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Main St. Pharmacy recall - CDC: Multistate Investigation of Suspected Infections Following Steroid Injections; Some contaminants now identified; Case count = 26 in 4 states (Updated June 28, 2013)

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  • Main St. Pharmacy recall - CDC: Multistate Investigation of Suspected Infections Following Steroid Injections; Some contaminants now identified; Case count = 26 in 4 states (Updated June 28, 2013)

    Multistate Investigation of Suspected Infections Following Steroid Injections

    Posted May 30, 2013 5:30 PM ET

    This website will be updated on Mondays and Thursdays by 2pm ET.


    At a Glance:

    Status: On-going Investigation
    Reported Cases: 20 *
    States reporting cases: 3
    Recall: Yes



    Initial Announcement
    May 30, 2013

    Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections


    State, Federal Health Officials Investigate Reports of Adverse Events among Patients Receiving Methylprednisolone Acetate Injections



    Summary of Investigation

    This information is preliminary and will be updated as additional details become available.

    CDC is aware of reports of suspected infections among persons who received preservative-free methylprednisolone acetate (MPA) 80mg/mL in 10mL vials produced by the Main Street Family Pharmacy in Newbern, Tennessee. CDC is aware of 20 reported cases from three states – Illinois, North Carolina, and Florida. The majority of these persons developed skin and soft tissue infections of unclear etiology following intramuscular injection of this product. Additional clinical information is being gathered. To date, no reports of meningitis or other life-threatening infections have been reported. All products labeled as sterile have been voluntarily recalled by the pharmacy. CDC is not aware of infections among persons who received products other than preservative-free MPA in the above formulation from this pharmacy. State and local health departments are working with CDC and FDA to evaluate this situation.

    *Case Definition: A person who developed a suspected infection associated with injection of a product, labeled as sterile, that was distributed by the Main Street Family Pharmacy (Newbern, TN) since December 1, 2012.
    Last edited by Catbird; May 31, 2013, 11:55 AM. Reason: typo



    "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

    "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

  • #2
    Re: Main Street Pharmacy recall - CDC: Multistate Investigation of Suspected Infections Following Steroid Injections

    CDC: Multistate Investigation of Suspected Infections Following Steroid Injections


    At a Glance:

    Status: On-going Investigation
    Reported Cases: 24 *
    States reporting cases: 4
    Recall: Yes


    *Case Definition: A person who developed a suspected infection associated with injection of a product, labeled as sterile, that was distributed by the Main Street Family Pharmacy (Newbern, TN) since December 1, 2012.



    "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

    "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

    Comment


    • #3
      Re: Main Street Pharmacy recall - CDC: Multistate Investigation of Suspected Infections Following Steroid Injections; Case count = 24 (Updated June 3, 2013)

      http://www.cdc.gov/hai/outbreaks/TN-...cy/index.html:

      At a Glance:

      Status: On-going Investigation
      Reported Cases: 24 *
      States reporting cases: 4
      Recall: Yes

      Summary of Investigation

      This information is preliminary and will be updated as additional details become available.

      June 6, 2013


      Suspected infections have occurred among persons who received either 80mg/mL or 40mg/mL of preservative-free methylprednisolone acetate (MPA) produced by the Main Street Family Pharmacy in Newbern, Tennessee. As of June 6th, CDC is reporting 24 cases from four states – Arkansas, Florida, Illinois, North Carolina. The majority of these persons developed skin and soft tissue infections of unclear etiology following intramuscular injection of this product. All products labeled as sterile have been voluntarily recalled by the pharmacy.

      State and local health departments are working with facilities to verify the accuracy of the pharmacy’s distribution records and to determine which patients may require active outreach. Healthcare providers are contacting patients to determine if they have had possible infections stemming from injections of recalled MPA. Suspected infections that meet the criteria below* are reflected in the case count presented on this webpage. Healthcare providers are reminded that any adverse reaction following injection with a recalled product from Main Street Family Pharmacy should be reported to FDA’s Medwatch system, which is designed to routinely collect these types of reports.

      On June 6, FDA reported detection of microbial contamination, including bacterial and fungal, in unopened vials of preservative-free MPA. Samples are being sent to CDC for further characterization. These findings emphasize the importance for providers to continue to ensure that all recalled products are no longer in use and returned promptly. Clinicians are also reminded that individual containers of compounded or preservative free medicine are intended for single-patient use only; they should not be used as a common source of supply for multiple patients.

      CDC is working closely with FDA and the health departments in affected states to monitor and to evaluate this situation. We will provide more information as it becomes available.

      *Case Definition
      : A person who developed a suspected infection associated with injection of a product, labeled as sterile, that was distributed by the Main Street Family Pharmacy (Newbern, TN) since December 1, 2012.



      "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

      "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

      Comment


      • #4
        Re: Main Street Pharmacy recall -CDC: Multistate Investigation of Suspected Infections Following Steroid Injections; Microbial contamination confirmed; Case count = 24 (Updated June 7, 2013)

        CDC Update June 10, 2013:


        At a Glance:

        Status: On-going Investigation
        Reported Cases: 25
        States reporting cases: 4
        Recall: Yes


        June 10, 2013

        As of June 10th, CDC is reporting 25 cases from four states – Arkansas, Florida, Illinois, and North Carolina...



        "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

        "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

        Comment


        • #5
          Re: Main Street Pharmacy recall - CDC: Multistate Investigation of Suspected Infections Following Steroid Injections; Microbial contamination confirmed; Case count = 25 (Updated June 10, 2013)

          CDC update for June 13th:



          At a Glance:

          Status: On-going Investigation
          Reported Cases: 26
          States reporting cases: 4
          Recall: Yes


          Summary of Investigation

          This information is preliminary and will be updated as additional details become available.
          June 13, 2013

          CDC and FDA have identified the bacteria and fungi cultured from unopened vials of preservative-free MPA from Main Street Family Pharmacy (MSFP) in Newbern, TN. These findings are important reminders that healthcare providers should not use any product produced by MSFP until further notice. In addition, complaints from patients exposed to products from MSFP should be taken seriously and should be promptly reported to both FDA MedWatch and the health department.

          In addition to the findings above, 4 of the 26 cases meeting the CDC case definition* have had bacteria or fungi detected from wounds: 2 patients had Enterobacter cloacae and Klebsiella pneumoniae, 1 had mixed bacterial culture not otherwise identified, and 1 had fungus highly suggestive of an Aspergillus sp., although further studies are needed for confirmation. Although bacteria and fungi have been isolated from unopened vials of MPA from MSFP, it is not possible to determine which infections are due to this contamination event versus other factors including improper handling and/or administration of medications at the injection facility.

          Clinicians are reminded that they should 1) use individual containers of compounded or preservative-free medicine for a single-patient only, and 2) promptly report to MedWatch any infection that might be related to a medication or medical device, even absent a recognized outbreak, as these reports can allow for early detection of a possible contamination event.

          Note: The next CDC web update is scheduled for Thursday, June 20.



          "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

          "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

          Comment


          • #6
            Re: Main St. Pharmacy recall - CDC: Multistate Investigation of Suspected Infections Following Steroid Injections; Some contaminants now identified; Case count = 26 in 4 states (Updated June 13, 2013)

            This CDC update shows that there haven't been any additional cases identified. However, not all patients who received injections of the contaminated product have been notified.


            Excerpt from "Multistate Investigation of Suspected Infections Following Steroid Injections

            Summary of Investigation

            June 27, 2013

            CDC and FDA have identified bacteria and fungi in unopened vials of preservative-free methylprednisolone acetate (MPA) from Main Street Family Pharmacy (MSFP) in Newbern, TN. On May 28, 2013, Main Street announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. Facilities should ensure that recalled products are no longer in use.

            All 96 facilities in 17 states that received recalled MPA distributed since December 1, 2012 from Main Street Family Pharmacy (MSFP), Newbern, TN have been contacted by state or local health departments. Only 81 facilities in 15 states administered MPA, with and/or without preservative, to patients; those facilities have been provided instructions on patient notification and are responsible for notifying their patients. To date, CDC has received information that the majority of exposed patients have been notified in 62 of these 81 facilities. Notification efforts have not been initiated or neared completion in the remaining 19 facilities (1 in AR, 8 in TX, and 10 in LA).

            Patients who are concerned that they might have received an injection with MPA from MSFP should contact their provider to confirm the origin of the MPA product. Patients are advised to seek medical attention if they develop symptoms suggestive of an infection resulting from an injection. Because incubation periods for fungal infections can be lengthy, patients should remain vigilant for signs and symptoms of infection for several months following a known injection with MPA from MSFP.

            CDC has not received reports of infections related to any MSFP product other than preservative-free MPA. As of June 27, 26 cases meeting the CDC case definition* have been reported. The majority of cases were reported within the first week of the investigation; since June 3, after notification efforts, only 2 additional cases have been reported. The majority of cases had local skin and soft tissue inflammation at the site of injection, without an identified pathogen. There have been no reports of life-threatening infections.

            Of 4 patients with positive cultures or histopathologic findings, 2 patients had Enterobacter cloacae and Klebsiella pneumoniae, 1 had Klebsiella pneumoniae, and 1 had Aspergillus sp. In addition to the risk from bacteria and fungi that have been isolated from unopened vials of MPA from MSFP, some of these suspected infections may be due to improper handling and/or incorrect injection practices.

            Clinicians are reminded that they should 1) use individual containers of compounded or preservative-free medicine for a single patient only, and 2) promptly report to MedWatchExternal Web Site Icon any infection that might be related to a medication or medical device, even absent a recognized outbreak, as these reports can allow for early detection of a possible contamination event.

            *Case Definition: A person who developed a suspected infection associated with injection of a product, labeled as sterile, that was distributed by the Main Street Family Pharmacy (Newbern, TN) since December 1, 2012."



            "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." - Herbert Simon

            "The benefits of education and of useful knowledge, generally diffused through a community, are essential to the preservation of a free government." - Sam Houston

            Comment

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