Seasons come and seasons go. Yes, in healthcare, too. We’ll open this week’s HOT Health Wonk Review looking at an enduring issue as Roy Poses of Health Care Renewal very nicely summarizes pharmaceutical marketing tactics and their effect on physicians and patients as it pertains to opiates. Some practices just keep coming around again.

Hope in a Bottle: Components of Purdue Pharma Stealth Marketing Campaign for Oxycontin Revealed by Legal Documents from Tennessee

The return of the good old days, sort of: a legal filing from the Tennessee Attorney General’s lawsuit against Purdue Pharma revealed multiple internal Purdue documents showing elements of the company’s stealth marketing campaign for Oxycontin.  These included: implied psychological manipulation of vulnerable physicians; perverse incentives for sales representatives; and use of third-party strategies (including creation of “astroturf” organizations) and miscellaneous deceptions.  More awareness and better understanding of such integrated, but deceptive marketing campaigns enables better resistance to them, and hence hopefully better professional decision making leading to better patient outcomes.  Previous stealth marketing campaigns have been revealed through litigation by the US government.  The Trump administration seems uninterested in pursuing corporate health care’s bad actors, but at least the baton has now been picked up by some state law enforcers.  Read more from Roy here.

While We’re Talking about Opioids…

Louise Norris of HealthInsurance.org tells us this year there has been an abundance of discussion about our national opioid abuse crisis and about strategies for addressing that challenge. But was the Affordable Care Act already helping address that crisis? Louise looks at how that ACA improved mental health coverage – including dramatically expanded access to additional treatment in some of the states hardest hit by the opioid crisis.

#CareTalk Podcast: Wry Healthcare Commentary with David Williams and John Driscoll

Podcast time, today our hosts David Williams and John Driscoll opine about the Right to Try law. “A great impulse and a dumb law,” says Carecentrix CEO John Driscoll. David Williams of Health Business Group agrees, “Right to try…who could argue with it, but it is a pretty cynical law.” It is redundant with compassionate use, and just removes the FDA to “take the smartest people out of the way,” says John. Lots of good stuff here as they look at a few other ways politics uses healthcare as a football. Watch, listen, learn right here.

High Deductible Health Plans: A Blunt Instrument that Doesn’t Work

High deductible health plans don’t work, so says Joe Paduda of Health Strategy Associates. Hear about why Joe calls high deductible plans “the bluntest of instruments” that has lots of nasty side effects and doesn’t reduce costs or improve care. Joe wonders “why the health plan industry is still selling these crappy plans.” Read more at Managed Care Matters where Joe talks about the ill effects of this health plan variant.

Much Ado About a Rounding Error? Looking at Sharing Ministries

Henry Stern of Insureblog channels Shakespeare while he questions if the faith-based ACA-compliant alternatives to ObamaPlans – now topping 1 million members – are such a good idea for people who need the assurance and reassurance of insurance or reinsurance. He’ll explain it all at this link.

Exploring Ethics: Is the Cost of Dying Worth It? Research Says Yes

Jason Shafrin at the Healthcare Economist asks if we are spending too much on end of life care and puts a new spin on the answer backed by research. He says we recognize that end of life care is expensive.  Conventional wisdom holds that we are spending too much on end of life care and we should just let people die at home in peace with hospice.  If only things were so simple.  The Healthcare Economist reviews new research that shows that end of life healthcare interventions may, in fact, by worthwhile. Paddle over to Jason’s blog at this link for a good discussion on an important topic.

Brush Up on Your Latin: Quo Vadis, Kentucky?

Tom Lynch of Workers’ Comp Insider recently attended a forum where he heard a presentation on the work requirements for Medicaid beneficiaries, a program called Kentucky HEALTH. Tom offers his perspective on the plan. It should be noted that a federal judge subsequently ruled the plan unlawful, but three other states are still developing plans for work requirements and other states are waiting in the wings. And this entire issue begs the question, where are we going, America? Is healthcare a right for all or privilege for those who can afford it? Tom kicks this football around a bit – on his private beach right here.

So now it’s time, dear Wonkers, to kick back, read the healthcare blogs and enjoy this summer day.

Photo by Anton Karatkevich on Unsplash

I’ll be doing some promotions which you will hear about later, but for now here’s the description on Amazon:
Retaining Expert Knowledge: What to keep in an age of information overload covers two major topics central to capturing and transferring expertise in organizations:

• Methodology and best practices for interviewing subject matter experts (SMEs) to capture their knowledge
• Identifying the SMEs to interview

The more critical problem is identifying the SMEs and the knowledge that needs to be captured.

One reason identifying the right experts is now so important is that in the next 10 years, the largest recorded exit of talented and knowledgeable workers from organizations will occur as baby boomers retire. In their wake, they leave their former employers understaffed and, even scarier, under-informed. Identifying the right SMEs is also critical because of the rapid acquisition of new knowledge. Some estimates say knowledge now doubles every two years, so it is crucial each organization identifies its journey and catalogues it individually and collectively.

This book provides managers with answers to the following questions:

• Are we talking to the right subject matter experts?
• What knowledge should we capture?
• What knowledge needs to be captured immediately as opposed to eventually?
• If we have limited resources, which experts are most important to speak with first?

Every organization has a history, a culture, and knowledge that may have lost its current relevance but not its importance. It is that broader vision of capturing knowledge, which this book addresses. It guides readers on how to preserve corporate knowledge and provides tools to assess organizational circumstances and judge the value of the resources to capture.

Retaining Expert Knowledge is a training resource, but it is also a business resource. As knowledge proliferates and organizational culture rapidly changes, now is the time to step back and determine what has been important to your organization’s success, where the organization is today, and what it will take to stay in the game tomorrow.

Your company houses knowledge, skills, attitudes, intellectual property, trade secrets, company culture, and individuals who will never be replicated exactly as they are today. Because they have demonstrated value in the past and are demonstrating value today, these treasures are worth preserving. This book shows how to preserve these valuable assets today for tomorrow’s successes.
You can buy this wherever you normally purchase your books.

Here’s a link directly to Amazon. 

This article is cross-posted at www.workingwithsmes.com.

In aviation, safety is always the primary concern. In fact, aviation’s safety record is so stellar that it is considered a model for healthcare. That is quite a testament.

However, a retired pilot friend recently bemoaned that the emphasis on FAA rules and regulations has overtaken concern about safety, and aviation is not better for the change.

“Now we’re only concerned about compliance. We have a cast of thousands as support staff. When I started flying in 1964, Part 91 federal regulations were about 30 pages. You could memorize it. Today, it is hundreds, if not thousands, of pages and nobody can possibly know everything that is in there. We are less safe today than we were 50 years ago,” he complained.

Making and keeping track of all those regulations costs aviation a lot of money. It requires a boatload of federal regulators to oversee them, and costs private carriers a bundle of money to hire people to monitor every jot and tittle of the laws. One misstep, and they can shut you down. And, he concludes, neither the passengers nor the airline employees benefit from this over-regulation.

Will Healthcare Follow Aviation Again?

Just about everyone in healthcare knows about the vaunted aviation checklist, and how it has become standard procedure in many operating rooms today. Books are written and consultants make good livings just teaching the checklist approach to safety. The checklist is a great tool. Healthcare is better for following aviation down that path.

But is healthcare going to benefit by following the FAA down the road to over-regulation? We can trip on our path toward safety by using regulations as stumbling blocks instead of using some common sense rules to pave a smooth road to improved quality and performance.

So Many Rules They Can’t Be Followed

Just yesterday, I was observing a training class that I wrote for a major pharmaceutical company that shall remain nameless, but one that we all know and love. We were training hourly line employees on procedures that affect product safety. To a person, they had one complaint: standard operating procedures were becoming downright cumbersome and made it very difficult to follow, let alone implement, them.

One veteran employee said when an incident occurs, someone writes another procedure and adds it to the book of procedures. Nothing else in the book is deleted or changed, and so it is becoming nearly impossible to follow. In fact, the employee complained that SOPs are written in response to each incident, meaning that many new SOPs only relate to one isolated incident each. The SOPs are losing their meaning and rationale. It is just a jumble of unrelated knee jerk reactions to specific incidents.

The employee concluded the company was creating more problems than it was solving by having a procedure manual that could not be followed. There are now so many rules to follow, the rules can no longer be followed, the employee complained.

Is All of Healthcare Headed Toward Unwieldy SOPs?

With the passage of the Accountable Care Act, known colloquially as ObamaCare, many believe that we are headed down a path of over-regulation. Where common sense and good medical practice once dominated the industry, healthcare practitioners (formerly called nurses and doctors) are overwhelmed with rules regarding how they practice, to which the actual art and science of medicine is taking a backseat.

At a recent visit accompanying a friend to a physician’s appointment at a hospital center, we observed that we were two of only four people sitting in a new waiting room with 25 chairs, two large receptionist desks – one that seated four and another with 12 stations – and a physician accompanied by a nurse and a receptionist carrying around a brochure rack deciding where to place it. Let me say that again. A highly skilled specialist was carrying around a brochure rack with his nurse and receptionist trying to find a place for it.

In this brand-spanking-new facility where our doctor’s office had been moved since our last visit (from a very modern, extremely functional office building now sitting vacant in the parking lot), we also observed not one – but two – printers behind the one receptionist desk and a wall of file drawers. We filled out our medical information on a clipboard, which we have done for each of his visits for the last three years to have it inserted into his manila file folder.

Sigh.

The Trend Is…

By personal experience as well as professional observation, the trend is toward more regulation, more staff to assure compliance with the rules, and an ongoing steady stream of physical and electronic paperwork to track patients.

Instead of continuing to ramp up our regulatory oversight into the stratosphere, perhaps it is time to – if I can paraphrase my retired pilot friend – throttle back and re-evaluate what we are really trying to accomplish.

Photo by NeONBRAND on Unsplash

by Peggy Salvatore and Terry McGinn

This article is cross-posted at www.workingwithsmes.com

Sometimes expert knowledge isn’t really knowledge at all. In fact, if your data sounds too good to be true, it just might be.  Sadly, for reasons of human sloth, greed or carelessness, sometimes the experts who supply your data are giving you bad information – and they know it.

In Finding Your SMEs, we discuss times when you may be dealing with conflicting expertise or when you may be asked to ignore some information and favor other information in your documentation to please a stakeholder. In those cases, you aren’t dealing in bad data. Rather, you are dealing with differences of opinion.

That’s an honest debate of the relevant facts.

Falsifying data to purposefully mislead someone is different than simple disagreement among experts.

When you are dealing with falsified data, there are no facts. There is no honest debate. There is only an intent to deceive. In regulated industries that depend on quality data to remain in legal compliance, falsified data can have many bad outcomes including products that are substandard, dangerous or deadly. Your best defense is to know your regulations and how to work with them because, remember, you can be guilty simply by omissions.

Remember Volkswagen? What About Your Drugs?

In 2015, the U.S. Environmental Protection Agency discovered that many VW cars were outfitted with software programmed to falsify data during emissions testing showing the cars met carbon dioxide emission standards. The brand suffered substantial damage and the company was exposed to up to $18 billion in fines when it was discovered the cars actually emitted up to 40 times the allowable amount. This attempt to defraud the public resulted in massive car recalls and a loss of company credibility along with profits.

Money lost. Reputation lost. Environment damaged.

In biopharmaceuticals, clinical trial data is the stuff upon which the Food and Drug Administration makes decisions about the safety and efficacy of pharmaceutical products. Does data get falsified there, too? Unfortunately, yes!

A 2001 study showed that falsification of scientific data used in FDA evaluations of experimental drugs was not uncommon, and it ranged from falsifying the identities of clinical trial subjects and their physical exam results to creating duplicate records to achieve the desired number of trial subjects.

It still happens today.

Just a few weeks ago, a Kyoto University research group headed by Nobel laureate Shinya Yamanaka was found guilty of fabricating all six main data figures in a study published in Stem Cell Reports. The study claimed it had modelled the blood-brain barrier in vitro using pluripotent stem (iPS) cells. Yamanaka, who won the 2012 Nobel Prize in physiology or medicine for discovering iPS cells, reportedly was going to donate his salary to the university as a mea culpa but the damage to his reputation will live beyond his paycheck.

Bad data can hurt – or even kill- patients and it exposes the biopharma research companies who rely on quality data to potentially billions of dollars in fines and, at the end of the day, the delay or loss of up to a billion dollars in research and development for a product that can’t be supported by strong, reliable data sets.

Is Your Data Subject to Tampering?

One of the ways to ensure that your data is valid is to have strong processes in place for data collection and auditing. Long before an FDA or compliance inspector finds a problem with your product or process, you can lock down your documentation with well-written and faithfully executed standard operating procedures.

By taking some strong action today, you can implement steps to avoid harm to your brand reputation, delayed or denied product approval, heavy fines, jail time and, of course, harm to patients.

If you would like to discuss your process for developing and implementing standard operating procedures, write to us at workingwithsmes@gmail.com and schedule a no-obligation appointment for a review of your organization’s data integrity vulnerabilities.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection.

By Peggy Salvatore and Terry McGinn

Each company in a regulated industry is required to follow written procedures.  The written procedure describes how steps or tasks are to be followed to achieve the desired outcome or result.  Having these steps identified permits the distant or precise way to achieve the end of your process or practice. 

Knowing the critical nature of having written procedures, your standard operating procedures and best practices need to follow a few procedures of their own so you can replicate what you do across your organization.  In other words, your standard operating procedures need to be transparent and streamlined.

One of the many purposes of the SOP or best practice process is to ensure that the process flow can meet expectations. Done well, your standard process or procedure should result in a quality product or achieve the desired result every time.

Knowledgeable and trained  personnel must have the SOP available to follow because no matter how many years’ experience they may have, even experts get stuck for a variety of factors. In fact, some experts know their jobs so well that they think they can skip or modify steps, take shortcuts, or do it from memory. This is a red flag!

The SOP should be written in a logical process flow that will allow someone looking for the cause of a failure later can pinpoint where a difficulty arose. Reviewing the SOP with someone internally or externally who is checking or auditing your procedure should allow them to identify what and where things  went wrong.

When you have a point of failure, an examination of the SOP should indicate gaps or problems that can include one or more of a host of issues including materials, equipment, environment and much more. Often, a failure can point to the source of your complications by reading the SOP against practice.

A well-written procedure or best practice document will:

1. Be written to describe the flow clearly to anyone trained on it
2. Include every essential step without including extraneous steps or materials that can and should be accessed elsewhere
3. Always be followed by everyone from the new hire to the veteran employee using the current SOP

Expect you will have changes to your SOPs on occasion. Expect you will need to review your documents periodically according to your SOP. And expect that when you have a clean, clear, streamlined SOP process that your errors should be few and easily identifiable.

To summarize, standard operating procedures and best practices need to follow procedures of their own so you can replicate what you do across your organization.  In other words, they need to be transparent. If they are the opposite of transparent – opaque – they are hard to follow and may result  in errors.

If you would like to talk to us about your SOP process, give us a call for a no-obligation preliminary review of your procedures.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection. To have a conversation about writing your standard operating procedures, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash

By Terry McGinn and Peggy Salvatore

We’ve been getting quite a bit of interest and feedback regarding our series on standard operating procedures, so we’ll continue writing about this topic this week.

After all, inherent in the word “expert” is the idea that something is done correctly. Correct procedures and best practices need to be captured and passed on. Sometimes, though, it seems the only people who care if the SOPs are followed are the experts who wrote them.

Truth is, everyone needs to care. Accountability right down to the last man or woman is absolutely the key essential ingredient in ensuring regulatory compliance.

Train for Accountability

Employees who are tasked with executing the many small, incremental steps are responsible only for their piece of the process. Sometimes in the laser-focus on one task, people may lose sight of the bigger picture. That bigger picture – a safe product going out the door – needs to be reinforced occasionally. Training usually steps in here for both reinforcement and correction. When that fails, the regulatory authorities will notice. Companies get slapped with government warnings and fines at a higher rate than the average person may realize. But if you are in a regulated industry, you know how often you are out of compliance.

Think about dialing the failure point back to its origin. The failure point is when the SOP is not correctly written, understood and applied.

Only then does the employee fail to perform to specifications.

Only then will training have to step in for often very expensive correction.

Only that will happen when an audit reveals you are out of compliance with your SOPs, and the Corrective and Preventative Actions (CAPAs) applied at that point of failure. That doesn’t need to happen.

In a perfect world, it should look like this:

If your current plant is not operating flawlessly as above, identify your points of failure:

1. How many people are asked to retrain personnel after a deviation or equipment issue?
2. How many SOPs do you have? Are they overwhelming or conflicting?
3. Are they easy to understand and do they follow a logical, stepwise process?
4. After a deviation, is the SOP reviewed?
5. Are people observing the CAPAs?

And, the big question…

Do your employees feel responsible and accountable for performing their jobs according to the SOPs in place?

Employees feel empowered when they are able to follow well-written SOPs, and when they are acknowledged for contributing to a well-run organization. Points of failure cannot be business as usual. Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

Maybe that is worth repeating:

Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

And the road to audit hell is paved with regulatory non-compliance.

The Solution

Dial back your points of process failure to the source.

Ask yourself:

• Are my SOPs well written?
• Do my employees feel a sense of responsibility for performing to specifications?

If your answer to either of those questions is, “No” or “I don’t know”, give us a call.

We would be happy to speak with you.

Unlike some problems in the universe, the problem of poorly-written and executed SOPs can be solved. Let’s do it.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection. To have a conversation, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash