Pharmacology and chemistry are two areas outside of my field of knowledge, much less expertise. However, common sense is not. Last November five courageous and honest retail pharmacists, three in Roanoke, Virginia and two in Springfield, Massachusetts, told me that shipping prescription and nonprescription medication to customers in uninsulated or temperature-controlled packaging and containers, especially in extreme temperatures, which do not maintain FDA- (Food and Drug Administration) mandated temperature standards, is both medically unsafe and unethical.
According to these pharmacists most prescription medications, such as metoprolol tartrate (beta-blocker) must be stored at room temperature between approximately 68°F and 77°F according to the Food and Drug Administration (FDA). Other medications such as Amgen’s Repatha SureClick (cholesterol-lowering) requires a storage temperature between 36°F and 46°F while Moderna’s COVID-19 vaccine requires a much colder transport storage between -13°F and 5°F until both medications are ready for use. Most drugs affecting the endocrine system or hormones are highly and adversely affected by excessive heat. This is especially true in regard to birth control pills.1 In plain words the birth control pills may be completely ineffective! The FDA has extremely strict guidelines for allowing exceptions to these temperatures called “temperature excursions” for very brief periods of time depending on the medication, which often total approximately no more than one to three hours or even much less time depending on the medication.2
According to an analysis of the serious dangers in the mailing of prescription drugs to American consumers in December 2020, NBC News stated, “Extreme temperatures can degrade medications, potentially rendering them unsafe or ineffective for patients. Industry guidelines make clear that pharmacies should package and ship medications in accordance with their recommended temperature range. But many mail-order pharmacy customers have no way of knowing whether their medicine has gone too far outside that range for too long [my emphasis].”3 Unfortunately, NBC News completely failed to mention that many national and independent retail pharmacies are just as negligent as such national or online pharmacies as Amazon Pharmacy, AllianceRx (Walgreens’ Home Delivery) and the Veterans Administration, which all mail prescriptions by not always following FDA guidelines throughout the United States.
The FDA has not only very strict temperature requirements for just transporting and storing medications. It also has very stringent guidelines for such other variables as humidity, precipitation, sunlight exposure, lid tightness and expiration dates, which can prevent chemical decomposition, and adversely affect the efficacy, safety and potency of any medication. However, most national retail pharmacies in the Roanoke area such as Walgreens, CVS, Kroger and many others have been mailing prescription medications, especially since March 2020 due to COVID-19, in very thin, flimsy paper and vinyl or plastic uninsulated bags issued by the United States Postal Service (USPS).
On November 9, 2020 a local national retail pharmacy in Roanoke, whom I will not name, shipped me metoprolol succinate 50 mg extended release tablets (beta-blocker), in a thin, white paper bag enclosed inside another non-insulated plastic bag via the USPS. Fortunately, the heart medication arrived one day after being shipped from the pharmacy. Unfortunately, however, all USPS mail being shipped from one location in Roanoke to another one in the same city since April 2015 must first be sent 105 miles south out of state to a Greensboro, North Carolina distribution center before local delivery. I seriously doubt that the cargo areas inside these trucks or tractor trailers transporting USPS mail on both Interstate 73 and U.S. Route 220 along with their distribution centers or warehouses are either air-conditioned or heated according to FDA recommended standards for prescription or nonprescription medication. That also certainly must include most trucks and distribution centers or warehouses owned by the United Parcel Service (UPS) and FedEx.
The evening after the metoprolol succinate 50 mg ER (extended release) tablets were delivered in the late afternoon to my black (heat absorbing) mailbox in early November 2020, which also faced the hot afternoon sun, I had a problem walking to my mailbox. A second problem was that none of my neighbors were home, and I did not want to disturb them after 9 p.m. Plus, I knew approximately when my medication had been delivered to my mailbox because I had “Informed Delivery” notification on my USPS smartphone app, which had taken a picture of any mail to be delivered for that day. A third problem was that it was unusually cold and already 32°F outside before 9 p.m. An even far greater problem was that according to my smartphone’s Weather Channel app the outside temperature was soon projected to be near 24°F in Roanoke after midnight. When I later telephoned my local pharmacist explaining my problem about walking to my mailbox etc. she explicitly told me that if I could not pick up the medication before midnight, I was to put it into the trash because of the extremely low outside temperatures. The next morning when I was able to walk much better I put the ninety day supply of metoprolol succinate 50 mg ER (extended release) tablets as instructed into the trash at the expense of the U.S. Treasury and ultimately the U.S. National Debt, which may soon be approaching $30 trillion by mid-March 2021.
That following afternoon was when I first seriously started to think about how much cardiac and other prescription medications that I had been mailed because of the COVID-19 pandemic from various local, national retail pharmacies during the hot summer months of June, July and August. During this time I had been mailed at least ten different prescription medications making me question their true efficacy or potency. This is also when the local daytime temperatures in Roanoke often averaged every day between 90°F and 100°F. This was especially true for the extremely hot and humid month of July, but less so for August. Last July Jeff Kronenfeld wrote in vice.com, “a mail carrier in Phoenix, Arizona, claimed to have cooked a steak to an internal temperature of 142 degrees Fahrenheit—medium rare—on the dashboard of his delivery vehicle, which doesn’t have air conditioning.”4
Over a month ago my local USPS mail carrier told me that this past summer his delivery truck could “easily reach triple digits” from 11 a.m. through 6 p.m. Likewise, he stated that during the winter in the same delivery vehicle where the mail is kept inside an unheated storage area, temperatures can “often plummet between 15°F and 32°F” or even lower on very cold days depending on the outside temperature. This obviously excluded the occasional day or even an entire week when a polar vortex, which occurred at least twice the previous winter in Roanoke, could dramatically decrease temperatures in the Upper South, Mid-Atlantic and New England states to cause “temperatures [temps] plummeting into the negatives.”5 There is also the possibility that future winters may become worse because of increasing scientific “evidence that climate change can weaken the polar vortex, which allows more chances for frigid Arctic air to ooze into the Lower 48 [states].”6 Unfortunately, the weather conditions existing during a typical winter (excluding a polar vortex) in both the upper and lower Midwest along with the Rocky Mountain states are far much worse than any winter weather usually occurring in both the Mid-Atlantic and Appalachian states. That especially makes me think that mailing or receiving any potential medications from Manitoba, Saskatchewan or any other Canadian provinces along with either North Dakota or Minnesota during the winter, where temperatures can easily plummet to -40°, in order to save money could be a potential nightmare without strict adherence to the proper FDA safety precautions.
Unfortunately, Capitol Hill despite its immense size comprising 100 Senators, 435 Representatives, hundreds of staffers along with five delegates and one resident commissioner, does not have a pharmacy on location. However, since 1997 the federal legislature has been relying on a small, private retail pharmacy, Grubb’s Pharmacy, located four blocks east from the Capitol at the corner of East Capitol and 4th Street at 326 East Capitol Street, NE for its prescription and nonprescription medication. According to CBS News, Grubb’s Pharmacy, “brings drugs by the carload to members of the House and Senate, who can simply pick up their prescription [and other] deliveries at the Capitol’s Office of the Attending Physician (OAP) ….”7 While legislators “can seek basic medical care at the [OAP] clinic for an annual fee just over $600 ….” this also includes access to Grubb’s Pharmacy, which makes “deliveries to the OAP occurring nearly every day.”8 I would be willing to bet my bottom inflated dollar that when Grubb’s Pharmacy delivers their prescription and nonprescription medications to the OAP office at Capitol Hill all these medications are delivered in highly temperature-controlled containers or bags depending on the medication. Indeed, it appears that I am 100% correct.9 In my opinion, all Americans deserve the same consideration and FDA-mandated safety standards as our esteemed Congressional representatives.
Congressman Ben Cline of the 6th Congressional District in Virginia immediately needs to introduce a bipartisan bill in the House of Representatives, which would supersede the state boards of pharmacy in all fifty states and U.S. territories, mandating that all prescription and nonprescription medications be mailed in temperature-controlled bags or containers in order to guarantee their efficacy, safety and potency according to FDA guidelines. This legislation would apply to all mail-order, independent and chain pharmacies with extremely high financial penalties for noncompliance. Consequently, this proposed legislation would greatly decrease the possibility of needless suffering and death, and improve the public health for all Americans throughout the United States both during and after the Covid-19 pandemic.10
Robert L. Maronic
February 28, 2021
Sources:
1 Kronenfeld, Jeff. “Most Postal Trucks Don’t Have Air Conditioning. That’s Bad News for Birth Control:
Being Exposed to High Temperatures Can Make Birth Control Pills Less Effective.” 1 Oct. 2019. Please see https://www.vice.com/en/article/9kedp5/most-postal-trucks-dont-have-air-conditioning-thats-bad-news-for-birth-control
or https://web.archive.org/web/20210208090119/https://www.vice.com/en/article/9kedp5/most-postal-trucks-dont-have-air-conditioning-thats-bad-news-for-birth-control. Archived 8 Feb. 2021.
2 Please see www.medlineplus.gov or https://medlineplus.gov/ in order to read about the FDA’s recommended storage of all prescription medication. However, most of these medications are never generally to be exposed even briefly to temperatures below 45°F or above 90°F. A second and perhaps the easiest effective way to read about the FDA’s recommended storage of any prescription medication is simply to google the name of the drug along with the phrase package insert (e.g. Google: metoprolol tartrate, package insert). Your search should result in a website or PDF of approximately ten pages at https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf or https://web.archive.org/web/20201107222704/https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf. Archived 7 Nov. 2020. (Please be forewarned that this preceding link for some unknown reason may not work on an Android smartphone.) Then search the PDF using either the words “temperature” or “excursion” for a quick reference about the medication’s FDA storage requirements.
3 Kaplan, Adiel et al. “Millions of Americans Receive Drugs by Mail: But Are They Safe? NBC News. 8 Dec. 2020.
https://www.nbcnews.com/specials/millions-of-americans-receive-drugs-by-mail-but-are-they-safe/ or https://web.archive.org/web/20201228233632/https://www.nbcnews.com/specials/millions-of-americans-receive-drugs-by-mail-but-are-they-safe/. Archived 13 January 2021.
4 Kronenfeld, Jeff. “Most Postal Trucks Don’t Have Air Conditioning. That’s Bad News for Birth Control: Being Exposed to High Temperatures Can Make Birth Control Pills Less Effective.” 1 Oct. 2019. Please see https://www.vice.com/en/article/9kedp5/most-postal-trucks-dont-have-air-conditioning-thats-bad-news-for-birth-control
or https://web.archive.org/web/20210208090119/https://www.vice.com/en/article/9kedp5/most-postal-trucks-dont-have-air-conditioning-thats-bad-news-for-birth-control. Archived 8 Feb. 2021.
5 Grossman, David and Jennifer Leman. “What Is a Polar Vortex? The Frigid Weather Pattern, Explained.” 14 Dec. 2020. https://www.popularmechanics.com/science/environment/a9897/polar-vortex-science/ or https://web.archive.org/web/20210224051826/https://www.popularmechanics.com/science/environment/a9897/polar-vortex-science/. Archived 24 Feb. 2021.
6 “How ‘Topsy Turvy’ Polar Vortex Brought Record Freeze to Texas.” Associated Press. 17 Feb. 2021. https://www.nbcnews.com/science/environment/topsy-turvy-polar-vortex-brought-record-freeze-texas-rcna290 or https://web.archive.org/web/20210224044918/https://www.nbcnews.com/science/environment/topsy-turvy-polar-vortex-brought-record-freeze-texas-rcna290. Archived 24 Feb. 2021.
7 “DC’s Oldest Community Pharmacy Fills Congress’ Prescriptions.” CBS News. 11 Oct. 2017. https://www.cbsnews.com/news/the-pharmacy-used-by-congress/ or https://web.archive.org/web/20210215070221/https://www.cbsnews.com/news/the-pharmacy-used-by-congress/. Archived 15 Feb. 2021. For a picture of Grubb’s Pharmacy on Capitol Hill, see https://www.statnews.com/2017/10/11/pharmacist-congress-drug-delivery/ or
https://web.archive.org/web/20210215071415/https://www.statnews.com/2017/10/11/pharmacist-congress-drug-delivery/. Archived 15 Feb. 2021.
8 Ibid.
9 Kim, Michael Dr. “Re: Grubb’s Pharmacy.” Message to Robert L. Maronic. 14 Jan. 2021. E-mail. According to Dr. Michael Kim, who is the current owner and President of Grubb’s Pharmacy in Washington D.C., when asked if his pharmacy “delivers all prescription or nonprescription medication to Capitol Hill,” and if his “pharmacy deliver[s] the medication in temperature-controlled bags or containers if necessary.” He promptly replied that “we deliver temperature-sensitive prescriptions in appropriate bags and/or containers during transit.” For more information about Grubb’s Pharmacy see
http://www.grubbspharmacy.com/Content/2166 or https://archive.vn/n60XU. Archived 28 Feb. 2021.
10 Peppers, Susan. “Delivering Your Meds on Time and at Temperature.” 10 June 2020. Express Scripts Pharmacy, which is located in St. Louis, Missouri, should be commended for mailing their medications in temperature-controlled containers. See https://www.express-scripts.com/corporate/articles/delivering-your-meds-time-and-temperature or https://web.archive.org/web/20201129071027/https://www.express-scripts.com/corporate/articles/delivering-your-meds-time-and-temperature. Archived 29 Nov. 2020.
