Excess pharmaceuticals

We have heard a lot about the problems of “how to get rid of” unwanted medicines and pills, often called “waste medicines”. Anytime that we hear of a problem framed in terms of the garbage mentality i.e. calling something a waste prejudges the kind of solution we want, we should prick up our ears and look for a better way to frame the problem.  How can we reuse the function of this product while eliminating discard entirely from our design?

First of all, where do excess pharmaceuticals come from:

  • Pharmacies have inventory which goes beyond its pull date i.e. last usable date.
  • Distributors have inventory which they don’t sell before it becomes expired.
  • Manufacturers produce more than they can sell. They may be required to change the design or dosage of a pill. They may be required to change a label or bottle. They may make product that fails to meet specification.
  • Deceased people often have large collections of medications.
  • Prescribed  personal medications may no longer be needed.
  • Over the counter medications may be bought in large and unnecessary quantities.

As you can see, there is not a single problem but several. You also need to know that there is an entire industry devoted to receiving, sorting and getting rid of excess medicines. Excesses that the industry generates in large quantities, especially  expired medications that are pulled from shelves by pharmacies and distributors, go to three or four large processors in the US who arrange for their disposal. So there is already a centralized processing business. From a ZW point of view, the mission of this industry needs to be changed to eliminate the discard and destroy mission and replace it with a 100% reuse goal.

Expired, sealed medications can usually be returned for credit so it is necessary for these processors to keep track of where a bottle came from and who manufactured it. The individual pharmacy is not expected to do this. Sometimes large quantities may be sent back to the manufacturer for some kind of reworking but it is more normal for excess medicines to “be disposed of” – that convenient circumlocution, beloved of the garbagemen,  that means no more than destruction, whether by controlled addition to a waterway, discard into a dump or incineration. However it can be positive that a centralized management unit already exists. Zero Waste designs normally require that some kind of central group of experts exists to apply the designs for reuse that are built into products.

Destruction of anything not actively wanted is a cultural requisite of our society. You oppose it literally at your peril.

A second route that is often discussed is the pouring of medicines and pills into toilets to be flushed down to a centralized wastewater treatment plant. It has been slowly discovered that many of these pharmaceuticals actually survive the various treatments at the wastewater plant and travel with the “purified” or “tertiary treated” output into a local stream, river or ocean.  The particular molecules entering the waterway are often so biologically active that they exert destructive and egregious effects on anyone or anything then consuming the water or living in it. People are being dosed with estrogens, fish and amphibian development is twisted into strange patterns and who knows what effect they have on bacteria or other one-celled organisms.

Two particularly troublesome chemicals that end up in waterways and in drinking water are cytotoxic agents (chemotherapeutic agents) and antibiotics. The cytotoxic agents are used for fighting cancer cells. They are known to be extremely toxic in nanogram doses (parts per trillion). There are ten million or so cancer patients in the US, many of whom receive these extreme poisons which pass into sewers and treatment plants and even into drinking water sources. Antibiotics are a danger even if no one ingests them. They cause any organisms they interact with to create mutant varieties that are resistant to them, and those mutated genes spread throughout the biosphere, destroying the intended usefulness of the original antibiotic.

These are the conventional lamentations but as usual, there is no reference to the enormous waste of low entropic molecular structures that are being discarded so cavalierly. Medicines, even more than other chemicals have been exquisitely constructed and purified and maintained. All of that requires herculean expenditures of effort, meaning the creation of huge plants, the running of expensive processes and the employment of an army of humans who consume gobs of resources of every description. All of this consumption is directed at the creation of highly specific molecules. When these molecules are discarded, is the waste merely the loss of a little bit of carbon, oxygen, nitrogen and sulfur? Of course not! This kind of misperception is the product of the garbage and recycling mentality which cannot see past the least important parts of discard.

Mainstream America has tangled with this problem through the lens of its narrow focus. As always, the only solutions proposed are the most wasteful, the most destructive and the most profitable to Big Garbage. For example, see the Alameda County disposal ordinance. This ordinance is being opposed by the pharmaceutical industry, for reasons that have nothing to do with environmentalism or conservation of resources. See legal opposition.  It is  not the financial power of an organized political garbage lobby which pushes such destructive legislation forward, as you might expect, but the cynical participation of a greenwashed, faux environmental movement that receives abundant funding from Big Garbage to insure that as many resources as possible are collected and sent to dumps and incinerators. And the gullibility of the public that asks no hard questions.

How can we do better than this unfortunate perception which views excesses as merely something to get rid of.  Let us first consider what the function of these medicines is. In this case, that is easy, since these are by and large highly specific molecules with single, targeted known uses. Their highest use is as medicine for humans.  Yet they are in the wrong hands. Where are there other humans who can make use of them?

This part of the design is also easy to answer. The world is full of humans who need these same medicines for their own diseases but cannot afford to purchase them.  Is there a way to transfer medicines from where they have no use to people who need them? To paraphrase another pernicious phrase: medicines without people for people without medicines. What are the obstacles?

Critics of various kinds of reuse often point to a single failure as a reason to return to the discard and dumping of everything, as though garbage dumping is victimless.  The word that stops discussion of unconventional alternatives is often safety. True, someone could die from ingesting a mislabeled drug, though there would probably be a thousand more whose lives would be saved or improved by a well run reuse program. Besides, iatrogenic deaths due to errors in labeling and dispensing of prescribed brand new drugs are considered to be the third leading cause of death in the US, yet no one considers banning prescription drugs. Read more here or here.

Most medicines are assigned expiration dates. “USE BEFORE NOVEMBER 1, 2012” The popular assumption is that on that magic date, the medicine is somehow useless. But how could such a claim be true? Expiration dates must be provided by government mandate.

In reality, many molecules do slowly degrade when exposed to heat, oxygen, light or other chemicals. The rate of that deterioration can be high, low or zero. The common Tums for example is just calcium carbonate. A reasonable expiration date would be when the sun turns red giant and incinerates the earth. Some biologically generated molecules may be much more short lived. Maybe half of them will degrade in five years. Maybe without refrigeration a vaccine may lose half of its effectiveness in a few days. But other organic molecules may last for fifty years. So it seems obvious that we need to know more than some arbitrary date. We need to know the actual, tested, realistic rate of degradation of each kind of medicine. This information is sometimes available, sometimes not. How much better for the manufacturer to be able to sell new medicines every six months, whether there is any need for it or not. Where else have we encountered this? Planned obsolescence once again raises its ugly head.

It is clear that there is a need for every medicine to have an actual, known, scientifically determined rate of deterioration as an integral part of its specification. This combined with the date of manufacture would allow anyone to understand whether the medicine has truly deteriorated, in a way that no expiration date can.

Read ProPublica article The Myth of Drug Expiration

There are other considerations. What is the history of a medication? Has it been out in the sun or preserved in a refrigerator or freezer? Fortunately there exist simple ways to tag packages that reveal critical portions of their thermal history. There are cheap tags that change color depending on the temperature. They are already in use for sensitive products.

Where did the medicine come from? When and where and how was it manufactured? What kind is it? What version and what dose? This kind of information can also be recorded cheaply and effectively. A radio frequency ID tag (RFID)  costs about a penny today but can remember a ton of information. A digital reader can extract this kind of information and display it instantaneously. Even a barcode can provide much of this information, especially when it provides a code which can then be looked up on the web.

What other history could affect the product? Were pills removed from a bottle (to be expected). Were wrong pills added? Is this fear exaggerated in the real world? Can effective labeling reduce the chances of this error to essentially zero? Can this action be monitored? If the probability is tiny, how does the theoretical possibility of a mistake compare to the elimination of an undeniably huge waste of product? If the fear mongering garbage world can invoke one or two unfortunate instances, is that all that a fear sensitized public will listen to?

In fact, the pharmaceutical industry purposely designs medicines, packages and prescription parameters to create as much waste as possible. Read ProPublica article “Senators Introduce Bill to Reduce Colossal Drug Waste 

For comparison, see this parallel effort by the food industry to cause food waste.

Remember the ZW principle about reusing packaging. When you are creating a package that will be reused a hundred times, you can afford to make it robust with special features, since it will not simply be disposed of after one use. This idea is immediately applicable to pill packaging. Why can’t pills be packaged in strong bottles that cannot be opened using a cap. We could use packages that only allow one pill at a time to be removed from the bottle. It would probably involve a recess inside the cap that can hold a single pill which is then released to the outside when the cap is rotated so the inner hole lines up with a delivery opening. In order to get many pills out, a consumer would need to destroy the package while the pharmacy would have simple tools for opening the package. Perhaps the package could even keep track of the total number of pills that have been removed. This might also cut down on the common problem of adolescents stealing sensitive medicines from their parents’ medicine cabinets, something we can’t afford to do when packages are made to be as cheap as possible.

Once again there are some technical approaches that can be used. There are special packaging devices such as blister packs that provide a way to protect a product down to small quantities. There is an industry devoted to making tamper-proof labels and closings. For example, see here  or here

The world is becoming increasingly interconnected with cheap, broadband devices using cheap spectrum. Is it unthinkable that some day, each bottle of medicine will have its own IP address and that some cheap, automatic chip inside the bottle can weigh (or count!) the pills inside continuously? The quest for privacy and a misplaced anger against authority, might induce some to empty the monitored bottle into another container early on, but this would surely be rare and tracking could still apply to 98% of medicines purchased. Each bottle would then have a recorded history of use.  Each bottle could periodically report on its temperature and maybe even some location data. The world is moving in this direction now that toasters have microchips. Michio Kaku in his book   Physics of the Future anticipates every eyeglass and even contact lens (and single pieces of paper!) being continually on the web as the necessary microchips go down to a penny apiece. So a web based bottle seems merely humdrum.

A recent article in C&E News (see Fighting Fake Drugs in References below) reports on important new technologies for labeling single pills and other medications. Tiny crystals of silicon dioxide or other inert materials can be labeled on the molecular level, then ground up into powders which are added to drugs. Each tiny crystal then bears a unique mark which can code information on product type, dosage and lot number.  These and other labels are given the name “taggants”.  Other forms are tiny pieces of DNA. Taggants are already a $100 million market and only part of the larger anti-counterfeiting market of one billion dollars which includes micro-marking of every single pill. The value of fake drugs sold today is estimated as $75 billion per year. While their impact on the reuse market is no worse than their impact on the prescription market, that is cold comfort. It is still desirable to eliminate drugs from being mistakenly reused. In fact, this is a typical advantage of Zero Waste methods. If the reuse channel can incorporate testing for fake, failed or mishandled product, then reused drugs can be more pure and reliable than newly prescribed drugs. This happens because the irresponsibility of “destroy waste by any means possible” is replaced by the responsible management of reused products with greater attention to all problems. In fact, problems that occur with reuse often point to problems in original manufacture that do not become evident in any other way. Ultimately, if reuse is incorporated as a positive value, the next step should be to start designing original manufacture to expedite the final reuse.

Can we get rid of the bottle entirely? In this internet saturated world, could we have dispensers that sit on the wall which are controlled by the internet, the way that chemical plants and smart houses already are? Let’s say the doctor prescribes one Zanax pill every day for you. The medicine could be placed in that wall dispenser by a provider and then every day, your pharmacy could send out a signal which causes one pill to drop onto the little shelf with a chime and a red light to remind you to take it. When you remove the pill, a signal goes back to the pharmacy. The pill inventory would never be under your control so if you finished needing Zanax, the pharmacy would know the secure history of the dispenser and could take back the pills into its own inventory. The dispenser could later be refilled with an entirely new kind of pill. The name and dosage of the medicine could scroll in a display along with side effects and other information.

One application where this dispenser idea would shine would be in fighting a plague like Tuberculosis where failure to take medicine is largely blamed for a worldwide resurgence of the disease. Part of the problem is that sufferers may be homeless so maybe a homeless shelter could have hundreds of these dispensers. Could the wrong person remove a pill? The person’s name would be shown in a display on the front but maybe the final dispensing would depend on a fingerprint sensor.  Could this technology be made to work and could its development be a new, Zero Waste business?

A recent article in the New York Times reported on he use of smartphones to keep track of pill taking times. The smartness was only invoked in recalculating  dosage times when a pill is missed.  No thought was given to, for example, a bluetooth connected dispenser for needed pills which coughed up pills exactly when needed without error.  The dispenser could be carried around, give an alarm when a pill was waiting and be stuffed with any kind of pill according to the prescription stored on the phone. Or just have a smart dispenser, without the phone.  The prescription would be automatically uploaded by the pharmacist by touching the smart dispenser to a circle on the counter. The dispenser would physically keep track of pills actually taken from its drawer, not just a digital counter that the human would  tick off.  Even more controls seem feasible.

There have been stories about pill abuse by caregivers. Some interns in senior managed care facilities may want to collect (steal!) as many Vicodin or Oxycontin pills as they can, due to their addictions. What if the pill could only be dispensed when the patient’s fingerprint or retinal scan was detected? It wouldn’t eliminate all possibility of abuse but it would help.

As usual, the underlying need is for a research project to sort out all of these devices and schemes. As usual, my goal in sketching out these approaches is not to create a final design but to show that there are possible approaches which need to be explored.

NOTE 1: On July 1, 2010, the federal government announced that it would spend $260 million dollars to destroy 40 million doses of H1N1 flu vaccine that had expired before being used. That is $6.50 per dose for destruction! They saw nothing wrong with this, citing polls of citizens who agreed it was better to be safe than sorry, and overproduce, when they did not originally know the virulence or timing of the flu infection.

I don’t know the circumstances of this destruction but I have to wonder at two things:

  • Could anything have been done, or could it be done in the future, to extend the life of these vaccines or design in an alternate use at the start.
  • Can the vaccine be separated into parts that are mixed at the last minute before use, such as the active part separate from adjuvants? In the event of non-use, could a large part of the combination still be usable?
  • If, say, five million of the quarter billion dollars that was so easily spent on destruction, were spent instead on ways to avoid destruction, would miraculous answers be the result? I think so, but wouldn’t it be cheap to find out? And isn’t it always better to learn for the future, rather than just spend the same kind of money over and over? Hint – not if you have the destruction contract.

As always, it is astounding what gigantic sums are expended for discard without a look backward, and yet design for avoiding waste will be denied even one dime on the grounds of insufficient funds.

NOTE 2: On June 5, 2011, my local newspaper The Daily Republic of Fairfield California reported a local collection event for expired drugs. The Police Department and Sewer District sponsored the event and the article described dozens of people donating up to duffel bags (!) full of unwanted pharmaceuticals, accompanied by expressions of relief that finally, someone was making good practices available to the public. The article’s headline was especially curious. “Residents practice safe drug disposal at Fairfield event” What was curious about it is that the article never mentioned safety or disposal at all. No one took any interest in what actually happened to the collected drugs which is reputedly the whole point of the event. The essence of the report was simply collection. This is the hallmark of a garbage industry inspired program. The public is first marinated in fears, then offered a bogus way out, packaged as a collection. No one asks what happens to the items. This is identical to the way that electronics recycling is being packaged. Read the article.

The pharmaceutical industry has developed ways to actually reuse drugs that they can control. Why don’t they simply try to discard everything? What is their secret? Very simple. THEY ACTUALLY UNDERSTAND THE MATERIALS THEY ARE WORKING WITH!  Recyclers and politicians typically think they can solve problems that they have no knowledge about, just by acting like bulls in a china shop. Chemical problems require chemists to solve them. This was the same principle that allowed me to run Zero Waste Systems as an intelligent, fine-tuned operation, reusing chemicals, because we were chemists. Here is the article:

HOW TO RECYCLE LIGHTLY USED DRUGS

When drugmakers design and test  dosage formulations of new medications, they mix hundreds of kilograms of the active pharmaceutical ingredient (API) with excipients such as polymer binders and inorganic salt lubricants to produce tablets. At this point in the drug development pipeline, time is short and supply of the API, which can cost thousands of dollars per kilogram, can become tight.

To avoid losing time and money by synthesizing more drug, a Bristol-Myers Squibb development team has engineered a process to recover kilograms of pristine APIs from unused or off-spec tablets generated during formulation testing (Org. Process Res. Dev. 2017, DOI: 10.1021/ acs.oprd.7boo146).

Daniel S. Hsieh and coworkers first crush tablets containing the
API, cellulose-based binders, magnesium stearate and silicon dioxide lubricants, and PVA-PEG polymeric tablet coatings. After dissolving the material in warm water, the researchers separate out polymer and other solids by centrifuge, remove soluble polymers by ultrafiltration, and then remove water by reverse osmosis to concentrate the API. In the final step, they add acetone to precip-itate  out and recrystallize the API.

This process, guided by theoretical modeling, is adjustable depend-ing on the solubility, density, and other physical properties of the drug and the excipients. Overall, the Bristol-Myers Squibb ap-proach recovers 9o% of the API with better than 99% purity, which is sufficient for  formulating new tablets and carrying  out other studies. Hsieh and his colleagues consider the approach green
engineering because it’s economical and minimizes waste generation. No chemical steps are required, water is  the separation medium, and mechanical energy rather than heat is the driving force for liquid separations  using membranes-STEVE RITTER
C&EN July 31, 2017 p. 9

Excreted Pharmaceuticals

Much of the above discussion applies to drugs and chemicals that are in bottles, not yet used. But what about those drugs that are taken as medicine and then, through urinary and fecal elimination routes, end up in sewers leading to waste treatment plants?

Because of the extremely dilute nature of these medicines, it is unclear how to capture or concentrate them under any circumstances. Clearly research is needed. One thing is clear though. From a Zero Waste viewpoint, it makes no sense to be mixing these dilute excretions in with the vastly larger sources from the general population. The only possibility of any management of these used, personal medicines will happen if the excretions are kept separate. Every hospital and clinic should have special toilets and collection systems to be used by people who are taking chemicals that should not escape into sewage plants. People undergoing chemotherapy should have special toilets installed in their houses that are separate from the public sewers. They could be plumbed into a tank that is pumped out and collected centrally for specialized processing. It might well be possible to selectively extract and recover some very expensive medicines from this effluent, so long as we are only dealing with hundreds or thousands of gallons, rather than acre-feet. Many such medicinals are worth a great deal more than gold. Remember that the goal of not mixing is not only to capture medicines but also to allow the capture of uncontaminated fertilizing values in the other effluent at the sewage plants.

As always, the basic incentive has nothing to do with the narrow question of whether some company can find a way to milk the problem for a huge profit. We cannot poison the waters of our planet with biologically active and powerful molecules, just because we can get away with it more cheaply than doing something intelligent to preserve the planet. Separate collection is a necessity of administering medicines and needs to be absorbed into that cost.

CONTAMINATION OF GROUND WATER WITH DISCARDED MEDICATIONS

A recent article in Environmental Pollutions (2014) picked up by C&E News * identified a study of two medications which not only traveled to the waste water treatment plant but were then found in nearby aquifers probably used by someone as drinking water. The two medicines were metformin, a diabetes medication and fexofenadine, an antihistamine. Probably the same result would have been found for many other medicines.  These are not medicines that healthy people want to be ingesting.

Metformin is likely the most prescribed diabetes drug in the world. It is dispensed as an extended release capsule taken one a day. It would be a perfect candidate for the kind of internet connected wall dispenser described up above. It needs to be dispensed once per day,  every day. Would it it travel through the body into wastewater or is it coming from unused bottles being emptied into toilets? Research is needed.  You cannot solve any problem by just looking at the end of the line, where the problem is already insoluble. You need to know where contaminants come from. The estimated half life in the body is about six hours and it is excreted in the urine.  But is this enough to explain its presence in wastewater?

A peculiar fact about metformin is that it is extremely high in nitrogen (C6N5H11). If offered to plant roots, you might expect it to be quickly absorbed as a fertilizer.

Since the collection of excess pharmaceuticals is generally mendacious, with all emphasis on the collection and no information on the fate, is it possible that medications are placed into wastewater after collection? No way to know.

* C&E News, 9/29/2014, p. 24

References

  • Chemical and Engineering News, Nov 2, 2015, p. 32
    Requiring Take Back of Unwanted Meds
    A survey of ordinances springing up around the country from counties who mandate the collection and incineration of excess pharmaceuticals. The standard, wasteful ways of making and distributing drugs is taken as a given as is the common obsession with destruction.
  • Chemical and Engineering News, February 23, 2015, p. 28
    Fighting Fake Drugs
    This article discusses new and standard ways to fight against the counterfeiting of drugs. China demands the use of bar codes, electronic monitoring, and standardized documentation. What’s new is the development of “taggants”, micron and nanosized particles that are inert enough to be added to pills but which bear identification markings that allow genuine drugs to be distinguished from counterfeits. Of course the article does not go into the application to reuse of excess drugs but the connection is hard to miss, once you realize the need.
The Seventh Annual Conference on Unused Drug Return was held on October 10-12, 2010 in Maine. See this notice.

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