Current Blood Programme and Measure to Secure the Safety of Blood Products in Japan

1
Current Blood Programme and Measure to Secure the
Safety of Blood Products in Japan
For a stable supply of safe blood products

• The Japanese Red Cross Society
• Fukuoka Red Cross Blood Center
• Technical Director, Kazuo Tokunaga

2
Changes in the volume of paid blood, banked blood
and donated blood
Unit ten thousand L
Bleeding and Blood Donor Supply Service Control
Law
Cabinet decision
Pharmaceutical Affairs Law
3
Changes in the number of donors (all over Japan)
(persons)
10 millions
130M peoples
Young donors are decreasing.
1 million
4
Changes in the supply of blood products for
transfusion (all over Japan)
Apheresis PC
(x 1000)
Finance of the BC become difficult due to the
decrease of supply and increase of cost for
safety.
5
Blood products for transfusion are supported by
100 through domestic products
MAP red cells PC Platelet Concentrate FFP Fresh
Frozen Plasma
Plasma Derivatives are depending on imports
46 of self-sufficiency ratio in albumin 88 of
self-sufficiency ratio in immunoglobulin 48 of
self-sufficiency ratio in Coagulation factor
VIII with the exception of imported
gene-modified blood products
Data of 2003 (Heisei 15)
Promotion of 100 of self-sufficiency with
domestic products by 2008 FY
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Law on Securing a Stable Supply of Safe Blood
Products

• A Law to revise a part of the Pharmaceutical
  Affairs Law and the Bleeding and Blood Donor
  Supply Service Control Law

The enforcement date was July 30, 2003 (Heisei
15)
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Law on Securing a Stable Supply of Safe Blood
Products

• Fundamental Principles
• To improve the safety of blood products
• To secure a domestic supply of blood products and
  
• to maintain a stable supply of blood
  products
• 3. To promote appropriate use of blood products
• 4. To ensure fairness and improve transparency
  in managing the blood program

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Law on Securing a Stable Supply of Safe Blood
Products

• Responsibilities of the those involved in the
  blood program
• Based on the fundamental principles of this
  Law,
• The national government must implement and
  perform basic and comprehensive measures for
  improvements of safety and for securing a stable
  supply of blood products, by striving to
  establish measures, policy and other necessary
  actions so as to educate, cultivate and promote
  peoples understanding and cooperation for blood
  donation and appropriate use of blood products.
  The basic policy for blood products is that blood
  products must be self-sufficient and must be from
  a secured stable supply.
• 2. Prefectural and municipal governments shall
  take necessary measures to obtain citizens
  understanding of blood donation and to assist
  blood collectors in the smooth acceptance of
  blood donation.

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Law on Securing a Stable Supply of Safe Blood
Products
Responsibilities of the those involved in the
blood program Based on the fundamental
principles of this Law, 3. Blood collectors must
strive to promote acceptance of donated blood, to
cooperate for improvements in safety, to secure a
stable supply of blood products and to protect
donors. 4. Manufacturers distributors of blood
products and others must strive to develop
techniques that contribute to securing a stable
and appropriate supply and improving the safety
of blood products they must also strive to
collect and provide information about such
techniques 5. Doctors and other medical
professionals must strive to use blood products
appropriately they must also strive to collect
and provide information concerning the safety of
blood products.
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Measures to secure the safety of blood products
Screening test, Inquiry of blood donation
history by centralized computer system
Interview, Self declaration
Blood donation
6 months storage period
Nucleic acid amplification test for HBV, HCV and
HIV
Viral inactivation
Virus clearance
FFP6 months storage period
Blood products for transfusion
Plasma derivatives
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Examination items of blood for transfusion
12
Total number of national HIV reports and the
number of donors with HIV positive
199910.04/M
200620.36/M
19871.34/Million
13
NAT implementing facilities and delivery of
specimens for NAT
20 to 30 thousands of specimens per day
60 BC will be centralized to 11 testing Labs in
2008 FY 20 plants in several years to improve
safety and efficiency
24 hours work
Chitose NAT Centre
Fukuchiyama NAT Centre
Tokyo NAT Centre
1999
Fukuoka
NAT (amplification, detection)
(1.52h)
Centralized testing Laboratory Manufacturing
plant In Jan. 2008
Automatic amplification equipment
Okinawa
Amplification and detection of extracted nucleic
acid
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Mainly through sexual intercourse
15
Legislating of the reports on the adverse effects
from medical institutions
The pharmaceutical Affairs Law Specific
Biological Products
Medical institutionsPharmacies
Legislating of the reports on the direct adverse
effects
Ministry of Health, Labour and Welfare
Manufacturers, etc.
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The Japanese Red Cross Society, Blood Management
Centre
Source plasmas
Donated blood specimens
Source plasmas
Donated blood specimens
The Japanese Red Cross Society, Plasma
Fractionation Centre
The Japanese Red Cross Society has 2 storage
facilities mentioned above that realize only in
the world the 10 years of storage for all the
specimens of donated blood since 1996 and 6
months of accumulation storage for source plasma
derived from donated blood (safety confirmation)
since 2005.
17
Risk of virus transmission by transfusion as the
result of look-back study - preliminary result-

• HBV
• 16-25 cases of infection per year
• 1 infection per 300-400 thousands of bags of
  donated
• blood
• HCV (difficult to estimate due to few cases)
• 1 or more blood product with individual NAT
  positive in
• 4 years (24 millions of bags)
• HIV (difficult to estimate due to few cases)
• 2 cases of blood with individual NAT positive
  in 4 years
• 1 or more case of infection in 4 years

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The staff of medical institutions are asked

• To contribute to collect and provide the
  information about the look-back review including
  the recipient information, etc.
• To implement the marker tests of infectious
  diseases after transfusion based on the
  Guidelines for blood transfusion practices.
• To continue to promote more right and appropriate
  use of blood products.
• To establish a transfusion therapy committee in
  hospitals, a system of responsible doctor and a
  blood transfusion division.
• To make records on the name and address of
  treated patients, date of treatment or
  prescription, name of product and its
  manufacturers serial number and lot number, and
  to store for 20 years or longer from the date of
  use.

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Approach of the Japanese Red Cross Society
on securing safety measures

• 1. Accuracy improvement of NAT (nucleic acid
  amplification test) was made by reduction in the
  number of specimen pools (50 to 20) in
  August,2004.
• 2. Identity verification at the time of the
  acceptance of blood donation by
  presentation of an ID card Drivers license,
  Passport, etc since October, 2004.
• 3. Accumulation storage of FFP (fresh frozen
  plasma) is prolonged to 6 months (180 days) from
  July, 2005.
• 4. Introduction of inactivation technique of
  infectious agents has been considered for several
  years but not introduced yet.

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Approach of the Japanese Red Cross Society
on securing safety measures

• Leukocyte removal before storage was introduced
  into platelet products and plasma products
  derived from apheresis in October, 2004 and July,
  2005, respectively, and will be introduced into
  each blood products from whole blood donation in
  January,2007 with a standard of white blood cell
  count 1x106 or less per bag.
• 6. Creation of self-imposed guideline of
  look-back review was done in August, 2004 and the
  Guidelines for Look-back studies was prepared by
  the Ministry of Health, Labor and Welfare in
  April, 2005.

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Approach of the Japanese Red Cross Society on
securing safety measures

• 7. Complete count survey regarding
  post-transfusion infections in medical
  institutions. We found more than 10 patients
  have already had antibody against HCV and HBV.
• Epidemiologic survey on HEV was done using the
  sera with high level of ALT, and found that HEV
  existed in Japan, especially at the Hokkaido
  Island. HEV NAT is routinely done for samples
  collected in Hokkaido.
• 9. The bacterial diversion system during
  collection of apheresis platelet was started
  since October, 2006 and will be introduced to the
  collection of whole blood since January, 2007,
  too. The first 25mL of a donation is inverted
  into a sample pouch and then used for standard
  donation accreditation testing.

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The Blood Services Headquarters of Japanese
Red Cross Society will continue to strive for
a Stable supply of further safe blood products
for the patients in spite of the severe
financial condition. 60 BC will be
centralized to 11 testing Labs in 2008 FY to
20 manufacturing plants in several years in
order to improve safety and efficiency.
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Thank you for your kind attention.