nhia ed resource- alternatives to affected syringes 9-4 …€¦ · ·...
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An NHIA Educational Resource for Home and Specialty Infusion Providers September 4, 2015
BACKGROUND: A Summary and Status of the Becton Dickinson (BD) 3 mL and 5 mL Syringe Drug Potency Issue For more than 30 years, health care providers in all settings (home infusion, hospital, long term, outpatient/ambulatory clinic) have utilized syringes in the preparation of compounded and admixed drugs for administration to patients in parenteral, enteral and oral formulations. Manufacturers have long sold these syringes in a wide range of multi-‐packs, with or without syringe tip covers included, to facilitate their use in the dispensing of compounded drugs. Resources such as Trissel’s Handbook on Injectable Drugs1 as well as Bing’s and Nowobilski-‐Vasilios’ Extended Stability for Parenteral Drugs2 have traditionally provided a compilation of available stability data for health care provider reference when determining suitable containers, including syringes, for compounded drug storage and administration. On August 18, 2015, the Food and Drug Administration (FDA) issued a MedWatch Safety Alert titled “Compounded Drugs Stored in Becton-‐Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning -‐ Do Not Use3,” describing reports of a loss of drug potency for certain medications such as fentanyl, morphine, methadone and atropine when stored in the syringes “over a period of time” prior to use. Not surprisingly, health care providers have had questions about the context of these issues. The FDA alert advised health professionals “not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (mL) and 5 mL syringes manufactured by BD unless there is no suitable alternative available.” The FDA alert also noted that “BD’s 10 mL, 20 mL and 30 mL syringes may also contain the same rubber stopper” as the stopper implicated in the loss of drug potency issue, and that “the company is alerting their customers not to use these syringes as a closed container system for compounded and repackaged drugs.” Additionally, the FDA alert noted that “This issue may extend to other general use syringes made by other manufacturers that were not cleared for the purpose of closed-‐container storage usage.” Prior to the publication of this FDA alert, both the syringe manufacturer (BD), and the Institutes for Safe Medication Practices (ISMP) had posted information about this drug potency issue on their respective websites on July 31. BD’s letter to customers4 described the loss of drug potency with certain compounded pharmaceuticals when stored for periods of time “exceeding 24 hours,” and went on to explain that their “plastic sterile hypodermic syringes are not FDA-‐cleared for storage of compounded pharmaceuticals.” BD also informed customers in this letter that they may periodically “modify some of the components of our syringes for various commercial and technical reasons” and that, while they do conduct testing to ensure the modifications do not impact the safety and performance of the syringe in its FDA-‐cleared use for general purpose fluid aspiration/injection, they do not test the modified syringes for the storage of compounded drugs and they do not alert users of the syringes to such product changes. In a “Technical Update to July 31st Customer Letter5,” posted in the same “Alert” section of the BD website, the manufacturer explains that “testing has revealed that the preparation of medications in reduced concentrations, typically for pediatric use, is more susceptible to active ingredient degradation than more typical dosage ranges,” and that they continue to investigate the matter with the intent to provide updates as information becomes available.
The ISMP Safety Alert Loss of drug potency6, also published on July 31st, provided additional details about the reports ISMP had received from hospital pharmacists related to compounded medications prepared in advance in 3 mL or 5 mL BD syringes. One of the medications, fentaNYL citrate injection, was diluted to 10 mcg per mL for pediatric use and prepared in the hospital pharmacy. In 3 syringes of diluted fentaNYL 10 mcg/mL sent to an outside laboratory for testing, the potency had declined to 67% on average within 48 hours, and by day 6, the potency was at 55%. Another hospital tested syringes of fentaNYL 5 mcg/mL in 3 mL syringes and found a range of potencies between 10% and 70%. Retesting at two other laboratories showed similar results. A third hospital reported inadequate patient analgesia, also with diluted fentanyl. ISMP learned from BD representatives that the issues may be related to plunger rod stoppers sourced from a secondary supplier, and that seemed to affect “pH sensitive” medications including methadone
Assessing Alternatives to the Storage of Compounded and Repackaged Medications in BD 3 mL and 5 mL General-‐Use Syringes
An NHIA Educational Resource for Home and Specialty Infusion Providers September 4, 2015
hydrochloride in addition to the fentanyl citrate already mentioned. ISMP noted that “Patient safety could be compromised if subpotent opioid doses cause a dose elevation that is followed by administration of a fully potent opioid at the higher dose via a syringe that does not have this issue.”
In response to the FDA’s August 18 MedWatch alert on this issue, ISMP posted “comments on BD syringe potency issue7” that noted “…we now realize that these syringes were never cleared by FDA for use as a closed container storage system for drug products, and the suitability of these syringes for that purpose has not been established. This calls into question what hospitals have been doing for years—preparing unit dose syringes in the pharmacy in advance of anticipated use, or obtaining prepared syringes from outsourcers.” While not explicitly stated in these comments, the same could be said for any health care setting in which pharmacies are compounding and preparing patient-‐specific and labeled unit dose syringes in advance of anticipated use. At this time, the only specific recommendation received from the FDA is to stop using BD 3 mL and 5 mL syringes for drug storage unless there is no suitable alternative. ISMP in its August 27th comments is advocating for a coordinated, carefully considered response: “We all need to work together to acquire information to better understand this issue, but for now, we cannot suggest that radical changes are warranted to what is currently the norm.” NHIA is actively reaching out to key stakeholders in order to stay informed regarding this situation and to collaborate on the best ways to address this challenge across multiple sites of care (including home and specialty infusion), so as to advocate for assuring patient safety and quality care in the most commonsense, least onerous ways. To further assist our home and specialty infusion members, NHIA has developed this educational resource that describes possible alternatives to the use of the affected 3 mL and 5 mL syringes, and can be adapted as updated information is released from the FDA and/or syringe manufacturers. In addition, BD has posted a “U.S. Alternate Stopper Quick Reference Guide8” providing specific catalog numbers and manufacturing dates for those syringes in which the alternate rubber plunger stopper from the secondary supplier was used, as well as those syringes for which no materials change has been made. As updates are published regarding this situation, information will continue to be posted to the members-‐only NHIA Product and Company News webpage, in addition to being promptly shared via the NHIA LISTSERV® Message Board. If your organization is not currently monitoring the NHIA LISTSERV Message Board, we strongly encourage you to sign up and stay informed at http://www.nhia.org/members/listserv.cfm.
BACKGROUND REFERENCES: 1Trissel LA. ASHP’s Interactive Handbook on Injectable Drugs, 18th ed. Bethesda, MD: American Society of Health-‐System Pharmacists; 2014. 2 Bing CD, Nowobilski-‐Vasilios A, eds. Extended Stability for Parenteral Drugs, 5th edition. Bethesda, MD: American Society of Health-‐System Pharmacists; 2013 3Accessed from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458955.htm 4Accessed from http://www1.bd.com/hypodermic/pdf/07-‐31-‐15-‐letter.pdf 5Accessed from http://www1.bd.com/hypodermic/pdf/07-‐31-‐15-‐letter-‐technical-‐update.pdf 6Accessed from http://www.ismp.org/newsletters/acutecare/articles/loss-‐of-‐drug-‐potency.aspx 7Accessed from http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=117) 8Accessed from http://www1.bd.com/hypodermic/pdf/US-‐Quick-‐Reference-‐Guide.pdf
An NHIA Educational Resource for Home and Specialty Infusion Providers September 4, 2015
NHIA has developed this educational resource for providers who are affected by the FDA’s August 18, 2015 safety warning regarding loss of drug potency for compounded medications stored in BD’s 3 mL and 5 mL general-‐use syringes (available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458955.htm). The FDA warning advises health care providers to stop using these syringes for any purpose other than the immediate withdrawal and administration of medications, if suitable alternatives are available. This NHIA educational resource describes possible alternatives to the use of the affected syringes, and can be adapted as additional information is released from the FDA and/or syringe manufacturers.
Is the drug previously dispensed from the pharmacy in an affected syringe, available in a
prefilled syringe?
Can the drug be dispensed in an unaffected syringe, or an alternative container with a different method of administration? (e.g., gravity infusion, ambulatory pump, elastomeric device, etc.) 1
Can the patient and/or caregiver be taught to safely withdraw the drug into a syringe for immediate use?
Can the drug be dispensed in a single-‐use or multi-‐use vial for withdrawal into a general-‐use syringe just prior to administration?1
Is the prescriber in agreement with this
alternative?
PROCEED WITH CAUTION: If previously dispensed
medication was compounded in syringes that caused reductions in potency, dose reductions may be required when substituting a replacement medication. Ensure proper monitoring procedures
are in place. 2
Is the prescriber in agreement with this
alternative?
No suitable alternative may be readily available. Consult with the prescriber regarding lack of available alternatives. Ensure proper monitoring procedures are in place if
medication must be dispensed in affected containers. 2
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
DISCLAIMER: The National Home Infusion Association (NHIA) produces educational resources as an aid to good clinical practice that reflects the input of its members and experienced clinicians in the field. Clinical material offered in these resources is intended as a guide for information purposes only and does not replace or remove clinical judgment or the professional care and duty necessary for each specific patient case. While great effort has been made to assure all information is complete and accurate as of the time this resource was issued, given the continuously evolving health care environment and the particular circumstances of individual cases, no assurance can be given that the information is entirely complete or accurate in every conceivable respect (and, as such, NHIA and its board members, committee/work group members, officers and employees disclaim all liability for the accuracy or completeness of this resource, and disclaim all warranties, express or implied to its incorrect use). Finally, any clinical care carried out that includes the use of this educational resource (as part of the assessment of alternatives to the storage of compounded and repackaged medications in BD 3 mL and 5 mL general-‐use syringes and/or in any other manner) should ultimately be provided within the context of a prescriber’s oversight and orders, locally available resources and expertise, and all relevant regulatory requirements. This resource does not address all elements of standard practice and, as such, presume and necessitate that individual clinicians and care providers fulfil such responsibilities.
References: 1Bing CD, Ross KL, Applying Stability Data in Patient Care. In Bing CD, Nowobilski-‐Vasilios A, eds. Extended Stability for Parenteral Drugs, 5th edition. Bethesda, MD: American Society of Health-‐System Pharmacists; 2013:3-‐22. 2Compounded Drugs Stored in Becton-‐Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning -‐ Do Not Use, accessed August 19, 2015 from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458955.htm
Assessing Alternatives to the Storage of Compounded and Repackaged Medications in BD 3 mL and 5 mL General-‐Use Syringes