Medicine and the Metric System, Part 2

(A previous post I wrote on the metric system and medicine is here. Hence, this is Part 2.)

When I was interviewed by Vox News for a podcast last month, I mentioned a recent recall involving confused unit dosing. I’d like to explore that issue in more depth this month.

August 2018 recall of children’s liquid medicine

A news release issued by the Pfizer Inc. on August 27, 2018, began with the following sentence:

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

Let’s take a closer look that. What that means is that if someone was paying attention to the number of units and not the units themselves (teaspoons vs. milliliters) — and why wouldn’t everyone expect consistency between the two? —that person could have given their child a significant overdose all the while thinking that they were following the directions.

As the Food and Drug Administration noted:

Pfizer concluded that the use of the product with an unmatched dosage cup marked in teaspoons rather than milliliters has a chance of being associated with potential overdose.

That is putting it mildly. Since there are roughly 5 mL in a teaspoon, giving the smallest dose in teaspoons could result in administering a whopping 20 mL more than prescribed. For a 72-95 pound 11-year-old child, the error compounds to an overdose of 60 mL when only a 15 mL dose was intended!

Image from this site: https://childrens.advil.com/childrens-advil-suspension

While not necessarily deadly, the recalls note that “The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness.”

I’m not a doctor, but I image the reactions could be worse for a small child whose health was compromised before the overdose was innocently administered by a caregiver.

We’re just not moving quickly enough to remove such errors from our medical system. As noted by the Institute for Safe Medication Practices in 2015:

While progress is being made in hospitals in regards to prescribing liquids in mL, many hospitals still use dosing devices that have household measures (e.g., teaspoonful, dessertspoonful, tablespoonful) and, as above, even drams and ounces. This sets healthcare professionals up to fail because the dosage scales on embossed cups are difficult to read, have dangerous abbreviations that are easily confused (e.g., TBS and TSP), and measures that are no longer used (e.g., drams). .

It’s easy enough to make mistakes moving between U.S. customary and metric units without having organizations responsible for our over-the-counter medicines layering on their own errors that might be difficult to immediately perceive.

But changing to the metric system will cost money, I hear some cry

One of the pushbacks I’ve gotten over the years is that it would cost money to switch to the metric system. Let’s take a second and consider the cost of a recall such as the one cited here.

According to Investopedia:

Though insurance may cover a minimal amount to replace defective products, a majority of product recalls result in lawsuits. Between lost sales, replacement costs, government sanctions, and lawsuits, a significant recall can become a multi-billion dollar ordeal. For multi-billion dollar companies, an expensive short-term loss can be easily overcome, but when shareholders and customers lose confidence, there may be greater long-term effects such as plummeting stock prices.

The bottom line: This recall of children’s medicine could have been completely avoided if we weren’t constantly juggling multiple measurement systems in this country.

I’m not saying that using one set of units would solve all problems. After all, it’s still possible a company could put out dosing instruction that contained a typo (or a host of other problems), but let’s do what we can to try to remove easily avoidable errors from the system.

Cost of a recall?

Based on some research I did, it sounds like an average recall cost is over $10 million dollars in direct costs (pulling product off the shelves, etc), while indirect costs (lawsuits, fines, and customer avoidance, stock price, harm to reputation) can mount for years after the recall.

That’s something to highlight when talking about using consistent measures and the cost to implement them.

Thanks for getting this far!

Linda

Some resources on the cost of recalls:

https://roadscholar.com/blog/how-much-do-product-recalls-really-cost
https://www.foodsafetymagazine.com/magazine-archive1/junejuly-2018/the-costs-of-foodborne-illness-product-recalls-make-the-case-for-food-safety-investments/

 

 

 

Measures and mistakes due to our lack of the metric system

The scene when the Spinal Tap’s manager discovers the prop is MUCH smaller than he expected.

In a scene in Rob Reiner’s mockumentary, This Is Spinal Tap, the rock group’s manager (played by Tony Hendra) goes to pick up a piece of scenery that is meant to evoke Stonehenge in connections with one of the group’s songs. He indicates that he’s quite pleased with the model with which he’s been presented with until he finds out that it is the finished piece and not a model. He expected something 18 feet high, not 18 inches high.

The designer (played by Anjelica Huston) seeks to defend herself and pulls out the napkin she’d been given to work from to show that the specifications indicated 18″ by 18″. She’d done exactly as instructed.

A zoom in on the napkin held in the character’s hand reveals the specifications she was given was, in fact, not 18 feet but 18 inches.

Within our measurement system, the difference between (“) and (‘)* is huge. In fact, the difference is 279.4 mm or 11 inches!

“Well,” defenders of our current measures might say, “that was done for comic effect and bears no relationship to the real world.”

I beg to differ by way of an example supplied to me by a coworker.

Her husband needed a metal bar fabricated and specified on the order “3/4″ x 3/4” x 1/2′ Long.” However, instead of getting a bar that was three-quarters of an inch wide and three-quarters of an inch thick and six inches long, he instead received a small block since the (1/2’), or a half foot, direction was read instead as part of an inch rather than part of a foot.

The instructions as provided to the fabricators.

Instead of a six-inch-long bar, he ended up with a block slightly smaller than an inch in all dimensions.

As if that isn’t confusing enough, the (“) and (‘) symbols can denote both lengths and durations. Thus, 5’ 4” could mean either five feet and four inches or five minutes and four seconds if there were no context indicating which measure was intended.

So, along with the many stumbling blocks of education and medicine, and other errors related to commerce, this particular vendor had to record the original order as a loss and make and send an item that actually conformed to what the customer had originally specified.

Such errors would be greatly reduced if orders were written in “mm” for the measures rather than in the easily mistaken (“) and (‘) units.

Thus, the order could have been written: “19.05 mm x 19.05 mm x 152.4 mm.”

A lot less ambiguous.

I wasn’t able to find any information on how frequently such errors are made, but if I only had to look to the office next to mine to find an example, can they be very far away from any of us in this country?

U.S. rulers often contain a confusing mix of whole, half, quarter, eighth and sixteenth units. Metric system rulers usually just mark on the whole (10) and half (5) counts.

In conducting research for this piece, I also came across information related to “how to read a ruler/tape measure.” One source went into detail about how to distinguish between the half- and quarter-inch marks on such tools. In contrast, metric system-based rules only have differing marks to help count the “fives” and “tens.”

As I continue to look, the more examples I find of how we’re making our lives more difficult since we don’t use the metric system exclusively in this country.

Have an example of confusion/problems you’ve encountered due to our lack of metric system adoption you’d like to share? Feel free to comment on this page or send an email to me at milebehind@gmail.com.

Stay tuned. Right now I’m researching our very early history with the metric system in this country. Luckily, prior to the last metric system push in the mid-1970s, our government put out a 200+ page document that goes into just such history. I’m now rereading it within the context of the book I’m writing.

Thanks for getting all the way down here.

Linda

* Note: Marks for feet and inches should always be indicated by straight lines, rather than by using quotation marks, which are usually curved. Did I have to look up how to make the straight lines to indicate feet and inches to write this article? Yes, yes I did.

 

 

 

 

 

 

 

 

 

 

 

 

Pharmaceutical Prescriptions, the Metric System and Your Safety (a Guest Post)

This week’s post was written by a contact I have in Australia. He asked me about how much of a medicine dosing problem we have here (citing a previous post of mine) and I sent him some basic information. After doing some research on his own, he put together this very nice article that he’s given me permission to share with you. Please enjoy.

In the September 1902 issue of The Journal of The American Medical Association, “Meyer Bros, Druggist” writes in the Miscellany column:

…It is not necessary to collect souvenir spoons in order to find out the great discrepancy in the size of a spoon when compared to the regulation “one fluid dram” measure. Unfortunately, some of the dose glasses are as far from the mark as any teaspoon. If physicians and pharmacists will give the subject particular attention, they can educate the public up to the point of using only accurately graduated medicine glasses when taking liquid remedies.

In the next paragraph he is quoted advocating the metric system:

The Metric System a Necessity — We have pointed out, says Meyer Bros.’ Druggist, on various occasions that the metric system would be adopted by the United States Government just as soon as our commercial relations with the world at large reached that proportion which would make the adoption of the metric system a matter of necessity. It seems that our country has reached that point. The committee on coinage, weights and measures has decided to report favorably the Shafroth bill providing for the adoption of the metric system by the government of the United States.

“One fluid dram”
In the intervening 111 years how much has changed? Well, the good news is that the pharmaceutical industry switched to metric measurements in 1971, only 69 years after the Meyer Brothers recommended it.

Up until then pharmacists and doctors used U.S. customary weights and measures for recording patient’s heights and weights. For dispensing medicines they had two systems: the metric system (grams and milliliters) and a medieval system called Apothecary’s Measure in which weights were measured in grains, scruples and drams, and liquids were measured in minims, fluid drams, (the “regulation ‘one fluid dram’ measure” mentioned in the Miscellany column) fluid ounces, pints quarts and gallons. It all sounds as if it would be used at Hogwarts School of Witchcraft and Wizardry.

What is a grain? Apparently, a grain of wheat was a standard measure of weight. (It was later standardized at 64.799 milligrams.) Twenty grains make a scruple and three scruples are a dram (also written as drachm). Finally, eight drams equal one ounce, of which twelve ounces are a pound. Simple, isn’t it? For liquids, a minim is the volume of water weighing a grain, and of course, Apothecary’s ounces, pounds, pints, quarts and gallons are not the same as the U.S. customary measures with the same names.

And to make sure we know it’s all medieval, apothecary’s measures were written using Roman numerals, so gr xx meant 20 grains.

Ron Aylor, a pharmacy technician in Georgia, has put a web site together to help train pharmacy technicians, and which includes a great explanation of Apothecary’s Measure and the symbols used to write them at: http://www.gpht.org/apothecary-system.html.

This assumes that every physician actually used those arcane symbols and Roman numerals to write prescriptions and didn’t just write “grains” instead. How many mis-doses have been dispensed by pharmacists or clerks who couldn’t decipher a physician’s handwriting to tell if he wrote “1 gram” or 1 grain” on a prescription, or didn’t know if the abbreviation “1gr” was for “one grain” or “one gram”?

The only thing more difficult to understand than the Apothecary system itself is why its use persisted for so long. The British Pharmacopia converted to metric measurements in 1963 and the US Pharmacopia in1971. You can still buy medication with the active ingredients listed as grains. The generic aspirin I found for sale over the internet is one example and some non-prescription herbal remedies also have their ingredients listed in grains, probably to avoid any taint of modernity or science.

“The Metric System a Necessity”
Around 70,000 children are admitted to hospital each year in the USA because they have taken an overdose of medicine. The majority of them have sneaked into the medicine cabinet and helped themselves, but it is astonishing that 18% (about 12,600 per year) are given an overdose of medication by their parents. (Note 1)

This happens because the dosing instructions are unclear, the measurements are misread, the parents use inaccurate household teaspoons for measuring doses of medicine and the whole procedure is unfamiliar or done in a hurry because the baby is crying and the parent is distracted.

This problem has been known about and discussed for a long time. In the article quoted previously from the Journal of the AMA, Meyer Brothers make the suggestion that customers should be taught to use properly graduated measures for dispensing medicines. This simple and straightforward action has still not been implemented completely in the century since it was proposed.

Question: If you prescribed a precise dose of medication would you tell the patient to measure it with:
A) a common household implement, or
B) a special-purpose accurate measuring device?

Good news if you manufacture medicines: The Food and Drug Administration (FDA) says you can do either. Over-the-counter (OTC) and prescription medicines are prescribed using measures of milliliters (mL), tablespoons (tbsp) or teaspoons (tsp). A standard teaspoon holds 5 mL, a tablespoon holds 15 mL.

In practice, a teaspoon is designed as a table accessory, not as a precise measuring device for medication and can vary between 3 and 7 mL depending on the design. This is a source of error up to 40% from the prescribed dose and was noted in the column by Meyer Brothers.

In addition to the inaccuracy of the spoon there are several human errors:

•  The abbreviations tsp and tbsp maybe confused, leading to under-dosing if the customer uses teaspoons where they should use tablespoons, or overdosing if they do the reverse.

• Patients may not understand the dose size. They are prescribed a dose of 5mL but take five teaspoons when they get home.

• Patients are given a dosing cup which holds 20 or 30 mL and fill it completely thinking it is the volume of the dose.

An underdosing error reduces the effectiveness of the medication and may be as bad as not taking any medication at all, as the dose is just too small to work. An overdose from the wrong sized spoon or overfilling the measuring device can lead to major medical complications or even death.

Surveys have shown that as many as 70% of adults preparing a dose of medicine for children made one of the errors listed above. (Note 2) Patients with visual impairment, poor English-language skills or impaired abilities are obviously likely to do make these sort of errors more often than the rest of the population. It is especially important to get doses right for children as OTC medications for them are most likely to be in a liquid form to make it easy for the child to ingest.

It is vitally important that things should change, but the Food and Drug Administration has only voluntary guidelines for the design and markings of dosing devices and it is still permissible to prescribe doses of OTC medicines in teaspoons or tablespoons and not mention milliliters at all.

The Institute for Safe Medication Practices (http://www.ismp.org/) is promoting two measures to improve prescribing practices:

1) They recommend that all doses should be prescribed in metric measurements only and not in teaspoons or tablespoons.

2) They are asking pharmacists to instruct their customers in the use and cleaning of dosing devices such as cups and oral syringes, and to supply them to their customers if they are not included with the medication.

(http://www.philly.com/philly/blogs/healthcare/We-need-to-go-metric-to-prevent-errors-with-oral-liquids.html)

In Britain, to enable the public to get used to metric measurements, drug manufacturers supplied 5 mL plastic spoons to be given away with each bottle of medicine. This was a great help during the changeover to metric measurement there, and would be an inexpensive and effective way to get customers used to doses in milliliters here in the US.

Some manufacturers, but not all of them, supply dosing devices with their medications. These may be simple measuring cups and spoons or more sophisticated droppers or oral syringes. It is not mandatory to supply them and FDA guidelines for their marking and instructions are only voluntary. (Note 3)

Even when a measuring device is supplied with the medicine, if it is badly designed it can be confusing to the customer. The FDA guidelines document shows examples such as the label on the package listing a dose in teaspoons only, and the accompanying dosing cup marked with:

• a scale of teaspoon, dessert spoon and tablespoon measurements all together
• a scale of fluid ounces and,
• a scale of milliliters

all of which would confuse anyone. Other errors they noted included stating a half-teaspoon dose or a 2 tsp dose on the packaging but not having a corresponding graduation on the cup.

All of these errors could be eliminated by a bit of careful thought at the design stage and some usability trials with customers.

Is it too difficult for an industry that makes profits of billions of dollars each year to make a simple device for measuring medicine doses, and to make the instructions and markings easy to understand? If the pharmacy companies are slow to act—on a problem that has persisted for over a century—why shouldn’t the FDA mandate a fix the problem?

Would it be too difficult to insist that all doses are in milliliters only? It would require minor changes to labels on bottles and packages, something that costs a few cents per bottle.

A national standard for describing and measuring doses would ensure a uniform method of measuring and dispensing medicines of all types, and would lead to customers performing the same procedure to dispense the medication, no matter what brand of medicine they purchased.

What would it cost? How many anxious visits to the hospital emergency room could be avoided?

Peter Goodyear

References:

Note 1 – http://healthland.time.com/2009/08/14/70000-u-s-kids-overdose-each-year-%E2%80%94-accidentally-%E2%80%94-on-everyday-household-meds/
Note – 2 Parents’ Medication Administration Errors

Role of Dosing Instruments and Health Literacy

H. Shonna Yin, MD et al  ARCHIVES of PEDIATRIC AND ADOLESCENT  MEDICINE/VOL 164 (NO. 2), FEB 2010

Note 3 – Guidance for Industry – Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products – FDA May 2011