New therapy for refractory multiple myeloma
The FDA granted accelerated approval to the oral exportin 1 (XPO1) inhibitor selinexor (Xpovio) used in combination with the corticosteroid dexamethasone to treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
The recommended starting dosage of selinexor is 80 mg taken orally with dexamethasone on Days 1 and 3 of each week. This combination is associated with many adverse reactions, including leukopenia, neutropenia, thrombocytopenia, anemia, nausea and vomiting, hyponatremia, and neurologic toxicity. Monitor patients for low blood cell counts and sodium levels and warn them that they may feel dizzy or confused. Tell them not to take the drug with other medications that may cause neurologic effects and to avoid potentially hazardous situations requiring alertness. Selinexor is dispensed with a Medication Guide fully describing the drug's risks and hazards.
Source: US Food and Drug Administration. FDA approves new treatment for refractory multiple myeloma. News release. July 3, 2019. Xpovio (selinexor) tablets, for oral use. Prescribing information. www.accessdata.fda.gov/drugsatfda_docs/label/2019/212306s000lbl.pdf.
Nasal powder for severe hypoglycemia
The FDA has approved the first glucagon therapy approved for emergency treatment of severe hypoglycemia that can be administered without an injection. Baqsimi (glucagon) nasal powder is provided in a single-use dispenser and is indicated to treat severe hypoglycemia in patients with diabetes age 4 years and older. Administered intranasally, the 3 mg dose need not be inhaled to be effective. The new drug is expected to simplify treatment in an emergency, an important advantage for patients who may be unconscious or experiencing a seizure. If the patient does not respond to treatment in 15 minutes, another 3 mg dose may be administered.
Baqsimi is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or to any of the excipients.
Source: US Food and Drug Administration. FDA approves first treatment for severe hypoglycemia that can be administered without an injection. News release. July 24, 2019.
Use of unprescribed antibiotics is prevalent
In a review of published research on the prevalence of nonprescription antibiotic use in the US, researchers uncovered an alarming public health hazard: the widespread use of antibiotics without a prescription. Based on a search of research articles from various databases from January 2000 to March 2019, the study revealed the following findings, which varied depending on population characteristics.
- The prevalence of nonprescription antibiotic use ranged from 1% to 66%.
- Storage of antibiotics for future use varied from 14% to 48%.
- The prevalence of intentions to use antibiotics without a prescription was 25%.
Sources for antibiotics obtained without a prescription included previously prescribed drugs, local markets or stores, and family or friends. Factors contributing to nonprescription use included easy access through markets or stores that obtain antibiotics internationally, difficulty accessing the healthcare system, costs of healthcare visits, long waiting periods in clinics, and transportation problems.
The authors concluded that use of nonprescription antibiotics is “a seemingly prevalent and understudied public health problem” in the US. They call for more study into strategies that would counter this unsafe practice.
Source: Grigoryan L, Germanos G, Zoorob R, et al. Use of antibiotics without a prescription in the U.S. population: a scoping review. Ann Intern Med. [e-pub ahead of print July 23, 2019]
Making endotracheal intubation safer
When performed in emergency situations outside of an OR, endotracheal intubation is a risky procedure. In circumstances that do not allow appropriate preparation and preoxygenation, traditional rapid sequence intubation (RSI), the simultaneous administration of an induction agent and muscle relaxant, may harm patients who have atypical airway anatomy, severe hypoxia, acidemia, or hypotension. In a recent discussion of contemporary practice, the authors argue that ketamine, a dissociative anesthetic, facilitates intubation and improves patient safety during two alternatives to RSI:
- delayed-sequence intubation, in which ketamine is used to allow airway preparation and preoxygenation in agitated patients
- ketamine-only breathing intubation, in which ketamine is used without a paralytic agent to facilitate intubation while the patient breathes spontaneously.
Dissociative doses of ketamine disconnect the patient from painful stimuli while leaving brainstem function intact, preserving or augmenting cardiovascular tone during the procedure and thus reducing many risks. The authors write that ketamine also offers hemodynamic benefits during standard RSI and is valuable for postintubation analgesia and sedation as well. “When RSI is not an optimal airway management strategy, ketamine's unique pharmacology can be harnessed to facilitate alternative approaches that may increase patient safety.”
Source: Merelman AH, Perlmutter MC, Strayer RJ. Alternatives to rapid sequence intubation: contemporary airway management with ketamine. West J Emerg Med. 2019;20(3):466-471.
Drug allergy toolkit available for clinicians
The Partnership for Health IT Patient Safety (Partnership), a national collaborative convened by ECRI Institute, has established workgroups for in-depth study of health information technology (IT) events and development of safe practice recommendations and toolkits. Safe Practices for Drug Allergies—Using CDS and Health IT is a toolkit designed to reduce adverse reactions associated with drug allergies. It focuses on using technology to standardize documentation, enabling clinical decision support (CDS) tools to provide more actionable information, monitoring alerts for effectiveness, and engaging patients to ensure collection of accurate drug allergy information.
Besides ECRI Institute, the Partnership consists of multiple patient safety stakeholders, including the Institute for Safe Medication Practices, The Joint Commission, HiMSS, and Wolters Kluwer. Access the drug allergy toolkit at https://assets.ecri.org/PDF/HIT-Partnership/ECRI-Drug-Allergy-Toolkit.pdf.