken, Brazil can look forward to the day when it joins countries such as Norway who, in partnership with Octapharma, have been able to achieve close to 100% self-sufficiency. To view the original presentation from Judi Miller please click here