The Cancer Drug Shortage: When Quality Fails

By Erika L. Roberts, ELR Lab Services LLC

Recently, during my annual mammogram, an anomaly was found that required a biopsy to determine if cancer was present. Now, I am not a stranger to medical procedures, and I am very well versed in the medical field, so I was aware that there was a chance that my biopsy could come back positive for breast cancer. I scheduled my biopsy for a week later; I would then learn my results within the week after the biopsy. While I was waiting, I researched options and treatments in the event of a possible cancer diagnosis. I read articles, scanned message boards, and spoke with my friends in the medical field who specialize in breast cancer. It was during this time that I discovered there is a critical shortage of lifesaving cancer drugs – not just for breast cancers but for a myriad of treatable cancers for both adults and children alike. My research then shifted from myself and the possibility of my own diagnosis to why there is a shortage and what is being done about it.

Thankfully, my results were negative, and I did not have cancer; however, I was disturbed and frightened about the shortage of drugs I had learned about during my research. Meeting other patients and speaking with them during my time in the waiting rooms and hearing their voices crack as they spoke about the possibility of a shortage of a therapy that they might need was heartbreaking. Of course, I was also nervous and concerned about my own journey, and being a person who needs to plan everything, I tried to wrap my head around what would happen if this shortage did indeed affect myself or the individuals I found in my company during my appointments. Unfortunately, these stories are in the media almost every day.

The Washington Post published an article a few short weeks ago stating that “At the end of last year, there were 295 active medication shortages, ranging from antibiotics and anesthetics to cardiac mediations and chemotherapy drugs.” That is a staggering number, and the “why” behind these shortages can be attributed to “low profit margins on generic drugs, an overreliance on foreign manufacturing, increasing quality risks and brittle supply chains.” As a quality expert who has worked in the field – specifically, for companies that manufactured cancer therapies – the “increasing quality risks” jumped out at me. From a professional standpoint, quality is the backbone of the pharmaceutical industry. A company can produce and distribute as many therapies as possible, but in the end, if it’s not a quality product (meaning safe and effective, etc.), there is not much good that therapy can do for patients.

Early in my career, a mentor of mine stated, “The company doesn’t make any money off a quality department, but without a quality department the company doesn’t make any money.” At the time, I was a fresh face in a new industry (biotechnology) and had no idea what that meant in terms of where quality fits into an organization. I just happened to find myself as a part of the Quality Control department of a startup, in charge of the environmental monitoring of a cleanroom-controlled manufacturing facility. I was fresh out of college and never really had any exposure to what quality departments were responsible for in the biotechnology industry. During my time working there and in my interactions with my colleagues, I learned very quickly how important quality is when it comes to manufacturing lifesaving treatments. Most of my days consisted of taking environmental samples of various cleanroom suites and reporting the results. When issues arose, the manufactured drug products would be put on hold from shipping until the anomalous results could be investigated, substantiated, and verified. At the time, I was concerned that the product was not getting to the patients in time and what effect that would have on their treatment. It was then that one of my mentors reminded me that putting out a safe, quality product is the most important job of the quality department. The investigations later found that there was indeed an issue with the cleanroom used for a certain part of the manufacturing process which, if not caught, could have led to contamination of the products that would have caused harm to the individuals this drug was supposed to help. Throughout my career, this same type of scenario played out multiple times at different companies, and each time the quality department was there to alert everyone and help rectify whatever situation to bring safe and effective treatments to patients.

However, quality does come at a cost, and how large or small your drug company is will determine how large or small the cost of quality is for the bottom line. More complex manufacturing facilities, like ones required for various cancer treatments, can require quite large quality departments and the costs can be significant. In a time when inflation is high and raw material costs are increasing, sometimes it is the quality department that finds itself the target of cost cutting. There is always room for increased efficiency and improvement, and advances in technology have led to that while helping to decrease the costs associated with a high level of quality. Theoretically, decreasing the costs associated with manufacturing drug products helps make them more accessible and affordable to patients in need. However, companies can take this cost-cutting too far and rely too heavily on efficiency gains with automation to detect issues and manufacturing defects that can derail a product’s release. Per The Washington Post article, Erin Fox, a pharmacist and professor at the University of Utah Health, says too often a single company is producing the lion’s share of a drug’s supply. She points to Accord Healthcare Inc., maker of three bedrock cancer drugs: methotrexate, cisplatin, and carboplatin. Accord has a large market share and “massive quality issues,” she says, which were first identified in a 2022 U.S. FDA inspection, resulting in a manufacturing shutdown of a facility in India. This is unacceptable. It is understandable that issues will come up at any facility, no matter how much is invested in quality, but to have “massive quality issues” is frightening.

So, what can be done to increase or incentivize quality for pharmaceutical companies?

3 Actions For Pharmaceutical Executives

1. Lead By Example

This can start at the top with the executives in the C-suites, who have a unique opportunity to lead by example when it comes to a culture of quality. Providing visibility to the quality departments and holding regular meetings for all department executives on a regular basis to discuss issues related to quality would be a great starting point. Not only should issues be discussed, but the successes of the quality department within the organization should also be emphasized. Celebrating successes and highlighting what is working within the organization is a wonderful way to encourage and foster a culture of quality within the executive level of the organization, which can then be disseminated to the rest of the organization.

2. Put A Firmer Emphasis On Quality In Training Programs

Another area in which quality can be pursued and fostered is a robust training program. Training is the cornerstone of quality, and it cannot be emphasized enough how putting time and resources into a robust training program can not only help the entire organization run more efficiently but will also help give employees and executives the tools they need to identify and rectify any quality or defect issues that may arise during the manufacturing process. Every organization is different and so should their training programs. Investing in a department of professionals dedicated to maintaining, developing, and executing a training program can pay dividends in the quality and efficacy of drug products produced. Professional training leaders can help to identify and zoom in on key areas of training that would target quality and provide options tailored to the needs of the trainees. Every department and individual, from top to bottom, should be given tools that will help foster a better understanding of the quality department and the role it plays in providing safe products to patients.

3. Provide Mentorship & Internship Opportunities

Lastly, companies would be wise to partner with universities in offering specialized internships to students and apprentices who have an interest in pursuing a career in the quality departments of pharmaceutical companies. These outreach opportunities can identify and help create a pipeline of professionals and sources of talent that would otherwise not be available. Mentorship and internship programs are very successful in helping to foster opportunities and create awareness of the multifaceted development, production, and manufacturing of pharmaceutical products. This will ensure that the necessary training and personnel are there and ready when a company needs them. With such a dynamic environment for production of drug products, it is important that companies have individuals ready when they need to scale up production (as is the case with the current shortage of cancer treatments). This would not only be prudent for the quality departments, but it could be extrapolated to other departments, like manufacturing, to ensure that capacity can be increased when needed.

Conclusion

The National Cancer Institute (NCI) provides staggering statistics on cancer. In 2020, it is estimated that 1,806,590 new cases of cancer will be diagnosed in the United States and 606,520 people will die from the disease. The most common cancers (listed in descending order according to estimated new cases in 2020) are breast cancer, lung and bronchus cancer, prostate cancer, colon and rectum cancer, melanoma of the skin, bladder cancer, non-Hodgkin lymphoma, kidney and renal pelvis cancer, endometrial cancer, leukemia, pancreatic cancer, thyroid cancer, and liver cancer. Approximately 39.5% of men and women will be diagnosed with cancer at some point during their lifetimes (based on 2015–2017 data). With these statistics, we as an industry cannot allow quality issues to delay or prevent treatment of cancer. It is a moral duty of our pharmaceutical companies and manufacturers to make sure we are fostering a culture of quality and providing safe and effective treatments to the patients who need them most.

About The Author:

Erika L. Roberts, MFS, is principal consultant and owner of ELR Lab Services LLC. Having more than 15 years of experience working in many different areas of the pharmaceutical/biotech manufacturing quality environments, she has particular expertise in sterility testing, microbial identification training, HPLC analysis, cGMP training, analytical chemistry, and pharmaceutical regulations. Roberts obtained a master’s in forensic science in 2006 with an emphasis in document examination.