Jackson Market P&T - 2024

SDSD

New/Updated Pharmacy Directives:

• Therapeutic Directive – Rabies Immune Globulin Dose Rounding (NEW) – Katie Schipper, PharmD presented a proposal to automatically round rabies immune globulin doses to the nearest vial size based on actual body weight (kg). While this directive aims to reduce medication cost, waste, and error locally, it may also serve as a template for other system sites that utilize more rabies immune globulin at their respective institutions. Cost savings for St. Dominic are approximately $1000 annually.
  
  
• Therapeutic Directive IV-PO Step-down Antimicrobials (UPDATED) – Katie Schipper, PharmD reviewed changes to the IV-PO Step-down Antimicrobial directive, which included minor updates to the inclusion and exclusion criteria for patients eligible to receive oral step-down. This directive was also updated to reflect cefdinir’s removal from formulary with cefuroxime becoming the oral step-down for cefotaxime and ceftriaxone.

• Therapeutic Directive IV-PO Step-down Folic Acid (UPDATED) – Katie Schipper, PharmD provided an update to this therapeutic directive, which reflected cost changes for IV and PO folic acid formulations.

• Therapeutic Directive Interchange Proposal – Colchicine-Probenecid (NEW) – Katie Schipper, PharmD proposed a therapeutic directive that would allow for an automatic interchange from Benemid (colchicine/probenecid) 0.5 mg/500 mg tablets to the individual components: Colcrys (colchicine) 0.6 mg and Probalan (probenecid) 500 mg tablets. This interchange proposal aims to eliminate the cost and waste associated with an infrequently ordered combination product by utilizing the supply of its components already stocked by pharmacy.

Renewal of Existing Pharmacy Directives:

• Therapeutic Directive Automatic Discontinuation Granix
• Therapeutic Directive Cardene and Cleviprex Transition to Oral
• Therapeutic Directive Integrillin
• Therapeutic Directive Pain and Sedation in Mechanically Ventilated Patients
• Therapeutic Directive Santyl Restrictions
• Therapeutic Directive Automatic Biosimilar Conversions
• Therapeutic Directive Cellulitis Step Down (RETIRED)

Policies and Procedures

Policy updates, revisions, and deletions were presented by Dr. Katie Schipper, PharmD. A summary of policies presented is below.

JOINT COMMISSION REQUIREMENTS

• Antimicrobial Stewardship Report – Andrew Watkins, PharmD presented the Standardized Antimicrobial Administration Ratio (SAAR) from January to March of 2024. SAAR data shows antimicrobial usage at St. Dominic Hospital by benchmarking prescribing trends against risk-adjusted data from institutions of similar size and acuity provided by the Center for Disease Control and Prevention’s National Healthcare Safety Network (NHSN). Any SAAR value > 1.0 indicates more antimicrobial days observed than predicted whereas SAAR values < 1.0 indicate fewer days observed than predicted.  Metrics include all antibacterials prescribed, broad spectrum antibacterials used predominantly for hospital-onset infections (e.g., piperacillin/tazobactam, cefepime, meropenem), antibacterial agents predominantly covering gram-positive infections (e.g., daptomycin, vancomycin, linezolid), and broad spectrum antibacterials predominantly used for community-onset infections (e.g., ceftriaxone, fluoroquinolones).  Overall, our total antibacterial prescribing habits continue to hold a SAAR of < 1.0 for the first quarter of 2024.  This trend was also reflected in SAARs for agents active against resistant gram-positive organisms as well as broad spectrum agents often used for community-acquired infections, with SAARs < 1.0.  However, broad spectrum agents predominantly used for hospital-onset infections continue to hold a SAAR > 1.0 in the ICU and wards. De-escalating to narrower agents when possible and limiting antibiotic regimens to shorter, guideline-directed durations can help further improve our metrics and patient care.

Medication Use Evaluations

• Opioid Stewardship in Postoperative Care – Connor Dowling, PharmD presented the findings from a medication use evaluation (MUE) conducted at St. Dominic Jackson-Memorial Hospital. This MUE focused on postoperative prescribing practices of opioids to compare St. Dominic with national guideline recommendations for postoperative pain management. Patients from July 2022 to July 2023 that were at least 18 years old and admitted for an inpatient orthopedic surgery with scheduled or as needed opioid orders were included in the study.  Those that received orders for ventilation bundles, patient-controlled analgesia pumps, or an active diagnosis of cancer were excluded from the review.  From the 60 patients included in the study, 19 patients (31.7%) received guideline-recommended, scheduled non-opioid medications postoperatively.  While the findings were not statistically significant, patients receiving scheduled non-opioids for postoperative pain management saw reduced morphine milligram equivalents (MME) compared to those who were not on guideline-recommended pain management regimens (24 [15.4-33] vs. 31.5 [15-51.3], median [IQR]; P=0.34). Moreover, the average pain scale at the time of any analgesics administration was reduced for patients receiving guideline-recommended therapy compared to those who were not (5.3 [4.1-6.3] vs. 6.8 [5.5-7.4], median [IQR]; P=0.18).  Based on this evaluation, patients receiving guideline-recommended postoperative pain management which includes non-opioid medications are more likely to utilize fewer opioids during their hospitalization while also reporting less pain.  Adoption of postoperative pain management guidelines and order sets may lead to a reduction in opioid utilization as well as adverse effects associated with opioid therapy while inpatient.

Pharmacy Reports

• Medication Reconciliation Statistics - Katie Schipper, PharmD presented medication reconciliation data for admissions, transfers, and discharges. The data specifically looked at physician compliance from November 2023 to May 2024 (month-to-date [MTD]) as well as at fiscal year-to-date (FYTD). Discharge medication reconciliation saw a compliance of 97.3% at FYTD, but admission and transfer medication reconciliations saw a much lower rate of compliance with 37.1% and 4.5% at FYTD, respectively.  Of note, both admission and transfer reconciliations compliance dropped to 35.1% and 3.7% during April 2024 but appear to be trending up with MTD rates at 36.3% and 5.6%, respectively. These findings can potentially be attributed to discharge medication reconciliation having a hard stop in Epic, while admission and transfer medication reconciliations do not. 

• Drug Diversion Committee Report – Katie Schipper, PharmD highlighted the findings from the Drug Diversion Prevention Program’s quarterly report for the first quarter of 2024. Since the program began collecting investigation data, there have been  11 investigations performed, 7 of which have occurred from January to March of 2024. Outcomes of these investigations include:, 5 cases were found to have no diversion, 4 have led to education for those involved, 2 have resulted in termination, and 1 case led to corrective action.  Additionally, one investigation led to diversion prevention measures by removing sharps containers from public restrooms as well as role-based Pyxis Access for PERT nurses and float pool nurses.  Of note, two investigations remain ongoing, and some cases have had more than one outcome.

• Adverse Drug Reaction Report – First Quarter 2024 - Katie Schipper PharmD presented data on adverse drug reactions (ADR) from first quarter 2024. This report includes data on adverse drug reaction reporting which classifies adverse effects and reactions based on degree of harm to the patient. Historically, the majority of ADRs occur before admission to the hospital or are self-limiting or benign and are associated with anticoagulants, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), and potassium-containing products. There were 41 total ADRs with 28 occurring before admission to the hospital (68.2%), 5 which were self-limiting or benign (22.0%), and 4 which were deemed to not be a drug reaction (9.8%). There were no instances of ADR leading to permanent disability, increased length of stay, or death.  Losartan, potassium-containing products, lisinopril, and apixaban were the most reported medications. While there were more ADRs reported in first quarter 2024 when compared to the fourth quarter 2023 report, all other reports from previous year featured more ADRs than the 41 from first quarter 2024.  No event in the last 12 months has led to permanent disability, increased length of stay, or death.

• Drug Shortage Update – Katie Schipper, PharmD provided an update on the current state of national drug shortages. The number of drug shortages has reached an all time high since ASHP started tracking drug shortage statistics 23 years ago. While new shortages are fortunately not on the rise, old shortages have yet to resolve leading to continued issues of medication procurement and access. Shortages are lasting for years without resolution, leading to increased impacts on patient care.

New/Updated Pharmacy Directives:

• Therapeutic Directive CRRT and SLED Dosing Antimicrobials (Adult) (NEW) – new directive for dosing antimicrobial medications for patients requiring continuous renal replacement therapy (CRRT) and sustained low-efficiency dialysis (SLED). This directive provides medication dosing recommendations based on flow rates for those patients requiring CRRT or SLED.
• Therapeutic Directive Renal Dosing Antimicrobials (Adult) 2024 (UPDATED) - update includes a purpose statement that states, “To improve patient safety and optimize patient outcomes, pharmacists will adjust antimicrobials as deemed appropriate using the below protocol and guidance.”
• Therapeutic Directive – Diabetes (UPDATED) – update includes verbiage regarding pharmacists' ability to round weight-based insulin orders and home insulin dose conversions to formulary insulin agents to nearest units.
• Therapeutic Directive – Nutrition Support (UPDATED) – update included the removal of respiratory therapists on the nutrition services team as they no longer provide the services for indirect calorimetry.
• Therapeutic Directive IVIG Dose Rounding (UPDATED) – updates included clearer dosing guidance for obese and non-obese patients specifically regarding how to dose patients whose actual body weight is less than ideal body weight.
• Therapeutic IV to PO Step-down Anti-epileptics (UPDATED) – now includes valproate syrup.
• Therapeutic Directive Automatic Constipation Prevention (UPDATED) – pharmacists can add docusate, polyethylene glycol, and/or senna. Exclusion criteria now include patients undergoing gastrointestinal surgery or patients with a confirmed ileus.
• Therapeutic Directive IV-PO Step-down Diltiazem (UPDATED) – updates to the product cost section of the IV-PO Step-down Diltiazem Directive. These cost updates include price changes to the parenteral and enteral dosage forms.
• Therapeutic Directive 4 Factor PCC Dosing 2024 (NEW) – directive indicates the mechanism of action, indication, uses, dosing, pharmacokinetics, contraindications, and monitoring. Pharmacy is automatically consulted for all 4-Factor PCC orders; upon consultation, a pharmacist can provide dosing recommendations for anticoagulation reversal utilizing 4-factor PCC.

Renewal of Existing Pharmacy Directives:

• Therapeutic Directive IV-PO Step-down Dexamethasone
• Therapeutic Substitutions Automatic Calcium Chloride to Calcium Gluconate
• Therapeutic Directive Metronidazole
• Therapeutic Directive MRSA Nasal PCR
• Therapeutic Guideline CAP Treatment
• Therapeutic Guideline HAP-VAP Treatments
• Therapeutic Guidelines UTI Treatment

Policies and Procedures

A summary of the policies presented is below.

JOINT COMMISSION REQUIREMENTS

• Antimicrobial Stewardship Report – presented the Standardized Antimicrobial Administration Ratio (SAAR) from 2022, 2023, and 2024. SAAR data shows antimicrobial usage at St. Dominic Hospital by benchmarking prescribing trends against risk-adjusted data from institutions of similar size and acuity provided by the Center for Disease Control and Prevention’s National Healthcare Safety Network (NHSN). Any SAAR value > 1.0 indicates more antimicrobial days observed than predicted whereas SAAR values < 1.0 indicate fewer days observed than predicted.  Metrics include all antibacterials prescribed, broad-spectrum antibacterials used predominantly for hospital-onset infections (e.g., piperacillin/tazobactam, cefepime, meropenem), antibacterial agents predominantly covering gram-positive infections (e.g., daptomycin, vancomycin, linezolid), and broad-spectrum antibacterials predominantly used for community-onset infections (e.g., ceftriaxone, fluoroquinolones).  Overall, our total antibacterial prescribing habits have held a SAAR of < 1.0 for all of 2022, 2023, and 2024.  This trend was also reflected in SAARs for agents active against resistant gram-positive organisms, with SAARs mostly ≤ 1.0. However, broad-spectrum agents predominantly used for hospital-onset infections have largely held a SAAR > 1.0 in the ICU and wards. As for SAAR data for antibacterial agents often used for community-onset infections, the ICUs have mainly held a SAAR < 1.0 whereas the wards have mostly seen SAARs ≥ 1. It was also reported that the days of therapy for piperacillin-tazobactam were the highest in January 2024 compared to overall month-to-month use in 2022 and 2023. This has been largely attributed to the time of year and initiation of piperacillin-tazobactam before narrow spectrum gram-negative antimicrobial. De-escalating to narrower agents when possible and limiting antibiotic regimens to shorter, guideline-directed durations can help further improve our metrics and patient care.

Medication Use Evaluation:

• Assessing Compliance to Current Hospital Restriction Criteria – findings of her medication use evaluation (MUE) surrounding sugammadex utilization compliance compared to hospital restrictions. Her results indicated 100% adherence to hospital restrictions, but 0% to the 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade due to no documentation of train of four (TOF). It was recommended to update the hospital’s restriction criteria to provide more clear verbiage regarding the use of sugammadex and the current restriction criteria.

Pharmacy Reports

• Medication Reconciliation Statistics – Areas for improvement include reconciling medications at admission and transfer of care.
• FDA Safety Alerts – summary of the 2023-204 FDA Drug Safety Alert Communications. The alerts included discussion regarding serious drug reactions to antiseizure medicines levetiracetam and clobazam, the addition of a boxed warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab), and an update on the FDA’s ongoing evaluation of reports of suicidal thoughts or action in patient taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for type 2 diabetes and obesity.
• Adverse Drug Event Report – adverse drug event report from January and February 2024. Medication includes naloxone, flumazenil, D50W, and vitamin K. There were no concerning trends identified during the review.

New/Updated Pharmacy Directives:

• Therapeutic Directive Automatic Calcitonin (DELETE)
• Therapeutic Directive Metoprolol (DELETE)
• Therapeutic Directive Opioid Partial Agonists (DELETE)
• Therapeutic Directive Anticoagulation (UPDATED) – update to the Anticoagulation Directive including an editorial change labeling Kcentra as 4-PCC, the addition of more lab ordering abilities for pharmacists, and the inclusion of the most recent CHEST guidance for perioperative bleed risk.
• Therapeutic Substitutions Automatic Stadol and Nubain (UPDATED) – consolidation of the Therapeutic Directive Opioid Partial Agonists with this automatic substitution policy. The addition includes information regarding formulary status for butorphanol and nalbuphine.   
• Medication Administration and Monitoring Guide (UPDATED) – new updates to the Medication Administration and Monitoring Guide which included the ICU Stepdown (6 Center)’s name change to the Progressive Care Unit (PCU), the authorization of dexmedetomidine (Precedex) use in the PCU, and mannitol being restricted to the emergency department and intensive care units.

Renewal of Existing Pharmacy Directives:

• Therapeutic Directive IV-PO Step-down Digoxin
• Therapeutic Directive Pharmacokinetic dosing IV-PO Step-down Phenytoin and Fosphenytoin
• Therapeutic Directive Epoetin alfa

Policies and Procedures

A summary of policies presented is below.

Formulary Review: Additions, Revisions, and Removals:

• Balfaxar and Kcentra (4FPCC) – Proposal to add Balfaxar to formulary and remove Kcentra from formulary. Data shows both products are equivalent in reversal for both warfarin as well as other anticoagulants.  The switch will occur on February 1, 2024 or soon thereafter. The decision was approved pending System P&T approval.

JOINT COMMISSION REQUIREMENTS

• Antimicrobial Stewardship Report – presented the Standardized Antimicrobial Administration Ratio (SAAR) from 2022 and 2023. SAAR data shows antimicrobial usage at St. Dominic Hospital by benchmarking prescribing trends against risk-adjusted data from institutions of similar size and acuity provided by the Center for Disease Control and Prevention’s National Healthcare Safety Network (NHSN). Any SAAR value > 1.0 indicates more antimicrobial days observed than predicted whereas SAAR values < 1.0 indicate fewer days observed than predicted.  Metrics include all antibacterials prescribed, broad spectrum antibacterials used predominantly for hospital-onset infections (e.g., piperacillin/tazobactam, cefepime, meropenem), antibacterial agents predominantly covering gram-positive infections (e.g., daptomycin, vancomycin, linezolid), and broad spectrum antibacterials predominantly used for community-onset infections (e.g., ceftriaxone, fluoroquinolones).  Overall, our total antibacterial prescribing habits have held a SAAR of < 1.0 for all of 2022 and 2023.  This trend was also reflected in SAARs for agents active against resistant gram-positive organisms, with SAARs mostly ≤ 1.0. However, broad spectrum agents predominantly used for hospital-onset infections have largely held a SAAR > 1.0 in the ICU, wards, and oncology units. As for SAAR data for antibacterial agents often used for community-onset infections, the ICUs have mainly held a SAAR < 1.0 whereas the wards and oncology units have mostly seen SAARs ≥ 1.  De-escalating to narrower agents when possible and limiting antibiotic regimens to shorter, guideline-directed durations can help further improve our metrics and patient care.
• Opioid Stewardship Report – preliminary information regarding the newly created Opioid Stewardship Committee. The report highlighted data from the fourth quarter of 2023 analyzing different specialties’ opioid ordering trends. Of note, some data excluded fentanyl orders to help adjust for analgosedation needs in the ICUs.  Moreover, the information only pertained to the order placed, not the number of administrations per patient.  The top specialties by morphine milligram equivalents (MME) were determined by average daily MME prescribed.  When excluding fentanyl, hospice and palliative care, internal medicine, and hematology and oncology were the top prescribers; when including fentanyl orders, nephrology, pulmonary medicine, and emergency medicine were the top prescribers.  Nephrology’s place as top prescriber for this group can likely be attributed to a fentanyl infusion that was incorrectly ordered under a nephrologist’s name.  Average days of opioid therapy were used to determine the top specialties by duration of therapy. For the fentanyl excluded group, internal medicine, thoracic and cardiovascular surgery, and neurosurgery were the top three prescribers.  For the fentanyl included group, pulmonary medicine, internal medicine, and thoracic and cardiovascular surgery held the top three spots.  Other than nephrology’s unexpected jump to top specialty for average daily MME when including fentanyl, the data appropriately reflects current practice.

Pharmacy Reports

• Automated Dispensing Cabinet Medications on Override (Annual Review) - list of Pyxis medications on override by device and explained the differences between override groups as well as that each Pyxis device is individually set with specific override settings. The committee approved the override medications with no requested changes.
• Medication Reconciliation Statistics - medication reconciliation data for admissions, transfers, and discharges. Discharge medication reconciliation saw a compliance of 97.3% at FYTD, but admission and transfer medication reconciliations saw a much lower rate of compliance with 37.4% and 37.2% at FYTD, respectively.  These findings can potentially be attributed to discharge medication reconciliation having a hard stop in Epic, while admission and transfer medication reconciliations do not. 
• Adverse Drug Event Report – November/December 2023 and Q3/Q4 Summary - adverse drug event report as well as a third and fourth quarter summary. The reports highlight the usage of naloxone (excluding OR and procedural areas), flumazenil, D50W, and vitamin K. In total between November and December, no orders were pulled on override and there was a total of 7 naloxone administrations, 1 flumazenil administration, 510 administrations of D50W, and 29 administrations of vitamin K.  Of note, naloxone’s administrations were slightly inflated for November as one patient received three doses. D50W was predominantly administered in the emergency department with 14.9% of the 510 administrations given there.  This was likely due to hypoglycemia on admission.  A similar trend for vitamin K was also observed, with 24.1% of all administrations occurring in the emergency department.  It should also be noted that two patients outside of the emergency department and not on any anticoagulation accounted for 31% of all vitamin K doses for November and December.   For the Q3/Q4 summary, there were a total of 32 naloxone administrations, 17 flumazenil administrations, 1,784 administrations of D50W, and 106 administrations of vitamin K.  Naloxone was utilized on average 5.3 times per month with usage peaking in August with 10 administrations.  Flumazenil saw an average of 2.5 administrations per month with a peak in August with 7 administrations.  D50W was used approximately 297 times per month, with October seeing the most administrations at 354.  Finally, vitamin K’s usage peaked at 26 administrations in October but ultimately averaged 17.7 administrations per month.  Overall, usage trends remained relatively similar for Quarters 3 and 4 with each agent having one month fall outside of one standard deviation from the average.
• Adverse Drug Reaction Report – December 2023 - adverse drug reactions (ADR) from December 2023. This report includes data on adverse drug reaction reporting which classifies adverse effects and reactions based on degree of harm to the patient. Historically, the majority of ADRs occur before admission to the hospital or are self-limiting or benign and are associated with anticoagulants, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), and potassium-containing products. There were 29 total ADRs with 21 occurring before admission to the hospital, 5 which were self-limiting or benign, and 3 which were deemed to not be a drug reaction. There were no instances of ADR leading to permanent disability, increased length of stay, or death.  Potassium, apixaban, and spironolactone were the most reported medications. In comparison to previous 2023 ADR reports, there were less ADR overall in December 2023.

Jackson Market P&T - 2023

SDSD

New/Updated Pharmacy Directives:

• Therapeutic Directive Pharmacokinetics (UPDATED) – update for the pharmacokinetics directive to reflect verbiage change and the addition of area under the curve (AUC) for vancomycin monitoring. Current vancomycin trough monitoring standards are unchanged.
• Therapeutic Substitutions Automatic Oral DM Agents (UPDATED) – update regarding automatic substitutions of oral diabetes mellitus agents, in particular sodium-glucose cotransporter 2 (SGLT2) inhibitors. SGLT2 inhibitors will remain non-formulary for a diabetes indication. Dapagliflozin (Farxiga) and empagliflozin (Jardiance) will be formulary restricted to non-diabetic indications. Canagliflozin and ertugliflozin (Steglatro) will be non-formulary.
• Therapeutic Directive Adult Aminoglycosides Dosing Guidelines (UPDATED) – update for aminoglycoside dosing guidelines. Updates included proper dosing criteria and specific monitoring parameters that will easily guide pharmacists.
• Therapeutic Guideline Critical Care Infusions (UPDATED) – updates to the critical care infusion guidelines which included goal parameters for various medications. The update also included the indication classification of nitroglycerin to align with EPIC build.

Renewal of Existing Pharmacy Directives:

• Therapeutic Directive Renal Dosing Baricitinib
• Therapeutic Substitutions Automatic Actemra (tocilizumab) Dose Rounding
• Therapeutic Substitutions Automatic Ancef Presurgical Prophylaxis
• Therapeutic Substitutions Automatic Mannitol Formulations

Policies and Procedures

A summary of the policies presented is below.

Formulary Review: Additions, Revisions, and Removals:

• Testosterone Cypionate Removal - presented data that supported against the usage of testosterone cypionate injections for post-operative patients. This formulary removal was approved.
• Empagliflozin and Dapagliflozin Update – presented updates regarding using empagliflozin (Jardiance) and dapagliflozin (Farxiga). Both agents will be formulary-restricted to non-diabetic indications.
• Iron Production Class Review – presented the formulary request for sodium ferric gluconate complex (Ferrlicit) and Iron Sucrose (Venofer). Ferric carboxymaltose (Injectafer), ferric derisomaltose (Monoferric), ferumoxytol (Feraheme), and iron dextran (INFeD) will be formulary restricted to outpatient use.
• Ophthalmic Vasoconstrictors Class Review – presented the FMOLHS P&T recommendations for ophthalmic vasoconstrictors. Tetrahydrozoline and phenylephrine will be on formulary. Naphazoline and naphazoline-pheniramine will be non-formulary.
• Caloric Agents (fat emulsions) Class Review – presented recommendations for fat emulsions. SMOFlipid will be formulary, Intralipid will be formulary restricted to patients with a fish allergy, Omegaven will be formulary restricted to patients with a direct bilirubin greater than 2 and needing parenteral nutrition up to two weeks, and Clinolipid and Nutrilipid will be non-formulary.
• Appetite Stimulants Class Review – presented recommendations for appetite stimulants. Megestrol tablets and oral suspension will be formulary. Dronabinol capsules will be formulary in contrast to the suspension which will be formulary restricted to pediatrics. Mirtazapine tablets and ODT will be formulary.
• Anti-Sialorrhea Agents Class Review – presented recommendations for anti–sialorrhea agents including glycopyrrolate, scopolamine, benztropine, and atropine ophthalmic will be on formulary.

JOINT COMMISSION REQUIREMENTS

Standards and Requirements

Antimicrobial Stewardship Report - trends of antimicrobial days of therapy and various antibiotic usage from 2019 – 2023. Antimicrobial usage has been elevated possibly related to short-staffing and unit cross-covering. Usage is anticipated to decline in the upcoming months. September antibiotic total cost exhibited a decline in comparison to recent months.

Pharmacy Reports

• Adverse Drug Reaction Report - adverse drug reactions for September 2023. There were fifty-five level zero reports meaning any adverse effect that occurred before admission to the hospital or causation of admission. Level one ratings equaled eleven and level nine ratings equaled three. The total adverse drug reactions for September 2023 totaled sixty-nine.
• Adverse Drug Event Report - adverse drug event report from September and October 2023. Medications include naloxone, flumazenil, D50W, and vitamin K.
• Drug Shortage Report (Third Quarter) - 10-year trend of national drug shortages. The top 5 drug classes shortages included antimicrobials, chemotherapy, CNS agents, fluids and electrolytes, and hormonal agents. The reasons for the shortages the majority due to unknown causes, or manufacturers would not provide. Current ongoing and active shortages are the highest in a decade.

New/Updated Pharmacy Directives:

• Therapeutic Directive IV Levothyroxine to Weekly Dosing (UPDATED) - updates consisted of verbiage changes
• Therapeutic Directive Renal Dosing (UPDATED) – updates consisted of verbiage changes. Metformin and sitagliptan were also removed from the renal dosing directive as they are both non-formulary.
• Therapeutic Substitutions Automatic Vaccines Adult (UPDATED) - the adult vaccines formulary now includes Prevnar 20. Pneumovax 23 will remain on formulary for patients who require it to complete their vaccination series.
• Medication Administration and Monitoring Guide (UPDATED) – new updates from the medication administration and monitoring guide which included medications that should be excluded from ICU stepdown areas such as neuromuscular blocking agents as well as other deep sedating agents, vasopressors, and IV naloxone.
• Therapeutic Substitutions Automatic Rifaximin (NEW) - proposal to allow for an automatic switch from rifaximin 550 mg to rifaximin 600 mg (three 200 mg tablets) to allow for generic interchange with 200 mg generic rifaximin.  The interchange from Xifaxan 550 mg tablets to generic rifaximin 200 mg tablets would save approximately $28,500 for the year.

Renewal of Existing Pharmacy Directives:

• Therapeutic Directive Automatic Discontinuation of Entereg
• Therapeutic Directive IV-PO Step-down Amiodarone
• Therapeutic Directive Pharmacist Driven Iron Deficiency Evaluation and Treatment in Heart Failure
• Therapeutic Directive Vitamin K Parenteral for Oral Administration
• Therapeutic Substitutions Automatic Fluconazole
• Therapeutic Substitutions Automatic IV IM Lorazepam to Midazolam
• Therapeutic Substitutions Automatic Lidocaine Patches
• Therapeutic Substitutions Automatic PO to IV Tranexamic Acid
• Therapeutic Substitutions Automatic PPI H2RA Duplicate
• Therapeutic Substitutions Automatic Stadol and Nubain
• Therapeutic Substitutions Automatic Therapeutic Lovenox Dosing Rounding

Policies and Procedures

A summary of policies presented is below.

Formulary Review: Additions, Revisions, and Removals:

• Antimalarial Class Review – Dr. Andrew Watkins, PharmD presented the formulary addition requests for Coartem and Malarone that was recently approved through system P&T.
• Pneumococcal Class Review – Dr. Andrew Watkins, PharmD presented the formulary addition request for Prevnar 20 for adult vaccination and the subsequent removal of Prevnar 13 from formulary.  PPSV23 will remain on formulary for patients who require it to complete their vaccinations.
• Reboyta Monograph – Dr. Andrew Watkins, PharmD presented the formulary request for Reboyta for recurrent C. difficile patients.  This medication will be restricted to the outpatient setting after patients complete initial treatment for C. difficile. 

JOINT COMMISSION REQUIREMENTS

Antimicrobial Stewardship Report - antimicrobial use trends showed a clear increase in July due to being down a pharmacist.  Antibiotic total cost per patient day trended up slightly likely secondary to being short a clinical pharmacist but should trend back towards baseline as staffing improves.

Pharmacy Reports

Adverse Drug Event Report – August 2023 Reports highlight the usage of naloxone, flumazenil, D50W, and vitamin K. In total between July and August, there were a total of 14 naloxone administrations, 9 flumazenil administrations, 634 administrations of D50W, and 33 administrations of vitamin K.  Of note, the naloxone and flumazenil administrations only included those outside of procedural areas.

New or Updated Therapeutic Directives

• Therapeutic Substitutions Automatic – Master Interchange - a new comprehensive therapeutic interchange document. There are no new or updated interchanges in this document, but all existing interchanges have been combined into a single document.

Annual Therapeutic Directive Renewals

• Therapeutic Directive Integrilin
• Therapeutic Directive Toradol Dosing
• Therapeutic Substitution Maintenance Fosphenytoin to Phenytoin IV
• Therapeutic Substitution Automatic IV Ciprofloxacin to IV Levofloxacin
• Therapeutic Substitutions Automatic PPI and SUP Switch and DC Protocol

Policies and Procedures

A summary of policies presented is below.

Formulary Review: Additions, Revisions, and Removals

• GI Cocktail Formulary Removal - proposal to replace GI cocktail for Maalox in the treatment of dyspepsia based on a randomized controlled trial studying the effectiveness of the cocktail. Removal of the cocktail would provide relief to patient care in the mist of the lidocaine shortage. This removal from formulary was approved.

Joint Commission Standards and Requirements

• Antimicrobial Stewardship Report – Carbapenem and fluroquinolone use continues to decrease. Vancomycin use has increased, but more data is needed as there was variance in reporting between Cerner and Epic data. Cefepime, piperacillin-tazobactam, and ceftriaxone use continue to increase. There was an increase antimicrobial cost in April and May as a result of a single patient with cryptococcal meningitis.

Pharmacy Reports

• FDA Safety Alerts – summary of FDA Drug Safety Alerts including investigating the risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia, updates on warnings used to improve safe use of prescription stimulants in the treatment of ADHD, and updates regarding the prescribing information for all opioid pain medicines.

New or Updated Therapeutic Directives

• Therapeutic Directive Pain and Sedation in Mechanically Ventilated Patients - updated to include mechanically ventilated patients in the emergency department in addition to the intensive care units. Now allows pharmacists to order chlorhexidine if not already ordered for mechanically ventilated patients. Updated infusions with new dosing parameters per system Epic build.
• Therapeutic Directive Cardene and Cleviprex Transition to Oral - updated to specific preferred concentration of nicardipine is 100 mcg/mL and allows pharmacists to automatically change from 200 mcg/mL to 100 mcg/mL if patient does not meeting exclusion criteria (ESRD on dialysis or requiring max doses of 15 mg/hr)
• Therapeutic Directive Diabetes Service - updated to clarify insulin dosing regimens as guidelines and not requirements and to include which departments/groups pharmacy will manage insulin for.

Annual Therapeutic Directive Renewals

• Therapeutic Directive Automatic Discontinuation Granix
• Therapeutic Directive Cellulitis Step Down
• Therapeutic Directive IV to PO Step-down Folic Acid
• Therapeutic Directive Nutrition Support
• Therapeutic Directive Santyl Restrictions

Policies and Procedures

• Antimicrobial Stewardship Committee Charter – NEW: The purpose of this Charter is to define the responsibilities, reporting, Executive Committee, and membership of the Antimicrobial Stewardship Committee.
• Antimicrobial Stewardship Policy – NEW: The purpose of this policy establishes the makeup and responsibilities of the Antimicrobial Stewardship Committee and its leaders.
• Investigation Drug Policy – UPDATED: This policy was updated to align with the health system’s policy. Definitions were added to outline what must be included in each study. The policy outlines the approval of studies, investigational budget, provider education, patient education and informed consent, receipt, storage, and dispensing of investigational drug supply.
• AcuDose-Rx Manual Charge Form - DELETED
• Acudose-Rx Controlled Drug Inventory Disposition Record - DELETED
• Acudose-Rx Access Manual Station Inventory by Medication Report - DELETED
• Adverse Drug Reaction Form - DELETED
• Cerner Downtime Pharmacy - DELETED
• Charging or Crediting Inactive Patient Accounts - DELETED
• Clozapine REMS WBC Count Report Form - DELETED
• Alteplase (activase) Freezing - DELETED

Medication Use Evaluations

• Epoetin Medication Use Evaluation Update: In January 2023, the Epoetin restrictions approved in October 2022 by the P&T committee were officially implemented. St. Dominic is no longer an outlier in blood growth factor costs as of January and February 2023 after restriction implementation. Cost per patient day went down significantly, and average cost savings per month is approximately $5,000. This data will continue to be tracked throughout the year.
• Evaluation of Piperacillin/Tazobactam Dosing in the Treatment of Pseudomonas aeruginosa Bacteremia: The purpose of this medication use evaluation wass to determine the appropriateness of piperacillin/tazobactam dosing for the treatment of Pseudomonas aeruginosa bacteremia at Saint Dominic Jackson-Memorial Hospital. All patients 18 years and older who were admitted to Saint Dominic Jackson-Memorial Hospital from May 1, 2021 through April 30, 2022 and treated for Pseudomonas aeruginosa bacteremia had their electronic medical records retrospectively reviewed for inclusion. Patient data was pulled based on ICD-10 diagnosis code. Patients were excluded if not treated with piperacillin/tazobactam therapy. Collected data included patient characteristics, bacteremia and treatment characteristics, and clinical outcomes. A total of 375 patients were reviewed for inclusion, in which 13 patients were deemed eligible and included in the evaluation. Of these 13 patients, 1 patient (7.7%) met the appropriate probability of target attainment of 90%. The average Pitt bacteremia score was 2.4. The most commonly prescribed piperacillin/tazobactam dose seen in this evaluation was 3.375 grams every 6 hours given as an intravenous push over 6 minutes (53.8%). An MIC of ≤ 4 was seen in 53% of patients, with the most common source of infection being unknown (38.5%). Average duration of therapy was 7.1 days, and average hospital length of stay was 13 days. Mortality was seen in 15.4% patients. Based on this evaluation, inappropriate piperacillin/tazobactam dosing for the treatment of Pseudomonas aeruginosa did occur in a majority of patients. Inappropriate dosing regimens lead to increased length of stay and all-cause mortality. Dosing regimens and infusion schemes need to be re-evaluated at our institution which is currently in process through system committees.

Formulary Review: Additions, Revisions, and Removals

• Hyaluronidase Formulary Addition: Hyaluronidase human injection (Hylenex®) is an injectable tissues permeability modifier This product is the recommended antidote post-extravasation of taxanes and vinka alkaloids and can be used off-label for other extravasation management, such as 10-50% dextrose, TPN, and radiographic contrast media. This agent is recommended to be added to formulary because when compared to other specific extravasation antidotes, hyaluronidase can be used to manage extravasation of a much wider range of agents.
• Dexrazoxane Formulary Addition: Dexrazoxane (Totect®) is an intravenous chemoprotectant agent indicated and recommended for the treatment of extravasation of intravenous anthracycline chemotherapy. This agent is being recommended to formulary since it is the only drug recommended as an antidote for anthracycline extravasation.

Joint Commission Standards and Requirements

• Antimicrobial Stewardship Report – the year-over-year antibiotic trends were presented. Antimicrobial days of therapy continues to decrease. Carbapenem days of therapy is nearing an all-time low, and fluoroquinolone use is exceeding its goal. Vancomycin and piperacillin/tazobactam have increased, and will both be an area of focus for antimicrobial stewardship. Ceftriaxone use has slightly increased, but is expected as we de-escalate therapy and decrease the use of other agents. Antibiotic total cost per patient per day continues to decrease, and has reached a low of $5.22 for March 2023.

Pharmacy Reports

• Adverse Drug Event Report – There were a total of 76 adverse drug reactions reported during this period, which is consistent with previous months. The medications most often reported included lisinopril, potassium, warfarin, losartan, and spironolactone. Most events were rated level 0, which means the event occurred outside of the hospital, and were likely the cause of hospital admission.
• Drug Shortage Report – The first quart of 2023 ended with an all-time high of drug shortages, at 301 active shortages. The top five drug classes with active shortages include antimicrobials, chemotherapy, CNS, fluids/electrolytes, and hormones. Most shortages are for unknown reasons (50%), and some of these shortages have been on-going for multiple years, some for over a decade. Ophthalmic and chemotherapy agents will likely be the largest issue for our hospital, as many do not have alternatives.

New or Updated Therapeutic Directives

• Therapeutic Substitutions Automatic Biosimilars (updated)
• Therapeutic Substitutions Automatic Oral Diabetes Agents (updated)
• Therapeutic Directive Antimicrobial Renal Adjustment Protocol
• Therapeutic Guideline CAP Treatment
• Therapeutic Guideline HAP-VAP Treatment
• Therapeutic Guideline UTI Treatment
• Therapeutic Directive Renal Dosing Antimicrobials (delete)

Annual Therapeutic Directive Renewals

• Therapeutic Directive Automatic Constipation Prevention
• Therapeutic Directive IVIG Dose Rounding
• Therapeutic Directive IV to PO Step-down Anti-epileptics
• Therapeutic Directive IV to PO Step-down Diltiazem
• Therapeutic Directive Metronidazole
• Therapeutic Directive MRSA Nasal PCR
• Therapeutic Substitution Automatic Calcium Chloride to Calcium Gluconate
• Therapeutic Substitution Automatic Fibrates
• Therapeutic Substitution Automatic Inhalers
• Therapeutic Substitution Automatic Iron Preparations
• Therapeutic Substitution Automatic Levemir to Lantus
• Therapeutic Substitution Automatic Penicillins and Cephalosporins
• Therapeutic Substitution Automatic Selective Serotonin Agonists
• Therapeutic Substitution Automatic Topical Antivirals

Policies and Procedures

• System Formulary Management Workflow
• Automated Dispensing Cabinet User Access
• Controlled Substances – Ordering and Receiving
• Controlled Substances – Issuing Medications Not Stock in Automated Dispensing Cabinets
• Controlled Substances – Waste, Disposal, and Returns
• Controlled Substances – Diversion or Tampering
• Controlled Substances – Inventory
• Medication Administration
• Medication Storage and Security
• Expired and Unusable Medications

Table 1. Crosswalk of Policies

Formulary Review: Additions, Revisions, and Removals:

• Gleolan Formulary Request - proposal for the addition of Gleolan to formulary was presented. This was approved for formulary for use by physicians who have been appropriately trained.
• Remdesivir Formulary Removal – removed from formulary to align with system formulary.

Joint Commission Standards and Requirements

Antimicrobial Stewardship Report - year-over-year antimicrobial trends were presented. There was a winter spike in overall days of therapy. Carbapenem and fluroquinolone use continues to decrease. Cefepime and piperacillin-tazobactam use is higher this month as compared to previous years, but trends will likely decrease as empiric treatment guidelines are implemented. Ceftriaxone use is increased likely due to de-escalation and will hopefully continue to trend upwards. Antibiotic cost per patient day continues to decrease since establishment of a full-time antimicrobial stewardship pharmacist.

Firstline Application - new cellphone application that hosts treatment guidelines as well as antimicrobial monographs and pathogen information. The application can be updated in real time to include the most recently approved facility guidelines. The application can also provide notifications regarding antimicrobial shortage information and recommended alternatives. Available now to download form the app store!

Appointment of Antimicrobial Stewardship Pharmacist – Andrew Watkins, PharmD was appointed the pharmacist lead for the antimicrobial stewardship program.

New or Updated Therapeutic Directives

• Therapeutic Substitution Automatic Beta Blockers (updated)
• Therapeutic Directive Epoetin Alfa (updated)
• Therapeutic Directive Anticoagulation (updated)

Annual Therapeutic Directive Renewals

• Therapeutic Directive Automatic Calcitonin
• Therapeutic Directive IV to PO Step-down Antimicrobials
• Therapeutic Directive IV to PO Step-down Dexamethasone
• Therapeutic Directive IV to PO Step-down Digoxin
• Therapeutic Directive Metoprolol
• Therapeutic Directive Opioid Partial Agonists
• Therapeutic Directive Pharmacokinetic dosing and IV to PO Step-down Phenytoin
• Therapeutic Substitutions Automatic 2nd Generation Antihistamines
• Therapeutic Substitutions Automatic 5 Alpha Reductase Inhibitors
• Therapeutic Substitutions Automatic Benzodiazepines
• Therapeutic Substitutions Automatic Diuretics
• Therapeutic Substitutions Automatic HMG CoA
• Therapeutic Substitutions Automatic Insulin Mixes

Policies and Procedures

• Downtime – Management
• Nightshift Pharmacist Coverage Policy – Management
• Prescription Pad Paper Policy – Compliance: Discharge prescription paper for printers no longer exists after the transition to Epic and therefore was removed from the policy. Prescription pads will only be stored in central pharmacy and will require a perpetual inventory. Prescription papers must be dispensed on a patient-per-patient basis. During downtime, sets of 10 papers will be dispensed to units, and nurse directors will be responsible for keeping count, documenting use of prescription pad paper, and returning the unused prescription pad papers. Diversion of prescription pads will follow the same procedure as diversion of controlled medications.
• Prescription Pad Paper – Standard Operating Procedures: outlines how the prescription pad paper will be ordered, received, stored, dispensed, documented, discrepancy resolution, and diversion. These procedures align with the national standards.
• Pharmacy and Therapeutics Committee – Management: update clearly outlines voting and non-voting members of the P&T Committee.
• Patient Information for Medication Dispensing and Administration – Clinical
• Apothecary Conversion Chart Policy – Clinical – DELETED
• Administration of Hypertonic Saline – Clinical: updated to align with the current Epic order set. This update lays out when a central line is and is not required and the language is updated for ISMP best practice. Some language involving nursing orders have been removed, as they were more procedural rather than a policy.

Medication Use Evaluation

• Evaluation of Status Epilepticus Treatment in the Emergency Department: Katelyn Miller, PharmD presented a medication use evaluation regarding status epilepticus treatment in the emergency department. Those presenting to the emergency department with and receiving treatment for status epilepticus between July 1, 2021 and July 1, 2022 were evaluated. Initial phase treatment agent and dose, therapy escalation requirements, and length of stay were collected from the electronic health record. Correct agents and doses for initial phase therapy were defined based on the American Epilepsy Society guidelines, including lorazepam dosed at 0.1 mg/kg/dose (max of 4 mg/dose that can be repeated once) and midazolam dosed at 10 mg/dose (in patients weighing greater than 40 kg) for one dose. Of the 37 patients included, 94.6% received noncompliant treatment with 74.3% of those being considered incorrect based on benzodiazepine dosing being lower than recommended. Noncompliant treatment was associated with an increased length of stay. Based on this analysis, ensuring guideline-compliant benzodiazepine dosing for treatment of status epilepticus in the emergency department could save 8.4 days per patient treated for status epilepticus and potentially lead to cost savings of $24,084 - $537,232 per year.

Formulary Review: Additions, Revisions, and Removals:

• Ensure High Protein Pudding: approved for addition to nutritional formulary.

Joint Commission Standards and Requirements

Antimicrobial Stewardship Report

• Andrew Watkins, PharmD presented the year-over-year antibiotic trends. Dr. Andrew Watkins, PharmD explained the differences in data source between Cerner and Epic, so data reported after May 2022 could be affected. Antimicrobial days of therapy increased in 2022 but remained significantly lower than in 2020. Carbapenem and Fluoroquinolone days of therapy have decreased, but there has been an increase in piperacillin/tazobactam and cefepime. This rise is expected as we decrease use of the other agents but will remain a target for antimicrobial stewardship. Vancomycin has increased since May 2022, but this could be due to a data issue with the new data collection source. Antibiotic total cost per patient per day has decreased from $15 in May, June, and July to $7 in November. A full time antimicrobial stewardship pharmacist started at St. Dominic in August. Decreasing overall antimicrobial agent use will be the goal for 2023 and the Antimicrobial Stewardship team will start holding regular meetings.
• Firstline Application – COMING SOON

Pharmacy Reports

• Adverse Drug Event Report – similar to previous reports

Jackson Market P&T - 2022

SDSD

New or Updated Therapeutic Directives

• Therapeutic Directive Pharmacist Driven Iron Deficiency (updated)
• Therapeutic Substitutions Automatic Ancef Presurgical Prophylaxis (updated)
• Therapeutic Substitutions Automatic CNS Stimulants – Wakefulness Promoting (new)
• Therapeutic Substitutions Automatic Hypnotics (updated)
• Therapeutic Substitutions Automatic Mannitol Formulations (new)
• Therapeutic Substitutions Automatic NSAIDs (updated)
• Therapeutic Substitutions Automatic Risperidone PO Formulations (updated)
• Therapeutic Directive Cardene and Cleviprex Transition to Oral (updated)
• Therapeutic Substitutions Automatic Steroids Topical (new)
• Therapeutic Substitutions Automatic Ophthalmic Antihistamines (new)

Annual Therapeutic Directive Renewals

• Therapeutic Directive Automatic Discontinuation Entereg
• Therapeutic Directive IV Levothyroxine to Weekly Dosing
• Therapeutic Directive IV-PO Step-down Amiodarone
• Therapeutic Directive Pain and Sedation in Mechanically Ventilated Patients
• Therapeutic Directive Pharmacokinetics
• Therapeutic Directive Renal Dosing Baricitinib
• Therapeutic Substitutions Automatic 5HT3 Antagonists
• Therapeutic Substitutions Automatic Actemra (tocilizumab) Dose Rounding
• Therapeutic Substitutions Automatic Alpha-Adrenergic Blocking Agents
• Therapeutic Substitutions Automatic Tetracyclines

Policies and Procedures

• Automatic Antimicrobial Dose Rounding in Epic – new dose rounding procedures detailing how antimicrobial doses will be rounded and which weight will be used for weight-based dosing in Epic. This will help minimize waste.
• Mediport Flushing Process – an alternate process for Mediport flushing has been proposed by the health system which will utilize saline flushes instead of heparin flushes. This process was trialed at Our Lady of the Lake starting in April and has been successful.
• Medication Administration, Who Can Administer – added glucagon to list of allowed medications for radiologic technicians.

Medication Use Evaluation

• Retacrit (epoetin alfa) – St. Dominic Hospital is above benchmark for cost per patient day for epoetin alfa. A review of dosing practices was performed and found that many patients received over twice the appropriate amount of epoetin alfa. A request for a new dose button of “10,000 units” will be made in Epic.

Formulary Review: Additions, Revisions, and Removals:

• Venofer (iron sucrose) Appeal to help facilitate IV iron replacement in heart failure patients and to help minimize costs, an appeal to add iron sucrose to formulary was made. Previously, Injectafer (iron carboxymaltose) was added to formulary, however, iron sucrose is half the cost of iron carboxymaltose ($500 vs. $1000). It was decided at system P&T to remove Injectafer from formulary and add Venofer to formulary. This request was approved at local St. Dominic P&T.

Formulary Review: Additions, Revisions, and Removals:

FMOLHS System P&T Class Reviews

• Everolimus Formulations
• Sirolimus Formulation
• Cyclosporine, Systemic Formulations
• Mycophenolate Formulations
• Hydroxyzine Formulations
• Urinary Anti-infectives
• Antifungals, vaginal
• Antifungals, Echinocandins
• Steroids, oral
• Steroids, parenteral
• Meningitis Vaccines
• Melatonin Receptor Agonists
• Non-barbiturate Hypnotics
• CNS Stimulants, Wakefulness Promoting
• CNS Stimulants, Amphetamines
• CNS Stimulants, Methylphenidates
• Antiviral Agents

Pharmacy Reports

• Drug Shortage Statistics – data regarding national drug shortage statistics was presented. In summary, ongoing, and active shortages has been above 200 at the end of each quarter since 2018. Shortages are not resolving. Pharmacy workload dedicated to managing drug shortages is increasing.
• Adverse Drug Event Report – 3^rd Quarter 2022 – similar to previous reports. Most were level 0 and level 1.
• DCOA FMOL – St. Dominic – data comparing medication costs per adjusted patient day to benchmark and other hospitals within the health system were presented. St. Dominic was only above benchmark for blood growth factors when excluding outpatient chemotherapy and specialty items. The blood growth factor cost is currently being addressed with updating orders in Epic and discussing medication use evaluation data with nephrology groups.

New and Update Pharmacy Directives and Interchanges:

• Therapeutic Substitution Automatic PO to IV Tranexamic Acid (new)
• Therapeutic Substitutions Automatic IV IM Lorazepam to Midazolam (new)
• Therapeutic Substitutions Automatic Urinary Anticholinergics (updated)
• Therapeutic Substitutions Automatic Lidocaine Patches (updated)
• Therapeutic Substitutions Automatic Ophthalmic Quinolones (updated)

Annual Renewal of Pharmacy Directives and Interchanges:

• Therapeutic Directive Renal Dosing
• Therapeutic Directive Renal Dosing Antimicrobials
• Therapeutic Directive Vitamin K Parenteral for Oral Administration
• Therapeutic Substitutions Automatic Ancef Presurgical Prophylaxis
• Therapeutic Substitutions Automatic Fluconazole
• Therapeutic Substitutions Automatic Namenda XR to IR
• Therapeutic Substitutions Automatic Phosphate Binder
• Therapeutic Substitutions Automatic PPI H2RA Duplicate
• Therapeutic Substitutions Automatic Ramelteon to Melatonin
• Therapeutic Substitutions Automatic Rapid Insulin
• Therapeutic Substitutions Automatic Therapeutic Lovenox Dose Rounding

Formulary Additions, Revisions, and Removals:

• IV Iron Formulations – Injectafer (ferric carboxymaltose) Appeal - approved as formulary restricted to hematology/oncology physicians only

• FMOLHS System P&T Annual Class Reviews

  • Antihistamines, 1^st Genergation, Part 1 (4:04)
  • Antihistamines, 1^st Generation, Part 2 (56:22.08)
  • Antihistamines, 2^nd Generation (4.02)
  • Sulfonylureas (68:20.20)
  • Biguanides
  • Thiazodinediones (68:20.28)
  • DDP-4 Inhibitors (68:20.05)
  • Opiate Agonists, Part 1 (28:08.08)
  • Opiate Agonists, Part 2 (28:08.08)
  • Opiate Partial Agonists (28:08.12)
  • NSAIDs, Part 1 (28:08.04.92)
  • NSAIDs, Part 2 (28:08.04.92)
  • Antivenom (80:04)
  • Insulins (68:20.08)
  • Analgesics and Antipyretics (28:08)
  • Analgesics and Antipyretics, misc. (28:08.95)

• Farxiga (dapagliflozin) Formulary addition – dapagliflozin was added to formulary for non-diabetic indications

• Ultomiris Formulary Revision – additional indications for use per FDA labeling were added in the outpatient setting.

• Nutrition Formulary Additions, Revisions, and Removals 

  • Remove Ensure EnLive and add Ensure High Protein
  • Remove Vital 1.5 and add Vital High Protein
  • Add Kate Farms 1.0 Standard and Kate Farms 1.5 Peptide
  • Remove Osmolite 1.5

FDA Safety Alert Summary

• The first alert warns that buprenorphine products that are dissolved in the mouth to treat opioid use disorders and pain can cause dental problems. These problems include tooth decay, cavities, oral infections, and loss of teeth, even reported in patients with no prior history of dental issues. The FDA recommends that healthcare professionals be aware that the benefit of these products outweighs the risk, but patients should be counseled on these potential side effects, educated on proper dental care while using these products, and be referred to a dentist as soon as possible after starting transmucosal buprenorphine. This warning will be included in the upcoming pharmacy newsletter.
• The second alert states the FDA is investigating a possible increased risk of death with Ukoniq (umbralisib), a lymphoma treatment medication. This was discovered from the initial findings form a clinical trial evaluating Ukoniq for the treatment of a related type of cancer. Due to the similarities between the two types of cancers that this drug is approved for and the type of cancer studied in the clinical trial, the FDA is re-evaluating the risk against benefit for its approved uses. The FDA recommends reviewing patients’ progress on this treatment and discuss the risk and benefits of using this treatment compared to others available. Ukoniq (umbralisib) is non-formulary at St. Dominic’s Hospital. This warning will be included in the upcoming pharmacy newsletter.
• The third alert states that the FDA recommends thyroid monitoring in babies and young children who receive injectable iodine-containing contrast media for medical imaging. The FDA is recommending newborns and children through 3 years of age have follow-up thyroid monitoring within 3 weeks after receiving iodine-containing injections of contrast media, aka “contrast dye”. Newborns, especially those born prematurely, as well as children in their first 3 years with underlying conditions may be at a higher risk for thyroid-related problems. While the FDA review showed underactive thyroid or a temporary decrease in thyroid hormone levels to be uncommon, the conditions should be identified and treated early to prevent future complications. The FDA has approved a new warning to the prescribing information for the class of iodinated contrast media (ICM) and monitoring recommendations for this age group. The FDA recommends healthcare professionals should perform appropriate monitoring in these patients for the possibility of hypothyroidism or a temporary decrease in thyroid hormone levels following ICM exposure. If decreased levels or thyroid disfunction is detected, patients should be treated and monitored as clinically needed to avoid future cognitive and developmental disabilities. Parents and caregivers should be counseled of these risks and informed of the follow-up monitoring needed. Dr. Schipper requested that our NICU physicians be educated on this warning and Dr. Dana agreed. This warning will be included in the upcoming pharmacy newsletter.
• The fourth alert states that the aforementioned drug Ukoniq (umbralisib) has been withdrawn due to safety concerns for possible increased risk of death outweighing the benefits with treatment. Updated findings from the UNITY-CLL clinical trial continued to show possible increased risk of death in patients being treated with Ukoniq. Based on these findings, the drug’s manufacturer, TG Therapeutics, voluntarily withdrew the drug from the market for its approved uses in marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA recommends health care professions to stop prescribing this medication and switch patients to alternative therapy. Ukoniq (umbralisib) is not on formulary at St. Dominic’s Hospital. This warning will be included in the upcoming pharmacy newsletter.
• The fifth alert warns of possible increased risk of death and serious side effects with the cancer medication Copiktra (duvelisib). This is warranted by the results of a clinical trial comparing Copiktra to another medication for the treatment of leukemia and lymphoma. This trial found Copiktra to have a possible increased risk of death, as well as side effects including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels. The FDA recommends healthcare professionals to consider the risks versus benefits of continuing Copiktra therapy compared to other available treatments and to advise patients of these findings. Copiktra (duvelisib) is not on formulary at St. Dominic’s Hospital. This warning will be included in the upcoming pharmacy newsletter.

New and Update Pharmacy Directives and Interchanges:

• Therapeutic Substitutions Automatic Vaccines Adult (updated)
• Therapeutic Directive Diabetes Service (updated)
• Therapeutic Directive Epogen (updated)

Annual Renewal of Pharmacy Directives and Interchanges:

• Therapeutic Directive Integrilin
• Therapeutic Directive Toradol Dosing
• Therapeutic Substitution Maintenance Fosphenytoin to Phenytoin IV
• Therapeutic Substitutions Automatic ARBs
• Therapeutic Substitutions Automatic H2 Antagonists
• Therapeutic Substitutions Automatic Hypnotics
• Therapeutic Substitutions Automatic IV Ciprofloxacin to IV Levofloxacin
• Therapeutic Substitutions Automatic Lidocaine Patches
• Therapeutic Substitutions Automatic PPIs
• Therapeutic Substitutions Automatic Suboxone Subutex to Buprenorphine
• Therapeutic Substitutions PPI and SUP Switch and DC Protocol
• Therapeutic Substitutions Risperidone PO Formulations

Antimicrobial Stewardship Report:

The default dose for ceftriaxone was increased from 1 gm daily to 2 gm daily to ensure adequate dosing for pneumonia. Based on NHSN SAAR (standardized antimicrobial administration ratio) for the previous 12 months, there is room for improvement in board spectrum antimicrobials, specifically, piperacillin-tazobactam, cefepime, and meropenem. A task force will be created to evaluate appropriate testing for C. difficile. 

Formulary Additions, Revisions, and Removals:

• Injectafer (ferric carboxymaltose) formulary appeal - approved with restriction to hematology/oncology physicians

Pharmacy Reports:

• Adverse Drug Event Report

New and Update Pharmacy Directives and Interchanges:

• Therapeutic Substitutions Automatic Stadol and Nubain (new)

Annual Renewal of Pharmacy Directives and Interchanges:

• Therapeutic Directive Automatic Discontinuation Granix
• Therapeutic Directive Cellulitis Step-Down
• Therapeutic Directive IV-PO Step-down Folic Acid
• Therapeutic Directive Nutrition Support
• Therapeutic Directive Santyl Restrictions
• Therapeutic Substitutions Automatic ACE Inhibitors
• Therapeutic Substitutions Automatic Antidepressants
• Therapeutic Substitutions Automatic Calcium Channel Blockers
• Therapeutic Substitutions Automatic Keppra XR or IR
• Therapeutic Substitutions Automatic NSAIDs
• Therapeutic Substitutions Automatic Seroquel Nasal Sprays
• Therapeutic Substitutions Automatic Topical Antifungals
• Therapeutic Substitutions Automatic Ursodiol

Antimicrobial Stewardship Report:

There was a reduction in overall antibiotic days of therapy, specifically in 2021 and 2022, due to efforts and interventions driven by our antimicrobial stewardship pharmacist. There was also a decrease in fluoroquinolone utilization, which aligns with FDA recommendations due to the concerning safety profile and black box warnings for this medication class. There is a need to decrease empiric broad-spectrum carbapenem use to prevent C. difficile infections and conserve gram negative bacteria susceptibilities. Vancomycin days of therapy has also decreased over 2021 and 2022, especially attributable the implementation of the MRSA PCR protocol. There was a significant increase in both ceftriaxone and azithromycin days of therapy over the course of 2020 due to their use for secondary bacterial pneumonia infections with COVID-19. However, after an automatic 3 days stop date policy for azithromycin use was approved by P&T in December of 2020, days of therapy were significantly reduced and have remained appropriately low.

Medication Use Evaluation:

Clevidipine Use for Perioperative Hypertension in Cardiovascular Surgery:  Clevidipine was added to formulary with restricted use criteria in the setting of cardiovascular surgery. Due to clevidipine’s higher cost over nicardipine, a request was made by the P&T Committee to ensure appropriate use was occurring. Those inpatient who underwent cardiovascular surgery and received clevidipine between April 2020 and November 2020 were evaluated. Perioperative hypertension medications and duration, time of clevidipine initiation, and systolic blood pressure at the time of clevidipine initiation were collected from the electronic health record. Appropriate use was defined as therapeutic failure on nicardipine infusion or clinical severity requiring rapid hypertension correction not amenable to the time needed for nicardipine titration. Of the 26 patients included, inappropriate use occurred in 58% of patients.

Pharmacy Reports:

• CMS Pharmacy Quality Report
• Adverse Drug Event Report

New and Update Pharmacy Directives and Interchanges:

• Therapeutic Substitutions Automatic Calcium Chloride to Calcium Gluconate (new)
• Therapeutic Substitutions Automatic Oral DM Agents (new)

Annual Renewal of Pharmacy Directives and Interchanges:

• Therapeutic Directive Automatic Constipation Prevention
• Therapeutic Directive IV-PO Step-down Antiepileptics
• Therapeutic Directive IV-PO Step-down Diltiazem
• Therapeutic Directive IV-PO Step-down Folic Acid
• Therapeutic Directive MRSA Nasal PCR
• Therapeutic Substitutions Automatic Fibrates
• Therapeutic Substitutions Automatic Levemir to Lantus
• Therapeutic Substitutions Automatic Ophthalmic Products for Glaucoma

Formulary Additions, Revisions, and Removals:

• Felbatol (felbamate) formulary removal - due to low usage and serious adverse events, this medication was removed from formulary

New and Update Pharmacy Directives and Interchanges:

• Therapeutic Directive Biosimilar Conversions (new)
• Therapeutic Directive IVIG Dose Rounding (new)
• Therapeutic Directive Opioid Partial Agonists (new)
• Therapeutic Directive Metronidazole Dosing (new)
• Therapeutic Directive Anticoagulation (updated)
• Therapeutic Substitutions Automatic 2nd Generation Antihistamines (updated)
• Therapeutic Substitutions Automatic Beta Blockers (updated)
• Therapeutic Substitutions Automatic HMGCoA Inhibitors (updated)
• Therapeutic Substitutions Inhalers (updated)
• Therapeutic Substitutions Automatic Insulin Mixes (updated)

Annual Renewal of Pharmacy Directives and Interchanges:

• Therapeutic Directive Automatic Calcitonin
• Therapeutic Directive IV-PO Step-down Antimicrobials
• Therapeutic Directive IV-PO Step-down Dexamethasone
• Therapeutic Directive IV-PO Step-down Digoxin
• Therapeutic Directive Metoprolol
• Therapeutic Directive IV-PO Step-down Phenytoin and Fosphenytoin
• Therapeutic Substitutions Automatic 5 Alpha Reductase Inhibitors
• Therapeutic Substitutions Automatic Benzodiazepines
• Therapeutic Substitutions Automatic Diuretics
• Therapeutic Substitutions Automatic Iron Preparations
• Therapeutic Substitutions Automatic Pens Cephs
• Therapeutic Substitutions Automatic Selective Serotonin Agonists
• Therapeutic Substitutions Automatic Topical Antivirals

Formulary Additions, Revisions, and Removals:

• Veletri (epoprostenol) Administration Protocol 
• Novel bupivacaine Formulary request - the committed voted to not add Xaracoll, Exparel, or Zynreleft to formulary due to lack of data of superiority over current formulary bupivacaine products
• Nafcillin to oxacillin formulary update - oxacillin will now be formulary and nafcillin will be non-formulary

Pharmacy Reports:

• CMS Pharmacy Quality Report
• Adverse Drug Event Report
• FDA Safety Alerts
  • Alcohol-based hand sanitizer - may cause serious eye injury from splashing or touching eyes after use
  • Tofacitinib - increased risk of serious heart related events, cancer, blood clots, and death
  • Statins during pregnancy - strengthened existing warning