Seems to me that stores never accept returns for any food or drug items, prescription or not. Don't know if this is a legal requirement or just stores CYA.

I don't know any grocer who won't take returned food. And the better one won't even put it back on the shelf.

Liability and public trust.

The integrity of the chain of custody of a drug must be documented and secure.

@Ben and NoMo,
I got a good chuckle there, and then saw the real concern from your posts: would pharmacies reshelve expensive returned drugs? Sadly, that's probably a real concern. The way to solve that is probably for returns to be made to a separate entity.

There are organizations that repurpose prescription meds, by the way, legally. Came about because in the early days of AIDS, people were dying and leaving behind tons of expensive meds that could help others. Returning meds to a single entity might make that more possible.

When my dog died, she left behind hydroids medicine that I tried to return to the vet's office. They declined, but offered to dispose of it forms. I asked why I couldn't get a partial refund, since the prescription was a three month supply and only seven doses were used, I was told that they can't be put in the position of being responsible for any possible adulteration of the medication.

This probably holds true to human medications as well.

@Good Reason,
I'm very sorry for your loss.

I don't think returning medication should be for reselling it, it should either be disposed of or repurposed the way that compassionate reuse organization does. (When you give meds to such orgs, they know who it comes from, etc) But if people could return medication for a refund, the amount of good information we get on whether drugs work or have side effects would suddenly become far more copious and robust. (See all the benefits I listed above.)

I even think people should be able to return drugs that went unused by a loved one who died, because we'd even get a lot of data about what people are being prescribed before death - and information that is now almost completely unmonitored about whether drugs might have contributed (big data). We could also find out if very sick people are being fleeced. As I pointed out above, most of what we know about drug side effects comes from after market surveys (meaning, after the drug is already on the market and being used by people). Allowing people to return drugs that don't wotk well or cause side effects would suddenly provide far more rapid, robust information about drug usage and side effects.

I think the other benefit us to finally introduce the idea that drug companies have to be more accountable for what they can do to create better outcomes and personalize treatment to minimize side effects. As it is, they have only the incentive to get away with as mch as they can. The only way that allowng drug returns would serve all of the above purposes is if, to get the return, patients and/ or their doctors had to fill out a quick standardized form providing the information about why, and agreeing to allow (anonymized) use of the data.

If I were a pharmacist and you come to me with a vial of prescription medicine, much of it unused, that you want to return. Aside for the honor system, how would I confirm the:
- Hygiene of the individual pills (did you touch them, drop them, did they come into contact with any other substance, etc.)
- Age of the pills (did you perhaps scoop up pills from old bottles and add them to this one to make them look like they were all from the same issue ?)
- Storage conditions (did they sit on a table in the hot sun, were they exposed to a humidifier ?, etc.)
- Contents (did other pills accidentally get added to this container by mistake, or otherwise ?)

Disposal is pretty much the only thing a responsible pharmacist can do with returned medications.

I am not advocating that medications be returned for restocking. I am advocating a change in the law, so that patients have a right to bring back medication for a refund which would instantly give feedback as to how well the meds really work, in addition to the other benefits listed above. In early discussion on this thread, it already seemed a bad idea for the recipient to be the original pharmacist.

Given that most of what we learn about medications comes not from trials but from aftermarket surveys, we stand to gain such better quality and more signiicant data if patients are allowed to return medications that don't work for them. (Not necessarily to the pharmacy, but a requirement would have to be provision of information for data analysis.)

You do bring up a good point, which is: how do we know that a patient isn't bringing back the medication because of poor handling? One possible solution is for dispensers to begin providing sensors that monitor temperature, which are dirt cheap. I'm not sure this is really necessary, though. If patients are not storing their medications properly so that they don't work or even degrade into dangerous byproducts, this is also information that will come from examining the returned pills, and good information to act on to improve patient care. It's not like a patient would be able to get another prescription for the drug if they bring it back as not effective for their condition. I suppose that would have to be worked into any rules. But if a lot of patients are getting particular drugs that don't hold up well under normal use, this is really important information to know right away. It could have major societal implications if we are talking about people developing resistant strains from subpotent antibiotics because a drug is too fragile under normal use. So here again, allowing people to return drugs when they don't really work would be well worth the cost. It's not like the margins on drugs would mean anyone loses money. And the benefits to research and advancement of medicine would be far in excess of anything that could be gotten from a similar investment.

Thanks for all the thoughtful comments!

If you had the right to return medication that didn't work or that had bad side effects, when would you consider doing so?

@Sense makes sense! At first I wasn't even interested in reading this post because it seemed ludicrous to return medications, for all of the sanitary/integrity comments mentioned. But returning the meds for disposal makes sense.

The one issue I see is that drug companies should not have to give refunds for the returns that are not their fault. For example, if someone is taking prescription meds for high blood pressure but is killed in a car accident, the company that sold the high blood pressure meds should not be on the hook to refund say, a 90 day supply of HB medication. In a case like this, maybe it is fair for the drug company to refund the "profit," and only keep the amount equivalent to the cost of the meds.

Oh my, can you imagine how many lawsuits and new legislation would ensue?

I agree with Sense's sentiment and ideas, but see some serious pitfalls in implementation.

@Makes sense,
Thanks for reading and sharing your thoughts!

I hadn't thought of that, but I agree, it makes sense for circumstances that really aren't their fault to be excluded. Another one I can think of is natural disaster. The case you brought up is interesting because usually people go 90 days to save money. People might not be inclined to care about returning meds after the death of a loved one, unless there is some kind of greater good that will come from the effort, such as possibly helping to prevent death related to med side effects. Studies of malpractice lawsuits (in BMJ) found that in a high percentage of cases, the medical institution taking responsibility and making sure it never happened again played a large role in what people were after from the suit, and institutions paid way less when they took responsibility, apologized, and used the situation to better their practices. Cases that did move forward often involved a child who needed to pay for future care related to the malpractice. People are on the whole are inclined to act if there is a greater purpose.

On the other hand, you are right, this could get complicated - the best laws and rules are usually the simplest, I hadn't really thought specifically about what the law would say. The law that allows people to sue junk unsolicited callers are really simple, didn't result in a lot of lawsuits, it had the intended effect of reducing junk callers. One could imagine abuse and yet that's not what happened. What do you think would be the simplest rule, one that wouldn't be abused by drug companies to always say "it's not our fault" but that would err on the side of providing great information for benefiting medicine?

I'm kind of moving back to thinking that maybe in the interest of simplicity, and eliminating battles and weaseling, companies should just have to take back and refund everything people bring back. It helps with proper disposal. I can see that making exceptions might deter people from considering it worth their time when it is necessary, since some documentation would have to be part of it. It would probably be better to give some tax concession to drug companies if they get a lot of disaster returns, for example. I don't think the companies should be in charge of the information, though, or that will lead to abuse.

I do think there's an important principal of medical systems having to be more sensitive to outcomes that would be furthered by such a program. New science is making the individualization of care more possible, and yet the public health mindset is still so often in the one-size-fits-all space. There's a great TED talk (what doctors can learn from each other?) discussing what happened when this group looked around the world for the best outcomes in specific conditions, per patients' judgment. They found that the best outcomes, as judged by patients, also turned out to be the least costly care.

The point is that after getting initial information, the drug companies would improve what they offer and how they offer it to better meet health needs. It could be a dissincentive to me too drugs.

@Sense

Actually, most of what we learn about medications comes from laboratory work and clinical trials. The FDA drug approval process exists to ensure statistically significant efficacy before the drugs are made available to the public. That's why it takes many years and millions of dollars before any drugs can be sold. The FDA allows trials to occur among larger and larger groups of patients to collect the data it needs to make a final determination.

The FDA requires the side effects to be documented in any drug ads and in education material given to doctors.

In terms of collecting efficacy data from the general public, there's a lot of statistical problems when you do this, such as self-selection bias. The FDA requires drug studies to be conducted in very controlled situations so that these biases don't skew the data. Moreover, it can be difficult for the average person to tell whether a drug is working or not.

For example, one of the most popular drugs are statins. They lower cholesterol. How do you know if your cholesterol levels are decreasing because of the drug? They could be changing because you changed your exercise routine, changed your diet, how your body interacts with the statin, or some combination. And we know that people are generally inaccurate when you ask them to recall their eating and exercising habits. I don't want to say they lie, but they embellish to varying degrees.

And let's not forget patient error. A drug may not work because the patient forgot to take his pill one day. Or the drug has to be consumed together with a meal, but the patient didn't. If the patient wants a refund, he will not admit to the error.

Sometimes patients are their own worst enemies. For example, they get a cold and demand an antibiotic. The problem is that antibiotics don't work on the cold virus. Doctors are often pressured into writing these prescriptions to keep their patients happy before they can make an accurate diagnosis. The patient wants relief ASAP and has seen how well antibiotics work on illnesses in the past. He doesn't understand the science behind the drug. The patient takes the antibiotics and doesn't get better quickly. The patient deems the drug as ineffective and would return it if he could. But the problem was not the drug.

As for the reason why you can't return drugs for a refund, I suspect this is drug company policy. The drug companies won't refund the pharmacies for returns and the pharmacies aren't going to eat the cost, which means consumers have to. Keep in mind, each prescription drug is a monopoly business. With a monopoly, the producer has a strong market position and doesn't need to have consumer-friendly policies, such as allowing refunds.

If you're really interested in learning more about why the industry does what it does, I would suggest you reach out to people working in the pharmaceutical industry and FDA. They'll know more about why the system is set up as it is.

@Apple
The you for your input, but I should probably clarify that if you read my original post, the question was a rhetorical one. While you and I have a disagreement in our views, I appreciate that you have taken the time to voice yours and hope we can continue the conversation.

In your reply, you have inadvertently confused what "premarket" and "postmarket" are in clinical studies. The premarket studies* usually involve small numbers of patients. The postmarket studies ARE the Phase IV of clinical trials, and Phase IV can even be beefed up at the expense of premarket data collection.**

What's more, "Pharmaceutical companies are systematically failing to fulfill their commitments to the FDA to do post-marketing (Phase IV) clinical studies of newly approved drugs, often required by the agency as a condition of approval. "

"...if advisory committee members were aware of the extraordinary failure of manufacturers to honor their Phase IV commitments, they might be less likely to recommend approval of a new drug based on the promise of a Phase IV commitment ...

"...for at least five and as long as 10 years after drug approval, all of the studies for 87 percent of these drugs had not been completed. For the 107 NMEs with Phase IV commitments approved between January 1995 and the end of 1999, not one drug has been classified by the agency as having completed commitments as of December 23, 1999."
Web Link

Phase IV studies are where we get the real world information about drugs on large numbers of people. Manufacturers are falling down on the job. I don't think I need to even go into the suppression of negative results in premarket trials.

I understand your concern, and it's a common perspective - because those who control the system don't have to be accountable to the patient perspective (since they get paid regardless) - but that particular perspective and examples infantilizes and denigrates both patients and doctors. I don't know any good doctor who is that irresponsible to prescribe like that or patient who can get a doctor to do what they want like that (even if they lived under a rock and didn't know that example by now), but I do know a doctor who was sued because the elderly patient refused to take the antibiotics and had amputations, and many people who would refused antibiotics even when suffering bacterial infections out of a belief that antibiotics are dangerous. Times have changed. The pendulum swings both ways.

If a drug is designed so poorly that it doesn't work in the real world under real world conditions, even with great instructions, then it's not really doing its job, is it - and the manufacturers or the FDA need to know. If everyone lies about their diet and no one in the world ever eats exactly the way needed so that a drug doesn't really work outside of a limited clinical trial, then it doesn't really work. If too many patients can't take a medication as directed so that it doesn't really work, then it doesn't really work. The manufacturer and especially the FDA need to know this, because when people aren't getting the expected benefits, their health is suffering and that ultimately costs the system a lot more. If patients who are prescribed antibiotics for infections are not finishing their medications, that puts everyone at risk from resistant strains developing - the only way anyone will ever know what is going on is if patients start returning their partly used prescriptions to get a refund. (And get the meds properly disposed of.) The way to get ALL the data is to (write a law to) allow patients to return medication for a refund, so long as they and/or their doctor fill out a standardized form allowing the appropriate data collection. Instantly, all Phase IV trials get completed.

Far more prevalent than the old hypotheticals is that side effects cause nonadherence to important medication regimens, and that this costs more money down the road and results in worse outcomes. The system and patients benefit when quality is judged by outcomes that matter to patients, in concert with their doctors.

Leading healthcare quality researching are beginning to understand that outcomes that matter to patients are the gold standard of quality. (Great TED talk if you haven't seen it.)
Web Link



*Premarket studies
-usually involve small numbers of patients
-usually involve uncomplicated cases
-can't usually discern rare but serious side effects
-may not be accurate if makers bury negative results
-are often not an adequate test of a product under real world conditions
-are rarely long-term (longer than a few weeks or months) even in drugs given long-term in the real world

**"FDA has long applied postmarket controls as a way to reduce premarket data collection..."
Web Link

Just a question - are you a doctor? Do you tell your patients you think they are lying? Give them a chance to either fess up or go see someone who treats them with respect and tries to figure out what is really going on if they aren't? (Ever heard of "informed consent"?)