Posted tagged ‘medicines’

Dispose of unused medications safely

September 26, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

Al wrote in, asking what she ought to do with unused medications, including some psychiatric drugs and controlled substances. It’s good to get those out of the house, safely—but how?

Parents should make sure to keep their homes free of unused medications. The misuse of prescription medications (usually narcotic painkillers) has surpassed motor vehicle accidents as the leading accidental cause of death in the US. A lot of these medicines, especially the ones that come into teenage hands, come from unused supplies lifted from parents. Teenagers don’t necessarily know what all of those pills do, and at least some of them are willing to gulp down handfuls just to see what will happen.

Toddlers, too, can find their way to unused, colorful vials in the medicine cabinet – some of which can kill with a single pill. And even adults really shouldn’t hoard antibiotics or other prescription meds. The risks are too high.

But what to do with all of these medicines? Tossing them down the a sink drain or flushing them down the toilet aren’t ideal. Water in municipal drains contributes to their accumulation in our drinking water (though even if we never flushed ‘em down, many are excreted in urine. There’s a pleasant thought.) The FDA does keep a list of “drugs you should flush,” consisting mostly of narcotics and similar medications that are just too dangerous to toss out any other way.

For most medicines, it’s safer to get them to a landfill rather than adding them to our water supplies. You can toss them into your household trash after mixing them with something disgusting, like cat litter, coffee grounds, or dirt. Alternatively, drugs can be incinerated along with other biomedical waste. I don’t know if most docs would agree to do this, but if my patients and families bring me leftover medications, I just add them to my “biohazard” box for transport and incineration. Doesn’t cost me much of anything to add a few vials now and then.

I’ve also seen drug stores selling mailing bags to return medications for destruction. The operative word, there, is ‘selling’—I think $4 for a bag. Not much, but 4 beans that you probably want to spend on something else!

What are you doing with that thing that we don't even know what it does?

Left your amoxicillin or Augmentin out of the refrigerator? It’s probably OK.

August 7, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

We get these calls a few times a month—a family, despite dire warnings that their child’s antibiotic MUST be refrigerated, leaves it out on the counter overnight. Can we call in a new prescription?

Sure we can. But we probably don’t need to.

Many children’s antibiotics come in liquid suspensions. Little ground-up particles of medicine (along with flavorings and colorings and stabilizers and other goodies, collectively called “excipients”) are mixed by the pharmacist with water, and the bottle is shaken. Voila, you’ve got a suspension. But the water can break down some molecules especially if the water gets warm. So some of these suspensions are supposed to be kept in the ‘fridge, especially amoxicillin and amoxicillin/clavulanate (commonly called Augmentin.) That’s in the product insert: “keep refrigerated.” And it’s on a little sticker the pharmacist puts on the bottle. But is it really necessary?

Trust science to find out!

From The Journal of Applied Pharmaceutical Science, 2012, comes a study using state-of-the-art liquid chromotography to determine the potency of amoxicillin/clavulanate stored in three ways: refrigerated, stored in a cupboard at room temperature, and with the bottle submerged in water at room temperature (to minimize fluctuations in temperature.) Both the amoxicillin and clavulanate components of the medication kept all of their potency for at least five days. After that, there was a drop off in potency no matter how the samples were stored, though the refrigerated sample stayed the strongest. The amoxicillin portion of the medication lost about 17% of its potency in the fridge after 10 days, versus 25% of its potency in the cupboard. The clavulanate portion was a little bit more sensitive, losing about half of its potency at room temperature by day 7 to 10.

The study was done in Nigeria, where frequent power outages make consistent refrigeration problematic, and where limited resources make it more difficult to easily replace medications. But the results should be applicable here, too: under ordinary household circumstances, both amoxicillin and Augmentin are stable if left unrefrigerated for 5 days, maybe even longer for amoxicillin alone. They considered up to 84 degrees ordinary room temperature—again, this was in Nigeria. I imagine in typical cooler American homes these medications might last even longer sitting on the counter.

Some factors might further influence unrefrigerated shelf life. Light, especially direct sunlight, could potentially break down medications faster; and if the liquid gets really warm, left in a car, that’s going to ruin the medication pretty quickly. And this study only looked at two penicillin-based antibiotics (amoxicillin and Augmentin.) I can’t vouch for other medicines that are supposed to stay in the fridge. But it’s nice to know that for these common antibiotics, a few days at room temperature probably makes no difference.

Drug expiration dates: Do they really matter?

July 24, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

Mernga wanted to know about drug expiration dates. Do drugs really “go bad”? Or this is just a scam to get people to buy fresh medicine?

The truth is, they’re a little of both.

There are sometimes two separate “expiration dates” on a prescription medication. The first is the one stamped on the package by the manufacturer. You’ll see that one if what you have is in the original packaging, like a tube of ointment or a small bottle of eye drops, or a bottle of pills if you’ve been given an original bottle straight off the shelf.  Sometimes the manufacturer’s stamp is on a box that the tube or bottle came in (the one you’ve already thrown away.)

exp date on package 1


exp date on package 2

The manufacturer’s stamped expiration date is a promise that the medication will keep its potency at least until that date, if it’s been stored correctly. It doesn’t mean that on that date it will actually go bad, but the manufacturer is saying, look, if you use this stuff past the date, we’re not responsible for it any more.

It turns out that many medications will keep at least most of their potency for a while after that date. The best studies that are looking into this are sponsored by the US government through “SLEP”—the Department of Defense Shelf Life Extension Program. This program tests the potency of medications that are kept in long-term strategic stockpiles for the government. It turns out that the feds are keeping big stores of anibiotics, morphine, antihistamines, and many other essential medications for use after The Zombie Apocalypse. To save money, they keep the medicines well-past their expiration dates, while testing selected lots for potency. On average, medications in the program are lasting 5-6 years past their dates—some lasting 15 years or more.

However, the drugs in this program are stored until optimal conditions, in a cool, dark, low humidity facility. They’re all in their original packaging, too. Drugs really can be sensitive to storage, and can rapidly lose their punch if exposed to heat or light, or if they’re moved from bottle to bottle, or removed from foil seals. Also, there’s a lot of variability in the shelf-life of medications, even between lots of the same medication. So though we know that most drugs will last past their dates, it’s hard to know specifically what medications on your shelf will last just a few months longer, or several years longer.

The form of the medication does seem to be important. Hard, dry pills last longer than creams or ointments or liquid drops. Reconstituted suspensions (where the pharmacist adds water and mixes it at their store) last the shortest, and are the most vulnerable to heat and storage conditions.

Though the main issue with older, expired drugs is potency—some get weaker with time—there’s been some concern that at least some medications actually become toxic when they’re old and past their prime. The classic example of this is an older formulation of tetracycline, which was reported in the 1960’s to become toxic to the kidneys if used well past its expiration date. That form of tetracycline is no longer sold in the USA, and it’s not really clear to me if that reaction was ever substantiated. I don’t think there’s much risk of old medicines becoming harmful—it’s more that they might not work as well or as reliably.

There’s a second date that will appear on any prescribed medication, a date typed on by the pharmacist that is usually 12 months after the prescription was filled. This date is added to discourage hoarding of medicines—after all, it may be unlikely that something prescribed a year ago is still needed. It also may be true that my moving pills from the original container (a big bottle) to the new container (a little bottle) they’ll lose some of the manufacturer’s guaranteed protection against aging. Though I don’t want anyone to hoard medicines, especially antibiotics and narcotics, depending on what the medicine is used for it sometimes makes sense to keep a medicine past the pharmacist’s date for occasional use. When in doubt, ask your doctor.

exp date on bottle

The bottom line: these dates are a guide, but for non-critical medications, especially if you’ve been good about storage, it’s probably fine to keep using them past their prime. If the medication is critical, I’d go ahead and keep an eye especially on the stamped manufacturer’s date. Stay safe, and keep important medicines fresh.

Save big on prescription drugs… with no catch

January 27, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

Some things are too good to be true. But every once in a while, there’s a genuine gem out there—in this case a website that does what it promises to do, with no strings and no catch. It’s free, and it doesn’t collect or sell private information, and it really is just there to help you.

Needymeds was founded in 1997 by a physician who’s since become a good friend. His organization and website are there only to help people find ways to reduce the costs of their medications. It’s entirely non-profit, and unlike other “drug discount” programs isn’t there to skim off marketing information or scam you with hidden costs. There are no costs, and no private health info is collected. You’re free to donate (and please do!), but everyone can use all of the site’s features without spending a penny.

You will find great stuff at the Needymeds site:

One of their best features is a drug discount card you can print yourself, right there, at no cost. I know from feedback from my patients that this card really works. It can save you big time, especially on brand-name medications that may not be on your insurance formulary. You can use it whether or not you have insurance, whether or not you have a copay, or to save money if you haven’t reached a deductible. Print it out, use it for your whole family, suggest it to your friends. There are no fees, no registration, no income or residency or insurance requirements, no nothing. It’s accepted at just about every chain. You can download and print the card from this page, which also includes more info about how it works.

There’s also an extensive, easily searched database of drug discount programs—organized by both drug names and by diseases. You can also find diagnosis-based camps and retreats, listings of helpful government programs, information about finding discounts on MRI/CT scans, mediation for medical bills, and a zip-code based, searchable listing of discount clinics. Feeling overwhelmed with this details of signing up for one of the hundreds of  pharmaceutical discount programs? There’s a searchable database of free- or low-cost paperwork assistance organizations in just about every state.

There’s plenty more good stuff, too. Visit the site and look around. You will find legitimate, no-catch ways to save money. Prescription medications can be hugely and stupidly expensive—here’s your best way to fight back.

Pharma weasel games: Tales of Concerta and Auralgan

June 25, 2011

The Pediatric Insider

© 2011 Roy Benaroch, MD

I’ve been pretty hard on big pharma in the past—drugs account for a huge part of the cost of health care, and drug companies haven’t always been transparent and fair in the way they’ve priced and marketed new medications. They’re businesses, I understand that, and they exist to make a profit. But the way they game the system to take advantage of gullible docs and patients is sometimes sickening. Two recent stories illustrate their weasel games.

Auralgan is an old medication, an ear drop used to treat the pain that comes with ear infections. For decades it was made with two ingredients, and was sold inexpensively alongside several generic versions. The original product was formulated before current FDA standards for marketing prescriptions, so it was “grandfathered in,” basically allowing it to be sold and marketed “as-is” without proof of safety and effectiveness. It seemed to work well enough, and I suppose no one complained.

A few years ago, the manufacturer of Auralgan “reformulated” the product, adding two more ingredients without changing the name. Naturally, they also reformulated the price—now, cheap Auralgan was priced at over $100. Furthermore, because the ingredients had changed, docs who prescribed “Auralgan” found that pharmacies could no longer substitute inexpensive generics, even though the generics had the ingredients that Auralgan originally contained. In one swoop, the manufacturer dramatically increased the price while eluding generic substitution. Clever, huh?

Maybe too clever. This year, US Marshalls swooped into a warehouse in Kentucky, confiscating 16.5 million dollar’s worth of Auralgan. All new drugs must be FDA approved, and “new Auralgan” had never received FDA approval. It was illegal to sell, and it’s now completely off the market.

A bigger company sells a much bigger drug, Concerta. It’s one of the most popular treatments for ADHD, and one of the biggest selling brand-name medications in the USA. But its patent has expired, ostensibly allowing generic manufacturers to sell their own version of the product (presumably at a lower price.) Johnson and Johnson, maker of Concerta, has fought the expiration of their patents for years in the courts, finally losing an appeal in 2010. But get this: after losing their patent-infringement suit against generic company Watson Pharmaceuticals, J&J turned around and cut a deal with its adversary in court. J&J will now be manufacturing, in their own facilities, an “authorized generic” of Concerta to be sold by Watson. Watson, of course, will pay J&J to make their generic Concerta for them. So J&J will in effect be making the profits off of their own, off-patent Concerta, plus the profits off of the “generic”, which will actually be sold by another company pretending to be their competitor. No wholesale prices have been released, but I’m guessing that this generic Concerta will be priced quite similarly to the brand name. J&J wins. You lose.

Tired of the weasel tricks? Would you like to hear about some real ways to save on prescription drugs? Start here.

Can doctors be bought?

October 5, 2008

As recently published in The New York Times, Dr. Charles Nemeroff from Emory University has been accepting millions of dollars of income from pharmaceutical companies and device manufacturers without accurate disclosure. In other words, he’s taking money from the companies whose products he is endorsing and supporting through published articles, speaking engagements, and research. Lots of money, and he’s been doing it for years.

Dr. Nemeroff is no ordinary psychiatrist. He’s published hundreds of papers, and has served on dozens of corporate boards. Until recently, he was the editor of the very influential journal Neuropsychopharmacology—and is said to have been driven from this position after an outcry over a positive editorial over a medical device made by a company with which Dr. Nemeroff had financial ties. Again, no disclosure was made of this at the time.

This case is far from isolated. Earlier this year it was widely reported that Dr. Joseph Biederman of Harvard University was caught in a similar scandal. He was recommending and endorsing an ever-increasing use of certain medications while taking millions of dollars from their manufacturers. In this case, Dr. Biederman was most closely associated with a trend towards diagnosing and treating bipolar illness in children with powerful antipsychotic drugs that had never been approved for this use by the FDA. (more…)