Aspects Regarding Diabetes Management in a Community Pharmacy in Romania

ISPAS Ana-Maria1, GHICA Manuela2, UDEANU Denisa-Ioana2*, TĂEREL Adriana-Elena2

1 Marie Curie Children’s Emergency Clinical Hospital, Bucharest (ROMANIA)

2 UMF „Carol Davila”, Faculty of Pharmacy, Bucharest (ROMANIA) 

adriana.taerel@yahoo.com, manuela.ghica@umfcd.ro, *denisa.udeanu@umfcd.ro, ispas.anamaria14082@gmail.com

Abstract 

Diabetes mellitus is one of the most serious growing threat to global health in 21st century, with related comorbidities that carry a huge cost for treatment. Having a high prevalence at global (9.3%) and national level (8.8%) in 2019, diabetes increases the risk of worsened outcomes in health threats, like Covid-19 pandemic. The aim of this study was to analyze aspects concerning diabetes management in Romania and the need to promote interdisciplinary collaboration between medical and pharmaceutical fields. Therefore, a study was conducted on reimbursed prescriptions from 287 diabetes patients (9-95 years old), collected during December 2019-May 2020 in a community pharmacy in Bucharest, Romania. The number of cases increased with age and was higher in women (55%) than in men, with the highest percentage in the 71-80 year old group (104 patients). We identified that 72% of recipes contained oral antidiabetic drugs, 17% oral antidiabetic drugs and insulin, 7% insulin, the most frequent prescribed substance being metformin (35.88%). In addition, pharmacoeconomic characteristics like: total retail price, total reimbursement cost and patient contribution were calculated. One or more underlying comorbidities were found at 240 patients, most common being cardiovascular (arterial hypertension-69.87%, ischemic cardiomiopaty-31.38%), metabolic (51.88%), digestive (gastritis-9.21%) and ocular (glaucoma-6.28%) diseases.

Keywords: Diabetes management, community pharmacy, Romania

Introduction 

Diabetes mellitus is a “chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves”, definition given by WHO (World Health Organization). According to the reports of the International Diabetes Federation (IDF), in the last 20 years the global estimated occurrence of diabetes (diagnosed and undiagnosed) in people aged 20–79 years has tripled: from 151 million (4.6% of the global population at the time) to 463 million (9.3%) in 2019. It is estimated that this number will reach 578 million by 2030 and 700 million by 2045 [1], [2], [3]. In Romania, diabetes was responsible for 1% of all deaths in 2016 and there were registered 1785300 cases in the adult population of 14382000 individuals in 2017 [4]. The PREDATORR study, the first national study analyzing the prevalence of diabetes mellitus and prediabetes in the Romanian individuals aged 20–79 (2014), founded a diabetes total prevalence of 11.6% [5]. In 2018, 860558 diabetic patients received treatment from the National Diabetes Program, and on the first trimester of 2019 the number reached 821587, suggesting an increase [6].

As one of the non-communicable diseases, which are the leading causes of premature global death, diabetes represents the leading chronic pandemic, being responsible for 1.6 million deaths (3% of all global deaths) in 2016 [4]. However, nowadays the world is facing another serious, more urgent threat that overwhelmed health services. In December 2019, a new strain of coronavirus was discovered in Wuhan, China, named as COVID-19 (coronavirus disease 2019) by the World Health Organization [7]. Reports from May 22 revealed that worldwide the number of confirmed cases has been  5 067 579, including 332 711 deaths  [8].

It is known that patients with diabetes are at risk of developing severe and life-threatening complications, along with cardiovascular diseases, diabetic kidney diseases, depression. Consequently, there can appear an increased need for hospital admissions, medical care, stress, a reduced quality of life for the entire family and death. In the context of COVID-19 outbreak, current data suggested that diabetes is one of the most common comorbidities in infected patients. Former studies showed a connection between diabetes and the high risk of infectious disease hospitalization and an increased incidence of postoperative pneumonia in patients with type 2 diabetes [9]. National reports from Italy and Romania supported the fact that diabetes is the second comorbidity associated with COVID-19:  33.9%, respectively 30.1% [10], [11]. A meta-analysis of nine retrospective cases from China (Xiang Wang et al.) has found that the prevalence of diabetes in severe infected patients was 17%, greater than the value in moderate patients (7%) [9]. 

National actions are required, focusing on the prevention and management of all forms of diabetes to avoid further complications. In addition to this, it should be adopted an innovative approach, based on promoting interdisciplinary collaboration, not only between different medical specializations, but also taking into consideration other specialists from sanity field, like clinical and community pharmacists [12].

Materials and methods

A retrospective study was conducted on reimbursed prescriptions including diabetes medication collected from 287 patients, during December 2019- May 2020 in a community pharmacy in Bucharest, Romania.  We recorded the following information: demographic variables (gender, age), type of antidiabetic treatment (insulin or oral antidiabetics) and INNs (International Nonproprietary Names). Depending on the type of recipe, pharmacoeconomic characteristics like: total retail price, total reimbursement cost and patient contribution were calculated. Moreover, we searched for associated comorbidities, finding prescriptions for chronic treatment for 240 patients, and then making a classification of the most common associated diseases based on the diagnostic code marked on the recipes.

Results and Discussions 

According to gender, the study included 159 females (55%) and 128 males (45%). From the age distribution, it can be observed that the number of cases increases with age. Patients are between 9 and 95 years old, two of them under 20, the majority belonging to the 71-80 years old age group (104 people), women predominating on 61-95 years old segment (Fig.1).

Fig.1- Distribution of patients according to age and gender

Our results were similar to data from a national statistical document (2018) that reported a high prevalence of diabetes in women (17% more cases) and people over 60 years old (>70%). Moreover, the PREDATORR study showed that diabetes prevalence increased by age. The percentage of persons with prediabetes was 16.5% and the highest percentage was recorded in the age group 60-79 years old [13], [5].

Concerning the type of antidiabetic treatment, we identified that 72% of patients received oral antidiabetic drugs, 17% oral antidiabetic drugs and insulin, 3% GLP1 agonists + oral hipoglycemic drugs, 7% insulin (another 1% received a combination of vitamins B along with insulin). The top 5 INN prescribed (oral administration) were metformin, gliclazid, sitagliptin and glimepirid, gliquidon and sitagliptin + metformin (Table 1).

Table 1 – Antidiabetic treatment

Type of treatment Type of substance INN Total

(No.)

Insulin

 fast-acting insulinum humanum  4
insulinum lisprum  12
insulinum aspartum  9
insulinum glulizinum  9
intermediate action and rapid onset insulinum lisprum  3
long-acting insulinum glarginum  48
insulinum detemirumum 13
Oral antidiabetic

agents

 biguanides metforminum 188
sulfonamides gliquidonum  18
gliclazidum  52
glimepiridum 19

combinations of oral blood glucose lowering drugs

 saxagliptinum  +metforminum 4
sitagliptinum +metforminum  16
saxagliptinum +dapagliflozinum  4
alpha glucosidase inhibitors acarbosum 3
dipeptidyl peptidase 4 (DPP-4) inhibitors sitagliptinum  19
saxagliptinum  2
sodium-glucose co-transporter 2 (SGLT2) inhibitors dapagliflozinum 11
glinide repaglinidum   3
glucagon-like peptide-1 (GLP-1) analogues dulaglutidum 10
exenatidum 3
combination of vitamins B B1/B6+B1/B1+B6+B12 7/31/33

From Table 1, it can be observed that the most prescribed oral glucose-lowering agents was metformin (35.78%). A synthetic biguanide, is currently one of the most frequently recommended medications for type 2 diabetes treatment worldwide, mentioned on the current version of World Health Organization Model List of Essential Medicines, since 2002 (the 12th list) [14], [15], [16]. 

Regarding the number of drugs, there was a small difference between patients who received monotherapy and the ones with two drugs on their prescription (39.02%, respectively 39.1%). It should be noted that 33 of the prescriptions with two drugs (113) had as second drug a combination of vitamins B. Prescriptions with three drugs represented 18.12%, with four drugs 3.14%, only one with five drugs (metforminum, dulaglutidum, insulinum glarginum, insulinum glulizinum and combination of vitamins B1, B6, B12).

As the number of diabetic cases is rising, the total cost for diabetes is substantial. Therefore, we calculated pharmacoeconomic characteristics for all the five types of treatment: total retail price, total reimbursement cost and patient contribution (Table 2).

Table 2 – Pharmacoeconomic characteristics from reimbursement diabetic prescriptions

Type of treatment

(90 days)

 Total retail price

 (Euro)

 Total reimbursement price (Euro) Patient contribution

(Euro)
insulin 3714.73 37714.73 0
insulin+combination of vitamins B 640.32 640.32 0
oral antidiabetic 11580.84 9562.17 2018.74
GLP1 agonists + oral antidiabetic 2212.05 2199.91 11.53
insulin+oral  antidiabetic 11351.50 11188.46 162.57

The average cost/recipe/90 days of treatment supported by national insurance for patients in the National Diabetes Program was: 176.89 euro (insulin recipe), 213.44 Euro (insulin and combination of vitamins B), 46.19 Euro (oral antidiabetics) and 233.09 Euro (insulin+oral hipoglycemic agents). In the last 10 years, data published by National Health Insurance House indicated that the budget allocated to diabetes has increased  6 times (representing 1.47% of total health expenditures in 2010). Moreover, the average cost/patient treated for diabetes/year was: 222.25 Euro and average cost/adult treated for self-monitored insulin-dependent diabetes/year was: 99.14 Euro (100 tests /3 months) [17].

In addition to this, the majority has one or more underlying comorbidities (240 patients), so just the treatment expenditures are a financial burden for national health system and patients. The most frequent associated diseases were of cardiovascular (arterial hypertension-69.87%, ischemic cardiomiopaty-31.38%), metabolic (51.88%), digestive (gastritis-9.21%), ocular (glaucoma-6.28%) nature and mental disorders (depression-2.93%). In the context of the current pandemic, 51% infected people admitted in hospitals from China had chronic diseases: including cardiovascular and cerebrovascular diseases, endocrine system disease, digestive system disease, respiratory system disease, and nervous system disease [7].

Future measures- The role of community pharmacists in diabetes management

Over the years, the role of the pharmacist has evolved from someone who was dispensing a drug to a patient, to a person who can assure medication therapy management. Community pharmacist is considered one of the most accessible health professionals, with long opening hours, patients visiting the pharmacy more frequently than doctor’s office. By means of pharmaceutical care, pharmacists can motivate and significantly increase low medication adherence, a global problem associated with higher health care costs [18], [19], [20], [21]. Therefore, literature data have indicated that in many countries there have been implemented pharmaceutical services and that pharmacy interventions can bring a positive contribution to the diabetes management [22]. Interventions consisted in pharmacist-provided group diabetes education, medication management, screening individuals at risk, supporting self-monitoring, with significant improvements in clinical outcomes. For instance, a meta-analysis of data from 2247 patient  found a significant reduction in hemoglobin A1C (A1C) levels in the pharmacists’ intervention group, while another study showed that management services not only helped to improve glycemic control, but also identified patients with uncontrolled hypertension and dyslipidemia, reducing total cholesterol and LDL [23], [24], [25], [26], [27]. In Norway, there was conducted a study showing the feasibility of using the pharmacy as a setting for diabetes interventions [28]. These examples should be followed by more countries, like Romania, where pharmacists are not involved in diabetes management programs. Authorities need to implement new measures, promoting interdisciplinary collaboration between medical and pharmaceutical fields.

Conclusions 

Diabetes mellitus is a major non-communicable disease, associated with increased morbidity and mortality. Our study showed that the number of cases increases by age, women being more affected. Diabetes represents a financial burden for health system due to the high cost of medications. Moreover, patients have other associated diseases, which increases the risk of worsened outcomes in infectious disease, as the case of Covid-19 pandemic. For this reason, education, prevention and diabetes cases monitoring are crucial to effectively respond to future epidemics like COVID-19. Community pharmacist can have a beneficial contribution to improving the public’s health and diabetes management.

REFERENCES 

  1. International Diabetes Federation. (2019). Diabetes Atlas, 9th edition.  International  Diabetes  Federation, pp.176
  2. Saeedi, P., Petersohn, I., Salpea, P., Malanda, B., Karuranga, S., Unwin, N., Colagiuri, S., Guariguata, L., Motala, A.A., Ogurtsova, K., Shaw, J.E., Bright, D., Williams, R. (2019). Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Research and Clinical Practice 157
  3. World Health Organization. https://www.who.int/health-topics/diabetes#tab=tab_1 
  4. World Health Organization. (2018). Noncommunicable diseases. Country profiles, pp. 223
  5. Mota, M., Popa, S.G., Mota, E., et al. (2016). Prevalence of diabetes mellitus and prediabetes in the adult Romanian population: PREDATORR study. J Diabetes 8(3), pp. 336‐344
  6. Romanian Ministry of Health. http://www.ms.ro/
  7. Chen, N., Zhou, M., Dong, X., Qu, J., Gong, F., Han, Y., Qiu, Y., Wang, J., Liu, Y., Wei, Y., Xia, J., Yu, T., Zhang, X., Zhang, L. (2020). Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. The Lancet, 395, pp. 507-513
  8. European Centre for Disease prevention and Control. (2020). Covid-19 situation update worldwide, as of 22 May 2020. https://www.ecdc.europa.eu/
  9. Wang, X., Wang, S., Sun, L., Qin, G. (2020). Prevalence of diabetes mellitus in 2019 novel coronavirus: A meta-analysis. Diabetes Research and Clinical Practice 164
  10. Gentile, S., Strollo, F., Ceriello, A. (2020). COVID-19 infection in Italian people with diabetes: Lessons learned for our future (an experience to be used). Diabetes Research and Clinical Practice 162
  11. Romanian National Center for Surveillance and Control of Communicable Diseases (2020). Covid 19 Weekly Surveillance Report. Data reported until May 17, 2020
  12. Wubben, D.P., Vivian, E.M. (2008). Effects of Pharmacist Outpatient intervention on Adults with Diabetes Mellitus: A Systematic Review. Pharmacotherapy 28(4), pp. 421-436
  13. National Center of Evaluation and Promotion Healthcare. (2018). Statistical data diabetes mellitus. https://insp.gov.ro/sites/cnepss/date-statistice-diabetul-zaharat/
  14. World Health Organization. (2002). WHO Model List of Essential Medicines – 12th List
  15. Qaseem, A., Barry, M.J., Humphrey, L.L, Forciea, M.A. (2017). Clinical Guidelines Committee of the American College of Physicians. Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline Update From the American College of Physicians. Ann Intern Med 166(4), pp. 279‐290
  16. Stancu, E., Carata, A., Tăerel, A.E., Soroceanu, V. (2014). The study of Pharmacopoeias used in the Romanian area in XVIII-XXth centuries: Evolution of proportions for drug substances and pharmaceutical preparations. Farmacia 62(5), pp.1037-1048
  17. National Health Insurance House. http://www.cnas.ro/page/programul-national-de-diabet-zaharat.html
  18. Roebuck, M.C., Liberman, J.N., Gemmill-Toyama, M., Brennan T.A. (2011). Medication Adherence Leads To Lower Health Care Use And Costs Despite Increased Drug Spending. Health Affairs 30(1), pp. 91-99
  19. Tăerel, A.E., Stancu, E., Turcu-Stiolica, A. (2014). Pharmaceutical assistance for the elderly. Modern research in health, education and social sciences: Conference Proceedings, pp. 163-167  
  20. Turcu-Stiolica, A., Tăerel, A.D., Turcu-Stiolica R. (2013). Identifying and measuring compliance and adherence in antidepressants taking. Procedia Economics and Finance 15, pp. 836-839
  21. Lum, Z.K., Siaw, M.Y.L., Lee, M.J.X. (2019). Impact of pharmaceutical care on mental well-being and perceived health among community-dwelling individuals with type 2 diabetes. Qual Life Res. 28(12), pp. 3273‐3279
  22. Krass, I., Armour, C. L., Mitchell, B., Brillant, M., Dienaar, R., Hughes, J., Lau, P., Peterson, G., Stewart, K., Taylor, S., Wilkinson, J. (2006). The Pharmacy Diabetes Care Program: assessment of a community pharmacy diabetes service model in Australia. Diabetic Medicine 24(6), pp. 677-683
  23. Nau, D.P., Ponte, C.D. (2002). Effects of a Community Pharmacist-Based Diabetes Patient-Management Program on Intermediate Clinical Outcome Measures. Journal of Managed Care Pharmacy 8(1), pp. 48-53
  24. Witry , M., Ernzen,  M., Pape,  A., Viyyuri, B.R. (2019). Pilot and Feasibility of Combining a Medication Adherence Intervention and Group Diabetes Education for Patients with Type-2 Diabetes. Pharmacy (Basel) 7(3), pp.76. 
  25. Machado, M., Bajcar, J., Guzzo, G.C., Einarson, T.R.  (2007). Sensitivity of patient outcomes to pharmacist interventions. Part I: systematic review and meta-analysis in diabetes management. Ann Pharmacother. 41(10), pp. 1569‐1582
  26. Costa, S,, Horta, M.R., Santos, R., et al. (2019). Diabetes policies and pharmacy-based diabetes interventions in Portugal: a comprehensive review. J Pharm Policy Pract 12(5)
  27. Pîrsean C., Neguț C., Stefan-van Staden R.I., Dinu-Pirvu C.E., Armean P., Udeanu D.I., (2019). The salivary levels of leptin and interleukin-6 as potential inflammatory markers in children obesity. PLoS ONE, 14(1).
  28. Risoy, A.J., Kjome,  R.L.S., Sandberg, S., Solvik, U. (2018). Risk assessment and HbA1c measurement in Norwegian community pharmacies to identify people with undiagnosed type 2 diabetes ± A feasibility study. PLoS ONE 13(2).