Cases - Business

Companies can survive the massive disruption of a pandemic—but only if they take steps now to inoculate against the threat of contagious misinformation and fatal chain-of-command breakdowns.

That warning co

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

mes from one of Canada’s most experienced disaster managers, who says even where a company has developed an emergency plan, few employees know about it, fewer are familiar with it, and nobody has tested it.

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

“The most comprehensive plan isn’t worth the paper it’s written on if no one has read it,” says Steve Armstrong, who worked on incident command protocols during his decades with the Canadian military, and

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

subsequently managed disaster responses for the Canadian Red Cross. Now the principal of Paratus Group, a disaster management consultancy, he advises organizations on creating and exercising emergency plans.

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

“It’s common to draft a plan and then put it on a shelf in somebody’s office. Some organizations might put it on their Intranet. But there’s no incentive to read it, so nobody does—until a crisis starts.”

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

t that stage, he says, it’s too late to comprehend the plan or troubleshoot its flaws. Worse—and this he knows from military maneuvers—the chances of people misreading and misinterpreting grow as the stress

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

atchets up.

As in everything from marketing to marriage, successful disaster management depends on regular, consistent communication before a crisis brews.

If talking about the pandemic possibility in adva

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nce of its arrival feels like fear mongering, it’s not. “The media already has that covered. People are hearing about this; it’s on their minds. Leaders have to face up to the tough questions, and address t

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

em to get them off the table,” Armstrong advises.

The alternative, he notes, is uncertainty, false expectations and mistrust that can undermine employee commitment to business continuity.

“For example, eve

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ybody is wondering what the sick leave and family leave policies will be in a pandemic. Who can stay home? Who gets paid?” It’s imperative to create policies that are concise, fair and realistic, and then le

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

staff know what they are. “People may not like the answers, but at least they have the right information.”

Make sure that your messaging is clear, and that it takes into account any unspoken assumptions ab

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

out your workplace culture. It does no good to tell employees to keep flu germs at home if everyone believes they’re expected to drag themselves in until they’re dead. Given predictions of absentee rates t

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

at could top 30 per cent in a pandemic, Armstrong says it has never been more important to ensure every employee understands the disaster plan, and knows what’s expected of them.

“People don’t realize what

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

0 per cent means. It’s huge, and it won’t affect an organization evenly.” Instead, entire divisions could fall ill—and so could the leadership.

Worse, the first person to succumb could be the one in charge

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

of the disaster plan.

But just giving everyone a copy of the plan isn’t going to work, he insists. Planning has to be done with everyone, at every level, in a meaningful way so that it’s relevant and it sti

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ks.

“Nothing beats good, old-fashioned face-to-face explanation and discussion, wherever possible.” Where that’s not possible, he recommends giving people bite-sized pieces, and asking for feedback. “Invite

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

employees and stakeholders to help craft the solutions to the pandemic problem. You’ll get their attention, you’ll get their buy in, and you’ll get good ideas.”

If that doesn’t seem possible, either because

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

the leadership won’t take preparedness seriously or because it doesn’t value input from the rank and file, then Armstrong believes the pandemic challenge will prove insurmountable. “A business that hasn’t p

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

anned is not likely to hold up well; an organization with a rigid hierarchy or bureaucracy is even worse off.”

What Armstrong means is this: with one-third of the workforce away, no individual autonomy mean

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

no business continuity, period. “People need to know that they have the authority to get the job done. A strict chain of command breaks down if any link is missing. And in a pandemic, links will be missing.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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