Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Maximising health benefits from community based interventions
- Nina L Barnett, Prof. Larry Goodyer, Head of the Leicester School of Pharmacy, Derek Taylor, UK Clinical Pharmacy Association Care of the Elderly Practice Interest Group & Caroline Bowyer, Senior Pharmacist, Elderly Care and NSF, Southampton University Hospitals Trust (9 May 2007)
-
Representative of the evidence base?
- Magnus I Hird (26 May 2007)
-
Can pharmacists prevent hospital admission?
- Janet Krska, Philip H Rowe (5 June 2007)
-
Contradictory results in randomised clinical trials concerning to pharmacists-led intervention: looking for one possible explanation
- Pedro Amariles, Loreto Saez-Benito, Maria Jose Faus (13 June 2007)
-
Why were recommendations not listed?
- William N. Jones (26 June 2007)
-
Inadequate manpower for effctive follow up on out of hospital heart failure patients.
- M E Nassar, M.D., Ph.D. (10 July 2007)
-
Holland Study
- Shailendra Kapoor (11 November 2007)
|
|
|||
|
Nina L Barnett, Consultant Pharmacist for Older People Northwick Park Hospital & London, Eastern and South East Specialist Pharmacy Services, Prof. Larry Goodyer, Head of the Leicester School of Pharmacy, Derek Taylor, UK Clinical Pharmacy Association Care of the Elderly Practice Interest Group & Caroline Bowyer, Senior Pharmacist, Elderly Care and NSF, Southampton University Hospitals Trust
Send response to journal:
|
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 |
|||
|
|
|||
|
Magnus I Hird, Pharmacist Practitioner Bloomfield Medical Centre, Blackpool, FY1 6JW
Send response to journal:
|
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 |
|||
|
|
|||
|
Janet Krska, Professor of Pharmacy Practice School of Pharmacy and Chemistry, Liverpool John Moores University, Byrom Street Liverpool L3 3AF, Philip H Rowe
Send response to journal:
|
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 p.h.rowe@ljmu.ac.uk The authors have no competing interests to declare. Competing interests: None declared |
|||
|
|
|||
|
Pedro Amariles, Prof. Pharmacology and Clinical Pharmacy University of Antioquia, Medellin-Colombia AA 1226, Loreto Saez-Benito, Maria Jose Faus
Send response to journal:
|
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 |
|||
|
|
|||
|
William N. Jones, Pharmacy Program Manager for Educational Development and Performance Improvement Southwest VA Consolidated Mail Outpatient Pharmacy
Send response to journal:
|
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 |
|||
|
|
|||
|
M E Nassar, M.D., Ph.D., retired Pittsford, NY 14534
Send response to journal:
|
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 |
|||
|
|
|||
|
Shailendra Kapoor, MD Johannesburg Hospital, Parktown, South Africa
Send response to journal:
|
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 |
|||