Many epinephrine self-injectors still potent long after expiration date

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(Reuters Health) - EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a new study that concludes patients might need expensive refills less often.

These autoinjectors contain a pre-set dose of epinephrine, a life-saving drug used by people at risk of experiencing anaphylaxis, a severe allergy attack. Untreated, anaphylactic shock can be fatal because blood pressure can drop suddenly and airways can narrow, making it difficult to breathe.

Patients who need these life-saving devices must carry at least one with them at all times and have access to one everywhere they go. Soaring prices and out-of-pocket costs for the autoinjectors have made it increasingly difficult for many patients to keep throwing out and replacing unused devices when they expire, researchers note in the Journal of Allergy and Clinical Immunology: In Practice.

The U.S. Food and Drug Administration (FDA) requires autoinjector expiration dates to ensure that the devices never contain less than 90% of the original dose of epinephrine, the study team notes.

For the study, researchers tested the contents of 46 different autoinjectors to see how much epinephrine remained after the expiration dates on the labels. Half of the devices were tested at least two years after their labeled expiration date. At this point, 80% of the devices still retained 90% or more epinephrine, indicating they were still effective under the FDA rules.

“If the expiration dating on these devices was changed, this means that patients would not need to replace their auto-injectors as frequently, limiting cost to them, their insurance, and the healthcare system, while still feeling secure that they have access to adequate treatment for anaphylactic reactions,” said lead study author Lynn Kassel of Drake University College of Pharmacy & Health Sciences in Des Moines, Iowa.

Devices six months past their labeled expiration date in the study still had 100% of the original epinephrine dose. One year after the labeled expiration date, devices still had 95% of the original epinephrine dose.

And all of the autoinjectors tested that were up to 30 months beyond their labeled expiration date still had 90% of the dose remaining.

The study tested far too few devices to help determine with certainty whether all epinephrine autoinjectors in the U.S. might be safely used past their expiration dates, Kassel said by email.

The authors also note that they did not test the expired injectors’ effectiveness in stopping an anaphylaxis episode.

“Until the FDA changes the expiration dating guidance for these devices, patients with anaphylactic allergies should carry auto-injectors that have not yet expired,” Kassel advised.

“The greatest risk of using an expired auto-injector is that the epinephrine is no longer potent enough to combat the anaphylactic reaction, and this could result in death or critical illness.”

Right now, the expiration date is 18 months from the time the product is manufactured, a duration that is shorter than the expiration date for most other medications, said Dr. Kao-Ping Chua of the C.S. Mott Children’s Hospital and the University of Michigan Medical School in Ann Arbor.

While the study results build on a growing body of evidence suggesting that expiration dates for epinephrine autoinjectors could be extended, in the meantime, patients should use the devices as labeled, Chua, who wasn’t involved in the study, said by email.

“I don’t think anyone should postpone refilling an epinephrine auto-injector if they can afford it,” Chua said. “In a life-or-death situation, you want to have as much certainty as possible that the rescue medication is going to work.”

SOURCE: bit.ly/2F7WrTT Journal of Allergy and Clinical Immunology: In Practice, online May 28, 2019.

Our Standards:The Thomson Reuters Trust Principles.

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Canadian panel calls for universal public drug coverage

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OTTAWA/TORONTO (Reuters) - A Canadian advisory council studying prescription drug coverage said on Wednesday the federal government should create a C$15.3 billion ($11.5 billion) universal, single-payer public pharmacare system, and warned that the current system requires a major overhaul.

A pharmacist counts prescription drugs at the at the CentreTown Pharmacy in Ottawa, Ontario, Canada, June 12, 2019. REUTERS/Chris Wattie

The council said the plan should be implemented no later than Jan. 1, 2027, with coverage for essential medicines in place by Jan. 1, 2022.

Canada is the only country with a universal health care system that does not include universal coverage for prescription drugs. Most prescriptions are paid for through employer-funded drug plans, while some are covered by government programs for the elderly, or people with low incomes or very high costs.

“We can’t tinker with what exists. We have to transform it,” council chair Eric Hoskins, a former Ontario health minister, said at a news conference.

The report said public and private drug providers had told the council the system is “near the breaking point.”

Canadian Prime Minister Justin Trudeau’s Liberal government has promised some kind of national pharmacare program, and its approach may be a key issue in the country’s October election.

Minister of Health Ginette Petitpas Taylor said in a statement that the government would “carefully study” the recommendations “over the coming months.”

The council estimated the national pharmacare would cost the federal government an additional C$3.5 billion at its launch in 2022, and C$15.3 billion in 2027.

If implemented in full, the plan would likely cut into profits of insurers and drugmakers in Canada, while saving employers and patients money.

Shares of three major insurers listed in Canada, Manulife Financial Corp, Sun Life Financial Inc and Great-West Lifeco Inc, all dropped.

‘SPACE’ FOR THE PRIVATE SECTOR

Canada’s drug insurance system is a patchwork of more than 1,000 public and 100,000 private plans, which can make it difficult for smaller payers to negotiate discounts with pharmaceutical companies.

The Canadian Life and Health Insurance Association (CLHIA)urged the government to work with private plans to negotiate lower drug prices. CLHIA president Stephen Frank said in a statement that all Canadians can have access to the medications they need “without putting at risk what’s working today.”

Hoskins said costs associated with the proposed program are already being paid by Canadians. By 2027, total prescription drug spending would be about 10% lower with the proposed changes, Hoskins said. Canadians spent C$34 billion ($25.6 billion) on prescription medicines in 2018.

Hoskins said he envisions “space” for the private drug insurance sector after a universal public program is rolled out.

“The profit that insurance companies generate through drug insurance plans is modest, I would describe it, compared to other aspects of benefits provided,” he said.

Pamela Fralick, president of pharmaceutical industry group Innovative Medicines Canada, said whatever path the government chooses, “no Canadian should be worse off than they are right now.”

NEW DRUG PRICE RULES IN THE WORKS

Speaking after the report’s release, Petitpas Taylor said work on the Canadian government’s proposal to reduce patented drug prices is still underway, and “movement” would come in the very near future.

New regulations, set to go into effect in January 2019, were delayed amid heavy lobbying from drugmakers.

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Patented drug prices in Canada are among the highest in the world. Government surveys show some 20% of Canadians are uninsured or under-insured.

In its most recent budget the Trudeau government promised modest changes, including new funds for expensive drugs that treat rare diseases.

Reporting by Kelsey Johnson in Ottawa and Allison Martell in Toronto; Editing by Bill Berkrot

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Traumatic injuries linked to later social dysfunction

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(Reuters Health) - Nearly half of trauma patients, even those without brain injuries, experience social deficits that make it harder for them to interact with friends and stay involved in the community, a recent study suggests.

Traumatic brain injuries have long been linked to an increased risk of a wide range of short-term and long-term physical and mental health problems that can dramatically reduce quality of life, researchers note in the journal Surgery. But doctors don’t yet have a clear picture of what type of social impairments may follow other types of traumatic injuries.

“Social functioning is considered a critical determinant of quality of life,” said lead study author Dr. Juan Herrera-Escobar of Brigham and Women’s Hospital and Harvard Medical School in Boston.

Broadly speaking, social function includes the ability to participate in organized and informal activities with friends, relatives, and people in the community or the workplace. Serious injuries can lead to physical and emotional issues that contribute to social deficits, and long hospital stays that keep patients away from their daily routines for weeks on end can make matters worse.

For the current study, researchers followed 805 adults hospitalized for moderate to severe traumatic injuries. During the year after the injury, 364 of them, or 45%, reported experiencing social dysfunction.

In the study, researchers assessed social function 6 months and 12 months after injuries. Each time, they asked patients how often physical or emotional challenges interfered with social activities in the previous four weeks.

Compared to patients who reported no social dysfunction, those who did tended to be younger and were more likely to be African American and have no more than a high school education. Patients with social dysfunction were also more likely to have had longer hospital stays, required mechanical ventilation in the hospital and have previous psychiatric illness.

People with a history of a major psychiatric illness, for example, were almost three times more likely to experience social dysfunction. Low education, meanwhile, more than doubled the risk of social dysfunction.

In addition, people with social dysfunction were over 16 times more likely to have post-traumatic stress disorder (PTSD) than those without social dysfunction, and about five and a half times more likely to have not returned to work after their accident.

It’s possible that people with lots of social support from family and friends or from patient support groups might have fewer challenges with social dysfunction after their injuries, Herrera-Escobar said by email.

“A strong family environment fosters resilience, which has been associated with better long-term outcomes after trauma,” Herrera-Escobar added. “We also believe that getting appropriate and timely treatments (rehabilitation, mental health services, etc.) for physical and mental health conditions can also help improve their social outcomes.”

The study lacked data on social functioning before patients’ injuries, and it’s possible that some people had impairments beforehand, the study team notes.

Even so, the results underscore the importance of considering social function in trauma care from the start instead of waiting to address this until after patients go home from the hospital, said Dr. Tim Platts-Mills, an emergency medicine researcher at the University of North Carolina at Chapel Hill who wasn’t involved in the study.

Pain management and treating people for depression, PTSD and other psychiatric issues may help minimize the social dysfunction, Platt-Mills said by email.

“The best approach is not to wait six weeks and then conclude that there is a problem,” Platt-Mills said. “A better approach is to work with the patient’s clinical team to try to address these problems early on.”

SOURCE: bit.ly/2Xb9NsA Surgery, online May 17, 2019.

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