Assessment of pharmacist-led patient counseling in randomized controlled trials: a systematic review

REVIEW ARTICLE

Assessment of pharmacist-led patient counseling in randomizedcontrolled trials: a systematic review

Lucas Miyake Okumura • Inajara Rotta •

Cassyano Januario Correr

Received: 13 February 2014 / Accepted: 10 July 2014

� Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014

Abstract Background Pharmacists’ counseling has

improved health-related outcomes in many acute and

chronic conditions. Several studies have shown how

pharmacists have been contributing to reduce morbidity

and mortality related to drug-therapy (MMRDT). However,

there still is a lack of reviews that assemble evidence-based

clinical pharmacists’ counseling. Equally, there is also a

need to understand structure characteristics, processes and

technical contents of these clinical services. Aim of the

review To review the structure, processes and technical

contents of pharmacist counseling or education reported in

randomized controlled trials (RCT) that had positive

health-related outcomes. Methods We performed a sys-

tematic search in specialized databases to identify RCT

published between 1990 and 2013 that have evaluated

pharmacists’ counseling or educational interventions to

patients. Methodological quality of the trials was assessed

using the Jadad scale. Pharmacists’ interventions with

positive clinical outcomes (p \ 0.05) were evaluated

according to patients’ characteristics, setting and timing of

intervention, reported written and verbal counseling.

Results 753 studies were found and 101 RCT matched

inclusion criteria. Most of the included RCTs showed a

Jadad score between two (37 studies) and three (32 stud-

ies). Pharmacists were more likely to provide counseling at

ambulatories (60 %) and hospital discharge (25 %); on the

other hand pharmacists intervention were less likely to

happen when dispensing a medication. Teaching back and

explanations about the drug therapy purposes and precau-

tions related to its use were often reported in RCT, whereas

few studies used reminder charts, diaries, group or elec-

tronic counseling. Most of studies reported the provision of

a printed material (letter, leaflet or medication record card),

regarding accessible contents and cultural-concerned in-

formations about drug therapy and disease. Conclusion

Pharmacist counseling is an intervention directed to

patients’ health-related needs that improve inter-profes-

sional and inter-institutional communication, by collabo-

rating to integrate health services. In spite of reducing

MMRDT, we found that pharmacists’ counseling reported

in RCT should be better explored and described in details,

hence collaborating to improve medication-counseling

practice among other countries and settings.

Keywords Medication adherence � Patient counseling �Patient medication knowledge � Pharmacist � Quality of

health care

Impact of findings on practice statement

• Randomized controlled trials (RCT) have proven that

medication counseling is effective for improving health

related outcomes.

• It is highly likely that medication counseling is

performed by explaining the correct ‘‘indication’’ or

Electronic supplementary material The online version of thisarticle (doi:10.1007/s11096-014-9982-1) contains supplementarymaterial, which is available to authorized users.

L. M. Okumura (&)

PGY 2 Oncology and Hematology Clinical Hospital, Federal

University of Parana, Curitiba, PR, Brazil

e-mail: [email protected]

L. M. Okumura � I. Rotta � C. J. Correr

Pharmacy Department, Federal University of Parana, Lothario

Meissner St, number 632., Jardim Botanico, Curitiba,

Parana 80210-270, Brazil

123

Int J Clin Pharm

DOI 10.1007/s11096-014-9982-1

‘‘drug therapy purposes’’ and also ‘‘precautions with

medication’’.

• Few RCT into medication counseling have reported

economic outcomes and most of these studies used only

partial economic analysis. Future investigations should

focus on opportunities costs and cost-effectiveness

analysis.

• There is a substantial need to improve the quality of

pharmacists-led RCT by reporting verbal and written

counseling, describing the outputs, withdrawals and the

randomization process.

Introduction

According to International Pharmaceutical Federation,

pharmacists should ensure that health management, disease

prevention and healthy lifestyle behaviors are incorporated

into the patient assessment and care process. Pharmacists’

interventions, such as medication and/or disease counsel-

ing, are a way to ensure that people derive maximum

benefits from drug therapy by individualizing care plans,

optimizing the communication between professionals,

improving patients’ medications, disease knowledge and

self-care [1].

Pharmacists’ counseling has improved health-related

outcomes in many acute and chronic conditions. Several

studies have shown how pharmacists have been contrib-

uting to reduce morbidity and mortality related to drug-

therapy (MMRDT) [2–7]. Health-related outcomes and

other surrogate endpoints have been used to demonstrate

effectiveness from these services, such as patients’ drug

therapy knowledge, disease knowledge, self-care and

medication adherence [5, 6].

Therefore, pharmacists’ counseling is a clinical service

that has been playing an important role to public health [2–

7]. However, there are few reviews that assemble and

discuss about evidence-based clinical pharmacists’ coun-

seling or education interventions that focus on pharmacy

practice. Equally, there is also a need to understand

structure characteristics, processes and technical contents

of these clinical services, instead of only reviewing the

effectiveness from clinical pharmacy services as published

elsewhere [8].

Aim of the review

The objective of this article is to review the structure,

processes and technical contents of pharmacists’ counsel-

ing interventions reported in RCT that had positive health-

related outcomes.

Methods

Literature search and inclusion criteria

We performed a systematic search in specialized databases

(Medline, IPA, SCOPUS, Cochrane Library and CINAHL)

to identify RCT, written in English, Spanish or Portuguese,

that evaluated pharmacists’ counseling or educational

interventions published between 1990 and 2013. This

systematic review was conducted according to the Coch-

rane Collaboration recommendations and PRISMA state-

ment [9, 10].

All RCT that reported pharmacist-led counseling or

education interventions were included. Observational

studies, such as crossover, cohorts, case–control and cross-

sectional studies were excluded. Figure 1 describes in

details the process of study selection and exclusion. Search

strategy is available in Appendix 1

Quality assessment

The methodological quality of trials was assessed with the

Jadad scale [11]. This scale is a simple, reliable and vali-

dated five-questions-based instrument that evaluates qual-

ity of articles by assessing their randomization, blindness

and withdrawals or dropouts. RCT that scores one may

have low methodological quality, while studies that score

five, the highest punctuation, are likely to have good

quality.

Data extraction and analysis

Data extraction was performed only for studies that had

interventions with positive and statistically significant

outcomes (p \ 0.05), which were categorized into three

domains: outcomes, studies characterization and counsel-

ing contents.

Clinical, economic or humanistic outcomes were

extracted as well as other commonly reported surrogate

outcomes in pharmacist-led RCT, such as lifestyle change

and disease or medication knowledge.

Pharmacists’ interventions were characterized according

to patients’ characteristics, duration of study, timing of

action, setting (where the patient received the service) and

clinical data sources.

Finally, verbal and written counseling were extracted

and analyzed regarding ‘‘what’’ was informed and ‘‘how’’

counseling or education process was performed. Published

visual materials were analyzed by its type (diary, cards,

reminders, leaflets, etc.), how it was provided to patients

and its content (whether it has drug information or disease

information).

Int J Clin Pharm

123

Results

Studies selection

Initially we found 753 articles. One hundred and thirty-four

registries were eligible for full text reading after abstracts/

titles screening and exclusion of duplicated articles.

Because 652 studies did not matched inclusion criteria, 101

remaining RCT were selected for data extraction and

analysis.

Quality of studies and common outcomes assessed

The majority of the included RCT showed a Jadad score

between two (37 studies) and three (32 studies). There were

no studies that scored four or five. Figure 2 describes the

number of included articles published from 1990 to 2013

with its respective Jadad scores.

All 101 included RCT reported statistically significant

outcomes (p \ 0.05) and lifestyle changes (63 %) and

clinical health outcomes (60 %) were more likely to be

reported. Drugs and disease knowledge (42 %) and

humanistic outcomes (28 %) were also common research

endpoints. On the other hand, economic outcomes were

rarely evaluated (5 %). Clinical pharmacists’ interventions

have been promoting better health-related outcomes as

follows:

a. Clinical outcomes: reduction of arterial blood pressure,

improvements in glycemic control, asthmatic crisis,

lipid profile, Helicobacter pylori infection, heart

failure, weight loss, pulmonary function improvement,

tobacco cessation, acute coronary syndromes, depres-

sion, renal transplantation, schizophrenia and osteopo-

rosis [3, 12–25, 32, 41–73, 76–106].

b. Humanistic outcomes: improvement of quality of life

and patients’ satisfaction with service [2, 7, 23, 27, 76,

92, 95, 100].

c. Economic outcomes: cost-effectiveness assessments

and cost savings related to use of drug therapy [25–27,

83, 84].

d. Lifestyle changes: consumption of more nutritive and

less caloric food, smoking cessation and promotion of

physical activities [28–31, 75].

Fig. 1 Selection of randomized controlled trials included in the systematic review

Int J Clin Pharm

123

e. Drug and disease knowledge: drug therapy self-mon-

itoring and how to improve the process of medication

use [5, 25, 33, 66–68, 71, 76, 91, 93, 94, 97, 99, 102–

104].

Studies characterization

From 101 included studies, 60 % took place in ambulatory

setting and 25 % on hospital discharge. Markedly, in 82 %

of the cases, the intervention did not started when dis-

pensing a medication. In other words, only 18 % of the

studies provided a counseling session in a dispensation

context. Follow-up was observed in 43 % of the cases in

the ambulatory setting; 39 % at patients’ home and 34 % at

community pharmacies (when patient returned for filling

prescriptions, for example).

Most of RCT (91 %) directed and structured their ser-

vices to specific diseases and conditions, such as diabetic

and depressive patients, smokers, asthmatics, etc. [34–38,

74, 75].

When we analyzed the process of care, in 70 % of cases

a systematic evaluation of drug therapy was performed and,

only in a few studies (5 %), a method (e.g.: Dader method)

or a validated algorithm was employed to review patients’

pharmacotherapy. Approximately 43 % of RCT have

described an individualized care plan and, in 50 % of them,

pharmacists made changes to patients’ drug therapy or

referred to another professional to adequate it. In 56 % of

the evidences, communication between the clinical phar-

macist and other health care providers was either by verbal

or written counseling.

Besides the process of drug therapy evaluation, face-

to-face follow-up was performed in 56 % of the cases

and, in 32 % studies, remote monitoring was reported as

a follow-up strategy (telephone, internet and others). In

most cases (60 %), pharmacists provided written mate-

rials to patients, such as a diary, self-monitoring card,

leaflets and other educative issues with informations

about drug use process and the disease. Medication

compliance devices such as pill boxes were poorly used

in the studies (8 %).

Fig. 2 Methodological quality

and quantity of the included

studies

Fig. 3 Network with verbal counseling representation. The amount

of studies found is proportionally represented with circles’ sizes and

lines are proportionally thicker when there are more than 10 RCT

reporting these characteristic from verbal counseling. Circles are also

proportionally represented by three different sizes: bigger circles

(C35), intermediate circles (\35) and smaller circles (\10 studies)

Int J Clin Pharm

123

Verbal counseling

Pharmacists have counseled patients by explaining the

correct ‘‘indication’’ or ‘‘drug therapy purposes’’ and

‘‘precautions with medication’’ (adverse reactions, drug

interactions, etc.) were more likely to be reported in the

101 analyzed studies. We observed that the process of

feedback or ‘‘teaching back’’ was also part of RCT coun-

seling interventions. In 35 studies, counseling included an

explanation about ‘‘the importance of drug use and com-

pliance’’, followed by 33 and 29 studies that respectively

reported ‘‘dosage regimen’’ and ‘‘administration’’ as part of

patient counseling. Fewer studies focused on ‘‘what to do if

missing a dose’’ and ‘‘how to store the medication’’ [6, 39–

42]. Figure 3 shows a network representation of verbal

counseling from included RCT in this review. It illustrates

the number of studies (size of circles) and the association

(thicker lines) between reported points of counseling.

Finally, it is important to mention that in a few cases, the

RCT used techniques from humanistic sciences, such as

behavioral strategies (e.g.: stages modification theory) and

patient-centered care [43, 44].

Written counseling

Written materials used in pharmacists’ counseling, descri-

bed in Fig. 4, followed the same pattern of characteristics,

so it was possible to group them in four domains: type of

material (leaflets, diaries, reminders, etc.); how pharma-

cists use it to provide counseling (whether it was passively

delivered to the patient or used together with a verbal

instruction); content (drug or disease information); and

specific characteristics (use of accessible content, use of

group counseling, etc.). Most of studies reported the

provision of a printed material (letter, leaflet or medication

record card), which had accessible, social and cultural-

concerned information (Arabic translation or Indian dia-

lect, for example) about drug therapy and disease [5, 26,

45–62].

RCT reported the use of reminder charts and diaries in

lower frequency. A smaller number of reports about group

and electronic counseling were also observed.

Discussion

Quality of studies and common outcomes assessed

Pharmacists’ counseling reported in the RCT had directed

and planned services to specific chronic and acute condi-

tions. These clinical services focused on achieving definite

outcomes and attending to patients’ needs.

Since the 90 s, the quality of these evidences has been

increasing during the years. The twenty first century is a

landmark, when considering the increasing proportion of

RCT which have scored by two and three points in Jadad

scale. It means that dropouts and withdrawals were repor-

ted and randomizations were well-conducted. There were

no articles that scored four or five because counseling and

education interventions are difficult to be masked or blin-

ded. Special attention should be given to the amount of

studies that scored zero and one in 2010/2011 and

2012/2013, which is unacceptable as it implies that one

decade before, in 2000/2001, there were almost the same

percentage of studies that did not reported studies outputs,

withdrawals and even the randomization process. In other

words, these simple reporting mistakes may mistrust

studies’ quality and improvements must be made through

Fig. 4 Network with visual material characteristics. White boxes represent more than 10 RCT and black boxes represent less or equal to 10 RCT.

The thickest lines represent more than 10 RCT and other thinner lines represent less than 10 RCT

Int J Clin Pharm

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years of experience with clinical pharmacy services and

RCT publications.

Lifestyle changes and clinical outcomes are commonly

chosen variables to demonstrate effectiveness of the

interventions, followed by patients’ drug & disease

knowledge and humanistic outcomes (patient satisfaction

with the service and quality of life). In spite of the proven

effectiveness in promoting and preventing drug therapy-

related morbidity, none has demonstrated to reduce mor-

tality, possibly due to RCT short follow up, and only 4 %

of the studies demonstrated economic outcomes. This may

be due to different practice scenarios, authors’ experience

and health systems. Assembling cost expenditures to other

health outcomes would not only evaluate efficiency of

these clinical services, but would also give more consis-

tency to other services projects implementations, especially

when the time spent by pharmacists to provide patient

counseling sections is considered. Additionally, when an

economic outcome was reported, there was only one RCT

with a cost-effectiveness analysis, while other two studies

described partial economic analyses, such as cost reduction

and cost prevention analysis.

Structure, processes and technical contents

of pharmacists’ counseling

When analyzing counseling setting, community pharmacy

was not often reported as a setting to conduct a clinical

service. In addition, drug dispensing was rarely reported in

RCT as timing to provide counseling; on the other hand,

follow-up was frequently done at pharmacies and at

patients’ home, mainly to detect adherence problems.

Because pharmacies have different public health concep-

tions, structures, objectives and health systems insertions in

many countries, these locations were poorly used as a RCT

setting. However, included studies have both demonstrated

a clear opportunity to provide medication adherence ser-

vices at pharmacies and also to be source of relevant

clinical information to other professionals and institutions.

The results of verbal and written counseling suggest two

special circumstances: (1) pharmacists’ counseling may be

related to positive health-related outcomes when done with

‘‘six items’’; and (2) written materials may be more

advantageous when delivered to support a counseling

process, by including disease and drug-specific information

with accessible contents. The most common printed

materials were leaflets, brochures & information sheets and

letters to other health professionals.

While performing counseling, according to this review,

a minimum of ‘‘six-point medication counseling’’ together

with the characteristics listed about written materials might

be considered when planning and developing a medica-

tion counseling service. However, we do not mean that

counseling should be reduced or standardized to definite

processes. On the contrary, additional patient-centered care

or behavioral strategies and adequate training should be

used to achieve all patients’ needs [43, 44].

Some concerns regarding the report of counseling inter-

ventions should be described. Only few studies reported the

role process of patient counseling, whereas other studies

have an incomplete report of the intervention, making it

impossible to be reproduced in other settings. An instrument

that could standardize or minimally structure a clinical

pharmacy service would have a great value to improve the

quality of pharmacist-led patient care. Recently, an attempt

has been made to describe pharmacist-led interventions by a

systematic tool (DEPICT: descriptive elements of pharma-

cist interventions characterization tool), which allows a

better understanding of clinical pharmacy services and its

components to ensure reproducibility of manuscripts and

external validity to a given practice scenario [106].

Limitations

This review is not free of limitations. At first, this review

excluded some RCT due to language selection (German

and Japanese) and other studies were not available even

after contacting the corresponding author.

Secondly, although Jadad scale is a well-known versatile

tool and validated to assess RCT quality of reporting, it may

not account for several limitations which go further than

randomization, blinding and withdrawal reporting. This tool

does not assess inclusion and selection criteria, intervention

suitability, sample statistical significance, external validity

and other bias inherent to studies’ design. Moreover, all

eligible RCT were included in this review, independently

from Jadad score because in some cases, there were inter-

esting visual materials reported in low scored RCT that may

benefit other pharmacy practice sites. On the other hand, it

would be a mistake to exclude RCT with low Jadad scores,

because this scale was neither developed to select studies to

systematic reviews nor validated to interventions that may

be difficult to blind or mask.

Lastly, this review has limitations related to verbal and

written counseling description. Unfortunately, few studies

described in more details how medication counseling was

performed, which not only compromised the innovation of

future pharmacists’ interventions, but also limited the dis-

cussions from this manuscript to a descriptive analysis of

what was done to patients [45].

Conclusion

As already known, pharmacist counseling is an interven-

tion directed to patients’ health-related needs, which also

Int J Clin Pharm

123

improves inter-professional and inter-institutional com-

munication. In spite of reducing morbidity related to drug

therapy, counseling should be more explored and better

reported to describe and critically discuss the details of

interventions, hence it would collaborate to improve

medication counseling practice.

According to the 101 RCT included in this manuscript

and in order to upgrade practice scenarios, we suggest that

the following statements may enhance pharmacists’ coun-

seling services: (1) counseling should be planned to attend

specific drug therapy or health conditions (hypertension,

anti-depressive drugs and etc.); (2) it should be imple-

mented to improve inter-professional communication and,

thus, patients’ problems resolution (seamless care model);

(3) be executed by using behavioral or patient-centered

care strategies to broaden the assessment of patients’ drug

therapy needs; and (4) be focused in at least ‘‘six-point

medication counseling’’ delivered with a written material

to improve patients’ understand about their drug therapy

and disease monitoring.

Funding This work was supported by CAPES/CNPq (Culture and

Education Ministry/Brazilian Government).

Conflicts of interest The authors declare that they do not have any

conflicts of interest with regard to this study.

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