Advice Pool - Reference and Education

Have you ever found yourself involved in an ethical dilemma? Even if you are not a counsellor or mental health professional, it is most likely that at some stage of your life, you have been directly or indirectly involved in a situation in which ethical conduct was to be c

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

onsidered.

The growth and standardisation of service industries, as well as the increasing awareness and obligation imposed by Privacy legislation, has led to the development of codes of conduct designed to protect both sides of the professional relationship - particularl

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

Examples of combination products may in

y the interests of clients. In counselling, ethical conduct is not only expected, but in many cases, is required by legislation.

So how does ethical conduct apply to the counselling relationship? Basically, ethics in counselling is comprised of two areas: confidentiality

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

and professional ethics.

Confidentiality

"For counselling to be maximally effective, the client must feel secure in the knowledge that what they tell the counsellor is to be treated with a high degree of confidentiality. In an ideal world a client would be offered

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

total confidentiality so that they would feel free to openly explore with the counsellor the darkest recesses of their mind, and to discuss the most intimate details of their thoughts." (Geldard & Geldard, 1998)

It is recommended that counsellors discuss confidentiality

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

Combination pro

issues with clients before the counselling relationship is established. In most cases, the counsellor will tell the client that their relationship will be relatively confidential. Relative confidentiality is required in order to improve the quality of the service, as on ma

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

ny occasions, the counsellor may have to: discuss session details with supervisors, exchange valuable information with other professionals, or maintain notes and formal records of every session that has occurred. Furthermore, there are legal issues involving confidentialit

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

y: if a court order is issued, the counsellor must release personal records in order to comply with legislation. This can be a very sensitive matter, especially when the counsellor acquires knowledge that a client is dangerous and may put other lives at risk. These dilemma

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

s are faced by many counsellors working in prisons, or with aggressive and potentially dangerous clients.

"While I worked for Drug Arm as a Project Officer for a programme called HART (Home Assessment Response Team), my role was to visit people in their own homes, who wer

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

e affected by substance misuse challenges. Sometimes their home was within the confines of Community Correction Centres. Because confidentiality was stretched sometimes at certain stages of their imprisonment, I would strongly recommend to my clients that it would be prefe

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

able for them not to mention names or dates so that I would not have that unnecessary information (and evidence) to cause them harm should there ever be the need to have my duty to report or disclose some evidence of a particular situation, challenged."

(Kathleen Casagran

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

Following aspects would a

de - Professional Counsellor)

Due to such situations, some counsellors even affirm that promising absolute confidentiality is unethical. The following are common aspects of a counselling relationship which prevent counsellors from providing absolute confidentiality to the

dd to the challenges in developing combination products:

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

ir clients:

- Keeping records of sessions and client's personal data;

- Release of information to Supervisors;

- Protection of third persons from endangering situations;

- Court orders or similar law enforcement issues which require information disclosure.

Professi

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

onal Ethics

Because counselling is not a regulated profession in many countries (including Australia), the use of a professional code of ethics is a method of guiding the quality of the services provided by counsellors, the quality of training provided to counsellors,

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

and protecting clients. These codes provide conduct guidelines for professionals and are an effective way to provide practice standards to many counsellors lacking experience or knowledge of the industry. It also serves the purpose of structuring the counselling industry,

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

providing common professional descriptions, definitions and service boundaries according to each type of counsellor.

The Australian Counselling Association is one industry association in Australia that provides ethical guidelines and a code of conduct for counsellors. Th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e ACA's Code of Ethics and Code of Practice are part of the Code of Conduct - which can be accessed from their website at www.theaca.net.au/docs/code_conduct.pdf.

Complying with ethical guidelines is one of the most important aspects of being a professional counsellor<

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

/u>. Creating awareness in both counsellor and clients of the boundaries of the services provided will lead to a better development of the profession, and overall improvement of industry standards. Counsellors are responsible for keeping up-to-date with professional codes

.

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

of ethics, confidentiality guidelines, and other relevant information.

Reference List
Geldard. D. & Geldard K., 1998. Basic Personal Counselling, 4th edition, Frenchs Forest, Prentice Hall.

©

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

Companies that provide selfless information through particip

Australian Institute of Professional Counsellors.

Subscribe to our FREE eZine.

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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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Advice Pool - Confidentiality and Professional Ethics in Counselling

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