2019

QUALITY IN THE FIRST PERSON

Character and Passion

Values matter in pharmaceutical roles

by Duane Stephens

When we in the pharmaceutical industry are asked about our jobs, we tend to respond by reciting the facts from our resumes, listing titles, companies, certifications and educational credentials. That is the what.

A better answer addresses why we choose to be in pharmaceuticals. When the entire goal of the industry is to improve, prolong or possibly save lives, the character and passion we exhibit every day are just as critical as the specialized skills and training that brought us here.

Merriam-Webster’s Dictionary defines character as "moral excellence and firmness."1 Likewise, passion is "intense, driving or overmastering feeling or conviction" and "a strong liking or desire for or devotion to some activity, object or concept."2 If we can make what we do personal and real, it is easier to do it with conviction and excellence.

Making the connection

At one point in my career, I worked in a laboratory at a pharmaceutical company. Every single batch of product was used to treat thousands of people. This realization was a sobering one.

I continually reminded myself that my mother and grandmother were taking heart medication the plant produced. I literally trusted their hearts to the skill and integrity of my fellow associates, including chemists, maintenance staff, quality assurance professionals, manufacturing personnel and packaging associates. I also tried to keep in mind that my associates were likely trusting me with the safety of their family members.

At times, it can be difficult to directly connect to the people who use the products we play a part in creating. But if you work in an industry such as healthcare or pharmaceuticals, you have a key role in treating real diseases in real people every day.

Who has more of a hand in patient treatment? Is it the nurse who places the medicine in the patient’s hand, or the person who operates the blender in manufacturing the medication? A case can be made for both; but with regard to product quality, it’s the latter, hands down. 

Consider three real-life scenarios:

1. A manufacturing associate carries a personal cellphone in to a pharmaceutical manufacturing area after being instructed not to do so. The associate loses the phone and asks security if anyone has turned one in. The answer is no. 

Around the same time, another associate in manufacturing hears a strange sound coming from the high-shear granulator. The processing is stopped, the equipment is opened, and the cellphone—or at least the remnants of it—can be seen. The cost of the active ingredient in the batch was $1 million, not to mention labor and excipient costs.

The associate likely did not intend to cause financial loss and damage to equipment. He did, however, willfully disregard specific instruction. This is where character comes in.

2. A technician in a pharmaceutical lab alters data after a test fails. When the output from the instrument is not as expected, rather than contact the laboratory supervisor or someone from the quality department, the technician cuts, pastes and copies data from previously analyzed samples to replace the atypical results.

This leads to an investigation into every test that individual ever performed, as well as significant retesting, which ultimately affects three separate clients that had contracted with the company for lab analyses. 

The technician’s motivation was most likely to avoid the extra work that would result from the atypical analysis or to avoid any repercussion related to personal performance. In either case, the individual showed little care for the client that paid for the work and, more importantly, the patients destined to receive the drugs being tested.

3. A pharmacist dilutes an intravenous (IV) cancer drug beyond what was prescribed. Because the patient’s insurance company will be billed for the full dose, but only a small portion of the inventory will be consumed, the pharmacist pockets the difference.

The pharmaceutical salesperson notices the supply and distribution records for the drug do not reconcile, and thus uncovers this illicit activity. Even though the salesperson was even further removed from the patient receiving the diluted life-saving medicine, he had the integrity to ask questions and demand a high standard from everyone involved in delivering the medication.3, 4

These scenarios are extreme, but I use them as warnings and examples to illustrate the potential impact of any individual’s actions and to emphasize the importance of never allowing quality to be compromised because of lapses in character, integrity or focus.

As a member of the pharmaceutical industry, I witnessed the first two scenarios firsthand from within pharmaceutical organizations. In the third scenario, I was on the customer side.

My first wife died from malignant melanoma cancer at the age of 29. As part of her five-year battle, she took the drug Interferon, which she received from the pharmacist in the scenario. I drove to Research Medical Center in Kansas City, MO, every week to pick up the Interferon syringes for her treatment. In all likelihood, the Interferon was diluted.

Quality as a calling

The pharmaceutical industry is best served by people who feel compelled to help improve the lives of others through medicine. Be diligent. Have integrity. If you are in a decision-making position, look for integrity and signs of strong character in the candidate-selection process.

Finally, make the work personal, and know who you really work for, because what you do affects people—maybe even someone you love.


References

  1. Merriam-Webster’s Dictionary, "Character," www.merriam-webster.com/dictionary/character.
  2. Merriam-Webster’s Dictionary, "Passion," www.merriam-webster.com/dictionary/passion.
  3. Department of Health and Human Services and the Federal Drug Administration, "Robert Ray Courtney; Debarment Order," Federal Register, Vol. 68, No. 202, 2003, www.fda.gov/downloads/ICECI/EnforcementActions/FDADebarmentList/UCM138383.pdf (case-sensitive).
  4. Robert Draper, "The Toxic Pharmacist," New York Times, June 8, 2003, www.nytimes.com/2003/06/08/magazine/the-toxic-pharmacist.html?ref=robertrcourtney&pagewanted=1.

Duane Stephens is quality assurance manager for clinical supply services at Catalent Pharma Solutions in Kansas City, MO. He earned a bachelor’s degree in chemistry from Missouri Western State University in St. Joseph. An ASQ member, Stephens is an ASQ-certified pharmaceutical good manufacturing practices professional and quality auditor.


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