Jennifer Gershman, PharmD, CPh

Pharmacists can play an important role in educating patients about autoimmune drugs to prevent medication errors.

Autoimmune diseases affect more than 24 million individuals in the United States, and the most common conditions are type 1 diabetes, multiple sclerosis (MS), lupus, inflammatory bowel disease (IBD), and rheumatoid arthritis (RA).

At least 80 known autoimmune diseases exist, and a plethora of therapies can be used to manage symptoms.

 Pharmacists can play a vital part of patient care by educating individuals about their autoimmune therapies to prevent drug-related problems at home. Evidence demonstrates that pharmacists can also decrease medication errors after hospital discharge through transition of care interventions and reduce emergency department visits.

Autoimmune Drug Medication Errors and Counseling Pearls

According to the National Coordinating Council for Medication Error Reporting and Prevention, “a medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.”

 Methotrexate (Rheumatrex) is prescribed for RA and psoriasis, and it is critical to ensure proper dosing and patient education for this medication to prevent adverse events.

Dosing of methotrexate for RA or psoriasis is once weekly as low-dose therapy, but is generally administered daily when used for cancer treatment.

Harmful or fatal errors with low-dose oral methotrexate have been reported to the Institute for Safe Medication Practices (ISMP), with the most common involving accidental daily dosing intended for weekly administration.

 Therefore, ISMP considers methotrexate a high-alert medication in both the hospital and community settings.

Patients should receive both verbal and printed instructions emphasizing the importance of once per week dosing for methotrexate prior to hospital discharge. ISMP’s ConsumerMedSafety.org website includes a free educational handout.

 Pharmacies can also dispense methotrexate as a weekly dose pack to prevent administration errors.

Patients should pick a day of the week that they will be taking methotrexate, and the pharmacy can include this with the instructions.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are often used to reduce pain associated with RA or lupus.

 Educating patients to read the OTC product’s Drug Facts label is extremely important to ensure they are not taking multiple NSAID products, which can lead to an increased risk of gastrointestinal bleeding.

 Corticosteroids are generally used for RA, IBD (short term), and lupus. Patients should avoid abruptly stopping therapy if they have been taking these medications for 3 or more weeks as they need to be tapered slowly to prevent disease flare-ups and adrenal insufficiency.

Levothyroxine (Synthroid) is commonly used to treat hypothyroidism, which can be caused by the autoimmune condition Hashimoto disease. Patients should be counseled to take levothyroxine on an empty stomach 30 to 60 minutes before breakfast for optimal absorption.

 Also, certain medications including calcium, antacids, and iron can bind to levothyroxine and potentially reduce the efficacy, so they should be separated by at least 4 hours.

Growing evidence suggests that hydroxychloroquine is not effective for the coronavirus disease 2019 (COVID-19) and could be harmful.10 However, hydroxychloroquine is FDA approved for the treatment of lupus and RA and has demonstrated efficacy for these conditions. The American Heart Association along with other organizations have emphasized the importance of identifying potential drug interactions that could cause cardiovascular adverse events (eg QTc prolongation, fatal arrhythmias) in patients with COVID-19, especially with the combination of hydroxychloroquine and azithromycin.

 These risks also apply to those using hydroxychloroquine for the FDA-approved indications, and pharmacists should educate patients about these cardiac effects.

Insulins used for type 1 diabetes are considered high-alert medications, and it’s important that patients know their dose to prevent administration errors. The U-500 insulin is concentrated and contains 5 times more insulin per ml than standard insulin.

 Patients should also be cautioned about severe worsening of MS after stopping the medication fingolimod (Gilenya). It is important for patients to consult their pharmacist and physician prior to discontinuing the therapy.

Autoimmune diseases. National Institutes of Health. Updated May 6, 2020. Accessed July 26, 2020. 

niehs.nih.gov/health/topics/conditions/autoimmune/index.cfm

De Oliveira GS, Castro-Alves LJ, Kendall MC, McCarthy R. Effectiveness of pharmacist intervention to reduce medication errors and health-care resources utilization after transitions of care: a meta-analysis of randomized controlled trials. 

. Published online June 30, 2017. doi: 10.1097/PTS.0000000000000283 

About medication errors. National Coordinating Council for Medication Error Reporting and Prevention. Accessed July 30, 2020. 

Grissinger M. Severe harm and death associated with errors and drug interactions involving low-dose methotrexate. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871236/

2020-2021 ISMP targeted medication safety best practices for hospitals. ISMP. Accessed July 30, 2020. 

ismp.org/sites/default/files/attachments/2020-02/2020-2021%20TMSBP-%20FINAL_1.pdf

High-alert medications-methotrexate. ConsumerMedSafety.org. Accessed July 30, 2020. 

consumermedsafety.org/tools-and-resources/medication-safety-tools-and-resources/high-alert-medications/methotrexate-rheumatrex-trexal

Rheumatoid Arthritis Treatment. Johns Hopkins Arthritis Center. Accessed July 31, 2020. 

hopkinsarthritis.org/arthritis-info/rheumatoid-arthritis/ra-treatment/

Chang-Miller A. Prednisone withdrawal: why taper down slowly? June 19, 2020. Accessed July 31, 2020. 

mayoclinic.org/prednisone-withdrawal/expert-answers/faq-20057923

Levothyroxine (oral route). Mayo Clinic. Updated February 1, 2020. Accessed August 1, 2020. 

mayoclinic.org/drugs/levothyroxine-oral/drg-20072133?p=1

Roden DM, Harrington RA, Poppas A, Russo AM. Considerations for drug interactions on QTc in exploratory COVID-19 treatment. 

. 2020;141(24):e906-e907. doi: 10.1161/CIRCULATIONAHA.120.047521 

Humulin R U-500. ConsumerMedSafety.org. Accessed August 1, 2020. 

ismp.org/sites/default/files/attachments/2018-11/u-500-insulinfinal.pdf

FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod). FDA. November 20, 2018. Accessed August 1, 2020. 

fda.gov/drugs/drug-safety-and-availability/fda-warns-about-severe-worsening-multiple-sclerosis-after-stopping-medicine-gilenya-fingolimod

Articles

Prevent Medication Errors in Autoimmune Disease

Pneumonia is a lung infection that can result in mild to severe illness across all ages, and common causes include viruses, bacteria, and fungi. Individuals at high risk of experiencing pneumonia include adults 65 years or older, children younger than 5 years, those with underlying health conditions, and smokers.

 Common causes of viral pneumonia are influenza and respiratory syncytial virus.

 Bacterial pneumonia is commonly caused by Streptococcus pneumoniae (pneumococcus), and it is important for patients to get the pneumococcal vaccine for prevention.

Treatment Recommendations Pharmacists can ensure that patients receive appropriate treatment for community-acquired pneumonia (CAP), which is acquired outside of the hospital setting. The CAP treatment guidelines were recently updated to recommend amoxicillin as a first-line agent unless patients have a penicillin allergy.

 Healthy outpatient adults with CAP who do not have underlying health conditions or risk factors for antibiotic resistant pathogens should receive 1 of the following treatments: amoxicillin 1 g 3 times daily (first line), or doxycycline 100 mg twice daily, or a macrolide (azithromycin 500 mg on the first day then 250 mg daily, or clarithromycin 500 mg twice daily, or clarithromycin extended release 1000 mg daily).

Evidence suggests that pneumococcal resistance (over 30%) can be associated with macrolides so this should be taken into consideration when selecting CAP treatments.

 Pharmacists should also educate patients about cardiac risks associated with azithromycin, including QTc prolongation, and assess for any potential drug interactions.

Patients with CAP and comorbidities should receive broader spectrum treatment in the outpatient setting.

 Combination therapy with amoxicillin/clavulanate or a cephalosporin (cef-podoxime, cefuroxime) and a macrolide (azithromycin, clarithromycin) or doxycycline should be started for initial treatment.

 Reserve fluoroquinolone monotherapy (levofloxacin, moxifloxacin, or gemifloxacin) for patients with drug-resistant CAP or ß-lactam allergies.

 Educate patients about serious adverse effects (AEs) that have been associated with fluoroquinolones, including tendinitis, tendon rupture, hypoglycemia, peripheral neuropathy, and mental health issues.

Individuals hospitalized with CAP will typically need combination therapy with a ß-lactam (ampicillin plus sulbactam, or cefotaxime, ceftriaxone, or ceftaroline) and a macrolide.

 Fluoroquinolone monotherapy (levofloxacin or moxifloxacin) can also be used. Patients with contraindications to macrolides and fluoroquinolones can receive combination therapy with a ß-lactam and doxycycline.

(HAP) and Ventilator-Associated Pneumonia (VAP) Nosocomial pneumonia, or hospital-acquired pneumonia (HAP), may occur during a hospital stay, and patients may experience ventilator-associated pneumonia (VAP) after being on a ventilator.

Melissa Santibañez, PharmD, BCCCP, a critical care pharmacist and an assistant professor in the department of clinical and administrative sciences at Larkin University College of Pharmacy in Miami, Florida, said that patients can present to the intensive care unit (ICU) with pneumonia due to any causative organism, including bacterial, viral, and fungal. Patients admitted to critical care units are also more likely to have complicating comorbidities, baseline immunosuppression, or other risk factors for multidrug-resistant organisms (eg, mechanical ventilation, indwelling venous catheters, parenteral nutrition, renal replacement therapy, or nursing home residence).

“The pharmacists’ role in these cases is essential, as they can ensure that patients receive ventilator pneumonia precaution order sets and that certain medications are being replaced regularly to prevent bacterial colonization (eg, administration lines for propofol and lipids),” said Santibañez. Pharmacists can play an integral role in proper antimicrobial prophylaxis against expected opportunistic infections for immunocompromised patients. “If a patient has been previously infected by a multidrug-resistant organism and/or had recent antimicrobial exposure within the past 90 days, infection prophylaxis and treatment regimens must be modified to ensure that the resistance patterns are being adequately covered and to minimize the likelihood of developing additional resistance,” she said.

Patients with COVID-19 pneumonia and those who are critically ill with non–COVID-19 pneumonias present in a similar fashion, as there is both an infectious part and an acute respiratory failure component to the illnesses. “More information is surfacing to sug- gest that recovery from COVID pneumonia is only the beginning, as ICU survivors of COVID pneumonia may still need to battle residual symptoms and a slowed return to baseline functioning upon their discharge,”said Santibañez.

The FDA issued an Emergency Use Authorization for remdesivir for the treatment of hospitalized patients with COVID-19.

 The National Institutes of Health (NIH) treatment guidelines were recently updated recommending prioritizing limited supplies of remdesivir for hospitalized patients with COVID-19 who require supplemental oxygen but who are not on high-flow oxygen, non- invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), as there is inadequate evidence of clinical benefit for these individuals.

The NIH guidelines were also recently updated to recommend the corticosteroid dexamethasone based on the preliminary results from the Randomized Evaluation of COVID-19 Therapy trial (RECOVERY; NCT04381936).

 Preliminary data from RECOVERY revealed that the mortality rate was lower among patients who were randomized to receive dexamethasone than among those who received standard of care.

 Based on these results, the NIH recommends using dexamethasone 6 mg per day for up to 10 days for the treatment of COVID-19 in patients who are mechanically ventilated and in those individuals who require sup- plemental oxygen but who are not mechanically ventilated.7 Clinicians should not use dexamethasone for the treatment of COVID-19 in patients who do not require supplemental oxygen.

Santibañez noted that dexamethasone access has become challenging because many wholesalers have run out of the drug. Clinicians may use alternative corticosteroids (eg, prednisone, methylprednisolone, or hydrocortisone) if dexamethasone is not available.

Pharmacists should educate patients about the pneumococcal vaccine and administer it to the recommended population (see 

). As individuals with influenza can also develop pneumonia, it is important for pharmacists to encourage patients to get an annual flu vaccine to prevent this complication. Patients can also lower the risk of pneumonia by ensuring that chronic medical conditions are controlled and by quitting smoking.

 Additionally, frequent handwashing with soap and water, wearing a mask, and social distancing are effective ways to prevent COVID-19 and complications including pneumonia.

Causes of pneumonia. CDC. Updated March 9, 2020. Accessed August 7, 2020. 

https://www.cdc.gov/pneumonia/causes.html

Pneumonia can be prevented––vaccines can help. CDC. Updated November 21, 2019. Accessed August 7, 2020. 

https://www.cdc.gov/pneumonia/prevention.html

Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia: an official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. 

. 2019;200(7):e45-e67. doi:10.1164/rccm.201908-1581ST 

FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. FDA. Updated July 10, 2018. Accessed August 8, 2020. 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-reinforces-safety-information-about-serious-low-blood-sugar-levels-and-mental-health-side

Kalil AC, Metersky ML, Klompas M, et al. Management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society. 

. 2016; 63(5):e61-e111. doi:10.1093/cid/ciw353

Remdesivir EUA letter of authorization. FDA. May 1, 2020. Accessed August 9, 2020. 

https://www.fda.gov/media/137564/download

COVID-19 treatment guidelines. NIH. Updated July 30, 2020. Accessed August 9, 2020. 

https://www.covid19treatmentguidelines.nih.gov/whats-new/

Horby P, Lim WS, Emberson JR, et al; RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with COVID-19––preliminary report. 

. Published online July 17, 2020. doi:10.1056/NEJMoa2021436

Pneumococcal vaccination: summary of who and when to vaccinate. CDC. Updated November 21, 2019. Accessed August 9, 2020. 

https://www.cdc.gov/vaccines/vpd/pneumo/hcp/who-when-to-vaccinate.html

Pharmacists can play an important role in pneumonia management and prevention.

Adult Pneumonia Management and Prevention

With influenza season approaching, it is critical to be prepared, because coronavirus disease 2019 (COVID-19) will likely still be circulating throughout the United States. Pharmacists serving on the front lines amid the pandemic also will play an important role in flu vaccine administration and education.

The CDC estimates that from October 1, 2019, to April 4, 2020, there have been 410,000 to 740,000 hospitalizations and 24,000 to 62,000 deaths related to influenza in the United States.

 Influenza vaccine efficacy varies and was 39% effective overall during the 2019-2020 season.

 A total of 185 influenza-associated pediatric deaths were reported to the CDC; generally, approximately 80% occur in those who were not fully vaccinated.

Promoting flu vaccines is critical to easing the influenza hospital burden, especially because COVID-19 will likely coincide with the upcoming season.

 Everyone 6 months and older should receive the current influenza vaccine, which offers the best way to prevent flu and serious complications, including hospitalization and death.

Even though the influenza vaccine does not protect against COVID-19, it can help keep patients healthy and prevent hospitalizations during the pandemic.

Both influenza and COVID-19 are infectious respiratory illnesses, but there are differences between the viruses (

. Flu symptoms typically include fever, cough, body aches, and fatigue, and patients may also experience vomiting and diarrhea.

Influenza Vaccines Available for Upcoming Season

Vaccine options are similar to the 2019-2020 flu season and include standard-dose quadrivalent, quadrivalent cell-based, and recombinant quadrivalent shots (

The live attenuated influenza vaccine nasal spray is also an option.

 For adults 65 years and older, 2 new vaccines are available for the 2020-2021 flu season. These include a quadrivalent high-dose vaccine (Fluzone High-Dose Quadrivalent), replacing the trivalent high-dose vaccine, and a quadrivalent adjuvanted vaccine (Fluad Quadrivalent), which is similar to the previous trivalent, with 1 additional influenza B component.

 Pharmacists should educate patients to get vaccinated before the end of October to ensure optimal protection and remind them that it takes about 2 weeks after administration for the flu vaccine to become fully effective.

Additionally, universal influenza vaccines are being investigated to provide long-lasting protection against most or all flu strains. There are currently 2 universal flu vaccines in the pipeline: FLU-v and M-001 (

Families should be counseled that children 6 months to 8 years of age require 2 doses of the flu vaccine separated by at least 4 weeks if they are receiving it for the first time or previously received just 1 dose.

 Families should ensure that they begin the vaccine process early for their children, especially those being vaccinated for the first time, because full efficacy occurs 2 weeks after administration of the second shot.

The World Health Organization named vaccine hesitancy as one of the 10 threats to global health in 2019.

According to a recent survey, approximately 25.8% of parents are hesitant for their children to receive the influenza vaccine.

 These results further emphasize the important role that pharmacists can play in countering vaccine hesitancy and the antivaccination movement. As schools begin to reopen, it is critical to ensure that children are vaccinated against influenza, because pediatric patients are at a high risk of serious complications.

The CDC’s Advisory Committee on Immunization Practices met June 24, 2020, and recommends any approved influenza vaccine for the upcoming flu season, listing certain conditions as contraindications for the live vaccine FluMist nasal spray and providing 

more information about antiviral drug interactions (

 Individuals at high risk of serious complications from the flu include adults 65 years and older, pregnant women, young children, and individuals with chronic health conditions including asthma, cardiovascular disease, diabetes, HIV/AIDs, and cancer.

 Most of these are also risk factors for severe COVID-19 complications, making flu vaccination especially critical this season. Pregnant women are at a higher risk of complications from influenza because changes in the immune system, heart, and lungs occur during pregnancy.

 One recent CDC study revealed that pregnant women may also be at an increased risk of COVID-19 complications including hospitalization, intensive care unit admission, and mechanical ventilation compared with nonpregnant women.

 Therefore, it is extremely important to get the influenza vaccine during pregnancy for maternal protection and to pass on protective antibodies to the developing baby as the COVID-19 pandemic continues during flu season.

Flu Vaccine Health and Safety Guidance During COVID-19

Pharmacists can serve as vaccine champions and promote a safe immunization administration environment. Experts including Anthony S. Fauci, MD

, director of the National Institute of Allergy and Infectious Diseases, and Robert R. Redfield, MD

, director of the CDC, provided testimony on June 23, 2020, on COVID-19 and the impending flu season.

 One of the hot topics centered on a new laboratory test, developed by the CDC, that checks for 3 viruses simultaneously: influenza viruses A and B and severe acute respiratory syndrome coronavirus 2, which causes COVID-19. This would enhance public health surveillance and provide an important diagnostic tool for detecting and treating coinfection with influenza and COVID-19, and on June 18, 2020, the CDC requested emergency use authorization (EUA).

 On July 2, the FDA issued the EUA for the test on July 2, making it the third diagnostic test for detection and differentiation of viruses causing influenza and COVID-19.

Other discussion points included goals for greater influenza vaccine coverage through education and increasing flu vaccines for uninsured, high-risk adults. The CDC awarded $140 million to 64 jurisdictions to enable state health departments to launch an initial scale-up for influenza season, and the funds will also support staffing and preparedness during summer.

, assistant professor of rheumatology at NYU Langone and NBC News medical contributor, discussed the concern of flu predisposing patients to COVID-19 complications, such as COVID pneumonia. “Thus, rather than having a direct protective effect from vaccination against influenza, getting the flu shot could indirectly protect folks from a bad outcome from COVID-19,” Azar said.

Although there are no vaccines currently available to directly protect against COVID-19, there are several investigational candidates currently going through clinical trials (

Considerations for In-Pharmacy Vaccinations During Pandemic

The CDC recommends that pharmacies and other facilities resume administering routine vaccinations to ensure that communities are protected from vaccine-preventable diseases, and influenza vaccination is emphasized to reduce the overall burden of respiratory illness especially during COVID-19.

 Specific guidance is provided to protect pharmacists, staff, and patients during vaccine administration.

 Pharmacies should implement strategies to screen patients for fever and COVID-19 symptoms prior to providing influenza vaccines, and face masks should be worn by pharmacists, staff, and patients.

 Eye protection should also be considered when administering immunizations.

 Gloves should be worn and changed between patients, and hands should be washed before and after vaccine administration. There should also be a dedicated space ensuring at least 6 feet between patients in line or waiting areas.

Walgreens recently announced that they resumed immunization services ahead of flu season with additional health and safety measures that follow the updated CDC guidelines.

Key measures include requiring all pharmacy team members to wear disposable face masks while administering immunizations. Patients are encouraged to wear a face covering when entering the pharmacy and will be provided with a face mask if they do not have one prior to receiving vaccines. All pharmacy team members administering vaccines will be given plastic face shields for additional protection. At least 6 feet of distance will be maintained between pharmacy areas for completing paperwork and waiting for immunizations.

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Maragakis LL. Coronavirus disease 2019 vs. the flu. Johns Hopkins Medicine. Accessed June 30, 2020. Updated July 20, 2020. 

https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-disease-2019-vs-the-flu

Influenza vaccine for the 2019-2020 season. FDA. Accessed June 28, 2020. Updated December 5, 2019. 

https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2019-2020-season

FDA approves Fluzone High-Dose Quadrivalent (influenza vaccine) for adults 65 years of age and older. News release. Sanofi. November 4, 2019. Accessed June 27, 2020. 

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Fluad Quadrivalent. FDA. Accessed June 27, 2020. Updated July 6, 2020. 

https://www.fda.gov/vaccines-blood-biologics/fluad-quadrivalent

Promising Results in Trial of Universal Flu Vaccine Candidate. News Release. National Institute of Allergy and Infectious Diseases; March 16, 2020. Accessed July 21, 2020. 

https://www.niaid.nih.gov/news-events/promising-results-trial-universal-flu-vaccine-candidate

Pleguezuelos O, James E, Fernandez A, et al. Efficacy of FLU-v, a broad spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study. 

. 2020; 5:22. doi: 10.1038/s41541-020-0174-9. 

NIH Report on Phase 2 Clinical Trial of BiondVax’s M-001 Universal Influenza Vaccine Candidate Concludes Both Primary Endpoints Achieved. News Release. BiondVax Pharmaceuticals Ltd.; June 10, 2020. Accessed July 21, 2020. 

https://www.biondvax.com/2020/06/nih-report-on-phase-2-clinical-trial-of-biondvaxs-m-001-universal-influenza-vaccine-candidate-concludes-both-primary-endpoints-achieved/

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. 2020;146(1):e20193852. doi: 10.1542/peds.2019-3852

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Keep up-to-date on flu vaccine options and counseling considerations, especially as coronavirus disease 2019 continues to strike.

Author | Jennifer Gershman, PharmD, CPh

Articles

Prevent Medication Errors in Autoimmune Disease

Adult Pneumonia Management and Prevention

Brace for Flu Season as COVID-19 Pandemic Persists

Pharmacists Are Key Players in Asthma Management