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Pharms, GI Docs Collaborate on IBD Biologics Use
By Ted Bosworth
Acollaboration between pharmacists and gastroenterologists to establish a standardized protocol for use of biologics in inflammatory bowel disease (IBD)—guided in part by telemedicine and data-mining electronic health records (EHRs)—has changed routine practice in a multicenter system and improved several quality-of-care benchmarks.
“A pharmacist-gastroenterologist co-management program for use of biologics in IBD patients is superior to a traditional gastroenterologistonly model with regard to laboratory screening prior to treatment and monitoring after drug initiation,” said coinvestigator Jennifer T. Chan, MD, of the Department of Gastroenterology, Kaiser Permanente Medical Center, in San Leandro, Calif.
IBD pharmacists were first introduced at Kaiser Permanente Northern California more than five years ago, and provide support for IBD management to more than 100 gastroenterologists across several affiliated Kaiser Permanente facilities. The concept of specialized pharmacists is not novel, according to Dr. Chan, but has not been applied in the field of IBD or in a nonacademic setting.
Since its inception, 42,000 patients have benefited from the pharmacist-run clinic, according to Karen Tokunaga, PharmD, the interim vice president of Pharmacy Strategy and Operation for Kaiser Permanente Northern California in Sacramento.
“There are four full-time pharmacists and 150 gastroenterologists who are part of the IBD clinic,” Dr. Tokunaga reported. The pharmacists collaborate “to ensure proper lab work is completed, titrate dosing and drive therapeutic drug monitoring,” she said.
“We are proud of this connected team of clinical experts who collaborate seamlessly across departments and specialties to provide the highest quality care to our patients,” she added.
Multisite Collaboration
Relative to other IBD clinics that employ pharmacists, the collaboration at Kaiser Permanente is also unique in its implementation across multiple geographic sites, Dr. Tokunaga noted. Gastroenterologists are encouraged but not required to refer patients to the pharmacy specialists.
When patients are referred, pharmacists screen for tuberculosis and hepatitis B, participate in selecting an agent, and educate patients about biologics, including potential side effects and costs. After the biologic is initiated, pharmacists monitor patients for symptomatic response through testing of C-reactive protein (CRP) and fecal calprotectin (FCP), and oversee therapeutic drug monitoring (TDM) when requested by the gastroenterologist.
“The pharmacists provide follow-up to gastroenterologists through the EMR [electronic medical record] system,” said Abhik Roy, MD, who, along with Fernando Velayos, MD, were collaborators on this study. Both Drs. Roy and Velayos are gastroenterologists working at centers in Kaiser Permanente Northern California. Dr. Roy presented these results at the 2021 annual meeting of the American College of Gastroenterology (abstract 70), in Las Vegas.
The protocol was evaluated by comparing patients who were managed by pharmacy specialists versus those managed in traditional gastroenterologistled care. The end points were screening before biologic therapy and TDM after biologic initiation.
The 2,533 IBD patients included in the analysis initiated biologic therapy from 2016 through 2019. The baseline characteristics, such as age (~43 years), sex (~50% male), race (~65% white) and type of IBD (approximately evenly divided between Crohn’s disease and ulcerative colitis) did not differ significantly between groups. The proportions of patients experienced with steroids or immunomodulators also were similar. Fewer than 7% were smokers.
Screening for hepatitis B (74.0% vs. 62.1%) and tuberculosis (77.1% vs. 65.5%) were both higher among the 938 patients who received collaborative care from a gastroenterologist and a pharmacy specialist relative to those in traditional gastroenterologistled care. After initiating the biologic, the rates of patients undergoing TDM (70.9% vs. 41.7%), CRP evaluation (73.2% vs. 52.2%) and FCP testing (48.9% vs. 15.5%) were higher when a pharmacy specialist was involved.
On multivariate analysis that adjusted for age, sex, ethnicity and Charlson Comorbidity Index, the odds of prebiologic testing were increased nearly twofold (odds ratio [OR], ~1.8), monitoring for CRP was increased more than twofold (OR, 2.51), and TDM (OR, 3.38) and monitoring for FCP (OR, 3.13) were increased by more than threefold in the collaborative care group.
The study was not designed to evaluate symptom follow-up or disease outcomes, which Dr. Roy acknowledged limits this evaluation, but he emphasized that the pharmacist–gastroenterologist collaboration increased the proportion of patients meeting process benchmarks of quality of care.
“Assessing patient response to symptoms, drug monitoring and inflammatory testing after starting biologic therapy may identify important variations and additional opportunities for a protocolized IBD pharmacist–GI partnership,” he said.
The study also shows the feasibility of a pharmacist–gastroenterologist partnership across a large regional system, demonstrating that such an approach “does not require colocation of the pharmacist and the gastroenterologist,” Dr. Roy said.
Strength in Numbers
As a pharmacist experienced in collaborating with gastroenterologists in the management of IBD at Cleveland Clinic, Shubha Bhat, PharmD, can corroborate the advantages identified in the Kaiser Permanente study. “It is not just the knowledge about medication management, including the use of biologics and biosimilars, that puts pharmacists in a suitable position to help manage patients on IBD medicines,” Dr. Bhat said. She explained that pharmacists also can typically follow up with patients more frequently than a clinical gastroenterologist.
“A clinical pharmacist is well equipped to help ensure completion of labs before starting a biologic and with screening and follow-up of patients once treatment is initiated in order to obtain markers of treatment response,” she said.
Dr. Bhat noted that the IBD pharmacist model has been well received at other IBD centers, and praised the Kaiser study for the support it provides to using telemedicine as a means of communication for the clinical team. Such strategies, she noted, allow pharmacists to follow up with patients more frequently than is generally practical for gastroenterologists.
100
Tasks performed, %
75
50
25
0
Collaborative care group Traditional GI care
73.2
52.2
48.9
15.5 70.9
41.7 74.0
62.1
CRP FCP testing Patients Screening for evaluation undergoing TDM hepatitis B
CRP, C-reactive protein; FCP, fecal calprotectin; GI, gastroenterology; TDM, therapeutic drug monitoring
