hospital inpatient self-administration of medicine programmes: a critical literature review

12
REVIEW ARTICLE Hospital inpatient self-administration of medicine programmes: a critical literature review Julia Wright Angela Emerson Martin Stephens Elaine Lennan Received: 12 October 2004 / Accepted: 3 March 2006 / Published online: 27 September 2006 Ó Springer Science+Business Media B.V. 2006 Abstract Aim The Department of Health, pharmaceutical and nursing bodies have advocated the benefits of self- administration programmes (SAPs), but their implementa- tion within UK hospitals has been limited. Perceived barriers are: anticipated increased workload, insufficient resources and patient safety concerns. This review aims to discover if benefits of SAPs are supported in the literature in relation to risk and resource implications. Method Electronic databases were searched up to March 2004. Published English language articles that described and evaluated implementation of an SAP were included. Outcomes reported were: compliance measures, errors, knowledge, patient satisfaction, and nursing and pharmacy time. Results Most of the 51 papers reviewed had methodo- logical flaws. SAPs varied widely in content and structure. Twelve studies (10 controlled) measured compliance by tablet counts. Of 7 studies subjected to statistical analysis, four demonstrated a significant difference in compliance between SAP and controls. Eight studies (5 controlled) measured errors as an outcome. Of the two evaluated sta- tistically, only one demonstrated significantly fewer med- ication errors in the SAP group than in controls. Seventeen papers (11 controlled) studied the effect of SAPs on pa- tients’ medication knowledge. Ten of the 11 statistically analysed studies showed that SAP participants knew sig- nificantly more about some aspects of their medication than did controls. Seventeen studies (5 controlled), measured patient satisfaction. Two studies were statistically analysed and these studies suggested that patients were satisfied and preferred SAP. Seven papers studied pharmacy time, three studied nursing time but results were not compared to controls. Conclusions The paucity of well-designed studies, flawed methodology and inadequate reporting in many papers make conclusions hard to draw. Conclusive evidence that SAPs improve compliance was not provided. Although patients participating in SAPs make errors, small numbers of patients are often responsible for a large number of er- rors. Whilst most studies suggest that SAPs increase pa- tient’s knowledge in part, it is difficult to separate out the effect of the educational component of many SAPs. Most patients who participated in SAPs were satisfied with their care and many would choose to take part in a SAP in the future. No studies measured the total resource requirement of implementing and maintaining a SAP. Keywords Hospital Medication Medicines Review Self-administration J. Wright (&) Pharmacy Department, Southampton University Hospitals NHS Trust, Tremona Road, Southampton, Hants SO16 6YD, UK e-mail: [email protected] A. Emerson Medicines Information Pharmacist-Research and Training, Wessex Regional Drug and Medicines Information Centre, Southampton University Hospitals NHS Trust, Southampton, UK M. Stephens Clinical Support Directorate, Southampton University Hospitals NHS Trust, Southampton, UK E. Lennan Southampton Cancer Centre, Southampton University Hospitals NHS Trust, Southampton, UK Pharm World Sci (2006) 28:140–151 DOI 10.1007/s11096-006-9014-x 123

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Page 1: Hospital inpatient self-administration of medicine programmes: a critical literature review

REVIEW ARTICLE

Hospital inpatient self-administration of medicine programmes:a critical literature review

Julia Wright Æ Angela Emerson Æ Martin Stephens ÆElaine Lennan

Received: 12 October 2004 / Accepted: 3 March 2006 / Published online: 27 September 2006

� Springer Science+Business Media B.V. 2006

Abstract

Aim The Department of Health, pharmaceutical and

nursing bodies have advocated the benefits of self-

administration programmes (SAPs), but their implementa-

tion within UK hospitals has been limited. Perceived

barriers are: anticipated increased workload, insufficient

resources and patient safety concerns. This review aims to

discover if benefits of SAPs are supported in the literature

in relation to risk and resource implications.

Method Electronic databases were searched up to March

2004. Published English language articles that described

and evaluated implementation of an SAP were included.

Outcomes reported were: compliance measures, errors,

knowledge, patient satisfaction, and nursing and pharmacy

time.

Results Most of the 51 papers reviewed had methodo-

logical flaws. SAPs varied widely in content and structure.

Twelve studies (10 controlled) measured compliance by

tablet counts. Of 7 studies subjected to statistical analysis,

four demonstrated a significant difference in compliance

between SAP and controls. Eight studies (5 controlled)

measured errors as an outcome. Of the two evaluated sta-

tistically, only one demonstrated significantly fewer med-

ication errors in the SAP group than in controls. Seventeen

papers (11 controlled) studied the effect of SAPs on pa-

tients’ medication knowledge. Ten of the 11 statistically

analysed studies showed that SAP participants knew sig-

nificantly more about some aspects of their medication than

did controls. Seventeen studies (5 controlled), measured

patient satisfaction. Two studies were statistically analysed

and these studies suggested that patients were satisfied and

preferred SAP. Seven papers studied pharmacy time, three

studied nursing time but results were not compared to

controls.

Conclusions The paucity of well-designed studies, flawed

methodology and inadequate reporting in many papers

make conclusions hard to draw. Conclusive evidence that

SAPs improve compliance was not provided. Although

patients participating in SAPs make errors, small numbers

of patients are often responsible for a large number of er-

rors. Whilst most studies suggest that SAPs increase pa-

tient’s knowledge in part, it is difficult to separate out the

effect of the educational component of many SAPs. Most

patients who participated in SAPs were satisfied with their

care and many would choose to take part in a SAP in the

future. No studies measured the total resource requirement

of implementing and maintaining a SAP.

Keywords Hospital Æ Medication Æ Medicines ÆReview Æ Self-administration

J. Wright (&)

Pharmacy Department, Southampton University Hospitals NHS

Trust, Tremona Road, Southampton, Hants SO16 6YD, UK

e-mail: [email protected]

A. Emerson

Medicines Information Pharmacist-Research and Training,

Wessex Regional Drug and Medicines Information Centre,

Southampton University Hospitals NHS Trust, Southampton,

UK

M. Stephens

Clinical Support Directorate, Southampton University Hospitals

NHS Trust, Southampton, UK

E. Lennan

Southampton Cancer Centre, Southampton University Hospitals

NHS Trust, Southampton, UK

Pharm World Sci (2006) 28:140–151

DOI 10.1007/s11096-006-9014-x

123

Page 2: Hospital inpatient self-administration of medicine programmes: a critical literature review

Introduction

Hospital inpatient self-administration programmes (SAPs)

in which patients self-administer their own medication

have been reported in the literature since 1959 [1]. The

United Kingdom Nursing and Midwifery Council have

advocated their introduction for many years [2] and the

Ashworth enquiry (1992) supported their use in the reha-

bilitation of hospitalised mental health patients [3]. Recent

publications have also advocated their implementation [4–

6]. In 2002 the Audit Commission produced a briefing

paper [7] and the United Kingdom (UK) Hospital Phar-

macists Group issued guidance on implementing one-stop

dispensing, patients’ own drugs and SAPs to support the

patient-focussed NHS redesign strategy [8]. However,

practice research undertaken at this time [9] suggested

fewer than half UK hospitals had implemented pro-

grammes. Reasons identified for not doing so were insuf-

ficient staff or staff time, and expected increase in nursing

workload. The 2003 Medicines Management in NHS

Hospitals self-assessment framework [10] further audited

whether hospitals had implemented SAPs.

A clear, concise definition of self-administration is dif-

ficult to find. In 1994 the Society of Hospital Pharmacists

of Australia, Committee of Specialty Practice in Rehabil-

itation, suggested that: ‘‘self-medication in a hospital set-

ting means that patients self-administer their medications

under staff supervision whilst in hospital’’ [11]. However,

by 2002 this had been revised to: ‘‘a strategy to identify

and address problems associated with the discharge pro-

cess’’ [12]. The philosophy behind self-administration is

described by Bird and Hassall [13] as being underpinned

by the belief that: ‘‘patients should be as independent as

possible, participate in their own care, make decisions

about their treatment in partnership with nursing and

medical staff and therefore be able to make informed

choices.’’ It is precisely this philosophy of patient care

Audit Commission supports [7] and is a central theme of

the NHS Plan [14]. The conventional method of medicines

administration was designed to protect the patient both

from doctors’ prescribing errors and from nurses’ mistakes

in administration [7]. Bird and Hassall question the tradi-

tional view that the nurse’s role in drug administration is:

‘‘to make sure the right drug is given to the right patient at

the right time’’ [13]; they suggest that nurses could play a

larger part in educating patients about their medicines and

help them to establish routines that work for them at home.

Implementing a SAP, it is argued, gives the nurse an

opportunity to achieve this.

Historically one of the largest barriers to implementing

SAPs has been the concern about patient safety, and

accountability if a patient suffered harm. Another concern

is the resources required to establish and maintain

programmes [9]. Nevertheless, several advantages have

been claimed, including improved patient knowledge about

medicines, improved compliance, improved patient com-

fort and empowerment [7].

Aims

The aim was to establish whether findings in published

literature answered the following questions:

• Do SAPs improve patients’ compliance with their

medication?

• Do SAPs affect risks associated with the medicines

administration?

• Do SAPs improve patients’ knowledge of their medi-

cation?

• Do SAPs improve patients’ satisfaction with their care?

• What resources are needed to implement and maintain

SAPs?

• Do SAPs result in fewer treatment failures?

• Do SAPs result in fewer drug related admissions?

• Do SAPs improve health outcomes?

• Are the benefits equal to or greater than the resources

required?

Method

A literature search was performed electronically. Databases

were accessed in March 2004 and searched back to their

electronic start dates. Searches were limited to the English

language. Search details are given in Table 1. Electronic

searching revealed 455 citations, some of which were

duplicated. Two researchers (JW and AE) performed the

primary selection of articles by studying titles and abstracts

independently, and reached agreement on articles for re-

view from primary sources. Papers were selected only if

they had involved the implementation and subsequent

evaluation of a SAP. One hundred and sixty-eight papers

were selected for review from primary source. Both

researchers read all the articles independently and reached

agreement by discussion on which to select for full review.

Papers were selected if they provided a description of the

SAP and this had been evaluated in an objective manner,

including the presentation of results in the form of quali-

tative or quantitative data. Purely descriptive or anecdotal

articles were excluded. Bibliographies of primary source

papers were examined to identify relevant cited works.

These were collected and screened for inclusion as outlined

above, and added to the set of papers for subject to full

review. A total of 51 papers were selected for full review.

All four researchers independently read the articles se-

Pharm World Sci (2006) 28:140–151 141

123

Page 3: Hospital inpatient self-administration of medicine programmes: a critical literature review

lected for final critical review. The literature review was

carried out in accordance with an appraisal tool developed

by the national Critical Appraisal Skills Programme

(CASP) collaboration for quantitative methodologies [15].

All four researchers met to discuss and summarise their

findings for each outcome.

Results

Summarised details of the primary studies reviewed and

outcomes are presented in Table 2. A more detailed table

including clinical specialty, study design and sample size,

evaluation methods and statistical details is available from

the authors on request.

Published literature reviews

One English language review of published literature was

found [63]. This search was limited to nursing databases

for 1983 to 1995 and found 12 empirical studies. Ten were

quasi-experimental, and two were action research. Eleven

non-empirical studies were also reviewed. Although the

research question and outcomes for this review were un-

clear, the authors concluded that, in spite of methodologi-

cal shortcomings, the outcomes from all the 12 empirical

studies substantiated findings from the non-empirical work:

that SAPs increased patients’ knowledge of drug regimens,

names and frequency of administration, but not their

knowledge of side effects. Additionally, they noted a

positive association between SAPs and improved compli-

ance in all but one study [16]. However, all studies in-

cluded in this review were judged by us to be of poor

quality. Four were excluded from this review in the second

sampling process.

Types of self-administration programmes

Self-administration programmes described in the literature

varied widely in their structure and content. Some had

many levels for a patient to complete, from patient

selection or request for medication, to periods of self-

administration monitored by nurses, to un-monitored self-

administration. The length of time spent at each level also

varied and could be either programme or patient specific.

Programmes in rehabilitation settings often required

patients to complete several levels over lengthy periods,

whereas those on acute settings usually comprised only one

level. Some programmes were designed for patients to

complete all levels before discharge. Indeed, being able to

successfully complete the final level of a rehabilitation

programme could be an indicator that a patient is ready for

discharge into the community, or to determine the level of

support required on discharge [64]. In more acute settings,

Table 1 Search strategy

Databases Date Search terms

Zetoc 1993 to Mar 2004 Self-administration and hospital

Self-medication and hospital

Cochrane Library [1] [2003]. Chichester, UK:

John Wiley and Sons Ltd.

Not stated Self-administration and hospitals

Self-medication and hospitals

Pharmline 1978 to Mar 2004 Self-administration

Self-medication

Embase via OVID 1980 to Mar 2004 Drug-self-administration * and hospital *

Self-medication * and hospital *

Medline via OVID 1966 to Mar 2004 Self-administration * and hospitals *

Self-medication * and hospitals *

Cinahl via OVID 1982 to Mar 2004 Self-administration * and hospitals *

Self-medication * and hospitals *

EPIC 1992 to Mar 2004 Performed by the Royal Pharmaceutical

Society of Great Britain

IPAB 1970 to Mar 2004 Performed by the Royal Pharmaceutical

Society of Great Britain

ScHARR http://www.shef.ac.uk/~scharr/ir/netting/ No date specified Self-administration

Self-medication

Drug-self-administration

British Library Thesis Index 1970 to Mar 2004 Self-administration and hospital

Self-medication and hospital

Department of Health websites http://www.doh.gov.uk/index.htm No date specified Self-administration

Self-medication

Agency for healthcare research and quality http://www.ahcpr.gov/ No date specified Self-administration

Self-medication

Drug-self-administration

* = Exploded term

142 Pharm World Sci (2006) 28:140–151

123

Page 4: Hospital inpatient self-administration of medicine programmes: a critical literature review

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Pharm World Sci (2006) 28:140–151 143

123

Page 5: Hospital inpatient self-administration of medicine programmes: a critical literature review

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144 Pharm World Sci (2006) 28:140–151

123

Page 6: Hospital inpatient self-administration of medicine programmes: a critical literature review

patients may be discharged before programme completion.

Most programmes contained elements of information pro-

vision and patient education, ranging from verbal coun-

selling by staff, through written information sheets and

information leaflets, to provision of diary cards, record

sheets and compliance aids. SAPs are varied and complex

interventions and this needs considering when reviewing

studies.

Discussion

Do SAPs improve patients’ compliance with their

medication?

Research into compliance is hampered because rates often

vary between treatments and over time for the same indi-

viduals [65]. Parkin [66] suggests that more patients

deviate from prescribed regimens after hospital discharge

due to non-comprehension than intentional non-

compliance. Twelve papers measured the effect on

compliance as an outcome [16–27]. Nine studies were

controlled [17–25], two uncontrolled [26, 27], and one

compared a SAP with a structured teaching programme

[16]. All samples were small; the largest [25] contained

178 patients in the experimental arm. Ten studies followed

patients up post-discharge, at time intervals ranging from

1 week to 4 months post-discharge and two studies con-

tained inpatients only [26, 27]. Tablet counts were used to

assess compliance in all studies. A drawback with these are

that patients may adjust numbers of tablets either deliber-

ately or inadvertently. In addition, different types of

administration errors may cancel out [28] e.g. an overdose

may cancel an error of omission; errors concerning timing

will not be detected. More covert approaches can encounter

ethical issues regarding informed consent [67]. In 10

studies counts were performed directly by the investigators.

The remaining two, relied on patient counts or the inves-

tigators’ judgement [17, 25]. Both these methods have been

shown to over-estimate compliance [68]. None of the

studies described how medication prescribed ‘‘as re-

quired’’ was assessed.

The methods used for rating patients as ‘‘compliant’’

varied. In four studies [16, 23, 24, 26] a compliance score

was calculated for each patient as the percentage correct

number of tablets remaining and it is assumed that Foster

et al. [22] used a similar methodology. This allows com-

parison between individual patients and groups. Jensen

[25] used a more complex calculation to score adherence

and Hannay [27] calculated an average compliance score

for the group. One study [20] measured the number of

patients having the correct number of tablets remaining.

Use of absolute ratings of compliance means that a patient

making one error, could be rated non-compliant in the

same way as a patient making many. Two authors [18, 19]

used ‘‘days deviation’’ in therapy as measures and pooled

data. The remaining study [21] measured numbers of

errors made then calculated an average percentage of non-

compliance to assign patients to one of three compliance

levels.

Of the studies subjected to statistical analysis, four

reported a significant difference [18, 19, 21, 23]. Although

a P value of 0.02 is quoted by D’Altroy et al., it is not clear

whether this relates to significance between both groups at

all levels of compliance. Beardsley et al. [19] found sig-

nificant differences (P < 0.01, t-test) in mean numbers of

‘‘deviation in days’’ treatment between the self-

administration group (1.8 days deviation) and controls

(3.6 days deviation). Wood et al. [21] reported signifi-

cantly more patients with greater than 15% non-compli-

ance in controls compared to the study group at 2 weeks

post-discharge (P < 0.02) and at 3 months post-discharge

(P < 0.05 chi-squared and Fisher’s exact tests). However,

the patient numbers in all groups were small and no sig-

nificant differences were found between the results for

patients with less than 15% non-compliance. Lowe et al.

[23] reported significantly better compliance scores for the

self-administration group compared to controls at 10 days

post-discharge (95% compared to 83%; P < 0.02 Mann–

Whitney U). Two studies [22, 25] reported no significant

difference in percentage compliance scores between the

study and control groups. One of these [22] is quoted in ‘‘A

spoonful of Sugar’’ [6] as supporting the hypothesis that

SAPs improve patient compliance. Proos et al. [16]

reported no significant difference in compliance scores

between a group of patients receiving a structured educa-

tion programme and a group participating in a SAP. Whilst

the results from the studies are inconclusive, it is evident

that some patients will comply and others will have sig-

nificant non-compliance problems irrespective of whether

they participate in a SAP.

Do SAPs affect risks associated with medicines

administration?

Medication errors can be considered a measure of risk as

well as non-compliance. Eight studies measuring errors

were reviewed [28–35]. Design and methodology varied

considerably. Six studies used tablet counts [28, 30–32, 34,

35], one used disguised observation [31] and two used

structured interviews [29, 33]. Five studies were controlled,

three of these [33–35] were randomised and followed up

patients after discharge; however, randomisation broke

down in one [34]. Pereles et al. [35] claimed a ‘‘significant

Pharm World Sci (2006) 28:140–151 145

123

Page 7: Hospital inpatient self-administration of medicine programmes: a critical literature review

improvement in compliance for the self-administration

group as measured by the proportion of medication errors

of the total doses administered (0.045 vs. 0.086,

P < 0.001)’’. Details of the total numbers of errors made

and total doses are not provided, only averages. However,

the numbers of serious errors (with a potential for health

risk) were analysed separately and not found to be statis-

tically different between groups. All serious errors were

errors of omission, it is unclear how this methodology

would have captured other types of error. Newcomer and

Anderson [33] failed to demonstrate a significant differ-

ence in missed doses between groups, but details of

methodology are lacking. Studies containing larger patient

numbers [33, 35] lost approximately one third of patients to

follow up.

Davidson’s controlled study [32], is limited by small

patient numbers and short timescale. Wandless and Davie

[28], found patients using written reminders made statis-

tically fewer errors in self-administration than those with-

out reminders.

Only one study [31] compared errors made by patients

with those made by nurses and technicians. Out of 1135

administered doses, nurses made 21errors (3.86% error

rate) and technicians made six (1.02% error rate). Seven-

teen errors of omission and 10 errors of commission (any

dose incorrectly administered as a wrong or unscheduled

drug or wrong dose) were made. The self-administering

group made 153 errors in administering 3548 doses (4.3%

error rate). All these were errors of omission, but the study

design prevented detection of errors in dosing and timing.

All the errors were made by six patients; nine made no

errors. Although Shannon’s study [34] contained small

numbers in each group, 3 out of 11 study patients and 4 out

of 10 controls made no errors, and 88 out of a total of 105

errors made by controls, were made by 2 patients. If data

from these two patients were to be excluded, the control

group would have made fewer errors than the study group.

Reibel [29] reported that 7 patients made errors accounting

for 87% of total errors, and an unusual study by Libow and

Mehl [30], in which patients self-administered two sets of

placebo medication, also demonstrated that a high pro-

portion of total errors were made by one patient who re-

quired correction almost every day. This illustrates the

need to consider the range of the data in relation to indi-

vidual patients, before drawing conclusions from pooled

data alone.

Do SAPs improve patients’ knowledge of their

medicines?

Seventeen papers [16, 19, 20, 23, 25, 33, 35–45] were

selected for review that studied the effect of a SAP on

patients’ knowledge about their medicines. Five were

randomised and controlled [20, 23, 33, 35, 36], five were

controlled [19, 25, 37–39] and five were designed only to

test patient knowledge before and after taking part in the

programme [40–44]. A further randomised, controlled

study [16] compared the effect of a structured teaching

programme with a SAP on patients’ knowledge. Traiger

and Bui’s [45] uncontrolled study only measured patients’

knowledge at discharge and is thus methodologically

flawed.

SAPs’ structure varied and included verbal counselling

with or without additional written information or remind-

ers. Three randomised controlled studies measured

knowledge at a single point in time [20, 23, 33], and sev-

eral studies utilised a before-and-after design, testing

knowledge at more than one point. Whilst enabling base-

line measurements to be used for stratifying or matching

variables, it may introduce bias by sensitising patients

during the baseline measurements. This effect is likely to

be greater in studies where knowledge is tested more than

twice. Before-and-after designs are methodologically weak

because secular trends or other concurrent changes make it

difficult to attribute observed changes to the intervention

being studied [69].

Two studies [42, 44] used written questionnaires, mix-

ing open and closed questions. Fifteen [16, 19, 20, 23, 25,

33, 35–41, 43, 45] used verbal questioning or question-

naires. Of these, 14 used open questions and one closed

[40]. In the studies using open questions, details of how

questions were scored are only described in five of the

papers [16, 36, 39, 41, 43]. Details of questions and

questionnaires were provided in 10 studies [16, 25, 35,

38–44].

The use of structured interviews is subject to interviewer

bias although this can be reduced if an independent re-

searcher is used. Inter-rater reliability can also be prob-

lematic. Hoffman et al. [40] used a 10 point questionnaire

was used that required true/false answers, thus having a

50% chance of correct guess. In the randomised, controlled

studies, Newcomer and Anderson [33] reported statistically

significant improvement in patients’ knowledge of drug

names, time to take, adverse reactions (P < 0.005) and side

effects (P < 0.0025), details of the evaluation methodology

are lacking. Lowe et al. [23] found a statistically significant

increase in patients’ knowledge of their medication pur-

pose. Pereles et al. [35] reported statistically significant

gains in knowledge over time for drug names, appearance,

time to take and purpose in both the study and control

groups, but no significant differences in knowledge of side

effects. However, no significant differences were found in

any of the parameters between the groups, implying that

patients will learn over time irrespective of the system.

146 Pharm World Sci (2006) 28:140–151

123

Page 8: Hospital inpatient self-administration of medicine programmes: a critical literature review

In the controlled studies, Jensen [25] reported significant

increases in knowledge in both study and control groups

from admission to 16 weeks post-discharge, with signifi-

cantly higher scores in the study compared to control

group. Beardsley et al. [19] reported statistically significant

differences between study and control groups in the

‘‘number of questions missed regarding knowledge of

treatment’’ at 1-month post-discharge follow-up. Scores

out of a possible 60 points are quoted, however, details of

questions and methods are lacking. Furlong [39] reported

statistically significant differences in knowledge gain in

both groups for drug name and dose, and purpose, from

admission to 8-week post-discharge, and for time to take,

in just the study group. Neither group showed significant

differences in increased knowledge regarding side effects;

there were no significant differences between the groups.

No P values are quoted for any differences stated and the

control group was small. The data regarding knowledge

and numbers of medications were assessed collectively for

each group and analysed using chi-squared tests. The au-

thors acknowledge that multiple testing may have led to

type 1 error resulting in spuriously significant findings.

The results of four out of the five uncontrolled studies,

comparing differences in patients’ knowledge before and

after having taken part in a SAP, were analysed statistically

[40–43]. Hoffman et al. [40] reported statistically signifi-

cant increases in knowledge for 5 out of 10 questions

requiring true/false answers relating to post-partum stand-

ing order medication. In addition, the percentage of correct

answers in post-test scores increased for each question.

Pelletier et al. [41] reported statistically significant differ-

ences in knowledge from admission to discharge, in drug

name, appearance, purpose and time to take and less

improvement in drug strength, however, the standard

deviations quoted are all well in excess of the mean dif-

ferences stated. In the study by Ng et al. [43], statistically

significant improvement in knowledge regarding side ef-

fects and compliance concerns was reported, but no dif-

ference in improvement in knowledge concerning regimen

and purpose. However, details of the statistical evaluation

are not stated, the number of patients is small and the study

period was only 1 week.

As most programmes contain some provision of infor-

mation to patients either in the form of verbal counselling

or explanation, written information leaflets or diary re-

minder cards, it is difficult to ascertain whether it is the

education component of the programme that has the most

impact on increasing knowledge or whether it is because

the patient is responsible for taking their own medication

or a combination of the two. Two uncontrolled studies

attempted to investigate this. Thomas et al. [42] measured

knowledge at five points: on entry to the study, then fol-

lowing an educational programme, then following a SAP

at discharge and 1 month following discharge. Statistically

significant differences in percentage correct answers were

reported on entry, compared to after an education pro-

gramme (P < 0.01) and prior to commencing self-admin-

istration compared to discharge (P < 0.05), but no

significant differences between scores were achieved from

discharge to 1-month post-discharge follow-up. The largest

average percentage change in test scores was obtained

between entry to the study and post-education, suggesting

that education about medicines contributes more to

knowledge gain than participation in a SAP, although the

results also suggest that there was some additional gain in

knowledge during the programme. The randomised con-

trolled study by Proos et al. [16] aimed to compare dif-

ferences in knowledge as a result of a SAP compared to a

structured teaching programme. Patients in both groups

had higher scores in all knowledge test categories at dis-

charge compared to entry, however, statistically significant

differences between the groups were only found in the

categories of name, purpose, time to take and side effects

for SAP compared to structured teaching participants.

Some controlled studies seem to indicate that patients’

knowledge improves with time irrespective of whether

they participate in a SAP [37, 39], although control pa-

tients in one [35] received discharge counselling and the

number of controls in another [39] was small. In all the

studies data had been pooled for analysis and so the level

of patient’s pre-existing knowledge could not be taken into

account.

Do SAPs improve patient’s satisfaction with their care?

Measuring satisfaction with healthcare is difficult, partic-

ularly when views are determined whilst the patient is in

hospital or requires further care, as this may bias their

response. Seventeen papers [23, 25, 29, 37, 39, 40, 45–55]

were selected for review that had undertaken some measure

of patient satisfaction. Five were controlled studies [25, 37,

39, 45, 55]. All used a questionnaire or structured inter-

view; one was an informal survey [48]. One study [46]

used a mixture of multiple choice and open questions, four

used questions requiring yes/no/indifferent answers

[40, 45, 47, 52], three used Likert rating scales [25, 52, 54],

two, [39, 51] used open questions and Deeks and Byatt [55]

used a variety of questioning methods. Details of questions

were not provided in seven of the seventeen papers [23, 29,

37, 48, 49, 50, 53]. Five studies were postal surveys [40,

45, 47, 51, 55]. Those using multiple choice or yes/no/

indifferent answers had higher response rates [40, 47] than

those using open or mixed questions [51, 55]. High num-

bers of patients who had experienced SAPs responded in

favour of self-administration compared to nurse-adminis-

tration: 76–100% [23, 39, 40, 46, 49, 50]. Similarly when

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patients were asked whether they would choose to self-

administer in future if offered a choice, many of those who

had experienced a SAP answered in favour; 81–100% [37,

52, 55]. Only 20% of controls in the Leadbeater [37] study

said they would choose self-administration and all five

control patients in the Furlong study [39] preferred nurse

administration in the belief that it was more convenient for

the nurse and saved time, although, 9 patients in the study

group said they preferred self-administration because it

saved nursing time. The results from only two studies [25,

55] were statistically analysed. Jensen [25] reported 73.7%

of patients in both study and control groups preferred self-

administration and the self-administration group scored

significantly higher for understanding their medication and

coping on discharge, compared to admission. Deeks and

Byatt [55] reported a statistically different response

depending on control patients’ age; 45% of younger pa-

tients ( < 60 years of age) would choose self-administration

compared to 18% of older patients (>60 years). They also

found self-administering patients reported a significantly

better overall impression of their care (P < 0.05) and were

significantly more satisfied on their feeling on discharge

compared to controls (P = 0.008) The reasons why patients

were included or excluded from self-administration are

unclear, thus the control group could contain a dispropor-

tionate number of patients who would be unsuitable for

self-administration; this could explain why there were

more elderly patients in the control group. Work by Tho-

mas [70] also supports the perceptions of patients in the

control groups of the papers reviewed i.e. that approxi-

mately 80% of patients would prefer nurse-administration

if offered a choice.

Most patients who have experienced a SAP will be

satisfied with their experience and would chose this again,

but the majority of patients who have never experienced

self-administration are more likely to choose nurse

administration.

What resources are needed to implement and maintain

SAPs?

No studies were found which measured the overall impact

on resources of implementing a SAP. Several studies at-

tempted to measure the impact on pharmacy and nursing

time, but most of the data quoted are anecdotal, and lack

detail of methodology or tasks being undertaken. It is

difficult to measure time accurately when staff are subject

to constant interruptions, unless independent observers are

used. Furthermore, the validity of detailed time and motion

studies for individual staff groups could be questioned,

since it is the overall impact that is important as tasks

within a SAP could be undertaken by a variety of profes-

sionals.

No studies assessed an overall impact on time. Seven

papers [17, 56–61] contained some evaluation of pharmacy

time. Four lacked details of methodology. The amount of

time required by pharmacy staff is heavily influenced by

programme design. Figures given ranged from 15 min for

uncomplicated discharge counselling [17] to up to an hour

for complicated consultations [17, 58] or to start a typical

elderly patient on a full programme [59]. Johnson et al.

[56] suggested that a rehabilitation ward required 4–5 h of

pharmacist time daily if the pharmacist was responsible for

monitoring compliance and dispensing medication. Beau-

mont et al. [60] suggested that 105 min of technician time

and 90 min of pharmacist time per week was required for

dispensing a seven level programme for rehabilitation pa-

tients, but the report lacks details. Pearce [61] reported the

pharmacist required 10 min per patient at ward level with

an additional 10.4 min per patient for dispensing a mean

number of 5.6 medications per patient. It should be noted

that all papers reported figures before introduction of Pa-

tients’ Own Drug Schemes, which are now routine practice

in most UK hospitals. The amount of time required to

dispense one month’s supply of medication for patients

will be accounted for in the implementation of these

schemes. In most cases this will be offset by the cost saved

by not having to dispense inpatient supplies or by using

patients’ own medication [71–74]. No studies were found

that compared the amount of pharmacy time spent before

programme implementation with that required to set-up,

and maintain it.

Three papers [49, 60, 62] were reviewed which had

attempted some evaluation of nursing time, although

methodology was not described. It is suspected that two of

these papers [60, 62], are describing the same programme.

Although more nursing time was needed in early levels,

time was saved on later ones, but it is unclear whether

timings quoted are based on empirical data. Anderson and

Poole [49] reported 15 min instruction per patient was

required to start patients on a single level post-partum

obstetric programme and the amount of time spent on

medication rounds did not decrease.

Do SAPs result in fewer treatment failures, drug related

admissions or improve health outcomes?

No studies were found that measured the effect of SAPs on

treatment failures, drug related admissions or health out-

comes.

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Conclusion

Although SAPs have been reported in the literature for

many years and appear to be based on sound ideology and

commonsense, the vast majority of research is descriptive

and anecdotal. There is a paucity of well-designed studies

using sound methodologies. Most of the studies reviewed

had serious methodological flaws. Some were quasi-

experimental based on single sites, limiting generalisabil-

ity. Many used too small a sample size or had low response

rates, and little or no attempt was made to establish the

impact that non-responders or dropouts might have on the

findings. In most of the studies evaluation was undertaken

by practitioners providing the service, there was poor

control for investigator or observational bias.

The rationale for SAPs is based on the belief that im-

proved patient education leads to improved knowledge per

se and this will, in turn, improve concordance. Research has

shown that patients feel they receive insufficient informa-

tion about their medicines [75], in particular side effects

[76], and that providing patients with information improves

knowledge and satisfaction [77]. However, enhancing

knowledge does not necessarily improve compliance with

medication regimens. There are studies that demonstrate a

positive correlation between knowledge and compliance

and others that fail to find an association [78]. This may be

because medication knowledge is not a unitary concept, but

comprises different knowledge components. Clearly, fac-

tors that govern compliance are complex and varied. The

results from the studies reviewed failed to provide conclu-

sive evidence that SAPs improve compliance.

It is evident from the studies reviewed that patients do

make errors when participating in SAPs and the number of

errors may be higher than those made by other health

professionals when administering medicines. The impact of

these errors is not reported. There is insufficient evidence

to judge whether patients who have participated in a SAP

make fewer errors on discharge than those who have not

participated in a programme.

It is now widely accepted that the traditional concept of

compliance contains many questionable assumptions such

as that the patient is a passive, unquestioning recipient of

advice. It assumes that any problems with compliance are

associated with the patient alone [79]. The modern ap-

proach of achieving concordance means the patient is an

active participant in treatment decisions. On this basis it is

not possible to have a non-concordant patient; only a

consultation or a discussion between the two parties con-

cerned can be non-concordant [80]. The provision of

information, therefore, is important in achieving concor-

dance. Information can influence positively either directly,

e.g. how to take a medicine, or indirectly, e.g. correcting a

misunderstanding. However, information e.g. on risks of

treatment may have a negative influence [81]. Once con-

cordance is achieved, the issue of adherence to the agreed

regimen is an important goal that the SAP should support.

Most SAPs included information provision to patients,

most commonly as verbal explanations or counselling.

Some provided written information varying in format and

type. Studies lacked full descriptions of information pro-

vided making assessment difficult. Although most studies

seem to suggest that SAPs contribute positively to

increasing knowledge, it is not clear whether it is the

informational component of the programmes or the self-

administration component, or the combination of the two

that has the most importance.

Research suggests that patients who have taken part in

programmes feel they have benefited from them and would

take part again. The importance of giving patients a choice

is central to current UK government health policy. No

studies have measured the total resource requirement of

implementing and maintaining a SAP. Many of the claimed

advantages of SAPs are not substantiated by good scientific

research. The proportion of patients eligible for a SAP have

been reported as between 10 and 50% [27, 31, 47, 56] for

rehabilitation and as few as 26% [61] for cardiology,

suggesting that traditional methods of administration are

required for many patients.

There appears to be three theoretical reasons for estab-

lishing a SAP:

1. Diagnostic—to see whether a patient can cope with

self-administration before discharge.

2. Educational—to teach a patient how to self-administer

accurately before discharge.

3. Empowerment—to maintain a patient’s independence

and ability to self-care.

Some SAPs have been established without clearly de-

fined, or with inappropriate, goals. These may vary

depending on the clinical setting and differ between pa-

tients. To achieve concordance the patient’s view must be

given primacy in setting goals. Measuring how many pa-

tients achieve adherence to the regimen that should lead to

their desired goals could be used to evaluate the effec-

tiveness of a programme. It may, however, be more

important to identify patients not achieving desired thera-

peutic outcomes and considering strategies to remove

barriers that are preventing this. Health services are con-

tinually evolving and interventions are frequently intro-

duced to address perceived problems in the way in which

services are delivered. As many of these are based on

common sense or political ideology with little supporting

research evidence, there is potential for significant oppor-

tunity costs should the intervention be inefficient or inef-

fective. Well-designed research studies are needed to

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evaluate changes in practice retrospectively as well as

prospectively, to ensure that the desired objectives are

being met. In the case of SAPs further research is required,

in particular, to answer the following questions: Do SAPs

improve concordance in patients who are known to be poor

compliers? Do SAPs enable patients to learn more about

their medicines than an educational programme? What are

the total resources required to implement and maintain a

SAP in a modern day setting?

Acknowledgements The authors thank Dr. David Brown Ports-

mouth University for his valuable help in drafting this manuscript.

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