Beyond use dating multidose ointment
The proposed chapter requires institutions to maintain their own list of HDs, including those on the NIOSH list and any others they determine to be hazardous. Hazardous drugs have been associated with spontaneous abortion and congenital malformations.11,12 In a 2012 retrospective study of nurses who had reported exposure to antineoplastic drugs (n=7482 women who each became pregnant), an associated 2-fold risk for spontaneous abortion was identified.11 The risk was increased to 3.5-fold in nulliparous women.If an HD is in a unit dose packaging, there are no further requirements for alteration prior to dispensing to the patient.1 If non-antineoplastic drugs need to be transferred from their packaging to a prescription bottle, they should be counted with equipment (spatula, tray) dedicated for use with these drugs. If the literature addresses only one of these factors, then USP guidance should be followed when assigning a BUD.Along with addressing storage and handling, USP provides measures for protecting those administering HDs.1 When the dosage form allows, a closed-system transfer devices (CSTD) should be used to administer an HD. Critical interpretation of sources is necessary to determine a conservative and safe BUD.These risk levels can then be used to determine appropriate BUDs as summarized in Table 3.
The compounding supervisor is responsible for developing the training and demonstrating procedures for personnel involved. For CSPs, the literature should address both stability and sterility of the final preparation.1,3 If the dates are different for stability and sterility, then the shorter of the 2 dates should be used to assign a BUD.When multiple-dose containers are used to make CSPs then the container should be inspected and disinfected with each use. 4 According to the American Psychiatric Association 2010 guidelines for major depressive disorder, the choice of initial antidepressant is usually based on the adverse effect profile because the effectiveness of the agents is similar.5 They suggest that for most patients a selective serotonin reuptake inhibitor (SSRI), a serotonin/norepinephrine reuptake inhibitor (SNRI), mirtazapine, or bupropion are appropriate. Naughton M, Clarke G, O’Leary OF, Cryan JF, Dinan TG. Single-dose containers should be used within 1 hour if opened in worse than International Standards Organization (ISO) Class 5 air quality and within 6 hours if exposed to ISO Class 5 air quality or better. Pharmacologic options for patients who fail to respond to an appropriate dose of the first antidepressant include changing to an alternative antidepressant, augmenting therapy with nontraditional antidepressants (e.g., lithium, buspirone, anticonvulsants), or combining antidepressants. A review of ketamine in affective disorders: current evidence of clinical efficacy, limitation of use and pre-clinical evidence on proposed mechanisms of action. These should be negative pressure separate rooms that are externally ventilated. Introduction In light of drug shortages, concerns about outsourcing pharmacy services, and unique patient needs, Hospital Pharmacy Services is often required to compound pharmaceutical preparations.Hazardous drugs that require refrigeration will need to be placed in a refrigerator in a negative pressure room. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. To ensure appropriate compounding practices and assignment of a beyond-use-date (BUD), appropriate resources should be consulted and multiple factors including stability, sterility, compatibility, and risk level should be considered.1-3 This article summarizes steps in determining the most appropriate BUD for a compounded sterile preparation (CSP) or a compounded nonsterile preparation based on United States Pharmacopeia (USP) guidance and best practices.Chapter The proposed chapter requires personal protective equipment (PPE) to be worn when handling HDs, and describes its use in detail.1 The appropriate use of gloves, gowns, and head, hair, and shoe covers, as well as eye and face protection is discussed in the proposed chapter. National Institute for Occupational Safety and Health website. However, if there are any deviations between the literature and the institution’s practices, then USP guidance should be used to assign a BUD.Appendix F of the chapter is a table that lists certain activities involving HDs (eg, receiving, stocking) and the PPE that is required. Deviations include differences in brands, concentrations, or formulations of products used; types of containers or devices; risk level; environmental variables; and storage conditions.and the Centers for Disease Control and Prevention provide guidance on compounding using single-dose and multiple-dose containers. usp=37&nf=32&s=0&official On=May 1, 2014 Accessed June 10, 2014.1,4 Multiple-dose containers should be discarded after 28 days, unless otherwise specified by the manufacturer. Prepared by: Aparna Reddy, Pharm D PGY2 Drug Information University of Illinois at Chicago June 2014 Return to top The National Institute of Mental Health estimates that every year 6.7% of adult Americans experience major depressive disorder (MDD).1 Women are more likely to have MDD than men, and the disease is most prevalent in people age 40 to 59 years.2 In fact, between 20 antidepressants were the most common prescription drug class taken by adults age 18 to 44 years.3 Despite the numerous antidepressants currently available, approximately 50% of patients with MDD fail to respond to their first treatment, and 35% do not achieve response with 2 treatment courses. Rapid resolution of suicidal ideation after a single infusion of an NMDA antagonist in patients with treatment-resistant major depressive disorder.The rooms in which HDs are stored and compounded also require certain air changes per hour (ACPH). See the Table for required ACPH for compounding nonsterile and sterile HDs, as well as a detailed description of other engineering controls. Centers for Disease Control and Prevention website. Compounded sterile preparations include injections, aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, irrigations for wounds and body cavities, and ophthalmic drops and ointments.1 Other preparations can generally be classified as nonsterile.2 When compounding nonsterile preparations, stability and compatibility need to be considered.In general, separate areas should be designated in the facility for unpacking of HDs, compounding of nonsterile HDs, and compounding of sterile HDs. Rockville, MD: The United States Pharmacopeial Convention; 2014. When compounding sterile preparations stability, sterility, compatibility, and risk level need to be considered.1 Compounding of sterile preparations is guided by USP .1,2 USP provides guidance on appropriate compounding practices and assignment of BUDs.