Drug Shortage: A Story of Self-Inflicted Management Tragedies

My blood boils when I read an article such as the one that appeared in the New York Times yesterday entitled Supply of a Cancer Drug May Run Out Within Weeks, by Gardiner Harris. This is one of many articles that has appeared lately about the mounting crisis of drug shortages across the country. This time it is the drug to treat acute lymphoblasic leukemia, which most often strikes children ages 2 to 5.

The article quotes the president of the American Society of Clinical Oncology saying that he hopes that the FDA's hard work can help avert a crisis. The FDA is always brought into the middle of the political quagmire of pharma companies, medical professionals and patients. But the FDA is not the "bad guy."

If you were to map the drugs that are in short supply to the FDA's Inspection Observations, Warning Letters and Consent Decrees, you will find a long history of problems that would have given any reasonable management plenty of time to permanently solve the problems.

The truth is that the problems are self-inflicted. There is not one problem that cannot be solved with the right management and the right technical and scientific expertise to establish a capable manufacturing process and facility.

Quality Assurance is not totally off the hook. Often QA cannot see the forest for the trees. They strain the gnat and swallow the camel. Often they are busy policing the proper use of indelible blue ink that they do not see the cumbersome, non-value-added administrative activities that are choking the quality management system.

I read Mr. Harris' article and though of my healthy grandchildren. Thank God.

My heart goes out to those patients who are dependent on life-saving drugs.

C'mon people get your act together!



The QA Pharm

New Years Resolutions for Pharma Quality Assurance

Like anyone else, coming to the end of the year brings a time of reflection and anticipation. I look back and ask the question, "Have I made a difference in anyone's life?" I look forward and ask, "What do I want to change that I either have control or can influence?"

For the pharmaceutical professional, these questions are not only personal--but professional.

The Quality Assurance professional should always have the sense of a high calling. That calling needs to go beyond being the "checker" who culls out the defects to being the applied scientist or engineer who helps to design quality into the product.

This reminds me of the dear soul who proudly showed me the bucket of discarded product that she plucked off the conveyor belt. The occasion was a plant tour to understand how this company saw the role of the quality function. The next stop on the tour was the QC lab that was backed-up with samples. The analysts were randomly selecting their favorite tests to squeeze in before their next coffee break. It didn't take long to determine that the view of the quality function at this client was anchored in---approximately the 1950s.

On the other hand, there are companies on the cutting edge science and technology with breakthrough products that fulfill the dire need of desperately sick people. Yet, in their evolution, these very bright people did not pay sufficient attention to FDA compliance.

Looking back...

As I look back, I see pharma companies ranging in their quality assurance evolution from knuckles still dragging the ground to walking upright, but tripping over their own feet. So there is still plenty of work to do, and the enlightened--and bold--quality professional is not short of ground material to make a difference.

I say "bold" for a reason. In my opinion, the single factor holding back the quality professional, and consequently the company is the lack of courage.

The economy is not to blame for everything, but working on the inside of just about any company is an environment that is fraught with fear. Timidity is rampant. It is rare to find someone who has the balance of panache and guts to tell the Emperor that he is butt naked. It is a game of not making waves, keeping your head low--and for Pete's sake never pointing out a problem to your manager that makes him have to speak to his director. (Like that's going to happen.)

Looking forward...

My prediction is that the winnowing process will continue in our industry and those with neutered quality assurance departments will either be acquired and rehabbed--or fail. In true Darwinian fashion, the fittest will survive to reproduce.

Regardless of the situation, I would suggest these resolutions for the quality assurance professional:

1. I will make myself more valuable through continuing education that will make me a more enlightened quality professional. These will include real courses from recognized institutions, not trendy certifications.

2. I will find my voice and speak up when I see unacceptable quality and regulatory compliance risks. I may need personal coaching on how to deliver negative messages, but I will not stop going up the chain of command until I am satisfied that reasonable action has been taken.

3. I will learn how to make the business case when I see an opportunity for improvement. As a professional who has been conditioned not to be influenced by cost, I need to learn to how to develop and deliver proposals that speak in the universal language of business---money.

4. I will get out of my cubicle to see what others are doing to broaden my industry perspective. I will resist the notion that my daily working experience is necessarily typical of the industry.

5. I will understand how my role fits into the business process cycle and will hold myself accountable for results, even if the results are bad news. This may mean developing standard cycle times and finding efficiencies to complete my part on time.

6. (And my personal favorite) I will no longer prepare a useless slide deck for a management presentation on "what went wrong and recommendations" until management has supported the recommendations from  the previous presentation for the same problems that went wrong. I give myself permission to expect more out of management, especially when it comes to doing my job right.

Happy New Year!


The QA Pharm

Top Ten Ways to Make GMP Training Relevant

Most GMP training that I encounter is not necessarily bad--just irrelevant. In fact the same could be said for the Training Department. They jealously guard their turf and deliver mediocre, perfunctory training. Names get checked off the list, and the Training Department goes about their business being irrelevant. (Ouch!)


There is nothing that could be more exciting and fulfilling than being part of a dynamic training group that equips its organization to be a finely tuned work force of scholars that embrace GMPs as a business enabler.


Unfortunately, rather than a graduate education in the pharmaceutics of regulations, our best and brightest are subjected to a mind-dulling deck of tired old PowerPoint slides.


Frankly, the problem is endemic and here's why:

1. The concepts are not applied to the real world. We herd the mignons into the cafeteria and deliver the obligatory annual GMP training with total disrespect for what each employee does as part of his/her job everyday.

2. Training topics are not strategic. The lack of the broader view of the state of the industry and regulatory enforcement trends keeps GMP training from being proactive or responsive to the changing regulatory environment.

3. Training is not data-driven. The topics selected are often disconnected from the problems at the site as revealed at quality metric review forums such as Quality Management Review.

4. Training is the ubiquitous excuse (punishment) for corrective and preventive action. The easy out is to say that a failure can be addressed by training without truly determining the root cause.

5. The training method is not effective. When everything from a step change to a total system re-design is handled by "Read and Understand," it is difficult to distinguish between minor and really significant training topics.

6. The trainers are dreadfully boring. It's amazing how much we devalue the importance of training as evidenced by the little emphasis we place on the design and delivery skills we place on the people we put in those positions.

7. Lack of attendance is tolerated. When there is a conflict in one's schedule, the training class is always the loser. Nothing ever happens if you don't attend, because usually know one knows. No one really cares.

8. Leaders don't go to training either. It's comes down to not really expecting leadership to be trained, as though there is some special dispensation with the privileged class. They certainly aren't examples to follow.

9. The priority of the production manager is getting product out the door, not the skills and capability of his/her workers. In fact, he/she may be totally unaware of whether the workforce is getting the right training, or current with meeting individual training requirements.


10. Measurable improvement in skills and knowledge is not rewarded. We reward what we value, and training isn't it.


So, class, here's your assignment:


Turn each of these negative statements into a positive one. Then perform a self assessment of your organization against these statements.


Don't be defeated if the results are pathetic. You are in good company. It's all about what you do with the information starting right now. 


Turn these into vision statements. Discuss the practical, measurable steps you can take to improve the relevance of your GMP training.


Keep it going, and watch amazing things happen!



The QA Pharm

Where were you on September 11? Let us never forget.

I remember exactly where I was and exactly what I was doing on September 11, 2001. The time and place have been indelibly etched in my brain.

It was Washington, DC where I heard the announcement. I heard the sirens and saw the army helicopters fly overhead and patrols of army vehicles in the street. It was am image of a city under siege. The burning, crumbling Twin Towers and the caved-in Pentagon were replayed on the news channels. Eventually the reality of it all sank in--our homeland was attacked.

Then the news came out about Flight 93 downed in Shanksville, PA. "Let's Roll" became the rally cry of my personal heroes onboard the plane that fateful day. I was within spitting distance of the Capitol Building at the time, the likely intended target.

I passed many makeshift memorials on my walk to the train station for my failed attempt to find transportation to just about anywhere. The Capitol flag was at half-mast. People milled about. Strangers talking to strangers. I felt anger and pain for our country.

The memorial service at the National Cathedral was going on in the Admirals Club the day I was able to fly out of Dulles. Travelers turned their chairs to face the television. Little-by-little the club turned into a sanctuary. There were tears. There were prayers.

Nothing would be the same, other than our resolve to not to let our enemies take away our lifestyle. I felt a surge of patriotism and a sense of duty, and I knew that I would never be the  same.

So in honor of September 11th and all those who gave their lives--and my heroes buried among the ashes in Shanksville--I am getting on an airplane.



The QA Pharm