Have you ever walked into your local pharmacy to pick up a medication that you desperately needed only to find they were out of stock?
There have been a growing number of drug shortages and discontinuations in recent years, causing concern for both patients and physicians alike. Medications may be commercially unavailable for a variety of reasons, including problems due to the manufacturing process, inadequate supply of raw materials, facility limitations due to safety and sterility concerns, discontinuation of a drug due to decreased usage or declining manufacturer profits, or the introduction of a newer drug. Sometimes only certain doses and dosage forms of a particular drug, or specific combinations are discontinued. Regardless of how these drug shortages occur, the reality is that this situation leaves many people without access to the medication they require.
Drug shortages can have serious implications for patient care including the delay of medical procedures, therapeutic substitutions with second or third choice therapies which may be less clinically effective, or relying on therapies that have an increased risk for patient side effects. The University of Utah Drug Information Service reports that the rate of new shortages is increasing with long-term shortages not resolving. The most basic products required for patient care are short: saline, dextrose, hydromorphone, morphine, fentanyl, ketamine, and sterile water.1
The Food & Drug Administration (FDA) and the American Society of Health-System Pharmacists (ASHP) publish an up-to-date list of current shortages, discontinued drugs, medications that are not commercially available and resolved shortages.
FDA Drug Shortage Database: www.fda.gov/Drugs/DrugSafety/DrugShortages
ASHP Drug Shortage List: www.ashp.org/Drug-Shortages
Compounding pharmacists may be able to help during drug shortages by obtaining quality pharmaceutical ingredients and compounding the needed drug in the most appropriate dose, dosage form, and flavor to help ensure that patients get the critical care they require. Cases arise in which although there is not a shortage, mass-market medications may need to be adjusted to fit a patient’s unique need. Perhaps a patient requires a lower dose than what is commercially available or flavors need to be added to make a medication more palatable for pediatric patients. Pharmacists can also prepare medications which are free of problem-causing additives.
Pharmacists would not be able to compound a medication if it has been withdrawn from the market due to health risks and concerns.
Helping During the Flu Season
In the United States, influenza activity often begins to increase in October and November typically peaking between December and February, and lasting as late as May. The Centers for Disease Control and Prevention (CDC) estimates that influenza has resulted in between 9.2 million and 35.6 million illnesses, between 140,000 and 710,000 hospitalizations and between 12,000 and 56,000 deaths each year since 2010.2,3 Increased demand for medications used in the prevention of influenza or to lessen the symptoms of the virus has created drug shortages during past influenza seasons.
Tamiflu (oseltamivir phosphate) is an antiviral drug used to keep the influenza virus from multiplying in the body and reduce symptoms. A liquid version of this medication is available and particularly useful for pediatric and adult patients who have difficulty swallowing capsules. Pharmacists can compound the commercially available capsule form of the drug into a flavored suspension on an emergency basis, using FDA-approved directions. The FDA reports on its website that there is no current shortage of these medications.4,5 However, should increase demand create a shortage, it is our goal to be able to provide patients with this much needed therapy.
By Juan Lopez, PharmD
Juan Lopez, PharmD is a personalized medicine pharmacist with Pharmacy Specialists Compounding Pharmacy in Altamonte Springs, FL. Pharmacy Specialists is proud to be Central Florida’s only nationally inspected and accredited compounding pharmacy. For more information on how personalized medicine can help you please call 407-260-7002, email Juan@MakeRx.com, or visit MakeRx.com.
References available upon request.