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Understanding the expanding role of pharmacy services in outpatient cystic fibrosis care
Abstract
Cystic fibrosis (CF) patients utilize an average of 10 (±5) medications per day. Given the complexity of the medication regimen, the CF Foundation (CFF) recommends pharmacists as members of the CF care team. The areas of pharmacy services have been identified in the literature. “Limited access pharmacists” are consulted to answer questions, assist in evaluating serum drug concentrations, provide medication education, and monitoring for drug‐drug interactions. Reduction in hospital length of stay has been shown through this collaboration. “Full access pharmacists” provide comprehensive medication therapy management resulting in medication adherence and access improvements, sustainability of treatments, improved provider communication, reduced medication errors and costs, expedited medication refill authorization, increased utilization of respiratory therapists, enhanced discussion of medications with CF team members, and reduction in the number of pharmacies utilized by patients to fill CF medications. An integrated CF pharmacy team are essential members of the multidisciplinary CF care team that have been shown to improvement in CF medication access, increases in body weight and body mass index, reduction in prior authorization submission times, reduction in medication delivery times, expedited medication refill authorizations, increased collaboration with respiratory therapists, augmented discussion of medication with CF team members, and reduction in the number of pharmacies utilized by CF patients. There is a need to further evaluate the impact of outpatient CF pharmacy services due to the improvements in the care on patients and families affected by CF, and as the number of CFF‐accredited care centers integrate CF pharmacy teams throughout the country increases.
This article is protected by copyright. All rights reserved.
... The institution has 8 specialized CF providers and a comprehensive support team consisting of clinical pharmacists, a pharmacy technician, nurses, social workers, a dietician, a psychologist, and respiratory therapists. The health system's integrated health system SP (HSSP) model, similar to the "integrated pharmacy team" described by Zobell et al, 8 encompasses the constant interaction between patients, pharmacy patient advocates (PPAs), ambulatory clinical pharmacists, and the SP. The PPA role is filled by certified pharmacy technicians and is similar to the SP technician role described by Zobell et al. 8 The integrated HSSP model supports patients by determining benefits eligibility, completing prior authorizations (PAs) and appeals for insurance approval, and obtaining financial assistance through assistance programs such as copay assistance cards or grants. ...
... The health system's integrated health system SP (HSSP) model, similar to the "integrated pharmacy team" described by Zobell et al, 8 encompasses the constant interaction between patients, pharmacy patient advocates (PPAs), ambulatory clinical pharmacists, and the SP. The PPA role is filled by certified pharmacy technicians and is similar to the SP technician role described by Zobell et al. 8 The integrated HSSP model supports patients by determining benefits eligibility, completing prior authorizations (PAs) and appeals for insurance approval, and obtaining financial assistance through assistance programs such as copay assistance cards or grants. This model has been shown to improve medication access, adherence, appropriate medication usage, and communication with providers or other health care members within a health system. ...
... This model has been shown to improve medication access, adherence, appropriate medication usage, and communication with providers or other health care members within a health system. [8][9][10][11] HSSP models have shifted the focus to providing efficient and safe patient care rather than on focusing primarily on specialty medication dispensing. 12 Previous studies have shown the benefit of pharmacy services on improving CF medication adherence and patient outcomes [12][13][14][15][16][17] as well as the benefit of an integrated pharmacy team and SP on decreasing the time to insurance approval 18 and the time to the initiation of treatment (turnaround time). ...
BACKGROUND: The approval of elexacaftor-tezacaftor-ivacaftor (ELX/TEZ/IVA) expanded highly effective cystic fibrosis transmembrane receptor modulator therapy to approximately 90% of persons aged 12 years and older with cystic fibrosis. Clinical pharmacists and pharmacy technicians played a key role in planning for ELX/TEZ/IVA initiation prior to US Food and Drug Administration approval as well as initiating therapy after approval. OBJECTIVE: To evaluate the impact of pharmacy services on time to ELX/TEZ/IVA initiation. METHODS: A retrospective chart review evaluated 146 patients aged at least 12 years with cystic fibrosis qualifying for ELX/TEZ/IVA at a single health system between October 21, 2019, and April 1, 2020. RESULTS: Patients filling ELX/TEZ/IVA at an integrated health system specialty pharmacy (HSSP) vs an outside specialty pharmacy (SP) started on therapy an average of 10.8 days sooner (10.8 days ± 14.0 vs 21.6 days ± 18.8, respectively; P = 0.006). More patients filling at an HSSP received ELX/TEZ/IVA within 14 days of the prescription being written compared with outside SPs (82.0% vs 41.4%, respectively; P = 0.001). Before ELX/TEZ/IVA initiation, patients were hospitalized for a cystic fibrosis-related complication for an average of 6.26 days (range = 0-183) compared with 1.16 days (range = 0-91) after ELX/TEZ/IVA initiation. Lastly, an estimated $134,810 was saved in hospitalization dollars in the 105 patients that were able to fill ELX/TEZ/IVA at an HSSP by initiating the drug an average of 10.8 days sooner than outside SPs. CONCLUSIONS: The results of this study demonstrate the value of an integrated HSSP model. The ability to fill specialty medications at an integrated HSSP may optimize medication access, control costs, and improve patient outcomes for patients receiving care within a health system. DISCLOSURES: Dr Loucks has accepted payment for reviewing content of Lexicomp through Wolters Kluwer Consulting and for presenting and attending the American Society of Health System Pharmacists (ASHP) Summer Meeting in June 2022. Dr Loucks is also a Workgroup Chair for the ASHP Pharmacist Section of Specialty Pharmacy Practitioners - Section Advisory Group on Outcomes and Value. Dr Simonsen was a participant in the Vertex Pharmaceuticals Advisory Board in April 2019 and accepted payment for travel and expenses. The remaining authors have no conflicts of interest or financial interests to disclose. This work is in part supported by the Statistical Expertise and Network (StatNet) Award of Cystic Fibrosis Foundation.
... However, because of the single site nature of the study, a relatively small sample size, and limited ability to evaluate risk factors for PMN, there is a continued need for studies to explore rates of PMN in oncology and how different patient care models impact PMN rates. 2 Integration with providers, clinics, and other services within the health system enables HSSPs to often overcome common barriers to access while meeting the needs of manufacturers and payers. [5][6][7][8][9][10][11][12][13][14][15][16][17] HSSPs have also demonstrated the ability to ensure patients can afford high-cost specialty therapies, which may be a particularly pressing concern for cancer treatments as most patients are Medicare beneficiaries that do not qualify for manufacturer assistance. 6,9,12,[18][19][20][21][22] By collaborating with other health system services, such as social workers and financial advisors, HSSPs provide comprehensive care that ensures patients can access, afford, and initiate specialty medications in a timely manner. ...
... The short time to medication access seen in the population of patients that filled medication at an HSSP aligns with previous research demonstrating that HSSP integration leads to fast specialty medication access. 5,[7][8][9][10][11][12][13][14][15][16][17]28 The least common reasons for PMN was unaffordable copay or that the treatment was no longer appropriate. HSSP team members help patients obtain access to the treatment through prior authorizations and/or financial assistance obtained through foundations or manufacturer programs. ...
BACKGROUND: New oral oncology medications bring novel challenges when patients are initiating treatment. Rates of primary medication nonadherence (PMN), the rate at which a medication is prescribed but not obtained, of up to 30% have been reported for oral oncology medications. More research is needed to identify causes and develop strategies for health system specialty pharmacies (HSSPs) to improve cancer treatment initiation rates. OBJECTIVE: To evaluate the rate and reasons for PMN to specialty oral oncology medications in an HSSP setting. METHODS: We performed a multisite retrospective cohort study across 7 HSSP sites. Patients were included if they had an orally self-administered oncology medication referral generated by the health system of the affiliated specialty pharmacy between May 1, 2020, and July 31, 2020. Data collected at each site using pharmacy software and the electronic health record were deidentified and aggregated for analysis. After identifying unfilled referrals within a 60-day fill window, a retrospective chart review was performed to identify final referral outcomes and reasons for unfilled referrals. Referral outcomes were categorized as unknown fill outcomes (because of being referred to another fulfillment method or if received for benefits investigation only), filled by the HSSP, or not filled. The primary outcome was PMN for each PMN-eligible referral and secondary outcomes included reason for PMN and time to fill. The final PMN rate was calculated by dividing the number of unfilled referrals by total referrals with a known fill outcome. RESULTS: Of 3,891 referrals, 947 were PMN eligible, representing patients with a median age of 65 years (interquartile range = 55-73), near equal distribution between male and female (53% vs 47%), and most commonly with Medicare pharmacy coverage (48%). The most referred medication was capecitabine (14%), and the most common diagnosis was prostate cancer (14%). Among PMN-eligible referrals, 346 (37%) had an unknown fill outcome. Of the 601 referrals with known fill outcome, 69 referrals were true instances of PMN, yielding the final PMN rate of 11%. Most referrals were filled by the HSSP (56%). Patient decision was the most common reason for not filling (25%; 17/69 PMN cases). The median time to fill after initial referral was 5 days (interquartile range = 2-10). CONCLUSIONS: HSSPs have a high percentage of patient initiation of new oral oncology medication treatments in a timely manner. More research is needed to understand patient reasons for deciding not to start therapy and to improve patient-centered cancer treatment planning decisions. DISCLOSURES: Dr Crumb was a planning committee member with Horizon CME for the Nashville APPOS 2022 Conference. Dr Patel received funding and support for attending meetings and/or travel from the University of Illinois Chicago College of Pharmacy.
... Multiple studies have shown that involvement of a pharmacist in inpatient and outpatient settings results in improved outcomes for the treatment of infections, decreased length of hospitalizations, decrease in medication errors, and improved safety for PwCF. [63][64][65][66] Given that many medications and supplements are metabolized through the liver, PwCF with elevated liver enzymes, CFHBI, aCFLD, and post-transplant are at risk for complicated drug-drug interactions. Preventative measures, such as avoiding herbal supplements, minimizing or abstaining from alcohol, and obtaining hepatitis A and B vaccinations, should be discussed. ...
Background and Aims Cystic fibrosis (CF) may cause a spectrum of hepatobiliary complications, including portal hypertension, multilobular cirrhosis, and liver failure. Current guidelines on the detection and monitoring of hepatobiliary complications in CF were published in 1999. The CF Foundation assembled a committee to evaluate research advances and formulate revised guidelines for CF-associated liver disease. Approach A committee of hepatologists, gastroenterologists, pulmonologists, pharmacist, nurse, dietitian, individual with CF, and parent of a child with CF devised “population, intervention, comparison, and outcome” (PICO) questions regarding hepatobiliary disease in CF. PubMed literature searches were performed for each PICO question. Recommendations were voted on with 80% agreement required to approve a recommendation. Public comment on initial recommendations was solicited prior to formulation of final recommendations. Results 31 PICO questions were assembled, 6,401 manuscripts were title screened for relevance, with 1,053 manuscripts undergoing detailed full text review. Seven recommendations were approved for screening, 13 for monitoring of existing disease, and 14 for treatment of CF-associated hepatobiliary involvement or advanced liver disease. One recommendation on liver biopsy did not meet the 80% threshold. One recommendation on screening ultrasound was revised and re-voted on. Conclusions Through a multidisciplinary committee and public engagement, we have assembled updated recommendations and guidance on screening, monitoring and treatment of CF-associated hepatobiliary involvement and advanced liver disease. While research gaps remain, we anticipate that these recommendations will lead to improvements in CF outcomes through earlier detection and increased evidence-based approaches to monitoring and treatment.
... The engagement of this healthcare team can have a positive impact on a patient's ability to manage their disease and access and adhere to medications [7][8][9]. For pharmacists in particular, this impact is not always fully understood or solicited, although a 2021 paper found that the integration of pharmacists into a CF healthcare team could reduce hospital length of stays, increase medication adherence and access, reduce medications errors and costs, and improve provider communication [10]. To help patients and providers address the challenges of chronic disease management, the medical industry has focused considerable attention recently on digital health technologies (DHTs), including smartphone apps. ...
Background:
Digital health technologies (DHTs) have shown potential to improve health outcomes through improved medication adherence in different disease states. Cystic fibrosis (CF) requires care coordination across pharmacies, patients, and providers. DHTs can potentially support patients, providers, and pharmacists in diseases like CF, where high medication burden can negatively impact patient quality of life and outcomes.
Methods:
In this prospective cohort study, a CF-specific mobile application (Phlo) was distributed to adults with CF who received care at the University of Utah Cystic Fibrosis Center, used an iPhone, and filled prescriptions through the University of Utah Specialty Pharmacy services. Participants were asked to use Phlo for 90 days with an optional 90-day extension period. Participants completed four surveys at baseline and after 90 days. Changes in patient-reported outcomes, adherence, clinical outcomes, and healthcare resource utilization from baseline to 90 days were tracked.
Results:
Phlo allowed users to track daily regimen activities, contact their care team, receive medication delivery reminders, and share progress with their healthcare team. A web-based dashboard allowed the care team to review reported performance scores from the app. Most patients (67%) said the app improved confidence in and motivation for continuing their regimen. The most important reported benefit of Phlo was having a single location to manage their whole routine.
Conclusions:
Phlo is a mobile health technology designed to help patients with CF manage their treatment regimen and improve patient-provider communication.
... The expanding role of hospital pharmacists embedded within outpatient clinics has been shown to improve patient safety, assist improvement in patient outcomes [16][17][18] and improve education on use of medicines and medication adherence, 19 however, this service requires appropriate resources. ...
Objectives
To evaluate (1) views and perceptions of patients/parents/carers and healthcare professionals on the medicines optimisation (MO) process following virtual outpatient clinic (VOC) during the COVID-19 pandemic and (2) the processes introduced at this time, identifying areas for improvements and suggest potential solutions.
Design
A mixed-methods service evaluation using qualitative and quantitative methods of the MO pathway in children aged 0–18 years following VOC across three specialist children’s units.
Semi-structured interviews were conducted over the telephone with the participants exploring their experiences and categorised into themes.
Process mapping sessions with the multidisciplinary team identified areas for improvement and an ease impact framework developed for potential solutions.
Outcome measures included: (1) themes from interviews, (2) patients satisfaction rates, (3) process maps and (4) development of a simplified future process.
Results
One hundred and twenty-five patients’ families were contacted: 71 families consented to participate and their views were categorised into four main themes: (1) patient experience, (2) communication, (3) need for virtual video consultations for patient education by hospital pharmacists and (4) need for electronic processes to send prescriptions to local pharmacies.
Median patient satisfaction rate was 96% (range 67%–100%). The convenience of receiving medications directly to patient’s homes; access to medicines information helplines and education provided by pharmacists were regarded as valuable. Communication between care providers, development of virtual video consultations by hospital pharmacists and electronic transfer of some prescriptions directly to community pharmacies were identified as areas of improvement.
Conclusions
Participants appreciated the pharmacy processes adopted during the pandemic, however, challenges and recommendations for improvement in delivering MO VOC were identified. As digital innovations evolve within the NHS, future research should focus on integrated care and improved communication between care providers with selected medications prescribed directly to community pharmacies using electronic prescription service, with clinical screening and education provided by hospital pharmacists.
Introduction
People with cystic fibrosis (pwCF) require a multidisciplinary care team due to disease complexity. The Cystic Fibrosis Foundation (CFF) notes that pharmacists are recommended, while other organizations consider pharmacists required. In 2016, the CFF initiated a grant program for CFF‐accredited care centers and affiliate programs (CFF‐ACCAP) to implement outpatient pharmacy services. The primary objective of this study was to compare surveys regarding pharmacy involvement in CFF‐ACCAP pre‐ and post‐grant implementation.
Methods
This was an IRB‐approved, survey‐based study. The surveys were distributed via the CF pharmacist‐pharmacy technician and center director e‐mail exchanges.
Results
There are currently 244 CFF‐ACCAP and 158 pharmacists. Forty‐two pharmacists completed the 2013 survey and 77 completed the 2023 survey. Practice site shifted from primarily the inpatient (58.5%) to outpatient settings (67.5%; p < .001). Most positions were created in the past 7 years (81%) with 50% currently or previously funded by the CFF grant program. CFF center director response decreased from 2013 to 2023 (106 vs. 48) but centers with a dedicated CF pharmacist increased from 2013 to 2023 (66%–86%; p = .014). In the 2023 survey, we received responses from 17 pharmacy technicians, who were newly included. Most of these technicians (64%) reported working in outpatient clinics.
Conclusions
Since 2013, pharmacy presence has grown at CFF‐ACCAP, partly due to the CFF grant program. Despite pharmacists not being required members of the multidisciplinary care team, their presence is notable in 65% of CFF‐ACCAP centers, where they contribute significantly to improving the care provided for pwCF.
Introduction:
Members of an integrated pharmacy team (pharmacists and pharmacy technicians) have roles that have been identified in the literature as part of the multi-disciplinary cystic fibrosis (CF) care team. One role that has not specifically addressed is the administration of routine and recommended immunizations to people with CF (PwCF). According to care guidelines, PwCF of all ages should be provided all age-appropriate and recommended immunizations. Pharmacists and pharmacy technicians can administer immunizations per state laws. The Primary Children's CF Center decided to implement a comprehensive pharmacy-driven immunization care process model to impact immunization rates.
Methods:
A 24-month retrospective analysis was conducted with pediatric (18 years) PwCF at the Primary Children's CF Center. The primary outcome measures were the percentage (%) of PwCF who received PPSV23, and/or HPV, and/or meningococcal conjugate vaccine (MCV) immunizations 1-year post care process model implementation (October 1, 2021 to September 30, 2022) as compared to baseline values. The secondary outcome measures are the total number of immunizations, the number of each immunization provided, and the financial impact of pharmacy-driven immunization care process model 1-year post implementation.
Results:
During the 1-year post care process model implementation (October 1, 2021, to September 30, 2022), a total of 523 immunizations were provided to 243 pediatric PwCF. The most frequent immunizations provided were PPSV23 (160/523, 31%) and Coronavirus Disease 2019 (COVID-19) (154/523, 29%). The baseline percentages of eligible PwCF of PPSV23, HPV, and MCV were 27% (58/217), 43% (32/74), and 24% (8/34), respectively. The 1-year post-implementation percentages of PPSV23, HPV, and MCV were 99% (217/218, p<0.00001), 91% (67/74, p<0.00001), and 97% (33/34, p<0.00001), respectively. For COVID-19 immunizations, 56% of eligible PwCF (181/321) have received their first dose. Of these 181 PwCF, 70% (126/181) have received at least one dose of their primary series or booster during the 1-year post implementation period. The rate of those PwCF who have received at least one dose of a COVID-19 immunization from the age of 6 months-4 years, 5-11 years, and 12-18 years, was 37% (30/82), 60% (78/129), and 66% (73/110), respectively. For the financial impact generated during the 1-year immunization care process model post implementation period, 404 non-VFC immunizations were given for an estimated profit of $11,930.
Conclusions:
The implementation of a pharmacy-driven immunization care process model is a way for integrated pharmacy teams to evolve with the CF center care model and have a role expansion in the care provided to PwCF. This article is protected by copyright. All rights reserved.
Better health and longer survival for many people with cystic fibrosis (PwCF) compels the continued evolution of the CF care model. Designed to deliver specialized care for a complex chronic condition, the model is organized around interdisciplinary healthcare teams at dedicated care centers. Introduction of CFTR modulators and the COVID-19 pandemic have catalyzed the model's evolution. Many PwCF on modulator therapies are experiencing better health and considering changes in their daily care routines. Some of the growing number of adults with CF are experiencing age-associated co-morbidities, requiring coordination with new specialists. The pandemic accelerated the use of telehealth, revealing tradeoffs from new configurations of care delivery. Herein we review the implications of these recent shifts and offer recommendations to improve the quality of care coordinated across the interdisciplinary teams and an expanding field of subspecialists, while supporting the ability of the patient to take on greater responsibility in disease management.
Care for people with cystic fibrosis (PWCF) is highly complex and requires a multi-disciplinary approach where the pharmacist plays a vital role. The purpose of this manuscript is to serve as a guideline for pharmacists and pharmacy technicians who provide care for PWCF by providing background and current recommendations for the use of cystic fibrosis (CF)-specific medications in both the acute and ambulatory care settings. The article explores current literature surrounding the role of pharmacists and pharmacy technicians, proven pharmacy models to emulate and pharmacokinetic idiosyncrasies unique to the CF population while also identifying areas of future research. Clinical recommendations for the use of CF specific medications are broken down by organ system including mechanism of action, adverse events, dosages, and monitoring parameters. The article also includes quick reference tables essential to the acute and chronic medication therapy management of PWCF.
This article is protected by copyright. All rights reserved.
Background:
Cystic fibrosis (CF) patients who grow Pseudomonas aeruginosa on respiratory culture are commonly prescribed inhaled tobramycin (TIS) to eradicate the organism. The objective of this study was to determine the impact of a pharmacy technician/pharmacist team, in conjunction with an integrated health-system specialty pharmacy (IHSSP), on the time from positive culture to prescribing and access to TIS in a pediatric CF clinic.
Methods:
A retrospective study of CF patients positive for P. aeruginosa who were prescribed TIS for eradication.
Results:
The study included 20 patients in the pre-group and 42 patients in the post-group. Total median (IQR) days from positive culture to TIS being shipped to the patient from the pharmacy was significantly different: 15 (10.25-21) days in the pre-group and 9 (7-14) days in the post groups (p=0.005). The time from positive culture to TIS prescribing was significantly different: 6 (5-12.75) days in the pre-group and 5 (3.75-6) days in the post-group (p=0.01). In the post-group median time from prescription to the patient receiving the TIS was significantly different between the two groups 2 (2-5) days IHSSP group versus 6 (3-9) external specialty pharmacy group (p=0.003)). Time from prescription to prior authorization approval was the same in both groups.
Conclusions:
The addition of the pharmacy team reduced time from culture to TIS being received by the patient. Patients able to fill at the IHSSP received their medication sooner than an external specialty pharmacy. The study shows the benefit of an integrated pharmacy model in conjunction with an IHSSP. This article is protected by copyright. All rights reserved.
Cystic fibrosis (CF) is one of the most common life-threatening, genetic conditions. People with CF follow complex, time-consuming treatment regimens to manage their chronic condition. Due to the complexity of the disease, multidisciplinary care from CF Foundation (CFF)-accredited centers is recommended for people with CF. These centers include several types of healthcare professionals specializing in CF; however, pharmacists are not required members. The purpose of this study was to identify the outpatient care needs of people living with CF that pharmacists could address to improve their quality of care. Healthcare members from a CFF accredited center and pharmacists were recruited to participate in semi-structured, audio-recorded interviews. Prevalent codes were identified and data analysis was conducted, guided by the systems engineering initiative for patient safety (SEIPS) model. The objective was to understand the medication and pharmacy-related needs of patients with CF and care team perspectives on pharmacists providing support for these patients. From the themes that emerged, pharmacists can provide support for people living with CF (medication burden, medication access, medication education) and the CF care team (drug monitoring and adherence, prior authorizations and insurance coverage, refill history). Pharmacists are well-positioned to address these difficulties to improve quality of care for people living with cystic fibrosis.
Objective:
To compare medication adherence, pulmonary exacerbations, healthcare utilization, and costs for patients with cystic fibrosis (CF) who utilized a pharmacy-based therapy management program to a matched control group. We hypothesized that patient management services would be associated with better medication adherence, and thus require fewer visits to the emergency room or hospitalizations.
Methods:
This retrospective, observational cohort study used claims data from the MORE2claims Registry®. The sample consisted of CF patients, aged 6+, who had ≥1 pharmacy claim for inhaled tobramycin, inhaled aztreonam, ivacaftor, or dornase alfa from 6/2/2014-5/31/2015. Adherence was measured as proportion of days covered (PDC). Propensity score matching and multivariable regression techniques were used to compare outcomes in program participants to matched controls.
Results:
Of the 236 intervention and 724 control patients meeting selection criteria, 202 were propensity-matched from each cohort. Relative to the control cohort, program patients had 23% higher mean PDC for tobramycin (IRR = 1.23, P = 0.01) and were twice as likely to be adherent to tobramycin (PDC ≥ 80%) than matched controls (OR = 2.14, P = 0.04). Program patients had fewer ER visits (IRR = 0.52, P < 0.01) and slightly lower ER costs (IRR = 0.66, P = 0.06) than the control patients.
Conclusion:
A pharmacy-based therapy management program for CF patients was associated with higher adherence to inhaled tobramycin and lower ER rates. Pharmacies that provide therapy management can support effective CF care management.
Objective
To describe the critical need for pharmacists’ involvement in outpatient care for people living with cystic fibrosis (CF).
Data Sources
Not applicable.
Summary
CF is a pulmonary condition that affects more than 30,000 children and adults in the United States and 70,000 people worldwide. Various complex medication regimens are given to patients with CF, some depending on the type of mutation they have in their cystic fibrosis transmembrane conductance regulator (CFTR) protein. With such complex medication regimens and the increased number and variety of treatments that have become available, the medication use burden intensifies for individuals living with CF and their caregivers. Young people living with CF have a particularly difficult time adhering to medications and other therapies as they begin to rely less on their caregivers and assume greater medication management responsibility for their care. Adolescents in particular report low adherence rates from about 40% to 47% for airway clearance methods and even lower for nutritional recommendations at approximately 16% to 20%. In inpatient settings, pharmacists have been successful in making medication use recommendations that have improved adherence for patients with CF while in the hospital. However, limited research has explored how provision of pharmacist supportive care and patient education in outpatient settings can improve medication adherence and quality of life for people living with CF.
Conclusion
There is potential for provision of outpatient pharmacy clinical services to increase medication adherence and overall quality of care for patients with CF. Higher rates of medication adherence in patients with CF could in turn improve patient outcomes and reduce overall healthcare costs as a result of fewer re-hospitalizations. Pharmacies can implement programs designed to provide comprehensive support services and medication management from pharmacists and staff that are trained in CF care.
Objectives:
The purpose of this study is to characterize the impact of pharmacy services on medication adherence and hospitalizations for pediatric cystic fibrosis (CF) patients.
Methods:
A retrospective health insurance claims analysis and patient medical charts review from January 1, 2014 to December 31, 2016 of patients from the Pediatric Intermountain CF Center was performed. Adherence to dornase alfa and hospital admissions for pulmonary exacerbations pre and post the implementation of an integrated pharmacy team were reviewed. Dornase alfa adherence was measured by the medication possession ratio (MPR) both monthly and yearly.
Results:
Fifty-four patients met inclusion criteria. The mean dornase alfa yearly MPR improved from 0.75 (2014) to 0.92 (2016). Patients were 2.8 times more likely to be adherent to dornase alfa when followed by integrated pharmacy team model (P < 0.001), and 2.4 times more likely to be adherent when followed by a dedicated CF clinic pharmacist only (P = 0.001).
Conclusion:
The study demonstrated that pharmacy services improved adherence to dornase alfa.
Poor treatment adherence is common in cystic fibrosis (CF) and may lead to worse health outcomes and greater healthcare utilization. This study evaluated associations between adherence to pulmonary medications, age, healthcare utilization and cost among CF patients.
CF patients aged ≥6 years were identified in a national commercial claims database. A 12-month medication possession ratio (MPR) was computed for each pulmonary medication and then averaged into a composite MPR (CMPR) for each patient. The CMPR was categorized as low (<0.50), moderate (0.50-0.80) or high (≥0.80). Annual healthcare utilization and costs were measured during the first and second year, and compared across adherence categories using multivariable modeling.
Mean CMPR for the sample (N=3,287) was 48%±31%. Age was inversely related to CMPR. In the concurrent year, more CF-related hospitalizations were observed among patients with low (event rate ratio [ERR] (95% confidence interval [CI]): 1.35 (1.15-1.57)) and moderate (ERR (95% CI): 1.25 (1.05-1.48)) versus high adherence; similar associations were observed for all-cause hospitalizations and CF-related and all-cause acute care use (hospitalizations + emergency room) in the concurrent and subsequent year. Rates of CF-related and all-cause outpatient visits did not differ by adherence. Low and moderate adherence predicted higher concurrent healthcare utilization costs by 8,493 (-1,691; 19,709), respectively, compared to high adherence.
Worse adherence to pulmonary medications was associated with higher acute care utilization in a national, privately insured cohort of CF patients. Addressing adherence may reduce avoidable healthcare use.
Rationale:
Cystic fibrosis (CF) is an autosomal recessive disease characterized by abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction. The use of medications to slow the progression of lung disease has led to significant improvement in survival. An evidence review of chronic medications for CF lung disease was performed in 2007 to provide guidance to clinicians in evaluating and selecting appropriate treatment for individuals with this disease. We have undertaken a new review of the literature to update the recommendations, including consideration of new medications and additional evidence on previously reviewed therapies. A multidisciplinary committee of experts in CF pulmonary care was established to review the evidence for use of chronic medications for CF lung disease and make treatment recommendations. Published evidence for chronic lung therapies was systematically reviewed and resulting treatment recommendations were graded based on the United States Preventive Services Task Force scheme. These guidelines provide up-to-date evidence of safety and efficacy of chronic treatments of CF lung disease, including the use of novel therapies that have not previously been included in CF pulmonary guidelines.
Cystic fibrosis is a recessive genetic disease characterized by dehydration of the airway surface liquid and impaired mucociliary clearance. As a result, individuals with the disease have difficulty clearing pathogens from the lung and experience chronic pulmonary infections and inflammation. Death is usually a result of respiratory failure. Newly introduced therapies and aggressive management of the lung disease have resulted in great improvements in length and quality of life, with the result that the median expected survival age has reached 36 years. However, as the number of treatments expands, the medical regimen becomes increasingly burdensome in time, money, and health resources. Hence, it is important that treatments should be recommended on the basis of available evidence of efficacy and safety.
The Cystic Fibrosis Foundation therefore established a committee to examine the clinical evidence for each therapy and to provide guidance for the prescription of these therapies.
The committee members developed and refined a series of questions related to drug therapies used in the maintenance of pulmonary function. We addressed the questions in one of three ways, based on available evidence: (1) commissioned systematic review, (2) modified systematic review, or (3) summary of existing Cochrane reviews.
It is hoped that the guidelines provided in this article will facilitate the appropriate application of these treatments to improve and extend the lives of all individuals with cystic fibrosis.
Background:
Cystic Fibrosis (CF) is a genetic disease requiring patients to take multiple medications per day. Multiple barriers exist affecting access and adherence. Studies have demonstrated the positive outcomes of pharmacist involvement in CF care. The purpose of this study is to characterize the impact of pharmacy technicians on medication access in the care of CF patients.
Methods:
A retrospective review and analysis of patient medication profiles for patients followed by the integrated pharmacy care process model was performed. Two electronic prescription pathways with pharmacy technician involvement were analyzed. One pathway using a specialty pharmacy CF pharmacy technician (SP technician) examined CF specialty medication delivery times. The other pathway examined the impact of the clinic-based CF pharmacy technician (CB technician) on the number of filling pharmacies for patients.
Results:
One-hundred and fifty-three patients met inclusion criteria in the CF specialty medication delivery analysis, and 56 patients met inclusion criteria filling pharmacy analysis. The median delivery time for dornase alfa decreased from 8 days to 3 days, p<0.00001. The number of patients utilizing 1 filling pharmacy increased from 8 (14%) to 21 (38%), (p=0.005); and utilizing 3 filling pharmacies decreased from 14 (25%) to 1 (2%), (p=0.003).
Conclusion:
The study demonstrated that pharmacy technicians as part of an integrated health-system pharmacy care process model improve medication access in the care of CF patients. This article is protected by copyright. All rights reserved.
Background:
This study was undertaken to determine if the presence of a clinical pharmacy team impacted patients' access to cystic fibrosis transmembrane conductance regulator (CFTR) modulators.
Methods:
A retrospective chart review of electronic medical records from the University of Iowa Hospitals and Clinics (UIHC) was conducted. Data were collected regarding the timing of prior authorization (PA) submissions and approvals from 2012 to 2018. The Wilcoxon rank-sum test was used to compare the meantime (days) between prescription and PA submission dates, and PA submission and approval date for all patients included in the analysis. Comparisons were made for pre- and postpharmacy services eras as well as the UIHC Specialty Pharmacy versus a non-UIHC Specialty Pharmacy.
Results:
Sixty-three patients were included in the final analysis. The average time between prescription date and PA submission was 12.5 days (standard deviation [SD] = 17.4 days) in the preclinical pharmacy services era and 3.5 days (SD = 5.8 days; P = .028) in the postclinical pharmacy services era. The average time to PA submission significantly decreased from 9.8 days (SD = 13.1 days) to 1.3 days (SD = 4.2 days; P < .0001) when prescriptions were filled by the UIHC Specialty Pharmacy vs a non-UIHC Specialty Pharmacy.
Conclusions:
There was a significant benefit to CFTR modulator prescribing when clinical pharmacy services were incorporated in our cystic fibrosis (CF) care team, which will become increasingly important with the anticipation of new CF medications in the near future.
Cystic fibrosis (CF) is a complex genetic, multiorgan disease. The CF Foundation (CFF) recommends a multidisciplinary team (physician, nurse, respiratory therapist, dietitian, physical therapist, social worker, mental health coordinator, clinic coordinator, and pharmacist) to work with patients and families. The objective of our study was to describe the impact of a pharmacist involved in the care of patients and families from their perspective. The CF Patient and Family Experience of Care (PFEC) is a voluntary, 50‐question telephonic or internet‐based survey designed to continuously collect information from patients and their families regarding their care experience. From August of 2017 through February of 2018, five questions were added to the internet survey to assess the impact of the pharmacist on the care experience. From the 666 respondents, 54% reported that a pharmacist was involved in their CF care. At two CF clinics designated as “full access” to a pharmacist, respondents reported a higher percentage of the CF–team discussed medications compared to those from three clinics designated as “limited access” to the pharmacist (95% vs 67%). Respondents in clinics with “full access” to a pharmacist were significantly more likely to get their medications refilled on time (78% vs 63%) and reported using fewer pharmacies to fill their medications. Pharmacist involvement in CF care may improve patient's access to medication and the ability to sustain use.
Objective:
The purpose of this study was to develop a cystic fibrosis (CF)-specific patient and family experience of care survey that CF care centers could use to inform quality improvement efforts.
Methods:
A literature search and query of CF care centers was conducted to identify existing surveys. Individuals with CF, their families, and health care professionals were also asked what to include. Following this process, a draft survey was developed and then reviewed by focus groups. Finally, a version was piloted at 25 CF care centers to validate and further refine the instrument.
Results:
No CF-specific surveys were found in the literature. Focus group participants stated that they understood the survey questions and that they covered important aspects of care, particularly infection control. The pilot test of the instrument with 485 participants supported its validity by demonstrating significant differences across centers and that most of the 3 care dimensions had acceptable internal consistency (Cronbach α: adults, 0.71-0.85; children, 0.68-0.79).
Conclusion:
A CF-specific patient and family experience of care survey was developed with input from individuals with CF, their families, and health care professionals. The instrument was validated and has been deployed to CF care centers.
Background
Cystic fibrosis (CF) patients are often treated with aminoglycoside (AG) antibiotics during infective pulmonary exacerbations. Achieving pharmacokinetic and pharmacodynamic (PK/PD) targets to improve outcomes and counteract resistance is paramount. PurposeThe primary objective was to compare the number of pediatric CF patients achieving AG PK/PD targets when a clinical pharmacist (CP) managed therapeutic drug monitoring (TDM) compared with usual care (UC). MethodsA retrospective cohort study was conducted on the records of 40 CF patients that received AGs and 2 serum samples between 1/2007 and 5/2009. Chi-square and Student's t-test were used to analyze nominal and continuous variables, respectively. ResultsTwenty-nine patients with 52 courses of AGs were included the CP group, and 22 patients with 42 courses were included the UC group. Ninety-eight percent of patients in the CP group reached AG PK/PD targets compared with 71% in the UC group, P<0.001. Patients in the CP group reached the AG PK/PD target in a mean of 1.90.8 days compared with 4.8 +/- 3.4 days in the UC group, P<0.0001. The average LOS in the CP group was 9 +/- 5 days compared with 12 +/- 7.5 days in the UC group, P=0.033. The mean number of levels per patient was 2.7 in the CP group compared with 5.2 (range of 2-20) in the UC group, P<0.001. Resource utilization associated with drug levels, dosing adjustments and LOS were 26,549, 14,069, and 40,683, 1,940,000, respectively, in the UC group. ConclusionCP managed TDM resulted in a significantly higher percentage of pediatric CF patients achieving AG PK/PD targets 3 days sooner with an average LOS that was 3 days shorter. CP managed TDM resulted in significantly fewer dosage adjustments, drug levels, and cost associated with serum sampling, drug wastage, and LOS. Pediatr Pulmonol. 2013; 48:1190-1194. (c) 2012 Wiley Periodicals, Inc.
Cystic fibrosis is the most common life-shortening autosomal recessive disorder in the white population, affecting approximately 30,000 persons in the United States.1 It is caused by mutations in a single gene on the long arm of chromosome 7 that encodes the cystic fibrosis transmembrane conductance regulator (CFTR) (Figure 1).2 CFTR has multiple functions involving fluid balance across epithelial cells. It acts as a chloride channel activated by cyclic adenosine monophosphate (cAMP)3 and may stimulate other chloride channels4 and inhibit sodium absorption by epithelial sodium channels.5 Mutations in the CFTR gene result in defective chloride transport in the epithelial cells in . . .
A program in which pharmacists help care for cystic fibrosis patients is described.
The Egleston Cystic Fibrosis Center at Emory University houses outpatient clinic facilities and a 10-bed inpatient unit and is affiliated with Egleston Children's Hospital. The center provides full-service care for nearly 500 patients. Patients with mild to moderate exacerbations of pulmonary problems can receive their entire course of therapy at the center, and those with severe illness may complete their hospital stay there. A care team consisting of pharmacists, physicians, nurses, and others provides preventive and acute care. Patients can choose a "care partner" who will assist them with their care during any hospitalizations and at home. Both patient and care partner are taught drug administration, nutrition, and physical therapy and meet regularly with the care team. Patients must receive their medication education from a pharmacist before they can administer their own drugs. Pharmacists at the center also evaluate serum drug concentrations, stock the automated dispensing device, monitor for drug interactions, answer drug information questions, and attend multidisciplinary rounds. Pharmacy residents can work with the care team through rotations and clinic experience.
Pharmacists at a cystic fibrosis center provide clinical services to patients and promote self-care.
This comprehensive State of the Art review summarizes the current published knowledge base regarding the pathophysiology and microbiology of pulmonary disease in cystic fibrosis (CF). The molecular basis of CF lung disease including the impact of defective cystic fibrosis transmembrane regulator (CFTR) protein function on airway physiology, mucociliary clearance, and establishment of Pseudomonas aeruginosa infection is described. An extensive review of the microbiology of CF lung disease with particular reference to infection with P. aeruginosa is provided. Other pathogens commonly associated with CF lung disease including Staphylococcal aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans and atypical mycobacteria are also described. Clinical presentation and assessment of CF lung disease including diagnostic microbiology and other measures of pulmonary health are reviewed. Current recommendations for management of CF lung disease are provided. An extensive review of antipseudomonal therapies in the settings of treatment for early P. aeruginosa infection, maintenance for patients with chronic P. aeruginosa infection, and treatment of exacerbation in pulmonary symptoms, as well as antibiotic therapies for other CF respiratory pathogens, are included. In addition, the article discusses infection control policies, therapies to optimize airway clearance and reduce inflammation, and potential future therapies.
Effect of a total care specialty pharmacy model on cystic fibrosis clinical outcomes
- Autry E
Identifying and overcoming barriers to adherence at an adult cystic fibrosis center by the addition of a pharmacist
- Anstead M
Pathophysiology and management of pulmonary infections in cystic fibrosis
- RL Gibson
- JL Burns
- BW Ramsey
The pharmacist's role in supporting people living with cystic fibrosis
- O Abraham
- JS Li
- KE Monangai
- AM Feathers
- D. Weiner
Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health
- PJ Mogayzel
- ET Naureckas
- KA Robinson
A survey of the pharmacist's role at US CFF‐accredited centers‐a director's perspective
- ZN Bhakta
- ZJ YD
- RJ Kuhn
- K Sabadosa
- M Chin
- BC Marshall
Effect of a total care specialty pharmacy model on cystic fibrosis clinical outcomes
- E Autry
- A Ferrante
- PL Ramsey
- RJ Kuhn