28 posts tagged “FDA”

5 Earth-friendly ideas for patients

Posted April 27th, 2018 by

As Earth Month winds down, explore some environmental pointers, including how to donate (gently used) wheelchairs, what to do with empty pill bottles (earbud/jewelry case, anyone?) and where to dispose of unused meds (April 28, 2018, happens to be National Prescription Drug Takeback Day at 5,000+ sites across the U.S… read on!).

1. Donate unused medical supplies. Before adding unused supplies or gently used equipment to your trash heap, see if they’re on the wishlist of organizations that accept medical surplus, such as InterVolMedshare and Project C.U.R.E. (click to see lists of what they’ll take).

InterVol’s general rules of thumb for donations?

  • Would you want the item/supplies used on you?
  • Does it have one year left before the expiration date, if it goes in the body?
  • Does the equipment function as intended (no broken or missing parts)?
  • Is the equipment in good shape (no rust, rips, tears, etc.)?

2. (Properly) hand over unused medications. Few organizations accept prescription drug donations from individuals, and drug donation and redistribution laws vary by state. Look into the regulations where you live and comment below if you know of any organizations that accept donated medications (such as Insulin for Life, which collects some insulin and diabetes supplies).

Note: This Saturday is National Prescription Drug Takeback Day (April 28, 2018, from 10 a.m. to 2 p.m.), sponsored by the U.S. Drug Enforcement Administration twice a year so that people can bring unused or expired medications to a local collection site for safe disposal (search for a site near you). In the last Takeback Day in October 2017, people dropped off 456 tons of drugs.

3. Safely dispose of unused drugs and medical waste on your own. Cancer.net offers these pointers for medication disposal: “If you decide to take the matter into your own hands, you should always follow the disposal instructions found on the drug label or the patient information leaflet that comes with the prescription. Do not flush medicines down the toilet or sink unless this information specifically tells you to.”

The U.S. Food and Drug Administration lists the few medications that should be flushed— but check with your local water treatment and/or sanitation department about any rules or regulations.

The U.S. Environmental Protection Agency offers this info on proper disposal of discarded needles, sharps and other medical waste. Wondering what to do with old oxygen tanks? See this guide.

4. Find new uses for empty pill bottles. An Indianapolis-based charity called The Malawi Project organized a hugely successful pill bottle collection drive to send the ubiquitous orange containers to the African country hit hard by HIV (where people were carrying their pills loose or wrapped in paper). After a million pill bottles quickly poured in, the organization stopped accepting donations — but they still encourage people look into other organizations still collecting them, or contact local animal shelters to see if they need them.

Recycle Nation says that few communities accept the orange (#5 plastic) pill bottles in their recycling programs, but a company called Preserve collects them at natural food stores across the country (check out this map) to use in their recycled plastic products. CVS Pharmacy is reportedly working on pill bottle recycling programs.

People have come up with lots of other creative ways to reuse or upcycle pill bottles — just a few neat ideas include:

  • “Hide-a-key” container (with a rock glued on top)
  • Earbud/headphone holder
  • Jewelry case
  • Mini sewing kit
  • Child-proof storage for quarters (for parking or laundry), pins, nails/screws, medical sharps or other small items

5. Go paperless with your insurance company and doctor’s office. Opt for electronic communication, if you’re comfortable with it. Many providers now offer email and/or text reminders rather than snail mail postcards or phone calls. Also, hospital gowns can be a drag for patients, and the paper ones contribute to medical waste. Depending on the medical setting and type of visit, ask your healthcare provider if it’s necessary to fully undress and wear a gown or use other (optional) disposable items for your visit.

Happy Earth Month!

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What’s the right-to-try bill + possible pros and cons?

Posted March 30th, 2018 by

The U.S. House of Representatives recently passed legislation that could give terminally ill patients the “right to try” experimental treatments — so what’s the controversy? Catch up on the topic and share your thoughts below.

“Right-to-try,” in a nutshell

The “right-to-try” bill aims to give terminally ill patients who’ve exhausted all other treatment options quicker and easier access to an “experimental treatment” (this is a medication or treatment product that has passed “phase one” of the clinical trial process but has not yet received full Food and Drug Administration [FDA] approval). See this PatientsLikeMe guide to clinical trials to learn more about trial phases and the FDA drug approval process.

The House failed to pass the bill on the first try, on March 13, but voted 267 to 149 to pass it on March 21.

All in favor…

Backers of the bill have cited these “pros” in their reasoning:

  • 38 states have already passed their own versions of “right-to-try” legislation, so a federal version of the law would grant access to experimental treatments nationwide.
  • Although the FDA has existing “expanded access” (or “compassionate use”) policies that allow the use of investigational treatments in the most dire cases, patients must apply to the FDA for permission to receive the treatment — so “right-to-try” would eliminate the step of needing to apply.
  • Most terminally ill patients don’t qualify to participate in clinical trials, so “right-to-try” could give them quick access to treatments that are still in the middle of years-long trials.

All opposed…

People who are against the bill have some arguments of their own:

  • Four former FDA commissioners issued a joint statement opposing the federal “right-to-try” legislation, saying it would “create a dangerous precedent that would erode protections for vulnerable patients.” (When the FDA is involved in “expanded care” cases, it tries to provide any additional information on dosages, side effects and safety considerations — so removing the FDA from the process may eliminate expert guidance and safeguards.)
  • Many drugs that make it through phase I of clinical trials (smaller initial studies to test for safety) fail to survive phase II of trials because they’re not proven to be effective — so “right-to-try” may open the door to developers peddling “snake oil” or hyped-up/unproven treatments to the most desperate patients.
  • “Right-to-try” may not significantly expand access to treatments — the FDA says it grants approval in 99 percent of requests through the “expanded access” policies and often authorizes emergency requests immediately over the phone. And few pharmaceutical companies offer access to experimental treatments without FDA approval because of ethical and legal concerns.

“No ethical company that I know of would make their experimental medicine available outside of the FDA’s regulatory oversight process,” Kenneth Moch, CEO of drug developer Cognition Therapeutics, tells the Associated Press. “The FDA are not the bad guys here. You may not like their processes but they are involved here for a variety of reasons.”

Modern Healthcare points out that using an experimental treatment can derail a patient’s health insurance coverage for additional medical treatment or hospice care thereafter.

“If the bill is passed and signed, the campaign that made it law may not stop there,” Modern Healthcare also reports. “Some believe there is a chance the program’s scope could be expanded beyond terminally-ill patients to one day include those with severe chronic conditions.”

Next up, the “right-to-try” bill heads to the Senate. If they pass it, the president (who has expressed support) is expected to sign it into law.

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