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Effectiveness of visits from community pharmacists for patients with heart failure: HeartMed randomised controlled trial

BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39164.568183.AE (Published 24 May 2007) Cite this as: BMJ 2007;334:1098

Rapid Response:

Contradictory results in randomised clinical trials concerning to pharmacists-led intervention: looking for one possible explanation

Contradictory results in randomised clinical trials concerning to
pharmacists-led intervention: looking for one possible explanation

Pedro Amariles. MSc. Professor Faculty of Pharmaceutical Chemistry,
University of Antioquia, Medellin, Colombia. Research group on
Pharmaceutical Care, University of Granada, Spain.

Loreto Sáez-Benito. MsC. Research group on Pharmaceutical Care,
University of Granada, Spain.

Maria Jose Faus. PhD, Pharm.D. Professor Faculty of Pharmacy,
University of Granada, Spain. Research group on Pharmaceutical Care,
Faculty of Pharmacy. University of Granada, Granada, Spain.

Dear Editor:

The recently published HeartMed (1) trial showed that isolated
interventions by community pharmacists, in patients with heart failure
(HF), do not yield a significant decrease neither in hospital readmissions
nor in mortality, over six months after discharge from hospital. We have
read with great interest the possible explanations for these unexpected
results, suggested by the authors and rapid responses, which are mainly
concerned with the following issues: sample size, main outcome measures,
health professionals who carry out the interventions, and design of the
intervention. We agree with the reasons provided, however we consider that
an intervention focused on patients results is the key element of success,
of any program intended to improve outcomes for patients with heart
failure.

Several earlier trials, namely the Homer (2) and the Medman (3) study
support the findings by Holland et al, while, on the contrary, a number of
randomized clinical trials (4-6) have demonstrated positive effects on
admissions, mortality, quality of life, and length of hospitalization,
concluding that pharmacist-led intervention can significantly improve
patients’ outcomes. As it can be seen in the appendix below, the
contradictory results across studies are seemingly connected with
substantial differences in the interventions; process vs. results and
process together.

Based on this, we propose a pharmacist intervention consisting of a
series of key elements. To begin with, pharmacist’s intervention must not
only focus on the process (degree of compliance of HF patients), but on
the outcomes of pharmacotherapy (parameters of effectiveness and safety,
i.e., exertional dyspnea, exertional fatigue, weight, heart rate, blood
pressure (BP), and potassium and sodium levels). Therefore, pharmacist’s
interventions should be based on the follow up of the effectiveness and
safety of drug therapy through a patient outcomes assessment, within the
framework of a multidisciplinary team. This will allow feedback from GPs
to make appropriate changes in the pharmacotherapeutic management of
patients. In order to assess pharmacist intervention it would be also
useful to know whether the reasons for admissions are due to effectiveness
or safety problems.

Furthermore, since patients with HF are at high risk for re-
hospitalisation, we consider very important to discuss the predictive
factors for readmission (7), such as: age, atrial fibrillation, BP, serum
sodium and potassium levels, diabetes mellitus, polipharmacy, absence of
patient motivation, depression, dependent in self-care, functional
capacity, New York Heart Association (NYHA) classification, previous
hospitalisation and not having a specific follow-up plan, thus
implementing different types of interventions based on evidence-based
factors in readmissions in this group of patients. As for the design of a
tailored intervention, it is important that the pharmacist sets the goals
and draws up a plan of action to achieve them.

REFERENCES

1. Holland R, Brooksby I, Lenaghan E, Ashton K, Hay L, Smith R, et
al. Effectiveness of visits from community pharmacists for patients with
heart failure: HeartMed randomised controlled trial. BMJ 2007;334:1098.

2. Holland R, Lenaghan E, Harvey I, Smith R, Shepstone L, Lipp A, et
al. Does home based medication review keep older people out of hospital?
The HOMER randomised controlled trial. BMJ 2005;330:293.

3. The Community Pharmacy Medicines Management Project Evaluation
Team. The MEDMAN study: a randomized controlled trial of community
pharmacy-led medicines management for patients with coronary heart
disease. Fam Pract 2007;24:189-200.

4. Gattis WA, Hasselblad V, Whellan DJ, O'Connor CM. Reduction in
heart failure events by the addition of a clinical pharmacist to the heart
failure management team: results of the Pharmacist in Heart Failure
Assessment Recommendation and Monitoring (PHARM) Study. Arch Intern Med
1999;159;160:1939-45.

5. Tsuyuki RT, Johnson JA, Teo KK, Simpson SH, Ackman ML, Biggs RS et
al. A randomized trial of the effect of community pharmacist intervention
on cholesterol risk management: the Study of Cardiovascular Risk
Intervention by Pharmacists (SCRIP). Arch Intern Med 2002;162:1149-55.

6. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on
medication adherence and persistence, blood pressure, and low-density
lipoprotein cholesterol: a randomized controlled trial. JAMA 2006;296:2563
-71.

7. Anderson MA, Levsen J, Dusio ME, Bryant PJ, Brown SM, Burr CM, et
al. Evidenced-based factors in readmission of patients with heart failure.
J Nurs Care Qual 2006;21:160-7.

Appendix. Some characteristics of study with contradictory results
concerning to pharmacists-led intervention

Study with “negative” results

Study: HeartMed trial (1)

• Intervention focused to process (P): Two home visits consisting of:
Patient education (P), encourage completion of sign and symptom,
monitoring diary cards (P), remove discontinued drugs (P), and fed-Back
recommendations to the GP and local pharmacist (P)

• Results/Conclusions: Community pharmacist intervention did not lead
to reductions in hospital admissions nor in mortality and no statistically
significant difference in quality of life

Study: HOMER trial (2)

• Intervention focused to process (P): Two home visits consisting of:
Patient education (P), remove out of date drugs (P), inform local
pharmacist if a compliance aid is needed (P), and inform GP of drug
reactions or interactions (P)

• Results/Conclusions: Significantly higher rate of hospital
admissions, and not significantly improve quality of life or reduce deaths

Study: MEDMAN trial (3)

• Intervention focused to process (P): One or more consultations
(according to pharmacist determined patient need) consisting of:
Assessments of therapy, medication compliance, lifestyle (P) and fed-Back
recommendations to the GP (P)

• Results/Conclusions: No statistically significant differences in
lifestyle factors nor in the global score for appropriateness of
treatment, few differences in quality of life, the total National Health
Service cost increased, significant improvements in satisfaction score,
and no differences in self reported compliance

Study characteristics with “positive” results

Study: The PHARM trial (4)

• Intervention focused to process (P) and results of the
pharmacotherapy (R): Clinical Pharmacist evaluation that included :
Medication evaluation (P), therapeutic recommendations to the physician
(P), patient education (P), and telephone follow-up at week 2, 12 and 24
to identify drug-related problems, and the occurrence of clinical events
(R)

• Results/Conclusions: Outcomes in Heart Failure can be improved with
a clinical pharmacist as a member of the multidisciplinary heart failure
team

Study: SCRIP trial (5)

• Intervention focused to process (P) and results of the
pharmacotherapy (R): Regular follow up, consisting of: Interview by the
pharmacist (P), point of care cholesterol measurement (R), patient
education (P), and referral to the doctor according to cholesterol
measurement (R)

• Results/Conclusions: Community pharmacist intervention improved
cholesterol management for patients at high risk for cardiovascular
disease

Study: FAME trial (6)

• Intervention focused to process (P) and results of the
pharmacotherapy (R): Regular follow up, consisting of: Interview by the
pharmacist (P), measurement of adherence (P) BP (R) and LDL-C (R),
individualized patient education (P), medication dispensed using adherence
aid (P), regular follow up with clinical pharmacist every 2 months (R)

• Results/Conclusions: A pharmacy care program lets to increases in
medication adherence and persistence, reduction in BP, and discontinuation
of the program decrease medication adherence and persistence

Competing interests:
None declared

Competing interests: No competing interests

13 June 2007
Pedro Amariles
Prof. Pharmacology and Clinical Pharmacy
Loreto Saez-Benito, Maria Jose Faus
University of Antioquia, Medellin-Colombia AA 1226