1. Drug Promotion: The Pharmaceutical Representative.
This lecture/workshop is aimed at equipping the audience with basic concepts to bear in mind when dealing with promotion material provided by the Pharmaceutical Industry. GPs have traditionally been the main recipient of visits from medical representatives. This later branched to hospital prescribers to access prescribing habits further up the chain, and later to PCT/Trust formulary representatives.
Now with the arrival of non-medical prescribers, the amount of promotional material is likely to increase to cover these prescribers.
Promotional material is not all negative and can be useful to some extent.
Making the most of Promotional Material.
(All material available on NeLM)
London Medicines Information Service (Northwick Park Hospital) - June 2008

2. Drug Promotion – the Pharmaceutical Representative.
NHS Standards
ABPI Code of Practice
Company Representatives
The ‘meeting’
Tricks of the trade
Evaluating Product Information
Quiz
Pharmaceutical companies aim to promote their products in a number of ways for example advertising and pharmaceutical representatives (reps).
To ensure that this is done in a fair and ethical way various guidelines and standards have been produced.
The above will be covered in this session.
London Medicines Information Service (Northwick Park Hospital) - June 2008

3. Drug Promotion by Pharmaceutical Companies.
Journal advertisements
Mailings
Samples
Sponsored meetings
Gifts
Direct-to-consumer advertising
Company representative visits
Pharmaceutical companies promote medications in a number of ways including:
Journal advertisements - appear in relevant journals and within relevant articles (eg: a new chemotherapy agent for bowel cancer may appear in the Journal of Clinical Oncology or Gastroenterology within the pages of an article on bowel cancer).
Mailings – unsolicited mail shots are sent to a large number of health care professionals. Mailing lists may be obtained from professional bodies.
These ‘glossy’ documents can be persuasive tools which should be viewed with caution.
Samples – samples of a product may be provided only to a healthcare professional qualified to prescribe that product. They must not be provided to administrative staff. Samples may only be supplied in response to written requests which have been signed and dated. No more than 10 samples of a particular medicine may be provided to an individual health professional in one year. The sample size must be the smallest available presentation of that particular medicine on the UK market. Interestingly the MHRA rejected a compliant about promotion of Nicotinell chewing gum at football matches involving the handing out of free samples (Ref: PJ 2007 (279) 463)
Company sponsored meetings – companies may provide audio-visual presentations directly, bring in an outside speaker or have a stand at a conference and informally speak to delegates.
Gifts – these must be inexpensive and relevant to the practice of the professional. Pens, note pads, mouse pads, etc are generally considered appropriate.
Direct-to-consumer advertising – by law companies cannot advertise prescription only medications (POM’s) directly to the general public in the UK. This prohibition does not apply to vaccination campaigns carried out by companies and approved by the health ministers. Advertising to the general public should not suggest that one product is better than (or equivalent to) another identifiable treatment/product, or that the effects of taking it are guaranteed.
Company representative visits – are aimed at any health care professional who is likely to influence prescribing. This includes YOU.
London Medicines Information Service (Northwick Park Hospital) - June 2008

4. Commercial Sponsorship – Ethical Standards for the NHS (Nov 2000)
NHS Standards.
Commercial Sponsorship – Ethical Standards for the NHS (Nov 2000)
Who is the guidance aimed at?
Sponsorship, inducements and hospitality
Research and development
Potential conflicts of interest
The Department of Health produced guidance in 2000 called ‘Commercial Sponsorship – ethical standards for the NHS’.
The guidance is for all health professionals working within the NHS and relates to the acceptable standards for accepting sponsorship and hospitality from commercial organisations.
The guidance covers inducements and hospitality, research and development and examples of potential conflicts of interest (e.g.: If a company offers to provide training for staff, employers should be careful not to be pressurised into altering their own activity in order to be in accordance with the sponsors wishes, where they are not backed by evidence).
London Medicines Information Service (Northwick Park Hospital) - June 2008

5. Advertising Regulation.
Advertising is regulated by a combination of:
Statutory (legal) - Medicines and Healthcare products Regulatory Agency (MHRA)
Self-regulation (codes of practice)- Association of the British Pharmaceutical Industry (ABPI)
Advertising of medicines is controlled by a combination of:
The statutory role of the Medicines and Healthcare products Regulatory Agency (MHRA) and self-regulatory bodies including the Association of the British Pharmaceutical Industry (ABPI).
Statutory:
Statutory measures (with both criminal and civil sanctions) enforced by the MHRA to ensure advertising is fully compliant with EC and UK medicines law. “The Blue Guide – Advertising and Promotion of Medicines in the UK” produced by the MHRA. This document includes information about advertising to the public, advertising to persons qualified to prescribe or supply, statutory action and how to complain plus other relevant information. This guidance should be read alongside the Medicines (advertising) Regulations 1994, SI No and the Medicines (Monitoring of Advertising) Regulations 1944, SI No. 1933, both as amended. These are available from:
Self-regulation:
Self-regulation through Codes of Practice for the pharmaceutical industry, administered by trade associations e.g ABPI
Copies of these regulations can be purchased from The Stationery Office (TSO), Books Publications Centre, PO Box 076, London SW8 5DT.
Complaints:
Complaints about promotion of medications can be made to either body. This should be made in writing, enclosing where possible a copy of the advertisement or promotional material, to:
MHRA Advertising Unit, Room , Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Or
The Director of the Prescription Medicines Code of Practice Authority, 12 Whitehall, London SW1A 2DY.
London Medicines Information Service (Northwick Park Hospital) - June 2008

6. ABPI Code of Practice.
Trade association representing manufacturers of prescription medicines.
Applies to about 75 UK pharmaceutical companies (60 non-member)
Covers all areas of promotion by the pharmaceutical industry
Compliance with code is obligatory for members
Not legally binding
Aim “promotion of medicines to health professions and administrative staff is carried out in a responsible, ethical and professional manner.”
The Association of the British Pharmaceutical Industry(ABPI) is a trade association representing manufacturers of prescription medicines. It was formed in 1930 and now represents about 75 companies which supply more than 80% of the medicines prescribed through the NHS.
Compliance with the Code is obligatory for members. In addition, 60 non-member companies have voluntarily agreed to comply with the code, so virtually all pharmaceutical companies operating in the UK accept the Code.
The aim of the code of practice is to ensure that the promotion of medicines to health professions and administrative staff is carried out in a responsible, ethical and professional manner.
The code covers all aspects of promotion by pharmaceutical companies including advertisements, activities of medical representatives, provision of inducements to prescribe (eg: gifts), sponsorships, etc.
London Medicines Information Service (Northwick Park Hospital) - June 2008

7. Code for Representatives.
ABPI Code of Practice (Clause 15) - covers oral information, as well as written
Must be adequately trained
Must not give misleading information
Must not offer inducement to gain interview e.g. fee
Must not cause inconvenience
Provision of hospitality
Medical representatives can provide a valuable source of information on new and existing prescribed medications.
All provisions in the ABPI Code of Practice relating to the need for accuracy, balance, fairness, and good taste apply equally to both oral information and written information.
Representatives must have adequate training and sufficient scientific knowledge to enable them to provide full and accurate information about the medicines they promote.
Representatives must not make claims or comparisons which are inaccurate, misleading, disparaging, in poor taste or which are outside the terms of the marketing authorisation (e.g.: an unlicensed indication). They must be able to provide a Summary of Product Characteristics (SPC) for the medicines they are promoting on request.
Representatives must ensure that the frequency, timing and duration of visits do not cause inconvenience. They should not use telephones, text messaging, s, telemessaging or faxing for promotional purposes except with the prior permission of the recipient. The number of calls made on a prescriber by the rep should be limited to (on average) 3 a year with additional visits if requested (and to follow up any reports of an ADR).
Hospitality may be provided as long as it is secondary to the purpose of the meeting and is not out of proportion to the occasion, and does not extend beyond members of the health profession or appropriate administrative staff. Inexpensive promotional material may be provided and must not cost more than £6 (excluding VAT). Items for use in the course of business such as pens, post-its, note pads, coffee mugs, etc may be provided. Items for home or car use are not allowed such as coasters, thermos flasks, travel adaptors, umbrellas, etc.
Discussion point: What is the opinion of the group? Do the reps that visit them fit the above profile?
London Medicines Information Service (Northwick Park Hospital) - June 2008

8. Local Policies for Representatives.
Local policies may exist relating to:
Appointment system for meeting clinicians
Leaving samples of medicines
Sponsorship of educational meetings
Frequency of meetings
Commonly PCT’s, GP’s, NHS Trusts or departments within Trusts have developed their own in-house policies relating to arranging meetings with pharmaceutical representatives, leaving samples of medicines / devices, sponsorship of meetings, and frequency of visits.
Discussion Point- Refer to handout 1 - ‘Example: A guide for Pharmaceutical Representatives’ (access via NeLM)
The handout provides the basic information for reps who wish to contact personnel at an NHS Trust. It sets some guidance to the content of information that should be provided in order to make the meeting productive to both parties. The guide clearly states the Trust’s position on samples and promotion of drugs not on their Formulary. In addition, the guidance has been approved by the Trusts D&T committee and explains the outcome of breaching the ‘rules’.
Since all PCT’s, GP’s, Trusts and departments are likely to approve slightly different guidance, reps requesting a meeting for the first time should be given a copy of the local guidance since it may differ from other departments/Trusts that the rep has already visited.
What are the opinions of the group? Does anyone already have a guidance in place? Would they add anything else?
London Medicines Information Service (Northwick Park Hospital) - June 2008

9. Representatives Objectives.
Sell company products
Inform and educate professionals
Gather information
Representatives are a means of selling the Company’s product however this is not their only role.
They can be a good source for information regarding a particular product if the information is supported by evaluated evidence.
Representatives will also use the meeting to gather information such as:
- use of the Company’s products within the organisation
- use of competitors products by the organisation
- local treatment policies
- who they should contact with respect to areas of interest
- changes in the NHS policies that may affect their product
It is worth noting that information on drug usage, competitor’s drug usage, cost etc. is often confidential to an organisation and should therefore not be divulged.
Discussion point- This would be an appropriate time to recap on the information so far by using the ‘drug promotion and the pharmaceutical representative quiz’ - handout 2. (access via NeLM)
Answers to the quiz can be given to the group after discussion – handout 3.
London Medicines Information Service (Northwick Park Hospital) - June 2008

10. ‘The meeting’. What’s in it for me? Be selective
By appointment with time limits
Be in control
Prepare standard questions
Beware of bold statements & ‘glossies’ (check evidence)
Meeting with representatives should be beneficial to you.
Representatives can provide you with information about new as well as existing products. They are a useful source of information about new indications, changes in Summary of Product Characteristics (SPC) and recently published trials. They can answer any specific questions you may have.
It pays to be selective. See representatives if you feel they have information to offer you (eg: new indication, new trials data, new product, etc).
See by appointment and only for those products of interest to you and relevant to your practice. Have set time limits for the meeting.
Take charge of the interview, ask for the information you want directly.
Depending on the medication, a list of standard questions to ask the representative may be useful. (We will discuss the STEPS list later)
Beware of bold statements and ‘glossies’ - do not necessarily take the information supplied at face value.
London Medicines Information Service (Northwick Park Hospital) - June 2008

11. Tricks of the trade. Appeal to authority Bandwagon effect
Appeal to pity
Red herring appeal
Appeal to curiosity
Testimonial
Here are some common techniques used by pharmaceutical reps:
Appeal to authority
Naming an eminent doctor or professor based at a nearby teaching hospital or centre of excellence and saying that they are an advocate of the product. This is aimed at making the prescriber feel vulnerable and out of their depth. The flaw in this is that the ‘specialist’ may be tertiary care and have experience of the product in seriously ill patients which may not relate to the primary care patient population. Many ‘independent’ opinions or ‘opinion leaders’ from industry tend to be paid and are often unaware of the greater impact of their agreement.
Bandwagon effect
The rep indicates that the product is widely prescribed by local hospitals. The flaw in this is that you do not know why the product is being so widely used.
Appeal to pity
The rep literally uses a sob story to get you interested. They may even announce that they cannot make their bonus without your prescribing. You should remain professional.
Red herring appeal
You are told a apparently interesting fact about the product but it is actual fact irrelevant. The rep is making the most of you lack of knowledge on the product. Stay with the clinical importance of claims and try an be prepared for the meetings to avoid this occurring. Taking notes and following up with colleagues or medicines information services (independent services) may assist.
Appeal to curiosity
This is similar to above and detracts your attention from the flaws in the product. Be armed with pre-set questions to ask the rep.
Testimonial
The rep presents the clinical data and then also adds in an emotional aspect along the lines of knowing someone who used the product.
(Taken from Pegler S. Whatever the appeal of drug lunches, take STEPS to avoid indigestion! PJ 2007 (278) Available at:
London Medicines Information Service (Northwick Park Hospital) - June 2008

12. Evaluating Product Information.
Are the claims backed up by evidence?
Are graphs/diagrams accurate and clear?
Be cautious of statistics and graphics
Beware of ‘best’ – ‘strongest’ – ‘unique’
Request the original references
Are the claims backed up by evidence?
Review the original source of information for specific claims made about a product in an advertisement or ‘glossy’. Reports can be manipulated or quoted out of context. The trials quoted are not necessarily of the best design (eg: a small sample size will lack power to show any significant changes), may be unpublished or published in obscure journals. Are the claims based on trials conducted in humans with the relevant condition/diagnosis? (eg: Animal/in vitro/healthy volunteer data). Is the trial relevant to the clinical situation?
Are graphs/diagrams accurate and clear?
Beware of the graphs! Check: does the axis start at zero? Are the scales sensible? Amputated charts can be misleading at a glance. Do the lines extend beyond final plotted point? Any indices of data variance (eg: standard error bars) to give an indication of possible variance from the line shown?
Be cautious of statistics and graphics
These are also pliable. (eg: “10x more potent than ..” the use of an appropriate dose will achieve an equivalent clinical effect. “Relative gain of 200%” can be small in absolute numerical terms). If something is of statistical significance it is not necessarily of clinical significance.
Beware of ‘best’ – ‘strongest’ – ‘unique’
Superlatives generally cannot be substantiated:
‘Best’ cannot be substantiated as there are too many variables to enable such a sweeping claim to be proven.
‘Unique’ implies a special/different/new feature.
You can request copies of the original references and/or independent published evidence from peer reviewed journals. Where a Company makes a ‘claim’ you can request the evidence they used from them however, do not assume that this is the only evidence available since the Company may have been selective with the evidence used for the ‘claims’.
Discussion point- Download the advertisements for the 5 prescription medications and all the related references (as outlined in the ‘Lecture/Workshop Materials sheet – access via NeLM) . Ask the group if they can guess what complaint was made for each advert.
Answers to this exercise can be given to the group after the discussion – handout 4. (access via NeLM)
London Medicines Information Service (Northwick Park Hospital) - June 2008

13. Points to consider: S Safety T Tolerability E Effectiveness P Price
S Simplicity
One STEP better?
The STEPS acronym is useful when looking for evidence in the 5 separate (Safety, tolerability, effectiveness, price and simplicity) areas to weigh up the advantages of one product over another.
Safety: applies to the likelihood of long term or serious side effects caused by the drug (Remember that rare but serious adverse reactions to new drugs may be poorly documented)
Tolerability: is best measured by comparing the pooled patient withdrawal (or drop out) rates between the new drug and its most significant competitor, rather than trying to weigh the relative incidence of side effects.
Effectiveness: how does the product compare with the current preferred treatment? This information is sometimes difficult to obtain. A large amount of information will compare the active drug to placebo but not against another active drug. Check what the product was compared to in the trials that are quoted.
Price: this should take into account the direct and indirect costs (eg: costs of monitoring, additional visits to the doctor, etc)
Simplicity: Think of the patient. Factors that may be important in the simplicity of use, e.g. liquid formulation, frequency of dosing, ease of use of delivery device, etc.
(Taken from Pegler S. Underhill J. Evaluating promotional material from industry: an evidence – based approach. PJ 2005 (274) Available at:
Discussion point- Refer to the ‘literature evaluation exercise’ - handout 5 and get the group to work on the Yasmin and Didronel PMO examples using the format provided in the handout. (access via NeLM)
Answers to this exercise can be given to the group after the discussion – handout 6. (acess via NeLM)
London Medicines Information Service (Northwick Park Hospital) - June 2008

14. Summary. See representatives if you wish View information objectively
Ask for further information
Colleagues will use MI as an independent information source – you.
Summarise the key messages as on the slide
Also, refer to specific code of ethics such as the ‘Nursing and Midwifery Council’s Code of professional conduct’, Pharmacists’ code of ethics, etc depending on your audience. In essence, all these codes tend to have similar messages when it comes to working with the pharmaceutical industry:
Uphold the reputation of the profession
Profession status not used in the promotion of commercial products or services
Refuse any gift, favour or hospitality that may be interpreted now or in the future as an attempt to obtain preferential consideration
See the checklist for lecture/workshop materials for further reading. (access via NeLM)
London Medicines Information Service (Northwick Park Hospital) - June 2008