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Digg It - Conducting Risk Assessments for Hazardous Substances
To manage Hazardous Substances a requirement is to conduct Risk Assessments for each of the hazardous substances. The process required to ensure that all risks identified with using a substance is controlled under the Queensla
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
nd Workplace Health and Safety Regulations is described below. The requirements for other legislation will be quite similar.
When is it a requirement to conduct a risk assessment?
Legislation requi
When is it a requirement to conduct a risk assessment?
Legislation requi
; 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
es that Hazardous Substances risk assessments are required at the following times:
- As soon as practicable after it is used;
- Within five years after the last assessment;
- When a work practice involving t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e substance is significantly changed;New information about the substance’s hazards is available; Health surveillance or monitoring shows control measures need to be reviewed; and New or improved contr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
l measures are implemented.Are you asking why you have to complete a risk assessment at all of these times? Let’s have a look at the benefits:
- You will know before using the substance the risks to you employe
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
es, therefore, allowing you to put controls in place to reduce the risks. Reviewing the assessment every five years allows you to identify if anything has changed, therefore, altering your risk significance. Including
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
if there is a less hazardous substance that could be used.Changes in work practices may impact other areas of risk in conjunction with the use of the substance, for example: changing from fine powder to pelletised fo
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
m.If the manufacturer changes the substance, this may affect your practices or employees differently. Health Surveillance and monitoring are tools used to measure your controls. If there is a significant chang
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
in the results this is your first indication that your controls are not performing as you had anticipated.Regularly employees, suppliers, manufacturers or even visitors will identify new or improved control measures.
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
A risk assessment is required to ensure that no further risk will be introduced.What needs to be included in the risk assessment? The legislation requires that the following are included in the ris
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
assessment:
- Identification of the hazardous substance;
- If the substance’s MSDS is available; a review of the MSDS;
- If the substance’s MSDS is not available; a review of available equivalent information
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
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
rveillance and monitoring needed for the substance.MSDS’s and consumer packaging is an invaluable source of information when conducting your risk assessments, they will contain a substantial amount of the information
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
required, for example: Substance Product Name; Chemical and Physical properties; Health Hazards and Safe Use. Generic assessments may be prepared for the workplace where the substance is used in the same or similar circumstan
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
es. For example: An assessment prepared by an industry body or trade association about the use of brake fluid at service stations.
Controlling the Risks Identified: Now that the identificati
Controlling the Risks Identified: Now that the identificati
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
n of the risks, monitoring / surveillance requirements and control measures have been identified – YOU need to ensure that they are implemented. The effectiveness of your controls can be measured by monitoring / surveillance d
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
ta; incident / accident trending; training and the review of your risk assessment. What records are required to be maintained? Legislation requires that the following recor
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ds are maintained for each risk assessment:
- The date the assessment was conducted;
- The substance’s product name or other information;
- Whether the degree of risk is assessed to be significant;
- T
.
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
e control measures for the use of the substance that were in place when the assessment was done; andThe type of monitoring that is needed and the intervals at which the health surveillance must be done. Condu
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
ting risk assessments for hazardous substances is not difficult and is not a chore. Completing this risk assessments and complementing processes will protect the health of yourself, your friends, your employees and your family
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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