In Light of Prescription Drug Shortages, Ethical Concerns Arise

Across the U.S., an increase in drug shortages is causing headaches for patients and healthcare professionals alike. Learning that a long-term or preferred brand of medication is unavailable can rattle your nerves and leave you feeling unsettled.

Drug shortages impact a wide range of medicines including painkillers, anesthetics, antibiotics and even cancer treatments. Sometimes a shortage is related to production distribution. Other times, it can entail more serious issues such as recalls and quality concerns.

For instance, manufacturers may suspend production due to quality problems with their drug. Even if production is only halted for a few weeks, it can take months to get back to normal quantities.

According to the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012, drug shortages are generally caused by one of the following:

• Requirements related to complying with good manufacturing practices
• Regulatory delay
• Shortage of an active ingredient
• Shortage of an inactive ingredient component
• Discontinuation of the manufacture of the drug
• Delay in shipping of the drug
• Demand increase for the drug

The Dangers of Drug Shortages

A shortage in certain prescription drugs can be alarming for patients, especially those facing an emergency health complication or potentially fatal disease.

Other risks associated with a drug shortage may include:

• Adverse reactions to a new drug
• Delay of patient care
• Higher prices for medication
• Fewer alternatives to treat health condition  Pharmaceutical drug shortages increased more than five-fold from 2008 to 2014. The median duration of shortages is 210 days.

It can take roughly 10 to 15 years for a drug to be approved, plus billions of dollars in research and development costs. These factors are causing many manufacturers to develop fewer products, leaving fewer alternatives in case of a drug shortage. Additionally, after large mergers and acquisitions, similar products between companies may be discontinued to save on costs.

Here’s several of the most recent drug shortages currently affecting consumers across the nation.

Bicillin L-A (penicillin G benzathine)

Penicillin G benzathine, commonly used to treat syphilis, is the only recommended treatment for pregnant women infected or exposed to syphilis. Sole manufacturer Pfizer has announced a shortage of the drug due to a manufacturing delay. Currently, it is unknown when quantities of the drug will be back to normal levels.

The Centers for Disease Control and Prevention (CDC) has suggested the following measures for patients:

• Refrain from the use of Bicillin L-A for treatment of other infectious diseases like streptococcal pharyngitis.
• Adhere to the recommended dosing regimen, as additional doses to treat early syphilis do not enhance efficacy.
• Contact your pharmacists/distributors to obtain the drug if you do not have product readily available.

Epinephrine Injection

Epinephrine injections manufactured by Amphastar and Hospira are both facing shortages. Amphastar has attributed its shortage to an increased demand. Hospira, on the other hand, has stated its shortage is related to manufacturing delays.

While there are alternative epinephrine injections available, the chemical structure of products can differ. For instance, some products are only preservative-free epinephrine, whereas others are preservative-free and sulfite-free epinephrine. Switching from one type to another can lead to negative side effects or other complications.

Dextrose

B. Braun Medical Group is experiencing intermittent shortages across many of their IV solution products like their dextrose injection. The company released information saying that it is tightly managing its inventory in an effort to address manufacturing process shortfalls. With a significant increase in demand, some dextrose injections may face sporadic backorders.

Unfortunately, this isn’t the only issue with B. Braun’s dextrose injections. In early 2016, the company issued a recall after reports of packaging leaks and visible microbial growth.

Overcoming a Drug Shortage

There are several options available to ensure a drug shortage doesn’t disrupt your health care.

Here are a few suggestions to keep in mind when it comes to your prescriptions:

• Do not let your prescription medication completely run out before ordering a refill. Shortages can make it challenging for pharmacists to find an alternative when they’re given little notice.
• Talk with your doctor about possible shortages. Find out if there’s a plan in place for a similar product.
• Learn about potential generic drugs available. Sometimes these are very comparable to brand name products.

With the enactment of the Food and Drug Administration Safety and Innovation Act, manufacturers are now required to notify the FDA of production issues or other problems that may increase the likelihood of a shortage. Medical professionals and lawmakers are also working on future bills to help reduce the number of prescription drug shortages, as well as the harmful effects they have on consumers.