Compliance? Who Cares…..?

Are regulations negotiable?
Who are the MHRA?

Currently these are issues for all of us working in the pharma and medical devices industry. From 1st April 2003, the Medicines and Healthcare products Regulatory Agency (MHRA) has replaced both the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) as the competent authority.

Although we have the competent authority for regulating devices and licensing drugs, does this leave the need for a Professional Code of Conduct within the industries unaddressed? Is this the time for this deficit to be addressed? The lack of a Professional Code of Conduct will forever limit the perception of the role of the medical/pharma representatives to that of a salesperson, instead of being seen as a highly trained Professional whose integrity is tied into a Professional accountability through a Code of Conduct.To promote any product within the clinical setting demands a Professional responsibility and accountability, not only to your employer and customer, but also to the patient. It is because of patient involvement and the patients’ legal rights that compliance with the competent authority is not enough. “Within the framework of Clinical Governance NHS organizations are accountable for continually improving the quality of their services and safeguarding high standards of Care”.

A Professional Code of Conduct would create the opportunity for all Medical/Pharma companies to support their customers and the quality initiatives demanded by Clinical Governance 1998.

REGULATIONS ARE MANDATORY!

All medical companies train their representatives on their products and applications. However, to go into any area where clinical care is delivered, compliance with all current standards relating to informed consent, patient confidentiality, infection control/decontamination and risk management regulations must be met.

What is in your Professional Code?

How many boxes can you tick?

WILL YOU:

 YesNo
Promote high standards of professional conduct?  
Adopt standards that will protect the public and benefit the profession?  
Carry out all roles and responsibilities in such a way as to promote patients rights?  
Maintain patient confidentiality?  
Maintain patient confidentiality relating to delivery of product?  
Show evidence of continuing education and competencies?  
Let no act or omission on your part place the patient at risk?  
Act only within your expected pool of knowledge as legally defined in your contract of employment?  
Report to appropriate body any adverse incidents?  
Comply with all current standards-  
Infection Control/Standard Precautions  
Management Regulations – Risk Management  
Decontamination & Track, Trace and Audit  
Informed Consent  

OnTarget would be happy to hear your views, e-mail us at compliance@ontargetmag.com.
For further information contact Theatre Skills at info@theatreskills.com or phone
0141 951 5646

Written by Diane Irvine of theatre Skills Training Ltd.