Lindsay R. Kohler, PharmD Candidate

The drug shortage crisis has dominated health care over the past decade. In an attempt to subdue the crisis, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on July 7, 2012,

 which strengthened the agency’s abilities to advance and safeguard public health.

Despite the added authority from the act to collect user fees from industry, enhance the safety of the drug supply chain, increase stakeholder involvement in FDA processes, and promote innovation to speed access to effective and safe new drugs, drug shortages remain a monstrous obstacle for health care personnel and patients.

 A multitude of factors can cause these shortages, including manufacturing issues, natural disasters, raw material shortages, and regulatory delays.

These shortages affect patient care by causing medication errors, compromising or delaying medical procedures, and requiring replacement of first-line therapies with alternative medications.

 In a survey from the American Society of Health-System Pharmacists, 61% of hospitals reported that the shortage of small-volume parenteral saline solution was having a severe impact on daily operations and patient care.

 In a follow-up survey, 75.6% of hospitals claimed that the impact of the shortage was severe and 67.8% reported that the injectable opioid shortage was continuing to have a severe impact on daily operations and patient care.

 Close to 8% of these hospitals also reported a safety event resulting in at least temporary harm to patients.

Efforts to combat the shortages are as costly as they are complex. For 2013, an estimated $209 million was spent for more expensive substitutes.

 Unfortunately, unlike typical economic models, the demands for drugs, saline, sterile water, etc, do not always necessarily drive the supply.

 Health care providers must be aware of the latest shortages and how they may affect patient care so that appropriate mitigation strategies can be implemented promptly.

As of July 5, 2019, 225 drugs were reported to have a shortage status. Recent critical shortages have included sterile water for injection, local anesthetics, electrolytes, cardiac emergency drugs, and generic chemotherapy agents.

 In 2010, intravenous (IV) oncologic medications topped the list.

 Cytarabine, an agent for which there is no substitute, was a particularly worrisome shortage. Oncologists reported that hospitals had to delay treatment, give less-effective therapies, or ration their supply.

Drugs considered mainstays of therapy, such as electrolytes, morphine, and norepinephrine, also have been hard hit. The results of an FDA study done in collaboration with the University of Utah’s Drug Information Services show that more than half of the listed medications on the drug shortage list were for acute care.

 Certain formulations of pain medications have also fallen victim to the drug shortage epidemic, resulting in overdoses of drugs such as fentanyl and ketamine.

 Unfortunately, these shortages go beyond life-saving medications. With the shortage of IV bags and solutions, the issue is now encroaching on medication delivery.

It is essential that we continue to recognize that drug shortages have been a long-standing problem and continue to be an issue and that health care personnel consider shortages and work collectively to prevent future ones. Ninety percent of hospitals reported having experienced at least 1 drug shortage within the past 6 months that negatively affected patient safety.

 With a never-ending cycle of shortages, management of the issue has become particularly complex and requires a multifaceted approach.

Under Title X of the FDASIA, the FDA is required to maintain and communicate an up-to-date list of drugs determined to be in shortage.

 Pharmacy personnel must aid in the distribution of this information throughout the health care industry on a continuing basis; however, pharmacist staff often bear this burden.

Institutions, such as Cleveland Clinic, see no resolution to the turmoil in the near future and have plans to build a 503B-compliant compounding facility that would allow them to sell drug products to other hospitals.

 Intermountain Healthcare, Ascension, SSM Health, and Trinity Health are also stepping up and working with the US Department of Veterans Affairs to pool the resources of their collective 450 hospitals and create their own generic drug company in an effort to combat the shortages and rising drug prices.

 Furthermore, states are taking an interest in legislation that would allow them to import more drugs from neighboring countries.

What this growing movement ultimately highlights is that institutions are getting restless for a solution to the seemingly endless crisis. The wasted energy and time spent to minimize the impact of these shortages cannot be underestimated. Thus, we must strive to continue the fight against drug shortages and shed light on the detrimental effects that the issue continues to have on patient care.

Food and Drug Administration Safety and Innovation Act (FDASIA). FDA website. www.fda.gov/regulatory-information/selected-amendments-fdc-act/ food-and-drug-administration-safety-and-innovation-act-fdasia. Updated March 28, 2018. Accessed October 1, 2019.

Chrzan J. Drug shortages impact hospitals, pharmacies, patients and the economy. Healthcare Packaging. March 13, 2019. healthcarepackaging.com/article/drug-short- ages-impact-hospitals-pharmacies-patients-and-economy. Accessed October 1, 2019.

Ventola CL. The drug shortage crisis in the United States: causes, impact, and management strategies. P T. 2011;36(11):740-757.

Fox ER, McLaughlin MM. ASHP guidelines on managing drug product shortages. 

. 2018;75(21):1742-1750. doi: 10.2146/ajhp180441.

Chen SI, Fox ER, Hall MK, et al. Despite federal legislation, shortages of drugs used in acute care settings remain persistent and prolonged. 

 (Millwood). 2016;35(5):798-804. doi: 10.1377/hlthaff.2015.1157.

Cooley H, Leventis C. Best practices for hospitals and health systems in an era of drug shortages. McKesson website. mckesson.com/blog/preparing-for-drug-shortag- es/. Published July 9, 2019. Accessed July 9, 2019.

Kacik A. Worsening drug shortages leave providers scrambling for alterna- tives. Modern Healthcare. May 21, 2018. modernhealthcare.com/article/20180521/ NEWS/180529993/worsening-drug-shortages-leave-providers-scrambling-for-alter- natives. Accessed October 2, 2019.

Articles

The Food and Drug Administration Safety and Innovation Act was signed into law in 2012, but the crisis continues.

Drug Shortages Have Monstrous Effects on Health Care

The childhood cancer survivorship, treatment, access, and research (star) act is the most extensive pediatric cancer bill ever signed into law.

The bill was passed by the Senate on March 22, 2018, followed by the House of Representatives on May 22, 2018, and then signed into law by President Donald J. Trump on June 5, 2018. Since the bill was introduced in Congress, in 2015, it has gained a tremendous amount of support. Individuals have begun to recognize the alarming funding gaps that exist for the resources needed to make any advancements in care for pediatric patients with cancer. Therefore, the act largely focuses on expanding opportunities for childhood cancer research, improving efforts to identify and track childhood cancers, and enhancing the quality of life of survivors.

 Specifically, more funds have been allocated for the collection of biospecimen and demographic information, the creation of programs to evaluate and provide adequate treatment for survivors, and grants to state childhood cancer registries.

 The act states that $30 million will be provided each fiscal year from 2019 to 2023 to support such activities.

 Under the act, the US Department of Health & Human Services will be responsible for the development, maintenance, and oversight of how the funds should be awarded.

 Furthermore, the act requires the inclusion of at least 1 pediatric oncologist on the National Cancer Advisory Board.

The National Cancer Institute (NCI) Surveillance, Epidemiology and End Results study in 2014 found that about 1 in 285 children in the United States will recieve a cancer diagnosis before their 20th birthday.

 Furthermore, an estimated 175,000 cancer cases are diagnosed annually in children younger than 15 years around the world.1 Sadly, less than 40% of patients receive a diagnosis and are adequately treated, with most patients residing in high-income countries.

 Of those who are treated, about 90% will receive treatment under clinical trials through the NCI’s Pediatric Oncology Branch.

 The trials funded by the NCI have been very successful, with some cancer survival rates reaching 80%.

 Although such statistics are promising, of the 109 new oncology medications developed since 1990, just 2 were developed and approved by the FDA to treat childhood cancers.

 And patients who beat childhood cancer often have late effects. These can include impaired growth and neurologic development after radiation therapy and may have unintended effects on other parts of the body, according to the NCI.

 Results from research by St. Jude Children’s Research Hospital show that more than 95% of survivors of childhood cancer experience late effects.

The passing of the STAR Act is a big victory for both advocates and families who have been adamant about the lack of treatment as a result of inadequate funding

and research. Up until the passage of this bill, just 4% of federal funding had been allocated for childhood cancer.

 Although that increase has been approved in principle, it has yet to be appropriated. Ensuring that the key institutions and programs receive all funding will be essential in the years to come. Likewise, it is imperative to recognize that the care for pediatric patients with cancer does not stop here. With drug companies reluctant to develop new chemotherapy drugs, unique treatment options for each childhood cancer have remained limited. Unfortunately, many drug companies view individualized chemotherapy as largely unprofitable. Thus, providing pharmaceutical firms with hard data and statistics is of the utmost importance in persuading them to take a different view.

With more research being conducted on childhood cancers, the hope is that new and improved chemotherapy regimens will appear. Pharmacists must ensure that they are up-to-date on the latest drugs. Helping other providers understand these regimens is crucial to keeping patients safe. As the research supported by the STAR Act gains momentum, oncology pharmacists should be attentive to new publications and the discoveries they detail.

 is a PharmD candidate at the University of Kentucky College of Pharmacy in Lexington.

Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA

, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy.

Byrne B. STAR Act, others aid in fight against cancer. 

. May 12, 2018. andalusiastarnews.com/2018/05/12/star-act-others-aid-in-fight-against-cancer/. Accessed January 31, 2019.

Brummel SE. Childhood cancer STAR Act of 2018 (public law 115-180).

. scipol.duke.edu/content/childhood-cancer-star-act-hr-820-s-292-115th-congress. Accessed January 31, 2019.

Cancer in children & adolescents. Cancer Facts & Figures 2014. 

acco.org/wp-content/uploads/2014/11/ACS-Special-Report-2014.pdf

National Institutes of Health. Surveillance, Epidemiology, and End Results Program. National Cancer Institute website. seer.cancer.gov. Accessed January 31, 2019.

Childhood Cancer Foundation. Childhood cancer facts. I Care I Cure website. icareicure.org/get-informed/childhood-cancer-facts/. Accessed January 31, 2019.

The childhood cancer survivorship, treatment, access, and research (STAR) legislation means pharmacists must be up-to-date on the latest chemotherapy regimens. 