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Digg It - Preparing for Your Own Hurricane Katrina
Disaster struck the southern United States in August, 2005 as Hurricane Katrina did major damage to New Orleans and southern parts of Louisiana, Mississippi and Alabama. We don’t yet understand the full impact of the storm in terms of lives lost, families disrupted, and the impact on the
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
American and global economies. But we know that a key part of our responsibility as executives and managers is to anticipate disastrous events like Katrina and be ready for them. Here are some of the things I’ve observed about the Katrina experience that are applicable to the business
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
rena, especially in the areas of business continuity planning and disaster recovery:
1. No one wants to follow the mediation plan if it’s an inconvenience, but everyone chastises you afterwards for not pushing harder.
If Hurricane Katrina had swerved at the last minute and missed New Or
1. No one wants to follow the mediation plan if it’s an inconvenience, but everyone chastises you afterwards for not pushing harder.
If Hurricane Katrina had swerved at the last minute and missed New Or
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
eans, then I can guarantee that the press would be having a field day telling everyone how stupid it was to evacuate so many people. This is one of those “damned if you do and damned if you don’t” situations that make it so hard to be in a position of responsibility. No matter how well
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ou do, it isn’t good enough in the eyes of some people. And if you’re perceived as over-cautious in a situation where nothing happens, then the criticism will be just as fierce.
2. Pre-disaster exercises don’t help if you don’t apply what you’ve learned.
FEMA (the U.S. Federal Emergenc
2. Pre-disaster exercises don’t help if you don’t apply what you’ve learned.
FEMA (the U.S. Federal Emergenc
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y Management Agency) conducted a week-long exercise in 2004 to help Louisiana emergency officials plan for the possibility of a hurricane very much like Katrina. But some of the processes used in the exercise were ignored when Katrina hit, including a process for the large-scale evacuati
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
n of people who don’t have their own transportation.
3. Your contingency plans need their own contingency plans. Part of the New Orleans contingency plan was to use the Superdome to shelter people who didn’t have anywhere else to go. But the Superdome had to be evacuated when toilets b
3. Your contingency plans need their own contingency plans. Part of the New Orleans contingency plan was to use the Superdome to shelter people who didn’t have anywhere else to go. But the Superdome had to be evacuated when toilets b
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
cked up, the air conditioning broke down, and high winds ripped a hole in the roof.
4. No matter how much you plan, you still have to improvise when the disaster strikes.
There is no amount of planning that will anticipate every possible outcome, and there comes a point where additional
4. No matter how much you plan, you still have to improvise when the disaster strikes.
There is no amount of planning that will anticipate every possible outcome, and there comes a point where additional
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
planning makes no sense. You have to be prepared for surprises, and make sure that you have the right people in leadership positions to make the on-the-spot decisions that are required.
5. Insurance policies don’t begin to make up for the loss of business and goodwill, and obviously don
5. Insurance policies don’t begin to make up for the loss of business and goodwill, and obviously don
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
’t make up for the loss of life.
Don’t let an insurance company be your disaster plan. Think of an insurance policy as a safety net if everything else in your plan fails.
6. Contingency plans need to have a defined and published trigger event, and the contingency plans need to be execu
Don’t let an insurance company be your disaster plan. Think of an insurance policy as a safety net if everything else in your plan fails.
6. Contingency plans need to have a defined and published trigger event, and the contingency plans need to be execu
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ed when the trigger event occurs.
I believe that more lives would have been saved if each area of the coast had an evacuation plan with a timetable. For example, “If a category x hurricane is headed for this area, then y hours before its scheduled arrival, everyone must be evacuated exce
I believe that more lives would have been saved if each area of the coast had an evacuation plan with a timetable. For example, “If a category x hurricane is headed for this area, then y hours before its scheduled arrival, everyone must be evacuated exce
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
t designated critical personnel. Here is how that will happen ....” Without a trigger event, everyone holds out a little longer before acting, pushing beyond reasonable limits. This happened on a large scale with Katrina, as both federal and state agencies delayed before taking any acti
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
n.
7. Any disaster has secondary and tertiary consequences that are difficult to anticipate.
Katrina caused localized gasoline shortages throughout the Southeast United States as panicked car owners rushed to fill their tanks. It’s still not clear how badly the storm will hurt the U.S.
7. Any disaster has secondary and tertiary consequences that are difficult to anticipate.
Katrina caused localized gasoline shortages throughout the Southeast United States as panicked car owners rushed to fill their tanks. It’s still not clear how badly the storm will hurt the U.S.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
economy, but there is a potential for an economic recession as a result of the hurricane.
8. Disaster planning is all about compromises.
That’s hard to deal with emotionally; it’s kind of like the idea of “acceptable losses” in an army battle. On the one hand, we don’t want to give up
8. Disaster planning is all about compromises.
That’s hard to deal with emotionally; it’s kind of like the idea of “acceptable losses” in an army battle. On the one hand, we don’t want to give up
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
anything if disaster strikes. On the other hand, there is a cost of being ready for a disaster, whether or not the disaster ever occurs. Making compromise decisions is tough.
9. Risk and Hazard aren’t the same thing, and our business continuity plans have to take the difference into ac
9. Risk and Hazard aren’t the same thing, and our business continuity plans have to take the difference into ac
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
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
ount.
Risk communication consultant Peter Sandman sums up the risk reaction in an equation: Risk = Hazard + Outrage. The idea is that the perceived riskiness of something is not just based on the probability of the bad thing occurring (what Sandman calls “hazard”) but also on the level
Risk communication consultant Peter Sandman sums up the risk reaction in an equation: Risk = Hazard + Outrage. The idea is that the perceived riskiness of something is not just based on the probability of the bad thing occurring (what Sandman calls “hazard”) but also on the level
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
f outrage that is felt when the bad thing happens. For example, car crashes have higher probability but lower outrage, while plane crashes have lower probability but higher outrage. That’s why planes are considered “riskier” than cars by most people. And that’s why Hurricane Katrina, w
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
hich destroyed the city of New Orleans and killed hundreds (maybe thousands) of people, is getting so much press coverage: people are outraged that something like this could happen.
When we do business continuity planning, we typically include a list of risks in our project plan. But we
When we do business continuity planning, we typically include a list of risks in our project plan. But we
.
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
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
don’t usually factor in the emotional “outrage” side of the equation. As a result, we focus our attention on the things that are more likely to go wrong, and not on the things that are more likely to get a bad reaction from the public if they go wrong. Guess which type of event hurts yo
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
r company more in the long run.
© 2005 MakingITclear, Inc. This article was originally published in the September, 2005 issue of the MakingITclear® Newsletter, a free monthly email newsletter published by MakingITclear, Inc. MakingITclear is a registered trademark of MakingITclear, Inc
© 2005 MakingITclear, Inc. This article was originally published in the September, 2005 issue of the MakingITclear® Newsletter, a free monthly email newsletter published by MakingITclear, Inc. MakingITclear is a registered trademark of MakingITclear, Inc
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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