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Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease ( PHARMACOP): a randomized controlled trial

Eline Tommelein (UGent) , Els Mehuys (UGent) , Thierry Van Hees, Els Adriaens (UGent) , Lucas Van Bortel (UGent) , Thierry Christiaens (UGent) , Inge Van Tongelen (UGent) , Jean Paul Remon (UGent) , Koen Boussery (UGent) and Guy Brusselle (UGent)
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Abstract
AIM: Few well-designed randomized controlled trials (RCT) regarding the impact of community pharmacist interventions on pharmacotherapeutic monitoring of patients with Chronic Obstructive Pulmonary Disease (COPD) have been conducted. We assessed the effectiveness of a pharmaceutical care program for patients with COPD. METHODS: The PHARMACOP-trial is a single-blind 3-month RCT, conducted in 170 community pharmacies in Belgium, enrolling patients prescribed daily COPD medication, aged ≥50 years, and with a smoking history ≥10 pack-years. A computer-generated randomization sequence allocated patients to intervention (n=371), receiving protocol-defined pharmacist care, or control group (n=363), receiving usual pharmacist care (1:1 ratio, stratified by center). Interventions, focusing on inhalation technique and adherence to maintenance therapy, were carried out at start of the trial and at one month follow-up. Primary outcomes were inhalation technique and medication adherence. Secondary outcomes were exacerbation rate, dyspnea, COPD specific and generic health status and smoking behavior. RESULTS: From December 2010 to April 2011, 734 patients were enrolled. 42 patients (5.7%) were lost to follow-up. At the end of the trial, inhalation score (Mean estimated difference [Δ],13.5%; 95% Confidence Interval [CI], 10.8-16.1; P<.0001) and medication adherence (Δ, 8.51%; 95%CI, 4.63-12.4; P<.0001) were significantly higher in the intervention group compared to the control group. In the intervention group, a significantly lower hospitalization rate was observed (9 vs 35; Rate Ratio, 0.28; 95%CI, 0.12-0.64; P=.003). No other significant between-group differences were observed. CONCLUSION: Pragmatic pharmacist care programs improve the pharmacotherapeutic regime in patients with COPD and could reduce hospitalization rates.
Keywords
pharmacist care, exacerbation, inhalation therapy, COPD, adherence, COPD ASSESSMENT TEST, QUALITY-OF-LIFE, MANAGEMENT PROGRAM, COMMUNITY PHARMACY, EXACERBATIONS, METAANALYSIS, TIOTROPIUM, PREVENTION, ADHERENCE, OUTCOMES

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Chicago
Tommelein, Eline, Els Mehuys, Thierry Van Hees, Els Adriaens, Lucas Van Bortel, Thierry Christiaens, Inge Van Tongelen, Jean Paul Remon, Koen Boussery, and Guy Brusselle. 2014. “Effectiveness of Pharmaceutical Care for Patients with Chronic Obstructive Pulmonary Disease ( PHARMACOP): a Randomized Controlled Trial.” British Journal of Clinical Pharmacology 77 (5): 756–766.
APA
Tommelein, E., Mehuys, E., Van Hees, T., Adriaens, E., Van Bortel, L., Christiaens, T., Van Tongelen, I., et al. (2014). Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease ( PHARMACOP): a randomized controlled trial. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 77(5), 756–766.
Vancouver
1.
Tommelein E, Mehuys E, Van Hees T, Adriaens E, Van Bortel L, Christiaens T, et al. Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease ( PHARMACOP): a randomized controlled trial. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY. 2014;77(5):756–66.
MLA
Tommelein, Eline, Els Mehuys, Thierry Van Hees, et al. “Effectiveness of Pharmaceutical Care for Patients with Chronic Obstructive Pulmonary Disease ( PHARMACOP): a Randomized Controlled Trial.” BRITISH JOURNAL OF CLINICAL PHARMACOLOGY 77.5 (2014): 756–766. Print.
@article{4221237,
  abstract     = {AIM: Few well-designed randomized controlled trials (RCT) regarding the impact of community pharmacist interventions on pharmacotherapeutic monitoring of patients with Chronic Obstructive Pulmonary Disease (COPD) have been conducted. We assessed the effectiveness of a pharmaceutical care program for patients with COPD.
METHODS: The PHARMACOP-trial is a single-blind 3-month RCT, conducted in 170 community pharmacies in Belgium, enrolling patients prescribed daily COPD medication, aged \ensuremath{\geq}50 years, and with a smoking history \ensuremath{\geq}10 pack-years. A computer-generated randomization sequence allocated patients to intervention (n=371), receiving protocol-defined pharmacist care, or control group (n=363), receiving usual pharmacist care (1:1 ratio, stratified by center). Interventions, focusing on inhalation technique and adherence to maintenance therapy, were carried out at start of the trial and at one month follow-up. Primary outcomes were inhalation technique and medication adherence. Secondary outcomes were exacerbation rate, dyspnea, COPD specific and generic health status and smoking behavior.
RESULTS: From December 2010 to April 2011, 734 patients were enrolled. 42 patients (5.7\%) were lost to follow-up. At the end of the trial, inhalation score (Mean estimated difference [\ensuremath{\Delta}],13.5\%; 95\% Confidence Interval [CI], 10.8-16.1; P{\textlangle}.0001) and medication adherence (\ensuremath{\Delta}, 8.51\%; 95\%CI, 4.63-12.4; P{\textlangle}.0001) were significantly higher in the intervention group compared to the control group. In the intervention group, a significantly lower hospitalization rate was observed (9 vs 35; Rate Ratio, 0.28; 95\%CI, 0.12-0.64; P=.003). No other significant between-group differences were observed.
CONCLUSION: Pragmatic pharmacist care programs improve the pharmacotherapeutic regime in patients with COPD and could reduce hospitalization rates.},
  author       = {Tommelein, Eline and Mehuys, Els and Van Hees, Thierry and Adriaens, Els and Van Bortel, Lucas and Christiaens, Thierry and Van Tongelen, Inge and Remon, Jean Paul and Boussery, Koen and Brusselle, Guy},
  issn         = {0306-5251},
  journal      = {BRITISH JOURNAL OF CLINICAL PHARMACOLOGY},
  language     = {eng},
  number       = {5},
  pages        = {756--766},
  title        = {Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease ( PHARMACOP): a randomized controlled trial},
  url          = {http://dx.doi.org/10.1111/bcp.12242},
  volume       = {77},
  year         = {2014},
}

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