The role of the pharmacist in the management of type 2 diabetes: current insights and future directions

Figures & data

Figure 1 Model of care for T2DM in primary care.

Note: Data from references 1 and 13–15.
Abbreviation: T2DM, type 2 diabetes mellitus.

Table 1 Processes involved in the care of patients with T2DM

Stage	Activity	Component
Initial assessment	History taking	Specific symptoms of glycosuria/hyperglycemic
		Predisposition to diabetes, eg, age, family history, obesity, lifestyle issues (eg, smoking, diet, alcohol, physical activity, occupation)
		Risk factors for complications: personal or family history of cardiovascular disease, overweight/obesity, smoking, hypertension, dyslipidemia
		Symptoms of complications, eg, cardiovascular symptoms, neurological symptoms, renal problems, foot and eye problems
		Other medical conditions
		Medications (if any)
		Education (if any)
		Psychosocial status, eg, attitudes about illness, expectations, resources – financial, social, and emotional
	Physical examinations	Weight/waist: BMI, waist circumference
		Cardiovascular system, eg, blood pressure measurement
		Eyes, eg, pupil dilation
		Feet, eg, skin condition, sensation
		Peripheral nerves, eg, sensation
		Urinalysis, eg, albumin
	Laboratory evaluation	Glycemia: HbA1c, BGL
		Lipids: LDL-C, HDL-C, total cholesterol, triglycerides
		Renal function: plasma creatinine (eGFR), albuminuria
		Other tests when necessary
Treatment plan	Individualized treatment targets	Glycemic control: BGL, HbA1c
		Control of risk factors for complications: lipids, blood pressure, BMI, cigarette consumption
		Urinary albumin excretion
		Physical activity
	Development of treatment plans	Antidiabetic medications
		Diet
		Physical activity
		Prevention/treatment of complications
	Patient education	Diabetes disease process
		Treatment targets
		Treatment plan
		Antidiabetic medicines: dosing instructions, use of insulin devices, storage requirements, special precautions, and common/important adverse effects
		Exercise
		Diet
		Prevention/treatment of complications, eg, foot care, smoking cessation, medications for high lipid/blood pressure levels
		Monitoring
		SMBG (using glucose meter and interpreting the results)
		Need for regular medical monitoring
Treatment administration	Medications prepared	Dispensed in accordance with legal requirements
	Appropriate instructions provided	Prescription labels on directions for use
		Ancillary labels (if required)
Monitoring	Monitor compliance to treatment plans	Medications
		Exercise plan
		Diet plan
		Prevention/treatment plans for chronic complications
		Scheduled medical monitoring
	Monitor treatment outcomes	Glycemic control: HbA1c, BGL, SMBG
		Control of risk factors for complications: lipids, blood pressure, BMI, cigarette consumption
		Presence of complications: cardiovascular system, peripheral nerves, renal, eyes, feet
	Monitor adverse effects	Presence of adverse drug effects
Review	Review of treatment plan based on monitoring results	Consider treatment plan adjustment
		Consider education adjustment
		Referral

Note: Data from references 1 and 13–15.

Abbreviations: BGL, blood glucose level; BMI, body mass index; eGFR, estimated glomerular filtration rate; HbA1c, glycosylated hemoglobin; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SMBG, self-monitoring of blood glucose; T2DM, type 2 diabetes mellitus.

Table 2 Components of pharmacist interventions evaluated in T2DM

Stage	Intervention	Component
Treatment plan/review	Medication review	Medication review^Citation27,Citation34^–^Citation36 Interventions based on patient outcomes (pharmacotherapy follow-up)^Citation29,Citation37^–^Citation41
Patient education	Patient education/consultation	Disease process^Citation27 Goal setting^Citation42 Lifestyle: physical activity, diet^Citation27,Citation42,Citation43 Medication^Citation27,Citation34,Citation35 Psychosocial support: patient health beliefs^Citation34,Citation35 SMBG: blood glucose meters^Citation42 Prevention/treatment of complications: foot care, smoking cessation, hypertension, dyslipidemia^Citation43 Unspecified^Citation42,Citation44,Citation45/customized content (ie, education program tailored to patient’s prior knowledge)^Citation46 Patient self-management services
Monitoring	Monitoring treatment outcomes	Review of blood glucose results^Citation36,Citation37,Citation42 Physical examination (blood pressure, weight, feet, skin)^Citation42 HbA1c measurement^Citation44
	Monitoring compliance	Adherence questionnaire^Citation45
Other	Partnership with other health professionals	Liaison with the prescribing doctor^Citation35,Citation42 Referral for patient education^Citation42,Citation44 Referral to a specialist nurse^Citation44 Referral for medical advice^Citation35,Citation37,Citation44

Abbreviations: HbA1c, glycosylated hemoglobin; SMBG, self-monitoring of blood glucose; T2DM, type 2 diabetes mellitus.

Table 3 Summary of systematic reviews of pharmacists’ interventions in diabetes care

Study	Study type and search details	Studies reviewed and settings (n)	Studies and participants	Interventions	Key outcomes			Conclusions and recommendations
					Clinical*	Humanistic	Economic
Blenkinsopp and Hassey^Citation48	Design: systematic review Databases: National Research Register, Cochrane Library, Current-Controlled Trials, National Electronic Library for Health, Medical Sumsearch, Medline, IPA, CINAHL, Amed, PsychINFO, Prodigy, Clinical Evidence, Electronic Medicines Compendium, Diabetes UK, Postgraduate Medicine Patient Notes, NHS Direct, Surgery Door, Patient UK, and Hand searches of non-indexed Medicus journals and conference proceedings Search dates: 1990–2003	Studies: RCT; controlled (1), effect of community pharmacy intervention in diabetes (T1DM or T2DM) (6) Settings: community pharmacy (7)	Total studies: 7 Total participants: 920	Various: clinical review (clinical assessment, goal setting and monitoring), referrals, HbA1c monitoring and feedback, pharmacist-/nurse-led education sessions, adherence service (centered around health beliefs, lifestyle, adverse effects, rationalizing therapy), identification/resolution of DRPs	HbA1c: 60% vs 40% controlled, −0.3% (2/7 studies) BG: −19.3 mg/dL [−1.07 mmol/L] (1/7) Medication problems: reduction in concerns/misbeliefs about medications Adherence: no change to significant improvement (2/7)	Patient knowledge: significant improvement in T2DM patients (1/7 studies)	Cost-effectiveness: savings from reduced use of other health services and changes in medication outweighed the additional costs of providing the community pharmacy-based consultation service (1/7 studies)	Evidence that community pharmacy interventions to improve diabetes care show promise, but require further evaluation
Wubben and Vivian^Citation51	Design: systematic review Databases: MEDLINE (1966), CINAHL (1937); Web of Science (1970); IPA (1970); and Cochrane Library Search dates: start dates shown in parentheses to August 2007	Studies: RCTs; controlled clinical trial (9) and cohort studies (1), pharmacist interventions in outpatient setting (11) Settings: clinics (14), community pharmacy (3), community health clinics (2), and community pharmacy/clinic (1)	Total studies: 21 Total participants: 3,981	Various: included: education on lifestyle or diabetes self-care, drug therapy review, case management, monitoring of glycemic control, and adjustment to patients’ pharmacotherapy regimen as needed	HbA1c: +0.2% to −2.1% (vs control 18/21 studies) SBP: −0.5 to −18.6 mmHg (n = 12/21) DBP: −0 to −17.4 mmHg (n = 12/21) TC: 0 to −39 mg/dL [0 to −1.0 mmol/L] (n = 3/21) LDL: −6 to −15.6 mg/dL [−0.16 to −0.40 mmol/L] (n = 5/21) HDL: +1.95 to −4.3 mg/dL [+0.05 to −0.11 mmol/L] (n = 4/21) TG: −13.0 to −53.4 mg/dL [−0.15 to −0.60 mmol/L] (n = 4/21)	NR	Cost effectiveness: potentially cost effective based on labor resources and costs to deliver DSM service (n = 1/21), service cost to product significant HbA1c reduction (n = 1/21)	Results supportive of a role for pharmacist in diabetes care. Evidence required from prospective studies of the efficacy of pharmacists in improving diabetes outcomes through the provision of self-management education and pharmacologic management. These findings required dissemination beyond the pharmacy profession
Collins et al^Citation21	Design: systematic review Databases: MEDLINE and Cochrane CENTRAL Search dates: inception to June 2010	Studies: RCT; pharmacist intervention in a diabetic population Settings: clinics (6), hospitals (2), community pharmacy (4), clinic/hospital (1)	Total studies: 14 (12 T2DM only) Total participants: 2,073	Various: two or more of the following components: diabetes education, instruction on diet and exercise, medication counseling and adherence assessment, and adjustment to patients’ pharmacotherapy regimen as needed	HbA1c: −0.76% (vs control; 14 studies, n = 2,073 subjects) FBG: −29.32 mg/dL [−1.62 mmol/L] (4 studies, n = 589 subjects)	NR	NR	Statistically and clinical significant improvement in glycemic control associated with pharmacist interventions. Longer trials trend to greater effect
Omran et al^Citation50	Design: systematic review Databases: MEDLINE, EMBASE, IPA, CINAHL, and Cochrane Library Search dates: (start date not provided) through to March 12, 2011	Studies: RCT; controlled (6), pharmacist intervention to improve medication adherence in adults with T2DM (2) Settings: clinics (1), hospitals (2), community pharmacy (3), care center (2)	Total studies: 8 (only T2DM) Total participants: 3,930	Various: education-based (individual patient education), behavior-based (unit of use packaging, refill reminders, BGM), affective-based (enhanced communication, regular follow-up, feedback on BG measures) and provider-targeted (improved pharmacist-physician communication) strategies	Adherence: significant improvements in adherence rates (n = 5/8 studies)	NR	NR	Pharmacist intervention generally improve adherence rates, but the impact on clinical outcomes has not been established
Santschi et al^Citation20	Design: systematic review and meta-analysis Databases: MEDLINE via PubMed (1950 to March 2012), EMBASE (1980 to March 2012), CINAHL (1937 to March 2012), and Cochrane Central Register of Controlled Trials (up to March 2012) Search dates: start date not provided; end dates as given above	Studies: RCTs; impact of pharmacist care on major CVD risk factors among outpatients with diabetes Settings: Outpatient clinics (11) and community pharmacy (4)	Total studies: 15 (12 T2DM only) Total participants: 9,111	Various: 1) medication management (monitoring of drug therapy such as adjustment and change of medications, medication review from patient interviews, or assessment of medication compliance); 2) educational interventions to patients (medications, lifestyle, and physical activity or about compliance); 3) feedback to health care professional (DRPs identification, recommendation and discussion with physician regarding medication changes or problems of compliance, development of treatment plans); 4) measurement of CVD risk factors	SBP: WMD −6.2 mmHg ([−7.8 to −4.6], P < 0.001) (n = 12/15 studies, 7/12 significant) Studies conducted in community pharmacy greater reduction in SBP (−10.0 mmHg vs −5.5 mmHg) DBP: WMD −4.5 mmHg (−6.2 to −2.8), P < 0.001 (n = 9/15, 3/9 significant) TC: WMD −15.2 mg/dL (−24.7 to −5.7) [−0.39 mmol/L (−0.64 to −0.15)], P = 0.002 (n = 8/15, 2/8 significant) LDL: WMD −11.7 mg/dL (−15.8 to −7.6), [−0.30 mmol/L (−0.41 to −0.20)] P < 0.001 (n = 9/15, 5/9 significant) HDL: WMD +0.2 mg/dL (−1.9 to 2.36) [−0.005 mmol/L (−0.049 to 0.061)], P = 0.846) (n = 6/15, 0/6 significant) BMI: WMD −0.9 kg/m^2 [−1.7 to −0.1], P = 0.026) (n = 5/15, 2/5 significant)	NR	NR	Evidence to support pharmacist interventions improve management of major CVD risk factors among outpatients with diabetes. Further research needed to assess which pharmacist interventions are most effective, implementable, and least time-consuming and to demonstrate cost-effectiveness of pharmacist interventions in this setting
Pousinho et al^Citation49	Design: systematic review Databases: PubMed, Cochrane Central Register of Controlled Trials, and Web of Science Search dates: Inception to January 2015	Studies: RCTs; pharmacist interventions vs usual care in T2DM Settings: community pharmacy (8), primary care clinics (8), hospital clinics (16), and hospitals (4)	Total studies: 36 Total participants: 5,761	Various: One or more of the following: counseling and education on diabetes, medication, lifestyle modification, and self-monitoring; reinforcement of medication adherence or complications screening; provision of materials such as educational leaflets and pill boxes; medication review; identification and resolution of drug-related problems; discussions with the primary care provider regarding pharmacotherapy; adjustment of pharmacotherapy; and referrals to other health care professionals	HbA1c: −0.18% to −2.1% (vs control 24/26 studies) SBP: −3.3 to −23.05 mmHg (n = 17/18) DBP: −0.21 to −9.1 mmHg (n = 14/15) TC: +18.95 to −32.48 mg/dL [0.49 to −0.84 mmol/L] (n = 10/13) LDL: +7.35 to −30 mg/dL [+0.19 to −0.78 mmol/L] (n = 12/15) HDL: −5.8 to +11 mg/dL [−0.15 to +0.28 mmol/L] (n = 9/12) TG: +12 to −62 mg/dL [0.14 to 0.70 mmol/L] (n = 9/12) BMI: Reduced (n = 12/14) Adherence: Improved (n = 11/13) 10-Year CVD risk: improved (n = 6/6)	HRQoL: Improved (n = 11 studies)	Cost effective (n = 3/26 studies)	Need for future studies to look at which elements of pharmacists’ interventions contribute to the observed benefits
Aguiar et al^Citation19	Design: systematic review and meta-analysis Databases: PubMed/MEDLINE, Scopus, and Lilacs Search dates: (start date not provided) up to July 2015	Studies: RCTs; effect of pharmacist interventions on glycemic control Settings: hospital outpatient clinics (15), community pharmacy (8), community based clinics (4) and research center (1)	Total studies: systematic review 30, meta-analysis 22 Total participants: systematic review 4,051, meta-analysis 2,715	Variable: Most involved medication review (n = 25/30). Multifaceted actions to address identified DRPs, including educating patients (concerning diabetes, lifestyle, and self-monitoring) or providing medication counseling (100.0%); sending suggestions or recommendations to the physician regarding changes in medication (46.7%); adjusting pharmacotherapy on the basis of protocols previously established in collaboration with the healthcare team (23.3%); and referring patients to other health professional (eg, dentist) (16.7%)	HbA1c: mean difference −0.85% ([95% CI: −1.06, −0.65]; P < 0.0001) Subgroup analysis: no significant difference in the reduction in HbA1c levels according to the country where the study was conducted, type of contact with the patient, whether a medication review was performed; autonomy of the pharmacist to change drug therapy, provision of support resources, frequency of intervention, and adequate random allocation Outpatient clinic vs community pharmacy: HbA1c effect more pronounced, but not significant (−0.98% vs −0.65%; P = 0.08) HbA1c benefit: Greater in those with baseline HbA1c > 9.0% (−1.18% vs −0.63%; P = 0.007)	NR	NR	Pharmacist interventions improve glycemic control in patients with type 2 diabetes, benefits appear greater in younger patients or those with higher baseline HbA1c levels

Notes:

* The values shown within square brackets [] are calculated values in SI units based on the published results. The values shown within parentheses () represent the number of studies reviewed which addressed the outcome (denominator) and the number which showed positive results (numerator).

Abbreviations: RCT, randomized controlled trial; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; DRP, drug related problem; BG, blood glucose; NR, not reported; DSM, disease state management; SBP, systolic blood pressure; DBP, diastolic blood pressure; TC, total cholesterol; LDL, low-density lipoprotein; HDL, high-density lipoprotein; TG, triglyceride; FBG, fasting blood glucose; BGM, blood glucose monitoring; CVD, cardiovascular disease; WMD, weighted mean difference; BMI, body mass index; HRQoL, health-related quality of life; CI, confidence interval; CINAHL, Cumulative Index to Nursing and Allied Health Literature; IPA, International Pharmaceutical Abstracts.

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