Annals of Long-Term Care: Clinical Care and Aging. 2016;24(1):17-24.
Received July 23, 2015; accepted September 8, 2015.
John Hertig, PharmD
8626 E. 116th St. Suite 200
Fishers, IN 46038
Phone: (317) 275-6083
The authors received funding for this project in the form of a research grant from Becton Dickinson Medical - Diabetes Care. Dr. Brown is currently an employee of Eli Lilly and Company, but was not at the time of the study. Eli Lilly and Company had no involvement in the study.
1Purdue University College of Pharmacy, Center for Medication Safety Advancement, Fishers, IN
2Eli Lilly and Company, Indianapolis, IN
The prevalence of diabetes is increasing in older adults, many of whom are treated in long-term care (LTC) facilities. Insulin pens offer improved safety and accuracy of dosing compared with a vial and syringe. However, insulin pens still pose certain safety risks. The authors conducted a survey of LTC health care professionals to determine the prevalence of insulin pen utilization, to identify barriers to the implementation of insulin pens, and to assess the safety of insulin pen use in LTC settings. Risk mitigation strategies and best practices for insulin pen use were also solicited. A majority of survey respondents reported using both insulin pens and insulin vials in their facilities, most commonly for reasons of improved cost and safety. Despite some reports of insulin pen medication errors, survey respondents agreed that insulin pens can be used safely in the LTC setting and that they are clinically useful. Suggested strategies for risk mitigation included labeling each pen with two patient identifiers, requiring insulin pen training and education for all new hires administering medication, and limiting the variety of pens on formulary.
Key words: insulin pen, insulin vial, diabetes, medication safety, needle sticks, medication error
The prevalence of diabetes is continuously increasing among older adults, many of whom reside in long-term care (LTC) facilities. As of 2011, there were 1.6 million people residing in nursing homes, and 25% of these residents had been diagnosed with diabetes.1-3 Diabetes is the primary reason for 12% of nursing home admissions among residents aged 45–75 years.4 These residents have more comorbid conditions, are prescribed more medications, and experience more hospitalizations than residents without diabetes.5 Therefore, safe and effective glycemic control is necessary in this patient population to reduce the risk of diabetic complications.
The majority of the older adult population (≥65 years old) in the United States has type 2 diabetes mellitus, and pharmaceutical treatment typically requires a multidrug therapeutic regimen that includes insulin.5 According to the American Association of Clinical Endocrinologists and the American Medical Directors Association, insulin should be considered for all patients with type 2 diabetes when noninsulin antihyperglycemic therapy fails to achieve target glycemic control or when a patient has symptomatic hyperglycemia.6-7
Although insulin therapy is an important aspect of glycemic control, several barriers exist to both initiation and continuation of insulin therapy in the older adult population.8 For example, insulin is classified by the Institute for Safe Medication Practices (ISMP) as a “high-alert medication,” meaning that insulin carries a heightened risk of causing significant patient harm when used in error.9 Additionally, older adults have a higher risk of hypoglycemia than the general population, due to age-related factors such as reduced renal function, slowed hormonal regulation, greater difficulty injecting insulin, and increased likelihood of being on multiple medications.10 Therefore, it is imperative to find a safe and efficacious way to deliver insulin to older adults with diabetes.
Insulin pens have been shown to reduce some of the barriers to effective insulin treatment, such as dosing errors and hypoglycemic events. Switching from insulin vials to insulin pens has also been shown to significantly reduce healthcare costs.11 Additionally, older adults may prefer to use insulin pens because of features such as audible clicks and large dosing windows.12
The use of insulin pens does come with some safety concerns. For example, if one insulin pen is used on more than one patient, the patient’s biological matter can flow back through the needle into the insulin reservoir, presenting a risk of cross-contamination and transmission of blood-borne diseases. Both the front and back end of the pen needle have the potential to be contaminated after use and become a source of disease transmission through a needle stick, so effective safety pen needles must be selected.13 There have been several reports of an insulin pen being used on more than one patient in the inpatient setting, although there have been no reports to date of this happening in the LTC setting.14
The Centers for Medicare and Medicaid Services (CMS) recently updated the State Operations Manual to include F-Tags (correspondence to regulation with which a facility is not in compliance, according to the Medicare surveyor) regarding medication errors and infection control (F332, F333, and F441). As an example of medication errors, CMS specifically cites insulin pen administration errors and warns that it could also be classified under F441–Infection Control.15
A survey of LTC health care professionals was conducted to assess current trends of insulin pen utilization in LTC settings. The goal of the study was to determine the prevalence of insulin pen utilization in the LTC setting, to identify barriers to insulin pen utilization, and to describe best practices and risk mitigation strategies for ensuring safe use of insulin pens in the LTC setting.
Survey Design and Participants
After an analysis of primary literature regarding best practices and risk mitigation strategies of insulin pen utilization, a 45-question guided-logic survey was developed using Qualtrics© (Provo, UT). The survey questions were reviewed for clarity and content by medication safety experts within academic, hospital, and the pharmaceutical industry settings. The survey was granted an exemption by the Purdue University Institutional Review Board.
Adaptive questioning was utilized in the survey. All participants were presented with demographic questions about themselves (eg, gender, profession) and about the setting in which they work (eg, facility type, geographic setting). Questions that solicited responses on a Likert scale regarding insulin pen use, medication errors, and risk mitigation strategies, were posed to participants, depending on whether they identified their facilities as using insulin vials, insulin pens, or both.
The survey was distributed electronically to LTC health care professionals with membership in the American Health Care Association (AHCA), the National Association Directors of Nursing Administration in Long Term Care (NADONA/LTC), or the American Association for Long Term Care Nursing (AALTCN) organizations. The survey opened February 9, 2015, and closed on March 13, 2015, with one email reminder sent in the interim. The email inviting survey participation described the purpose of the study, the estimated length of time it would take to complete the survey, the study investigators, and how the data would be stored. Participation was voluntary, and no compensation was offered. Participants gave consent prior to entering the survey. The survey was an open survey, but only those provided with the link to the survey were able to participate. Throughout the survey, respondents were able to review and change their responses before submitting them. The surveys did not have to be fully completed to be included in the data analysis. If a particular question was not answered, it was not included as a data point.
At the end of the survey, respondents who identified their facilities as using insulin pens had the opportunity to provide their contact information so that they could be questioned further about best practices when transitioning from insulin vials to insulin pens in LTC settings. If the contact information was provided, one of the investigators contacted the respondent and asked nine questions about the benefits and/or challenges of using insulin pens. Each respondent was asked the same nine questions (Figure 1).
Survey responses were submitted anonymously, and results were compiled and analyzed in aggregate in Qualtrics© (Provo, UT). Descriptive statistics were used to interpret the information.
The survey was initiated by 234 participants and completed by 199 participants. The mean survey completion time was 10 minutes. The majority of health care professionals who completed the survey were nurses practicing in a nursing home setting (Table 1).
Prevalence of Insulin Pen Use
More than half of respondents (n=149; 68%) indicated that insulin pens are on formulary at their institution, and one-half of these respondents also had insulin vials at their institution (n=120; 55%). Approximately one-third of respondents’ facilities used insulin vials only (n=70; 32%). The most common reasons cited for using both insulin pens and insulin vials were cost or payer preference and physician preference (Figure 2).
The most common reasons cited for not using insulin pens were safety and cost (Figure 3).
The most commonly cited challenges associated with using an insulin vial and syringe were the time needed to administer and prepare injections (n=27; 41%), medication waste (n=19; 29%), and dosing accuracy (n=16; 24%). Only 27% (n=18) of the respondents that used insulin vials only or both insulin vials and insulin pens identified no challenges with using insulin vials. In contrast, the majority of insulin pen users identified no challenges regarding the use of insulin pens (n=82; 62%). Some insulin pen users identified properly labeling the expiration of the pen as (n=17; 13%) as well as waste (n=21; 16%) to be challenges associated with insulin pen use.
A majority of insulin pen users saw reduced waste to be a benefit of insulin pen use (n=86; 61%). Other benefits identified by insulin pen users included decreased time to prepare insulin (n=109; 77%), more accurate dosing (n=106; 75%), patient satisfaction (n=67; 48%), reduction in needle sticks (n=67; 47%), cost savings (n=65; 46%), and decreased time to administer (n=74; 52%).
Insulin Pen Use Errors
Approximately half of all respondents (n=105; 52%) reported no needle sticks during insulin administration at their facility, and 5% (n=10) were not sure. Of the 43% (n=86) whose facility had experienced a needle stick, 23% (n=19) of the needle stick events occurred with an insulin pen, versus 76% (n=63) with an insulin vial and syringe. The percentage of respondents indicating a needle stick was similar between those using a safety syringe or needle (n=40; 48%) and those without a safety syringe or needle (n=36; 43%).
Approximately 6% of respondents (n=8) said that an insulin pen being used on more than one resident in their facility had been reported, versus 93% (n=128) respondents indicating that such an error had not been reported at their facility. In the few cases in which an insulin pen was used on more than one person, these errors were most commonly reported through a voluntary error reporting system (n=3; 38%); in other cases, the errors were observed during routine observation or were reported to a supervisor or someone in the pharmacy. The majority of respondents were not concerned about insulin pen errors not being reported (n=172; 84%), agreed that insulin pens can be used safely in the long-term care setting (n=169; 86%), and agreed that insulin pens are clinically useful (n=166; 85%).
Risk Mitigation Strategies for Insulin Pen Use
Respondents indicated their level of agreement with various risk mitigation strategies for the safe use of insulin pens in the LTC setting proposed in the survey, which were based upon strategies recommended in the literature (Figure 4). The two strategies with which most respondents agreed were requiring insulin pen education and training for all new hires administering medication (n=182; 95%) and labeling each pen with at least two patient identifiers (n=173; 91%). Additional strategies that respondents agreed with included: labeling each pen with auxiliary label “This pen must be used for only ONE patient”, conducting a Failure Mode and Effects Analysis (FMEA) and implementing the risk mitigation strategies identified, providing continuous education on proper pen preparation and administration, develop written guidelines for each type of pen used, develop prescribing protocol, and store pens in the pharmacy until administered.
The survey responses indicated that most facilities already have several practices in place to mitigate safety risks associated with the use of insulin pens. Most survey respondents reported that insulin pens were stored in the same refrigerator as other insulin products (insulin vials, other residents’ pens) prior to administration (n=125; 88%), while some stored insulin pens in a medication cart (n=18; 13%) and in either an automated dispensing cabinet or the resident’s personal refrigerator (n=2; 1%). After administration, the resident’s insulin pen was primarily stored on a medication cart (n=112; 79%). A majority of the respondents labeled the insulin pens with the resident’s name (n=135; 96%), and approximately half used another identifier such as a patient identification number (n=78; 56%) or the patient’s location (n=79; 56%). More than half of respondents also included dose (n=89; 64%) or instructions (n=84; 60%) in their labeling of insulin pens. The majority of respondents said that the insulin pen was sent home with the resident after the resident was discharged (n=98; 70%), whereas 20% (n=28) said that insulin pens were properly disposed after discharge.
With regards to training and education, the majority of respondents (n= 117; 83%) reported that their facilities educate their staff on insulin pen preparation and administration upon hiring or when using a new device. Only 39% of respondents said that their facilities train staff annually on insulin pen preparation and administration, and 44% said that their facilities have insulin administration included as part of their annual competency test.
Qualitative Reports of Best Practices for Insulin Pen Use
Upon completion of the survey, 43 respondents provided their facility’s best practices when using insulin pens. The most common best practice that respondents shared was education for all licensed staff. Many stressed that this is the most important strategy to ensure pens are used safely and not shared between residents. They suggested that education take place not only at the time of hiring or when a new device is being used, but also continuously. They also said that regular audits to check for competency is important. Some respondents mentioned auditing the pens at specified time intervals to ensure proper labeling (eg, with patient name and expiration dates). The majority of respondents stressed the importance of labeling the individual pen with at least the patient name. Some also put the labeled pen in a plastic bag and label the bag, and one respondent mentioned that they put the pen in a toothbrush holder and label the toothbrush holder.
Qualitative Reports of Best Practices for Transitioning from Insulin Vials to Insulin Pens
Nine respondents provided their contact information so that they could participate in an interview. Out of these nine respondents, the investigators were able to interview four respondents.
Of the four respondents we interviewed, two had made the transition from using insulin vials to insulin pens at their facilities recently, and the other two had switched to using insulin pens several years ago. The most common reason for switching from insulin vials to insulin pens was safety. One interviewee said the transition to insulin pens was made specifically in response to a high rate of needle sticks with the vial and syringe and in order to reduce costs under Medicare Part A through the reduction of waste associated with the insulin pens. Additionally, the interviewee stated that the pen provides more accurate dosing, which means less hypoglycemia and better-managed patients. All four interviewees indicated that cost was not a major factor underlying the decision to use insulin pens, because, as one interviewee stated, “most insurance companies now pay for both vials and pens for Part D residents.”
All four interviewees identified education for the nursing staff as the biggest challenge to making the transition to insulin pens. Each interviewee indicated that proper education is vital to successfully instructing on the safe use of insulin pens. Interviewees suggested contacting drug manufactures to obtain educational materials and insulin pen models, in order for nurses to gain hands-on experience.
Another challenge was ensuring that the insulin pens are properly labeled. All facilities ensure the pens are labeled individually. At three of the facilities, the pharmacy labeled the pens. At one facility, initially, the pharmacy labeled the box of pens and the nursing staff labeled each individual pen upon first use; however, they later moved to ensuring the pharmacy labeled the pens individually prior to sending to the facility. All recommended a label with expiration date be affixed to the pen, with some recommending brightly colored labels to draw nurses’ attention. Additionally, one facility recommended having a reference sheet with a complete list of expiration dates for each type of pen to aide nurses in correctly identifying the expiration of an insulin pen. One facility also recommended having a process in place—for example, not keeping all the pens in one drawer or box on the medical cart—to ensure the correct pen is used for the correct resident. They also stressed the importance of auditing the pens to ensure they are used and labeled correctly.
All interviewees recommended using safety needles to reduce needle sticks. One interviewee noted that they had no needle sticks in the 4 months since switching from insulin vials to insulin pens with a safety needle. When asked if the facility would consider switching back to using insulin vials, all four stated they would not switch back and that they are satisfied with using the insulin pens.
A majority of the facilities surveyed indicated that they are currently using both insulin pens and vials in LTC, whereas only about one-third of respondents indicated they use insulin vials only. Differences between insurance companies’ formulary restrictions were cited as a common reason for using both forms of insulin. For example, one insurance company may reimburse for an insulin pen, whereas another insurance company may only reimburse for an insulin vial. Cost was also cited as a reason to supply both forms; for example, it would not be cost-effective to use an insulin pen for patients requiring a high dose of insulin (greater than 40 units per day).
Still, insulin pens are underutilized in the United States as compared to other developed countries. According to a study conducted by RNCOS, a leading market research and information analysis company, only 17% of insulin units are delivered through insulin pens in the Unites States, compared with 88% in Europe and 95% in Japan, although the majority of that data is from the outpatient community.16 With new concentrations of insulin becoming available in a pen (U-300 glargine developed by Sanofi-Aventis, U-200 degludec being developed by Novo-Nordisk, and U-200 insulin lispro and U-500 insulin human developed by Eli Lilly and Company),17 there is a need to disseminate best practices in regards to pen utilization to improve patient safety as well as clinical outcomes.
Interestingly, the primary reason given by respondents who use insulin vials only was cost savings, the same reason given by more than half of the respondents using both insulin vials and insulin pens. Studies have shown that the use of insulin pens compared to the use of insulin vials can result in a cost reduction.18,19 Bazalo et al found that the insulin cost per patient-day for patients in LTC decreased from $10.29 to $4.08 when switching to insulin pens from vials.19 Interview participants whose facilities switched from insulin vials to insulin pens confirmed that they found insulin pens to be cost-effective.
The second most commonly cited reason not to use insulin pens was safety. The safety reasons were two-fold: concern about risk of a pen being used on more than one patient, and concern about needle sticks. Respondents indicated that there have been reports of an insulin pen being used on more than one patient in the LTC setting. Despite these reports, the survey respondents agreed insulin pens can be used safely in the LTC setting and that they are clinically useful.
Through this survey, we aimed to identify risk mitigation strategies that LTC facilities recommend to enhance safety with insulin pens in the LTC setting. The respondents identified storing insulin pens in the refrigerator prior to first use and then on the medication cart after first administration; labeling each pen with two patient identifiers; requiring insulin pen training and education for all new hires administering medication; and limiting the variety of pens on formulary to be strongest risk mitigation strategies. These and other best practices with which the respondents agreed have been commonly cited within the literature.20,21
The utilization of two patient identifiers is common, most likely due to The Joint Commission requirement and National Patient Safety Goal.22 Barcode medication administration (BCMA) has been widely used in hospitals and has been shown to improve patient safety. One study conducted by Brigham and Women’s Hospital found that barcode technology reduced documentation errors by 80% and reduced wrong-dose errors by 33%.23 Although respondents indicated that BCMA can prevent medication errors, it does not prevent all medication errors.
The reports from the media of insulin pen errors cited that administration errors were most likely due to a knowledge deficit.24 However, recently published findings of ISMP from a multihospital system state that, despite implementation of best practices to prevent the sharing of insulin pens, such as order-specific barcoding and barcode system alerts, errors still occurred, and for reasons other than knowledge deficit, such as system issues, at-risk behaviors, and human errors.24 Respondents indicated that education as vital to ensuring insulin pens are used safely. Campaigns have been initiated to improve the safety of insulin pen use. The Centers for Disease Control and Prevention (CDC) and the Safe Injection Practices Coalition (SIPC) started the “One and Only Campaign” to raise awareness about safe injection practices.25 The campaign provides education resources and marketing materials to promote the safe use of insulin pens as well as other injectable medications. Additionally, ASHP Advantage has recently started a program, “One Pen, One Patient,” with the focus of providing strategies for ensuring the safe use of insulin pens in the hospital. “One Pen, One Patient” is also conducting a mentored quality improvement activity to provide institutions using insulin pens with an opportunity to learn from each other and strategize how to overcome challenges associated with insulin pen use.26 These resources represent only the beginning of a coordinated national effort needed to ensure the safe use of insulin pens.
In contrast with the concern that the use of insulin pens can pose an increased risk of needle sticks, reduction in needle sticks was seen as a benefit to approximately half of those respondents who use insulin pens. One respondent interviewed after the survey switched to insulin pens due to issues with needle sticks with vial and syringe, and they have not experienced a needle stick incident since switching. Although safety pen needles result in greater expense when compared with safety syringes, respondents stated they are worth the cost in order to protect their staff. The interviews indicated that insulin pen safety needles may not be covered by insurance; however, it is worth noting that CMS states, “Insulin syringes equipped with a safe needle device, in their entirety (syringe and device), are also Part D drugs and should be managed like any other Part D drug the sponsor places on its formulary. Part D sponsors must make safety enabled insulin syringes available on their formularies for all of their institutionalized beneficiaries.”27 The results of this survey indicate that there are misconceptions regarding the cost and safety of insulin pens and needles.
This study is the first, to our knowledge, that has examined the prevalence and safety of insulin pen utilization in the LTC. There have been other studies highlighting the benefits to using insulin pens in the LTC setting, but these were based on an extrapolation of data from research conducted in other populations and then applying them to the LTC setting.8,18 The authors of one study16 stated, “Although no studies specifically assessed the use of pen devices in older patients with diabetes living in LTC facilities, such patients are likely to experience the benefits demonstrated in the general populations of patients with diabetes.” Therefore, more research is needed in this area to validate these findings.
There are some limitations to the present study. In order to reach as many health care professionals as possible, the survey was distributed via newsletter publication and email listserv. This eliminated the possibility of calculating a response rate, because it was unknown how many people received/opened the email or read the newsletter. Additionally, respondents did not have to answer all of the questions in order to complete the survey, further limiting the ability to calculate a true denominator. However, when the authors analyzed the data on completed surveys only, there was not a significant difference between these results and those of the analysis of all surveys. The survey was anonymous, and respondents did not have to provide the name of their facility. It is possible, albeit unlikely, that multiple health care professionals from the same facility could have completed the survey. Of note, access to the survey tool was unique to each participant, ensuring that the survey was completed only once per individual.
The results of our survey of health care professionals in the LTC setting suggest that the majority of LTC facilities are utilizing insulin pens. The survey revealed insulin pen medication errors have taken place in LTC facilities. However, facilities are choosing to use insulin pens over insulin vials primarily for enhanced safety, and they have been successful in implementing insulin pens. Health care professionals believe insulin pens are clinically useful and can be used safely in the LTC setting. Further studies are needed to assess and validate the risk mitigation strategies identified through this research.