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Repackaging of Single-Dose Vials Clarified by CMS

by Published On: Jun 22, 2012
CMS

On June 15, the Centers for Medicare and Medicaid Services (CMS) issued Safe Use of Single Dose/Single Use Medications to Prevent Healthcare-associated Infections, a Survey and Certification Letter clarifying the conditions under which providers and suppliers may repackage single-dose or single use vials (SDV) into smaller doses, each intended for a single resident or patient. 

In the letter, CMS: 

  • Details the applicable United States Pharmacopeia (USP) and U.S. Food and Drug Administration (FDA) standards.
  • Distinguishes permissible "repackaging" from inappropriate "reuse."
  • Provides instructions to surveyors.
  • Reiterates CMS policy that providers and suppliers will be cited for the reuse of SDVs for multiple patients as an infection control deficiency.

More details of the letter: 

  • Under certain conditions, it is permissible to repackage single-dose or single use vials [referred to in this memo as "SDVs"] into smaller doses, each for a single patient: "The United States Pharmacopeia (USP) has established standards for compounding which, to the extent such practices are also subject to regulation by the Food and Drug Administration (FDA), may also be recognized and enforced under §§501 and 502 of the Federal Food, Drug and Cosmetics Act (FDCA)."

  • "The USP compounding standards include USP General Chapter 797, Pharmaceutical Compounding - Sterile Preparations ("USP <797>"). Under USP <797>, healthcare facilities may repackage SDVs into smaller doses, each intended for use with one patient."

  • Among other things, these standards mandate:

    • "The facility doing the repackaging must use qualified, trained personnel to do so, under International Organization for Standardization (ISO) Class 5 air quality conditions within an ISO Class 7 buffer area. All entries into a SDV for purposes of repackaging under these conditions must be completed within 6 hours of the initial needle puncture."

    • "All repackaged doses prepared under these conditions must be assigned and labeled with a beyond use date (BUD), based on an appropriate determination of contamination risk level in accordance with USP <797>, by the licensed healthcare professional supervising the repackaging process."

    • "Administering drugs from one SDV to multiple patients without adhering to USP <797> standards is not acceptable under CMS infection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the CDC, ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately."

  • CMS Deficiency Citation Policy: "Healthcare facilities that do not adhere to USP <797> standards but reuse SDVs for multiple patients must be cited for deficiencies under the applicable infection control standards for each type of provider/supplier.  Healthcare facilities that utilize appropriately stored medications, derived from repackaged SDVs and prepared in accordance with USP <797> must not be cited solely on the basis of this practice."

Background 

  • Participating providers and suppliers with infection control requirements include:

    • 42 CFR 418.60 for hospices, "The hospice must maintain and document an effective infection control program…(a)…The hospice must follow accepted standards of practice to prevent the transmission of infections and communicable diseases, including the use of standard precautions."
    • 42 CFR 483.65 for SNFs/NFs, "The facility must establish and maintain an infection control program designed to provide a safe, sanitary and comfortable environment and…prevent the development and transmission of disease and infection."
    • 42 CFR 484.12(c) for home health agencies (HHA), "The HHA and its staff must comply with accepted professional standards and principles that apply to professionals furnishing services…"

  • Among CMS' expectations for compliance with recognized standards for infection control is the expectation that SDVs not be used for multiple patients, due to the risk of spreading infectious diseases.

  • The practice of reuse is in conflict with nationally recognized standards (such as those issued by the CDC - See CDC: http://www.cdc.gov/injectionsafety/CDCposition-SingleUseVial.html; Outbreaks in Outpatient Settings:http://www.cdc.gov/HAI/settings/outpatient/outbreaks-patient-notifications.html

  • CMS policy is to cite the reuse of SDVs for multiple patients as an infection control deficiency. The rise in drug shortages has reportedly led to questions/concerns about CMS policy, including the suggestion that drug shortages may be aggravated by the waste of SDV medications exceeding the needed dose for a single patient.

  • CMS is not changing policy on this matter.

  • In the letter, CMS does offer the following clarification: "When previously unopened SDVs are repackaged consistent with aseptic conditions under the requirements of USP <797>, and subsequently stored consistent with USP <797> and the manufacturer's package insert, it is permissible to administer repackaged doses derived from SDVs to multiple patients, provided that each repackaged dose is used for a single patient in accordance with applicable storage and handling requirements."

Permissible repackaging under controlled conditions

  • "Under the FDCA, a drug with a name recognized in the USP must comply with compendial identity standards, or be deemed adulterated, or misbranded, or both. To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs."

  • Included among USP's standards "…are those related to the practice and quality for compounded sterile preparations, USP 797: General Chapter 797, Pharmaceutical Compounding - Sterile Preparations ("USP <797>"), the latest version of which was issued in 2008. According to USP <797>, facilities that use medications repackaged from SDVs must, among other things, ensure that:
    • The medications are repackaged under specified conditions, using qualified, trained personnel under ISO Class 5 conditions utilizing a primary engineering control (PEC), located within an ISO Class 7 buffer area (the area where the PEC is physically located and which is used for preparing supplies used for drug repackaging under the hood).
    • SDVs exposed to ISO Class 5 or cleaner air are not used more than 6 hours after initial needle puncture.
    • All repackaged doses "…must be assigned a beyond use date (BUD) based on determination by the licensed [] professional supervising the repackaging process of an appropriate contamination risk level for compounded sterile preparations (CSPs) and direct testing or extrapolation from reliable literature sources and other documentation (see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding-Nonsterile Preparations, USP <795>)."
    • The BUD and storage conditions for safe use are identified on a label, in addition to the correct name, concentration and volume of the drug, and route of administration.

Distinguishing permissible 'repackaging' from inappropriate 'reuse' 

  • To assess compliance with CMS's infection control requirements, it is essential to distinguish:
    • Repackaging: "…the appropriate repackaging of a previously unopened SDV in accordance with USP <797> into multiple smaller doses;" from
    • Reuse: "…the inappropriate subdivision of the contents of a SDV for multiple patients that is not performed in accordance with USP <797>."

Citation Instructions

  • Citations must reflect the manner and degree (non-long term care) or scope and severity (long term care) of the deficiencies.
  • Surveyors are expected to recognize obvious evidence of inappropriate reuse of SDVs. They must ask for evidence from facilities using repackaged SDVs regarding how they ensure the SDVs have been repackaged in accordance with USP <797>. If surveyors find evidence that medications in their original SDVs are being used for multiple patients or residents, it would indicate that the provider/supplier is not using SDVs repackaged in accordance with USP <797>. 

No citations for appropriate repackaging & subsequent use   

  • "Providers/suppliers using medications that have been appropriately repackaged from SDVs and subsequently stored in accordance with USP <797> standards must not be cited for this specific practice."

Repackaging under Arrangement

  • "A facility may use medication doses repackaged from SDVs by an off-site vendor under an arrangement with the facility, or by an off-site centralized sterile compounding facility under the control of the facility or its parent health system." Surveyors must ask for evidence that the  facility obtained documentation from the vendor or centralized sterile compounding facility of its adherence to current USP <797> requirements. Requirements for providers/suppliers typically mandate that services provided under arrangement be in compliance with applicable standards.

  • The ASHP Foundation offers a tool for assessing contractors who provide sterile products:   ; "Start using Sterile Products Outsourcing Tool now." This is provided by CMS as information only; it does not constitute an endorsement, nor is use of this tool required.
 



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