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Posted: November 3, 2001

Addenda: Nov. 12 & 21, 2001; Feb. 12, 2002; Mar. 15 & 16, 2003; Jan. 14, Feb. 12 & Apr. 21, 2007

Link Updated: Aug. 29, 2005; Jan. 14; Apr. 21, 2007; May 26, 2011

 

Donor deferral for taking medication

A transfusion medicine fellow working in Wisconsin wants to know how members evaluate potential blood donor medications for acceptability. He is aware of the usual deferral requirements for donors taking certain medications, such as the following:

  • Finasteride (Proscar, Propecia), isotretinoin (Accutane): Defer 1month after receipt of last dose
  • Acitretin (Soriatane): Defer 3 years
  • Etretinate (Tegison): Defer indefinitely
  • Ingestion of aspirin-containing medications or those that irreversibly inhibit platelet function within 36 hours of donation precludes use of donor as sole source of platelets
The blood bank fellow points out that new prescription drugs and over-the-counter medications enter the marketplace daily, and donors may report use of a drug not specifically noted in a facility's procedures manual.  Appendix 4-2 of the 13th Edition of the Technical Manual (see below) lists drugs that many blood centers DO consider acceptable without approval from a blood center physician. The Armed Services Blood Program Office formerly made its drug deferral list available to the public as a 132-page PDF file on its web site (removed from public access Feb. 2007).

The transfusion medicine fellow is asking our experienced blood banking community for any additional practical criteria or suggestions to help define which donors should be deferred for taking medications.

Editor's Note: Below are the drugs listed in appendix 4-2 of the 13th Edition of the AABB Technical Manual that many blood centers DO consider acceptable without approval from a blood center physician:

  • Tetracyclines and other antibiotics taken to treat acne.
  • Topical steroid preparations for skin lesions not at the venipuncture site.
  • Blood pressure medications, taken chronically and successfully so that pressure is at or below allowable limits. The prospective donor taking antihypertensive drugs should be free from side effects, especially episodes of postural hypotension, and should be free of any cardiovascular symptoms.
  • Over-the-counter bronchodilators and decongestants.
  • Oral hypoglycemic agents in well controlled diabetics without any vascular complications of the disease.
  • Tranquilizers, under most conditions. A physician should evaluate the donor to distinguish between tranquilizers and antipsychotic medications.
  • Hypnotics used at bedtime.
  • Marijuana (unless currently under the influence), oral contraceptives, mild analgesics, vitamins, replacement hormones, or weight reduction pills.

The following responses were submitted:

  1. The drugs listed in appendix 4-2 of the 13th Edition of the AABB Technical Manual that many blood centers consider ACCEPTABLE without approval from a blood center physician include the following:
    • Tetracyclines and other antibiotics taken to treat acne.
    • Topical steroid preparations for skin lesions not at the venipuncture site.
    • Blood pressure medications, taken chronically and successfully so that pressure is at or below allowable limits. The prospective donor taking antihypertensive drugs should be free from side effects, especially episodes of postural hypotension, and should be free of any cardiovascular symptoms.
    • Over-the-counter bronchodilators and decongestants.
    • Oral hypoglycemic agents in well controlled diabetics without any vascular complications of the disease.
    • Tranquilizers, under most conditions. A physician should evaluate the donor to distinguish between tranquilizers and antipsychotic medications.
    • Hypnotics used at bedtime.
    • Marijuana (unless currently under the influence), oral contraceptives, mild analgesics, vitamins, replacement hormones, or weight reduction pills.

  2. A Boston blood banker/Compliance Officer wrote that the question under discussion is also an ongoing debate in his donor centers. They have downloaded the Armed Services drug list (no longer available to the public). This list was reviewed by their Medical Directors and tailored to their former policies and current donors. They then incorporated this list into a database and placed it on-line on an intranet server. They currently have 2,368 drugs listed on their intranet, so it is quite convenient to have them in a searchable database. They will be making provisions for groups of drugs like oral contraceptives, antihypertensive and other similar groups with the note of them be used for the presumed purpose, i.e., a man taking birth control medication would not be approved by such a "blanket" approval. They strictly state that the medication must be on the list for the donor to be approved; otherwise the Medical Director needs to approve each case. They are considering two improvements for this issue: (i) allowing the nursing staff to make this decision, and (ii) adding a page to the site that allows Medical Directors to update the drug list.

  3. A blood bank physician in Cincinnati said that they evaluate new medications as they are reported by donors or in the Physician's Desk Reference (PDR) addendum publications; (access is limited to US MDs with valid DEA registration). They consider the medical indications for each medication and compare the drugs to currently acceptable medications. They also review adverse effects and check to see if the FDA has indicated that use in pregnancy is safe, unsafe or if safety is unknown. The Cincinnati blood banker recommends (without providing a specific reference) that drugs considered appropriate to cause deferral should defer the donor for at least 4 times the half-life of the medication.

  4. A blood banker at a large university setting in Pennsylvania says the following: "I take a very liberal stance on donor medications (other than those defined by regulations). My main concern is WHY is the donor is on such-and-such a medication rather than WHAT is the drug in question. The vast majority of medications will have minuscule serum concentrations at any given time of donation, so my concern is not that the recipient will be adversely exposed to some drug, but that either the donor will be adversely affected by the donation because they are on medication and/or the recipient will be adversely affected from a potential bacterial infection, for example, from a donor who is taking antibiotics for an acute sinus infection. For example, we have allowed donation by women who are taking prophylactic tamoxifen as part of a high risk breast cancer surveillance program. Asthma medications (prescribed oral or inhaled) are another class of drugs where I am more concerned about the donor's state of health at the time of donation rather than the recipient who might be exposed to the drug. Having said this, however, there are virtually no studies in the literature examining the potential adverse effect(s) that drugs in the donated unit might have on the recipient (and this also includes most category X drugs, like proscar, for example, where the data is typically gathered from animals who receive large doses). I have wondered, for example, if some of the transfusion-related allergic reactions we see are related to the drugs that the donor was on at the time of donation (including over-the-counter drugs, herbal medications, etc.). Doubtful, but again, there are no studies. Bottom line, I do not feel that drug levels in the donor are to the extent that we need to overly worry about it in the recipient."

ADDENDA Nov. 12, 2001

  1. An international member of the e-network added that the following information is a contribution from the Netherlands. Their local criteria are directly derived from their national Guideline. According to the responding member, the policies as outlined by the November posting of the e-network are nearly identical to their guidelines. In addition to the points as noted their rules allow donation to be authorised by their donor assistants (without referring to a donor center physician) according to the follow criteria:
    • blood pressure medications - if a donor takes a beta-blocker the dose must have been unchanged during the last 4 weeks 
    • oral antihistamines - if the donor is symptom-free on the day of attendance
    • oral antimycotics - if taken for skin or nail mycosis
    • eye/ear preparations or intralesional corticosteroids

According to the responding member, "Other medications may be allowed at the discretion of the attending donor physician (depending as always on the indication) but never systemic immunosuppressive medication or systemic corticosteroids or the teratogenic medications listed in the circular."

ADDENDA Nov. 21, 2001

  1. A physician blood banker in Milan who works at a blood donor center had the following comments regarding medications and blood donor acceptability. At her center they do not accept donors who are taking beta-blocker medications. She cites a study by her group (presented at the 1997 AABB Meeting) in which they observed a significant increase in serious reactions (with decrease in pulse rate) among donors who use this class of drugs. They speculate that these drugs inhibit the physiologic mechanism compensating for the blood loss during donation. She reports that they also do not accept donors who use more than two different agents to control hypertension, since in her experience this usually reflects a more severe degree of hypertension.

ADDENDA Mar. 16, 2003

  1. The Editor notes the following earlier issues on this forum are germane to this discussion:

ADDENDA Jan. 14, 2007

  1. A colleague in a Rocky Mountain state reports that his hospital has an on-site blood donor collection center which supplies a significant amount of the blood and blood products that their patient population uses. The hospital-based donor screening process includes the deferral of individuals who are taking medications beyond those listed by the AABB Standards (i.e., Finasteride, dutasteride, acitretin, etc.). He comments that his donor center has a "long list" of medications (which is updated frequently) to defer donors – sometimes for protection of the donor, sometimes for the protection of the recipient. His question, however, concerns primarily individuals who wish to donate apheresis platelets, but who are on a medication to lower their blood pressure or their lipid levels, and the risk of using a blood product from such a donor for a patient in their NICU or CICU, since many of these patients weigh only a few kilograms.

    The inquiring colleague acknowledges that he considers two classes of medications that are particularly concerning to the hospital-based donor program: a) ezetimibe / simvastatin, and b) angiotensin II antagonists (Diovan®, Cozaar®, Atacand®, Micardis®, Avalide®). Vytorin® has warnings of drug-drug interactions associated with rhabdomyolisis/myopathy and is contraindicated in nursing mothers. The angiotensin II antagonists have red, bolded-type warnings that they cause fetal/neonatal morbidity and mortality, and warnings to mothers not to take these medications and nurse their babies. They currently defer donors who are taking these medications, but because these are very popular medications, they defer of a significant number of donors. The inquiring colleague has reason to believe that once deferred, some of the deferred donors go to other blood collection sites to make a donation, and he feels that this creates an inherent inconsistency, since some collection centers do not defer donors for taking the medications listed above. He asks if his concerns are well founded and if the practice of deferring donors for taking the above medications is appropriate.

ADDENDA Feb. 12, 2007

  1. The same colleague whose question is posted in #8 (ADDENDA Jan. 14, 2007) above has submitted a follow up query. He states that if one goes to Lexi-Drugs Online (www.crlonline.com, User ID and password required to access) and enters into the "Search for" field ...

    Vytorin® … and selects from Lexi-Drugs Online, then scrolls down to Patient Education , one finds:

    Patient Education See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during and for 1 month following therapy. Consult prescriber for appropriate contraceptive measures. This drug may cause severe fetal defects. Do not donate blood during or for 1 month following therapy. Do not breast feed.

Crestor® … and selects from Lexi-Drugs Online, then scrolls down to Patient Education, one finds:

Patient Education Take at same time each day with or without food. Follow cholesterol-lowering diet and exercise regimen as prescribed. Avoid excess alcohol. You will have periodic blood tests to assess effectiveness. You may experience constipation (increased exercise, fluids, fiber, and fruit may help); headache, dressing, dizziness, insomnia (use caution when driving or engaged in potentially hazardous tasks until response to drug in known). Report unusual chest pain, swelling of extremities, weight gain of >5 lb/week, or persistent cough. Contact prescriber immediately with persistent muscle or skeletal pain, joint pain, or numbness, or any sign of allergic reactions (skin rash, difficulty breathing, tightness in throat, choking sensation, swelling of mouth or face). Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during and for 1 month following therapy. Consult prescriber for appropriate
contraceptive measures. This drug may cause severe fetal defects. Do not donate blood during or for 1 month following therapy. Do not breast feed.

Caduet® … and selects from Lexi-Drugs Online, then scrolls down to Patient Education , one finds:

Patient Education See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during therapy. Consult prescriber for instructions in appropriate contraceptive measures. This drug can cause severe fetal defects. Do not donate blood while taking this medication and for some period of time after discontinuing. Do not breast-feed.

He comments about the above as follows: "I am having trouble understanding how we can draw donors who are on these medications. Does anyone have any insight into this?"

  1. Debra Kessler RN,MS, Director, Special Donor and Community Health Services at the New York Blood Center (attribution used with permission) writes in response to #8 and #9 above that on behalf of the AABB Donor History Task Force (DHTF), for which she is the current chair, she would like to post the following response to the communications above.

    The DHTF made a decision early on to limit the medications on the Medication Deferral List used as part of the AABB Donor History Questionnaire materials, to those indicated as cause for deferral by FDA. The Rocky Mountain state colleague is citing information he found on the web regarding blood donation restrictions for these medications. If one reviews the actual FDA approved package inserts, there is NO recommendation for blood deferral for these medications. Therefore the DHTF will take no action at this time. It is important to remember that the Donor History Questionnaire User’s Guide allows individual centers to locally add medications to the end of the Medication Deferral List as they see fit. The Rocky Mountain state colleague may exercise this option to deal with any medication he is concerned about.

ADDENDA April 21, 2007

  1. The Editors wish to alert readers that as of February 21, 2007, the Armed Services Blood Program (ASBP) website has posted the following message on their website:

    "Note: The ASBP Standardized Donor Deferral Lists are no longer available in the public area of the ASBP Web site. These lists are provided as guidance to military blood collection centers and are now accessible only to military staff members. We regret any inconvenience this may cause."

    The CBBS Webmaster sent an email in early March to the ASPO Webmaster to inquire about the removal of these lists. As of this date, no response has been received.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator

James Iqbal, MD
CBBS e-Network Forum Associate Editor & Moderator

The e-Network Forum is supported in part by the California Blood Bank Society (CBBS) and the American Red Cross Blood Services (ARCBS) and endorses collegial discussion among blood banking and transfusion medicine professionals. However, neither the CBBS nor the ARCBS in any way endorse the specific views and opinions expressed in the forum. The forum is not intended as a substitute for medical or legal advice and the content should not be relied upon for any medical or legal purposes. Readers should make their own determinations as to: (i) what constitutes appropriate medical, technical, and administrative practices, and (ii) how best to comply with laws and regulations relevant to their questions. For the latter, they should consider consulting, as to any medical matters, a qualified physician, and, as to any legal matters, an attorney familiar with related state and federal laws. The user of the forum, by accessing same, assumes all risks arising out of such use and releases CBBS and their respective members, directors, officers and agents from and against any loss, damage, claim or liability arising out of such use of the Forum.
 
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