The role of pharmacists in control and management of type 2 Diabetes Mellitus; a
review of the literature
D Og. O’Donovan, S. Byrne, L. Sahm
Author Affiliations:1- Pharmaceutical Care Research Group, School
of Pharmacy, University College Cork, Cork, Ireland
Improving glycemic control is the key to reducing both micro-vascular and macro-vascular
complications, associated with type 2 Diabetes Mellitus. This review examines the
contributions of pharmacists to the long term prognosis of patients with type 2
Diabetes Mellitus by improving their control and management. A systematic literature
search was conducted. Twenty-three studies were identified that demonstrated the
effect of pharmacist intervention on HbA1c. In all cases, it was reported that pharmacist
intervention was successful in reducing HbA1c in patients with type 2 Diabetes Mellitus.
The minimum reduction obtained was 0.5% with a maximum reduction of 3.4%. Pharmacist
intervention proved successful in improving patients’ lipid profiles, cardiovascular
outcomes, body mass index and other complications associated with type 2 Diabetes
Mellitus. It was also reported that there were economic advantages associated with
pharmacist management of type 2 Diabetes Mellitus. Pharmacist intervention in type
2 Diabetes Mellitus patients was successful in leading to reductions in mortality,
morbidity and cost of treatment.
HbA1c, Type 2 Diabetes Mellitus, Pharmacist's interventions, Glycemic control
Diabetes Mellitus (DM) is a chronic disease characterized by the body’s inability
to process sugar. Type 2 DM is a form of diabetes which results from defects in
insulin secretion, with insulin resistance also being a major factor . Type 2
diabetic patients are prone to hyperglycaemia and also suffer from metabolic disturbances
. In the long term, DM leads to organ damage and is associated with a whole host
of micro-vascular and macro-vascular complications . People with DM are also
at increased risk of cardiovascular diseases. DM is a growing problem, globally,
and it is estimated that the numbers of DM patients world-wide will rise from 135
million in 1995 to 300 million in 2025 .
Glycemic control is fundamental to the management of type 2 diabetic patients. HbA1c
is now recognized as the monitoring test of choice for assessing medium and long
term glycemic control in diabetic patients [4, 5]. Currently, the American Diabetic
Association (ADA) recommends that the general HbA1c target of non-pregnant adults
is “below or around” 7% . This is a general recommendation, however, and the
ADA proposes that certain subgroups (those with a short duration of DM or no significant
risk of cardiovascular disease (CVD)) can aim for HbA1c of less than 7%, if it can
be achieved without adverse effects or risk of hypoglycemia. The ADA recommends
that a target of greater than 7% may be more suitable for some patients, in order
to reduce the incidences of side-effects such as hypoglycemia, or in order not to
have impact on the patient’s quality of life . Similarly, the National Institute
for Health and Clinical Excellence (NICE) recommend a general target of HbA1c of
6.5% for type 2 DM patients, but this level may occasionally be set above 6.5% .
It is recommended that the actual level set for each individual patient should only
be set in consultation with their General Practitioner (GP), and the patient should
be involved in the process. Setting a target HbA1c of less than 6% is not recommended
due to increased risk of severe hypo-glycaemia, which could prove harmful in some
A high HbA1c indicates that the patient consistently had poor glycemic control over
the past three months. Improved glycemic control is the key to reducing both micro-vascular
and macro-vascular complications in patients with type 2 DM. The United Kingdom
Prospective Diabetes Study (UKPDS) demonstrated that for every 1% reduction in HbA1c
there is a 21% drop in the risk for any diabetes-related endpoint, a 21% reduction
in deaths related to diabetes, and a 37% reduction in micro-vascular complications
. A follow-up study to the UKPDS showed that at completion of the original study,
although the differences in glycemic control between those receiving intensive therapy
and those on dietary therapy were lost, there was a continued reduction in the risk
of micro-vascular disease and myocardial infarction [11, 12]. With this in mind,
reduction in HbA1c level is to be strongly recommended to the patients.
To reap the benefits of modern medical therapies, more efficient and more effective
interventions to aid people in following medical regimens are needed . Recently
there has been interest in broadening the role of the community pharmacist beyond
the traditional product-orientated functions of dispensing and distributing medication,
to include a greater role in public health . The pharmacy profession is increasingly
being recognised as having a strategic position in health promotion, due to their
in-depth knowledge of the rational use of medicines . The role of the pharmacist
as part of a multidisciplinary approach cannot be over-emphasized. Pharmacists are
now a critical part of the healthcare teams and they are taking more responsibility
for clinical outcomes of drug therapy . There are a number of limitations to
the potential role that pharmacists may play however, including: lack of prescribing
power on a part of pharmacists and a deficit of suitably qualified pharmacists with
clinical experience in some countries. These may be further compounded by economic
constraints, particularly in the third world countries.
dherence to therapy is also a vital component of any medication regimen and pharmacists
are ideally positioned at the interface of the patient and his/her medicine to influence
medication adherence in a positive manner . The World Health Organisation (WHO)
(2006) have stated that to address the problem of low adherence to long-term therapy
for chronic conditions “pharmacists have an important role to play, which is much
more than selling medicines” . They summarized that this role included the “seven-star
concept”, in which a pharmacist is described as a caregiver, communicator, decision-maker,
teacher, lifelong learner, leader and manager and is thus perfectly positioned to
carry out effective interventions. These roles of the pharmacist enable him or her
to successfully carry out interventions which have been shown to improve drug therapy,
save costs, prevent undesirable side effects, and improve the clinical outcomes
for patients . It is being increasingly accepted that community pharmacists
are well equipped and well trained to provide interventions for chronic conditions.
Intervention programs involving the community pharmacist are one of the few interventions
that are proven successful, generating benefits that are ten times greater than
the costs . All of the roles that a pharmacist can play as part of a multi-disciplinary
team are dependent on the pharmacist being suitably qualified in a number of competencies,
which may not always be the case, especially in the third-world countries.
This review examines the contributions of pharmacists to the long term prognosis
of patients with type 2 DM by improving their control and management. It is our
hypothesis that pharmacists can play a major role in reducing HbA1c and improving
both glycemic control and quality of life for the patient.
The studies included in this systematic review were identified through a search
of Cochrane Library Databases, Medline, Embase, PsycINFO, ERIC, Dissertation and
Sociological Abstracts, CINAHL and PubMed®. The search was conducted in February
2009. Search terms were “type 2 diabetes mellitus” and “pharmacist intervention”.
All available years in each database were searched. Only papers that were published
in English and used human subjects were considered. An initial search using the
above search terms in abstracts, identified 31 published articles. Full texts for
all articles were obtained and independently read in full by the primary investigator
and another co-author in order to identify those papers suitable for inclusion in
Studies which took place in the community, outpatient, primary care and hospital
(secondary care) settings were all included. Randomized controlled trials, observational
studies and retrospective cohort reviews were included. Twenty three papers were
deemed suitable for inclusion in this review, if they met the following inclusion
Contained patients with type 2 DM
Was designed to assess improvement in HbA1c, lipids, cardiovascular measurements,
body mass index (BMI), by pharmacists intervention
Had a defined outcome
Had clear inclusion and exclusion criteria
In cases where a paper’s suitability was not decided unanimously, a consensus was
reached by all three authors. Twenty three papers were deemed suitable for this
Using a Microsoft Excel® spreadsheet, data were extracted from the chosen studies.
No blinding, regarding to a journal or author was done. Data were extracted for
authors, year of publication, randomization quality criteria, patient details, intervention
details, endpoint and outcome measures, baseline and post-intervention results and
Outcome measures of interest included the effect of pharmacist intervention on:
Cardiovascular System and BMI
Other diabetes-related complications (micro-albuminuria, retinopathy, foot complication
and health issues
Mental health and medication issues
This review concentrates on 23 studies that were available in full text and identified
as suitable. The majority of studies included (19) are from American population
[20, 21, 23-25, 27-31, 33-41]. The remainders are from Australian [19, 22, 32] or
European population .
The specific pharmacist interventions reported in the studies varied. Most of the
studies involved pharmacist education to the patient about their type 2 DM [20,
21, 23, 24, 26, 29, 31, 33, 34, 39-41]. One study involved the patients being referred
to diabetes educators . Three studies also referred to “medication counseling”
[21-23]. Some studies relied on collaboration with the primary care physician before
any medication adjustments were made [21, 31, 37], while others allowed for the
pharmacist adjusting the therapy, using algorithms that had been drawn up specifically
for that purpose [23, 25, 31, 33, 35, 39]. A number of studies mentioned medication
monitoring and management [27, 29-34, 38, 41]. In terms of patient’s contact with
the investigator during the study, some studies involved clinical visits or scheduled
consultations at regular intervals [19, 20, 23, 24, 27, 31, 32, 37, 39], while some
studies involved telephone contact [20, 22, 23, 37, 39]. One of the studies involved
a pharmacist-managed primary care clinic , while another study took place in
a “physician-supervised, pharmacist-managed primary care clinic” .
The follow-up varied between the studies. It was not possible to extract exact follow-up
data from all of the studies. Most studies reported follow-up in months, while in
some cases the follow-up data was converted to months. It was assumed that there
were 30 days in a month and 4 weeks in a month for conversion purposes. Minimum
follow-up was 4.0 months  and maximum follow-up was 42.0 months . Mean follow-up
was 12.0 ± 8.3 months.
Effect of Pharmacist Intervention on HbA1c
All 23 studies reported that pharmacist interventions were very successful at reducing
HbA1c in type 2 DM patients [19-41]. In two studies, it was not possible to extract
exact data on HbA1c reduction, but rather the number of patients with HbA1c ≤ 7%
was reported. In both of these studies, pharmacist intervention was successful at
increasing the number of patients with HbA1c ≤ 7% [28, 31]. In the first study,
the relative risk (RR) of achieving a HbA1c level of ≤ 7% was significantly higher
in the intervention group (RR 5.19, 95% Confidence Interval (CI) 2.62-10.26).
In the second study the percentage of patients with HbA1c ≤ 7% increased from 19%
to 50% (p<0.001).
Figure 1: Effect of pharmacist intervention on HbA1c
If we examine observational studies and the intervention groups associated with
the randomized controlled trials (RCTs), the beneficial effect of pharmacist intervention
on HbA1c is statistically significant in all cases. There was a mean reduction in
HbA1c of 1.5% (Standard Deviation (SD) ±0.8%). This is demonstrated in Figure 1
(error bars have been included where possible). In all cases the reduction in HbA1c
between baseline values and final values was statistically significant (p<0.05).
A number of studies had the benefit of a control group [19, 20, 22, 25, 26, 29].
Figure 2 demonstrates that the HbA1c reduction in the intervention groups (mean
reduction: -1.3% ± 0.7%) was greater than the reduction in control groups (-0.4%
± 0.5). Error bars have again been included where it was possible to extract the
data from the original publication.
Effect of Pharmacist Intervention on Lipids
A total of thirteen studies reported an improvement in patient’s lipids to some
degree. Several studies reported that pharmacist interventions had a favorable outcome
on patient’s lipid levels [21, 24, 26, 27, 30, 31, 33-35, 40, 41]. Five studies
reported a decrease in patient’s total cholesterol (TC) (range of decrease: 16 -
23 mg/dl) [21, 26, 30, 33, 41]. Looking at low-density lipoprotein-cholesterol (LDL-C),
seven studies reported a decrease in patient’s values (range of decrease: 8.9 -
27 mg/dl),[21, 27, 30, 34, 35, 40, 41] and two studies reported an increase in the
number of patients with optimal LDL-C values (<100mg/dl, based upon ADA guidelines)
over baseline (range 17%-21%)[24,31]. Six studies reported a decrease in patient’s
triglyceride (TG) levels [21, 30, 33-35, 41]. One study reported a favorable increase
of 4mg/dl in patient’s levels of high-density lipoprotein (HDL-C) levels, while
another study reported that the number of patients with optimal HDL-C values increased
(optimal HDL-C values >45mg/dl for men or >55mg/dl for women, based on ADA guidelines).
Finally, two studies reported an increase in the rate of LDL-C measurement in patients
receiving a pharmacist intervention,[20, 30] and another study reported an increase
in full-lipid profiling (p<0.05).
Figure 2: Effects of pharmacist intervention compared to control groups in controlled
trials (all results were statistically significant p<0.05).
Effect of Pharmacist Intervention on the Cardiovascular System and BMI
One of the studies reported that patients in the intervention group experienced
a statistically significant, greater reduction in BMI than patients in the control
group (-0.6 kg/m2) . Seven studies reported that patients subjected to the pharmacist
intervention experienced a statistically significant drop in systolic blood pressure,
ranging from 3.4mmHg to 8mmHg [21, 26, 27, 33, 35, 38, 40]. Three of the studies
reported a statistically significant drop in diastolic blood pressure in pharmacist-managed
patients [21, 33, 38]. Another controlled study reported that patients in the intervention
group experienced significant reductions in both systolic and diastolic blood pressure
compared with the control group . In addition, two studies reported that pharmacist-managed
patients had statistically significant increased doing use of aspirin [31, 38].
Daily aspirin is recommended in type 2 DM patients with a high risk of CVD by both
NICE and ADA [42, 43].
Effect of Pharmacist Intervention on other diabetes-related complications and health
One study reported that the level of micro-albuminuria was significantly reduced
in pharmacist-managed patients (p<0.001) , and two studies reported an increase
in the frequency of micro-albuminuria screening (p<0.05) [30, 31]. Five studies
reported an increase in the number of patients having retinal examinations [20,
27, 30, 31, 34]. Six studies reported an increase in the number of patients having
regular foot examinations [20, 24, 27, 31, 34, 36]. One study reported an increase
in the number of pharmacist-managed patients being referred for “dietary instruction”
. Two studies indicated an increase in the rate of influenza vaccination, in
pharmacist-managed patients [27, 30].
Effect of Pharmacist Intervention on Mental health and medication issues
One of the studies reported significant improvements in well-being and a decrease
in the risk of non-adherence . In this study, well-being was measured by the
12-item Well Being Questionnaire (W-BQ12)  and non-adherence was measured by
the Brief Medication Questionnaire (BMQ) . One of the studies measured patient’s
knowledge about the disease and its complications and about their medication, using
a questionnaire specifically developed by the authors for that purpose. They reported
a significant increase in knowledge in the patients who received a pharmacist intervention
compared with the control patients . They also reported a significant difference
in the resolution of drug-related problems in the intervention group . Another
study reported a significant increase in the mental component score of the 12-Item
Short Form Health Survey (SF-12) in pharmacist-managed patients . One study
indicated an increase in the quality of life in pharmacist-managed patients as measured
by the EuroQol-5D (EQ-5D) questionnaire .
Economic benefits of Pharmacist Intervention
Three studies reported on the cost benefits of the pharmacist intervention. Cranor
et al. reported that medical costs decreased by $1200 per patient per year .
Garrett et al. reported that costs per patient were $918 lower than expected .
Ragucci et al. estimated that their study lead to a cost avoidance of $59,040, across
all their patients (n=142) as a result of decreases in HbA1c.
The studies show that interventions by a pharmacist are successful in reducing HbA1c
in patients with type 2 DM [19-41]. These figures indicate a minimum HbA1c reduction
of 0.5% per patient  with a maximum reduction of 3.4% . Ultimately, pharmacist
intervention in type 2 DM patients can lead to reductions in mortality, morbidity
and the cost of treatment.
Most of the interventions examined here centered on education of the patient and
counseling in some form. Pharmacists already provide this service to their patients,
so it could be argued that pharmacists are already having a beneficial effect on
glycemic control to some degree. It is reasonable to assume that the improvement
was due to the regular contact between the patient and the healthcare professional.
There is also an ease-of-access factor to consider, because the patient will be
travelling to their pharmacy to collect their prescription on a regular basis, in
Pharmacists are ideal for undertaking interventions in type 2 DM patients because
of their specific training in pharmacology and medication management. Many type
2 DM patients have to take a lot of medications and have a complex dosing regimen.
The pharmacist is well placed to educate the patients about their medication and
clarify their regimen to improve adherence.
Pharmacist intervention also proved beneficial in increasing screening for the complications
associated with type 2 DM [20, 21, 24, 27, 30, 31, 34, 36]. It may be speculated
that regular contact with the pharmacist may be successful at ‘reminding’ patients
that they need regular appointments with other healthcare professionals, to screen
for complications. The benefits of pharmacist intervention were also evident through
improvements in type 2 DM patient’s general health. Improvements were seen in blood
pressure [21, 22, 26, 27, 33, 35, 38, 40], lipid profile [21, 24, 26, 27, 30, 31,
33-35, 40, 41] and BMI . All these improvements have a beneficial effect on
the patient’s overall cardiovascular health.
The beneficial effects of pharmacist interventions on mental health and medication
adherence are noteworthy. The complications associated with type 2 DM can have an
adverse effect on patient’s quality of life , so any improvement in quality
of life may indicate a lower instance of complications. The reported decrease in
risk of non-adherence  will ultimately result in a reduction in complications,
which is linked with better glycemic control.
The effects of pharmacist interventions were positive when compared to other types
of intervention to control type 2 DM. A 2003 systematic review of the effect of
specialist nurse-led interventions in diabetes mellitus found no real evidence of
any reductions in HbA1c levels . A systematic review of patient self-monitoring
of blood glucose in type 2 DM found that it was “of limited clinical effectiveness
in improving glycemic control” . Another study examined the impact of education
for people with type 2 DM, as delivered by diabetes educators and dieticians, and
found that “overall there did not appear to be a significant difference between
individual education and usual care” .
There were a number of limitations to the studies reviewed. It was not possible
to extract enough relevant raw data from the original published studies to produce
a meta-analysis of the data. There were a lot of studies that were observational
in nature or non-controlled [21, 23, 24, 27, 28, 30, 31, 33-35, 37-39]. This means
that the reduction in HbA1c may not have been due to the pharmacist intervention.
The mean study period was relatively short (12.0±8.3 months) and it was seen that
studies with longer durations showed greater reductions in HbA1c [20, 21, 23, 29,
36, 37, 39]. Selection bias in some of these studies is also an issue. Studies where
patients had higher baseline HbA1c levels showed greater improvements over the course
of the pharmacist intervention [20, 21, 23, 29, 36, 37, 39]. Future randomized control
trials need precise pairing between groups to reduce this effect.
Other future investigations could examine the effect of pharmacist intervention
on high-risk patients or patients with complex dosing regimens. It is also important
to determine the effect of pharmacist intervention on adherence. There is also a
huge scope to establish the cost benefits of pharmacist intervention on type 2 DM.
Type 2 DM is a major problem in modern society, and as more countries join the ranks
of industrialized nations, the burden will only increase. The bulk of the cost associated
with treating diabetes comes from the complications that develop over time, as a
result of poor glycemic control.
It has been proven that by improving the glycemic control of patients and keeping
their HbA1c as close to their target as possible, the complications associated with
diabetes will be reduced. This means a lower cost in the disease treatment, improved
quality of life for the patient and a reduced burden on society as a whole.
It has been shown that pharmacists can be successfully used to reduce HbA1c. Pharmacist
intervention has been demonstrated to be an effective and economical means to manage
patients in order to reduce HbA1c and the complications associated with type 2 DM.
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Table 1: The papers were deemed suitable for inclusion in this Review.