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Pharmacist Medication Review Study Design Concerns
- Joel W Hay (28 January 2005)
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Drug Interactions
- Roger C Hayter (30 January 2005)
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Re: Drug Interactions
- John david leopold (4 February 2005)
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Pharmacist Medication Review
- Michael G Scott, Anita Hogg,James mcElnay,Christine Clark. (4 February 2005)
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Could increased readmission be linked to increase General Practitioner visits?
- Richard L Davies (6 February 2005)
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Study design should go beyond answering a single question of Outcome
- Abdullah Mohammed (9 February 2005)
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Response to HOMER trial paper
- David R Green (10 February 2005)
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HOMER trial was not a clinical medication review
- Duncan Robert Petty, Theo Raynor, Arnold Zermansky, David Alldred, Peter Bowie, Nick Freemantle (16 February 2005)
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Authors' response to comments on the HOMER trial
- Richard Holland, On behalf ot the HOMER trial investigators (7 March 2005)
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Pharmacist Medication Reviews
- Caroline S Bowyer, Gary Todd Care of the Elderly Practice Interest Group UKCPA and Nina Barnett, Pharmacy Adviser for Older People, London SE and Eastern Specialist Pharmacy services (9 March 2005)
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Joel W Hay, Assoc. Professor University of Southern California School of Pharmacy, Los Angeles CA 90089 USA
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To The Editor: The Holland et al. [BMJ, doi:10.1136/bmj.38338.674583.AE (published 24 January 2005)] findings that pharmacist medication reviews for home- dwelling patients are associated with a 30% increase in emergency hospitalizations and a greater reduction in global health score (as measured on a Visual Analog Scale) is paradoxical, counterintuitive and inconsistent with the U.S. literature on pharmacist management of medication therapy.[1-3] The authors attribute these results to either 1) an increase in health care-seeking behavior by intervention patients who become better-sensitized to their health conditions, 2) an increase in hospitalizations among frail intervention patients who otherwise would have died, 3) an increase in iatrogenic medication adherence among intervention patients, and/or 4) an increase in intervention patient confusion and anxiety about health care services. While all of these explanations imply strong pharmacist intervention effects (good or bad), it would be valuable to have more details about the patient sample and their reasons for hospital readmission. 11 of the excess hospitalizations in the pharmacist intervention group (20%) were accounted for by just two of the 429 intervention patients and 15 excess hospitalizations (27%) were accounted for by 5 other intervention patients. The patients were not stratified by baseline diagnosis with the unfortunate result that nearly twice as many cancer (Odd Ratio 2.1, p<.05, one-tailed) and neurological (stroke, senility and/or dementia) (Odd Ratio 1.6, p<.05, one-tailed) patients were assigned to the intervention group as to the control group. None of the other baseline diagnosis differences appear significant across treatment groups, but because of their high relative hospitalization propensity, it would be useful to see if the main findings still obtain when baseline cancer and neurological diagnosis patients are excluded from the analysis. This sample is atypical in that all patients were quite elderly (mean age 85.5) averaged 5.9 drugs daily, and were recruited from an initial inpatient admission. Patients admitted to the hospital initially because of iatrogenic medication prescribing, or other issues of relatively poor health care quality (e.g. inappropriate medical diagnosis or treatment) would be more likely to be recruited into this study than patients recruited from the community or from ambulatory settings. It is not clear that the pharmacist interventions utilized in this study were specifically designed to address and correct such health care quality issues. The study certainly raises a very valuable cautionary note that medication management interventions, particularly in the frail elderly, and particularly in patients averaging more than five daily medications need to be designed and planned very carefully to ensure that the intervention benefits outweigh the risks. But because of these study design concerns it is not clear how relevant these findings are to the broader issue of assessing the value of medication therapy management services. Sincerely, Joel W. Hay, PhD
1. Etemad L, Hay J. Cost Effectiveness Analysis of Pharmaceutical Care in a Medicare Drug Benefit Program. Value in Health. 2003, 6(4):425- 435. 2. Yuan Y, Hay JW, McCombs JS. Mortality and hospitalization impacts of pharmacist consultation in ambulatory care. Am J Manag Care 2003;9:101–12. 3. McCombs JS, Cody M, Parker JP, Johnson KA, Besinque K, Borok G, Ershoff D, Groshen S, Hay J, Nichol MB, Nye MT. The Kaiser Permanente/USC Patient Consultation Study: Change in Use and Cost of Health Services. Am J Health-Syst Pharm 1998. 55(2):2485-99. Competing interests: None declared |
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Roger C Hayter, Geriatrician Bro Ddyfi Community Hospital, Machynlleth, SY20 8AD
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A possible adverse effect of pharmacy review of older peoples' medications is an inappropriate medical response to the identification of possible drug interactions. In many cases the appropriate response is either to continue the prescription having assessed that the risk of harm from the interaction is less than the likely benefit of continuing the drug(s); or to ensure that the relevant drug doses are titrated to mitigate the ill-effects of the interaction. If many of the doctors treating the study patients were unused to responding to pharmacy reviews, there could have been a tendency to withdraw beneficial drugs when possible interactions or other side-effects were identified. If this adverse effect did occur, one would expect it to become smaller as the local doctors acquired more experience of assessing pharmacist-initiated referrals. Competing interests: None declared |
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John david leopold, Consultant Physician SWn-y-mor, sa34je
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Sir. A reduction of mortality rate of one quarter per six months would be a spectacular result for any intervention.. Greater than most common interventions. This study was not designed, powered, or analysed so as to enable us to know how much of this benefit to credit to the 100% increase in Phamacist, the 45% in GP, or the 30% in hospital episodes. It seems to have been designed with the primary objective of fewer hospital admissions..is this a fair assumption? Kind regards David Leopold
Competing interests: None declared |
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Michael G Scott, Chief Pharmacist Antrim Area Hospital BT41 2RL, Anita Hogg,James mcElnay,Christine Clark.
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We read with interest the report of the study by Holland and colleagues, which showed that home-based medication review by pharmacists increased the rate of readmission to hospital. Our experience, using a hospital-based medication review as part of a randomised, controlled evaluation of an integrated medicines management service, shows that readmissions are reduced by 7.9% at 12 months.1 1. Holland and colleagues suggest that the intervention might have increased adherence and thereby induced iatrogenic disease, although they then dismiss the possibility as a previous study showed no improvements in adherence. This, in itself, is curious because improved adherence was presumably one of the principles on which the design of this study was based. The risk of iatrogenic disease in this age group is serious and warrants careful attention. A fundamental principal of pharmaceutical care is that the prescribed medicines must be appropriate in the first place. Medication appropriateness can be measured using the Medication Appropriateness Index (MAI)2. An assessment of medication appropriateness at the time of discharge from hospital or after the medication review, might have offered more insight into the possibility of iatrogenic illness. In our experience, medication reviews are associated with a marked increase in MAI score. 2. It is difficult to understand how a meaningful or clinically- relevant medication review can take place without access to the medical record. Without this information the pharmacist undertaking the review and offering advice on how to take the medications can do little more than repeat the instructions on the labels. It is not possible to make an assessment of the patient’s ability, preferences or medicine-taking behaviour in their proper context. However, we disagree with this suggestion that effective medication review can take place with the medical record but without the patient. In our experience, meaningful medication review can only occur when both the medical record and the patient are present, in the context of an integrated service. 3. Our experience of training pharmacists to undertake effective medication reviews suggests that pharmacists need significant experience of clinical practice in order to do this competently. Although some post –qualification education had been received by the participating pharmacists, their level of clinical practice was not documented.. The authors say that possible drug reactions and interactions were reported to the GPs. It is not clear from this whether other medication-related problems, which are often harbingers of medication-related morbidity, were reported and neither is it clear what action the GPs took in response to this information. 4. Professor Christine Bond, in her comments to the Pharmaceutical Journal (29th January 2005)3 points out that there are many unknowns between the intervention and outcome in this study. We concur with her comments and also wish to suggest that some of the problems might have arisen from the practice model on which this study was based i.e. a visiting pharmacist who was not part of the regular service. We suggest that pharmaceutical expertise could be used more effectively within the framework of a care team, all members of which have access to a common medical record. MG Scott PhD FPSNI MCPP Chief pharmacist, United Hospitals Trust, Antrim A Hogg BSc MPSNI Clinical Services Development Pharmacist, United Hospitals Trust, Antrim JC McElnay PhD FPSNI FACCP Dean of The Faculty of Science and Agriculture, The Queens University of Belfast CM Clark PhD FRPharmS Principal Research Fellow in Clinical Therapeutics (part-time), University of Bradford School of Pharmacy References 1. Beagon P, Scott MG,McElnay JC. Quantifying the impact of an intensive clinical pharmacy service on re-admission rates to hospital. Pharmacy World and Science 2004; 26: A9 2. Hanlon JT ,Schmader KE, Samsa GP,Weinberger ,M, Utttech KM,lewis IK et al. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992;45:1045-1051 3. Moberley T. Medication review hangs in the balance. Pharm J 2005;274:106 Competing interests: None declared |
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Richard L Davies, General Practitioner 703 Leeds and Bradford Road, Stanningley, Pudsey, Leeds LS28 6PE
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The trial by Holland et al looking at home based medication review by pharmacists as an admission avoidance scheme produced interesting results. Not least the counterintuitive result that significatly higher rates of hospital readmissions were found in the intervention group. The authors suggest some explanations for this finding, may I suggest another. The increase in General Practioner visits to the intervention group may have led to more readmissions. There was a visit rate ratio of 1.43 (1.14 to 1.80; p=0.002) in the intervention group when compaired to the control group. These extra visits seem to have been propted by the 2.58 recomendations or comments from pharmacisits to the General Practioner's per patient visited. The pharmacists may have been acting as a screening tool for unwell patients who needed readmission. It can be argued that there is always a proportion of patients struggling on at home who if seen by a member of the primary health care team action, including admission, would be considered to try to stabilise their condition. Competing interests: None declared |
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Abdullah Mohammed, Clinical Research Fellow The Cardiothoracic unit,Northern General Hospital,Sheffield ,UK
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Editor –The paper by Holland etal. [1] highlights our current trials design obsession of measuring an arbitrary outcome instead of understanding the cause of such outcome through rigorous design aimed at unravelling both the cause and effect of an intervention. Clearly , the authors assumed a sound hypothesis –Polypharmacy is a cause of drug adverse effects and interactions which has been shown to increase hospitalisation. It follows that an intervention that is likely to reduce this effect is likely to reduce hospital admissions. A much more informative study, however, would have been to look at the outcome of hospitalisation as well as its causes in both groups. An even better study design would shed a light on the specifics of intervention. It is relevant in this study to know the causes of admissions in each group. It is also valid to ask what are the interventions by the pharmacist in the intervention group that could have explained increased admission rates. Neither of these important issues is mentioned in the paper which could have been easily collected from patients’ admission data. The unexpected negative outcome of the study made every one eager to know the possible causes of this unexpected result. If we to turn the fundamental conclusion of this study around and assume that the study had shown a positive outcome with significantly fewer admissions in the intervention group .The result would have been accepted and used as evidence to promote new community pharmacist role in order to avoid hospital admission ,without necessarily understanding how the result is being achieved. In research, it looks neat to attempt to answer one specific question at time, which allows easier statistics calculations.This ,however , should not stop us from addressing the important issue of understanding how the outcome is reached. This can be achieved by having an open mind to the hypothesis under study and allow the study design to go beyond answering a single question. Refrences: 1.Does home-based medication review keep older people out of hospital? The HOMER randomised controlled trial Richard Holland, Elizabeth Lenaghan, Ian Harvey, Richard Smith, Lee Shepstone, Alistair Lipp, Maria Christou, David Evans, Christopher Hand. BMJ 2005;330:293, doi:10.1136/bmj.38338.674583.AE Competing interests: None declared |
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David R Green, Interface Development Pharmacist Colchester General Hospital CO4 5JL
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The HOMER trial is a useful piece of work but raises some important points with regard to the definition of what is a medication review. Since no clear definition of a medication review is given within the paper the conclusions are devalued considerably. The Room for Review document (available from http://www.medicines-partnership.org/) gives a structure for reviews at various levels, with the top level involving patient and pharmacist in consultation with access to the patient's notes. Since home based consultations may or may not have this access can we assume that the reviews included in the paper were not at this optimum level? I also suspect from the information within the paper that most of the effort was at the level of drug usage review now being built into the new pharmacy contract. This tends to concentrate on compliance issues. If this is effective but without appropriate clinical input patients who become concordant will expect a greater degree of adverse drug reactions as is pointed out in the paper. If, however, the drug prescribed is inappropriate as well the likelyhood of adverse events is compounded. This is why we still have a considerable number of drug related admissions into hospitals as reported in an earlier BMJ paper published last year. The other key issue not developed within the paper is the degree of education and experience of the pharmacists involved together with the scope of the education and training provided. This is recognised within the new pharmacy contract with an expectation of a competency assessment to be in place before such work is undertaken. I agree with the authors that their study highlights the need for more research in this very imprtant field but am wary that their paper is being quoted in various journals without the background. This could set the agenda for proper medication review back considerably and this would have a detrimental effect on both the nGMS and the new pharmacy contract. What is more important is that this evidence, if taken out of context, could result in patients being denied their medication reviews and therefore their access to best therapy and advice. David Green
Competing interests: None declared |
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Duncan Robert Petty, Research Pharmacist University of Leeds, Theo Raynor, Arnold Zermansky, David Alldred, Peter Bowie, Nick Freemantle
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Dear Editor, Holland et al (1) describe the results of a home based medication review by a pharmacist, after hospital discharge, that gave results that they describe as “counter-intuitive” because the intervention appeared to increase hospital admissions. Their results do appear to be at odds with previous research of interventions described as “medication review”. Three large randomised controlled trails of pharmacist conducted clinical medication review - containing a total of 3,197 subjects - in UK general practice (2,3,4) have not shown any affect on hospitalisation. These studies included participants of all ages (but mostly the elderly) who were living in the community and who were probably less acutely ill than in this study. However, the key issue is the definition of "medication review". The Holland et al. paper describes their intervention as: "Two home visits by a pharmacist .......... to educate patients and carers about their drugs, remove out of date drugs, inform general practitioners of drug reactions or interactions, and inform the local pharmacist if a compliance aid is needed." We would argue however that this is not a holistic medication review which has been defined as “a structured critical examination of the patient’s medicines with the objective of reaching an agreement with the patient about treatment, optimising the impact of medicines, minimising the number of medicine-related problems and reducing waste.” (5) Thus a large component of what is commonly understood as medication review is to optimise the treatment regimen. This does not appear to be a component of the intervention in this study but was an important part of the intervention in other studies. (2,3,4) It is arguable however, that during a hospital admission it is likely that treatment would already have been optimised. Further rationalisation, after discharge, would therefore usually not be necessary and therefore the intervention may not be expected to reduce hospitalisation in this cohort of patients. It would be of interest to know how frequently interventions were made by the pharmacists e.g. how frequently a recommendation on adverse drug reactions and interventions were made to the GP; how many patients were recommended a compliance aid; and whether patients who received an intervention were those who subsequently had a hospital readmission or if the admission was for an unrelated cause. In the mean time, the results of this study should not cast doubt on the efficacy of full pharmacist medication review, using all patient data to optimise therapy. Reference 1. Holland R, Lenaghan E, Harvey I, Smith R et al. Does home based medication review keep odler people out of hospital? The HOMER randomised controlled trial. BMJ Online bmj.com. 2. Zermansky AG, Petty DR, Raynor DK, Freemantle N, Vail A, Lowe CJ.Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice. BMJ. 2001 Dec 8;323(7325):1340-3. 3. Mackie CA, Lawson DH, Campbell A, Maclaren AG, Waigh R. A randomised controlled trial of medication review in patients receiving polypharmacy in general practice. Pharmaceutical Journal. 1999; 263: R7. 4. Krska J, Cromerty 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 and Ageing.2001; 30: 205-11. 5. Room for Review. Task Force on Medicines Partnership and The National Collaborative Medicines Management Services Programme. http://www.medicines-partnership.org/medication-review/room-for-review/ Competing interests: None declared |
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Richard Holland, Senior Lecturer in Public Health Medicine School of Medicine, Health Policy & Practice, University of East Anglia, Norwich, NR4 7TJ, On behalf ot the HOMER trial investigators
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To the Editor In response to our article there have been a number of valid questions raised: (1) Joel Hay questions whether excluding patients with cancer or a neurological diagnosis would change the results. We have re-analysed our primary outcome either removing these patients or adding in a co-variate adjusting for the presence or absence of these diagnoses. Neither analysis altered the rate ratio found. (2) Joel Hay also questions whether it was appropriate to recruit from hospital. This source was chosen as it identified a group who on discharge, are likely to have drug changes. A number of UK studies have highlighted this finding. We therefore considered this group to be vulnerable to medication errors (duplication, unclear changes to medication etc.) and therefore potential beneficiaries of our intervention. (3) We agree with David Leopold that a reduction of mortality rate by one quarter over six months would have been a spectacular result. Our study was not designed to demonstrate such a change. We specifically powered our study on the basis of hospital admissions data, not mortality. A further study would need to recruit over 2,540 patients in order to have 80% power to investigate a potential 25% reduction in mortality. (4) Michael Scott suggests that we too readily dismiss the possibility that our intervention improved adherence. This was not our intention. We have no evidence as to whether we improved adherence, and we simply commented that whilst some investigators have demonstrated improved adherence through medication review, others have not. We agree that one of our aims was to improve adherence. (5) Michael Scott also questions whether a meaningful medication review can be conducted without access to a medical record. We agree that access to such a record is ideal. Nonetheless, gaining access to such records outside hospital, or general practice is difficult. We set out to ask a pragmatic health service question based around a service that had already been implemented in pilot form by Norfolk Social Services. In hindsight, it may have been enhanced by access to clinical records though this would have been difficult to negotiate. Importantly, within the new pharmacy contract, whilst it will pay community pharmacists to undertake medication reviews, it is unlikely that there will be access to clinical notes until IT systems are considerably more advanced than is currently the case. Such pharmacy-based reviews will have access to far less information than our HOMER pharmacists as they will not be able to witness a patient’s social circumstances, or check on drug storage/hoarding. (6) Richard Davies may be justified connecting the increased hospital admissions with the increase in GP home visiting. Further analysis has demonstrated that amongst those admitted to hospital the rate of GP home visits was almost double that of patients not admitted (rate ratio 1.98, 95% C.I. 1.56 to 2.50, p<0.001), although the direction of this association is uncertain. (7) Abdullah Mohammed suggests that our study design should have gone beyond answering a single question. Again space limited what we could present. We have investigated cause of admission in both groups. Only two differences were found: there were eight readmissions (3.4%) amongst intervention patients with endocrine abnormalities (these involved fluid and electrolyte abnormalities, or hypoglycaemia). This compared to only one equivalent control admission (0.6%), [Fisher’s exact test = 0.05]. In contrast, there was an excess of surgical complications in the control group (3.9% vs. 0.9%, p=0.02). However, it should be stressed that testing for these differences involved multiple statistical testing (21 different causes were investigated). Since neither of these differences were predicted, or pre-specified in advance these results should be treated with caution. Overall, data on cause of admission do not shed useful light on our main finding. (8) David Green, Michael Scott and Duncan Petty would have liked further information about our intervention. We regret that in the space available we could only cursorily describe this. We plan to publish more descriptive detail in due course. (9) In response to David Green, we feel that any medication review programme, including that within the new pharmacy contract, should either be based on existing evidence, or should be the subject of further evaluation. Our study we believe, serves as a useful reminder that plausible interventions do not always have intended effects. Competing interests: None declared |
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Caroline S Bowyer, Senior Pharmacist Elderly Care Care of the Elderly Practice Interest Group, United Kingdom Clinical Pharmacy Association (UKCPA), Gary Todd Care of the Elderly Practice Interest Group UKCPA and Nina Barnett, Pharmacy Adviser for Older People, London SE and Eastern Specialist Pharmacy services
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This study (1) showed that pharmacist home based medication review was associated with increased hospital admission rates in older people suggesting that these patients were somehow disadvantaged by pharmacist home visits. There are some key issues, discussed below, that we believe may affect the interpretation of these results. It is unclear what additional training pharmacists conducting the interventions obtained, what their specific area of practice was and whether they were assessed for competency prior to undertaking these reviews. The work by Stewart et al (2) in Australia was associated with reduced hospital admissions and mortality and participating pharmacists were required to undertake a specific qualification in medication reviews to be included in the study. It is worth noting that Zermansky (3), who showed benefits of medication review in GP practices was a pharmacist with a clinical diploma. We are not told what constituted a medication review in this study, nor if there was a standard questionnaire or assessment used which was validated or had been used in some of the other trial work cited. Pharmacists did not appear to have full access to patient records from the GP surgery or from previous hospital admissions, in contrast with the Zermansky work (3). It was not stated whether the discharge medication list the pharmacists were given had been verified as correct with no omissions. As highlighted by other respondents, the groups were not well matched for diseases, especially for dementia patients. There were a large number of drop-outs in the control group and 67 did not receive a medication review. The authors suggest that pharmacists in this trial were encouraging patient adherence to medication however no measure of adherence was made to support this claim. We feel some concern that the study is vague about the recommendations made by the pharmacists; how many were actioned by the GPs? Were the pharmacists instrumental in prompting the additional GP visits or did this happen after prescribing changes had been made? Home based medication reviews by pharmacists, or indeed pharmacist home visits, may identify vulnerable elderly people with unmet clinical needs. This may explain the much higher rate of GP visits and higher readmission rates in this group, reflecting an attempt to meet those needs. It is also unclear whether a few patients having multiple-readmissions may have distorted the results. There is no measure of appropriateness of readmission, number of multiple admissions for particular patients or comparison of re-admission rates in these two groups with usual readmission rates for over 80 year olds recently discharged in the locality. In summary, it is difficult to draw any firm conclusions without knowing the reasons for the emergency admissions and how many of them were iatrogenic. References 1. Richard Holland, Elizabeth Lenaghan, Ian Harvey, Richard Smith, Lee Shepstone, Alistair Lipp, Maria Christou, David Evans, and Christopher Hand Does home based medication review keep older people out of hospital? The HOMER randomised controlled trial BMJ, Feb 2005; 330: 293 2. Stewart S, Pearson S, Luke CG, Horowitz JD. Effects of home-based intervention on unplanned readmissions and out-of-hospital deaths. J Am Geriatr Soc 1998;46: 174-80 3. Arnold G Zermansky, Duncan R Petty, David K Raynor, Nick Freemantle, Andy Vail, and Catherine J Lowe Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice BMJ, Dec 2001; 323: 1340 Competing interests: None declared |
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