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MASAC Recommendations Regarding Standards of Service for Pharmacy Providers of Clotting Factor Concentrates for Home Use to Patients with Bleeding Disorders

November 16, 2008
PDF icon MASAC Document31.48 KB
  • Bleeding disorders such as hemophilia are chronic disorders characterized by bleeding episodes that may occur spontaneously or after mild to severe trauma. The timing and severity of bleeding episodes are unpredictable, even for patients on regularly scheduled treatment; thus providers of clotting factor concentrates must be able to effectively respond to varying frequency and dosing needs.

    There are a number of pharmacy providers who supply clotting factor concentrates to patients with bleeding disorders treated at home. When patients do not receive optimal service from these providers, there is potential for adverse health events that lead to poor outcomes and/or increased costs.

    MASAC acknowledges the necessity of cost efficiency in the provision of health care, yet cost efficiency should not occur at the expense of quality patient care. The purpose of this document is to establish minimum standards of service for pharmacy providers to meet the specific needs of individuals with bleeding disorders.





    Patients with bleeding disorders require clotting factor concentrates for prevention and treatment of bleeding episodes. It is essential that any pharmacy provider dispensing clotting factor concentrates for home use provide services that meet the minimal standards delineated below.

    A.  Pharmacy Provider Staff Knowledge of Clotting Factor Concentrates and Ancillary Supplies

    1. Pharmacy provider staff shall have sufficient knowledge and understanding of bleeding disorders to accurately follow the instructions of the prescribing physician and assure high quality service for the patient.
    2. Pharmacy provider staff shall be experienced with filling and handling prescriptions for the full range of clotting factor concentrates.
    3. Pharmacy provider staff shall be knowledgeable about necessary ancillary supplies.
    4. Pharmacy provider staff shall be knowledgeable about containers for the disposal of hazardous waste.
    5. Pharmacy provider staff shall direct patients to contact their established treating physicians for all medical and therapeutic questions.
    6. Pharmacy provider staff shall direct staff medical questions and concerns to the treating physician.


    B.  Clotting Factor Concentrates and Ancillaries

    1. Pharmacy providers shall be able to provide the full range of available concentrates, including all available assays and vial sizes.
    2. Pharmacy providers shall be able to provide all necessary ancillary supplies for administration of clotting factor concentrates. Examples of ancillary supplies include, but are not limited to: needles; syringes; gauze; anesthetic creams; sterile field pads; sterile gloves.
    3. Pharmacy providers shall provide containers for the disposal of hazardous waste, and the collection of such containers shall be arranged pursuant to state and federal law.
    4. Some consumers of clotting factor concentrates require additional services, such as nursing services. If the pharmacy providers do not offer these services directly, they shall coordinate with the nursing agencies to ensure that all of the patient’s needs are adequately met.


    C.  Processing of Prescription Orders

    1. Pharmacy provider staff shall work with prescribing physicians to ensure that prescription orders are filled within 48 hours.
    2. Prescriptions of clotting factor concentrates shall be dispensed as written by the prescribing physician. No changes or substitutions shall be made unless approved by the physician.
    3. If the prescription does not indicate a specific brand name of product, the pharmacist shall ask the prescribing physician which product should be dispensed.
    4. Filling of all prescription orders shall be within plus or minus 5-10 % of prescribed assays, barring extenuating circumstances. This standard shall not be violated by dispensing a number of vials so excessive that it would compromise compliance or so low a dose that it would compromise medical outcome.
    5. Clotting factor concentrates shall have acceptable outdates based on diagnosis and frequency of treatment. Short-dated product (outdate within 6 months) shall only be dispensed after consultation with the prescribing physician.
    6. Pharmacy provider staff shall supply any ancillary supplies required by the patients and prescribed by their physicians.


    D.  Hours of Operation / Access to Staff

    1. Pharmacy providers shall be open, at a minimum, Monday through Friday, excluding holidays, during regular business hours (9:00 am to 5:00 pm) in their service area time zones. If a pharmacy serves all 48 contiguous states, it will need to be open from 9:00 am until 8:00 pm Eastern Time, Monday through Friday, not including holidays.
    2. Pharmacy staff shall provide 24-hour emergency access including multilingual interpreters in case of emergency.
    3. If the pharmacy receives a call about an emergency situation, the treating physician shall be notified immediately. Pharmacy provider in consultation with the treating physician shall have plan in place to ensure that, in case of emergent need, patient shall have access to factor concentrate within 12 hours of expressed need, with a goal of 3 hours where logistically possible.


    E.   Delivery

    1. Routine orders from established patients shall be correctly filled and delivered within 48 hours from the time the order is placed.
    2. If the pharmacy receives a call about an emergency situation, the treating physician shall be notified immediately. Pharmacy provider in consultation with the treating physician shall have plan in place to ensure that, in case of emergent need, patient shall have access to factor concentrate within 12 hours of expressed need, with a goal of 3 hours where logistically possible.
    3. Pharmacy providers shall have a plan in place to meet delivery requirements in the event of a natural disaster.
    4. Product shall be delivered to the location requested by the patient that has been determined by the pharmacy provider to be appropriate and safe.
    5. Shipping of all clotting factor concentrates shall meet all federally mandated standards, including those for temperature control.
    6. Pharmacy providers shall adhere to all HIPAA confidentiality guidelines.
    7. Pharmacy providers shall have an emergency contact number for customers to report problems with deliveries.


    F.   Recordkeeping, Billing and Product Recall

    1. Pharmacy providers shall have an accurate record-keeping system that meets state and federal requirements. In addition, pharmacy providers shall have treatment prescription information available for patients and prescribing physicians.
    2. Pharmacy providers shall explain patient copay, deductible and coinsurance payment responsibilities, and lifetime cap limits clearly at the time the first order is placed and annually when updating insurance information, or sooner if there has been a change in insurance.
    3. Pharmacy providers shall provide a statement of factor cost per unit dispensed to the consumer.
    4. Pharmacy providers must be able to trace the path any bottle of clotting factor concentrate has taken and the way it has been handled from the time it left the manufacturer until the time it is delivered to the consumer.
    5. Pharmacy providers shall participate in the National Patient Notification System for clotting factor concentrate recalls.




    EMERGENCY:  a situation in which the patient’s condition requires immediate medical attention and/or treatment.


    HOME USE:  use of clotting factor concentrate in the home or another outpatient setting.


    PHARMACY PROVIDER:  an entity that dispenses clotting factor concentrates to patients for home use.


    Specialty Pharmacies Self-Reporting Having Met or Exceeded
    MASAC Recommendation #188 Standards:

    Abitacare LLC DBA Vital Care RX
    Accredo’s Hemophilia Health Services
    Accurate Rx Pharmacy
    AHF, Inc.
    Allcare Specialty Pharmacy
    ARJ Infusion Services
    Axium Healthcare Pharmacy
    BioScrip Infusion Services
    BIOMED Pharmaceuticals
    BioPlus Specialty Pharmacy Services

    Bleeding and Clotting Disorders Institute (BCDI)
    Bleeding Disorders Resource Network, LLC
    Care For Life
    Chartwell Midwest Indiana
    CoaguLife Pharmacy
    Cottrill’s Pharmacy, Inc.
    CuraScript, Inc.
    CVS Caremark
    Diplomat Specialty Pharmacy
    ECM Home Health Services, Inc./Family Factor
    Factor One Source Pharmacy
    FactorSource America
    Factor Support Network Pharmacy
    Hemophilia Alliance
    Hemophilia First, LLC
    Hemophilia of the Sunshine State (HOSS)
    Herdon Pharmacy
    HF HealthCare
    HPC Specialty Pharmacy
    Humana Specialty Pharmacy
    Inverness Apothecary Trinity
    Long's Specialty Pharmacy
    Matrix Health Group
    MedPro Rx, Inc.
    National Cornerstone Healthcare Services, Inc.
    Orchard Pharmaceutical Services
    Paragon Healthcare, Inc.
    PrecisionRx Specialty Solutions
    Senderra Rx Partners, LLC
    Specialty Therapeutic Care
    Twelvestone Health Partners
    U & I Pharmacy (U & I INC USA)


    Members of the Hemophilia Alliance:
    Affinity Biotech
    BloodCenter of Wisconsin, Inc.
    Boston Hemophilia Center
    Cardeza Foundation Hemophilia Center
    Cardinal Glennon Hemophilia Homecare
    Cascade Hemophilia Consortium
    Children’s Hospital & Research Center at Oakland
    Children’s Hospital Medical Center of Akron
    Children’s Hospital of Los Angeles
    Children’s Hospital of Michigan
    Children’s Hospital of Orange County
    Children’s Hospital of Philadelphia
    Children’s Hospitals and Clinics of Minnesota
    Children’s Medical Center at Dallas-North Texas Hemophilia Center
    Children’s Memorial Hospital, Chicago
    Children’s National Medical Center HTC
    Cincinnati Children’s Hospital Medical Center
    Comprehensive Bleeding Disorders Center
    Cook Children’s Medical Center
    Dartmouth-Hitchcock Hemophilia Center
    Dayton Children’s Medical Center
    Fairview University Hemophilia & Thrombosis Center
    Georgetown University Hospital
    Great Lakes Hemophilia Foundation
    Gulf States Hemophilia and Thrombophilia Center
    Helen DeVos Children’s Hospital
    Hemophilia Center of Central Pennsylvania
    The Hemophilia Center at Phoenix Children’s Hospital
    Hemophilia Center of Rhode Island
    Hemophilia Center of Western New York
    Hemophilia Center of Western Pennsylvania
    Hemophilia of Georgia
    Hemophilia Outreach Center
    Henry Ford Hospital
    Idaho Hemophilia Treatment Center
    Indiana Hemophilia and Thrombosis Center
    Kansas City Regional Hemophilia Center
    Louisiana Center for Bleeding and Clotting Disorders
    Lucile Packard Children’s Hospital
    Maine Medical Center/Maine Hemophilia and Thrombosis Center
    Mary M. Gooley Hemophilia Center
    Mayo Comprehensive Hemophilia Center
    Miami Comprehensive Hemophilia Center
    Michigan State University Center for Bleeding Disorders & Clotting Disorders
    Mountain States Regional Hemophilia and Thrombosis Center
    Nationwide Children’s Hospital
    Nemours Children’s Clinic
    New England Hemophilia Center
    Northwest Ohio Hemophilia Treatment Center
    Northwestern Center for Bleeding Disorders
    Oklahoma Center for Bleeding Disorders
    Oregon Hemophilia Center
    Orthopaedic Hospital
    Pennsylvania Comprehensive Hemophilia Program
    Puget Sound Blood Center
    Rady Childrens Hospital San Diego
    Roger Maris Cancer Center
    Rush Children’s Hospital
    South Dakota Center for Blood Disorders
    South Texas Comprehensive Hemophilia Center
    St. Louis University Center for Bleeding and Thrombotic Disorders
    UC Davis Hemophilia Treatment Center
    University of California, San Francisco
    University of Cincinnati Medical Center
    University of Iowa Hospitals and Clinics
    University of Kentucky Hemophilia Treatment Center
    University of North Carolina at Chapel Hill
    University of South Florida
    University of Wisconsin Hospital Center
    Vanderbilt University Medical Center
    Virginia Commonwealth University
    West Michigan Cancer Center & Institute for Blood Disorders



    This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends particular treatment for specific individuals and in all cases recommends that you consult your physician or local treatment center before pursuing any course of treatment.