Dapagliflozin (Farxiga) has been FDA-approved for adults with chronic kidney disease to reduce the risk of eGFR decline, end-stage renal disease, cardiovascular death and hospitalization for heart failure.

The Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC) updated recommendations for several vaccines. Key changes that could impact testing include:

Pneumococcal vaccines

• PCV13 (Prevnar 13) continues to be recommended for routine pneumococcal vaccination in children ≤ 18 years.
• There are three pneumococcal vaccines recommended for adults:
  • Two conjugate vaccines: PCV15 (Vaxneuvance) and PCV20 (Prevnar 20)
  • One polysaccharide vaccine: PPSV23 (Pneumovax 23)
• Adults aged 19–64 years with certain underlying medical conditions (see below) or age ≥ 65 years (if never received before):
  • PCV20 x 1 or
  • PCV15 x1 followed by PPSV23 x1 ≥ 12 months later (can be given ≥ 8 weeks later if immunocompromised)
  • Certain underlying medical conditions (unchanged from prior recommendations; *indicates an immunocompromised state): alcohol use disorder, cigarette smoking, diabetes, chronic heart, lung or liver disease, sickle cell disease/asplenia*, taking immunosuppressive drugs* (e.g., chemotherapy, long-term systemic steroids), HIV infection*, malignancy*, solid organ transplant*, chronic renal failure*
• The update above applies to the following sections:
  • p. 324 (Vaccinations for Special Groups): Older Adults, Diabetes, Sickle Cell Disease & Other Causes of Asplenia and Immunodeficiency boxes
  • p. 325 (Vaccinations for Adults): Pneumococcal box
  • p. 329-330: Pneumococcal Vaccines (including Study Tip Gal)
  • Sickle Cell Disease, Asthma, Tobacco Cessation, Diabetes, and Transplant chapters

Shingles vaccine

• p. 325 & 331: Shingrix recommendations have expanded to include adults aged ≥ 19 years if immunosuppressed (or expected to become immunosuppressed).
• This update also applies to p. 408 in the Infectious Diseases III: Antivirals and Antifungals chapter.

Hepatitis B vaccine

• p. 325-326: a hepatitis B vaccination series is now recommended for all adults aged 19–59 years or age ≥ 60 years if at risk for hepatitis B virus infection (or want to receive vaccination).

The Centers for Disease Control and Prevention (CDC) now recommend the following treatment options for latent tuberculosis (TB) in pregnant patients (without preference):

• Isoniazid and rifampin daily for 3 months
• Rifampin daily for 4 months
• Isoniazid daily for 6 or 9 months

The Infectious Diseases Society of America (IDSA) and the American College of Gastroenterologists (ACG) have both released updates for the treatment of Clostridioides difficile infection (CDI):

• First (initial) episode: preferred first-line treatment options remain the same (fidaxomicin or oral vancomycin).
• Second episode (first recurrence): can be treated with any of the following regardless of the antibiotic used for the initial episode (unless noted):
  • Fidaxomicin 200 mg PO BID x 10 days
  • Vancomycin tapered and pulsed regimen (e.g., vancomycin 125 mg PO QID for 10 days, then BID for one week, then once per day for one week, then every 2 or 3 days for 2-8 weeks)
  • Vancomycin 125 mg PO QID x 10 days (if metronidazole was used to treat the initial episode)
• Subsequent episodes: treatment options for the third episode or greater remain the same.
• Bezlotoxumab has a more defined role in the prevention of recurrent CDI. It can be considered in high risk patients (e.g., age ≥ 65, immunocompromised, severe presentation and/or a second episode within the past 6 months) and must be used in combination with antibiotics active against C. difficile (e.g., fidaxomicin or oral vancomycin). A labeled warning advises caution when used in patients with a history of heart failure.

The Sexually Transmitted Infections Treatment Guidelines, 2021 published by the Centers for Disease Control and Prevention contain an update for chlamydia treatment. The preferred regimens are:

• Non-pregnant adults: doxycycline 100 mg PO BID x 7 days
• Pregnant females: azithromycin 1 gram PO x 1 dose

Empagliflozin (Jardiance) has been FDA-approved to reduce the risk of cardiovascular death and hospitalization in patients with heart failure with reduced ejection fraction.

The American College of Chest Physicians (CHEST) released a second update to the Antithrombotic Therapy for the Treatment of Venous Thromboembolism (VTE) Disease guideline:

• In patients with cancer-associated thrombosis, oral factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) are preferred over low molecular weight heparins (e.g., enoxaparin).

The 2022 American Diabetes Association (ADA) Standards of Care update was published. Key changes that could impact testing include:

Screening

• p. 614: everyone should be tested for diabetes beginning at 35 years old.

Diabetic Kidney Disease

• p. 615: SGLT2 inhibitors are recommended in patients with an eGFR ≥ 25 mL/min/1.73m² and urine albumin ≥ 300 mg/g to reduce CKD progression and cardiovascular events. Finerenone is recommended in patients unable to use an SGLT2 inhibitor. An ACE inhibitor or ARB continues to be recommended in patients with albuminuria.

Treatment for Type 2 Diabetes

• p. 616: although metformin is still generally considered to be first-line, initial treatment depends on comorbidities and patient-specific factors.

Semaglutide (Wegovy) injection has been FDA-approved for weight management in adults with obesity or who are overweight with at least one additional weight-related condition (e.g., hypertension, type 2 diabetes, dyslipidemia).

On the clipboard describing USP 797 cleaning requirements, the minimum frequency of cleaning the carts should be monthly.

In the section under Collecting Duct, the second to last sentence in the paragraph should say, “Potassium-sparing diuretics (including aldosterone antagonists) work in the distal convoluted tubule and collecting duct to decrease Na and water reabsorption and increase K reabsorption.

All controlled substances (schedule II – V) can be stored in a locked cabinet or dispersed among other drugs. Prior to this change, schedule II drugs needed to be stored in a securely locked cabinet or vault and could not be dispersed throughout the stock of non-controlled drugs.

The following update impacts the last sentence in the section under Biologics and Biosimilars.

The FDA approved two interchangeable biosimilar products in 2021. The following are interchangeable:

• Insulin glargine-ygfn (Semglee) for insulin glargine (Lantus)
• Adalimumab-adbm (Cyltezo) for adalimumab (Humira)

Regarding the prescription drugs that do not require child-resistant packaging, colesevelam powder should read ≤ 3.75 grams/package.

The 4th bullet in the Methadone Study Tip should read “(days 271 - 365).”

The following update impacts the last sentence of the second paragraph under the Substituting Biologics section.

The FDA approved two interchangeable biosimilar products in 2021. The approval allows for the substitution of the following biosimilars without the need for a separate prescription:

• Insulin glargine-ygfn (Semglee) for insulin glargine (Lantus)
• Adalimumab-adbm (Cyltezo) for adalimumab (Humira)

The following update impacts the Study Tip “Considerations to Determine if Loss or Theft is Significant.” The California Board of Pharmacy now defines the following as reportable significant loss of controlled substances:

• Loss of any quantity due to employee theft.
• Tablets, capsules or oral medications in a quantity ≥ 99 dosage units.
• Single-dose injectable medications, lozenges, films (oral, buccal, sublingual), suppositories or patches in a quantity ≥ 10 dosage units.
• Multi-dose medications (e.g., vials, containers) or medications administered by continuous infusion in a quantity ≥ 2 units.
• Any loss deemed significant by the pharmacist-in-charge.

The following updates were made to secure prescription form requirements:

• In addition to the features noted on p. 120 and 121, security prescription forms must now contain a barcode and the prescriber's pre-printed address.
• The serial number formatting has also changed from 15 digits (3 letters followed by 12 numbers) to 12 digits (any combination of letters and numbers) that corresponds with the barcode.

As of January 1, 2022, exceptions to the mandatory electronic prescribing (e-prescribing) law include:

• Prescriptions issued by a veterinarian.
• Prescriptions issued in a hospital emergency department or urgent care clinic if the patient is homeless without a preferred pharmacy, the patient lives outside of California or the geographic area of the hospital/clinic, or the prescription is issued when the preferred pharmacy is closed.
• The prescription will be dispensed outside of California.
• Electronic data transmission is not available due to a temporary technological or electrical failure.

The last paragraph on the page should read: A pharmacy must contact the recipient (i.e., pharmacy, prescriber or patient) and board within 12 hours of the recall notice. An outsourcing facility must contact the recipient (i.e., pharmacy, prescriber or patient) and the board within 24 hours of the recall notice.

Under the second bullet that states “Six quantity check-off boxes,” the second sub-bullet should read “May be checked by the prescriber to correspond to the written quantity of the drug.”