Commentary

Insulin without prescription requires patient education

In 1922, the first insulin was made available for human use. The discovery and use of insulin revolutionized diabetes treatment and improved life for people with the disease, especially type 1. Nearly 95 years later, insulin remains the mainstay of treatment for type 1 diabetes and gestational diabetes, as well as for many people with type 2 diabetes.

Wealth of available products

Since then, the evolution of insulin continues to advance. There are currently at least 15 insulin products in the U.S. market, with more in the pipeline. During the past century, new formations and delivery systems have improved the pharmacokinetics and pharmacodynamics of the drug and ease of use for patients. In the past year alone, the introduction of “concentrated” or “low volume” insulins has increased the choices available.

Susan Cornell

It is known that insulin analogues provide longer and shorter durations of actions that more closely mimic normal insulin secretion in response to fasting and prandial needs. In comparison with neutral protamine Hagedorn, or NPH, long-acting insulin analogues are associated with a lower incidence of hypoglycemia. In addition, regular human insulin has a slower onset and longer duration of action compared with rapid-acting insulin analogues, resulting in less postprandial control and increased frequency of hypoglycemia.

Barriers to adherence

However, despite the progress in insulin development and its administration, barriers to insulin adherence remain at the forefront for many clinicians, educators and patients. The American Diabetes Association categorizes barriers to insulin adherence into three main areas: patient barriers, medication factors and system factors. Patient barriers can include forgetting to request or pick up refills, remembering to take the dose, fear of insulin, depression or health beliefs about the insulin. Medication factors include regimen complexity, multiple daily dosing, cost and adverse drug reactions. System factors include suboptimal follow-up or support.

Using the Morisky Medication Adherence Scale in patients on insulin with type 1 and type 2 diabetes, Farsaei and colleagues reported low adherence due to embarrassment, time consumption, feeling worse after the injection, difficulties in preparation of the injection, forgetfulness, hypoglycemia, weight gain, cost and insulin drug shortage.

Considering all the factors that go into optimal insulin prescribing, dosing and administration, the barriers of cost and access to medication can be presupposed. Today, many people in the United States do not have insurance, are underinsured or have large out-of-pocket deductibles. Due to these circumstance, many patients avoid or cannot visit their primary or specialty care prescribers, often for durations of at least 1 year. The delay or avoidance of such prescriber visits leads to patients’ inability to obtain needed prescriptions or refills for their medication, including insulin. This has led to an increase in the purchase of over-the-counter insulins, which do not require prescriptions. It is estimated that 15% of people who buy insulin purchase it OTC.

OTC insulin

In today’s health system, many practitioners are unaware that some of the older insulin formulations can be purchased without a prescription. The two types of human insulin available OTC are human insulin regular (Humulin R, Lilly; and Novolin R, Novo Nordisk) and human insulin NPH (Humulin N, Lilly; and Novolin N, Novo Nordisk). Created in the early 1980s, these insulin products take longer to metabolize than some of the newer prescription versions. The prices range from more than $200 a vial to as little as $25, depending on the pharmacy where patients buy them.

The versions of insulin available OTC were approved for sale that way because they are based on a less concentrated formulation, which theoretically did not require a licensed medical practitioner’s supervision for safe use. According to the FDA, the availability of this form of insulin allows patients with diabetes to obtain necessary medication in urgent situations without delays. Also, with the increase in copayments and premiums, or when people lose their insurance coverage, patients turn to nonprescription insulin because it is more affordable.

Patient education

Of course, the prescription insulin analogues are better and safer and more closely match normal insulin physiology, resulting in less fluctuation in blood glucose levels and better glucose control. However, during these unsettling health care times, clinicians often need to educate patients on how to do the wrong thing the right way.

Without oversight and training from a health care professional, the use of OTC insulins can be dangerous. However, if it is a matter of insulin or no insulin, OTC insulin can be lifesaving. Therefore, it is essential to have a crucial conversation with patients to educate them on the correct dose to use with OTC insulin, which is often the same dose as the analogue they were previously taking.

Patients need to understand that the OTC insulins work differently than the prescription products they are accustomed to. Knowing the signs and symptoms of hypoglycemia and hyperglycemia, along with when to effectively use self-monitoring blood glucose, is essential. Also, educating patients on managing their diabetes under less-than-optimal circumstances can help reduce diabetes-related conditions and complications.

It is important to note that patients can also obtain OTC insulin syringes. A 10-count package of insulin syringes can be purchased for $2 to $3 along with the insulin without a prescription. The pharmacist can work with patients to help them in obtaining the correct OTC insulin, syringes and other needed supplies to manage their diabetes until optimal therapy can be acquired.

Health care providers must realize that for many patients, insulin is not the problem, but getting the insulin is.

References:
  • American Diabetes Association. Clin Diabetes. 2016;doi:10.2337/diaclin.34.1.3.
  • Cefalu W, et al. Diabetes Care. 2015;doi:10.2337/dci15-0023.
  • Farsaei S, et al. Prim Care Diabetes. 2014;doi:10.1016/j.pcd.2014.03.001.
For more information:
  • Susan Cornell, PharmD, CDE, FAPhA, FAADE, is associate director of experiential education and associate professor in the department of pharmacy practice at Midwestern University Chicago College of Pharmacy in Downers Grove, Ill. She is a certified diabetes educator and clinical pharmacy consultant, specializing in community and ambulatory care practice. She can be reached at: scorne@midwestern.edu. She reports no relevant financial disclosures.

In 1922, the first insulin was made available for human use. The discovery and use of insulin revolutionized diabetes treatment and improved life for people with the disease, especially type 1. Nearly 95 years later, insulin remains the mainstay of treatment for type 1 diabetes and gestational diabetes, as well as for many people with type 2 diabetes.

Wealth of available products

Since then, the evolution of insulin continues to advance. There are currently at least 15 insulin products in the U.S. market, with more in the pipeline. During the past century, new formations and delivery systems have improved the pharmacokinetics and pharmacodynamics of the drug and ease of use for patients. In the past year alone, the introduction of “concentrated” or “low volume” insulins has increased the choices available.

Susan Cornell

It is known that insulin analogues provide longer and shorter durations of actions that more closely mimic normal insulin secretion in response to fasting and prandial needs. In comparison with neutral protamine Hagedorn, or NPH, long-acting insulin analogues are associated with a lower incidence of hypoglycemia. In addition, regular human insulin has a slower onset and longer duration of action compared with rapid-acting insulin analogues, resulting in less postprandial control and increased frequency of hypoglycemia.

Barriers to adherence

However, despite the progress in insulin development and its administration, barriers to insulin adherence remain at the forefront for many clinicians, educators and patients. The American Diabetes Association categorizes barriers to insulin adherence into three main areas: patient barriers, medication factors and system factors. Patient barriers can include forgetting to request or pick up refills, remembering to take the dose, fear of insulin, depression or health beliefs about the insulin. Medication factors include regimen complexity, multiple daily dosing, cost and adverse drug reactions. System factors include suboptimal follow-up or support.

Using the Morisky Medication Adherence Scale in patients on insulin with type 1 and type 2 diabetes, Farsaei and colleagues reported low adherence due to embarrassment, time consumption, feeling worse after the injection, difficulties in preparation of the injection, forgetfulness, hypoglycemia, weight gain, cost and insulin drug shortage.

Considering all the factors that go into optimal insulin prescribing, dosing and administration, the barriers of cost and access to medication can be presupposed. Today, many people in the United States do not have insurance, are underinsured or have large out-of-pocket deductibles. Due to these circumstance, many patients avoid or cannot visit their primary or specialty care prescribers, often for durations of at least 1 year. The delay or avoidance of such prescriber visits leads to patients’ inability to obtain needed prescriptions or refills for their medication, including insulin. This has led to an increase in the purchase of over-the-counter insulins, which do not require prescriptions. It is estimated that 15% of people who buy insulin purchase it OTC.

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OTC insulin

In today’s health system, many practitioners are unaware that some of the older insulin formulations can be purchased without a prescription. The two types of human insulin available OTC are human insulin regular (Humulin R, Lilly; and Novolin R, Novo Nordisk) and human insulin NPH (Humulin N, Lilly; and Novolin N, Novo Nordisk). Created in the early 1980s, these insulin products take longer to metabolize than some of the newer prescription versions. The prices range from more than $200 a vial to as little as $25, depending on the pharmacy where patients buy them.

The versions of insulin available OTC were approved for sale that way because they are based on a less concentrated formulation, which theoretically did not require a licensed medical practitioner’s supervision for safe use. According to the FDA, the availability of this form of insulin allows patients with diabetes to obtain necessary medication in urgent situations without delays. Also, with the increase in copayments and premiums, or when people lose their insurance coverage, patients turn to nonprescription insulin because it is more affordable.

Patient education

Of course, the prescription insulin analogues are better and safer and more closely match normal insulin physiology, resulting in less fluctuation in blood glucose levels and better glucose control. However, during these unsettling health care times, clinicians often need to educate patients on how to do the wrong thing the right way.

Without oversight and training from a health care professional, the use of OTC insulins can be dangerous. However, if it is a matter of insulin or no insulin, OTC insulin can be lifesaving. Therefore, it is essential to have a crucial conversation with patients to educate them on the correct dose to use with OTC insulin, which is often the same dose as the analogue they were previously taking.

Patients need to understand that the OTC insulins work differently than the prescription products they are accustomed to. Knowing the signs and symptoms of hypoglycemia and hyperglycemia, along with when to effectively use self-monitoring blood glucose, is essential. Also, educating patients on managing their diabetes under less-than-optimal circumstances can help reduce diabetes-related conditions and complications.

It is important to note that patients can also obtain OTC insulin syringes. A 10-count package of insulin syringes can be purchased for $2 to $3 along with the insulin without a prescription. The pharmacist can work with patients to help them in obtaining the correct OTC insulin, syringes and other needed supplies to manage their diabetes until optimal therapy can be acquired.

Health care providers must realize that for many patients, insulin is not the problem, but getting the insulin is.

References:
  • American Diabetes Association. Clin Diabetes. 2016;doi:10.2337/diaclin.34.1.3.
  • Cefalu W, et al. Diabetes Care. 2015;doi:10.2337/dci15-0023.
  • Farsaei S, et al. Prim Care Diabetes. 2014;doi:10.1016/j.pcd.2014.03.001.
For more information:
  • Susan Cornell, PharmD, CDE, FAPhA, FAADE, is associate director of experiential education and associate professor in the department of pharmacy practice at Midwestern University Chicago College of Pharmacy in Downers Grove, Ill. She is a certified diabetes educator and clinical pharmacy consultant, specializing in community and ambulatory care practice. She can be reached at: scorne@midwestern.edu. She reports no relevant financial disclosures.