Diabetes risk assessments and HbA1c-measurements in community pharmacies.

OBJECTIVES: Due to a lack of clear symptoms, type 2 diabetes (T2D) can remain undetected for many years. The aim of the study was to explore if Norwegian community pharmacies could identify individuals with a high risk of developing T2D by offering a diabetes risk assessment service. This study also investigated if the service recruited individuals that the national guideline recommends for diabetes risk assessment, and the proportion of participants who had visited their GP at least once a year. METHODS: During the inclusion period (September 2016 to the middle of April 2017), pharmacy customers 45 years or older wishing to participate contacted the pharmacy staff. Included participants completed a diabetes risk test and participants with a high risk were offered an HbA1c measurement. At two months after intervention, all participants were followed up. KEY FINDINGS: Of the 245 participants, 27% had a high risk of developing T2D. Of these, 46%, 43% and 9% had HbA1c values corresponding to normal (<39 mmol/mol [5.7%]), prediabetes (39-47 mmol/mol [5.7-6.4%]) or above cut-off for diabetes (≥48 mmol/mol [≥6.5%]), respectively. A total of 86% of the participants were in at least one category that the guideline recommends for a diabetes risk assessment, and 88% had visited their GP at least once a year. CONCLUSIONS: Norwegian community pharmacies can identify individuals with a high risk of developing T2D by offering a diabetes risk assessment service. Individuals who sought out the service were within the relevant demographics for testing, and a high proportion visited their GP at least once a year.

Pharmacists' experience of a diabetes risk-assessment service and analytical quality control in community pharmacies - A focus-group study.

BACKGROUND: Healthcare services such as diabetes risk-assessment are increasingly common in community pharmacies. Knowledge of community pharmacists' experiences of such services could ease the implementation of a larger-scale service. OBJECTIVES: To explore Norwegian pharmacists' experience of a diabetes risk-assessment service, including analytical quality control, in a community-pharmacy setting. METHODS: Three focus-group interviews were conducted in Norway between August and September 2017. Systematic text condensation was used, an analytic approach well suited for thematic content analysis across interview data. Fourteen pharmacists took part, recruited from a project offering a diabetes risk-assessment service, including measurements of Glycated hemoglobin A1c (HbA1c), in Norwegian community pharmacies. RESULTS: The pharmacists emphasized the importance of using their knowledge and skills to promote good health. They considered offering this service as being compatible with their role as pharmacists. As communication is an essential part of their work, the pharmacists evaluated their communication skills as being good. Nevertheless, how to communicate the offering of this service was seen as a challenge, for instance recruiting participants and communicating in an understandable and professional way. Inclusion of the whole pharmacy staff as a team was experienced as an important success factor for implementation of a risk-assessment service. Analytical quality control was perceived as being a natural part of their job and a manageable task. CONCLUSIONS: Offering a diabetes risk-assessment service is in line with the way a selected group of Norwegian community pharmacists perceived their professional role. However, they were uncomfortable recruiting participants, and expressed the wish for more support from the pharmacy chain. Our results add performance of analytical quality control as part of the ongoing development involving expansion of pharmacists' professional role. Future implementation studies may also benefit from giving both the pharmacy staff and customers sufficient time to familiarize themselves with the new service before measuring effects.

Quality Control of Norwegian Pharmacy HbA1c Testing: A Modest Beginning.

BACKGROUND: Many pharmacy services involve laboratory testing using point-of-care (POC) instruments. Our aim was to describe the implementation of quality control of the HbA1c POC instruments and investigate the performance in internal quality control (IQC) and external quality control (EQA) for HbA1c POC instruments in Norwegian community pharmacies. METHODS: Two project pharmacists from each of 11 pharmacies participated in a training program covering capillary blood sampling, how to use the POC HbA1c instrument (DCA Vantage) and IQC and EQA. The pharmacies were enrolled in an EQA program for HbA1c, and their performance was compared with that of general practitioners' (GP) offices. RESULTS: Two of 89 (2.2%) IQC measurements were outside the acceptance interval. Seven out of 11 pharmacies sent in results in EQA in all the three surveys during six months. Two pharmacies did not analyze the control material in any of the surveys, one pharmacy analyzed the control material in one of the surveys, and one pharmacy analyzed two of the surveys. Of these pharmacies, 56-100% obtained "very good" evaluation for trueness and 71-100% obtained "very good" evaluation for precision. The corresponding numbers for GP offices were 75-87% for trueness and 84-94% for precision. No pharmacies obtained a "poor" evaluation. CONCLUSIONS: Norwegian community pharmacies can perform IQC and EQA on a HbA1c POC instrument, and the performance is comparable with that of GP offices. The compliance in the EQA surveys was modest, but the duration of the study and participation in the EQA program was probably too short to implement all the new procedures for all pharmacies.

Risk assessment and HbA1c measurement in Norwegian community pharmacies to identify people with undiagnosed type 2 diabetes - A feasibility study.

OBJECTIVES: Determine the feasibility of using a diabetes risk assessment tool followed by HbA1c-measurement in a community-pharmacy setting in Norway. METHODS: In this longitudinal study two pharmacists in each of three community pharmacies were trained to perform risk assessments, HbA1c-measurements and counselling. Pharmacy customers who were > 18 years old and could understand and speak Norwegian or English were recruited in the pharmacies during a two-months-period. Information about the service was presented in local newspapers, social media, leaflets and posters at the pharmacy. Customers wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. A HbA1c measurement was performed for individuals with a moderate to high risk of developing diabetes. If HbA1c ≥ 6.5% they were recommended to visit their general practitioner for follow-up. The pharmacies performed internal and external quality control of the HbA1c instrument. RESULTS: Of the 211 included participants 97 (46%) were > 50 years old. HbA1c was measured for the 47 participants (22%) with high risk. Thirty-two (15%) had HbA1c values < 5.7%, twelve (5.4%) had values between 5.7%-6.4%, and three (1.4%) had an HbA1c ≥ 6.5%. Two participants with HbA1 ≥ 6.5% were diagnosed with diabetes by their general practitioner. The third was lost to follow-up. Results from internal and external quality control for HbA1c were within set limits. CONCLUSION: The pharmacists were able to perform the risk assessment and measurement of HbA1c, and pharmacy customers were willing to participate. The HbA1c measurements fulfilled the requirements for analytical quality. Thus, it is feasible to implement this service in community pharmacies in Norway. In a large-scale study the inclusion criteria should be increased to 45 years in accordance with the population the risk test has been validated for.

The microINR portable coagulometer: analytical quality and user-friendliness of a PT (INR) point-of-care instrument.

Regular measurement of prothrombin time as an international normalized ratio PT (INR) is mandatory for optimal and safe use of warfarin. Scandinavian evaluation of laboratory equipment for primary health care (SKUP) evaluated the microINR portable coagulometer (microINR®) (iLine Microsystems S.L., Spain) for measurement of PT (INR). Analytical quality and user-friendliness were evaluated under optimal conditions at an accredited hospital laboratory and at two primary health care centres (PHCCs). Patients were recruited at the outpatient clinic of the Laboratory of Medical Biochemistry, St Olav's University Hospital, Trondheim, Norway (n = 98) and from two PHCCs (n = 88). Venous blood samples were analyzed under optimal conditions on the STA-R®Evolution with STA-SPA + reagent (Stago, France) (Owren method), and the results were compared to capillary measurements on the microINR®. The imprecision of the microINR® was 6% (90% CI: 5.3-7.0%) and 6.3% (90% CI: 5.1-8.3) in the outpatient clinic and PHCC2, respectively for INR ≥2.5. The microINR® did not meet the SKUP quality requirement for imprecision ≤5.0%. For INR <2.5 at PHCC2 and at both levels in PHCC1, CV% was ≤5.0. The accuracy fulfilled the SKUP quality goal in both outpatient clinic and PHCCs. User-friendliness of the operation manual was rated as intermediate, defined by SKUP as neutral ratings assessed as neither good nor bad. Operation facilities was rated unsatisfactory, and time factors satisfactory. In conclusion, quality requirements for imprecision were not met. The SKUP criteria for accuracy was fulfilled both at the hospital and at the PHCCs. The user-friendliness was rated intermediate.