Insulin Pens in Acute Care Settings: Clinical Effectiveness, Cost- Effectiveness, and Guidelines

Transcription

1 CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings: Clinical Effectiveness, Cost- Effectiveness, and Guidelines Service Line: Rapid Response Service Version: 1.0 Publication Date: July 24, 2017 Report Length: 10 Pages

2 Authors: Calvin Young, Charlene Argáez Cite As: Insulin pens in acute care settings: clinical effectiveness, cost-effectiveness, and guidelines. Ottawa: CADTH; 2017 Jul. (CADTH rapid response report: summary of abstracts). Acknowledgments: Disclaimer: The information in this document 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. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or 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. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH. CADTH is not responsible for any errors, omissions, 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 contents of this document or any of the source materials. This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites. Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada s federal, provincial, or territorial governments or any third party supplier of information. This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user s own risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors. About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system. SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 2

3 Table 1: Selection Criteria Population Intervention Comparator Outcomes Study Designs Research Questions 1. What is the clinical effectiveness of insulin pens compared to insulin vials in acute care settings? 2. What is the cost-effectiveness of insulin pens compared to insulin vials in acute care settings? 3. What are the evidence-based guidelines regarding the use of insulin pens in acute care settings? Key Findings Two systematic reviews (one with meta-analysis), four non-randomized studies, and three economic evaluations were identified regarding the clinical effectiveness or costeffectiveness of insulin administration via insulin pens for patients with in an acute care setting. Additionally, one evidence-based guideline was identified. Methods An updated literature search was conducted on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. The original search was run on February 15, No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. This updated search was also limited to English language documents published between February 15, 2015 and July 17, Internet links were provided, where available. Selection Criteria One reviewer screened citations and selected studies based on the inclusion criteria presented in Table 1. Patients with requiring subcutaneous insulin in an acute care setting Insulin administration via insulin pen Q1-2: Insulin vials Q3: No comparator Q1: Efficiency, clinical benefit or harm, safety Q2: Cost-effectiveness Q3: Evidence-based guidelines Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, nonrandomized studies, economic evaluations, evidence-based guidelines SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 3

4 Results Rapid Response reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials, non-randomized studies, economic evaluations, and evidence-based guidelines. Two systematic reviews (one with meta-analysis), four non-randomized studies, and three economic evaluations were identified regarding the clinical effectiveness or costeffectiveness of insulin administration via insulin pens for patients with in an acute care setting. Additionally, one evidence-based guideline was identified. No relevant health technology assessments or randomized controlled trials were identified. Additional references of potential interest are provided in the appendix. Overall Summary of Findings Two systematic reviews 1-2 (one with meta-analysis), 2 four non-randomized studies, 3-6 and three economic evaluations 7-9 were identified regarding the clinical effectiveness or costeffectiveness of insulin administration via insulin pens for patients with in an acute care setting. Detailed study characteristics are provided in Table 2. The identified literature made varied conclusions regarding the clinical effectiveness and cost-effectiveness of insulin pens compared to insulin vials and s. 1-9 However, a majority of studies reported that insulin pen usage offers advantages. 2-3,5-6,8-9 These advantages included improved clinical outcomes, 2-3,9 higher patient adherence, 3,6 ease of use, 5 and reduced total health care costs. 9 Two studies reported no difference or inconclusive results between the two insulin delivery methods. 1.4 Finally, one economic evaluation 7 reported a decrease in insulin wastage and associated acquisition costs when switching from insulin pens to insulin and vials. One evidence-based guideline 10 was identified regarding insulin delivery methods in adults with type 1. This guideline, which was published by the Agency for Healthcare Research and Quality, recommends that adults with type 1 who inject should have access to the insulin injection delivery device they find allows them optimal wellbeing, often using one or more types of insulin injection pen. 10 A number of other recommendations are made regarding the management of type 1 in adults. 10 Table 2: Summary of Included Studies on the Clinical Effectiveness or Cost-Effectiveness of Insulin Administration Via Insulin Pens for Patients with Diabetes in an Acute Care Setting First Author, Year O Neill, Study Characteristics 5 included RCTs Pregnant women with Intervention Comparator(s) Outcomes Conclusions Systematic Reviews and Meta-Analyses Various insulin regimens ( or pen) and types of Various insulin regimens ( or pen) and types of Adverse events Macrosomia Caesarean section delivery Due to very low quality evidence, unclear if different insulin types and SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 4

5 Table 2: Summary of Included Studies on the Clinical Effectiveness or Cost-Effectiveness of Insulin Administration Via Insulin Pens for Patients with Diabetes in an Acute Care Setting First Author, Year Lasalvia, Racsa, Horne, Study Characteristics pre-existing type 1 or type 2 N = 554 MA performed 17 included studies Mostly adult patients with type 2 N = NR Patients with type 1 or type 2 N = 8,189 General medicine patients with type 2 N = NR Ramadan, Patients with type 1 and type 2 N = NR Slabaugh, Elderly insulinnaive patients with type 2 N = 3,172 Kelton, Patients with N = NR Intervention Comparator(s) Outcomes Conclusions insulin insulin Fetal anomalies regimens in pregnant women with preexisting type 1 or 2 provide benefit over each other devices Aspart insulin 3 ml vials of rapid-acting insulin lispro 10 ml vials of Non-Randomized Studies Lispro insulin Economic Evaluations 3 ml pens of rapid-acting insulin aspart 3 ml pens of A1C Hypoglycemia Adherence Persistence Patient preference QoL Clinical outcomes Medication adherence Utilization Annual inpatient stays Total health care costs Glycemic control Ease of use Convenience Patient preference Pain Adherence Persistence Insulin wastage Associated acquisition costs MA suggested pen devices showed better results for mean A1C change, hypoglycemia, adherence, and persistence Risk of bias identified in all included studies use reduced mean annual inpatient stays and reported a higher adherence Insignificant differences were observed for remaining outcomes No difference in glycemic control was observed between the two groups s were easier to use and were less painful than vial and cohort demonstrated higher adherence and lower rate of discontinuation Switching to 3 ml vials of rapid-acting insulin lispro (from 3 ml pens of rapidacting insulin aspart) SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 5

6 Table 2: Summary of Included Studies on the Clinical Effectiveness or Cost-Effectiveness of Insulin Administration Via Insulin Pens for Patients with Diabetes in an Acute Care Setting First Author, Year Bossi, Study Characteristics Patients with N = 360 Ayyagari, Adult patients with type 2 N = 13,428 Intervention Comparator(s) Outcomes Conclusions basal insulin detemir basal insulin detemir Direct and indirect costs of a 10-day in-hospital insulin treatment Patient safety and satisfaction A1C reduction Hospitalization rate Total health care costs Pharmacy costs over 1 year of follow-up Adherence was associated with less insulin wastage and a cost reduction of $ per patient Switching to 10 ml vials of basal insulin determir (from 3 ml pens of basal insulin determir) was associated with reduction in insulin wastage and associated acquisition costs Although insulin pens had higher median direct costs, there was a savings in total expense when indirect costs (including injuries costs) were considered No observed difference in patient safety Adherent pen users demonstrated greater reduction in A1C, lower hospitalization rates, and higher pharmacy costs than nonadherent vial users No significant difference in total health care costs were observed Abbreviations: A1C = glycosylated hemoglobin; MA = meta-analysis; NR = not reported; QoL = quality of life RCT = randomized controlled trial. SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 6

7 References Summarized Health Technology Assessments No literature identified Systematic Reviews and Meta-Analyses 1. O Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing [Internet]. Cochrane Database Syst Rev Feb [cited 2017 Jul 21] 3;2:CD PubMed: PM Available from: 2. Lasalvia P, Barahona-Correa JE, Romero-Alvernia DM, Gil-Tamayo S, Castañeda- Cardona C, Bayona JG, et al. Pen devices for insulin self-administration compared with needle and vial: systematic review of the literature and meta-analysis. J Diabetes Sci Technol; 2016 Jul. Available from : Randomized Controlled Trials No literature identified. Non-Randomized Studies 3. Racsa PN, Meah Y, Ellis JJ, Saverno KR. Comparative effectiveness of rapid-acting insulins in adults with. J Manag Care Spec Pharm Mar;23(3): PubMed: PM Horne J, Bond R, Sarangarm P. Comparison of inpatient glycemic control with insulin vials versus insulin pens in general medicine patients. Hosp Pharm Jun;50(6): Available from: PubMed: PM Ramadan WH, Khreis NA, Kabbara WK. Simplicity, safety, and acceptability of insulin pen use versus the conventional vial/ device in patients with type 1 and type 2 mellitus in Lebanon. Patient Prefer Adherence. 2015;9: Available from: PubMed: PM Slabaugh SL, Bouchard JR, Li Y, Baltz JC, Meah YA, Moretz DC. Characteristics relating to adherence and persistence to basal insulin regimens among elderly insulinnaive patients with type 2 : pre-filled pens versus vials/s. Adv Ther Dec;32(12): Available from: PubMed: PM Economic Evaluations 7. Kelton KA, Perk S, Loveland S, Perez-Nieves M, Fu H, Peng X. Economic outcomes with the conversion of insulin delivery methods in hospitals. J Med Econ May;20(5): PubMed: PM SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 7

8 8. Bossi AC, Veronesi G, Poerio CS, Braus A, Madaschi S, Destro M, et al. A prospective study for introducing insulin pens and safety needles in a hospital setting. The SANITHY study. Curr Diabetes Rev. 2016;12(4): Available from: PubMed: PM Ayyagari R, Wei W, Cheng D, Pan C, Signorovitch J, Wu EQ. Effect of adherence and insulin delivery system on clinical and economic outcomes among patients with type 2 initiating insulin treatment. Value Health Mar;18(2): PubMed: PM Guidelines and Recommendations 10. Guideline summary: Type 1 in adults: diagnosis and management. In: National Guideline Clearinghouse [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ) Aug [cited 2017 Jul 21]. Guideline summary available from: See: Insulin Delivery, fourth point SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 8

9 Appendix Further Information Previous CADTH Reports 11. Insulin pens in acute care settings: safety, cost-effectiveness, and guidelines [Internet]. Ottawa (ON): CADTH; 2015 [cited 2017 Jul 21]. Available from: /RB0797%20Insulin%20Pens%20Final.pdf 12. Re-use of insulin pens and insulin vial portions: safety and guidelines [Internet]. Ottawa (ON): CADTH; 2008 [cited 2017 Jul 21]. Available from: Insulin pen-fill formulations (pre-assessment) [Internet]. Ottawa (ON): CADTH; 2004 [cited 2017 Jul 21]. Available from: Non-Randomized Studies Alternate Population 14. Hertig JB, Brown K. Utilization of insulin pens in long-term care [Internet]. Managed Health Care; 2016 Jan [cited 2017 Jul 21]24(1). Available from: Clinical Practice Guidelines Uncertain Methodology 15. Frid AH, Kreugel G, Grassi G, Halimi S, Hicks D, Hirsch LJ, et al. New insulin delivery recommendations. Mayo Clin Proc Sep;91(9): PubMed: PM Haines ST, Miklich MA, Rochester-Eyeguokan C. Best practices for safe use of insulin pen devices in hospitals: recommendations from an expert panel Delphi consensus process. Am J Health Syst Pharm Oct 1;73(19 Suppl 5):S4-S16. PubMed: PM Lizarondo L. Evidence summary - insulin injection: self-administration with insulin pens [Internet]. The Joanna Briggs Institute, EBP Database. JBI@Ovid Jan [cited 2017 Jul 21] (JBI Recommended Practice). Requires subscription Review Articles 18. Smallwood C, Lamarche D, Chevrier A. Examining factors that impact inpatient management of and the role of insulin pen devices. Can J Diabetes Feb;41(1): PubMed: PM Maffettone A, Rinaldi M, Ussano L, Fontanella A. Insulin therapy in the hospital setting: a time for change? [Internet]. Ital J Med [cited 2017 Jul 21]10(1). Available from: Spollett G, Edelman SV, Mehner P, Walter C, Penfornis A. Improvement of insulin injection technique: examination of current issues and recommendations. Diabetes Educ Aug;42(4): PubMed: PM SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 9

10 Additional References 21. Lutz MF, Haines ST, Lesch CA, Szumita PM. Facilitating the safe use of insulin pens in hospitals through a mentored quality-improvement program. Am J Health Syst Pharm Oct 1;73(19 Suppl 5):S17-S31. PubMed: PM Rosenberg AF. Participation in a mentored quality-improvement program for insulin pen safety: opportunity to augment internal evaluation and share with peers. Am J Health Syst Pharm Oct 1;73(19 Suppl 5):S32-S37. PubMed: PM DiMario S, Smallwood C, Chandran A, Satiel-Berzin R. Safety pen needle (SPN) devices in the acute care setting: an analysis of health resource utilization (HRU) in the United States [Internet]. Lawrenceville (NJ): International Society for Pharmacoeconomics and Outcomes Research (ISPOR) [cited 2017 Jul 21]. Available from: Wang L, Vecchiet J. Comparing medical utilization between insulin pen and vial users within a pediatric Medicaid Accountable Care Organization [Internet]. Columbus (OH): Partners for Kids; 2015 [cited 2017 Jul 21]. Available from: SUMMARY OF ABSTRACTS Insulin Pens in Acute Care Settings 10