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What information is available on the management of potential drug interactions with the COVID-19 vaccine?

Introduction
To date, 3 COVID-19 vaccines have gained emergency use authorization (EUA) for use in the United States.1-3 The Pfizer-BioNTech and the Moderna vaccines were the first 2 vaccines to gain EUA from the Food and Drug Administration (FDA).4 Both the Pfizer-BioNTech and Moderna vaccines utilize messenger RNA (mRNA) technology and require 2 doses administered either 21 or 28 days apart, respectively.1,2 The third vaccine to gain EUA approval was produced by Janssen and Johnson & Johnson. Unlike the first 2 EUA-approved COVID-19 vaccines, the Janssen vaccine is a single-dose, adenovirus-vectored vaccine.3 While all of these COVID-19 vaccines have shown to be efficacious, information on potential drug interactions is lacking. A separate FAQ document has been previously published addressing the potential interactions between COVID-19 vaccines and immunosuppressant agents. This FAQ will address frequently asked questions regarding interactions between non-immunosuppressing medications and COVID-19 vaccines.

Included and excluded medications in trial protocols
Table 1 provides information on medications that were excluded and permitted in the COVID‑19 vaccine trials for Pfizer-BioNTech, Moderna, and Janssen vaccines.5-11 Due to the limited information on drug interactions with the COVID-19 vaccines, excluded medications in COVID-19 vaccine clinical trials provide insight into potential gaps in safety and efficacy data for COVID-19 vaccines when used with certain concomitant medications. However, excluded medications should not be interpreted as contraindications to COVID-19 vaccination.

Table 1. Excluded and relevant permitted medications in COVID-19 vaccine pivotal trials.5-11
Vaccine
Excluded Medications
Relevant Permitted Medications
Pfizer-BioNTech
COVID-19 treatment
 
COVID-19 non-study vaccine
 
Immunosuppressive therapy, blood, plasma, immunoglobulins, and radiotherapy during the study or 60 days before the study
 
Systemic corticosteroid use for <14 days within 28 days before the study
 
Systemic corticosteroid use of ≥20 mg/day of prednisone or equivalent for ≥ 14 days within 28 days before the study to 1 month post first vaccine dose for phase 1 or 7 days post first vaccine dose for phases 2 and 3
 
Inhaled and nebulized corticosteroid use within 28 days before the study to 1 month post first vaccine dose for phase 1 only
 
Influenza vaccine within 14 days before or after the study vaccine
 
Other vaccines within 28 days before or after the study vaccine, unless medically necessary
 
Prophylactic antipyretics and pain medications to prevent symptoms from the study vaccine
Systemic corticosteroids <20 mg/day of prednisone or equivalent or <14 days (had to be discontinued 28 days before the study)
 
Inhaled (phase 2 and 3 only), nebulized (phase 2 and 3 only), intra-articular, intrabursal, and topical (ie, skin and eyes) corticosteroids
 
Antipyretics and pain medications used to treat symptoms from the study vaccine or other conditions
 
Contraceptive hormonal and non-hormonal products including oral, injectable, transdermal, subdermal, intravaginal, and intrauterine
 
HIV ART that has been stable for at least 6 months (phase 3 only)
Moderna
COVID-19 non-study vaccine
 
Participation in interventional study to prevent or treat COVID-19
 
Immunosuppressive therapy for >14 days within 6 months before the study
 
Topical tacrolimus within 14 days before study screening for phase 2 only
 
Systemic corticosteroids ≥10 mg/day for phase 1 and ≥20 mg/day for phases 2 and 3 of prednisone or equivalent for >14 days within 6 months before the study
 
Systemic immunoglobulins or blood product within 3 months before the study (4 months for phase 1)
 
Influenza vaccine within 14 days before or after the study vaccine for phases 2 and 3
 
Other vaccines within 28 days before or after the study vaccine for phases 2 and 3
 
Live vaccines within 4 weeks and inactivated vaccines within 2 weeks before or after the study vaccine for phase 1 only
Corticosteroids <20 mg/day of prednisone or equivalent or <14 days
 
Low dose topical, ophthalmic, inhaled, and intranasal steroid preparation were permitted in phase 1, but not specified for phase 2 or 3
 
Antipyretic or analgesic medications used to prevent or treat fever or pain were recorded
 
Contraceptive hormonal and non-hormonal products including oral, injectable, transdermal, subdermal, and intrauterine  
 
Stable HIV ART (phase 3 only)
 
Janssen
COVID-19 non-study vaccine
 
Investigational drugs (including COVID-19 prophylaxis) within 30 days before the study
 
Investigational immunoglobulins or monoclonal antibodies within 3 months before the study
 
Convalescent serum for COVID-19 within 4 months before the study
 
Investigational vaccine within 6 months before the study
 
Antineoplastics, immunomodulating therapies, or radiotherapy during the study or 6 months before the study
 
Chronic or recurrent use of systemic corticosteroids at a dose of ≥20 mg/day of prednisone or equivalent for ≥2 weeks during the study or 6 months before the study
 
Immunoglobin during the study or 3 months before the study
 
Blood products during the study or 4 months before the study
 
Live attenuated vaccines within 28 days before or after the study vaccine
 
Inactivated vaccines within 14 days before or after the study vaccine
Systemic corticosteroids <20 mg/day of prednisone or equivalent or <2 weeks
 
Ocular, topical, or inhaled steroids
 
Antipyretics for post-vaccination symptom relief as needed
 
Prophylactic antipyretic use was not encouraged, but considered for special circumstances/comorbidities
 
Contraceptive hormonal and non-hormonal products including oral, injectable, transdermal, subdermal, and intrauterine
 
HIV ART that has been stable for 6 months (phases 1b and 2b only)
 
Abbreviations: ART=antiretroviral therapy; COVID-19=Coronavirus Disease 2019; HIV=human immunodeficiency virus

Coadministration with other vaccines
Interim guidance from the Centers for Disease Control and Prevention (CDC) on the use of COVID-19 vaccines previously stated that COVID-19 vaccines should be separated from other vaccines by a minimum of 14 days, out of an abundance of caution.12,13 However, the CDC now recommends that other vaccines can be administered without regard to timing, including at the same time as the COVID-19 vaccine. This shift in recommendations is based on experience with non-COVID-19 vaccines and more substantial safety data for the COVID-19 vaccines.

Analgesics
The CDC recommends avoiding prophylactic doses of analgesics prior to the COVID-19 vaccine due to the unknown impact this may have on vaccine-induced antibody development.12 This concern stems from 2 open-label, randomized control trials conducted in the Czech Republic in 2009 that examined the effect of prophylactic acetaminophen prior to infant vaccinations on febrile reactions and antibody response.14 Infants were randomized to receive either 3 prophylactic doses of acetaminophen every 6 to 8 hours within 24 hours or no prophylaxis after the primary vaccination (trial 1) or boosters (trial 2). The primary outcome of febrile reaction incidence was statistically lower in the prophylactic acetaminophen group with both trials. The secondary outcome was a descriptive assessment of immunogenicity 1 month after primary vaccinations and boosters. The immunogenicity demonstrated higher mean antibody concentrations in infants who had not received prophylactic acetaminophen across the primary and booster vaccinations. However, the rates of achieving the antibody threshold for immunity were similar among the 2 groups. Therefore, a negative clinical impact from prophylactic acetaminophen cannot be concluded in this study.

The effect of antipyretic analgesics on immune response post-vaccination continues to be an area of interest and prompted a review article from Saleh and colleagues in 2016, which concluded that that prophylactic dosing of antipyretic analgesics decreased antibody response, but none demonstrated a clinical impact on post-vaccine immunity.15 Based on this review, the American Society of Pain and Neuroscience (ASPN) suggests that data on the impact of non-steroidal anti-inflammatory drugs (NSAIDs) on immunity and vaccine efficacy  inconclusive and unlikely to impact practice algorithms.16

Antivirals
HIV antivirals
Patients with stable human immunodeficiency virus (HIV) disease were included in the COVID-19 vaccine clinical trials for Pfizer-BioNTech, Moderna, and Janssen.3,5,17 The number of HIV patients included in these trials was 196 for Pfizer-BioNTech (0.5%), 179 for Moderna (0.6%), and 983 for Janssen (2.5%). The definition of stable HIV disease varied slightly among the trials, but all required a low viral load typically achieved through HIV antiviral therapy; therefore, HIV antivirals were allowed in the clinical trials.

The HIV Medicine Association (HIVMA) notes there is no evidence of an interaction between HIV medications and the COVID-19 vaccine, and they do not recommend that patients stop their HIV treatment when they receive the vaccine.18 They note that stopping HIV medications puts patients at a greater risk for HIV-related illnesses.

Other antivirals
Pfizer-BioNTech and Moderna excluded patients with hepatitis B virus (HBV) and hepatitis C virus (HCV) infections in phases 1 and 2 of clinical trials.5-8 In phase 3, Pfizer-BioNTech allowed for patients with inactive HBV or HCV with sustained virologic response to participate in the trial. In phase 3, Moderna allowed patients with pre-existing conditions that had been stable for at least 3 months to participate in the trial but provided no further HBV or HCV information. Janssen excluded patients with active HBV and HCV in phases 1a and 2a of their clinical trial.10,11 In phases 1b and 2b Janssen allowed patients with comorbidities that were well-controlled over the last 12 weeks to participate in the trial but provided no further HBV or HCV information. Guidance from the American Association for the Study of Liver Diseases (AASLD) recommends continuing HBV and HCV antivirals at the time of COVID-19 vaccination.19

Non-systemic corticosteroids
Inhaled corticosteroids
Inhaled corticosteroids were allowed in the COVID-19 vaccine clinical trials for Pfizer-BioNTech and Janssen.5,10,11 The clinical trial for Moderna allowed inhaled corticosteroids in phase 1 but did not specify whether these were permitted in phase 2 or 3.7 Table 1 includes details on corticosteroid formulations and doses that were excluded and permitted across the COVID-19 vaccine trials. The American Academy of Allergy, Asthma, and Immunology (AAAAI) states that there is no data suggesting that inhaled corticosteroids, as well as leukotriene receptor antagonists impact mRNA vaccine efficacy, and medications should not be held for vaccination.20

Local steroid injections
The Spine Intervention Society (SIS) describes corticosteroid use in COVID-19 vaccine trials and provides recommendations on timing of corticosteroid injections relative to the vaccines.21 Both Pfizer-BioNTech and Moderna trials allowed for corticosteroid use that did not exceed 20 mg/day of oral prednisone equivalents for up to 14 days. Individually, Pfizer-BioNTech specified that it allowed localized corticosteroid injections while Moderna did not specify this. A standard corticosteroid injection for pain exceeds 20 mg/day of oral prednisone equivalents, however prednisone equivalents may not be comparable here due to the difference in pharmacokinetics between an oral and injectable corticosteroid. The SIS recommends timing elective corticosteroid injections for pain no less than 2 weeks prior to and 1 week after mRNA COVID-19 vaccines. Specifically, SIS states that if a corticosteroid injection is given following the timeline above, but still in proximity (not defined) to the mRNA COVID-19 vaccine, dexamethasone or betamethasone is the preferred corticosteroid, as they have less immunosuppressive effects when compared to other corticosteroids. For adenovirus vector-based COVID-19 vaccines, SIS recommends timing elective corticosteroid injections 2 weeks before and no less than 2 weeks following vaccination, based on the peak efficacy of the vaccine.22

The American Society of Interventional Pain Physicians (ASIPP) guidance document recommends that corticosteroid injections for pain be timed 2 to 4 weeks prior to the mRNA COVID-19 vaccines.23 Two weeks is appropriate for shorter acting steroids, such as dexamethasone or betamethasone, while 4 weeks is appropriate for long-acting steroids, such as 80 mg or greater of methylprednisolone or triamcinolone. Additionally, ASIPP recommends that corticosteroids injections for pain be timed 2 weeks after the mRNA COVID-19 vaccines. If a patient cannot wait for 2 weeks due to severe pain, it is recommended to use a local anesthetic or lowest possible dose of a short acting steroid. The same recommendation applies for patients who have received 1 dose of the mRNA vaccine, are in severe pain, have no comorbidities, and cannot wait until 2 weeks after the second dose.

The American Academy of Orthopaedic Surgeons recommends avoiding musculoskeletal corticosteroids for 2 weeks before and 1 week after COVID-19 vaccination, without regard to vaccine type.24

The ASPN provides additional commentary on epidural and neuraxial steroid administration.16 They state that there is no evidence that concomitant treatment with COVID-19 vaccination will result in increased adverse outcomes or attenuated immune response. Thus, they recommend that epidural and neuraxial steroid injections do not need to be held or avoided due to COVID-19 vaccination.

Allergen Immunotherapy
The American College of Allergy, Asthma, and Immunology (ACAAI) and American Academy of Otolaryngic Allergy (AAOA) both advise not to receive the COVID-19 vaccine on the same day as an allergy shot due to lack of studies on coadministration.25,26 Additionally, if both agents are administered on the same day it can make it difficult to track reactions. However, expert opinion is unclear on the timeframe of separation between these agents and the COVID-19 vaccine. The AAAAI recommends not administering allergen immunotherapy (AIT), such as an allergy shot, within 48 hours of the mRNA COVID-19 vaccine to avoid confusion about which agent caused a reaction, should one occur.20 However, the AAAAI states that there is no expected drug interaction between AIT and the mRNA COVID-19 vaccine.

COVID-19 treatment with plasma or monoclonal antibodies
The CDC recommends that patients who have received treatment for COVID-19 in the form of plasma or monoclonal antibody (mAb) should wait 90 days before receiving the COVID-19 vaccine.12 There is a concern that these agents could interfere with immune response to the vaccine. Currently, there is no data on COVID-19 vaccine use in patients who have received these agents. Based on the half-lives of plasma and mAbs along with the low reinfection rates within 90 days of an initial infection, deferral of the vaccine appears appropriate. If a patient contracts COVID-19 after receiving the first dose of the vaccine, but before completing the vaccine series and is treated with plasma or a mAb, a 90-day deferral period for the second dose is still recommended.

Antiepileptics
Experts have noted a theoretical concern of an interaction between antiepileptics and COVID‑19 vaccines.27 The COVID-19 vaccines will produce cytokines as part of their immune response which can impact certain cytochrome P450 (CYP) enzymes. Specifically, cytokines like interferon-gamma have been known to decrease CYP 1A2 and CYP 3A4, among other CYP enzymes. Antiepileptic medications that rely on these CYP enzymes for metabolism may have decreased metabolism, resulting in toxic, supratherapeutic levels and adverse events. Example antiepileptics that are metabolized through CYP enzymes include carbamazepine, phenytoin, phenobarbital, ethosuximide, and zonisamide. Although there are no current studies between these antiepileptics and the COVID-19 vaccine, there have been case reports of toxicities with these medications after the influenza vaccine which also produces cytokines that can impact CYP enzymes. Patients who are on these antiepileptics should be monitored for medication toxicities after receiving the COVID-19 vaccine, but use of antiepileptics is not a contraindication to COVID-19 vaccination.

Dermal Fillers
The CDC, American Society of Plastic Surgeons (ASPS), and American Society of Dermatologic Surgery (ASDS) report that infrequently patients who have dermal fillers and receive the mRNA COVID-19 vaccine may experience swelling near the site of the dermal filler.12,28-30 This has only been reported with the mRNA COVID-19 vaccines, and the swelling appears to be temporary and responds to corticosteroid treatment. Patients with dermal fillers should be made aware of this adverse event; however, it should not prevent them from receiving the vaccine.

The ASPS and ASDS provide detail about the patients who experienced these dermal filler reactions.28, 29 The swelling occurred in 3 patients with dermal fillers within 2 days of receiving the Moderna vaccine. The patient ages were 29, 46, and 51 years old, and the time of dermal filler placement prior to the vaccine was unknown, 6 months, and 2 weeks, respectively. Two of the patients had facial swelling, and 1 patient had lip angioedema. All 3 patients had resolution of these adverse events.

Overall, delayed dermal inflammatory reactions are rare and have been noted with both hyaluronic acid and non-hyaluronic acid fillers.29 These reactions can be immunologically triggered by vaccinations, dental procedures, or viral and bacterial diseases. The reactions are temporary and frequently resolve without any intervention; however, if needed, the reactions can be treated with corticosteroids, antihistamines, or hyaluronidase.11,28,29

Summary
High-quality data and information evaluating drug interactions with COVID-19 vaccines are lacking. Several medications may have potential concerns for interacting with the COVID-19 vaccine. With certain drugs, such as injectable local steroids and analgesics, the major concern is blunting the desired immune response to the COVID-19 vaccine. Additionally, the COVID-19 vaccine may impact the efficacy and safety of several medications, such as dermal fillers and antiepileptics. Due to limited information on drug interactions, it is important to reference COVID-19 vaccine clinical trial protocols for excluded and permitted medications to understand how the vaccines were studied. Additionally, many medical organizations have provided guidance for evaluating potential drug interactions with the COVID-19 vaccine, which are summarized in Table 2. As more information becomes available, these recommendations are expected to evolve, and should be referenced frequently.

Table 2. Summary of potential drug interactions between COVID-19 vaccines and non-immunosuppressive medications.1-3,12,16,18-29
Medication
Source of Information
Conclusion
Vaccinations
CDC12


FDA EUA Fact Sheets1-3		Other vaccinations do not need to be separated from COVID-19 vaccines.

No information on the use of COVID-19 vaccines concomitantly with other vaccinations.
Analgesics (acetaminophen, NSAIDs)
CDC12




ASPN16		Acetaminophen or NSAIDs can be used to manage COVID-19 post-vaccination symptoms but should not be used prophylactically.


No guidance to suggest withholding NSAIDs prior to receiving vaccine.
Antiviral medications
HIV antivirals
 HIVMA18There are no interactions between HIV medications and the 3 COVID-19 vaccines. Do not stop HIV therapy for COVID-19 vaccination.
HBV/HCV antivirals
AASLD19Patients receiving antiviral therapy for HBV or HCV should not withhold their medications for COVID-19 vaccination.
Non-systemic corticosteroids
Steroid injections (local; intra-articular, epidural)

SIS21,22







AAOS24


ASIPP23



ASPN16		Elective corticosteroid injections for pain should be timed no less than 2 weeks prior to and 1 week after mRNA COVID-19 vaccines.

Elective corticosteroid injections for pain should be timed no less than 2 weeks prior to and 2 weeks after adenovirus-vector COVID-19 vaccines


Steroid injections for pain should be time 2 weeks before and 1 week after COVID-19 vaccines, regardless of vaccine type.

Steroid injections for pain should be timed 2 to 4 weeks before and 2 weeks after mRNA COVID-19 vaccines.


Epidural steroid injections do not need to be deferred due to COVID-19 vaccination.
Inhaled corticosteroids
AAAAI20There is no evidence that inhaled corticosteroids impact the immunogenicity of mRNA COVID-19 vaccine.
Allergy shots
ACAAI, AAOA25, 26


AAAAI20		Do not receive the COVID-19 vaccine on the same day as your allergy shot.

Allergen immunotherapy should not be given within 48 hours of the mRNA COVID-19 vaccine.
COVID-19 treatment with plasma or monoclonal antibodies
CDC12COVID-19 vaccines should be separated from COVID-19 treatment with plasma or monoclonal antibodies by 90 days following treatment.
Antiepileptics
Letter to the Editor – European Journal of Epilepsy27Theoretical concern that immune response of the COVID-19 vaccine could decrease metabolism of antiepileptics. Monitor for toxicities after vaccination.
Dermal fillers
CDC, ASPS, ASDS, The Aesthetic Society12, 28-30Infrequently patients with dermal fillers who received an mRNA COVID-19 vaccine experienced swelling. History of dermal filler use is not a contraindication to the mRNA COVID-19 vaccine.
Abbreviations: AAAAI=American Academy of Allergy, Asthma, and Immunology; AAOA=American Academy of Otolaryngic Allergy; AAOS=American Academy of Orthopaedic Surgeons; AASLD=American Association for the Study of Liver Diseases; ACAAI=American College of Allergy, Asthma, & Immunology; ASDS=American Society for Dermatologic Surgery; ASIPP=American Society of Interventional Pain Physicians; ASPN=American Society of Pain and Neuroscience; ASPS=American Society of Plastic Surgeons; CDC=Centers for Disease Control and Prevention; COVID-19=Coronavirus Disease 2019; EUA=emergency use authorization; FDA=U.S. Food & Drug Administration; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human immunodeficiency virus; HIVMA= HIV Medicine Association; NSAIDs=non-steroidal anti-inflammatory drugs; SIS=Spinal Intervention Society

References:

  1. Emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). U.S. Food and Drug Administration. Updated June 25, 2021. Accessed July 13, 2021. https://www.fda.gov/media/144413/download
  2. Emergency use authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). U.S. Food and Drug Administration. Updated June 24, 2021. Accessed July 13, 2021. https://www.fda.gov/media/144637/download
  3. Emergency use authorization (EUA) of the Janssen COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). U.S. Food and Drug Administration. Updated July 8, 2021. Accessed July 13, 2021. https://www.fda.gov/media/146304/download
  4. COVID-19 vaccines. U.S. Food and Drug Administration. Updated July 9, 2021. Accessed July 13, 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines#news“
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  9. A phase 2a, randomized, observer-blind, placebo controlled, dose-confirmation study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 COVID-19 vaccine in adults aged 18 years and older. ClinicalTrials.gov. May 28, 2020. Updated May 5, 2021. Accessed July 26, 2021. https://clinicaltrials.gov/ct2/show/NCT04405076
  10. Clinical protocol ENSEMBLE. Johnson & Johnson. December 14, 2020. Accessed July 13, 2021. https://www.jnj.com/coronavirus/ensemble-1-study-protocol
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  12. Interim clinical considerations for the use of COVID-19 vaccines currently authorized in the United States. Centers for Disease Control and Prevention. Updated July 2, 2021. Accessed July 13, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
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  24. AAOS Patient Safety Committee. Timing of musculoskeletal cortisone injections and COVID vaccine administration. American Academy of Orthopaedic Surgeons. March 9, 2021. Accessed July 13, 2021. https://www.aaos.org/about/covid-19-information-for-our-members/guidance-for-elective-surgery/timing-of-musculoskeletal-cortisone-injections-and-covid-vaccine-administration/
  25. Frequently asked patient questions about the COVID-19 vaccine. American College of Allergy, Asthma, and Immunology. May 14, 2021. Accessed July 13, 2021. https://acaai.org/news/frequently-asked-patient-questions-about-covid-19-vaccine
  26. AAOA member resource: COVID-19 vaccine FAQ. American Academy of Otolaryngic Allergy. December 23, 2020. Accessed July 13, 2021. https://www.aaoallergy.org/news-from-aaoa/covid-19-vaccine-faq/
  27. Kow CS, Hasan SS. Potential interactions between COVID-19 vaccines and antiepileptic drugs. Letter. Seizure. 2021;86:80-81. doi: 10.1016/j.seizure.2021.01.021
  28. ASPS guidance concerning FDA reported adverse events in patients with dermal fillers receiving the SARS-CoV-2 mRNA vaccine. American Society of Plastic Surgeons. January 2021. Accessed July 13, 2021. https://www.plasticsurgery.org/for-medical-professionals/covid19-member-resources/covid19-vaccine-dermal-fillers
  29. Avram M, Bertucci V, Cox SE, Jones D, Mariwalla K. American Society for Dermatologic Surgery guidance regarding SARS-CoV-2 mRNA vaccine side effects in dermal filler patients. American Society for Dermatologic Surgery. December 28, 2020. Accessed July 13, 2021. https://www.asds.net/Portals/0/PDF/secure/ASDS-SARS-CoV-2-Vaccine-Guidance.pdf
  30. Lund HG. Facial fillers and COVID-19 vaccine. The Aesthetic Society. Accessed July 13, 2021. https://www.surgery.org/professionals/covid-19/facial-fillers-and-covid-19-vaccine

Prepared by:
Jessica Kulawiak, PharmD (Class of 2021)
University of Illinois at Chicago College of Pharmacy

Reviewed by:
Amanda Gerberich, PharmD, BCPS
Clinical Assistant Professor, Drug Information Specialist
University of Illinois at Chicago College of Pharmacy

August 2021

The information presented is current as July 13, 2021. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making.