We all take low-cost essential medical products for granted. Kind of similar to a chef who no longer has access to salt and pepper. It is those simple components that will marginalize a dish and cause a restaurant to go under. Drug shortages (#Drugshortages) of some of the most common drugs can cripple a healthcare system. Never mind having to deal with a new virus infection or natural disaster. Imagine not being able to have emergency surgery due to a shortage of baking soda.
Drug Shortages of Sodium Bicarbonate?
For most of us that don’t know, sodium bicarbonate is important in emergency medical procedures. Sodium bicarbonate is also known as baking soda. Let me clarify before anyone goes out to buy cases of Arm and Hammer baking soda. The sodium bicarbonate in question has a high purity and undergoes strenuous tests and purifications to be used in hospitals. The injection is commonly used in critical care settings during advanced cardiac life support (ACLS). These injections are also used to manage metabolic acidosis, hyperkalemia and to increase urinary pH. Sodium bicarbonate injections may be used as an antidote for selected products such as tricyclic antidepressants, methyl alcohol, phenobarbital, or salicylates.
As you can see, such a simple product with many uses. This shortage has resulted in health care providers carefully prioritize procedures and delaying some operations. All these hassles are due to a manufacturing issue at Pfizer’s Hospira division. As an added bonus, Pfizer recalled 47 lots of the product due to potential microbial contamination. It has gotten so serious, that there is a temporary approval to import sodium bicarbonate injections from Australia. Ultimately, the safety of the patient is of the utmost concern.
Sterile Talc Powder
The next product that faces drug shortages is talc or talcum powder. most people might recognize it as baby powder. Talcum powder is a clay mineral made up of hydrated magnesium silicate and mined in open pits. In medical use, it is sterilized for use in treating certain forms of lung problems. One such problem is malignant pleural effusion. This problem occurs when there is excessive fluid buildup around the lungs. Which results in shortness of breath and chest pain. The condition is often triggered by lung or breast cancer. Sterile talc powder injection can adhere in the lungs to the chest wall and prevent the buildup of fluids for months.
The shortage is mostly due to manufacturing issues. First, it started when the company recalled more than 25,000 canisters of an aerosolized version because a defective stem valve was hindering delivery of sufficient amounts of the substance. Second came an FDA inspection which found a series of manufacturing-quality problems. Some of the more serious issues included shipping talc to customers before getting the results of sterility tests. Including inadequate training of staff on drug quality, and failing to sufficiently investigate 86 customer complaints about defects in talc containers. Once again the FDA has approved importing a foreign-made talc product to mitigate the shortage.
As I did more research into drug shortages, it seems that it is fairly regular occurrence in the pharmaceutical industry. The FDA is currently tracking about 55 treatments with shortages in the supply chain. There are several factor associated with drug shortages. First let’s start with consolidation. There are only a few drug makers left for certain products. Think about the Takeda Airbag recall. how many different vehicles were affected since most cars use only a few suppliers to make their vehicles. The pharmaceutical business works the same way and can breakdown when one supplier faces a crisis. Secondly, most of these drugs are old and have been around for a long time. Margins are thin and investing money in upgrades or reformulation will not bring in a good return.
A third reason is just in time manufacturing. These products don’t last forever so pharmaceutical companies don’t build up huge inventories. The ultimate effect is on the patient. Most health care systems have managed with the drug shortages but at a higher cost. When one desired drug is unavailable, hospitals and doctors are forced to seek more expensive alternatives. These alternatives seem to have less proven effectiveness or more side effects. This results in more hospital time, higher hospital expenses as well as more cost on the health care system.
You can find a list of drug shortages at the FDA’s website or clicking this link: https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
Do you know of any drug shortages in your region?