Product Drift

As we continue to have multiple biosimilar and potential interchangeable approvals for the same reference product, it is important to consider how product drift will impact biosimilar products approved at different times, as well as the characteristics of the biosimilar product itself.

Ha Kung Wong (2019). Will product drift cause a rift? PharmaManufacturing

Excellent article on biosimilars and product drift. The rush for biosimilars needs to always remember how biologics are extremely sensitive to changes in the manufacturing process. Biosimilars require the most robust of quality systems and I worry that companies attracted to them for their price savings might cut corners.

A great primer on the topic is: Ramanan, S. & Grampp, G. Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing. BioDrugs (2014) 28: 363. 

Let’s make sure that we don’t get another Thalidomide, we don’t need other examples for our GxP classes and new employee orientations.

John Oliver on Medical Devices

I firmly believe that quality and ethics go hand-in-hand, and frankly it shakes some of my confidence on my profession when I read of organizations that supposedly subscribe to quality principles and standards (such as the ISOs) still not meeting the grade.

There are four widely accepted principles in biomedicine, which applies equally to medical devices and pharmaceuticals:

  • Principle of respect for autonomy
  • Principle of nonmaleficence
  • Principle of beneficence
  • Principle of justice

It seems a failure of ISO 13458 that adherence to this quality standard does not lead to results aligned to these four principles. It should surprise no one who knows me that this is one of the reasons I support strong regulations in this space.

Sources

  • Beauchamp T, Childress J. Principles of Biomedical Ethics, 7th  Edition. New York: Oxford University Press, 2013

Quality and Ethics are Inseparable

There is a strong correlation between quality and ethics. Leadership’s demonstration of their philosophy and practice of ethical behavior impacts the whole organization in education, government or commercial enterprises

Dennis Sergent, The Ethics of Quality. The W. Edwards Deming Institute Blog

Quality is a management methodology, a set of ethics and a grab-bag of technical skills and tools (many of which are not unique to quality).  Dennis Sergent does a good job riffing off of Deming’s Code of Professional Conduct, and in light of my recent post “Being a Quality Leader” I wanted to briefly talk about how leadership is perhaps the most effective lever in producing an ethical organization.

There are three major parts of ethical leadership:

  1. Conscientiousness
  2. Moral identity
  3. Cognitive moral development, meaning how sophisticated one’s thinking is about ethical issues

Ethics and Quality are hand-in-hand. You cannot create a quality product if you do not have an ethical framework. I often think this is a part of Deming’s message that has been lost.

When things go seriously bad

An owner and four former employees of a now-shuttered Framingham compounding pharmacy were convicted Thursday of federal charges related to a 2012 meningitis outbreak that’s killed more than 100 people who took tainted drugs made at the facility, authorities said.

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

To say that the crimes of the  New England Compounding Center have changed the very regulations for compounding pharmacy in this country is no overstatement. For those of us in other  regulated industries, and for those in quality in other fields, this is an important case to reflect on.

According to prosecutors, pharmacists “knowingly made and sold numerous drugs” in an unsafe manner. “The unsafe manner included, among other things, the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers. They also approved the use of expired drug ingredients, and the mislabeling of those drugs in order to deceive customers.”

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

It is important to reflect that we in Quality, that everyone in our industries, has a commitment to the health and well-being of our customers that is nothing less than a moral imperative. That the imperative question for us and our organizations is always “Have I done enough to ensure the best quality and safety.”

There have now been 11 employees or executives of the drug compounding company convicted of ignoring safety precautions and forging documents to allow contaminated drugs to be manufactured and shipped.

Shira Schoenberg “Former compounding center employees convicted in deadly meningitis outbreak ” Boston Business Journal (2018)

Prominent Doctors Aren’t Disclosing Their Industry Ties in Medical Journal Studies. And Journals Are Doing Little to Enforce Their Rules

Prominent Doctors Aren’t Disclosing Their Industry Ties in Medical Journal Studies. And Journals Are Doing Little to Enforce Their Rules
— Read on www.propublica.org/article/prominent-doctors-industry-ties-disclosures-medical-journal-studies/amp

People need to realize the only way to truly build trust is through transparency. If there is nothing to hide, don’t hide it.