An Bras Dermatol. 2012;87(4):590-5.
Brazilian blood donation eligibility criteria for
Critérios brasileiros de elegibilidade à doação de sangue para
Carlos Gustavo Wambier
Benedito de Pina Almeida Prado Júnior
Caroline Silva Pereira
Norma Tiraboschi Foss
Abstract: A focused and commented review on the impact of dermatologic diseases and interventions in the
solidary act of donating blood is presented to dermatologists to better advise their patients. This is a review of
current Brazilian technical regulations on hemotherapeutic procedures as determined by Ministerial Directive
#1353/2011 by the Ministry of Health and current internal regulations of the Hemotherapy Center of Ribeirão
Preto, a regional reference center in hemotherapeutic procedures. Criteria for permanent inaptitude: autoim-
mune diseases (>1 organ involved), personal history of cancer other than basal cell carcinoma, severe atopic
dermatitis or psoriasis, pemphigus foliaceus, porphyrias, filariasis, leprosy, extra pulmonary tuberculosis or
paracoccidioidomycosis, and previous use of etretinate. Drugs that impose temporary ineligibility: other syste-
mic retinoids, systemic corticosteroids, 5-alpha-reductase inhibitors, vaccines, methotrexate, beta-blockers,
minoxidil, anti-epileptic, and anti-psychotic drugs. Other conditions that impose temporary ineligibility: occu-
pational accident with biologic material, piercing, tattoo, sexually transmitted diseases, herpes, and bacterial
infections, among others. Discussion: Thalidomide is currently missing in the teratogenic drugs list. Although
finasteride was previously considered a drug that imposed permanent inaptitude, according to its short half-
life current restriction of 1 month is still too long. Dermatologists should be able to advise their patients about
proper timing to donate blood, and discuss the impact of drug withdrawal on treatment outcomes and to res-
pect the designated washout periods.
Keywords: Blood banks; Blood transfusion; Teratogenic dangers
Resumo: Uma revisão centrada no impacto de doenças e intervenções dermatológicas no ato solidário de doar
sangue é apresentada aos dermatologistas para melhor aconselhamento dos seus pacientes. Esta é uma revisão
das atuais normas técnicas brasileiras sobre procedimentos hemoterápicos conforme determinado pela Portaria
Ministerial no 1353/2011 do Ministério da Saúde e atuais normas internas do Hemocentro de Ribeirão Preto,
um centro de referência regional em procedimentos hemoterápicos. Critérios para inaptidão definitiva: doen-
ças autoimunes (>1 órgão comprometido), antecedente pessoal de câncer diferente de carcinoma basocelular,
dermatite atópica ou psoríase graves, pênfigo foliáceo, porfirias, filariose, hanseníase, tuberculose ou paracoc-
cidioidomicose extrapulmonares e uso prévio de etretinato. São condições de inelegibilidade temporária: uso
de outros retinóides sistêmicos, corticoides sistêmicos, inibidores da 5-alfa-redutase, vacinas, metotrexato, beta-
bloqueadores, minoxidil, anticonvulsivantes e antipsicóticos. Outras condições responsáveis por inaptidão tem-
porária: acidente ocupacional com material biológico, "piercing", tatuagem, doenças sexualmente transmissí-
veis, herpes, infecções bacterianas, entre outras. Discussão: Talidomida atualmente não consta na lista de medi-
cações teratogênicas. Apesar do uso da finasterida já ter sido considerada como critério para inaptidão definiti-
va, de acordo com sua meia-vida curta a restrição atual de 1 mês ainda é demasiadamente longa.
Dermatologistas devem ser capazes de aconselhar seus pacientes sobre o momento adequado para doar sangue
e discutir o impacto da suspensão de medicações nos resultados do tratamento de forma a respeitar os perío-
dos de restrição designados.
Palavras-chave: Bancos de sangue; Perigos teratogênicos; Transfusão de sangue
Received on 05.12.2011.
Approved by the Advisory Board and accepted for publication on 23.01.2012.
* Work performed at the Faculty of Medicine of Ribeirão Preto - University of Sao Paulo – Sao Paulo (SP), Brazil.
Financial Support: None
Conflict of Interest: None
MD, PhD Dermatologist - Division of Dermatology. Internal Medicine Department. Faculty of Medicine of Ribeirão Preto, University of São Paulo (FMRP-USP)
– Sao Paulo (SP), Brazil.
MD - University of Ribeirão Preto (UNAERP) – São Paulo (SP), Brazil.
MD, MS Hematologist - Hemotherapist in Charge of the Blood Transfusion Unit - Emergency Unit - Hospital of Clinics of Ribeirão Preto. Hemotherapy Center
of Ribeirão Preto – University of São Paulo (USP) – Sao Paulo (SP), Brazil.
MD, PhD Dermatologist - Associate Professor. Division of Dermatology. Internal Medicine Department. Faculty of Medicine of Ribeirão Preto, University of São
Paulo (FMRP-USP) – Sao Paulo (SP), Brazil.
©2012 by Anais Brasileiros de Dermatologia
An Bras Dermatol. 2012;87(4):590-5.
Brazilian blood donation eligibility criteria for dermatologic patients 591
Dermatologic diseases and interventions can
potentially interfere with aptitude to blood donation.
Brazilian technical regulations on hemotherapeutic
procedures are currently based on the Ministerial
Directive #1353/2011 by the Ministry of Health (MS),
which is valid for Brazilian territory and has recently
substituted the Resolution RDC #153/2004 by the
National Sanitary Surveillance Agency (ANVISA).
The adoption of regulations is required for safety and
quality assurance of blood samples and its compo-
nents. Such regulation determines that all blood
donors must sign an informed consent form, decla-
ring to donate the blood for whoever may require and
that the donated material will be submitted to labora-
tory tests required by current law and technical regu-
lations. Before blood donation, the candidate under-
goes an interview with a trained health professional of
tertiary degree in a private and confidential environ-
ment to evaluate past medical history and current
health status to secure donation safety for both the
recipient and the donor.
During the course of this interview some der-
matologic conditions or drugs might determine eligi-
bility. The volunteer may de dismissed due to prohibi-
tions and restrictions that can be temporary or perma-
dermatologists to better advise their patients on the
impact of the treatments and conditions in blood
donation by reviewing national regulations by the
Ministerial Directive #1353/2011, and local, more
strict, internal regulations from the Regional Center
for Hemotherapy – Hospital of Clinics of Ribeirão
Preto – Faculty of Medicine of Ribeirão Preto –
University of São Paulo (Hemotherapy Center of
1This review provides a reference guide to aid
According to the current regulations volunteers
may donate blood if the criteria to safeguard donor or
recipient safety are fulfilled. Individuals must be at
least 18 years old and must not have completed 68
years of age. Sixteen and 17 year-old volunteers are
allowed to donate blood if a signed informed consent
is provided by a responsible adult. Minimal body
weight is 50kg. For whole blood donations male
donors must respect a minimum interval of two
months between donations and may donate up to
four times a year. Female donors may donate up to
three times a year, with a minimum interval between
donations of three months. The minimal interval for
donation of plasma and platelets by apheresis is 48
hours, and shall not exceed four donations in the
period of two months and one month respectively, or
12 and 24 donations in a year, respectively.
Dermatologic conditions and drugs may restrict blood
donation according to the data presented on tables 1-
3. Since it is unpractical to list all dermatologic disea-
ses, current regulations may serve as a guideline for
case-by-case decision for aptitude.
BENEFITS CONFLICT WITH BLOOD DONATION:
HEMOCHROMATOSIS, POLYCYTHEMIA VERA,
AND PORPHYRIA CUTANEA TARDA (PCT)
Patients with porphyrias, including PCT, are
currently permanently ineligible for blood donation.
PCT is the most frequent of porphyrias, and although
it can be triggered by viral infections such as Hepatitis
C, B, and HIV , many patients are negatively screened
and many patients present high serum iron, iron satu-
ration and ferritin levels, resembling patients with
hemochromatosis. Patients with polycythemia vera
may present dermatologic symptoms such as aquage-
be perfect candidates to donate blood from therapeu-
tic phlebotomy sessions, they fail to qualify as blood
donors. One of the principles of blood donation is
that volunteers must not present direct or indirect
ment with benefits to the donor, which may compro-
mise interview reliability and recipient safety, by a risk
of a less truthful acknowledgement of risk behaviors
during the interview. In the United States, FDA does
not prohibit the use of blood from therapeutic blee-
dings, but requires that blood intended for transfu-
sion be labeled with the donor’s disease.
rement is considered to be a barrier to the use of
blood for transfusion. Providing therapeutic phleboto-
my free of charge, even if the donor is ineligible as an
allogenic blood donor, is a form of increasing inter-
view reliability from such donors. Therefore, if pro-
perly requested, the FDA may allow omitting labeling
for blood from hereditary hemochromatosis donors if
the establishment clearly states in the informed con-
sent for donation that they provide therapeutic phle-
botomy free of charge.
3-12Although these patients may seem to
1Thus, phlebotomy is considered a treat-
INCREASED INFECTION RISK: BODY PIERCING,
TATTOO, OCCUPATIONAL BIOLOGIC ACCIDENT,
SEXUALLY TRANSMITTED DISEASES, AND SEXUAL
Individuals must wait six months to be eligible
to donate blood if piercing or tattoo were performed
under safe sanitary conditions (sterile or disposable
equipment). Otherwise, they are deferred for one
suffered occupational biologic accident or acquired
and treated sexually transmitted diseases such as
1This period also applies to individuals who have
1Keeping a piercing in any muco-
An Bras Dermatol. 2012;87(4):590-5.
592Wambier CG, Pereira CS, Prado Jr BPA, Foss NT
sa or experiencing sexual activity with increased infec-
tion risks such as male homosexual intercourse,
sexual promiscuity, and prostitution will cause a
deferral of one year since the last exposure
The volunteer is considered unsafe and therefore is
temporarily ineligible to donate blood. Individuals
with low infection risk are deferred for six months,
while those with higher infection risks must wait for a
full year. Other situations with increased infection
risks such as nail beauty care in manicure or pedicure
saloons with unsafe sanitary conditions, such as sha-
red supplies are unlisted. Although those with genital
herpes simplex are allowed to donate blood after the
healing period of the lesions, in case of primary infec-
tion it could be considered criteria of sexually trans-
RISK OF OCCULT DISEASE: LICHEN PLANUS
AND HERPES ZOSTER
Lichen planus and herpes zoster are formal
contraindications to blood donation. After complete
cure, patients are allowed to donate blood only after
six months. Lichen planus may be associated with viral
infections such as hepatitis C.
associated with malignancy and HIV infection.
primary herpes zoster virus infection (chickenpox) is
usually unrelated to immunodeficiency, individuals
may donate blood after three weeks of its cure.
14Herpes zoster may be
AUTOIMMUNE DISEASES: ALOPECIA AREATA,
CUTANEOUS LUPUS ERYTHEMATOSUS, PEMPHI-
GUS, AND VITILIGO
Patients with pemphigus foliaceus or autoim-
munity involving more than one organ are currently
ineligible for blood donation.
such as alopecia areata, cutaneous lupus erythemato-
sus, and vitiligo fit into the category of skin autoimmu-
ne diseases with no more than one organ involved
(skin) and thereby may suffer no restrictions.
Although memory lymphocytes may be conta-
minants in the transfusion components, in the lack of
evidence of transmission of such diseases by blood
donation, current legislation prohibits blood dona-
tion from people with severe or multi-organ involve-
ment. Pemphigus vulgaris patients may be considered
permanently inapt to donate by following the pemp-
higus foliaceus criteria.
Severe forms of psoriasis, including extensive
cutaneous involvement cause permanent inaptitude
to donate blood.
sis, without arthritis, are allowed to donate, provided
they are not using prohibitive drugs.
individuals that presented erythroderma are only
deferred for six months, since exacerbation of under-
lying skin disease such as psoriasis is frequently its
1Patients with mild forms of psoria-
1It is curious that
TABLE 1: Inaptitude period to blood donation by der-
matologic diseases according to the Ministerial
Directive #1353/2011, Ministry of Health, Brazil
Inaptitude time Disease / Condition
Autoimmune diseases (>1 organ
Atopic dermatitis (severe)
Personal history of cancer
Squamous Cell Carcinoma (invasive)
Tuberculosis (extra pulmonary)
5 yearsParacoccidioidomycosis (pulmonary)
Occupational accident with infective
Piercing or Tattoo (unknown sanitary
conditions or in mucosa).
Sexually Transmitted Diseases
Dengue (hemorrhagic form)
Piercing or Tattoo (sterile/disposable
3 months Plastic Surgery (local anesthesia)
2 weeks Bacterial infections, uncomplicated
Allergic reactions (dermatitis or
Herpes Simplex (including genital)
Small procedures (e.g. removal of
warts and nail)
Skin lesions at the site of venipuncture
During course /
None Basal Cell Carcinoma or in situ
Squamous Cell Carcinoma
An Bras Dermatol. 2012;87(4):590-5.
Brazilian blood donation eligibility criteria for dermatologic patients 593
Patients with personal history of leprosy are
currently forbidden to donate blood despite treat-
ment and cure, in comparison with patients with pre-
vious history of pulmonary tuberculosis, who can
donate blood 5 years after the cure.
for leprosy and the population is frequently exposed
to the bacilli. Foss et al.
ty (10/324) by ELISA Anti-PGL1 (IgM) in healthy blood
donors from the Hemotherapy Center of Ribeirão
Preto. Although all 10 healthy donors turned out to be
leprosy free during screening and follow-up, the fre-
quency of positive serologic test was higher than in 21
patients with tuberculoid or borderline leprosy from
the same study (0/16 patients with tuberculoid lepro-
sy and 0/5 patients with borderline leprosy). It is pru-
dent to prohibit blood donation from patients who
have been treated for leprosy, because of increased
individual susceptibility and possible reinfection. It
would be proper to include leprosy household con-
tacts in the same list.
1 Brazil is endemic
16detected almost 3% positivi-
Dermatologists are the only physicians who
prescribe all of the teratogenic drugs listed on table 2.
Neither methotrexate nor thalidomide use have been
cited in the current national hemotherapy regulations
as cause of inaptitude to blood donations, in spite of
well-known teratogenic effects. The Brazilian ministry
of health further advises prohibitive measures for
breast-feeding and blood donation for thalidomide,
but it is absent in this ministry directive.
sy currently imposes permanent inaptitude for dona-
tion in cases of erythema nodosum leprosum, thalido-
mide could also be indicated (off-label) for severe pru-
rigo nodularis, neutrophilic dermatoses, and cuta-
neous lupus erythematosus.
Isotretinoin users must abstain from blood
donations for at least 1 month.
taken etretinate are permanently ineligible for blood
permanent inaptitude, but since 2011 people who
have taken acitretin can donate after a washout period
of 3 years.
that has substituted etretinate in the treatment of pso-
riasis and diseases of keratinization. Although acitretin
presents reduced half-life, re-esterification to etretina-
te is possible (reverse metabolism) by ethanol inges-
tion and etretinate has extremely long elimination
period because of accumulation in adipose tissue.
Blood donation criteria seem to follow the recom-
mendations for anti-conception for female users,
however topical retinoids are unmentioned.
1Those who have ever
1Previously, acitretin use was a cause of
1, 2Acitretin is a second-generation retinoid
TABLE 2: Dermatological drugs and vaccines that preclude blood donation according to the Ministerial
Directive #1353/2011, Ministry of Health, Brazil
ReasonInaptitude time Drug
Vaccines (attenuated microorganisms)**
Antipsychotic drugs (Pimozide)
Vaccines (toxoids/ inactivated microorganisms)
Anti-epileptic drugs (Carbamazepine)
Platelet Concentrate****5 daysNSAIDs
*Drugs methotrexate and thalidomide are unlisted. ** Includes Bacillus Calmette-Guérin intradermal vaccine. *** Although topical
steroids are not a contraindication to blood donation, the disease might be **** Inaptitude time for platelet concentrate donation only.
594 Wambier CG, Pereira CS, Prado Jr BPA, Foss NT
An Bras Dermatol. 2012;87(4):590-5.
5-α α-REDUCTASE INHIBITORS
Finasteride users must not donate blood for at
least 1 month since the last dosage and dutasteride
users must abstain from blood donations for at least 6
was even more prohibitive for finasteride users.
Finasteride use was carried out as a permanent impe-
diment to blood donation, which probably resulted in
loss of blood donors during the 18 months it was
Because finasteride has a short half-life (2-12
hours, Table 3) the washout period could be even
shorter, such as one week, especially with a low dosa-
ge of 1 mg per day. Dutasteride, on the other hand,
presents a long half-life of 5 weeks (Table 3), and
demands a longer washout period.
if patients with male-pattern alopecia or benign pros-
tatic hyperplasia would sacrifice treatment for more
than one month to donate blood. Balding patients
would hardly endure long period only to donate
blood if taking dutasteride. For these blood donors
finasteride or topical products would be more appro-
Labeling changes could be implemented on
hemotherapy derivatives from patients taking terato-
genic drugs to prevent them from being transfused to
1Past regulatory resolution RDC #343/2002
24It is questionable
Volunteers who have undergone surgery are
temporarily deferred according to the type of surgery
and clinical evolution. If performed under local anes-
thesia, plastic surgery patients are deferred for three
months (Table 1). If it is performed under general,
epidural or spinal anesthesia, the deferral time is six
after removal of warts, nails, and other minor derma-
actions to reduce the consumption of allogeneic
hemocomponents must be considered, such as met-
hods to reduce intraoperative bleeding or planning
for autologous transfusion, which must be performed
at least three days prior to the surgery.
1Individuals may donate after healing period
1In the case of elective surgery
Current national regulations do not advise
about the use of injectable cosmetic products.
However, the internal directives of the Regional
Center of Hemotherapy, which are more prohibitive,
list a 1-month restriction since the last injection of
botulinum toxin A, regardless of therapeutic or cos-
metic use. There are no specific restrictions for fillers
or non-injectable cosmetic treatments, such as LASER
treatments and chemical peels.
The unlisted cosmetic treatments are managed
on a case-by-case decision, most probably as minor
surgical treatment, prohibited during healing and
AUTOLOGOUS BLOOD TRANSFUSION
As it imposes no interpersonal transmission,
the impediment criteria are less strict. It can only be
performed if requested by the patient´s physician and
approved by the hemotherapist in charge. Although
the blood samples are submitted to the same tests,
even patients with chronic viral infections are eligible
TABLE 3: Drugs prescribed by dermatologists that may cause blood donation ineligibility.
Half-lives and current inaptitude times are presented
Drug ClassDrug Half-Life* Inaptitude Time
120 days (84-168 days)
5-α-Reductase Inhibitors Dutasteride
6 hours (2-16 hours)
*Based on Lexi-Drugs (Smartphone/PDA Software for Physicians) Lexicomp © 2010 Lexi-Comp Inc. Hudson, OH. **Active reverse-
metabolite of acitretin is etretinate. ***Methotrexate is listed in the internal regulations of Hemotherapy Center of Ribeirão Preto.
Brazilian blood donation eligibility criteria for dermatologic patients 595 Download full-text
An Bras Dermatol. 2012;87(4):590-5.
for autologous blood donation.
patient with psoriasis taking methotrexate is schedu-
led to have an elective surgery, which could result in
severe blood loss. According to internal regulations of
the hemotherapy center, the patient must be off of
methotrexate for 30 days before being eligible to
donate for the general population (Table 3). This
requirement about methotrexate is waived since the
blood will be given back to the same patient with
autologous blood donation.
1For example, a
Although it is the hemotherapist´s role to deci-
de if a volunteer meets the suitability requirements for
the solidary act of donating blood, it is the dermatolo-
gists’ role to provide information for their patients
about proper medication withdrawal and timing to
donate blood and discuss implications for treatment
outcomes. Dermatologists should also warn patients
with a dermatologic diagnosis that carries a risk of
occult disease to restrain from donating blood for at
least six months after complete cure, as patients may
forget the diagnosis after cure, making a presumptive
diagnosis impossible by the hemotherapist. Thus, der-
matologists can contribute to the safety of blood trans-
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Carlos G. Wambier
Division of Dermatology, Department of Internal
Medicine, Faculty of Medicine of Ribeirao Preto -
University of Sao Paulo. 3900
Bandeirantes Av. Hospital of Clinics FMRP-USP, 4
14049-900 Ribeirao Preto, SP
How to cite this article: Wambier CG, Pereira CS, Prado Junior BPA, Foss NT. Brazilian blood donation eligibility
criteria for dermatologic patients. An Bras Dermatol. 2012;87(4):590-5.