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In Part I of this series, I explained the definition of pharmaceutical expiration dates and ‘do not use beyond’ dates, and how both are determined. Additionally, I reviewed information from the Shelf Life Extension Program (SLEP) database, which led to a temporary Emergency Use Authorization in 2009, permitting the use of certain Tamiflu products (to treat H1N1 influenza) for up to an additional five years beyond the imprinted expiration date. (See Part I of this series for more information. )

Part II will examine the data regarding use of common antibiotics beyond their expiration dates.

The following is excerpted from my upcoming book, Armageddon Medicine.

Does a can of tuna go bad overnight? What about a bottle of medicine? Common sense suggests the answer is no, but is there any evidence?

The primary source of information regarding the prolonged stability of medications comes from the Shelf Life Extension Program database. Rather than discard millions of dollars worth of expired drugs stockpiled for emergency use, the U.S. federal government tested representative lots of selected medications for extended stability. These stockpiled drugs are aimed at emergency use for injuries and infections rather than chronic diseases such as diabetes, heart disease, and asthma. The most useful data for the layman is related to drugs to combat bacterial and viral infections.

Of the antibiotics tested, all passed assays for stability, potency, and appearance for at least a year beyond the original expiration date.

Of the lots tested, the following had their expiration date extended by the number of months indicated.

A summary of the Shelf Life Extension Prorgarm (SLEP) data is available in The Journal of Pharmaceutical Sciences, Vol. 95, No. 7, July 2006.

The Medical Letter, a respected professional newsletter, addressed the topic of expired medications in both 1996 and 2002. Regarding safety, they say: “The only report of human toxicity that may have been caused by chemical or physical degradation of a pharmaceutical product is renal tubular damage that was associated with use of degraded tetracycline. . . Current tetracycline preparations have been reformulated with different fillers to minimize degradation and are unlikely to have this effect.” (The Medical Letter, Vol. 44, Issue 1142, October 28, 2002.)

Liquid preparations may be much less stable, and degrade more quickly if frozen or heated. The Medical Letter advises that “Drugs in solution, particularly injectables, that have become cloudy or discolored or show signs of precipitation should not be used.” For oral medications, color changes may also be related to the dyes rather than the drugs. The primary concern pertaining to eye drops is microbial contamination once the preservative becomes ineffective.

Overall then, the concern is not regarding safety, but rather effectiveness. “Many drugs stored under reasonable conditions retain 90% of their potency for at least 5 years after the expiration date on the label, and sometimes much longer,” per The Medical Letter.

The SLEP data does not describe testing for any controlled-release antibiotics, such as Biaxin XL and Augmentin XR. Controlled-release delivery systems vary from drug to drug and would require testing not only of the medication itself, but the delivery system as well, to assure adequate drug delivery. Therefore, the regular versions of both Biaxin and Augmentin may be preferable for stockpiling. Essentially the only advantage of controlled-release antibiotics is less frequent dosing.

In the case of antibiotics, a 10-25% loss of potency over time may make little difference in treatment, and could be made up for by higher dosing in serious infections. Even now, generic medications are only required to be within 20% of the stated amount, and so the dose administered may already vary as much as 50% from one generic to another, or from pill to pill. For example, a 100 mg brand-name tablet must contain 95-105 mg of the active drug, whereas a generic of the same is permitted to have 80-125% active compound. Also, generics may not be equivalent in terms of integrity, dissolution properties, or coatings. In the case of generics, “Made in the USA” is probably preferable to those manufactured elsewhere.

To sum it all up, the good news is that most tablets and capsules are very likely safe and quite likely effective for several years beyond the printed expiration date. Using expired medications may suffice for a decade beyond the end of the world as we know it. (But what then?)

In my next post I will examine the use of other common drugs beyond their expiration date. – Cynthia J. Koelker, MD.

About The Author: Cynthia J. Koelker, MD is the author of the book 101 Ways to Save Money on Health Care. The book explains how to treat over 30 common medical conditions economically, and includes dozens of sections on treating yourself. Available for under $10 online, the book offers practical advice on treating: respiratory infections, pink eye, sore throats, nausea, diarrhea, heartburn, urinary infections, allergies, arthritis, acne, hemorrhoids, dermatitis, skin infection, lacerations, lice, carpal tunnel syndrome, warts, mental illness, asthma, COPD, depression, diabetes, enlarged prostate, high blood pressure, high cholesterol, and much more.

Dr. Koelker has recently started a new medical blog on surviving TEOTWAWKI, ArmageddonMedicine.net. She welcomes your questions, comments, and critiques.

The evaluation of “Medical Assets” depends greatly upon the evaluator and the mission. For the purpose of this discussion, I consider people, places and things collectively and individually as “assets”. This discussion is meant for a group of non-medical personnel who need to assess whether a person, place, or thing will further their short and long term goals (mission). But how do you make that assessment or know when it has been done properly?

Base assumptions:
1) The group has little to no medical knowledge.
2) The needs include general medicine, surgical procedures, veterinary medicine, and dentistry.
3) The most important asset is the person with their knowledge and experience, then items and equipment.

Background:
Our group contains three medical asset personnel: one primary medical asset, two as secondary medical assets. Of these three personnel, two are physicians and one a first responder with combined 25 years of experience in urgent care, primary care, wound care, triage and multiple site/multiple personnel management. We are now in the early phases of putting together a group of 19-to-23 individuals for TEOTWAWKI purposes. We have been increasingly interested in preparation for two years, and frequently reference SurvialBlog.com as well as other sites.

What this is:
This is an attempt to clarify and describe our group philosophy towards the medical component of our group. This approach, we believe, can be used for most other group components (mechanics, security, agriculture, etc.). Our hope is that responses to this article by other readers will help improve our approach. What this is not: Within the confines of this article, we do not propose to give a list of supplies, instruments, books, courses, and medicines – that has mostly been done on this site and others; however, a brief description of what our group is working towards will be offered. Although a much more detailed discussion is good and necessary, it is large and beyond the scope of this article. Additionally, there are no one-size-fits-all solutions and flexibility in planning is important.

Mission: This is perhaps the first critical assessment. The mission is the task or job that must be done. The mission dictates the personnel, supplies, and equipment. The mission can be as simple as basic wound care for a group of a dozen or so while tending an herb garden, versus multiple trained medical personnel running a clinic or hospital for a town of 2,000 people. Different missions may have completely different supply, equipment and staffing considerations. The U.S. military has a long history of thought on these issues and scalable units, each with it’s own supply and equipment lists. Army Field manuals provides a framework that does not require reinvention and many manuals can be found in digital format on the Internet.

Personnel:
Within the context of personnel we think terms of knowledge, experience, and functional capacity.

Knowledge and experience are two concepts are interrelated and cannot be separated. The day after TEOTWAWKI where an individual trained and what initials they put after their name is secondary (at best) to what they know and can do. In other words, give me an experienced fleet navy corpsman over any M.D. doing research at Harvard, a good large animal veterinarian over most freshly trained primary care physicians, or an experienced ER nurse over a radiologist. Their initials, race, gender, or language can never matter as much as what they have in their hands and head. The paper a nursing/medical/dental/veterinary license or diploma is written on can substitute for toilet paper if supplies run low.

Where the rubber meets the road you want a tire that can roll; however, most modern medical providers in developed countries are trained to function in highly complex and fragile environments that are far from austere. When the electricity goes away and the tertiary care structure collapses leaving us without many diagnostic and treatment tools, your favorite internist or psychiatrist may be more of a liability than an asset. Take away the operating room, support staff and surgical instruments and many modern surgeons may not be as valuable to a small group as an experienced and trusted EMT with multiple survival skills. A modern medical provider that is willing to seek further training should more quickly become an asset than a layperson without any formal training. Knowledge and experience can be gained through: 1) formal non-university courses such as wilderness medicine, BLS/ACLS/ATLS as well as 2) rigorous long-term academic courses such as a medical, nursing, veterinary or dental school 3) less rigorous academic courses at your local vo-tech or community college in EMT or nursing fields (think task orientation for selection), 4) volunteering, which could include overseas medical missions (excellent practical experience), many rural fire departments, and more rarely, stateside emergency rooms. The discovery channel is not very helpful in this regard.

Knowledge via reference material should be carefully maintained in a dry, safe area. Most medical providers have quite a collection of books in their area of expertise, but a well-rounded collection of both digital and non-digital format is required. We value the digital format for storage and carry, but are concerned with vulnerability to damage and catastrophic loss. Without specific recommendations, we value many of pocket-sized manuals meant specifically for training as well as many of the military manuals. Procedural references need good illustration. These reference materials may be used by the primary medical asset to help train the rest of the group to perform in an assistant’s role. Many high-level specialty references require frequent updating, but most basic references do not since human anatomy and physiology have changed little in recent years. In digital format we have stored many texts from the 19th and 20th century that do not involve a great deal of modern technology.

If you plan to share a pot of soup with your “docs” when the lights go out and count on them for medical treatment like they count on you for experience and knowledge in agriculture, blacksmithing, or perimeter defense then you must identify what you expect them to be able to do, both medically and non-medically. Beyond skill and knowledge these expectations should include functional capacity. Functional capacity can be degraded by a lack of equipment and medicines as well as their physical, emotional, and mental capacity. A poor survival attitude, refusal to contribute in non-medical roles, or a severe physical handicap might also affect their secondary and tertiary job assignments as well as their ability to perform medically. A small group should not be able to keep them busy all day applying Band-Aids (hopefully), so be mindful that many medical personnel often do not posses many other secondary skills to offer a group due to their focus and long hours in their profession. Make very few assumptions and ask if they can pull weeds, sew a sock, shoulder a weapon, or mend a roof. Our Plan: The needs of even a small group encompass so many areas that a single traditionally trained individual will not be “ready to go” off the shelf. Additional training and skills are almost certainly needed. If we did not already have medical personnel, we would search for an individual(s) who had or could gain the ability to perform most of the following:

• Basic assessment of ABCs
• Airway control
• Hemorrhage control and I.V. access
• Rudimentary chest needle decompression and tracheotomy
• Basic wound care and dressings, including suture/staple placement
• Basic labor and delivery skills, pre and postpartum management
• Dental preventative care, evaluation, extractions and fillings
• Reduction and immobilization of dislocations or fractures
• Basic preventative medicine (where to place the latrine, sterilize water, etc.)
• Evaluate and treat infections
• Basic veterinary care (some basic care may be common to most species)
• Have knowledge of herbal medicine and be willing to establish an herb garden
• Evaluate and treat pelvic and abdominal conditions (+/- surgical intervention)
• Basic supportive and nursing care, including temporary catheter placement
• The willingness and ability to teach all of the above as a force multiplier

Place:
How much area to dedicate to the medical component depends, again, on expected tasking. For a small group that is relatively healthy and in a peaceful locale, only an interior room is needed for temporary periodic isolation of infectious diseases and routine recovery. A larger group under fire would seek a larger room or multiple rooms with protection from projectiles, perhaps below grade. In all cases, the ideal would be an area that is clean and well lit with running water, a heat source and space to perform procedures.

Our plan:
For a group of two dozen who are relatively healthy in an area expected to have good OPSEC, we allocate only a smaller interior room for a 2-3 week, 2-3 person isolation or recovery need. If a larger need arises we can hang sheets from 550 cords to separate out space in a larger open shop area, ward style – this is less than ideal in terms of environmental control or security. Longer term, we plan a below grade basement area that would be an improvement in most all ways.

Supplies and Equipment:
As a recurring theme, supplies generally follow from the defined mission. The caveat here is that the mission may change in ways you cannot predict. You may start out with an EMT as your primary asset for fifteen people during an expected three month event and two years later find yourself part of a larger community that includes a surgeon and ER physician, still partially grid down. Like beans and bullets, you need to be deeper in Band-Aids than you might expect. If you consider the list of tasks you need your medical asset to perform, the equipment list becomes clear: airway control requires bag-valve-masks and ET tubes; lacerations are repaired with suture material as well as forceps, scissors and needle drivers; for a bad tooth dental extractors are needed. Splint material, coban, gloves, scalpels, a host of different needles and dressing material will make it to the list. The list can be enormous – worse without defining what your group actually needs or what your “doc” can actually use. We won’t even touch on use of conventional and traditional (herbal) medicines in this article. Supplies, whether consumable or non-consumable (stainless steel retractor versus gauze), perishable or non-perishable (medicines versus cotton balls) must be stored properly. Stainless steel instruments can rust, mice will love to nest in gauze, and isopropyl alcohol burns. Certain supplies, such as pain medicine and “medicinal Everclear” will need to be secured from people (including the “doc”) as well as the environment using a rotational two-party accountability system. Medical supplies, like any other, should be pre-positioned if possible. They are better than gold when you need them – treat them as such. Beyond direct use, there is always the potential to use as a barter item, although (much like now) medical support and supplies are devalued until they are needed. In a rapid collapse scenario (EMP, etc.) expected die off should go parabolic, leaving many non-perishable supplies available for many years. In a slow, stair-step multi-generational decline (i.e. peak oil, resource depletion, chronic conflict) many consumable perishable and non-perishable supplies will eventually be used up, but not adequately replaced thereby creating chronic shortages.

Sources and Storage:
The Internet is a game changer for supplies as well as information. eBay is a really good starting point for instruments and supplies, like Amazon.com is for printed material. Most supplies are less expensive via eBay than we can purchase from traditional medical vendors and with better OPSEC. The quality is fine as long as you keep to top rated sellers, and many sellers also have a separate web site. Being successful on the Internet often means that you know exactly what you need and what the item should cost through other vendors. Many non-perishable supplies (surgical instruments, etc.) are relatively inexpensive for now and store well, so we stack them deep. In our case medicine is not difficult to obtain, but legal restrictions apply to many medicines, nonetheless. I generally agree that veterinary supplies can often be substituted without much difficultly and that, again, the web is a good source. Several good articles on this and similar topics apply. Because of perishability, relatively good group health, and our relatively good access we do not stack medicines as deeply. We store much of our non-perishable items in five gallon non-food grade buckets. They stack well with our food pails and can be stored in the same area. Perishable items (medicines) do best in a refrigerated environment; most perishables like hydrogen peroxide need to be stored away from light.