DHCS has released an article on the updated guidance from the American Association of the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD/ISDA).

Testing and treatment for HCV has declined sharply since the COVID-19 pandemic. In response, the new AASLD/ISDA guidelines recommend universal HCV screening for all adults 18 years or older. Universal direct-acting antiviral (DAA) treatment continues to be strongly recommended for all people with a chronic HVC and a life expectancy > 12 months. Treatment algorithms have been simplified and a new algorithm has been added for incomplete treatment adherence for persons who have missed ≥ 7 days of DAA therapy.

For more information, see the DHCS article.

DHCS released an article about a significant drug-drug interaction between statins and gemfibrozil. When gemfibrozil is combined with statins, there may be increased risk of statin-associated muscle symptoms (SAMS), including rhabdomyolysis, a rare, serious syndrome involving the rapid breakdown of skeletal muscle, with the release of potentially nephrotoxic substances. The product prescribing information for all statins advises against the concomitant use of statins and gemfibrozil. Some recommended therapy alternatives include:

• Fenofibrate which is preferred over gemfibrozil due to significantly lower risk for muscle-related toxicity compared with statin-gemfibrozil combination therapy.
• If fenofibrate is not well-tolerated, atorvastatin or rosuvastatin could be considered in combination with gemfibrozil due to a lower magnitude for a potential interaction.
• The combination of lovastatin, pravastatin, or simvastatin with gemfibrozil is not advised.

For more information, see the DHCS article.

DHCS has released a new article focused on the use of aspirin for primary prevention of cardiovascular disease. This article focuses on three key learning objectives: understanding current USPSTF recommendations, assessing 10-year CVD risk, and identifying risk factors for bleeding.

In 2022, the USPSTF published an update on the use of aspirin for primary prevention of CVD. The following recommendations are as follows:

• Initiation of aspirin for primary prevention can be considered for adults 40 to 59 years of age with a 10-year CVD risk of 10% or greater.
• Aspirin is not recommended for adults 60 years of age or older or adults of any age who are at risk for bleeding.

The USPSTF analysis was based on a systematic review of 13 clinical trials and microsimulation modeling study. They found that aspirin for primary prevention significantly reduced MACE but did not lower mortality. A baseline CVD risk estimation is important for establishing an initial reference point which can help optimize treatment options. AHA recently introduced the PREVENT Online calculator at the beginning of 2024 which may provide a more personalized and comprehensive risk assessment. There is currently no formal guidance, but providers can expect it to be incorporated in upcoming guidelines for CVD prevention. Risk-enhancing factors include family history of CAD, elevations in inflammatory and lipoprotein biomarkers, and medical conditions such as familial hypercholesterolemia, CKD, metabolic syndrome.  

A retrospective claims analysis was conducted to evaluate current aspirin use among Medi-Cal members with risk factors for bleeding. Factors that can contribute to increased risk of bleeding include age >70, concomitant use with NSAIDs, and history of PUD. The results showed many members fall into one of these three categories and may benefit from educational outreach. If aspirin is initiated, providers should counsel all patients of the risk for bleeding and review the signs and symptoms of bleeding.

DHCS has released an article that suggests alternatives to diphenhydramine for older adults. The antihistamine diphenhydramine is a widely utilized antihistamine, particularly among older populations, but presents risks due to its anticholinergic properties. While it effectively treats various conditions like allergies and insomnia, its prolonged usage may result in tolerance and adverse effects such as confusion and dry mouth. The 2015 Beers Criteria advises against its use in individuals aged 65 years or older. As a safer alternative in managing allergic reactions and insomnia, second-generation antihistamines are recommended for older adults due to their diminished sedative effects. Several alternatives, including cetirizine HCl and loratadine, are listed on the Medi-Cal Rx Contract Drugs List.

The California Medi-Cal Drug Use Review (DUR) program has issued their annual summary of updates on immunization guidelines, products, and research in collaboration with the California Department of Public Health (CDPH) Immunization Branch.

Highlights include:

• This is the first fall/winter season where vaccines are available for SARS-CoV-2 (COVID-19), influenza, and RSV. Patients should be encouraged to stay up to date on all vaccinations.
• Everyone 5 years of age or older should get one dose of an updated COVID-19 vaccine to protect against serious illness from COVID-19.
• Children 6 months through 4 years of age need multiple doses of COVID-19 vaccines to be up to date, including at least one dose of updated COVID-19 vaccine.
• People who are moderately or severely immunocompromised may get additional doses of updated COVID-19 vaccine.
• For the 2023-2024 season, inactivated influenza vaccines (IIVs), recombinant influenza vaccine (RIV4), and live attenuated influenza vaccine (LAIV4) are available (all quadrivalent).
• Previously, the Advisory Committee on Immunization Practices (ACIP) had recommended additional safety measures when administering egg-based influenza vaccine to people who have had severe allergic reactions to egg. In June 2023, ACIP and CDC recommended that people with an egg allergy may receive any influenza vaccine (egg-based or non-egg based) that is otherwise appropriate for their age and health status.
• Hepatitis B (HepB) screening is recommended at least once during a lifetime for all adults and for anyone who requests testing.
• All children 2 through 23 months of age with no previous pneumococcal conjugate vaccine (PCV) vaccination should receive either PCV15 or PCV20, according to recommended PCV dosing and schedules.
• For children with an incomplete PCV vaccination status, use of either PCV15 or PCV20 for catch-up vaccination is recommended for:
  • Healthy children 24 through 59 months of age
  • Children 24 through 71 months of age with specified health conditions
• Both the American Academy of Pediatrics (AAP) and the American Cancer Society have endorsed the strategy of offering HPV vaccine to children at 9 years of age.
• In June 2023, the ACIP recommended that all adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
• In February 2023, the ACIP recommended the two-dose JYNNEOS vaccine series for people 18 years of age or older who are at increased risk of mpox infection.
• In June 2022, the FDA licensed a second MMR vaccine. Both MMR vaccines are interchangeable for all indications for which MMR vaccination is recommended.

The full text is available on the DHCS bulletin.

DHCS has published a new article on the concomitant use of glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors in the treatment of type 2 diabetes (T2DM). Both GLP-1 agonists and DPP-4 inhibitors work to manage T2DM by increasing GLP-1 to promote insulin secretion and decrease glucagon release. The FDA, ADA and AACE do not recommend the concomitant use of GLP-1 agonists and DPP-4 inhibitors due to the lack of evidence for beneficial outcomes on combined therapy and increased risk for side effects. If a patient is on both a GLP-1 agonist and DPP-4 inhibitor, the ADA and AACE recommend continuing the GLP-1 agonist and to discontinue the DPP-4 inhibitor without the need for a taper due to lack of strong evidence in decreasing CV events and weight loss in DPP-4 inhibitors.

DHCS has released an article covering several recent efforts to improve perinatal mental health conditions through the availability of new resources identifying and supporting best practices for health care professionals. In February 2023, the Alliance for Innovation on Maternal Health (AIM) published a patient safety bundle as an evidence-based resource to address drivers of maternal morbidity and mortality. In May 2023, the American College of Obstetricians and Gynecologists (ACOG) published 2 clinical practice guidelines focused on (1) screening and diagnosis and (2) treatment and management of perinatal mental health conditions including depression, anxiety and anxiety-related disorders, bipolar disorder, acute postpartum psychosis, and symptoms of suicidality. ACOG has also published several resources on their website including the Lifeline for Moms Perinatal Mental Health Tool Kit and a free e-module titled “Addressing Perinatal Mental Health Conditions in Obstetric Settings” for continuing medical education credit.

On November 4, 2022, the Centers for Disease Control and Prevention (CDC) issued an updated Clinical Practice Guideline for Prescribing Opioids for Pain. The guidelines apply to outpatients ≥ 18 years of age with acute pain, subacute pain, or chronic pain. These guidelines exclude pain management for sickle cell disease, cancer-related pain, palliative care, and end-of-life care. Key recommendations include:

• Maximize use of non-opioid therapies when possible and only consider opioids if the benefits of therapy are expected to outweigh the risks.
• Before starting opioids for pain, establish realistic treatment goals and discuss a plan for discontinuation if the expected benefit is not realized.
• If opioid therapy is indicated, an immediate-release (IR) product is preferred. Extended-release or long-acting (ER/LA) opioids should be reserved for severe, continuous pain.
• When initiating opioids in opioid-naïve individuals, prescribe the lowest effective dosage for no longer than the expected duration of pain severe enough to require opioids, and evaluate the potential benefits and risks when considering an increase in dose.
• Clinicians and patients should jointly weigh the benefits and risks of continuing opioid therapy, and risk mitigation strategies should be employed.
• If the benefits of opioid therapy do not outweigh the risks, other therapies should be optimized, and opioids should be gradually tapered to a lower dose.
• Unless there are warning signs of impending overdose, opioid dosages should not be rapidly reduced or discontinued.

In addition, on April 13, 2023, the Food and Drug Administration (FDA) announced new requirements for safety label changes for the safe use of opioids. The updates includes label changes for IR and ER/LA opioids, in addition to a new label warning about opioid-induced hyperalgesia (OIH) and a description of symptoms differentiating OIH from opioid tolerance and withdrawal. If a patient is suspected to be experiencing OIH, an appropriate dose decrease or switch to a different opioid product can be considered. Patients should be advised on the risks of OIH and to never increase their opioid dosage without first consulting a healthcare professional. Further information on these changes can be read in the DHCS DUR educational article.

On March 29, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of 4 milligram naloxone hydrochloride nasal spray as an over-the-counter (OTC) product for non-prescription use. Naloxone is a lifesaving medication that when administered can rapidly reverse the effects of an opioid overdose. The nasal spray can be sold directly to consumers online or purchased locally in pharmacies, gas stations, and grocery stores. The manufacturer’s estimated timeline for Naloxone’s OTC availability on U.S. shelves and online retailers is late summer 2023. In the meantime, the prescription product, as well as other naloxone formulations which are not yet approved for OTC use, will remain available at the pharmacy by prescription or pharmacist-furnishing, as well as community distribution sites. More information is available in the DHCS DUR bulletin.

For the pharmacological management of postpartum pain, the American College of Obstetricians and Gynecologists (ACOG) recommends shared decision making using a stepwise, multimodal approach. Postpartum pain from vaginal or caesarean delivery includes acute perineal, uterine, and incisional pain. ACOG Guidelines recommend non-opioid analgesics as first-line treatment options for postpartum pain. These include acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs). For breakthrough pain, a low-dose, low-potency, and short-acting opioid can be considered for use as needed, limited to the shortest duration possible. Options for opioid pain medication include codeine, hydrocodone, oxycodone, tramadol, and morphine. It is important to note that codeine and tramadol should be avoided when breastfeeding since these drugs can be excreted in the breast milk and cause excess sleepiness and respiratory depression in breastfed infants. More information on this clinical review can be found on this DCHS bulletin.

On January 12, 2023, the Drug Enforcement Administration (DEA) eliminated the DATA-Waiver Program. Effective immediately, waiver applications will no longer be accepted. All prescriptions for buprenorphine will now only require a standard DEA registration number. The previously used DATA-Waiver (also known as X-Waiver) registration numbers are no longer needed for any prescription. Any practitioner with a current DEA registration that includes Schedule III authority may now prescribe buprenorphine for Opioid Use Disorder (OUD) in their practice. There are no longer any limits on the number of patients a prescriber may treat for OUD with buprenorphine. New training requirements will go into effect on June 21, 2023, for all prescribers of controlled substances. More information on this announcement is available on this DHCS bulletin.

The California Medi-Cal Drug Use Review (DUR) program has issued their annual summary of updates on immunization guidelines, products, and research in collaboration with the California Department of Public Health (CDPH) Immunization Branch.

Highlights include:

• Vaccine providers can offer JYNNEOS (Mpox vaccine) to any patients who may be at risk, and persons who request vaccination should receive it without having to attest to specific risk factors.
• ACIP now recommends HepB vaccination for all adults 19-59 years of age regardless of risk factors.
• Routine annual influenza vaccination is recommended for everyone 6 months of age or older without contraindications.
• New for the 2022-2023 flu season, the following three flu vaccines are preferentially recommended for adults 65 years of age or older: quadrivalent high-dose inactivated influenza vaccine (HD-IIV4), quadrivalent recombinant influenza vaccine (RIV4), or quadrivalent adjuvanted inactivated influenza vaccine (aIIV4).
• All standard-dose unadjuvanted IIV4s are now approved for anyone six months of age or older.
• Children as young as 6 months are now eligible for their primary vaccination series against COVID-19.
• Currently, the CDC recommends one updated (bivalent) booster dose for everyone 5 years of age or older if it has been at least two months since the last dose and for children 6 months to 4 years of age who completed the Moderna COVID-19 vaccine primary series and if it has been at least two months since their last dose.
• There is no booster recommendation for children 6 months to 4 years of age who got the Pfizer-BioNTech 3-dose primary series, including children who previously received a 3-dose monovalent Pfizer-BioNTech primary series.
• ACIP now recommends use of either PCV20 alone or PCV15 in series with PPSV23 for all adults 65 years of age or older, and for adults between 19 and 64 years of age with certain underlying medical conditions or other risk factors.
• ACIP expanded their recommendations for immunodeficient or immunosuppressed adults 19 years of age or older to include two doses of RZV for prevention of herpes zoster.

The full text is available on the DHCS bulletin.

On November 8, 2022, the U.S. Food and Drug Administration (FDA) issued a communication regarding increasing reports of serious side effects from individuals exposed to fentanyl, heroin, and other illicit drugs contaminated with xylazine. Xylazine is used in animals as a sedative and pain reliever. It is not safe for use in humans and may result in serious or life-threatening side effects similar to those seen with opioid use. It is unknown if the effects of xylazine are reversible with naloxone, or if the reversal agents used for xylazine in veterinary medicine are safe or effective in humans. Xylazine is not detectable by routine toxicology screens. Health care professionals should continue to administer naloxone for opioid overdoses and consider xylazine exposure if patients are not responding to naloxone or when there are signs or symptoms of xylazine exposure (e.g., severe, necrotic skin ulcerations). More information on the drug safety announcement is available on this DHCS bulletin.

DHCS has published a new educational article on latent tuberculosis infection (LTBI). People with LTBI cannot spread tuberculosis as the infection is contained; five to ten percent of people with LTBI will progress to active disease. Over two million Californians have LTBI. Disparities in incident rates are severe with up to a 52x higher rate among those born in other countries vs people born in the US. Providers can use the California TB Risk Assessment Tools available through California DPH to identify members at high risk for LTBI. Screening and treatment for LTBI fell during the 2020 COVID pandemic and has yet to fully recover.

The full article is available here.

The CDC recommends everyone 6 months of age and older receive the influenza vaccine each year, and this is of increased importance during the continuing COVID-19 pandemic. Current ACIP recommendations permit coadministration of the influenza vaccine with the COVID-19 vaccines. It is recommended that early vaccination (as soon as vaccine is available) be considered for women in the third trimester of pregnancy and for children 6 months – 8 years of age who need two doses.
Of note, history of egg allergy is now a precaution and no longer a contraindication to administration of inactivated influenza vaccine (IIV). However, history of severe allergic reaction (anaphylaxis) after receiving any influenza vaccine is a contraindication to administration of egg-based IIV4s and LAIV4.
ACIP has new recommendations for the administration of serogroup B meningococcal (MenB) vaccine, including a recommended booster dose for individuals age 10 and up with increased risk. MenB vaccination is also recommended for persons aged 16 through 23 years of age.

Adults 19 years and older can receive many vaccines, including the flu vaccine, at their pharmacy covered under SFHP Medi-Cal Outpatient Pharmacy Benefit. Click here for a complete list of SFHP covered vaccines.

Children 18 years and younger are eligible for vaccinations through California Vaccines for Children (VFC) Program. Contact VFC at 1-877-243-8832 for more information

Statins are commonly used for preventing and treating the build-up of fats, cholesterol, and other substances in and on the artery walls (atherosclerosis) and have been shown to reduce the incidence of heart attacks, strokes, and death. On July 20, 2021, the U.S. Food and Drug Administration (FDA) announced it is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients.

The FDA still recommends that most patients stop statins once they learn they are pregnant. Patients should not breastfeed when taking a statin because the medicine may pass into breast milk and pose a risk to the baby. Although many patients should be able to stop statins temporarily until breastfeeding ends, patients who are at high risk of heart attack or stroke who require statins after giving birth should not breastfeed and should use alternatives such as infant formula. Statins are safe to prescribe in patients who are not pregnant but may become pregnant and unintended exposure to statins in early pregnancy is unlikely to cause harm to the developing fetus. To read the full safety announcement, more information will be found in this DHCS Drug Safety Communication.

On September 17, 2021, the U.S. Food and Drug Administration (FDA) announced a voluntary manufacturer recall of all lots of varenicline (Chantix) 0.5 mg and 1 mg tablets due to levels of a nitrosamine impurity above the FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans associated with long-term use, but there is no immediate risk to patients taking this medication. The FDA recommends that patients taking recalled varenicline should continue with their current medication regimen as prescribed, until either their pharmacist provides a replacement, or their doctor prescribes a different medication. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline. More information is available on the DHCS Drug Safety Communication bulletin.

DHCS has released a drug safety communication on lamotrigine. On March 31, 2021, the U.S. Food and Drug Administration (FDA) announced a review of in vitro study findings showed a potential increased risk of arrhythmias in patients with heart disease who are taking lamotrigine. Due to these findings, the FDA is now requiring additional studies to evaluate heart risk across the entire class of sodium channel blockers. At this time, other sodium channel blockers approved for epilepsy, bipolar disorder, and other indications should not be considered safer alternatives to lamotrigine in the absence of additional information. Health care professionals should advise patients taking lamotrigine to contact their healthcare provider or seek immediate medical attention if they experience an abnormal heart rate or irregular rhythm, or symptoms such as a racing heartbeat, skipped or slow heartbeat, shortness of breath, dizziness, or fainting.

DHCS released a clinical review including recommendations around benzodiazepine use. Overprescribing of benzodiazepines and co-prescribing benzodiazepines with opioids may lead to serious side effects, including death. When prescribing, care should be taken to limit use of benzodiazepines to the shortest possible duration and utilize gradual discontinuation (tapering) to minimize the risk of withdrawal symptoms. Prescribers should regularly assess the need for benzodiazepine use in patients who take these medications and discuss strategies for discontinuation when the risks outweigh the benefits, and consider alternative treatments if benzodiazepines are needed long-term. The overall use of benzodiazepines in the Medi-Cal population has decreased steadily over the last five years, with a 50% decrease in Medi-Cal utilizing beneficiaries with at least one paid claim for a benzodiazepine from 2016 to 2020. However, some beneficiaries remain at increased risk for benzodiazepine-related adverse events, including adults of 65 years of age or older that accounted for 3% of the paid claims for benzodiazepines in the Medi-Cal program during 2020.

DHCS released a clinical review on the recommendations of the American Dental Association (ADA) and the American Academy of Pediatric Dentistry (AAPD) regarding routine management for acute dental pain. These guidelines specify non-opioid analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, as first line agents. NSAIDs have been shown to be more effective at reducing pain than opioid analgesics, and combination therapy using NSAIDs and acetaminophen has been associated with more benefit and fewer side effects compared to opioid-containing regimens. If use of opioids for management of acute dental pain is warranted, the Centers for Disease Control and Prevention (CDC) recommends that clinicians prescribe the lowest effective dose of immediate-release opioids and at no greater quantity than needed for the expected duration of pain severe enough to require opioids (three days or less will often be sufficient and more than seven days is rarely ever needed).  For more details on the clinical review, click here.

A Medi-Cal drug safety communication entitled “Stronger Warning Labels for Benzodiazepines” has been published on the DHCS website. Benzodiazepines are widely prescribed for generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder. On September 23, 2020, the FDA announced the Boxed Warning for all benzodiazepines must be updated to adequately warn patients and caregivers about the serious risks of abuse, misuse, and addiction. Taking benzodiazepines with alcohol, prescription opioids, and illicit drugs increases the risk of severe respiratory depression and even death. Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even at recommended dosages. When discontinuing or reducing benzodiazepine dosages, it is important to taper to avoid withdrawal reactions, such as potentially life-threatening seizures.

Changes will also be required for the Medication Guide, as well as the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections of the prescribing information

DHCS has released the 2020 immunization update, summarized below.

• The rate of pediatric vaccination has declined significantly during the COVID-19 pandemic.
• The American Academy of Pediatrics (AAP) and CDC recommend that immunizations be brought up to date as quickly as possible and that, when possible, the clinic physically and temporally separate sick visits from well visits.
• Providers and clinic staff should strengthen parents’ understanding and confidence around vaccination using the CDC’s Strategic Framework.
• Flu vaccination this year is critically important to reduce the impact of respiratory illness in the population and the burden on the healthcare system during COVID-19.
• ACIP recommends routine vaccination of children for Hepatitis A and that adults at risk of infection or severe disease be vaccinated as well.
• ACIP also recommends the use of either Tdap or Td vaccination where previously only Td was recommended.

DHCS has released a clinical review on the standards of care for treatment of type 2 diabetes. The ADA has recently updated their diabetes treatment guidelines. The first line treatment recommendation by the ADA is still metformin, along with lifestyle modifications (i.e. diet, exercise, etc.). Updates to adjunctive recommendations include citing more updated evidence to support the benefit of SGLT2 inhibitors and GLP-1 agonists in patients with cardiovascular disease (CVD), heart failure, and increased risk of developing CVD.

SGLT2i: dapagliflozin, empagliflozin, and canagliflozin
GLP-1RA: semaglutide and dulaglutide

A retrospective cohort study for 2019-2020 evaluating the use of pharmacotherapy in type 2 diabetes in the Medi-Cal population found differences between the Fee for Service (FFS) and Managed Care Plan (MCP) beneficiaries. While the rate of metformin monotherapy prescribing was equivalent between FFS and Medi-Cal, about double of the proportion in the FFS population (10%) vs MCP (5%) used metformin + SGLT2i. Meanwhile, a slightly higher percentage of people used metformin with a GLP-1RA in the MCP population vs the FFS population.

The American College of Rheumatology recently published the organization’s first guideline on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs). Patients with RMDs face unique challenges as pregnancy may be associated with serious maternal or adverse fetal outcomes. This guideline reviews medication use in men and women for preconception, and in women during pregnancy and while breastfeeding. More information including the full guideline is available in this DHCS educational article.

A Medi-Cal Drug Safety Communication entitled “Improving Quality of Care: Update of Risks Associated with Use
of Fluoroquinolones” has been published on the DHCS website. The bulletin reiterates the warning that fluoroquinolones may contribute to the spread of antibiotic-resistant bacteria and may also result in serious side effects. Providers should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infection (UTI), as the risks outweigh the benefits. More information and clinical recommendations are available in the DHCS drug safety communication.

On April 1, 2020, the U.S. Food and Drug Administration (FDA) requested a manufacturer’s market withdrawal of ranitidine. Ranitidine is a histamine-2 blocker commonly used as an over the counter medication to relieve and prevent heartburn. The FDA laboratory testing results showed that levels of a compound called N-nitrosodimethylamine (NDMA) may increase to unacceptable levels over time and when stored at higher than room temperature. NDMA is classified as a carcinogen based on animal studies. All ranitidine products, including the oral liquid/syrup, will be withdrawn by their manufacturers and will not be available on the U.S. market.

Health care professionals should advise patients about other treatment options before stopping ranitidine. To date, the FDA’s testing has not found NDMA in famotidine, cimetidine, esomeprazole, lansoprazole, or omeprazole. In light of COVID-19, the FDA recommends patients and consumers not to take their medicines to a drug take back location, but follow the specific disposal instructions in the medication guide or package insert. The FDA also has recommendations on safe medication disposal at home. More information is available in the DHCS drug safety communication.

On March 4, 2020, the U.S. Food and Drug Administration (FDA) announced it is strengthening existing warnings about serious behavior and mood-related changes with montelukast.  Although the prescribing information contains warnings about the mental health side effects, including suicidal thoughts or actions, many health care professionals are not aware of the risks or alternatives to this medication. The list of mental health side effects associated with use of montelukast are mentioned in the DHCS Drug Safety Communication.  The FDA is now requiring a Boxed Warning be added to the prescribing information that will describe these serious side effects.  This will also include recommendations that montelukast should be used to treat allergic rhinitis only in patients who cannot tolerate or are not being treated effectively with other allergy medications. Health care professionals should consider counseling all patients about these risks and discuss the possible options of other safe and effective allergy medications.  More information is available in the safety announcement on the FDA Website.

A Medi-Cal drug safety communication called “Improving the Quality of Care: Risks Associated with Use of Gabapentin” has been posted on the DHCS website.  This bulletin summarizes the best practices for responsible prescribing of gabapentin and describes the potential risks associated when combining with opioids. On December 19, 2019, the FDA announced that serious, life-threatening, and fatal respiratory depression has been reported with use of gabapentin and pregabalin. Most cases occurred in association with co-administered central nervous system (CNS) depressants, especially opioids, in the setting of underlying respiratory impairment, or in the elderly.

Before prescribing gabapentin with opioids, the potential risks and benefits should be discussed with patients. When prescribing gabapentin concomitantly with opioids, a prescription for Naloxone or another FDA approved drug for the complete or partial reversal of opioid-induced respiratory depression should be offered to patients and/or caregivers.

A Medi-Cal Alert entitled “New Global Guidelines for the Treatment of Asthma” has been published on the DHCS website, communicating on the conclusions of the most recent Global Initiative for Asthma (GINA) report.

The GINA Scientific Committee conducted a comprehensive review of the risks and consequences of starting asthma treatment with short acting β2-agonists (SABAs) alone and evaluated the impact of inhaled corticosteroid (ICS) in mild asthma on exacerbations and death. The Global Strategy for Asthma Management and Prevention report concluded that there is sufficient evidence to recommend that adults and adolescents with asthma should not be treated with SABAs alone.  Instead, they should receive either symptom-driven (in mild asthma) or daily ICS-containing treatment in order to reduce risk of serious exacerbations and asthma related death.

DHCS has released the 2019 immunization update, summarized below.

• Flu vaccines for the 2019-2020 flu season are now available at local pharmacies. The CDC recommends everyone who is 6 months of age and older to receive a flu shot every year. It is recommended that people get vaccinated by the end of October, but vaccination should continue to be offered throughout the entire flu season.
• In light of large outbreaks in California and other states, on October 24, 2018, ACIP recommended routine immunization against the Hepatitis A virus for all persons 1 year of age or older experiencing homelessness.
• ACIP recommends catch-up HPV vaccination for all persons 26 years of age or younger. Adults aged 27 through 45 years may benefit, although public health benefit of HPV vaccination in this age range is minimal; shared clinical decision-making is recommended. For more information, providers may refer to the Morbidity and Mortality Weekly Report on the CDC website.
• The CDC advises implementing the interim guidance in the context of a comprehensive infection prevention program to prevent transmission of all infectious agents among patients, health care personnel, and visitors. For more information, refer to the updated Interim Infection Prevention and Control Recommendations for Measles in Healthcare Settings, which is available on the CDC website.
• New Pre-kindergarten (Childcare) and School Immunization Requirements in California  :
• Two (rather than one) doses of varicella-zoster virus (chickenpox) vaccine are required for entry into transitional kindergarten (TK), kindergarten, or for 7th grade advancement.
• Two doses of measles, mumps, and rubella (MMR) vaccine and three doses of hepatitis B vaccine are required for admission or transfer for most K-12 students.
• Pre-kindergarten children entering childcare facilities are now required to have the varicella-zoster virus chickenpox vaccine at 15 months of age or older, rather than at 18 months of age or older.
• For more information, providers may refer to the New Regulations (July 1, 2019) FAQs on the Shots for School website.

Children 18 years of age or younger are eligible for vaccinations through California Vaccines for Children (VFC) Program. Please contact VFC at 1-877-243-8832 for more information.

Anti-cholinergic medications, including Benztropine and Trihexyphenidyl, are often prescribed to prevent or treat antipsychotic-induced extrapyramidal symptoms (EPS). This bulletin recommends against prophylactic use of anticholinergic medications, and recommends that continued therapy should be re-evaluated in patients with controlled symptoms every three months.  The long term use of concomitant anticholinergics and antipsychotics can result in adverse effects including cognitive impairment and worsening of tardive dyskinesia, especially with persons 65 years of age or older.

A Medi-Cal Drug Safety Communication entitled “Sleep Behavior Risks with Select Sleep Aids” has been published on the DHCS website. This bulletin is focused on the warning released by the FDA on April 30, 2019 requiring safety label changes including a Boxed Warning for eszopiclone, zaleplon, and zolpidem because of the risk of complex sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. The document also includes a summary of previous FDA warnings around insomnia medications.

A Medi-Cal Drug Safety Communication entitled “Risks with Sudden Discontinuation of Opioids” has been published on the DHCS website. The bulletin is focused on the warning released by the FDA on April 9, 2019 that a sudden discontinuation of opioids or a rapid dose decrease can cause serious harm in patients who are physically dependent. The document further includes a list of actions to consider when tapering a patient who is opioid dependent.

The bulletin includes links to resources at the FDA website.

A Medi-Cal Drug Safety Communication entitled “Updated Adverse Effects from Fluoroquinolones” has been published on the DHCS website. The bulletin reiterates the warning that fluoroquinolones may increase the risk of ruptures of an aortic aneurysm or aortic dissection. The FDA has added this warning to the prescribing information for all fluoroquinolones.

Morphine Equivalent Daily Dose
A Medi-Cal Clinical Review Update titled: “Morphine Equivalent Daily Dose” was published on the DHCS website. The bulletin outlines how morphine equivalent daily dose (MEDD) is used to indicate patient risk. It also suggests resources to aid in responsible prescribing, including a mobile MEDD calculator.

Naloxone Regulations – January 2019

Starting January 1, 2019, California prescribers are required by Assembly Bill 2760 to offer a prescription to a patient for naloxone or another FDA approved complete or partial opioid-reversal agent as a rescue when one or more of the following is present:

• The dosage is ≥ 90 Morphine Equivalent Daily Dose
• Opioids and benzodiazepines are prescribed concurrently
• The patient has increased risk of overdose (History of overdose, substance use disorder, or risk for returning to a high dose)

The prescriber is also required to educate the patient and/or guardian on overdose prevention and the use of naloxone.

Vaccines – September 2018

CDC recommends everyone who is 6 months of age and older receive a flu shot every year.

Adults 19 years of age and older can receive many vaccines at their pharmacy covered under SFHP Medi-Cal Outpatient Pharmacy Benefit: influenza, MMR, meningococcal, pneumococcal, varicella, Tdap/Td, Typhoid, Hib, HPV, Hep A & B, and herpes zoster – including SHINGRIX®. Click for a complete list of SFHP covered vaccines.

Children 18 years or younger are eligible for vaccinations through California Vaccines for Children (VFC) Program. Contact VFC at 1-877-243-8832 for more information.

We encourage providers to register and access California Immunization Registry (CAIR), a state wide database of regional registries that consolidate immunization records, in order to see what vaccinations have been administered by participating providers and pharmacies.

CURES– September 2018

It is mandatory to consult the CURES 2.0 database prior to prescribing, ordering, administering, or furnishing a Schedule II-IV controlled substance. This applies to any health care provider with both a DEA Controlled Substance Registration Certificate and California licensure as a:

• Dentist
• Physician
• Naturopathic Doctor
• Optometrist
• Osteopathic Doctor
• Physician Assistant
• Podiatrist
• Registered Certified Nurse Midwife (furnishing)
• Registered Nurse Practitioner (furnishing)

For more information, please visit the CURES website (https://oag.ca.gov/cures).

Additive Toxicity – July 2018

A Medi-Cal Prospective DUR Update titled: “Additive Toxicity Alert Now Focused Only On CNS Depressants” was published on the DHCS website. The bulletin outlines the FDA communication regarding the risk of combined use of opioid medications with benzodiazepines or other drugs that depress the central nervous system. The bulletin further outlines changes to the additive toxicity prospective DUR alert in fee-for-service Medi-Cal.

Fluoroquinolones –July 2018

A Medi-Cal DUR drug safety communication titled: “Adverse Effects from Fluoroquinolone Antibiotics” was published on July 31, 2018. The bulletin outlines the strengthened warnings that the FDA is adding to the prescribing information for fluoroquinolones. The new label changes will include that hypoglycemia, can lead to coma, and another new label will also make the mental health side effects more prominent and consistent across the fluoroquinolone drug class. The full safety announcement is available on the Drug Safety and Availability page of the FDA website. 

Nicotine Replacement Therapy –March 2018

A Medi-Cal DUR educational bulletin titled: “In the Pharmacy: Pharmacists Furnishing Nicotine Replacement Products” was published on March 30, 2018. The bulletin describes strategies to promote smoking cessation, including brief interventions (less than 10 minutes) by health care providers that are shown to be effective. The bulletin summarizes best practices for responsible prescribing of NRT products.

Drug Safety Communication – February 2018

In January 2018, the FDA announced safety labeling changes required for prescription cough and cold medicines containing codeine or hydrocodone. These products are now limited to use in adults 18 years or older; use in children is no longer indicated or recommended. Codeine/guaifenesin 10mg-100mg/5mL oral liquid for cough is available on SFHP formulary; as of 2/15/18, the age minimum was increased from 12 to 18 in accordance with labeling changes. The FDA announcement, including a full list of affected medications, is available at https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm.