DOCSLIB.ORG

Low Utilisation of Diabetes Medicines in Iran, Despite Their Affordability (2000–2012): a Time-Series and Benchmarking Study

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Low Utilisation of Diabetes Medicines in Iran, Despite Their Affordability (2000–2012): a Time-Series and Benchmarking Study Open Access Research BMJ Open: first published as 10.1136/bmjopen-2014-005859 on 16 October 2014. Downloaded from Low utilisation of diabetes medicines in Iran, despite their affordability (2000–2012): a time-series and benchmarking study Amir Sarayani,1 Arash Rashidian,2,3 Kheirollah Gholami4 To cite: Sarayani A, ABSTRACT Strengths and limitations of this study Rashidian A, Gholami K. Low Objectives: Diabetes is a major public health concern utilisation of diabetes worldwide, particularly in low-income and middle-income ▪ medicines in Iran, despite To the best of our knowledge, this is the first countries (LMICs). Limited data exist on the status of their affordability (2000– study to evaluate the pattern of utilisation and 2012): a time-series and access to diabetes medicines in LMICs. We assessed the affordability of diabetes drugs in a low-income benchmarking study. BMJ utilisation and affordability of diabetes medicines in Iran as or middle-income country over a period of time. Open 2014;4:e005859. a middle-income country. ▪ We used data from OECD countries to assess the doi:10.1136/bmjopen-2014- Design: We used a retrospective time-series design adequacy of utilisation in Iran. 005859 (2000–2012) and assessed national diabetes medicines’ ▪ Our findings showed that utilisation of diabetes utilisation using pharmaceuticals wholesale data. drugs does not seem to be adequate. Although ▸ Prepublication history for Methods: We calculated defined daily dose the affordability of essential diabetes medicines this paper is available online. consumptions per population days (DDDs/1000 is achieved, optimising the pattern of use To view these files please inhabitants/day; DIDs) indicator. Findings were requires screening for undiagnosed patients and visit the journal online benchmarked with data from Organization for Economic improving management of diagnosed cases. (http://dx.doi.org/10.1136/ Co-operation and Development (OECD) countries. We also ▪ National wholesale data were used to estimate bmjopen-2014-005859). employed Drug Utilization-90% (DU-90) method to drug utilisation; however, these data may not Received 4 June 2014 compare DU-90s with the Essential Medicines List reflect the real drug consumption by patients. Revised 19 August 2014 published by the WHO. We measured affordability using Accepted 21 August 2014 number of minimum daily wage required to purchase a 12 http://bmjopen.bmj.com/ treatment course for 1 month. prevalence of 8.3% in 2011, while approxi- Results: Diabetes medicines’ consumption increased mately 80% of patients with diabetes reside from 4.47 to 33.54 DIDs. The benchmarking showed that in low-income and middle-income coun- 2 medicines’ utilisation in Iran in 2011 was only 54% of the tries. Proper management of diabetes con- median DIDs of 22 OECD countries. Oral hypoglycaemic sists of interventions targeting the patient’s agents consisted over 80% of use throughout the study diet, exercise status and prescribing medi- period. Regular and isophane insulin (NPH), cines (insulin and oral hypoglycaemic glibenclamide, metformin and gliclazide were the DU-90 agents).3 Currently, medicines are an essen- drugs in 2012. Metformin, glibenclamide and regular/NPH tial part of diabetes management guidelines on September 28, 2021 by guest. Protected copyright. insulin combination therapy were affordable throughout for most patients. Insulin would be started the study period (∼0.4, ∼0.1, ∼0.3 of minimum daily readily after diagnosis of type-1 diabetes and wage, respectively). While the affordability of novel insulin preparations improved over time, they were still would be added to the therapeutic regimen unaffordable in 2012. of type-2 diabetes as required. In addition, Conclusions: The utilisation of diabetes medicines was oral hypoglycaemic agents, for example, met- relatively low, perhaps due to underdiagnosis and formin, are usually initiated alongside life- inadequate management of patients with diabetes. This style modifications at diagnosis of type-2 had occurred despite affordability of essential diabetes diabetes.4 Thus, appropriate utilisation of medicines in Iran. Appropriate policies are required to diabetes medicines should be high on the address the underutilisation of diabetes medicines in Iran. agenda for health policymakers.5 Previous studies have reported different util- isation patterns of diabetes medicines in differ- For numbered affiliations see 6–8 et al6 end of article. ent countries. For example, Melander analysed data from 10 European countries INTRODUCTION (1994–2003) and identified an increasing Correspondence to ’ Dr Arash Rashidian; Diabetes is a major public health concern trend in diabetes medicines consumption. [email protected] worldwide, with an estimated global They also observed large differences in Sarayani A, et al. BMJ Open 2014;4:e005859. doi:10.1136/bmjopen-2014-005859 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005859 on 16 October 2014. Downloaded from utilisation patterns among these countries, and concluded METHODS that these might have occurred due to the differences in Design diabetes screening and management patterns in those A retrospective time-series design was used to investigate countries.6 Few reports exist on the affordability of medi- the trends of utilisation and affordability for diabetes cines and the utilisation patterns of diabetes medicines in medicines in Iran (2000–2012). We benchmarked the low-income and middle-income countries where the rate of drug utilisation with the most recent available burden of diabetes is believed to be more significant than data from 22 countries in 2011. high-income countries.29National studies in Iran, an upper-middle-income country, have estimated a significant National data sources prevalence of diabetes in the country (7.7% in 2005 and Annual wholesale data were obtained from Iran’s Food 8.7% in 2007), of which over 45% were undiagnosed and Drug Organization. The data are produced based cases.10 11 Moreover, a meta-analysis reported that the on the sales’ reports of wholesale companies to commu- prevalence of diabetes in Iran is increasing by 0.4% annu- nity and inpatient pharmacies all over the country and ally.12 Still, very few reports exist on the utilisation patterns has been available as an electronic medium since 2000. of diabetes medicines in order to show the current situ- Each pharmaceutical product (medicinal dosage forms) ation of diabetes pharmacotherapy in the country. is identified with a generic name and a unique code in the database and can be linked to the manufacturer or Health and pharmaceutical system in Iran import company, the wholesale company, the number of The healthcare system in Iran is primarily based on a gov- sold items and their total retail price. Diabetes medi- ernment funded primary healthcare system and social cines available on the market during the study period health insurance plans that facilitate access to secondary were identified based on consultation with experts and and tertiary care. The private sector is the main provider the National Drug List. Several examinations were of ambulatory care in urban areas.13 In 2010, social carried out to assess the quality of the data. Generic healthcare insurance covered 84% of the population.14 codes were set as the main standard for accuracy exam- Insurance organisations’ reimbursement policies for ination. We looked for discrepancies in recorded medicines follow a general rule: covering 90% of generic—or brand-generic codes, dosage forms, produ- inpatient and 70% of outpatient costs if the provider has cer/importer and wholesale companies’ data. To stand- a contract with the insurance organisation.15 Almost all ardise pharmaceutical consumption data per inhabitant, community and hospital pharmacies have contracts with we obtained annual population figures from the major insurance organisations and the lowest priced Statistics Center of Iran. generic product is usually set for reimbursement pur- poses. This means that the users might pay more than the International data source 10% (inpatient care) or 30% (outpatient care) expected We collected data on diabetes medicines utilisation in 22 http://bmjopen.bmj.com/ copayments at the time of use. Hence, major concerns countries of the Organization for Economic Co- exist among health policymakers regarding out of pocket operation and Development (OECD) via the Health expenditures for health services.16 Still, it has been Data: Pharmaceutical market database.22 argued that adequate affordability of medicines has been achieved in Iran.17 18 Implementation of a generic-based Evaluating utilisation patterns in Iran pharmaceutical policy including a highly regulated The Anatomical Therapeutic Classification/Defined National Drug List and medicines pricing systems may Daily Dose (ATC/DDD) methodology was used to stand- have contributed to the assumed adequacy of access to ardise the raw sales data. The latest version of the ATC/ on September 28, 2021 by guest. Protected copyright. medicines in Iran.19 20 Since 2001, international compan- DDD guideline (2013) was retrieved from the website of ies (brand or generic products) became more involved in the WHO Collaborating Centre for Drug Statistics the local pharmaceutical market and the market size Methodology.23 In the present study, the ATC codes of expanded from US$661 million in 2003 (of which 20.5% A10 group were used to standardise diabetes medicines. were imported products) to over US$2.3 billion in 2008 We used second (all diabetes medicines), third (insulin (of which 33.6% were imported products).19 It is esti- or oral hypoglycaemic agents) and fifth (individual mated that the pharmaceutical market size in Iran would pharmaceutical substance) level of ATC classification be US$3.65 billion in 2013.21 for each data line recorded in the data set and the DDD quantities were entered respectively. To calculate Objectives the number of DDDs per 1000 inhabitants per day In the present study, we evaluated the trends of diabetes (DID), the following formula was used: (number of medicines’ utilisation in Iran during 2000–2012 using DDDs×1000)/(number of population×365).6 We sum- national pharmaceuticals wholesale data.
Load more

Recommended publications
  • LANTUS® (Insulin Glargine [Rdna Origin] Injection)
    Rev. March 2007 Rx Only LANTUS® (insulin glargine [rDNA origin] injection) LANTUS® must NOT be diluted or mixed with any other insulin or solution. DESCRIPTION LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non- pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- B B Gly-30 a-L-Arg-30 b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. It has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 IU (3.6378 mg) insulin glargine. Inactive ingredients for the 10 mL vial are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. Inactive ingredients for the 3 mL cartridge are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4. CLINICAL PHARMACOLOGY Mechanism of Action: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
    [Show full text]
  • Comparison of Adjunctive Therapy with Metformin and Acarbose in Patients with Type-1 Diabetes Mellitus
    Original Article Comparison of adjunctive therapy with metformin and acarbose in patients with Type-1 diabetes mellitus Amir Ziaee1, Neda Esmailzadehha2, Maryam Honardoost3 ABSTRACT Objective: All the aforementioned data have stimulated interest in studying other potential therapies for T1DM including noninsulin pharmacological therapies. The present study attempts to investigate the effect of adjunctive therapy with metformin and acarbose in patients with Type-1 diabetes mellitus. Method: In a single-center, placebo-controlled study (IRCT201102165844N1) we compared the results of two clinical trials conducted in two different time periods on 40 patients with Type-1 diabetes mellitus. In the first section, metformin was given to the subjects.After six months, metformin was replaced with acarbose in the therapeutic regimen. In both studies, subjects were checked for their BMI, FBS, HbA1C, TGs, Cholesterol, LDL, HDL, 2hpp, unit of NPH and regular insulin variations. Results: Placebo-controlled evaluation of selected factors has showna significant decrease in FBS and TG levels in the metformin group during follow up but acarbose group has shown substantial influence on two hour post prandial (2hpp) and regular insulin intake decline.Moreover, Comparison differences after intervention between two test groups has shown that metformin has had superior impact on FBS and HbA1C decline in patients. Nonetheless, acarbose treatment had noteworthy influence on 2hpp, TGs, Cholesterol, LDL, and regular insulin intake control. Conclusion: The results of this experiment demonstrate that the addition of acarbose or metformin to patients with Type-1 diabetes mellitus who are controlled with insulin is commonly well tolerated and help to improve metabolic control in patients.
    [Show full text]
  • Diabetes Mellitus: Patterns of Pharmaceutical Use in Manitoba
    Diabetes Mellitus: Patterns of Pharmaceutical Use in Manitoba by Kim¡ T. G. Guilbert A Thesis submitted to The Faculty of Graduate Studies in Partial Fulfillment of the Requirements for the Degree of MASTER OF SCIENCE Faculty of Pharmacy The University of Manitoba Winnipeg, Manitoba @ Kimi T.G. Guilbert, March 2005 TIIE UMYERSITY OF MANITOBA F'ACULTY OF GRADUATE STTJDIES +g+ù+ COPYRIGIIT PERMISSION PAGE Diabetes Mellitus: Patterns of Pharmaceutical Use in Manitoba BY Kimi T.G. Guilbert A ThesisÆracticum submitted to the Faculty of Graduate Studies of The University of Manitoba in partial fulfillment of the requirements of the degree of MASTER OF SCIENCE KIMI T.G. GTIILBERT O2()O5 Permission has been granted to the Library of The University of Manitoba to lend or sell copies of this thesis/practicum, to the National Library of Canada to microfïlm this thesis and to lend or sell copies of the film, and to University Microfilm Inc. to publish an abstract of this thesis/practicum. The author reserves other publication rights, and neither this thesis/practicum nor extensive extracts from it may be printed or otherwise reproduced without the author's written permission. Acknowledgements Upon initiation of this project I had a clear objective in mind--to learn more. As with many endeavors in life that are worthwhile, the path I have followed has brought me many places I did not anticipate at the beginning of my journey. ln reaching the end, it is without a doubt that I did learn more, and the knowledge I have been able to take with me includes a wider spectrum than the topic of population health and medication utilization.
    [Show full text]
  • Soliqua – Criteria
    Criteria Based Consultation Prescribing Program CRITERIA FOR DRUG COVERAGE Insulin glargine; lixisenatide (Soliqua) subcutaneous injection Initiation (new start) criteria: Non-formulary lixisenatide/glargine (Soliqua) will be covered on the prescription drug benefit when the following criteria are met: Must meet criteria for both individual agents lixisenatide and insulin glargine. Criteria for lixisenatide: • Diagnosis of Type 2 Diabetes Mellitus • Intolerance to preferred GLP-1 agonists liraglutide (Victoza) AND injectable semaglutide (Ozempic) • No personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) • No personal history of gastroparesis • On maximally tolerated metformin dose (dose appropriate per renal function) or allergy or intolerance* to metformin (includes both metformin IR and XR) • And meets one of the following criteria: o Inadequate glycemic response on both basal and bolus insulin despite high dose requirements (total daily insulin dose of 1.5 units per kilogram of body weight or more OR greater than 200 units) OR o Has experienced recurrent nocturnal hypoglycemia with basal insulin defined as: 3 or more episodes of nocturnal hypoglycemia (BG less than 70 mg/dL) over the preceding 30 days that persists despite basal insulin dose reduction (including decrease in NPH dose and subsequent switch to and dose adjustment of insulin glargine) Criteria for insulin glargine • Use in patients with type 1 diabetes mellitus as basal insulin -OR- • Use in patients with
    [Show full text]
  • Type 2 Diabetes Adult Outpatient Insulin Guidelines
    Diabetes Coalition of California TYPE 2 DIABETES ADULT OUTPATIENT INSULIN GUIDELINES GENERAL RECOMMENDATIONS Start insulin if A1C and glucose levels are above goal despite optimal use of other diabetes 6,7,8 medications. (Consider insulin as initial therapy if A1C very high, such as > 10.0%) 6,7,8 Start with BASAL INSULIN for most patients 1,6 Consider the following goals ADA A1C Goals: A1C < 7.0 for most patients A1C > 7.0 (consider 7.0-7.9) for higher risk patients 1. History of severe hypoglycemia 2. Multiple co-morbid conditions 3. Long standing diabetes 4. Limited life expectancy 5. Advanced complications or 6. Difficult to control despite use of insulin ADA Glucose Goals*: Fasting and premeal glucose < 130 Peak post-meal glucose (1-2 hours after meal) < 180 Difference between premeal and post-meal glucose < 50 *for higher risk patients individualize glucose goals in order to avoid hypoglycemia BASAL INSULIN Intermediate-acting: NPH Note: NPH insulin has elevated risk of hypoglycemia so use with extra caution6,8,15,17,25,32 Long-acting: Glargine (Lantus®) Detemir (Levemir®) 6,7,8 Basal insulin is best starting insulin choice for most patients (if fasting glucose above goal). 6,7 8 Start one of the intermediate-acting or long-acting insulins listed above. Start insulin at night. When starting basal insulin: Continue secretagogues. Continue metformin. 7,8,20,29 Note: if NPH causes nocturnal hypoglycemia, consider switching NPH to long-acting insulin. 17,25,32 STARTING DOSE: Start dose: 10 units6,7,8,11,12,13,14,16,19,20,21,22,25 Consider using a lower starting dose (such as 0.1 units/kg/day32) especially if 17,19 patient is thin or has a fasting glucose only minimally above goal.
    [Show full text]
  • Use of Inhaled Human Insulin in Patients with Diabetes Mellitus Meghan K
    Volume X, No. I January/February 2007 Mandy C. Leonard, Pharm.D., BCPS Assistant Director, Drug Information Service Editor Use of Inhaled Human Insulin in Patients with Diabetes Mellitus Meghan K. Lehmann, Pharm.D., BCPS by Linda Ghobrial, Pharm.D. Drug Information Specialist Editor I ntroduction: Diabetes mellitus is a concentration >200 mg/dL in the pres- Dana L. Travis, R.Ph. Drug Information Pharmacist metabolic disease characterized by ence of symptoms, or a 2-hour OGTT 2 Editor hyperglycemia and abnormal carbo- value of >200 mg/dL. The diagnosis hydrate, fat, and protein metabolism. is then confirmed by measuring any David A. White, B.S., R.Ph. Diabetes has a very high prevalence one of the three criteria on a subse- Restricted Drug Pharmacist 2 Associate Editor worldwide. There are approximately quent day. 20.8 million (7%) people in the 1 Marcia J. Wyman, Pharm.D. United States who have diabetes. Classification: Most patients with D rug Information Pharmacist Diabetes results from defects in insu- diabetes mellitus are classified as hav- Associate Editor lin secretion, sensitivity, or both. Al- ing either type 1 or type 2. Type 1 Amy T. Sekel, Pharm.D. though the exact cause remains un- diabetes (previously known as juve- D rug Information Pharmacist clear, genetics and environmental fac- nile diabetes) accounts for about 10% IAnss otchiaiste IEsdsituoer tors such as obesity and lack of exer- of all diabetes cases and is usually cise appear to be involved. diagnosed in children and young David Kvancz, M.S., R.Ph., FASHP 2 Chief Pharmacy Officer adults.
    [Show full text]
  • Step-Wise Dosing and Titration of Insulin for Type 2 Diabetes in the Ambulatory Setting Last Update 5/2010
    Step -Wise Dosing and Titration of Insulin for Type 2 Diabetes in the Ambulatory Setting last update 5/2010 Insulin When to Starting dose Average Average Average Average Adjust Insulin dose every When to Change to Different Regimen start fasting Pre-lunch Pre-supper Bedtime 3 days until BG < 130, or Recheck A1C every 3 months AM BG BG BG BG optimal dose is reached Goal<130 Lantus A1C greater 10 units or up to Greater Increase dose by 2-4 units at If after 3 months if A1c is greater than 7% (glargine) than 8% on 0.2 units/kg SQ at than 130 bedtime. and optimal bedtime dose has been reached OR Levemir 2 or 3 bedtime mg/dL with fasting blood glucose at goal, consider (detemir) antidiabetic (DC sulfonylurea if Optimal long acting (basal) adding a pre-meal bolus insulin at the largest OR agents OR part of regimen) insulin dose keeps bedtime meal of the day, pre-meal bolus insulin at NPH insulin 1 or 2 agents and AM fasting glucose each meal or 70/30 premix insulin. if Serum values consistent. Creatinine greater than 2 DC all oral agents except Metformin. Increase long acting (basal) Pre-meal A1C greater 2-4 units of rapid Greater insulin dose by 2-4 units at bolus with than 7% with acting or regular than 130 bedtime rapid acting optimal long insulin SQ at each Increase AM rapid/regular OR regular acting (basal) meal (base dose) Greater insulin dose by 2-4 units. insulin insulin. than 130 AND with Increase lunch rapid/regular Greater than insulin dose by 2-4 units.
    [Show full text]
  • Combination Use of Insulin and Incretins in Type 2 Diabetes
    Canadian Agency for Agence canadienne Drugs and Technologies des médicaments et des in Health technologies de la santé CADTH Optimal Use Report Volume 3, Issue 1C Combination Use of Insulin and July 2013 Incretins in Type 2 Diabetes Supporting Informed Decisions This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). The report contains a comprehensive review of the existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) available to CADTH at the time of report preparation. The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this document to ensure that its contents are accurate, complete, and up to date as of the date of publication, CADTH does not make any guarantee to that effect. CADTH is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this document or in any of the source documentation.
    [Show full text]
  • Combination Therapies with Insulin in Type 2 Diabetes
    Reviews/Commentaries/Position Statements REVIEW ARTICLE Combination Therapies With Insulin in Type 2 Diabetes 1 HANNELE YKI-JA¨RVINEN, MD, FRCP patients who are poorly controlled on oral drugs. One may also predict from these data that if the insulin dose is lowered less than ϳ30% when patients are transferred he U.K. Prospective Diabetes Study lar end points but only on surrogate from insulin alone to insulin combined (UKPDS) demonstrated that inten- markers of risk of micro- and macrovas- with sulfonylurea or metformin, glycemic T sive glucose control with insulin or cular complications, mostly data on gly- control will be better during insulin com- sulfonylureas markedly reduces the risk cemia, body weight, insulin doses, lipids, bination therapy. This is documented by of microvascular complications (1). For and in a few studies, also accurate data on analysis of data from studies in previously myocardial infarction, the reduction in the frequency of hypoglycemias. insulin-treated patients (Table 2). In these comparisons, glycemic control was better risk (16% for a 0.9% decrease in HbA1c) According to a Medline search (1966– was of borderline significance but corre- 2000), insulin alone has been compared in most (19 of 25) comparisons, but the sponded closely to epidemiological pre- with insulin combination therapy in a to- insulin dose was decreased by only 19% dictions (14% decrease for a 1% drop in tal of 34 prospective studies that lasted at in the combination regimens using met- HbA ) (2). These data demonstrated that least 2 months and reported data on HbA formin and by 21% in comparisons using 1c 1 insulin and sulfonylureas (Table 2).
    [Show full text]
  • Guide to Starting and Adjusting Insulin for Type 2 Diabetes*
    Guide to Starting and Adjusting Insulin for Type 2 Diabetes* * Adapted from Guide to Starting and Adjusting Insulin for Type 2 Diabetes, ©2008 International Diabetes Center, Minneapolis, MN. All rights reserved. www.cadth.ca Supporting Informed Decisions Many people with type 2 diabetes need insulin therapy. A variety of regimens are available. Here are some tips when discussing insulin therapy:1 • Discuss insulin early to change negative perceptions (e.g., how diabetes changes over time; insulin therapy as a normal part of treatment progression). • To encourage patient buy-in, it may be more strategic initially to begin with a regimen that will be the most acceptable to the patient even if it may not be the clinician’s first choice (e.g., pre-mixed instead of basal-bolus regimen).2 • Provide information on benefits (e.g., more “natural” versus pills, dosing flexibility). • Consider suggesting a “trial” (e.g., for one month). • Compare the relative ease of using newer insulin devices (e.g., pen, smaller needle) versus syringe or vial. • Ensure patient is comfortable with loading and working a pen (or syringe). • Link patient to community support (e.g., Certified Diabetes Educator [CDE] for education on injections and monitoring; nutrition and physical activity counselling). • Show support — ask about and address concerns.2 Consider initiating insulin if…3 • Oral agents alone are not enough to achieve glycemic control or • Presence of symptomatic hyperglycemia with metabolic decompensation or • A1C at diagnosis is > 9%. Timely adjustments
    [Show full text]
  • Tresiba-Product-Monograph.Pdf
    PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION TRESIBA® insulin degludec injection TRESIBA® FlexTouch® 100 U/mL, Solution for injection in a pre-filled pen TRESIBA® FlexTouch® 200 U/mL, Solution for injection in a pre-filled pen Subcutaneous Antidiabetic Agent Long-Acting Basal Insulin Analogue ATC Code: A10AE06 Novo Nordisk Canada Inc. Date of Initial Authorization: AUG 25, 2017 101-2476 Argentia Road Date of Revision: Mississauga, Ontario JUL 23, 2021 Canada L5N 6M1 Submission Control Number: 250276 Product Monograph Master Template Template Date: September 2020 TRESIBA® (insulin degludec injection) Page 1 of 2 RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions 03/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ..............................................................................................................2 1 INDICATIONS ..................................................................................................................4 1.1 Pediatrics ................................................................................................................4 1.2 Geriatrics ................................................................................................................4 2 CONTRAINDICATIONS ..................................................................................................4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................4 4 DOSAGE AND ADMINISTRATION
    [Show full text]
  • Study Protocol
    CLINICAL TRIAL REPORT ZP4207-17086 (ZEA-DNK-02170) 16.1 TRIAL INFORMATION 16.1.1 PROTOCOL AND PROTOCOL AMENDMENTS This appendix includes Document Date, Version Clinical trial protocol Version 1.0, 08 June 2018 (valid in Slovenia and the USA) Version 3.0, 08 January 2019 (valid in Germany) Section 16.1.1: Protocol and Protocol Amendments Clinical Trial Protocol, final version 1.0 ZP4207-17086 (ZEA-DNK-02170) Clinical Trial Protocol A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with T1DM treated with insulin Sponsor code: ZP4207-17086 Synteract: ZEA-DNK-02170 EudraCT number: 2018-000892-33 Coordinating investigator: Prof. Dr. med. Thomas Danne Allgemeine Kinderheilkunde Diabetologie, Endokrinologie, Klinische Forschung Diabeteszentrum für Kinder und Jugendliche AUF DER BULT Kinder- und Jugendkrankenhaus Janusz-Korczak-Allee 12 30173 Hannover Germany Sponsor: Zealand Pharma A/S Smedeland 36 2600 Glostrup, Copenhagen Denmark Version: final version 1.0 Date: 08 June 2018 GCP statement This trial will be performed in compliance with Good Clinical Practice, the Declaration of Helsinki (with amendments) and local legal and regulatory requirements. 08 June 2018 CONFIDENTIAL Page 1/55 Zealand Pharma A/S ClinicalTrial Prolocol, final ve¡sion 1.0 zP 42A7 -1 7 A 86 (ZEA-DN K-02 1 L Slgnature¡ and agreoment wlth protocot Tltle: phase A 3, ¡andomized, double-blind, placebo- and aclivg-controlled, parallel-arm trial to assess the efficac¡ safety, and pharmacoítinetics of dasiglucagon rela¡ve to placebo and GlucaGeno when edministered as a rescue thêrapy for sevãre triposivcemia ¡n children w¡th TlDM treated with insulin we, the undersigned, agroe to conduct lhls trlal according to lhe Trlal protocol.
    [Show full text]