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Pseudobulbar affect

Pseudobulbar affect Dextromethorphan (DXM) has been re-purposed several times over the past seven decades: first as a cough suppressant, then as a compounded formulation with quinidine for treatment of pseudobulbar affect.  As such, the drug Nuedexta® came on the market. 

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Grant Clinical Consulting

The speed of change in new drug development, evidence-based medicine, and best practice requires a strong base of understanding and an ongoing study of new medication innovations and utilization. 

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Nausea & Vomiting

The mechanism of delay-nausea (>24hours) involves stimulation of neuroreceptors other than serotonin. Dopamine mediations dominate this type of nausea. This leads to the benefit seen with phenothiazines (chlorpromazine, promethazine) and butyrophenone (haloperidol). The use of 5HT-3 antagonists, such as ondansetron, is not beneficial in this phase of emesis control as it lacks dopaminergic activity. The use of other drugs, such as dexamethasone, metoclopramide, droperidol, and olanzapine, may provide relief.

Biosimilars

A biosimilar is a highly similar biological product with no clinically meaningful differences from an existing FDA-approved reference product. “No clinically meaningful differences“ include the safety, efficacy, purity, and potency of the drugs, which has typically been demonstrated by pharmacokinetic (PK) and pharmacodynamic (PD) studies.

Compounding

Compounding is an essential aspect of the pharmacy profession, encompassing sterile and nonsterile preparation of medications. United States Pharmacopeia (USP) Chapters 795 and 797 regulate nonsterile and sterile compounding, respectively.  It allows for personalized dosages to be tailored to individual patients, making it a crucial component of drug delivery. The Food and Drug Administration (FDA) has divided compounded products into two categories: 503A and 503B. Medications prepared for specific patients based on orders from a licensed prescriber fall under 503A, which is considered traditional compounding. Meanwhile, 503B outsourcing facilities are subject to more stringent regulations. These facilities can compound and distribute non-patient-specific preparations, unlike those falling under 503A. Most hospitals and mainstream retail compounding pharmacies operate under 503A.

Cold storage transportation

The stability of drugs being stored can be affected by transportation. Maintaining a temperature between 2 to 8 degrees Celsius is necessary for cold chain products, while frozen products must be kept below minus 10 degrees Celsius. An “ultra-cold chain” may sometimes require holding temperatures below minus 80 degrees Celsius.  Pharmacies commonly handle the packaging and delivery of these drugs, as they are equipped to manage their storage and transportation needs.

Ketamine

Ketamine is FDA-approved as a rapid-acting IV dissociative general anesthetic.  There has been increased interest in its off-label use for pain control, administered via various routes.  This Fast Fact reviews the use of ketamine in palliative care, primarily for analgesia.

As an anesthetic, ketamine is given IV or IM.  For pain, the parenteral solution can be delivered at much lower doses by oral, intranasal, transdermal, rectal, and subcutaneous routes. The onset of analgesia is 15-30 minutes; the duration of action is 15 minutes to 2 hours, possibly longer orally.  A greater portion of ketamine is metabolized to a breakdown product with less affinity for NMDA receptors (norketamine) when taken orally versus IV.  It is not yet clear if this reduces the analgesic properties of oral ketamine in a clinically significant way.