Digg It - Business

Hazardous Substances, you would think that the name itself would indicate that caution needs to be taken. Then why do so many people have such a lax attitude to managing hazardous substances, risking the health of their employees, friends and family?

When I go to worksites I repeate

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

dly see things which demonstrate that not enough people think much about the hazards involved in hazardous substances:

Hazardous substances in drink bottles
Hazardous substances stored in unlabelled containers
Incompatible substances stored together
N

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

Examples of combination products may in

o register of Material Safety Data Sheets (MSDS) or stored in no logical order for easy retrieval in an emergency

No MSDS at all

Chemwatch or ChemAlert only available to Supervisor’s

Contractors bringing in hazardous substances with no MSDS

Different 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.

ypes of Gas Cylinders being stored together

No bunding to contain spills

Only recently there was a news article where a young boy went to the fridge and drank what he thought was a bottle of juice. However, unbeknown to the youngster, he just drank a bottle of garden

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

insecticide! Luckily, the young boy survived; but not before a having his stomach pumped and five days in hospital.

There are significant health, safety and environmental issues with all hazardous substances. As demonstrated by the incident with the young boy, it is not restricted

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

Combination pro

o workplaces. Does your family understand the risks?

In each and every state of Australia, Hazardous Substance is managed through the Health and Safety regulations. Why, you might have asked are there so many regulations? Because it has been proven that these substances cause a risk

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

to people, including …. YOU!

To easily manage the minimum requirements we only need to look at the regulations.

For example, the legislation for employers under the Workplace Health and Safety Regulations in Queensland requires employers to:

Obtain an Material Safety Data

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

Sheet (MSDS)

Record and Display MSDS

Label containers

Complete a risk Assessment

Retain Records

Control Exposure

Conduct Monitoring and Health Surveillance

Maintain a register of MSDS

Complete Induction and Training

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

>For those readers wondering ‘How am I going to manage all of this’; IT’S NOT THAT HARD. A brief look at the requirements reveals:

Obtain a Material Safety Data Sheet (MSDS) If you purchase hazardous substances, the supplier should also supply a MSDS. If they d

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

on’t request a copy of the current MSDS. There is also a requirement that the MSDS’s be updated every five years to ensure the correct information is held.

Recording and displaying MSDS When you receive a MSDS it must keep it in a register, and keep a copy close to

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

here the substance is being used to allow workers who may be exposed to refer to it easily.

Labelling Containers When you purchase containers of hazardous substances they will be labelled. If the substance is decanted (put into another container) ensure the correct

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

Following aspects would a

labelling is attached / fixed to the container.

Risk Assessment You need to conduct a risk assessment for each of the hazardous substances they have. Why? To ensure any risk identified with using the substance is controlled.

Retain Records There ar

dd to the challenges in developing combination products:

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

e several records that need to be retained in relation to hazardous substances; they are:

Risk Assessments: o For each substance record the product name or other information, control measures for the substance, date of assessment, degree of risk, monitoring required and if a

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

ny health surveillance is required.

If the risk assessment shows a significant risk you must keep the risk assessment, monitoring results and health surveillance reports for 30 years.
If the risk is not significant you must keep the risk assessment for 5 years.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
li>

Monitoring Results:

Ensure any workers who may have been exposed receive a copy of the results; and
Allow workers access to inspect monitoring results at any time.

Health Surveillance:

Keep health surveillance reports.

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

/ul>

Induction and Training:

Keep induction and training records for 5 years, the record must include:

Date of the session;
Topics dealt with at the session;
Name of person who conducted the session;
Names of workers who attende

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

Professional from academic institutions, pharmaceutical industries, health care indust

d the session.Controlling Exposure Implement any controls as identified by the risk assessment. Remember, if having identified Personal Protective Equipment (PPE) as a control the following needs to be done:

Supply the PPE;
Train personnel in the

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

use of the PPE; and

Ensure the PPE is worn.

Conduct Monitoring and Health Surveillance Complete monitoring or health surveillance if it was identified during the risk assessment as a control.

Register of MSDS’s The MSDS register must contain the following:

.

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

i>A list of all hazardous substances used at the workplace; and

The current MSDS for each substance.

You must also allow employees who may be exposed to hazardous substances to inspect the register at any reasonable time.

Induction and Training All employers must g

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

Companies that provide selfless information through particip

ive induction and training to workers who may be exposed to a hazardous substance.

Meeting the regulations for hazardous substances is not difficult and is not a chore. Completing some simple 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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/20140/diggit-Managing-Hazardous-Substances.html">Managing Hazardous Substances</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/20140/diggit-Managing-Hazardous-Substances.html]Managing Hazardous Substances[/url]

Your Operations Manual is a crucial tool in your Internal Management tool kit. It contains all the information you need to run your business day-by-day, face crises calmly, and lets you to back fill in a hurry.

Business law is one of the branches of the huge field of law. There are many things one has to keep in mind when starting a business; let it be a small or a large business. Breaking these laws may land you in deep trouble, so it is always advisable to have some basic knowledge of both small business law and business corporate law. With this knowledge, you are sure of being able to run your business smoothly without any hindrance from the law whatsoever!

Is honesty missing from management today? Does honesty have any impact on morale, productivity, employee turnover? Find out the latest research results and how a manager can apply these results on a day to day basis.

Tags

Links

Digg It - Managing Hazardous Substances

Related Articles: