What Patients Need to Know about Pharmaceutical Supply Chains—Chapter 1
Everything a critcal thinker needs to know about the supply chains for SARS-CoV-2 injections—packed with facts and evidence that can't be refuted.
[Note from Hedley: I shall be sharing the 13 chapters of What Patients Need to Know about Pharmaceutical Supply Chains, one day at a time, over the next 2 weeks]
CHAPTER 1: ABOUT THIS BOOK
Who is this book for?
This book is for the enlightenment of patients. So, if you were, are, or could be a patient, this book is for you. From now on, I’m speaking to you, the patient.
Prescription and over-the-counter drugs (drugs from here on) are the single biggest intervention in medical practice. The supply-chains that make them are the vehicle by which drugs get into your body. Once in, you cannot get them out.
This book aims to explain to you all the things you need to know about developing, producing, and distributing drugs in the supply chain – all written in an easy-to-understand fashion.
You will also be a curious patient, someone who likes to ask questions and get answers, based on facts and evidence.
As well as being a curious patient, you may well find the contents here useful in your chosen line of work or profession. That would include people working inside and outside the industry where a deeper knowledge of pharmaceutical supply chains will help them carry out their work more effectively.
Then there are curious patients who have been damaged in some way by pharmaceutical supply-chains or wish to avoid being damaged in the future.
There was a tragic event in 2007 where patients died and suffered serious adverse reactions, after a toxic material had been substituted for a genuine raw material in the supply chain for heparin. Despite intense activity between Governments, Regulatory Authorities and the industry, there is nothing to prevent it happening again. That, and the issues of counterfeiting and diversion of cargo for illicit economic benefit, will be covered later.
Finally, you may want to get your questions on the COVID-19 response answered. Questions such as:
“Why did so many critical items go into short supply?”
“Why were over 90% of raw materials sourced from China?”
“What risk management plans were in place?”
Most tellingly “Who was in charge of it all?!”
What should you take away from this book?
As a patient, what picture comes to mind when you think of pharmaceutical supply-chains?
Not a single one?
Lorries pulling up at the hospital unloading bay?
Vans delivering into your local pharmacy?
If those are mainly the pictures that come to mind, you should get a lot out of this book.
There is much more to it than that. That’s only the tip of the iceberg. The journey through the various production stages, beginning with raw materials, sees drugs and their components travel tens, if not hundreds of thousands of miles. They go through multiple airports, seaports, countries, and continents. They are acted upon, handed over, acted upon again, handed over again…
…and so it goes.
The typical length, from beginning to receipt of the product in your hand, is around three years. That is the cumulative lead-time. It means that the companies at the beginning (raw material producers) are producing materials for drugs that will be needed in three years’ time.
The quantities they produce depend on projections, estimates, and forecasts. These are handed down from the companies along the chain. The company developing or selling the drugs at the top of the chain must start the ball rolling, based on sales expectations in their business plans.
When a seismic change in demand occurs, as with COVID-19, it is going to severely challenge the best of supply chains. When the supply chains have been neglected by their owners for decades, we get what we got – chaos and confusion everywhere.
This is an extract from Supply Chain Management in the Drug Industry, 2011:
Left unattended, supply chains lay around doing the human equivalent of lounging on the sofa, drinking pop (soda), eating sweets (candy), and watching TV. They behave like neglected children.
No other sector seems to have neglected its (supply chain) children to the degree that pharmaceuticals have. The parents are now paying the price for all those years of neglect. The big question is: How do they get the children up off the sofa to start to become productive members of society?
In this book, you will join me in getting under the skin of what has gone wrong in pharmaceutical supply chains. That will help you make informed decisions on the drugs you take from a position of knowledge and understanding.
Why listen to me?
I am the author of Wiley’s SUPPLY CHAIN MANAGEMENT IN THE DRUG INDUSTRY: Delivering Patient Value for Pharmaceuticals and Biologics.
I signed up in 2008 and the book published in April 2011. In Chapter 17, the final chapter, I made the following comment:
In earlier chapters we expressed concern about the malaise that currently pervades pharmaceutical supply chains. The author [me] has a name for the condition. I have termed this serendipity induced chronic-disconnectedness, accompanied by change inertia (SICCI = sicky; please excuse the awful pun).
The serious meaning behind this is that the frantic search to discover blockbuster drugs has resulted in a disconnected industry which in turn is disconnected from its supply chains. This, together with the continued belief that serendipity can form the basis of a sustainable business model, kills the will to change.
Although the book sold in 35+ countries, for its content on professional management of the supply-chain, the messages on the need for massive change for the better did not permeate to the right quarters—CEOs and investors in large pharmaceutical companies (big pharma). Big pharma is the alpha male of the industry.
Undeterred, I’ve continued to preach the important messages ever since, through publications, speaking at and co-chairing conferences, webinars, podcasts, and on LinkedIn [up until being kicked off August 2021].
In doing that, I seem to have acquired a dual identity in the industry. One is Hedley the consultant, working with companies who want the knowledge, understanding and strategy to help build their brand in the pharmaceutical supply chain.
The other Hedley is attempting the impossible of taming the big pharma monster, by advocating and speaking on radical reform of the industry, for the benefit of all involved.
It is my strong belief that the more you, as a patient, are informed on the workings of the machinery that will insert drugs into your body, the greater the chance of a return to former glory for the pharmaceutical industry. Let’s do it together!
Finally, the words of George W. Merck, founder of the Merck of today, to add a much-needed ray of hope:
“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that they have never failed to appear. The better we have remembered it, the larger they have been!”
Wise words indeed.