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Areas Of Medication Expertise

Adverse Drug Reactions

Chronic Pain

Drugs and Narcotics

Geriatrics

Hospice/
Palliative Care

Hospital Pharmacy

Infusion Pharmacy

Long Term Care

Medical-Legal Issues

Nursing Homes

Overdose

Pain Management

Pharmaceutical Care

Pharmacology

CASE TYPES

Defense, Nursing Home Pharmacy

Defense, Retail Pharmacy

Defense, Insurance Company

Defense, Health-System

Defense, Individual v. Ohio State Board of Pharmacy

Plaintiff, Individual v. Individual

Defense, Individual v. Health-System, LTCF

Defense, Individual v. Individual (Federal)

EXCERPTS

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.

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..

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..

Compounding

Compounding is an essential aspect of the pharmacy profession, encompassing sterile and nonsterile preparation of medications. United States Pharmacopeia (USP) Chapters 795.

Nausea & Vomiting

The mechanism of delay-nausea (>24hours) involves stimulation of neuroreceptors other than serotonin. Dopamine mediations dominate this type of nausea.

Methadone

Methadone, an agonist of mu and delta and an antagonist at the NMDA (N-methyl-D-aspartate) receptor, offers a unique treatment option. Pain negatively affects the NMDA

Frequently Asked Questions

Yes.  Whether it is workflow assessment, regulatory oversight, or clinical services, GCC will evaluate, review, and report any findings and make recommendations for correction or improvements.

Yes/No.  If the organization prefers onsite consultative services, I will establish timelines for such services and coordinate travel, meetings, and outcome delivery with the organization.

Yes.  Although the quality of the services doesn’t change, the dedication of time to the organization does.

Yes/No.  If the organization wants a written report of findings and recommendations, I will provide this.  However, if the organization does not want this and prefers an oral report only, this can be arranged.

Yes.  If you or your loved one wants a review of the drugs that are currently prescribed or supplements being taken, with the purpose of understanding the medications, consider if negative side effects are due to the drugs, or recommend alternative choices.

Yes.  GCC can make written recommendations to the prescribers, such as physicians, with the consent of the patient or responsible party.  

No.  The services are billed 100% to the individual or responsible party.

Yes.  Although the quality of the services doesn’t change, the dedication of time to the patient and/or family does.

Yes.  For an individual, four hours is the minimum number of hours billed.  

No.  Each patient is different, and their past medical history and medication records are varied.  

Yes.  To learn more, e-mail or call GCC for a free initial conversation.  If you want to proceed, a fee schedule will be sent out for your review.

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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.

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.

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.

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.

Methadone

Methadone, an agonist of mu and delta and an antagonist at the NMDA (N-methyl-D-aspartate) receptor, offers a unique treatment option. Pain negatively affects the NMDA receptor through what is postulated as an interaction on the excitatory transmitters (glutamate and aspartate), resulting in central sensitization. Using an NMDA blocking agent is thought to reduce or interfere with the discharge threshold, making it less sensitive and able to restrain the transmittal of pain signals.