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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
Corresponding author:Laura 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.
Keywords:
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 [1]. Type 2 diabetic patients are prone to hyperglycaemia and also suffer from metabolic disturbances [1]. In the long term, DM leads to organ damage and is associated with a whole host of micro-vascular and macro-vascular complications [2]. 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 [3].

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% [6]. 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 [6]. 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% [7]. 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 cases [8-10].

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 [10]. 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 [11]. 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 [12]. 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 [13]. 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 [14]. 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 [15]. 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” [16]. 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 [17]. 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 [18]. 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.
Study selection
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 this review.
Inclusion criteria
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 criteria (Table1);
  1. Contained patients with type 2 DM
  2. Was designed to assess improvement in HbA1c, lipids, cardiovascular measurements, body mass index (BMI), by pharmacists intervention
  3. Had a defined outcome
  4. 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 review [19-41].
Data extraction
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 main findings.

Outcome measures of interest included the effect of pharmacist intervention on:
  1. HbA1c
  2. Lipids
  3. Cardiovascular System and BMI
  4. Other diabetes-related complications (micro-albuminuria, retinopathy, foot complication and health issues
  5. Mental health and medication issues
  6. Economic costs
Study characteristics
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 [26].
Pharmacist Interventions
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 [27]. 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 [36], while another study took place in a “physician-supervised, pharmacist-managed primary care clinic” [28].
Follow-up
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 [29] and maximum follow-up was 42.0 months [24]. 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)[28]. In the second study the percentage of patients with HbA1c ≤ 7% increased from 19% to 50% (p<0.001)[31].

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[30], 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)[24]. 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)[36].

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) [22]. 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 [22]. 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 issues
One study reported that the level of micro-albuminuria was significantly reduced in pharmacist-managed patients (p<0.001) [21], 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” [36]. 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 [19]. In this study, well-being was measured by the 12-item Well Being Questionnaire (W-BQ12) [44] and non-adherence was measured by the Brief Medication Questionnaire (BMQ) [45]. 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 [26]. They also reported a significant difference in the resolution of drug-related problems in the intervention group [26]. 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 [30]. One study indicated an increase in the quality of life in pharmacist-managed patients as measured by the EuroQol-5D (EQ-5D) questionnaire [32].
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 [24]. Garrett et al. reported that costs per patient were $918 lower than expected [27]. 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.[38]
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 [22] with a maximum reduction of 3.4% [21]. 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 any case.

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 [22]. 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 [46], so any improvement in quality of life may indicate a lower instance of complications. The reported decrease in risk of non-adherence [19] 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 [47]. 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” [48]. 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” [49].

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.
 
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