What You Need to Know About Expired EpiPens

Consumer Reports / Ginger Skinner / August 26, 2016

Are they safe? And will they be effective in an emergency?

Anne McMaster, a retired nurse in Seattle with a serious allergy to bees, used to buy a new EpiPen every year when her current one expired. That stopped about three years ago when her out-of-pocket costs for the potentially life-saving medication spiked and she couldn't afford the higher price. Instead, she just kept her old injector, figuring an expired EpiPen is better than no EpiPen at all.

"I would never tell anyone else to do it because of the risks of it not working," McMaster says. "But for me, it was a risk I had to take."

Although there are some lower-cost alternative injectors on the market, and Mylan, the maker of EpiPen, says it is introducing programs to make the device more affordable for consumers, many Americans are wondering whether it is indeed okay to use expired EpiPens.

It's important to replace your epinephrine injector before the expiration date stamped on the pen. That’s because epinephrine deteriorates over time and relying on an outdated one (past the standard 12- to 18-month expiration date) can leave you with an auto-injector that's less effective, or not effective at all, when you most need it.

But what should you do if you are having an allergic emergency and the only injector you have is an expired one? It's probably better to use it than not, some experts say.

"If a patient were to experience an allergic emergency that required use of epinephrine and the only injector available was an outdated one, I would use it," says Andrew Murphy, M.D., a board-certified allergist at the Asthma, Allergy and Sinus Center in West Chester, Pa. "The risk would be that the epinephrine would have degraded and you may not get an optimal dose."

An April 2015 study in the Annals of Allergy, Asthma & Immunology looked at 35 expired EpiPens and found that injectors that were up to two years past their expiration date could retain 90 percent or more of the initial dose listed on labeling.

Murphy stresses that you shouldn't use any injector, even if it's technically not expired, if the medicine is pink or brown (instead of colorless), cloudy, or contains solid particles. In that case, "the medicine clearly has decayed and the injector should not be used at all," Murphy says.

Murphy also says that anytime you use an auto-injector—expired or not—you should call 911 or go to the emergency room, even if the shot seems to be working. That's because severe allergic reactions can require more than just a shot of epinephrine.

Storing and Disposing EpiPens
Be sure to store epinephrine auto-injector properly. And that doesn't mean in the refrigerator: Extremes of heat or cold can degrade the medicine, as can exposure to light and humidity. So while you might need to carry one around with you, when you are at home or work store it at room temperature in a dry, dark place. And while it might be tempting to keep a spare in the glove compartment of your car, that's probably not a good idea because it can get too hot or cold, in there. If your child needs one while at school, ask the nurse to keep it. Many schools have special lockers for such medicines.

It's also important to properly dispose of expired EpiPens or used injectors, says Barbara Young, Pharm.D., of the American Society of Health-System Pharmacists.

Auto-injectors thrown into in your household trash could prick or injure people or pets in your home. Instead, if you've used the injector, give the device to the healthcare professional you saw afterward. Take expired EpiPens to a doctor’s office, hospital, or pharmacy for disposal, Young says.

You can find a drop-off location near you at SafeNeedleDisposal.org.

A final tip: When filling an EpiPen prescription, ask the pharmacist to give you auto-injectors with the latest expiration date.


Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

The Cost Of A Life-Saving EpiPen Has Increased 400% Since 2007

From Consumerist / August 19, 2016 / By Laura Northrup

If you or someone in your family has severe allergies, the EpiPen is a familiar and essential product. Yet if you have good health insurance, what you may not know is that the cost of the pens has increased significantly since pharmaceutical giant Mylan acquired the drug in 2007.

Different sources list different prices, but the cash price for an EpiPen has increased somewhere between 400% and 600% in the last decade since Mylan acquired the product. A pack of two pens can cost hundreds of dollars at retail.

According to reporting in Bloomberg BusinessWeek from last year (warning: auto-play video at that link), Merck got rid of the EpiPen, which wasn’t a big money-maker at the time, by selling it to Mylan. The auto-injector pen contains about a $1 dose of the drug epinepherine, yet somehow costs 400% more on the wholesale market, and the cost to insurance companies and patients forced to pay retail has probably increased even more.

While the EpiPen is a 25-year-old device, there is no direct generic equivalent. One important money-making strategy for Mylan has been to hand out free pens to familiarize people with the product. The company has also been working to make sure that the pens end up purchased in bulk for schools and in other public places for allergic emergencies…just like the automated defibrillators that are now easy to find. Mylan has even worked with the same consultants as defibrillator-maker Medtronic.

Well, okay, but what can patients actually do about those high prices? For lower-income patients whose insurance doesn’t cover the devices, there’s a patient assistance program, and the company also offers coupons that bring the co-pay down if your insurance does cover the device.

You can also opt out of using Mylan’s product altogether. Dosing your own epinepherine in a syringe isn’t recommended, but there’s another auto-injector on the market that costs less than an EpiPen. Since it isn’t a generic, you can’t just receive one at the pharmacy when your doctor has prescribed EpiPens.

When our colleagues down the hall at Consumer Reports checked prices for the device, they found that the Adrenaclick cost less than half as much as the EpiPen. Another alternative product, Auvi-Q, was recalled and taken off the market earlier this year.

Check with your insurance company, but all of these products should be covered: it’s just that the ubiquity of the EpiPen makes it the first product that doctors and patients both think of. It’s the Kleenex or Band-Aid of lifesaving injector devices.

What’s important is to make sure that everyone knows how to use the alternative device, if your doctor agrees that one of : the allergic person and other household members should know how to administer the drug.

For children, make sure that parents and other caregivers, as well as staff and nurses at the school know that the device is an Adrenaclick and not the more familiar brand.

Though that may not help much either: one parent who spoke to MarketWatch said that her high-deductible health plan means that a two-pack of EpiPens costs $500 with a discount coupon from Mylan, while a two-pack of the Adrenaclick cost $400.

https://consumerist.com/2016/08/19/the-cost-of-a-life-saving-epipen-has-increased-400-since-2007/

Is there a cure for high drug prices?

Anyone who takes medication realizes how much the cost has risen. 
Bernie Sanders gave CR's article "A Must Read" designation on his website.

Consumer Reports / updated July 29, 2016

The cost of prescription drugs for tens of millions of Americans rose $2 billion last year, and all signs point to a continued rise. At stake is nothing less than the ability of Americans to afford the medicines they need. Can we stop the madness?

Last August, Martin Shkreli, then the CEO of Turing Pharmaceuticals, did something considered so reprehensible that he was dubbed “the most hated man in America.” What caused the outrage? He increased the price of a little-known but important drug called Daraprim from $13.50 to $750 per pill. Daraprim is the best treatment for toxoplasmosis, an infection to which those with HIV/AIDs or cancer are susceptible.

The story went viral, and calls came from around the country, including from U.S. Rep. Elijah Cummings, D-Md., to stop drug entrepreneurs from gouging consumers for pure profit. Overnight, Shkreli became the poster child of pharmaceutical greed. And yet raising the price of a drug by that much is 100 percent legal.

What makes the case of Daraprim so important is that it brought a serious—and growing—healthcare problem out into the open: America spends a tremendous amount of money for prescription drugs—$424 billion last year alone before discounts, according to a new report by IMS Institute for Healthcare Informatics, a firm that tracks the pharmaceutical industry. And that number is rising fast with no sign of slowing down. What’s more, there are few regulations that shield consumers from the Martin Shkrelis of the world, or from drug companies that decide to raise prices to astronomical levels.

The Rampant Rise of Drug Prices

The practice of raising drug prices on new—and old—medications is common and widespread. From a nationally representative telephone poll conducted by Consumer Reports Best Buy Drugs in March, we learned that three in 10 Americans (about 32 million people) were hit with price hikes within the previous 12 months, costing them an average of $63 more for a drug they routinely take—and a few paid $500 or more. We also found price increases on everything from longtime generics used to treat common conditions such as diabetes, high blood pressure, and high cholesterol to new treatments for diseases such as hepatitis C. Our poll shows that when people were hit with higher drug costs, they were more likely to take unhealthy measures such as skipping doctor appointments, tests, or procedures, or not filling their prescriptions or taking them as directed.T

Take the case of Marlene Condon, a nature writer living in Crozet, Va. Two years ago she paid about $32 for 180 tablets of hydroxychloroquine (a generic available for almost two decades) to treat her rheumatoid arthritis. When the drug’s price more than doubled to $75, Condon says she was annoyed but paid the bill anyway. Then, last September, the price of her drug skyrocketed, costing her $500 out of pocket. Condon panicked and did what thousands of Americans do under those circumstances: She stopped taking the drug. Her arthritis pain grew much worse. Walking and doing simple household chores such as washing the dishes became almost impossible.

The Forces of Profit

Our analysis suggests that high prices for generic and brand-name drugs stem in part from a battle over profit between mammoth industries—big pharma and insurance companies—with consumers caught in the middle. On the one hand, pharmaceutical companies blame insurance companies for passing along high costs to consumers. And insurance companies point to very high-priced drugs for which there are few or no alternatives, which ultimately affects how much insurance coverage people receive and how much they must pay out of their pockets.

“Even as more patients have health insurance coverage, many more are facing high pharmacy deductibles and rising out-of-pocket costs, and other barriers to care, putting their ability to stay on needed therapy at risk,” says Holly Campbell, a representative at PhRMA, an industry association that represents pharmaceutical manufacturers.

“If there’s one treatment and there’s no alternative and no competition, then that’s where the challenge is,” says Matt Eyles, executive vice president of policy and regulatory affairs at America’s Health Insurance Plans (AHIP), a national trade organization for the insurance industry.

Click for more info: http://www.consumerreports.org/drugs/cure-for-high-drug-prices/

• Reason 1: Drug Companies Can Charge Whatever Price They Want
• Reason 2: Insurance Companies Are Also Charging You More
Reason 3: Old Drugs Are Reformulated as Costly ‘New’ Drugs
• Reason 4: Generic Drug Shortages Can Trigger Massive Price Increases
• Reason 5: Specialty Drugs Are Costing All of Us

What the Government Can Do

Consumers are looking to the government to take action to control drug prices. In our CR Best Buy Drugs poll, 77 percent of people taking a medication said the government should allow more generics onto the market sooner; 74 percent want the government to pressure drug companies to charge less. Seventy-nine percent say insurers should pressure pharmaceutical companies to lower drug prices; 81 percent said consumers should do the same.

More specific steps that could help control costs include asking the government to:

• Set a limit on out-of-pocket costs. That would ensure that consumers have some protection against very high costs or sudden large spikes in prices. For example, last year California enacted a law so that a consumer won’t pay more than $250 for a single prescription drug per month, or $500 for certain high-deductible plans.
• Approve more generic versions of common drugs. Currently, 4,300 generic drug applications await an FDA decision. The agency says it’s working to review new applications within 15 months.
• Allow limited importation of drugs from legitimate Canadian and European sources, which currently is illegal under U.S. law. The ability to import drugs from countries that have a regulatory system similar to that of the U.S. could alleviate shortages or moderate prices.
• Use government’s existing “march-in” rights. It works like this: If there is a problem with the public’s access to a drug (a supply shortage or an exorbitant price), and if a drug was developed using taxpayer money, the Department of Health and Human Services has the right to force the company to allow another manufacturer to make generic versions that are cheaper for the consumer.

What Drug Companies Can Do

The most obvious help pharmaceutical makers can provide is to charge less—or at least slow the pace of price increases. There is a precedent: Rising drug prices in the 1990s led to public outcry and congressional hearings. And fearing price controls, nine drug companies, led by Merck, made a pledge to keep price increases at or below increases in inflation.

“Pharma has a right to make a profit,” says Riley of the ACP, but it also has a “moral obligation” to be transparent about its pricing because it benefits greatly from government-funded research. “The American taxpayer has been providing the venture capital to fund their products,” he says. “The public deserves to realize a return on that investment in the form of medications they can afford.” But pharmaceutical industry representatives think the focus on price alone is misguided and threatens “to squander our opportunity to usher in the next wave of medical progress,” says Campbell at PhRMA. States are starting to fight back. This past June, Vermont passed the first legislation in the U.S. that requires drug companies to justify high costs and price increases, and to calculate the financial effect on insurance premiums with a select set of drugs. California is currently considering a similar bill.

What Consumers Can Do

Although much of drug pricing is out of consumers’ hands, consider these tips to find the best deals at the pharmacy:

• Talk to your doctor about the cost of the drug she is prescribing. For less expensive alternatives,ask about generics, which can cost up to 90 percent less. Your doctor might consider “therapeutic substitution”—a different drug that works as well. If your insurance drops or reduces coverage of a drug, your doctor can also help by appealing to your insurance company for an exception to cover the drug anyway. The administrative process for filing the exception is different with each insurance company and can take a few weeks before a decision is made.
• Shop around and negotiate. Consumer Reports’ secret shoppers have found that retail drug prices can vary widely, even within the same ZIP code. Our shoppers also found that asking, “Is this your lowest price?” could get you further discounts.
• Check online. If you pay out of pocket, check GoodRx to learn a drug’s “fair price.” You can also fill a prescription with a low-cost online pharmacy based in the U.S., such as HealthWarehouse.com. Be careful of fraudulent websites: Use only an online retailer that operates within the U.S. and displays the VIPPS symbol to show that it’s a Verified Internet Pharmacy Practice Site.
• Choose a plan that covers the medications you need. Compare plans during your open-enrollment period because coverage may change from year to year. Keep in mind that high-deductible plans have lower premiums but require you to pay a larger chunk of your drug costs.

Consumer Reports Is Working to Lower Drug Costs

You are outraged by rising drug costs, and we’ve listened. Because we do not accept money from the pharmaceutical industry, we can call it like it is. If a drug is too risky or a poor value, we are not afraid to say so. We want your voice to be heard by industry and government. We are advocating for a range of evidence-based solutions for lowering consumers’ out-of-pocket costs, ensuring access to essential medicines, and getting better value for our country’s prescription-drug spending—without sacrificing safety or effectiveness. See ConsumerReports.org/drugprices for more.

Editor's Note: This article also appeared in the August 2016 issue of Consumer Reports magazine.

Funding for the preparation of this article was provided in part by the Atlantic Philanthropies and by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumerfraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

*Clarification, July 29, 2016: An earlier version of this article indicated that Woodard’s injection lasts about a week. He gives himself a daily injection from a pen that lasts about a week.

Click for full article and more info: http://www.consumerreports.org/drugs/cure-for-high-drug-prices/

Biosimilars Are as Good as Brand-Name Drugs, New Study Finds

Consumer Reports /  Steve Mitchell / August 08, 2016

Similar versions of original pricey treatments for rheumatoid arthritis 
could save consumers billions

Remicade, Enbrel, and Humira can help relieve rheumatoid arthritis, psoriasis, and inflammatory bowel disease, but these biologic drugs can easily cost thousands of dollars a month out of pocket. Less-expensive versions of these, known as biosimilars, could be an option, and three could be headed to the market soon: A Remicade biosimilar was approved in April, and a Food and Drug Administration advisory committee recommended approving biosimilars of both Enbrel and Humira in July.

But some patient and physician groups have questioned whether biosimilars are as safe and effective as their brand-name counterparts. That’s because biologics contain proteins and often other compounds that can’t be replicated exactly, which means that a biosimilar is a close match but not identical to a biologic.

A new analysis published August 2 by the Annals of Internal Medicine should help put some of those concerns to rest.

The study, by researchers at Johns Hopkins Bloomberg School of Public Health in Baltimore and Brigham and Women’s Hospital in Boston, found that biosimilars have the same safety and effectiveness as their corresponding brand-name biologic. That’s important for you, because biosimilars are expected to cost up to 40 percent less than brand-name counterparts, a savings projected to amount to billions of dollars over the next several years, according to separate analyses by the RAND Corporation and Express Scripts.

To find out how biosimilars stacked up to the brand-name drugs, the new study looked at 19 clinical trials and other studies that were used to get biosimilar versions of Remicade, Enbrel, and Humira approved in the U.S., Europe, and other countries. Almost all of the participants in the studies, which looked at adverse effects, effectiveness, and how the medications are absorbed and metabolized in the body, were healthy volunteers or people with rheumatoid arthritis.

“Our results suggest that, for this important class of drugs, the biosimilar versions appear to have the same safety and efficacy profiles as their branded counterparts,” says Caleb Alexander, M.D., an author of the study and a co-director of the Center for Drug Safety and Effectiveness​ at the Johns Hopkins Bloomberg School of Public Health.  

“This is great news for patients, because these products will force prices down on this common and costly used class of biologic therapies, and ultimately save patients, insurers, and the health system billions of dollars,” Alexander adds.

It could be a while before biosimilars become available. That's because the manufacturers of the original, brand-name biologics are challenging the biosmiliar manufacturers' patents in court, delaying the launch of the less-expensive biosimilars.

That's what's happening with the biosimilar, Inflectra, the generic version of Remicade. It was approved in the U.S. in April, but its launch is delayed due to an ongoing patent challenge.

The FDA hasn’t yet approved the biosimilars of Enbrel and Humira, but both are already embroiled in patent challenges by the brand manufacturers.  

 Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

http://www.consumerreports.org/drugs/biosimilars-are-as-good-as-brand-name-medications-biologics/