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
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Dear Editor: The interesting article of Richard Holland, Ian
Brooksby, Elizabeth Lenaghan,and colleagues(BMJ 2007, 334: 1098, 26 May),
points out the expert manpower shortage to back up the efforts of the
visting pharmacist in his or her follow up of discharged heart failure
patients at their homes. 49 patient interventions vs 144 controls. The
results were that there was no reduction in hopital re-admissions(5%), and
presumably mortality. A somewhat similar study, published in the Ann of
Intern Med 2007;146:714-725, addressed non adherence to medications in
heart failure patients despite interventions by a nurse and a
pharmacist.
Two conclusions may be drawn from those studies: formulation of teams of
nurses, pharmacists, and primary care cardiologists to follw up with home
visits on those patients, may prove a more effective home based care with
hospital admission reductions and perhaps mortality. Such an approach has
yet to be researched and studied.
Second,it is clear that medication adherence etc may not be the main
problem, but rather the interventionists are dealing with different
etiologies of heart failure (valvular heart disease, hypertensive,
congestive cardiomyopathy of unclear etiology and other etiologies), and if
future studies narrow their findings to etiology of heart failure, then
the results may turn out to be more informative as to what type of
intervention is needed.
Competing interests:
None declared
Competing interests: No competing interests
Holland et al should provide an analysis of the patients’ outcomes as
they relate to acting upon or not acting upon the recommendations made by
the pharmacists. At the first visit, only 51% of the recommendations were
accepted completely or partially. Nothing in the article quantifies what
were the recommendations. If these had the potential to improve the
patients' outcome and then were not done, it may well be the results are
related to not acting upon reasonable recommendations.
The views expressed may not reflect those of the Department of
Veterans Affairs.
Competing interests:
None declared
Competing interests: No competing interests
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
The research by Holland et al (1) adds further to the body of studies
that have looked for (and failed to find) a change in total
hospitalisation rates resulting from a medication review delivered by
pharmacists (2,3). We believe it is important that pharmacist medication
reviews should not be decried simply on the basis of this finding and
question the relevance of assessing hospital admissions as the main
outcome measure for pharmacists’ interventions.
Firstly, although Holland’s studies involve patients with an
increased risk of admission (1,2), most pharmacist reviews are conducted
in patients with a lower, more typical risk of admission in whom there is
even less hope of showing any change. Studies involving these more typical
patients report hospitalisation rates of between 8 and 18% (4, 5). An
analysis of admissions within one of these studies demonstrates the lack
of association between the intervention and admissions. (6)
Secondly, any pharmacist intervention is realistically only likely to
affect hospitalisations that are related to drug therapy. Several surveys
of hospital admissions (7,8,9) concur in estimating the rate of
preventable drug-related admissions to be between 4.2% and 4.7%. If 13% of
patients reviewed by pharmacists (midpoint of published studies 4,5) are
liable to become hospitalised and only 4.5% of these admissions are drug-
related and preventable, a mere 0.59% of these patients present a
realistic opportunity for the pharmacist to prevent a hospitalisation. In
this situation, the best we can hope for is that hospitalisations might be
reduced from 13% to 12.41%. This would be extraordinarily difficult to
detect in any research study, requiring in excess of 100,000 patients for
only 80% power, but assuming that 100% of potentially preventable
hospitalisations would actually be prevented. We recognise that the
figures upon which we have based these calculations are approximate and
subject to technical objections, but since the apparently necessary sample
sizes are two orders of magnitude beyond achievability, we are confident
in our essential conclusion that attempts to show a reduction in total
hospitalisations in such a population are unlikely to succeed.
Thirdly, the primary purpose of medication review is not reducing
hospital admissions, but improving patients’ knowledge, concordance and
use of medicines. Numerous studies, including those from Holland’s group,
have found the most frequent outputs from pharmacists conducting reviews
to be recommending monitoring, removing unnecessary drugs from repeat
prescriptions and providing advice on compliance and the prevention of
potential adverse effects (1,2,4,5,10).
While in principle, the more specific end-point of preventable drug-
related hospitalisations should be more sensitive than total
hospitalisations, any study would still require approximately 2,800
patients to eliminate such admissions entirely or about 6,000 for a more
realistic success rate of 75%. This equates to an NNT of 170 pharmacist
reviews to prevent one drug-related hospitalisation, assuming fully
effective intervention or 226 for 75% effectiveness.
Thus it seems more appropriate to consider the potential benefits of
medication review using alternative endpoints such as increased treatment
effectiveness, reductions in adverse effects or costs. These outcomes may
be less striking than a prevented hospitalisation, but if they occur more
frequently, may be more amenable to statistical detection and perhaps of
greater clinical significance.
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,
doi:10.1136/bmj.39164.568183.AE (published 23 April 2007)
2. Holland R, Lenaghan, Harvey I, Smith R, Lipp A, Christou M et al.
Does home based medication review keep older people out of hospital? The
HOMER randomized controlled trial. BMJ 2005; 330: 293-7
3. Royal S, Smeaton L, Avery AJ, Hurwitz B, Sheik A. Interventions in
primary care to reduce medication related adverse events and hospital
admissions: systematic review and meta-analysis. Qual Saf Health Care
2006; 15: 23-31
4. Krska J, Cromarty JA, Arris F, Jamieson D, Hansford D, Duffus PRS,
Downie G, Seymour DG. Pharmacist-led medication review in patients over
65: A randomized, controlled trial in primary care. Age Ageing 2001; 30:
215-21
5. Zermansky AG, Petty DR, Raynor DK, Freemantle N, Vail A, Lowe C.
Clinical medication review by a pharmacist of elderly patients on repeat
prescriptions in general practice: a randomized controlled trial. BMJ
2001; 323: 1340-3
6. Krska J, Hansford D, Seymour DG, Farquharson J. Is hospital
admission a sufficiently sensitive outcome measure for evaluating
medication review services? A descriptive analysis of admissions within a
randomised controlled trial. Int J Pharm Pract 2007; 15: 85-91
7. Howard RL, Avery AA, Howard PD, Partridge M. Investigation into
the reasons for preventable drug related admissions to a medical
admissions unit: observational study. Qual Saf Health Care 2003; 12: 280-5
8. Cunningham G, Dodd TRP, Grant DJ, McMurdo MET, Richards RME. Drug-
related problems in elderly patient admitted to Tayside hospitals, methods
for prevention and subsequent reassessment. Age Ageing 1997; 26: 375-82
9. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Whalley TJ et
al. Adverse drug reactions as cause of admission to hospital: prospective
analysis of 18 820 patients. BMJ 2004; 329: 15 - 19
10. Holland R, Leneghan E, Smith R, Lipp A, Christou M, Evans D,
Harvey I. Delivering a home-based medication review, process measures from
the HOMER randomised controlled trial. Int J Pharm Pract 2006; 14: 71-79
Janet Krska, Professor of Pharmacy Practice and Philip Rowe, Reader
in Pharmaceutical Computing
School of Pharmacy and Chemistry, Liverpool John Moores University, Byrom
Street, Liverpool L3 3AF
e-mail: j.krska@ljmu.ac.uk
The authors have no competing interests to declare.
Competing interests:
None declared
Competing interests: No competing interests
Holland et al (1) write that "This community pharmacist intervention
did not
lead to reductions in hospital admissions in contrast to those found in
trials
of specialist nurse led interventions in heart failure" yet in their paper
cite,
amongst others, the Adelaide Study (2). In this paper, quoted in reference
to
the reduction in hospital admissions achieved, the intervention was
delivered
by a nurse and a pharmacist visiting the patient together.
Perhaps one could argue that maybe it is the nurse element of this
intervention that created the benefit seen but it would seem more likely
to be
due to the weaknesses already identified by the authors. One notable
difference between the two papers is the level of medication adherence
which
was reported as very good by Holland but in the Adelaide paper nearly half
of
patients had stopped at least some within a week of discharge. Analysis of
the CHARM trial programme (3) found that patients who adhered
to their placebo to a high level had better outcomes than those with low
adherence to the active candesartan, perhaps reflecting their overall
uptake
of all aspects of treatment and care.
Also of note is the high readmission rate seen in the Holland paper.
In the
sample size calculations a rate of 0.6 admissions per patient in 6 months
is
quoted, yet in the actual trial 246 admissions occurred in 291 patients, a
rate
of 0.85, a 40% increase. The reasons for this may have negated any impact
the pharmacists could have had and thus have affected the overall outcome.
It is widely acknowledged that we don't always do well with heart
failure (4).
Lack of confidence, worries about polypharmacy in often elderly and frail
patients, and lack of awareness of the relevant evidence have been cited
as
contributing reasons. It seems unlikely that the one-day training course
provided to pharmacists in this study would have been sufficient to
overcome
these issues making it harder to generate a benefit.
Finally perhaps this model was too isolated and simplified. The
recommendations of a Cochrane review (5) and the European Society of
Cardiology guidelines (6) for models of care in heart failure recognise
that
there is no clear optimal approach, but that a number of factors seem to
help.
Amongst these are a multidisciplinary approach, vigilant follow up within
10
days of discharge and intense education and counselling. The current trial
may not have allowed all of these to be addressed and combined with the
other limitations have precluded a beneficial effect being demonstrated.
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 doi: 10.1136/bmj.
39164.568183.AE
2. Stewart S, Pearson S, Horowitz JD. Effects of a home-based
intervention
among patients with congestive heart failure discharged from acute
hospital
care. Arch Intern Med 1998;158:1067-72
3. White HD. Adherence and outcomes: it's more than taking the pills.
Lancet,
2005; 366: 1989-91
4. Fuat A, et al. Barriers to accurate diagnosis and effective
management of
heart failure in primary care: qualitative study. BMJ, 2003; 326: 196
5. Taylor S, et al. Clinical service organisation for heart failure
(review).
Cochrane database of systematic reviews, 2006, issue 3
6. ESC Guidelines. Eur Heart J, 2005; 26: 1115-40
Competing interests:
None declared
Competing interests: No competing interests
The study by Holland et al usefully illustrates that a health benefit
from a limited intervention by a single health professional may not
produce the desired health outcomes. In their study, community pharmacists
were chosen to deliver an additional service, comprising of two home
visits, to aid in the management of Heart Failure and found no significant
reduction in hospital admissions. The authors compare this study, which
involved generalist community pharmacists, to a trial utilising specialist
heart failure nurses in the Glasgow (1), where their support did reduce
hospital admission. However, the Specialist Nurse interventions were
carried out over one year (with decreasing frequency) and included both
face to face and telephone consultation.
The specialist heart failure nurses were able to titrate medications
according to a protocol and make direct referrals to other professions,
whilst the community pharmacist could only make recommendations to the GP.
This inevitably led to an increase in work for the primary health care
team and we note that about half of the recommendations were actioned. The
HOMER trial (2) also observed this and suggests it may be due to the GPs
not having an existing working relationship with the community pharmacist.
Future work should also consider the use of more specialist pharmacists,
such as ‘Pharmacists with a Special Interest’ and/or pharmacist
independent prescribers to allow implementation and monitoring of
recommendations.
Reasons for hospital admission are varied, often interdependent and
the effect of medicines hard to isolate. This makes it difficult for any
trial running over a short time frame to detect appreciable reductions in
admissions. Furthermore, the community pharmacist now has the opportunity
for a sustained intervention through the repeat prescribing services that
are becoming widespread. With the advent of supplementary and independent
prescribing meaningful pharmacist intervention may well demonstrate the
health gains hoped for by the authors.
The real question is not whether community pharmacists per se can
deliver measurable health benefits, but whether appropriate service can be
constructed utilising their expertise and availability to deliver such
benefits as part of a multi-professional team. In summary, it seems to be
that the best way to deliver optimal healthcare to heart failure patients
should be the frequent input from specialist healthcare professionals as
part of team, rather than from one individual. We agree with the author’s
summary that research is needed to determine how intense such services
need to be.
References
1. Blue L, Lang E, McMurray JJ, Davie AP, McDonagh TA, Murdoch DR,et
al. Randomised controlled trial of specialist nurse intervention in heart
failure. BMJ 2001;323:715-8.
2. Holland R et al. Does medication review keep older people out of
hospital? The HOMER randomised controlled trial. BMJ 2005;330:293
Competing interests:
None declared
Competing interests: No competing interests
Holland Study
I came across this article today and was really fascinated by the
results of the study. However, I beg to differ from the conclusions drawn
by the researchers. My personal experience tells me that pharmacists can
make a major contribution towards the management of heart disease. It is
almost a team effort. And each and every member of the health team has a
major role to play.
Further studies are needed to confirm if the conclusions of the
Holland study are reproducible.
britloy1951@gmail.com
Competing interests:
None declared
Competing interests: No competing interests