Alan W. Carter

If PBMs Guard Access to Drugs, Then Quis Custodiet Ipsos Custodies? (Who Will Guard the Guardians?).

Insulin prices in the United States have risen dramatically in recent years, yet pharmacies cannot provide a stable price for a given insulin due to factors that are not widely understood. This commentary discusses the complex and obscure factors that drive today’s insulin prices with a discussion of the other players, besides the insulin manufacturer, who benefit from higher prices. An open discussion is critical regarding this drug and others that are essential to the lives of millions of people with diabetes. We’ll also explore whether the market introduction of biosimilar insulin will impact insulin prices.

An analysis of the assessment of glycated hemoglobin using A1cNow+ point-of-care device compared to central laboratory testing--an important addition to pharmacist-managed diabetes programs?

The diabetes epidemic is accelerating rapidly. If no progress is made in early detection, then early intervention and treatment-to-goal diabetes care will become an overwhelming burden on our health care system. Better utilization of self-monitoring of blood glucose in patients with type 2 diabetes not on insulin could be achieved with regular review of hemoglobin A1c (A1C) values. Educating patients about the importance of diet, exercise, and medication compliance is enhanced when evidence of average blood glucose control can be presented to the patient directly. Affordable, accurate point-of-care testing of A1C with A1cNow+™ (Bayer HealthCare, Terrytown, NY) utilized in pharmacist-managed outpatient diabetes programs may prove to be an important clinical tool for improving patient outcomes and reducing the cost of the expanding diabetes epidemic.

Quality Control of Insulins and Biosimilar Insulins: What Do We Know?

The quality of drugs manufactured for human use is something all of us assume to be a fundamental right as health care consumers. Once the manufacturing process is complete all pills/insulin vials/pens should look like the preceding lots produced. We take it for granted that the quality control system each manufacturer is required to have is working efficiently, that is, that any batches of insulin that do not fulfill minimum specifications will be quarantined and will not enter the market. This is at least the theory; however, it might not always be the case, at least not in all countries/regulatory worlds and we now have a global supply chain to consider. The object of this editorial is to openly discuss aspects that could have an impact on the quality of insulin available in this new global market. It is not our intent to find fault with any manufacturer of insulin (might it be the originators or those who manufacture biosimilar insulins), but to increase awareness of a lack of knowledge/information about this topic.

Analysis of the Injection Force of Solostar® Compared with other Disposable Insulin Pen Devices at Constant Volume Flow Rates

Insulin pen devices have greatly enhanced the portability and accessibility to insulin therapy for millions of people with diabetes. Comparison research data should be reviewed thoroughly. In this issue of Journal of Diabetes Science and Technology, the study presented by Thomas van der Burg is balanced in number of samples tested, same tensile meter, and identical units per second delivery rate into an open beaker. Mean plateau force of SoloSTAR® and KwikPen® were Significantly lower. KwikPen and SoloSTAR utilized 5-mm length 31-gauge (G) needles vs 6-mm 31G needles for FlexPen® and Next Generation FlexPen®, perhaps skewing results in favor of shorter needles instead of device design. Individual understanding of correct insulin use, appropriate self-monitoring of blood glucose, vision and dexterity capability, and affordability of therapy must be considered first. SoloSTAR holds one unique market advantage, delivery of up to 80 units of insulin per injection.

In the Biosimilar Marketplace Will There Be 50 Ways to Leave Your Insulin

The future biosimilar insulin marketplace could be a bane, benefit, or something in between, to patients under our care in the United States. Formulary preferred product status, with or without FDA interchangeability designation, coupled with current and proposed state pharmacy substitution laws may lead to an environment with as many as 50 different substitution guidelines depending on in which state a patient presents his or her prescription to be filled. If online global prescription supply options, often referred to as “Canada Drug,” are utilized, other country substitution guidelines come into play, which may yield a recipe for confusion, if not disaster.

FDA-Approved Biosimilar Insulin: Good Enough for Critical Care, Adulterated, or Counterfeit? How Can We Tell?

If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient’s home. Adulterated products could be considered “counterfeit” since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes.

Recommending Blood Glucose Monitors, a Pharmacy Perspective

Introduction: Selection of what blood glucose monitoring system to utilize has become an issue for physicians, diabetes educators, pharmacists, and patients. The field of competing makes and models of blood glucose monitoring systems has become crowded, with manufacturers touting improvements in accuracy, ease of use/alternate site options, stored results capacity, software evaluation tools, and/or price point. Methods: Personal interviews of 12 pharmacists from community and academic practice settings about monitor preference, as well as results from a national survey of pharmacist recommendations, were compared to actual wholesale sales data to estimate the impact of such recommendations on final monitor selection by the patient. Results: Accu-Chek® monitors were recommended 34.65% of the time and represented 28.58% of sales, with a success rate of 82.48% of being the monitor selected. OneTouch® monitors had 27.72% of recommendations but represented 31.43% of sales, indicating possible patient brand loyalty or formulary preference for that product. FreeStyle® monitors came in third for pharmacist recommendations and were selected by the patient 61.68% of the time when recommended. The category of “other monitor” choices was selected 60.89% of the time by patients given those suggestions. Included in the “other monitor” category was the new disposable monitor marketed as the Sidekick®. Based on sales data provided, the Sidekick® made up 2.87% of “other monitor” category sales, representing 68% of the “other monitor” segment. Conclusions: While patients frequently follow pharmacist monitoring system suggestions, the ultimate deciding factor is most often the final out-of-pocket cost to the patient. As a result, cost of supplies often becomes the most important determining factor in final monitor selection at the patient level. If the patient cannot afford to perform the recommended daily testing intervals, all other determining factors and suggestions become moot.

Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain:

The insulin content in vials/cartridges should be 95 U/ml upon release. No independent confirmation of insulin concentration is available when purchased in the pharmacy (end of the cold supply chain). We quantitatively measured intact insulin in randomly acquired multidose human insulin vials by standard analytical methods. Eighteen 10 ml vials from two manufacturers (M1 and M2) were randomly acquired. The intact insulin concentration ranged from 13.9 to 94.2 U/ml, mean 40.2 U/ml. No vial met the minimum standard of 95 U/ml. These results imply the cold supply chain impacts insulin concentrations to a larger extent than anticipated. Patients are paying high prices for insulin and should expect to receive insulin vials with adequate insulin content in return.

In Response to Letters to the Editor From the American Diabetes Association and Eli Lilly in Regard to: Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain:

Dear Editor, We are grateful for the opportunity to respond to comments from our colleagues at the American Diabetes Association (ADA) and Eli Lilly regarding the results of our insulin concentration measurements published in the December onlinefirst issue of this journal. We are in complete agreement that our preliminary findings do warrant further investigation as it is clearly in the interests of people with diabetes worldwide to have clarity in relation to this topic. Alan W. Carter and Lutz Heinemann

Improving the Drug Quality and Safety Net

When large quantities of contaminated, subpotent, or superpotent drugs are introduced into the medical supply pipeline, injury or death of hundreds or thousands of patients can occur. Tracing the origin of substandard and dangerous products and tracking across regions and countries where shipped is quite costly in both money and time. From patients’ perspective, timely access to quality product is paramount. Receiving deficient product threatens their survival and creates huge sums of financial cost to both them and the medical system. With the passage of HR 3204 the FDA must now find a way to be proactive in policing the global medical product supply line without restricting market availability. Without a comprehensive, world-focused implementation plan these new regulations will fail to protect the public.