Guidance for Industry
Recommendations for Donor Questioning Regarding Possible Exposure to Malaria
[PDF version of this document]
Draft Guidance
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this document should be submitted by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
Additional copies of this draft guidance are available from the
Office of Communication, Training and Manufacturers Assistance
(HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by
calling 1-800-835-4709 or (301) 827-1800, or from the Internet at
http://www.fda.gov/cber/guidelines.htm
For questions on the content of this draft guidance contact Mark
Heintzelman, Ph.D., by telephone at (301) 827-3524, or by telefax
at (301) 827-3534.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
June 2000
TABLE OF CONTENTS
- INTRODUCTION
- BACKGROUND
- RECOMMENDATIONS
- IMPLEMENTATION
- REFERENCES
Guidance for Industry
Recommendations for Donor Questioning Regarding Possible Exposure to Malaria
Draft - Not for Implementation
This guidance document represents FDA's current thinking on malarial risks for prospective blood donors. It does not create or confer any rights for or on any person and does not operate to bind FDA or
the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. |
- INTRODUCTION
This guidance document provides the recommendations of the Food and
Drug Administration (FDA) for donor questioning regarding travel to
vacation resorts located in malarious regions. These recommendations
apply only to donations containing intact red blood cells or
platelets. Donations used for preparing plasma, plasma components or
derivatives devoid of intact red blood cells or platelets are
excluded. In addition, the term "resident" is being defined for the
purposes of malarial deferral, to be a person that has resided in a
malarious area for five years or longer. This guidance document,
when finalized, will replace the recommendations in the guidance
entitled, "Recommendations for Deferral of Donors for Malaria Risk"
dated July 26, 1994, for deferral of blood donors for malaria risk.
Table of Contents
- BACKGROUND
Surveillance studies conducted by the Centers for Disease Control
and Prevention (CDC) since 1974 indicated no change in the frequency
of transfusion-transmitted malaria, estimated at 0.25 cases per
million blood units collected, compared with the experience under
previous donor deferral practices (Ref. 1). Nevertheless, more
recently obtained scientific data led some researchers and the
American Association of Blood Banks to reexamine the standards then
in place (Ref. 2, 3) and to propose revised standards for donors at
risk for malaria.
FDA brought this issue to public discussion at the June 29, 1993,
meeting of its Blood Products Advisory Committee. Subsequently, FDA
issued guidance to blood establishments regarding the deferral of
blood donors at increased risk for malaria in a guidance of July 26,
1994, entitled, "Recommendations for Deferral of Donors for Malaria
Risk." That guidance states that permanent residents of countries
where malaria is not endemic and who travel to an area considered
endemic for malaria by the Malaria Branch, CDC, Department of Health
and Human Services, should not be accepted as donors of Whole Blood
and blood components for one year after departure from the endemic
area, regardless of whether or not they have received anti-malarial
chemoprophylaxis. Currently, there are no approved tests to screen
donated blood for malaria, careful questioning is essential for
identifying prospective donors at risk for transmitting malaria.
Blood establishment personnel should carefully elicit the necessary
information regarding travel and disease history in order to defer
those at risk. Two recently reported fatal cases of transfusion-
acquired malaria underscore the need to maintain vigilance in
deferral of at-risk donors (Ref. 4, 7).
Four species of plasmodia infect humans: P. falciparum, P. malariae, P. ovale, and P. vivax. They are transmitted by infected female Anopheles mosquitoes. The malarial organisms have a worldwide distribution and are endemic in areas with Anopheles mosquitoes and
a human reservoir (Ref. 5). At the present time, malaria has
essentially been eradicated from most of Europe, the United States,
Australia, and Japan. It has not been naturally transmitted in
climates such as exist in Canada, the Nordic countries, and northern
Russia. The risk of developing malaria is directly proportional to
the density of the human reservoir, the density of the vector
population, and the resulting amount of exposure. In general, even
in endemic countries, there is little risk at altitudes above 5000
feet of elevation, and less in more temperate climates. Urban areas
are generally safer than rural ones (Ref. 5). Since female Anopheles
mosquito activity occurs primarily from dusk to dawn, risk of
exposure to malaria is highest at this time period. Nonetheless, it
is impossible to fully identify each and every individual's exposure
in an endemic area and the safety level required for the nation's
blood supply necessitates that visitors to areas endemic for malaria
be deferred regardless of the time of day of exposure. The Blood
Products Advisory Committee discussed this issue at their June 1999
meeting, and voted against allowing travelers to endemic areas to
donate blood, regardless of the time of day for the travel.
FDA has received requests for clarification regarding whether exclusion of travelers as blood donors, should include visitors to resorts located in rural areas in Mexican states considered at risk for malaria by the CDC (as listed in CDC's Health Information for International Travelers , known as the "CDC Yellow Book" or on CDC's web site, www.CDC.gov). This issue was discussed at a public meeting of FDA's Blood Products Advisory Committee on December 12, 1996. Since that time, FDA has reviewed the available information on risk of malaria at Mexican resorts. CDC provides information regarding these geographical areas and the risk of malaria.
Blood establishments are advised that the "CDC Yellow Book" is
revised periodically by the CDC, and blood establishment Standard
Operating Procedures and deferral practices should keep pace with
such revisions. The level of safety required for the blood supply
necessitates that standards be set such that risks for malaria that
may not require chemoprophylaxis for travelers may result in deferral
as a blood donor.
Table of Contents
- RECOMMENDATIONS
FDA's recommendations for deferral of blood donors at increased risk
for malaria are as follows:
- Permanent residents of non-endemic countries who travel to
an area considered endemic for malaria by the Malaria
Epidemiology Section, CDC, should not be accepted as donors
of Whole Blood and blood components, including platelets, prior
to one year after departure from the endemic area. After one
year has passed since departure from the malarious area, such
otherwise suitable prospective donors may be accepted provided
that they have been free of unexplained symptoms suggestive of
malaria and regardless of whether or not they have received
antimalarial chemoprophylaxis.
- Prospective donors who have had malaria and received an
appropriate treatment should be deferred for three years after
becoming asymptomatic.
- Persons that have previously resided in endemic countries
and now reside in the United States, such as immigrants,
refugees, citizens, or residents (for at least five years) of
endemic countries should not be accepted as donors of Whole
Blood or blood components, including platelets, prior to three
years after departure from the area. After the three year
period, otherwise suitable prospective donors may be accepted
if they have remained free of unexplained symptoms suggestive
of malaria.
- Persons that may possess a partial acquired immunity to
malaria, such as those that have previously resided in a
malarious region for at least five years (immigrants, refugees,
citizens, persons who have been or who are residents of endemic
countries), should not be accepted as donors of Whole Blood or
blood components, including platelets, for a period of three
years since their last visit to a malarious region.
- The following questions should be added to the donor
questionnaire:
- "Were you born in the United States?"
If the answer is yes, the donor should be asked,
- "Have you traveled outside of the United States in the
last three years?"
If so, determine if the area visited was a malarious area that should result in donor deferral.
If the answer to the question "Were you born in the United
States" is no, the donor should be asked,
- "When did you arrive in the United States?" and
- "Since your arrival, have you traveled outside the United
States?"
If the answer to the question in "5a" (above) is yes, or if
in question "ii" (above) it is determined that the prospective
donor has traveled out of the United States, follow-up
questions should be asked to determine the country or
geographical regions that have been visited.
Blood collection facilities should further question the prospective
donor regarding exposure history to better ascertain the actual risk
of exposure to malaria using the information contained in the
BACKGROUND section of this document. If questions persist about
whether a prospective donor traveled to a malaria endemic area, call
the Malaria Epidemiology Section, CDC, at (770) 488-7788. For other
questions concerning malarial risk and donor suitability, please
contact the Division of Emerging and Transfusion Transmitted Diseases,
Center for Biologics Evaluation and Research, FDA at (301) 827-3011.
When more than one deferral period applies to a donor, the longest
period of deferral should go into effect.
Table of Contents
- IMPLEMENTATION
The recommendations contained in this guidance may be implemented
immediately without prior approval from the FDA. Under 21 CFR 601.12
licensed establishments implementing these recommendations should
submit by official correspondence a statement in their annual report
indicating the date that the revised standard operating procedures,
consistent with these recommendations, have been established and
implemented.
Questions concerning these recommendations should be directed to the
Division of Blood Applications, Office of Blood Research and Review,
Center for Biologics Evaluation and Research, FDA at (301) 827-3524,
FAX (301) 827-3534.
Table of Contents
- REFERENCES
- Guerrero I, Weniger B, Schultz M. Transfusion malaria in the
United States, 1972-1981. Ann Intern Med 1983;99:221-226.
- Sazama K. Prevention of transfusion-transmitted malaria: Is it
time to revisit the standards? Transfusion 1991;31:786-788.
- Nahlen B, Lobel H, Cannon S, Campbell C. Reassessment of blood
donor selection criteria for United States travelers to malarious
areas. Transfusion 1991;31:798-804.
- US Army Medical Surveillance Activity. Transfusion-transmitted
P. falciparum malaria. Medical Surveillance Monthly Report (MSMR) ,
4:2(Feb/Mar), 1998, 13-14.
- Westphal R: Transfusion-Transmitted Malarial Infections. In
Smith, D and Dodd, R (eds.), Transfusion Transmitted Infections , ASCP
Press, Chicago IL, 1991, pp. 167-180.
- Malaria Surveillance - United States, MMWR 2/26/99, Vol 48,
No.SS1, CDC Surveillance Summaries.
- Transfusion-Transmitted Malaria - Missouri and Pennsylvania,
1996-1998, MMWR April 02, 1999/48(12); 253-256.
Table of Contents
|