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An ethical education

Taking the new BTEC Professional Certificate in pharmaceutical ethics and codes of practice

Apple & ChalkboardPharmaceuticalethics.com, a recently launched company, provides leadership and training on the ethical issues and codes of practice that are integral to the work of the pharmaceutical industry in the UK and Europe. The company's ethos, reflected in its training, is that pharmaceutical ethics is about more than just following rules. Among the tailored services the company offers to communicate this message are training, advice and education about media skills, standard operating procedures (SOPs) and audits.

All of the company's training services explore the fundamental ethical principles underlying pharmaceutical codes of practice. To consolidate these different strands, the company has now established a BTEC Professional Certificate in the fundamentals of pharmaceutical ethics and promotional codes of practice, which is accredited by international awarding body Edexcel.

I attended the inaugural external course (the training has previously been run in-house at several pharma companies) to understand the benefits it offered.

About the course
The objective of the course is to explore the inherent ethical principles underlying the promotion of medicines in the UK and to understand how those principles underpin the law and ethical Codes that relate to the promotion of medicines.

The intended outcome of the course is to enable participants to:

•    Develop their practical knowledge of the UK Code of Practice ethically and effectively to communicate about medicines

•    Realise that they already possess the essential attributes needed to make complex ethical decisions and to apply these skills to their own role

•    Accept that protection of patient safety is the foremost consideration in ethical decision making.

To complete the course, we used lectures, group activities and discussions, workshops and assessment and appraisal to achieve our targets, which were that participants should be:

•    Aware of the regulatory environment within which they carry out their role

•    Confident in implementing strategies to enable effective, ethical promotion

•    Proud of their role and the requirement for compliance and professionalism.

Holding the course
The stated aim of the course is to develop and enhance participants' knowledge of the UK Code of Practice, skills and attitudes to ensure safe and ethical promotional activities. However, the other 11 participants on the heavily over-subscribed course came from a variety of backgrounds and had a variety of personal objectives. For those who were new to the UK or worked outside traditional pharma (for instance, in an agency or a contract organisation), the primary objective of attending the course was to increase their knowledge of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice.

However, the majority of attendees were in the marketing function of pharma companies and had already taken the ABPI examination and wanted greater clarity on grey areas, and to sharpen their understanding and speed up the approval process by getting a grasp of the fundamentals underlying the Code, so that it would be easier to implement without having to refer chapter and verse to individual clauses for guidance.

The course was held at the Royal College of Surgeons over two days. The first day consisted of lectures and workshops, including a look at basic ethical principles unrelated to pharmaceutical promotion. These hypothetical scenarios gave us a chance to 'get our ethical ducks in a row' and to become accustomed to making 'grey area' decisions that had no clear right or wrong answer.

For many delegates, it was a radical departure from the clear-cut scientific world in which they operated and were trained, and represented the first time these kinds of ethical dilemmas had been considered in a formal, educational environment.

Having a small group of just 12 delegates (along with a handful of course trainers, administrators and Edexcel regulators) engendered open and candid conversation as, after introducing ourselves and our objectives at the beginning of the day, we all felt reasonably familiar with each other quite quickly. The seating arrangements also encouraged an open dialogue, as we sat facing each other in a square formation around the room. These small touches greatly increased the ease of the participants, and therefore the effectiveness of the course.

The main focus of the course was that promotion, in itself, is often regarded as something of a 'dirty word' in pharma, but that it shouldn't be; it is only inappropriate and unethical promotion that should be avoided.

To communicate this thought, the course opened with a unit designed to develop a detailed understanding of the central tenet of ethical behaviour in a promotional pharmaceutical environment.

Fundamentals of the course
The programme was delivered through formal presentations, problem-based learning and workshop sessions administered and facilitated by clinical educators.

As a professional qualification, three key elements were assessed:

•    Technical knowledge of the Code of Practice

•    Reflective Practice

•    Risk management.

Assessment was through verbal feedback delivered during the course and through a final two-hour examination, consisting of a multiple-choice questionnaire covering all aspects of the taught unit and an essay question on an item of course content. We completed group exercises during both days of the course and were given homework, which gave us an opportunity to test our individual understandings of the day's learnings.

By the time the examination (pass mark: 80 per cent) rolled around, the class was feeling slightly apprehensive but very well prepared after two intensive days of discussion, debate and thought experiments.

What we learned
Before we sat the examination itself, we discussed as a group what we had learned from the course and how well we had achieved the objectives we'd set for ourselves at the beginning.

Delegate comments about the benefits of the course included:

"Now I understand the thought process and I am more positive about making decisions rather than blindly following guidelines."

"I understand the Code better and feel confident now about applying it regardless of the medium: whether it's a publication, a meeting or anything else."

"I'm now more confident about speeding up approvals because of my greater awareness of the spirit of the Code. Now things might be done right first time instead of having to go through endless versions."

"I'm now able to take personal responsibility for ethical decisions by thinking through aims and motivations instead of just asking someone else, 'Can we do this?'"

After having a discussion about these achievements, we all took a deep breath and went into the exam. In the end, the vast majority who sat the exam passed, and a small number of participants will have sections of the final exam to retake. Congratulations to the inaugural class!

Pharmaceuticalethics.com plans to run more courses for anyone involved in the development and approval of promotional and non-promotional activities.

The Author
Victoria Farrell is the BTEC-awarded former editor of Pharmaceutical Marketing

To comment on this article, email pm@pmlive.com

20th January 2011

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