Rx Shelf Life

I’ve made it to middle age taking almost no medication. True, I consume the occasional NSAID or antibiotic for time-limited purposes, but I don’t get up each morning and gulp a handful of pills as do many of my colleagues of even younger age.

Thus, with the exception of one – Synthroid (levothyroxine sodium 0.15 mg tablets) for hypothyroidism – I do not personally support Big Pharma’s bottom line.

Actually, I’ve tried not to even support Abbott Labs (the original maker of Synthroid) over these past 25 years. One of the perks of being a physician – there are still a few left – is having access to samples. I’m not talking about controlled substances, mind you, but instead those agents that fall into the ‘maintenance Rx’ category, such as Synthroid.

Back in 2003, I contacted the Abbott rep who covered my territory. I said that I was taking Synthroid and did he have any samples he could leave for me? I was hoping that I might be provided a few months’ worth that would save me, for a short while, the effort and (minor) expense of going to the drug store every four weeks for a refill. Plus I figured I’d make his acquaintance for purposes of future invitations to pharmaceutical events, as we were still allowed by the Ethics Police back then to attend such gatherings.

The rep – I don’t even remember his name as he left the company shortly thereafter – came around to my office the following week, saying that he had “a few samples he could leave with me.”

He wasn’t kidding.

He hauled a huge box around which he could barely wrap his arms. Putting it down on the floor, he said “they’re going to expire before long, but maybe you can get some use out of them until then.”

At 150 mcg per day, it was well over a decade’s worth of Rx in that box. But the contents were stamped with a ‘use by’ date in 2005, then still two years in the future.

This morning, 29 April 2014, I took the very last dose from that original supply, nine years after expiration. And that milestone spurred me to write today of expiration dates in general.

Most of what is known about drug shelf life comes from a study conducted by the Food and Drug Administration at the request of the military back in the 1970s. With a large and expensive stockpile of drugs, the military faced tossing out and replacing its drugs every few years. What they found from the study is that 90% of the more than 100 drugs analyzed, both prescription and over-the-counter, were perfectly good to use even 15 years after expiry.

Granted, this doesn’t apply to every active moiety; tetracycline arguably has a much shorter shelf life, as do nitroglycerin, insulin, and most chemo agents and other liquid preparations.

So the expiration date doesn’t really indicate a point after which a medication has ‘gone bad.’ Medical authorities state that most expired drugs are safe to take, even those that expired years ago. It’s true that the efficacy of a drug may decrease over time, but much of the original potency still remains even a decade after expiry, especially if kept in cool dry storage.

In case you’re wondering, my family doc tests my thyroid panel regularly, and it has always been in the normal range, thanks to these long-expired pills.

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[Copyright 2013 @ The Alienist’s Compendium]


The Kennedy-Kassebaum Act, otherwise known as the Health Insurance Portability and Accountability Act (HIPAA), was passed by Congress and signed in 1996 by then-President Bill Clinton. It is a law with many good features; for example, it protects health insurance coverage for workers and their families when a breadwinner changes jobs or loses a job.

But it is also a many-headed beast, and has been both lauded and vilified almost since the day it became law.

One ongoing conundrum is its treatment of patient privacy. HIPAA establishes national standards for “covered entities” (think: providers and their agents) regarding the security of “protected health information” (think: medical records). These standards cover not only collection and storage, but also all subsequent transactions involving protected information. With very few statutory exceptions – court-ordered searches for missing persons or criminal investigations of child abuse are two – this information cannot be released by a covered entity without the written consent of the subject.

On the surface, that sounds good in an age in which privacy is eroding daily, Big Brother is watching, and identity theft is an ever-increasing problem.

But the pendulum always seems to swing too far.

*Recently, I accompanied a family member – who shares the same surname – to a doctor’s office, with the plan that I would go shopping and return later for pick-up. When I asked at the desk – the same desk at which I had stood less than 90 minutes previously – I was told that not only could the staff not tell me when my relative would be done, but they couldn’t even confirm that my relative was, in fact, in the office at all, “because it would be a HIPAA violation.”

*On one maximum security (locked) psychiatric unit that I once supervised, all of the patient charts were kept in a rolling cart at the nurses’ station for easy access of clinical staff. The cart was often turned toward those seated at the station’s desk, meaning that, if one had really good eyesight or even cared, the names on the charts could be seen by a person standing at the station’s window. Keep in mind that this was a locked unit, and the only people present were staff, committed patients, and the occasional escorted visitor. Still, we were told that we could be cited for a HIPAA violation if the cart remained facing the window where visitors could potentially see the names.

I mention these scenarios because it’s easy to lament how ridiculous rules and regulations have become… until one remembers what it was like in the past.

My maternal grandparents were married at the turn of the 20th century and then lived in the tiny hamlet of Appley, in far western Somersetshire, England. I’m not even sure how large is Appley today, mainly because I can’t find it in any recent census roster. Having visited once, I’m certain, though, that there are no more than a few dozen full time residents, if that many. In 1890 it must have been even smaller.

In good English form, though, there is a pub in town called the Globe Inn, which is still in business after more than a century. Appley is so small that the Globe is the only landmark that shows when the village is searched on Google Maps.


Apparently in the late 1890s, there was also a physician who called Appley home. I don’t know his name or anything about his practice, except that my grandmother talked about going to see him when she was a young woman.

If any of the locals had a perceived medical problem, they would have to walk to the doctor’s house and wait outside, rain or shine, until 9:00 a.m. At that time, a woman would emerge from the house and begin to interview the crowd that had gathered. This was not done in private. It was done on the sidewalk. The woman would listen, and then either tell the potential patient, “go home,” or else, “come inside.” Those admitted to the house would wait in the parlor until the doctor was able to see them.

So who was the woman screener? A nurse? A midwife? Someone in medical training? No, it was the doctor’s housekeeper, a resident of town with no formal education or experience who was making triage decisions as to who needed help and who didn’t!

I’m sure that much gossip started from those sidewalk screenings, and then traveled like wildfire in the confines of small-town Somerset. And that makes me think that HIPAA, properly implemented, ain’t such a bad thing after all.

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In recognition of how most of you felt yesterday morning, I thought a few words on veisalgia might be in order.

Veisalgia – known in the non-medical vernacular as the hangover – is the cumulative physiologic and psychological effect of over-consumption of alcohol. It is characterized by severe discomfort involving a pounding headache, dry mouth, dizziness, fatigue yet insomnia, nausea and vomiting, occasionally diarrhea, hyper-sensitivity to environmental stimuli.

Lautrec's 'The Drinker'

Lautrec’s ‘The Drinker’

Given how much veisalgia is discussed, little formal medical research has been done on the subject. This is likely a reflection that it’s not considered a pressing public health concern – no one usually dies from a hangover alone, despite the fact that many sufferers probably wish they would. Most observers see it as “just deserts.”

There are many contributors to the feelings of death-warmed-over – a lack of restorative sleep, altered glucose metabolism, vasodilatation, dehydration and electrolyte disarray, cortisol imbalances, hyperuricemia, and metabolic acidosis all play a role.

After consumption, alcohol (ethanol) is first converted to acetaldehyde, a substance that is far more toxic on the cellular level than is the alcohol itself. Acetaldehyde is then converted to acetate by oxidation. Genetically, some individuals accumulate these two metabolic toxins more quickly than others, which bodes poorly since high acetate levels then cause adenosine concentrations to rise in the central nervous system, and that markedly contributes to the classic bad headache.

Women are more prone to hangovers than men, and the older one gets, the more one is susceptible to hangovers. Not much you can change about that.

So what is one to do? Aside from abstain?

Well, choice of beverage does play a role. Congeners are chemical byproducts of the production of alcohol or the flavoring process, and many people are very sensitive to their presence. Dark liquors have up to thirty times higher concentrations of congeners than do clear liquors. So drink vodka over whisky.

But dark and clear alcohols alike contain small quantities of methanol, a very potent congener that arises during the distillation process; methanol is metabolized in part into the toxin formaldehyde. Needless to say, this will make you feel as if you’ve been embalmed, which in a sense is what formaldehyde is doing inside your body while you’re lying in bed moaning and lamenting that last round of drinks.

If you can avoid smoking, that will help. Studies have shown that the additive effects of acetaldehyde and nicotine can be most unpleasant in many who imbibe.

aspirin bottle 1899

aspirin bottle 1899

And while hydrating thoroughly and taking aspirin might help with some symptoms such as dry mouth and headache, there is little that can be done to shorten the duration of the hangover itself. That said, the myriad folk remedies of which one hears all share one common root – a placebo effect. Many of the more inventive ones border on sheer quackery.

Take heart, though: those before you have tried, and have failed, to find the magic bullet.

In ancient Rome, Pliny the Elder favored raw owl’s eggs or fried canary for those who had over-consumed. The “Prairie Oyster” restorative, introduced at the 1878 Paris World Exposition, called for raw egg yolk mixed with Worcestershire sauce, Tabasco sauce, and salt and pepper. By 1938, the Ritz-Carlton Hotel provided a hangover remedy in the form of Coca-Cola and milk. Ernest Hemingway relied on tomato juice and beer. And a 1957 survey by a folklorist at Wayne State University found widespread belief in the efficacy of heavy fried foods and post-binge sexual activity to stave off a hangover.

But there is one thing NOT to do: saunas and steam baths can be very dangerous by combining the effects of hyperthermia and dehydration and yielding possibly fatal cardiac arrhythmias in susceptible individuals.


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[Copyright 2013 @ The Alienist’s Compendium]

Snake Oil

‘Snake Oil’ is a generic term that comes to us from the days of traveling patent medicine hucksters. It is defined as a substance (or more recently, a political salve) that has no real value-as-advertised.

Snake Oil

Snake Oil

Chinese laborers on the Transcontinental Railroad in the American West in the 1860s often applied to their aching joints a topical lotion made from water snakes, for pain relief.

Two schools of thought evolved from this observation: that of the marketers (who felt that ‘foreign’ and ‘exotic’ goods would sell briskly) and that of the individuals schooled in ‘real’ (read: Western) medicine (who felt that the potion had no therapeutic value whatsoever).

The former gave rise to the hucksters, and for a while they were quite successful.

The latter gave rise to the definition of snake oil as worthless.

‘Worthless’ eventually won out. But perhaps that was a bit premature.

More recent studies of the water snake concoction reveal that the Chinese Water Snake (Enhydris chinensis) is unusually high in Omega-3. It is, in fact, a very effective anti-inflammatory, esp when applied topically, since essential fatty acids are known to be quickly absorbed trans-dermally, just as the traditional Chinese healers suggested.

Unfortunately, the hucksters didn’t go to China to find water snakes for their products. In this country, they used rattlesnakes, which do not contain anywhere near as much Omega-3, and thus are far less effective, or wholly ineffective, for analgesia.

Sometimes, their ointments contained no snake at all. Clark Stanley, a man later known as the ‘Rattlesnake King’ in the late 19th century, marketed a snake oil that the U.S. Bureau of Chemistry investigated in 1916; it was found to be totally devoid of snake, containing instead mostly mineral oil and only 1% fats … derived from beef.

Thus, the Western versions of snake oil were likely bunkum. And Stanley was fined $20 for his false advertising.

So, the next time someone tries to sell you snake oil, don’t summarily answer, ‘no thanks.’ Ask ‘what kind?’

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[Copyright 2013 @ The Alienist’s Compendium]

Rx Booze

When I started my training in the mid-1980s, there were still nurses working at the medical center who remembered early in their own careers keeping a refrigerator on the ward that was filled with cans of beer, which the docs would prescribe for patients who were undergoing alcohol withdrawal. Prescribing beer would allow a gradual taper of their daily consumption, and would prevent their going into full-blown delirium tremens while inpatient.

Prescribing beer worked just fine in avoiding DTs before benzodiazepines were available. But it also represented a throwback to a time when medicinal use of alcohol was not nearly so innocent and altruistic.

In my post from last week on cresol, I made the observation that “if one presumes that humankind’s search for euphoria and an altered state of consciousness is not going to vanish anytime soon, then substance abuse is a problem that is here to stay.”

For this reason alone, it should have been painfully evident to policymakers that the 18th Amendment to the U.S. Constitution, enforced by the National Prohibition (Volstead) Act, was doomed to failure.

For thirteen years starting on 16 January 1920, there was a ban on the production, sale, and distribution of alcohol in the United States. But like most futile social policies, there were legal loopholes, plus illegal ways to circumvent the law, that were big enough through which to drive a Model T delivery truck. Farmers, for example, were allowed to grow grapes and produce wine (up to 200 gallons per growing season for their own consumption) under the guise of “preserving fruit.” Rabbis and priests could obtain wine, and congregations could partake, during religious ceremonies.

And physicians (as well as dentists and veterinarians) were allowed by the Treasury Department to prescribe alcohol for ‘medicinal purposes.’ Over 15,000 physicians applied for this privilege in the first six months of Prohibition alone. Having added special licensure allowed physicians to write up to 100 prescriptions for medicinal alcohol per month – a numerical allotment that was rarely if ever underutilized. Hooch was accordingly used to ‘treat’ a variety of ailments, including cancer, asthma, difficulty with lactation, diabetes, poor circulation, snakebite, anemia, typhoid, pneumonia, tuberculosis, coronary artery disease, high blood pressure, indigestion, depression – even the wonderfully vague and non-specific ‘old age.’ And if alcohol wasn’t listed as treatment for one’s ailment-du-jour, booze was still often used as a vehicle by which to ease the ingestion of other medications, as it tasted better than many pharmacy preparations.

Rx pad (courtesy Rose Melnick Medical Museum)

Rx pad (courtesy Rose Melnick Medical Museum)

So much for bubble gum flavored cough syrup.

Rx pad (courtesy Rose Melnick Medical Museum)

Rx pad (courtesy Rose Melnick Medical Museum)

Pharmacies were required to apply to be alcohol-dispensing entities. Some states were stricter than others, but especially near the Canadian and Mexican borders, and on the coasts, rules were often more lax and supplies were vast and difficult to control – pharmacies had no trouble keeping firewater in stock and their ‘sickly’ customers supplied. Prescriptions were filled for spiritus frumenti, or spirit of the grain, the term of art by which most physicians documented the necessary libation. Patients would quickly take such a prescription – they expired after three days – to a pharmacy and request the type of liquor they desired: gin, rye, scotch, whatever. Toward the end of Prohibition, when the sham was so obvious that hardly anyone even cared, more than a few pharmacies were actually filling prescriptions for champagne. And while some druggists only carried cheap alcohol better suited for cleaning, and often watered it down, it was apparently not rare that alcohol handed over the counter was brand name stuff like Jack Daniels in recognizable trademarked bottles – as long as it had a label affixed that said, “for medicinal purposes.”

See anything potentially analogous here vis a vis medicinal marijuana?

Anyway, doctors were supposed to be examining and diagnosing patients before any prescriptions were dispensed, but that stipulation was largely flouted. Every ten days, a patient willing to cough up the cash for a rote office visit could walk out with prescription-in-hand and shortly thereafter, down the street, head home with a pint of booze. There might have been some people who were given the tipple for actually-perceived medical need, but the whole process really just became a means by which physicians and pharmacists could earn a few extra bucks during hard times.

Doctors’ instructions varied, but generally they advised their patients to imbibe an ounce of alcohol every few hours or a tablespoon three times a day. One of my favorites was from a prescriber in Detroit in 1926: “take three ounces every hour for stimulation until stimulated.”

Those not even in the medical profession took notice. Bootlegger (and lawyer) George Remus incorporated a sham business entity called the Kentucky Drug Company. As a licensed supplier, this front allowed him to legally obtain and transport alcohol in company trucks to pharmacies all over the Midwest and South – that is, when he didn’t have his men hijack his own trucks en route and then divert the contents to speakeasies nearby.

The farce finally ended when Prohibition was repealed by the 21st Amendment on 5 December 1933.

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[Copyright 2013 @ The Alienist’s Compendium]

Cresol and Birth Control

Aside from the paternalism, subjectivity, and narcissism inherent, one problem with legislating morality is that such sweeping edicts often have (unintended?) public health consequences. A good example can be found with free needle exchanges for IV drug users. While I have never, and do not now, condone recreational IV drug use, if one presumes that humankind’s search for an altered state of consciousness is not going to vanish anytime soon, then substance abuse is a problem that is here to stay.

Accordingly, I must advocate for any measure that will prevent the spread of infectious, and often fatal, diseases, regardless of whether the cold hard reality of that scenario offends societal mores. To do anything less would be counter to the Hippocratic Oath.

But needle exchange is a discussion for another day. Today we deal with sex.

With currently free and unfettered access to all manner of contraceptive resources, including literature and both over-the counter and prescription preventatives, it might come as a surprise that it is well within the lifespans of our parents and grandparents that such was not the case.

The first American book on family planning, Moral Physiology, or A Brief and Plain Treatise on the Population Question, was written by Robert Owen, M.D., and published in 1831. This was followed the next year by Fruits of Philosophy: The Private Companion of Young Married People, by Charles Knowlton, M.D. And though birth control was not illegal at that time in the United States per se, it was certainly not a topic for polite (and mixed) company. Knowlton’s efforts raised the hackles of the Massachusetts courts – actually, his prosecution may have been just as much due to his stated atheism – and he was convicted of obscenity and jailed for three months for tackling in print such a prurient subject.

While admittedly unfortunate for Knowlton, the climate really changed in the 1870s with the arrival of Anthony Comstock. A postal inspector by trade with no formal medical knowledge or training, Comstock and his allies saw contraception as another facet of moral decay that lead to prostitution and venereal disease.

Suffice to say that the Comstock Act, immodestly named after its self-appointed champion, was passed by the U.S. Congress in 1873, and accordingly prohibited the possession and dissemination of not only pornography, but “any article or thing designed or intended for the prevention of conception or the procurement of abortion.” Many states jumped on the decency bandwagon with additional statutes of their own. The discussion of human reproduction and responsible family planning, even between physicians and their patients, was driven largely underground.

Advertisements for contraceptive products, where they existed at all, had to use euphemisms such as “marital aid” and “hygienic device.” Drug stores sold condoms as “rubber goods,” and cervical caps became known as “womb supporters.”

~ ~ ~ ~ ~ ~ ~ ~ ~

Lysol disinfectant has been around since the late 1880s, when it was first developed by chemist and physician Dr Gustave Raupenstrauch to help combat a cholera epidemic in his native Germany. As a cleansing solution, it also proved useful when enlisted in hospitals and homes during the worldwide Spanish flu pandemic of 1918-19.

But starting in the 1920s, Lehn & Fink, Inc., which marketed Lysol, initiated a (loud) whisper campaign to encourage another use for the product, one that had been around for a while but would soon become far more widespread with a little corporate encouragement.

Lysol began to be advertised widely for “feminine hygiene.” Print ads showed domesticated wifely types smiling with the caption, “I always douche with Lysol!” This wasn’t because of concerns about unpleasant odor, but rather a thinly veiled circumvention of the laws to tout Lysol as a form of birth control.

During the Great Depression in particular, extra mouths to feed were not desired. Condoms were relatively expensive (and often reused – yuck). Lysol was cheap – a 50¢ bottle of the concentrate made five gallons of disinfectant solution – and purportedly became the most commonly employed contraceptive of the 1930s. Lysol contained cresol, a phenol compound that was known to cause burning and inflammation of tissue. It was then a much stronger preparation than what is sold today. Surely it was annihilatory to semen, just as it was corrosive to the epithelial lining of the female reproductive tract.

The medical literature as early as the second decade of the 20th century was replete with cases of women sustaining Lysol poisoning from “uterine irrigation” (usually because of over-application or incorrect dilution at home). There were also deaths – at least five reported in the United States prior to WWI, though almost certainly the actual number is much higher. Despite this, Lysol continued to be marketed as “safe, gentle, and effective” for feminine hygiene.

Lysol ingestion, as opposed to its use for irrigation, was also a fairly common method of suicide in the first half of the 20th century. Why this didn’t alert medical observers to the potential toxicity of the substance inside the human body remains a mystery. And yet no one seems to have raised an alarm. Dr Joseph DeLee, a prominent American OB-GYN, went so far in 1938 as to publish practice guidelines that encouraged the irrigation of the vagina with Lysol during labor and delivery!

Lysol ad (courtesy of Mother Jones)

Lysol ad (courtesy of Mother Jones)

Once the cresol component in Lysol was replaced with ortho-hydroxydiphenyl in the 1950s, the marketing gradually shifted from feminine hygiene to toilet bowl cleaner, for which we largely know the product today. But this was a gradual tack, and untold numbers of women continued to suffer the consequences of using a caustic liquid in places never designed for it.

Sadly, although contraceptive pills and more efficiently-designed IUDs had been approved by the FDA as early as 1960, it wasn’t until the landmark privacy decisions of Griswold v. Connecticut (1965) and Eisenstadt v. Baird (1972) that the U.S. Supreme Court ruled that it was unconstitutional for the government to prohibit adults from using birth control, or to prevent their doctors from discussing the matter with them.

This was only 40 years ago.

As a physician, I continue to worry about the physical and mental wellbeing of my patients at large far more than I do about the personal beliefs of crusading elected officials.

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[Copyright 2013 @ The Alienist’s Compendium]