Abstract
Background
Urinary tract infections (UTIs) often lead to suboptimal antibacterial use. Pharmacists are accessible primary care professionals who have an important role to play in antimicrobial stewardship. Our objective was to evaluate the appropriateness of pharmacists’ antibacterial prescribing for patients with uncomplicated UTI.
Methods
We conducted a prospective registry trial with 39 community pharmacies in New Brunswick, Canada. Adult patients were enrolled if they presented to the pharmacy with either symptoms of UTI with no current antibacterial treatment (pharmacist-initial arm) or an antibacterial prescription for UTI from a physician (physician-initial arm). Pharmacists assessed patients; patients with complicating factors or red flags for systemic illness or pyelonephritis were excluded. Pharmacists prescribed antibacterial therapy or modified antibacterial therapy, provided education only, or referred to a physician, as appropriate. Antibacterial therapy prescribed was compared between study arms.
Results
Seven hundred fifty patients were enrolled (87% pharmacist-initial arm). The most commonly prescribed agents in the pharmacist-initial arm were nitrofurantoin (88.4%), sulfamethoxazole–trimethoprim (TMP–SMX) (7.8%), and fosfomycin (2.1%); in the physician-initial arm, nitrofurantoin (55.3%), TMP–SMX (25.5%), and fluoroquinolones (10.6%) were prescribed. Therapy was guideline concordant for 95.1% of patients in the pharmacist-initial arm and 35.1% of patients in the physician-initial arm (p < 0.001). For guideline-discordant therapy from physicians, pharmacists prescribed to optimize therapy for 45.9% of patients.
Conclusion
Treatment was highly guideline concordant when pharmacist initiated, with physicians prescribing longer treatment durations and more fluoroquinolones. This represents an important opportunity for antimicrobial stewardship interventions by pharmacists in the community.
Keywords: ambulatory, antimicrobial stewardship, guideline concordance, outpatient, pharmacist prescribing, pharmacists, service delivery, urinary tract infection
Résumé
Historique
Les infections urinaires sont souvent associées à une utilisation sous-optimale d’antibactériens. Les pharmaciens sont des professionnels de la santé de première ligne accessibles qui ont un rôle important à jouer dans la gouvernance antimicrobienne. Les chercheurs visaient évaluer la pertinence des prescriptions antimicrobiennes. Ils s’étaient donné comme objectif d’évaluer la pertinence des prescriptions des pharmaciens aux patients atteints d’une infection urinaire sans complication.
Méthodolodie
Les chercheurs ont réalisé une étude de registres prospectifs dans 39 pharmacies communautaires du Nouveau-Brunswick, au Canada. Les patients adultes participaient à l’étude s’ils se présentaient à la pharmacie à cause de symptômes d’infection urinaire non traités par des antibactériens (volet initial – pharmacien) ou s’ils se présentaient avec une prescription d’antibactériens fournie par un médecin (volet initial – médecin). Ils évaluaient les patients, excluaient de l’étude des facteurs de complication ou des signes de maladie systémique ou de pyélonéphrite. Ils prescrivaient un traitement antibactérien, un traitement antibactérien modifié, ne transmettaient que de l’information ou dirigeaient le patient vers un médecin, selon la situation. Les chercheurs ont comparé la thérapie antibactérienne prescrite dans les volets de l’étude.
Résultats
Au total, 750 patients ont été inscrits (87 % dans le volet initial – pharmacien). La nitrofurantoïne (88.4 %), le sulfaméthoxazole-triméthoprime (TMP-SMX) (7.8 %) et la fosfomycine (2.1 %) étaient les traitements les plus prescrits du volet initial – pharmacien, alors que la nitrofurantoïne (55.3 %), le TMP-SMX (25.5 %) et les fluoroquinolones (10.6 %) étaient surtout prescrits dans le volet initial – médecin. Le traitement respectait les lignes directrices dans 95,1 % des cas du volet initial – pharmacien et dans 35,1 % des cas du volet initial – médecin (p < 0,001). En cas de traitement prescrit par des médecins ne respectant pas les lignes directrices, les prescriptions des pharmaciens ont optimisé le traitement chez 45.9 % des patients.
Conclusion
Le traitement concordait fortement avec les lignes directrices lorsqu’il était amorcé par des pharmaciens. Les médecins prescrivaient des traitements plus longs, surtout composés de fluoroquinolones. Il s’agit d’une occasion importante d’interventions en gouvernance antimicrobienne de la part de pharmaciens communautaires.
Mots-clés : ambulatoire, concordance des lignes directrices, gouvernance antimicrobienne, infection urinaire, patients externes, pharmaciens, prescription par des pharmaciens, prestation des services
Introduction
Urinary tract infection (UTI) is a commonly encountered bacterial infection that often leads to treatment with antibacterial agents (1–3). It is also an important driver of inappropriate antimicrobial prescribing, often resulting in direct antimicrobial adverse events and secondary complications, including infection with Clostridioides difficile (3–5). With bacterial resistance on the rise and a limited pipeline of antibacterials with novel mechanisms of action, antimicrobial stewardship has become imperative to maintain the effectiveness of available antimicrobials (6).
Antimicrobial stewardship programs have traditionally been localized to hospitals and other institutions; however, community-based health care professionals also have a very important role to play in antimicrobial stewardship. As much as 50% of antimicrobial prescribing is inappropriate, in both hospital and community settings (7,8). Moreover, up to 93% of antimicrobials in Canada are dispensed in the community setting (9).
Pharmacists feature prominently in hospital-based antimicrobial stewardship programs (10) and could be key health care providers for antimicrobial stewardship initiatives in the community setting. Pharmacists are well positioned to have important roles in the management of various conditions, including UTI. Indeed, in some Canadian provinces, they have the authorization to independently prescribe medications for the treatment of uncomplicated UTI. The Outcomes of Urinary Tract Infection Management by Pharmacists (RxOUTMAP) study previously showed pharmacist management of UTI to be effective (overall sustained clinical cure of 88.9%, with no difference in whether patients saw a pharmacist or physician first), safe, and associated with high levels of patient satisfaction (11). Therefore, our objective was to further evaluate the appropriateness of antibacterial prescribing in the RxOUTMAP study.
Methods
The study design, setting, population, and intervention have all been described in detail elsewhere (11). Briefly, RxOUTMAP was a pragmatic, prospective registry trial that was conducted in 39 community pharmacies across the Canadian province of New Brunswick. Optional education on UTI management was provided to study pharmacists at the beginning of the study, in which about one-third of pharmacists participated. Either patients presented to the pharmacy with symptoms suggestive of UTI without having just received a prescription to treat it from another health care provider (pharmacist-initial arm), or they presented with a new prescription for UTI treatment from another health care provider (physician-initial arm). Pharmacists assessed patients for symptoms of UTI and then prescribed antibacterial therapy or modified antibacterial therapy, provided education only, or referred to a physician, as appropriate. Patients were excluded if they had complicating factors or signs or symptoms suggestive of pyelonephritis or systemic illness. Education was provided to all patients and included instructions to return if symptoms did not improve or worsened after a few days. Pharmacists sent documentation notes to the patients’ most responsible physicians summarizing their assessment, as well as their treatment and monitoring plan. Pharmacists did not order urine cultures, and if one was ordered by another health care provider (ie, for physician-initial arm patients), the results were typically not yet back when the patient presented to the pharmacist. Pharmacists conducted follow-ups with patients at 2 weeks to assess for resolution of symptoms, adherence to therapy, and whether adverse events were experienced. If patients did not achieve sustained clinical resolution, pharmacists reassessed the patients and provided them with either a modified treatment plan or a physician referral, as appropriate. The outcomes for efficacy, safety, and patient satisfaction have previously been reported (11).
Study outcomes
In this study, the main outcome was guideline concordance of the initial antibacterials prescribed by both pharmacists and physicians in the RxOUTMAP trial. Antibacterial therapy was considered guideline concordant when appropriate daily oral dosages of nitrofurantoin (for 5 d), trimethoprim–sulfamethoxazole (TMP–SMX) (3 d), TMP (3 d), fosfomycin (1 dose), or cefuroxime axetil (7 d) were prescribed or if circumstances warranted using a regimen outside of these first-line options. These regimens are consistent with local guidelines that were made available to study pharmacists, as well as with international guidelines (1,12,13). Other outcomes included descriptions of which antibacterials were prescribed and for what duration, as well as prescribing to optimize guideline-discordant therapy from physicians. These outcomes were prespecified before the initiation of the study.
Statistical analyses
Between-arm comparisons used χ2 or Fisher exact tests for categorical variables, as appropriate, and t-test was used for continuous variables. The Wilcoxon–Mann–Whitney test was used when data deviated from normality.
Ethics
The RxOUTMAP study was approved by the Health Research Ethics Boards of the University of Alberta (Pro00072493) and the Horizon Health Network (New Brunswick) (RS 2017-2443), and it was also registered on ClinicalTrials.gov (NCT03184818).
Results
Between June 2017 and April 2018, 750 patients enrolled; 656 were in the pharmacist-initial arm and 94 were in the physician-initial arm. Baseline characteristics of these patients are provided in Table 1. The average age was 40.9 (SD 16.0) years, and all were female. The 2-week follow-up was completed for 686 patients (91.5%). Patients in the physician-initial arm were more likely to have received any antibacterial agent (for any indication) in the 3 months preceding their presentation; however, of those who had recent exposure to an antibacterial, there was no significant difference between study arms in having recently received nitrofurantoin. Only 6.3% of patients overall had recent urine cultures with bacterial growth, and of these the most commonly encountered pathogen was Escherichia coli.
Table 1:
Baseline characteristics
| Characteristic | No. n (%)*
|
p-value† | ||
|---|---|---|---|---|
| Pharmacist-initial arm, n = 656 | Physician-initial arm, n = 94 | Overall, N = 750 | ||
| Age, y, mean (SD) | 40.4 (15.9) | 43.7 (16.1) | 40.9 (16.0) | 0.0692 |
| Biological sex, female | 656 (100) | 94 (100) | 750 (100) | > 0.99 |
| Weight, kg, mean (SD) | 70.0 (17.3) | 78.2 (35.8) | 71.0 (20.7) | 0.0585 |
| Serum creatinine, µmol/l, mean (SD); no. | 68.1 (16.4 ); 68 |
63.0 (7.1 ); 30 |
66.6 (14.4 ); 98 |
0.0345 |
| Dysuria | 556 (84.8) | 76 (80.9) | 632 (84.3) | 0.3308 |
| New or increased urinary frequency | 597 (91.0) | 86 (91.5) | 683 (91.1) | 0.8779 |
| New or increased urinary urgency | 525 (80.0) | 72 (76.6) | 597 (79.6) | 0.4396 |
| Suprapubic pain | 277 (42.2) | 53 (56.4) | 330 (44.0) | 0.0097 |
| Recent urine cultures with bacterial growth, past 3 mo | ||||
| Any bacterial growth | 16 (2.4) | 31 (33.0) | 47 (6.3) | 0.1037 |
| Escherichia coli | 6 | 24 | 30 | |
| Staphylococcus saprophyticus | 0 | 1 | 1 | |
| Enterococcus faecalis | 1 | 1 | 2 | |
| Streptococcus agalactiae | 2 | 2 | 4 | |
| Other | 6 | 3 | 9 | |
| Recent antibacterial exposure (past 3 mo) | 78 (11.9) | 22 (23.4) | 100 (13.3) | 0.0027 |
| Breakdown of recent antibacterial exposure‡ | ||||
| n | 78 | 22 | 100 | |
| Amoxicillin | 16 (20.5) | 5 (22.7) | 21 (21.0) | 0.7753 |
| Amoxicillin–clavulanate | 7 (9.0) | 0 (0.0) | 7 (7.0) | 0.3423 |
| Azithromycin | 6 (7.7) | 0 (0.0) | 6 (6.0) | 0.3340 |
| Cefuroxime axetil | 2 (2.6) | 2 (9.1) | 4 (4.0) | 0.2094 |
| Cephalexin | 11 (14.1) | 1 (4.6) | 12 (12.0) | 0.2926 |
| Ciprofloxacin | 1 (1.3) | 1 (4.6) | 2 (2.0) | 0.3933 |
| Clarithromycin | 3 (3.9) | 1 (4.6) | 4 (4.0) | >0.999 |
| Doxycycline | 4 (5.1) | 3 (13.6) | 7 (7.0) | 0.1773 |
| Erythromycin | 2 (2.6) | 0 (0.0) | 2 (2.0) | >0.999 |
| Moxifloxacin | 1 (1.3) | 1 (4.6) | 2 (2.0) | 0.3933 |
| Nitrofurantoin | 13 (16.7) | 4 (18.2) | 17 (17.0) | >0.999 |
| Norfloxacin | 2 (2.6) | 1 (4.6) | 3 (3.0) | 0.5295 |
| Penicillin V potassium | 5 (6.4) | 0 (0.0) | 5 (5.0) | 0.5832 |
| Sulfamethoxazole–trimethoprim | 9 (11.5) | 5 (22.7) | 14 (14.0) | 0.1838 |
Unless otherwise indicated
p-values for between-arm comparisons
Some patients received more than one agent
Antibacterial therapy was guideline concordant in 624 (95.1%) of pharmacist-initial orders and 33 (35.1%) of physician-initial orders (p < 0.001). The most common initial antibacterial prescribed by both pharmacists and physicians (ie, in the pharmacist-initial and physician-initial arms) was nitrofurantoin (88.4% and 55.3%, respectively) (Figure 1). The next most commonly prescribed antibacterials in the pharmacist-initial arm were TMP–SMX (7.8%) and fosfomycin (2.1%); in the physician-initial arm, they were TMP–SMX (25.5%) and fluoroquinolones (10.6%).
Figure 1:
Initial antibacterial selection: (A) pharmacist-initial (n = 656) and (B) physician-initial (n = 94) arms
TMP–SMX = Trimethoprim–sulfamethoxazole
Mean durations of initial antibacterials ordered are provided in Table 2, and Figure 2 further breaks down the distribution of the duration of therapy for the two most commonly prescribed antibacterials in both arms (nitrofurantoin and TMP–SMX). Nitrofurantoin was prescribed for 5 days in 97% of pharmacist-initial orders (mean 5.1 [SD 0.3] d), whereas 63.5% of physician-initial orders were for more than 5 days (mean 6.7 [SD 1.9] d; p < 0.001). TMP–SMX was prescribed for 3 days in 87% of pharmacist-initial orders (mean 2.9 [SD 0.3] d), whereas 62.5% of physician-initial orders were for more than 3 days (mean 4.8 [SD 1.6] d; p < 0.001). In addition to being inappropriate to use in general, fluoroquinolones tended to be prescribed for longer than 3 days in both arms.
Table 2:
Duration of initial antibacterial prescriptions
| Antibacterial | Days, mean (SD)
|
p-value* | |
|---|---|---|---|
| Pharmacist | Physician | ||
| Nitrofurantoin | 5.1 (0.3) | 6.7 (1.9) | <0.001 |
| TMP–SMX | 2.9 (0.3) | 4.8 (1.6) | <0.001 |
| Cefuroxime | 7.0 (0.0) | 7.0 (0.0) | |
| Ciprofloxacin | 5.3 (4.0) | 5.6 (2.2) | |
| Norfloxacin | 3.5 (1.0) | 7.0 (0.0) | |
p-values absent for antibacterials for which numbers were too small for a meaningful statistical analysis
TMP–SMX = Trimethoprim–sulfamethoxazole
Figure 2:
Duration of antibacterial therapy for (A) nitrofurantoin and (B) trimethoprim–sulfamethoxazole
When antibacterial therapy from physicians was guideline discordant, pharmacists prescribed to optimize therapy for 28 of 61 (45.9%) of these patients. When orders for nitrofurantoin from physicians were suboptimal, in almost all cases in which pharmacists prescribed to optimize these orders, they shortened the duration of nitrofurantoin (Table 3). For other agents, when pharmacists prescribed to optimize, they modified the duration, the agent, or both. There was no significant difference in rates of treatment failure when pharmacists modified physician orders than when they did not modify them (5 of 37 [13.5%] versus 3 of 53 [5.7%]; p = 0.266) (including cases in which pharmacists made modifications to orders that were guideline concordant). In only one case was the documented reason for modification the patient’s allergy history.
Table 3:
Antibacterial modifications by pharmacists to prescriptions by physicians
| Prescribed by physician | No change | Changed to
|
||
|---|---|---|---|---|
| Same agent
|
Different agent | |||
| Shorter duration | Longer duration | |||
| Nitrofurantoin | ||||
| × 3 days | 0 | 0 | 1 | 0 |
| × 5 days | 15 | 0 | 0 | 3 |
| × 7 days | 18 | 9 | 0 | 1 |
| × 10 days | 3 | 2 | 0 | 0 |
| × 14 days | 0 | 1 | 0 | 0 |
| TMP–SMX | ||||
| × 3 days | 5 | 0 | 0 | 4 |
| × 5 days | 6 | 0 | 0 | 3 |
| × 7 days | 1 | 1 | 0 | 4 |
| Ciprofloxacin | ||||
| × 3 days | 1 | 0 | 0 | 1 |
| × 5 days | 0 | 0 | 0 | 4 |
| × 7 days | 1 | 0 | 0 | 1 |
| × 10 days | 0 | 0 | 0 | 1 |
| Norfloxacin × 7 days | 1 | 0 | 0 | 0 |
TMP–SMX = Trimethoprim–sulfamethoxazole
Discussion
This study demonstrates that, in the management of uncomplicated UTI, pharmacists are highly guideline concordant in terms of antibacterial usage. We also demonstrated the potential utility of pharmacists prescribing to optimize guideline-discordant orders from physicians in this setting.
To our knowledge, our study is the first to evaluate guideline concordance in which pharmacists were not restricted in what antibacterial agents they could prescribe in the outpatient setting. A study of 1,063 patients treated for uncomplicated UTI by pharmacists in Scotland found treatment to be appropriate in all cases (14). It should be noted that in Scotland at the time of this study, the only antibacterial that pharmacists were able to initiate for UTI was TMP. In our study, where there was no restriction in antibacterial agents that pharmacists could prescribe, the guideline concordance of antibacterial therapy initiated by pharmacists for UTI was still very high at 95.1%. Our study is also, to our knowledge, the first to evaluate prescribing by community pharmacists as a means to optimize guideline-discordant therapy from physicians. The prescriptions for UTI treatment received from physicians were guideline concordant 35.1% of the time; this was improved to 64.9% guideline concordant as a result of pharmacists prescribing to optimize therapy.
Several clinical and policy implications can be inferred from this study. The role of primary care (community) pharmacists in antimicrobial stewardship programs is not well established, but the limited data that exist tend to place the role of the pharmacist in this setting as providing more passive interventions, such as delivering educational interventions and developing guidelines (15). However, passive interventions overall tend to show mixed results in terms of effectiveness, with concerns that the benefits could diminish over time, and they may be less effective at improving antimicrobial prescribing compared with active interventions (16–18). It is generally accepted that multi-faceted approaches are likely to have a greater effect (19). The ability of pharmacists to prescribe for UTI presents an intriguing opportunity from an antimicrobial stewardship perspective. The results of this study demonstrate a need for antimicrobial stewardship initiatives for community-based primary care or emergency department physicians, in particular regarding the appropriate duration of therapy for uncomplicated UTI; thus, coupling educational interventions with pharmacist prescribing could result in significant improvements in antibacterial prescribing. If pharmacists are more likely to adhere to guidelines when prescribing, then having more patients going to pharmacists for this care should result in an improvement in overall antibacterial prescribing. Moreover, if pharmacists take on a larger role in prescribing to optimize guideline-discordant prescriptions for UTI from physicians, this particular aspect could also have a profound effect on improving overall antibacterial prescribing for this indication.
Some potential limitations of this study should be noted. Pharmacists chose to prescribe for only half of guideline-discordant orders from physicians. It is unclear why pharmacists chose not to prescribe to optimize the other discordant orders and the reasons for this were not explored, but one potential reason may have been that they feared a negative response from the prescribing physician. It is possible that this rate would improve over time as pharmacists become more comfortable with making changes to physician orders when required. Of note, the ‘low-hanging fruit’ of fluoroquinolone use (which has become the target of many antimicrobial stewardship initiatives) by physicians was lower than expected at 10.6%. It is conceivable that if fluoroquinolone use was higher, as it appears to be in other jurisdictions, pharmacists would have intervened more because patient safety would then have been a larger issue (20). Indeed, in Alberta, Canada, the rate of fluoroquinolone use for UTI was estimated to be approximately 29% in 2016 (21), and data from the United States suggests that fluoroquinolone use is more than 40% for this indication (17). The number of patients in the physician-initial arm was relatively small compared with that in the pharmacist-initial arm, and it is unclear whether the rate of fluoroquinolone prescribing in the physician-initial arm would have trended more similarly to that in other jurisdictions if a greater number of patients had been enrolled in that arm. Another potential limitation is that patients in the physician-initial arm were much more likely to have had a recent urine culture, and this was mostly due to their physician ordering these tests for the current episode. The microbiology from these were predominantly E. coli, as expected, and having these results available did not result in a significant increase in clinical cure in the physician-initial arm over the pharmacist-initial arm (11), which provides further support to managing uncomplicated UTI without adjunctive laboratory monitoring. The standardized electronic case report forms positioned nitrofurantoin as the preferred agent in the pharmacist-initial arm (not in the physician-initial arm), and it is possible that this positioning may have influenced the choice of agent for some pharmacists. Although the study was designed to be pragmatic and collect real-world data, it was still a study, and therefore the Hawthorne effect cannot be ruled out. It is possible that guideline adherence for pharmacists could be lower outside of the study setting; however, even if guideline concordance by pharmacists is somewhat lower than what was shown in our study, it would still represent an improvement in antimicrobial prescribing over what is usual care.
Conclusion
Our study demonstrates that antimicrobial prescribing by pharmacists for uncomplicated UTI is highly guideline concordant, with physicians representing usual-care prescribing for longer treatment durations and more fluoroquinolones. This represents an important opportunity for antimicrobial stewardship interventions by pharmacists in the community. The challenge of tackling antimicrobial resistance in the community setting requires buy-in from both physicians and pharmacists, as well as from other prescribers, and all have the potential to have a significant impact. Future studies should evaluate changes in overall antimicrobial utilization and resistance rates over time in jurisdictions in which pharmacists are able to provide these services.
Acknowledgements
The authors acknowledge the pharmacists of the following New Brunswick pharmacies who participated in this study (in descending order of recruitment): Shoppers Drug Mart No. 191 (Saint John), Bowman’s Pharmasave (Fredericton), Shoppers Drug Mart No. 175 (Oromocto), Shoppers Drug Mart No. 193 (Quispamsis), Hampton Pharmasave, Jean Coutu Fredericton, Jean Coutu Saint Stephen, Shoppers Drug Mart No. 599 (Tracadie-Sheila), Familiprix Dieppe, Shoppers Drug Mart No. 195 (Saint John), Shoppers Drug Mart No. 176 (Fredericton), Shoppers Drug Mart No. 2005 (Dieppe), Dickison Pharmasave (Miramichi), Shoppers Drug Mart No. 177 (Grand Falls), Shoppers Drug Mart No. 593 (Moncton), Jean Coutu Dieppe Blvd (Dieppe), Shoppers Drug Mart No. 194 (Saint John), Pharmasave Steeves (Saint John), Shoppers Drug Mart No. 188 (Sussex), Shoppers Drug Mart No. 198 (Woodstock), Jean Coutu Champlain St (Dieppe), Shoppers Drug Mart No. 172 (Fredericton), Jean Coutu Tracadie-Sheila, Pharmasave Bathurst, Scotts Pharmasave (Miramichi), Shoppers Drug Mart No. 165 (Miramichi), Shoppers Drug Mart No. 187 (Miramichi), DRUGStore Pharmacy No. 389 (Sussex), Shoppers Drug Mart No. 594 (Shippagan), The Medicine Shoppe Miramichi, Loblaw Pharmacy No. 341 (Fredericton), The Medicine Shoppe Fredericton Co-op, Guardian Ross Drug Rookwood Ave (Fredericton), Blackville Pharmasave, Doaktown Pharmasave, Jean Coutu Saint-Georges St (Moncton), Pharmasave Elsipogtog, Shoppers Drug Mart No. 185 (Riverview), St. Mary’s Guardian (Fredericton). The authors also acknowledge the support of the Alberta Strategy for Patient Oriented Research Support Unit Consultation and Research Services Platform (www.absporu.ca) and the work of the biostatistical and data management staff at the Epidemiology Coordinating and Research (EPICORE) Centre, University of Alberta (www.epicore.ualberta.ca).
Funding Statement
This study was funded by investigator-initiated grants from the New Brunswick Pharmacists’ Association and the Canadian Foundation for Pharmacy.
Ethics Approval:
The University of Alberta Health Research Ethics Board and Horizon Health Network Research Ethics Board approved this study.
Informed Consent:
Patients provided informed consent to participate in the study.
Registry and the Registration No. of the Study/Trial:
This study was registered at ClinicalTrials.gov on June 14, 201. No. NCT03184818.
Funding:
This study was funded by investigator-initiated grants from the New Brunswick Pharmacists’ Association and the Canadian Foundation for Pharmacy.
Disclosures:
RTT receives personal fees from Shoppers Drug Mart, personal fees from Emergent BioSystems, grants from Merck Canada, and grants from Sanofi, outside the submitted work.
Peer Review:
This manuscript has been peer reviewed.
Animal Studies:
N/A
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