As anyone who needs insulin to treat diabetes can tell you, that usually means regular checkups at the doctor鈥檚 office to fine-tune the dosage, monitor blood-sugar levels and check for complications. But here鈥檚 a little known fact: Some forms of insulin can be bought without a prescription.
Carmen Smith did that for six years when she didn鈥檛 have health insurance, and didn鈥檛 have a primary care doctor. She bought her insulin without a prescription at Wal-Mart.
鈥淚t鈥檚 not like we go in our trench coat and a top hat, saying, 鈥楿h I need the insulin,鈥欌�� says Smith, who lives in Cleveland. 鈥淭he clerks usually don鈥檛 know it鈥檚 a big secret. They鈥檒l just go, 鈥楧o we sell over-the-counter insulin?鈥欌��
Once the pharmacist says yes, the clerk just goes to get it, Smith says. 鈥淎nd you purchase it and go about your business.鈥�
But it鈥檚 still a pretty uncommon purchase.
Smith didn鈥檛 learn from a doctor that she could buy insulin that way. In fact, many doctors don鈥檛 know it鈥檚 possible. When she no longer had insurance to help pay for doctors鈥� appointments or medicine, Smith happened to ask at Wal-Mart if she could get vials of the medicine without a prescription. To figure out the dose, she just used the same amount a doctor had given her years before.
It was a way to survive, she says, but no way to live. It was horrible when she didn鈥檛 get the size of the dose or the timing quite right.
鈥淚t鈥檚 a quick high and then, it鈥檚 a down,鈥� Smith says. 鈥淭he down part is, you feel icky. You feel lifeless. You feel pain. And the cramps are so intense 鈥� till you can鈥檛 walk, you can鈥檛 sit, you can鈥檛 stand.鈥�
Smith keeps the tools for controlling her diabetes in this kit, which contains metformin, syringes, fast-acting insulin for daytime use and slow-release for overnight. (Photo by Lynn Ischay for NPR)
Smith鈥檚 guesswork put her in the emergency room of , Cleveland鈥檚 public hospital, several times across six years.
The availability of insulin over the counter presents a real conundrum. As Smith鈥檚 experience shows, without training or guidance from a health care provider, it can be dangerous for a patient to guess at the best dosage and timing from version to version of insulin. On the other hand, being able to afford and easily buy some when she needed it may have saved her life.
There are two types of human insulin available over the counter: one made by and the other by . These versions of the medicine are older, and take longer to metabolize than some of the newer, prescription versions; they were created in the early 1980s, and the prices range from more than $200 a vial to as little as $25, depending on where you buy them.
Dr. Jorge Calles, an endocrinologist at MetroHealth, is alarmed to think that some people are self-medicating with any sort of insulin.
鈥淚t鈥檚 a very serious situation if they are selling it over the counter 鈥� without any control with a prescription, specifically,鈥� Calles says.
According to the medical consulting firm , about 15 percent of people who buy insulin in the growing U.S. diabetes market, purchase it over the counter without a prescription.
The U.S. Food and Drug Administration declined multiple requests by NPR for an interview on this topic. But, in an email, an FDA representative said that the versions of insulin now available over the counter were approved for sale that way because they are based on a less concentrated, older formulation, 鈥渢hat did not require a licensed medical practitioner鈥檚 supervision for safe use.鈥�
The broader availability of this form of insulin allows patients with diabetes to obtain it 鈥渜uickly in urgent situations, without delays,鈥� the FDA says, and is intended to .
Still, some people with diabetes, as well as some doctors, doubt that the benefits of that greater availability outweigh the risks, especially for patients who switch from one type of insulin to another without telling their doctor.
鈥淭his is not something that should be done without the help of a professional,鈥� says , who has Type 1 diabetes, and writes the blog. Kliff has followed and written about the expanding business of diabetes for years.
FDA officials are 鈥渂asically sticking their heads in the sand鈥� on this issue, Kliff says, and making a lot of assumptions.
鈥淭hey look at insulin as a drug,鈥� he says, 鈥渁nd say, 鈥楾here鈥檚 this enormous body of evidence that shows that the drug is safe.鈥� But, you know, there鈥檚 a little asterisk at the end there. What the little asterisk basically says is: 鈥榊ou know, that鈥檚 assuming that the patient is trained on it.鈥欌��
When asked about safety concerns, the FDA told NPR that the agency welcomes more research into the safety of over-the-counter insulin.
One state does require prescriptions for all insulin. , a health officer for Clark County, Ind., led the effort to require prescriptions in his state.
鈥淚 didn鈥檛 realize that insulin was over the counter in Indiana until two of my patients, who were in good control, suddenly had increased glucoses,鈥� Burke says. He asked them if they had changed their diet, lost weight, altered their workout routines. They had not.
鈥淭hey both admitted that they had decided to switch to over-the-counter insulin,鈥� Burke says, 鈥渨hich was different from what I had prescribed.鈥�
Over time, taking the wrong dosages destroys your body, Burke says. Poorly managed diabetes is the cause of a host of complications, such as high blood pressure, kidney disease, nerve damage, loss of eyesight and stroke.
Burke says he took his concerns to the American Medical Association. But the national doctor鈥檚 association told him there are no data showing that the drug鈥檚 over-the counter availability is a public health hazard. In fact, the AMA鈥檚 board noted, getting insulin without a doctor鈥檚 prescription may be an important way for some insulin-dependent patients to get access to the medicine they need.
Dr. Todd Hobbs is chief medical officer of Novo Nordisk in North America, which makes Novolin, one of the two versions of insulin sold over the counter. His company partners with Wal-Mart to sell its version under the brand name . (Wal-Mart declined to be interviewed for this story.)
Hobbs says Novo Nordisk鈥檚 version of insulin is for people who don鈥檛 have insurance, or who have to pay a lot for their other prescriptions 鈥� 鈥減eople who just, for whatever, reason have fallen through the cracks and either don鈥檛 have insurance coverage at the time, or are without coverage.鈥�
With ever-rising copayments and premiums, he says, many patients are turning to nonprescription insulin because it鈥檚 cheaper and all they can afford.
鈥淏ut we hope to try to help them to not have to do that,鈥� Hobbs says.
鈥淲e clearly think the newer versions are more close to what the body would do on its own,鈥� he says. The prescription versions are better and safer, he agrees, because they make it easier for patients to avoid wild fluctuations in blood sugar.
Carmen Smith doesn鈥檛 blame the insulin she was taking for her emergency room visits.
鈥淚nsulin is not the problem,鈥� she says. 鈥淚t is getting the insulin that is the problem. Once I got connected with my physician, life as a diabetic got a lot less complicated for me.鈥�
Smith is now on Medicaid. She has a doctor 鈥� and a prescription for one of the newer generation of insulins.
This story is part of a聽reporting partnership that includes聽, and .