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Cases - Occupational Health and Safety - Room for Improvement
As a newly appointed Principal OHS Consultant for a Justice Department I receive a number of Incident and hazard Report forms from staff working in a variety of roles. What I find alarming is that the Manager comments on many of these reports from staff show a lack of commitme
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
nt to a thorough risk assessment, which in turn leads to a lack of appropriate risk management.
Many comments are of a nature such as;
“There are no other contributing factors” (to a back injury sustained from getting out of an office chair). “The work environment is ergonomi
Many comments are of a nature such as;
“There are no other contributing factors” (to a back injury sustained from getting out of an office chair). “The work environment is ergonomi
; 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
ally appropriate”.
“There are no environmental issues” (contributing to a steam burn from reaching over a boiling kettle) “I have advised the staff member to be more careful in future”.
“This [ankle and knee] injury occurred because the staff member did not get the stepping p
“There are no environmental issues” (contributing to a steam burn from reaching over a boiling kettle) “I have advised the staff member to be more careful in future”.
“This [ankle and knee] injury occurred because the staff member did not get the stepping p
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
atform” (in order to relace a number of files in a compactus). “The staff member has been told to use the steps in future”.
There is a lack of analysis about a whole range of factors in these kind of typical responses. For example, assumptions are made about the ergonomic su
There is a lack of analysis about a whole range of factors in these kind of typical responses. For example, assumptions are made about the ergonomic su
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tability of a workstation, but my enquiries reveal that the workstation and the staff member have never had a professional assessment (made freely available by the agency!).
Questions are not asked about why there was a need to reach over a boiling kettle, and whether a differ
Questions are not asked about why there was a need to reach over a boiling kettle, and whether a differ
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nt layout in the kitchen would remove the need for this action.
Why does someone feel compelled to climb on compactus shelving rather than get the approved stepping platform? Were workload and time constraints considered? Were the steps within a reasonable distance from where
Why does someone feel compelled to climb on compactus shelving rather than get the approved stepping platform? Were workload and time constraints considered? Were the steps within a reasonable distance from where
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
the filing task was being performed? Was the compactus room sufficiently clear of clutter to allow the convenient use of the stepping platform?
Managers cannot rely on the “human factor” as an excuse to tolerate proven risk in the workplace. Staff DO have a responsibility to
Managers cannot rely on the “human factor” as an excuse to tolerate proven risk in the workplace. Staff DO have a responsibility to
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
work within the OHS policy framework, but the organisation should ensure that safety procedures and equipment are as practical and accessible as possible. It IS human nature to take risks for convenience and this risk in itself must be addressed in an overall approach to OHS.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
I was further amazed to read about a staff injury sustained by use of a long, sharp bodkin (somewhat crudely known as a “pig-stabber”) in order to punch a hole in a sheaf of papers so that they could be collated with a “filing pin” (another frequently identified and unnecessary
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
workplace hazard). The rest of the department has moved to another records management system using approved plastic folders and hole punches. The area in which this injury occurred has chosen not to comply with new requirements resulting in an injury, the need for immediate m
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
dical attention and completely avoidable worker’s compensation costs?
Why? Why? Why?
The truth is that many Managers and staff do not accept the “no-blame” principle, which seeks to identify and deal with hazards rather than pin the blame on the worker for not being careful e
Why? Why? Why?
The truth is that many Managers and staff do not accept the “no-blame” principle, which seeks to identify and deal with hazards rather than pin the blame on the worker for not being careful e
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
ough. In all of the above examples there were other options (workplace redesign, hazard elimination, alternate work practices etc) but they have chosen not to address these issues. It is much easier for management to subtly blame the worker, and to let the risk remain unaddre
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
sed. There are many examples of managers discouraging workers from submitting a Hazard Report as it is seen as “rocking the boat”.
What can be done to improve the management response to workplace hazards and injury?
For a start, Executive and senior management need to make O
For a start, Executive and senior management need to make O
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
S a genuine priority. It needs to be “talked up”, resourced and integrated in all decision making.
Secondly, managers need to be trained in the use of the Risk Assessment framework (i.e. how likely is the risk to occur and how severe are the consequences). There is an Austra
Secondly, managers need to be trained in the use of the Risk Assessment framework (i.e. how likely is the risk to occur and how severe are the consequences). There is an Austra
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
ian Standard for Risk Assessment training and implementing this training is an immediate priority for us.
Thirdly, management responses need to be monitored, especially via the Hazard Reports, and FOLLOWED UP by the OHS Coordinator (myself in this case). The resistance to cha
Thirdly, management responses need to be monitored, especially via the Hazard Reports, and FOLLOWED UP by the OHS Coordinator (myself in this case). The resistance to cha
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
ge has been significant, and I have already had many conversations in which I have had to emphasis the responsibility of management to identify, assess and manage risk. The Australian legislation in all states is very clear that this responsibility lies with management and not
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
workers. Workers are accountable for not following documented policies and procedures, providing the system allows this to occur.
Fourthly, Management and staff need to be trained in Hazard Management, with a strong focus on the highest level of intervention (which is the ELI
Fourthly, Management and staff need to be trained in Hazard Management, with a strong focus on the highest level of intervention (which is the ELI
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
INATION of risk from the workplace). Training and work instructions run a very poor last when it comes to managing hazards and risks.
Our injury rates have been high for some time. There has been a little work in the areas mentioned above, but the culture of safety and accou
Our injury rates have been high for some time. There has been a little work in the areas mentioned above, but the culture of safety and accou
.
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
tability is not well developed across the organisation. The number of injuries has plateau’d but I am hopeful that with a concerted effort, we can see a measurable and significant decline over the next 12 - 18 months. The cost of work injuries is also rising disproportionatel
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
. This should be a motivating factor for management. Is it really justifiable to spend $20m each year as a result of the inattention and lack of commitment to safety?
I think not. I expect that the picture will have improved markedly by the time 2007 arrives on our doorstep
I think not. I expect that the picture will have improved markedly by the time 2007 arrives on our doorstep
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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