September 2020 Pharmacy and Therapeutics Highlights

Topic

Decision

Overview and Comments

Consent Agenda

Informational only – approved via email prior to meeting

1. The following medications will be REMOVED from formulary: bacitracin injection, nesiritide injection, ranitidine injection, tablets, and suspension (all 3 were withdrawn from market per FDA); Premarin capsules (no usage in last 18 months).

2. The following biosimilar will be ADDED to formulary (reference product, Remicade®, already on formulary). This medication will be restricted to outpatient infusion center only with confirmed prior authorization: Infliximab-abda (Renflexis®).

3. Add chlorthalidone 25mg tablet to formulary due to low cost, significant non-formulary use, and benefits over hydrochlorothiazide.

Prevnar-13®:

ACIP recommendation changes for 65+ years

• Routine vaccination of Prevnar-13 (PCV13) is no longer recommended for all patients 65+ years and older.
• For higher risk patients who have never had PCV13 vaccination, providers should discuss engage in shared-decision making prior to vaccinating with PCV13 (see comments for details).

In 2014, ACIP recommended PCV13 be given to all patients 65+ years and older. Since that time, limited decrease in pneumococcal disease has been observed, leading ACIP to revise the recommendation in Nov 2019 to no longer recommend routine vaccination for all 65+ year old patients.

PCV13 may still be administered to patients according to shared decision-making. The following adults aged ≥ 65 years who have not previously received PCV13 may attain higher than average benefit from PCV13 vaccination:

• Persons residing in nursing homes/SNFs/LTC facilities
• Persons residing in settings with low pediatric PCV13 uptake
• Persons with chronic heart, lung, or liver disease, diabetes, alcoholism, those who smoke cigarettes, or who have more than one chronic medical condition.

Renflexis® and infliximab biosimilar review

• Renflexis® will be our default infliximab agent, pending insurance authorization.
• New start patients must fail a biosimilar, (e.g. Inflectra®, Renflexis®, etc…) prior to initiating on Remicade®, pending insurance authorization.
• All Medicare and commercial insurance patients should be converted to Renflexis® unless they have demonstrated prior intolerance to this agent.
• Switching between biosimilars will be limited to one switch whenever possible to reduce risk of developing of anti-drug antibody formation.

Biosimilars continue to be approved for various monoclonal antibodies including infliximab. Remicade®, the infliximab reference product, is one of the most utilized monoclonal antibodies at VMC. However, there are now 3 additional FDA approved biosimilars for Remicade®, all of which are less expensive and have potentially better reimbursement. Valley stands to have significant financial benefit from the increased utilization of biosimilars.

Biosimilars are medications that are “highly similar” to the reference product. Monoclonal antibodies can not have “generic” versions due to the fact they are manufactured from living cell lines. The alternative is instead biosimilars, which are FDA approved to be highly similar and nearly identical versions of the reference product. Inflectra®, Renflexis®, and Avsola® are all biosimilars for Remicade®.

Low-dose ketamine for acute pain in medical-surgical patients

• Promote use of low-dose ketamine in acute on chronic opioid patients that have high opioid requirements (> 90 MEDD) to decrease opioid usage. Consider a trial on surgical patients having high opioid requirements.
• Remove restrictions of requiring CCU observation for initiation of low-dose ketamine (defined as up to 0.2mg/kg bolus dose and continuous infusion of 0.1mg/kg/hour) for medical-surgical patients.
• Add language to the Pharmacy Pain CDTA (Collaborative Drug Therapy Agreement) to allow for trial of IV push ketamine bolus for chronic opioid patients.

Ketamine is a noncompetitive NMDA receptor antagonist that was initially approved for the induction and maintenance of general anesthesia. Since its approval, there have been additional benefits that have been observed with ketamine such as its use as an analgesic, antiepileptic, and antidepressant.

The “Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists” from 2018 support the use of ketamine as a stand-alone treatment or as an adjunct to opioids for acute pain.

At Valley Medical Center, there is a protocol to utilize low dose ketamine in the emergency department and operating rooms for its analgesic properties to help decrease the amount of opioid medications that are used.

Low dose ketamine is 5-10x less than the anesthetic dosing and typically has minimal adverse effects. This dosing is sub-dissociative and typically does not elicit the CNS toxicities commonly seen at higher dosing.

Adult IV Drip and Push Patient Placement Policy Review

Notable changes include:

• Amiodarone bolus and drips can now be initiated on 6S and SPCU.
• Haloperidol IV now requires telemetry; Haloperidol IM does not require telemetry.
• Low-dose ketamine can be initiated on med-surg units (no longer requires 6 hour CCU observation).

Re: haloperidol: the use of haloperidol IV is an off-label indication and carries safety risks of QTc prolongation. This risk may be not be as prevalent with IM haloperidol. Telemetry will now be required for IV doses of haloperidol. IM doses will not require telemetry.

Leapfrog Medication Reconciliation Medication Use Evaluation (MUE)

Informational only.

Valley continues to improve upon its annual medication reconciliation quality review, reducing number of inpatient medication discrepancies to 8% from 19%. However, opportunities still remain to improve the medication reconciliation process – most notably, having additional pharmacy medication history technicians to expand and enhance coverage.