Does home based medication review keep older people out of hospital? The HOMER randomised controlled trial
BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.38338.674583.AE (Published 03 February 2005) Cite this as: BMJ 2005;330:293
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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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Interface Development Pharmacist
Essex Rivers NHS Trust
Competing interests:
None declared
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Consultant Physician
South Wales
Competing interests:
None declared
Competing interests: No competing interests
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
Competing interests: No competing interests
Do not initiate medication organisation devices without prior detailed medication review and vigilant monitoring
Background
An estimated 50% of patients do not take their medicines as prescribed, which is decision intentional for an estimated 30% of these patients(1). Reasons for this intentional non-adherence are numerous and include a desire to reduce inconvenient effects, to avoid adverse effects, or a fear of medication dependence. For the remaining 70% of non-adherent patients, their behaviour is dominated by unintentional factors such as confusion and memory failure.(1)
Medication Organisation Devices (MODs) are an integral part of standard care to support patients suspected of being unintentionally non-adherent. Accurate data for the prevalence of their use are unavailable, however, conservative estimates indicate that in 2001 at least 100,000 people were using MODs in the UK; with an aging population, this number will have substantially increased over the past 13 years.(2)
MODs are usually a box or blister pack divided into days of the week with several compartments per day to allow for different dose timings. However, there is no definitive evidence for the effect(s) of MODs on adherence. The UK National Institute for Health Research Health Technology Assessment programme therefore funded a pilot randomised controlled study.
Objectives
Provide an indication of the effect(s) of MODs and generate data to inform a full trial of their effectiveness and cost effectiveness.
Methods
Patients were randomised to receive their usual prescribed medication either in standard packaging or a MOD. Patients were eligible if community dwelling, aged 75 years or more, self-medicating at least three different solid orally administered medicines and identified as non-adherent through a pill count three weeks after provision of a new medication supply. This was likely unintentional non-adherence based on self-report questionnaire data. Post-randomisation, adherence for two months was measured by pill count.
Findings
Post ethical approval from NHS East of England, 29 community dwelling patients were recruited. Three participants subsequently withdrew and one was excluded due to level of visual impairment being unsafe for standard care medication packaging. Of the remaining 25 participants, 12 received standard medication packaging and 13 received their medication in a MOD.
Five (38%) participants receiving a MOD experienced an adverse event (AE) or serious adverse event (SAE). No AEs or SAEs were reported for the control group. The table below summarises the (S)AEs recorded. The median (IQR) increase in adherence was 11% (0, 45) for MOD participants experiencing an (S)AE compared with 5% (0, 17) for standard packaging participants. An adherence increase exceeding 40% was measured for 35% (95% CI 21%) of the medicines prescribed for participants experiencing an AE compared with 13% (95% CI 10%) for those with no reported AE.
Discussion
The small sample size precludes determination of any definitive causal link between MODs and AEs. The relationship is, however, plausible; all of the participants described in the table were prescribed at least one medicine which may contribute to a fall and the increase in adherence for MOD participants was greater than for the control. The use of MODs appears to have resulted in a greater proportion of the prescribed medicine being administered and thereby increasing risk of iatrogenic events.(5)
The findings of this study are in agreement with previous studies designed to promote adherence which have reported increased mortality and healthcare costs for participants receiving the intervention.(6, 7) It is intuitive that increasing adherence to a medication may result in a dose related AE. It may therefore be prudent to review the prescribed dose of any medication with a high risk of dose related AEs (e.g. antihypertensives, hypoglycaemics, anticoagulants, and anticonvulsants) before introduction of an adherence intervention, and to monitor after its introduction to ensure treatment is optimised.
References
1. Gadkari AS, McHorney CA. Unintentional non-adherence to chronic prescription medications: how unintentional is it really? BMC Health Serv Res. 2012;12:98.
2. Nunney JM, Raynor DKT. How are multi-compartment compliance aids used in primary care? : Pharmaceutical Journal. 267 (7176) (pp 784-789), 2001. Date of Publication: 01 Dec 2001.; 2001.
3. Butt DA, Mamdani M, Austin PC, Tu K, Gomes T, Glazier RH. The risk of falls on initiation of antihypertensive drugs in the elderly. Osteoporos Int. 2013;24(10):2649-57.
4. British Medical Association and the Royal Pharmaceutical Society of Great Britain. British national formulary (version 67). London: BMJ Group and Pharmaceutical Press; 2014.
5. Routledge PA, O'Mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. Br J Clin Pharmacol. 2004;57(2):121-6.
6. Lenaghan E, Holland R, Brooks A. Home-based medication review in a high risk elderly population in primary care -- the POLYMED randomised controlled trial. Age & Ageing. 2007;36(3):292-7.
7. Pacini M, Smith RD, Wilson EC, Holland R. Home-based medication review in older people: Is it cost effective? PharmacoEconomics. 2007;25(2):171-80.
Competing interests: No competing interests