Code of Conduct Mock Exam Questions Flashcards

1
Q

Which of the following would be exempt from the Code of Practice since it does not meet the definition of a promotion?

Select one:
A. A supply of samples
B. Risk minimisation plans approved by the MHRA
C. Payment of expenses relating to a sponsored scientific meeting
D. Pamphlets listing prices and product descriptions of licensed medicines

A

B. Risk minimisation plans approved by the MHRA

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2
Q

Three of the following are regarded as promotion; which one is not?

Select one:
A. Sponsorship of scientific meetings
B. Provision of hospitality for promotional purposes
C. The supply of samples
D. Information related to adverse-reaction warnings

A

D. Information related to adverse-reaction warnings

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3
Q

A company is bringing a new medicine to market. As an initial promotion it offers a package deal whereby free genetic testing is offered to patients in order to assess the most effective way to use the medicine in each case.
How would this promotion be defined?

Select one:

A promotional aid that would not require disclosure
B. Not a transfer of value for the purposes of the Code
C. A direct transfer of value that would require disclosure Incorrect
D. An indirect transfer of value that would require disclosure

A

B. Not a transfer of value for the purposes of the Code.

Seen in clause 1:

It isn’t a direct transfer of value because it isn’t made directly by a company for the benefit of a recipient.

It isn’t an indirect transfer of value because it is not made on behalf of a company for the benefit of a recipient or through an intermediate and where the company knows or can identify the recipient that will benefit from the transfer of value.

seen in Clause 18.1 Package deals: Clause 18.1 does not prevent the offer of package deals which are commercial arrangements whereby the purchase of a particular medicine is linked to the provision of certain associated benefits as part of the purchase price. - Companies can provide genetic testing or other biomarkers specific testing in relation to rational use of one of its medicines.

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4
Q

The following statements about the ABPI Code of Practice may be true or false:

  1. The Code applies to the promotion of over the counter medicines to members of the health professions when the object of that promotion is to encourage their purchase by members of the public
  2. The Code does not apply to non-promotional information made available to members of the public about prescription-only medicines

Which of the following responses is correct?

Select one:
A. Both statement 1 and statement 2 are true
B. Statement 1 is true and statement 2 is false
C. Statement 1 is false and statement 2 is true
D. Both statement 1 and statement 2 are false

A

D. Both statement 1 and statement 2 are false.

The correct statements are: (clause 1)

the code applies to the promotion of medicines to members of the UK health professions and other relevant decision makers.

The code also applies to a number of areas which are non-promotional including information made available to the public about prescription only medicines.

It does not apply to the promotion of over the counter medicines to members of the health professions when the object o that promotion is the encourage their purchase by members of the public.

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5
Q

Which of the following professional persons must be employed by a scientific service?

Select one:
A. A registered nurse
B. A relevant decision maker
C. A registered medical practitioner 
D. A pharmaceutical representative
A

C. A registered medical practitioner

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6
Q

All digital promotional material must contain a link to the MHRA Yellow Card website.

If the address for this website should change, how long would a company have to update their material?

Select one:
A. 3 months
B. 6 months
C. 1 year
D. 2 years
A

C. 1 year.

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7
Q

In which one of the following digital sources should the prescribing information be provided as part of the material or as a link that does not require the reader to be online?

Select one:
A. Emails
B. Advertisements in electronic journals
C. Electronic detail aid intended to be used remotely
D. Electronic detail aid used by a representative when visiting health professionals

A

D. Electronic detail aid used by a representative when visiting health professionals

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8
Q

When setting up a remote promotional call, full details must be given about the caller’s

Select one:
A. role and purpose of the call
B. role and the company they represent
C. purpose and the company they represent
D. role, the company they represent, and the purpose of the call

A

D. role, the company they represent, and the purpose of the call

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9
Q

Four representatives offered hospitality for a meeting at a surgery.

Sam invited the partners of the health professionals to an evening wine and cheese event

Tanya gave a donation in lieu because the surgery were celebrating Heart Awareness Month

Steve reimbursed the receipted amount for trays of sandwiches at an after-hours meeting

Kate took the surgery’s food receipt for £16 and rounded it up to £20

Who followed the Code of Practice?

A

Steve.

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10
Q

A sample of a medicine may be provided to health professionals in the following ways:

  1. As a small supply of a medicine for familiarisation and to acquire experience in dealing with it
  2. A small supply of medicine for identification or similar purposes but which is not intended to be used in treatment
  3. A supply of non-medicinal product which does not have the active ingredient normally present.

Which of the above may be provided to all health professionals?

A

2 and 3 only.

Explanation - A sample is a small supply of a medicine provide to health professionals sot that they may familiarise themselves with it and acquire experience in dealing with it. A sample of a medicine may be provided only to a health professional qualified to prescribe that particular medicine.

A small sample which is provided only for identification or similar purpose and which is not intended to be used in treatment may be provided to any health professional but is otherwise subject to requirements to clause 17.

The supply of a product which is not a medicine because it does not contain the active ingredient normally present is not regarded as the supply of a sample.

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11
Q

When making appointments to call on hospital staff, representatives should

Select one:
A. place the wishes of the individual above the guidelines of the establishment
B. place the guidelines of the establishment above the wishes of the individual
C. consider both the wishes of the individual and guidelines and the establishment
D. use their discretion to decide the timing, frequency and duration of calls on hospital staff

A

C. consider both the wishes of the individual and guidelines and the establishment

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12
Q

Pens and notebooks provided in conference bags at company-organised scientific meetings and conferences

Select one:
A. may include the name of the company providing them and the name of a medicine if newly released

B. must not include any names of donor companies and must not include the name of any medicine

C. may include the name of the company providing them but must not include the name of any medicine

D. must not include any names of donor companies but may include the name of a medicine if newly released

A

C. may include the name of the company providing them but must not include the name of any medicine

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13
Q

Three of the following would be classed as breaches of the ABPI Code of Practice; which one is not a breach?

Select one:
A. Promotion of medicines prior to the grant of a marketing authorisation
B. Moderate donations to charities in return for representatives gaining interviews
C. Inducements made to healthcare professionals to prescribe promoted medicines
D. Modest donations to reputable charities made by companies in return for health professional’s attendance at company stands

A

D. Modest donations to reputable charities made by companies in return for health professional’s attendance at company stands

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14
Q

Promotional information about a company’s new products might be supplied to health professionals in a number of forms:

  1. In envelopes with a handwritten name and address
  2. In envelopes carrying a label such as ‘Important Safety Update’
  3. In print resembling independent editorial matter in journals
  4. In promotional information packs provided during declared sponsored activities

According to the ABPI Code of Practice, which of the above would be considered to be disguised promotion?

Select one:
A. 1 only Incorrect
B. 1, 2 and 3 only
C. 2, 3 and 4 only
D. 3 and 4 only
A

1, 2 and 3 only.

In Clause 12:
Promotional material sent in the guise of personal communications for example bu using envelopes or postcards addressed in real of facsimile handwriting is inappropriate. Envelopes must not bear words implying that the contents are non-promotional, for example that the contents provide information relating to safety.

When a company pays for or otherwise secures or arranges the publication of promotional material in journalism such material must not resemble independent editorial matter.

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15
Q

Provision of non-promotional, advanced notification of a new medicine prior to UK marketing authorisation is allowed under which of the following circumstances?

  1. When the product will significantly affect expenditure
  2. When a product is of particular interest to a prescribing healthcare professional
  3. When the likely cost or savings and budgetary implication are only directed at those responsible for making policy decisions on budgets.
Select one:
A. 1 and 2 only
B. 1 and 3 only
C. 2 and 3 only
D. 1, 2 and 3
A

B. 1 and 3 only.

Seen in Clause 3:
NHS organisations and other involved in the purchase of medicines need to estimate their likely budgets in advance and there is a need for them to receive advance information about the introduction of new medicines or changes to existing medicines which may significantly affect their level of expenditure.

Non-promotional information can be provided as advance notification but it must:
Only be directed to those responsible for making policy decisions on budgets and not those expects to prescribe.

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16
Q

Provided that they are carried out in a manner compatible with the ABPI Code of Practice, which of the following activities is permitted?

Select one:
A. Those which are designed to enlarge the market in a particular therapeutic area, such as disease awareness
B. Those which are designed to raise the profile of a particular pharmaceutical company in relation to a new drug
C. Those which include inducements to promote unlicensed medicines
D. Those which are designed to promote a new medicine prior to the grant of marketing authorisation

A

A. Those which are designed to enlarge the market in a particular therapeutic area, such as disease awareness

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17
Q

The ABPI Code of Practice definition of the term ‘promotion’ excludes which one of the following?

Select one:
A. Advertising in medical journals
B. Announcements relating to pack size changes provided there are no product claims.
C. Participation in sales exhibitions
D. Use of online interactive data systems

A

B. Announcements relating to pack size changes provided there are no product claims.

18
Q

Which of the following would be exempt from the Code of Practice since it does not meet the definition of a promotion?

Select one:
A. A supply of samples
B. Risk minimisation plans approved by the MHRA
C. Payment of expenses relating to a sponsored scientific meeting
D. Pamphlets listing prices and product descriptions of licensed medicines

A

B. Risk minimisation plans approved by the MHRA

19
Q

Promotional material may be sent in which forms without prior permission from the recipient?

Select one:
A. Hard copy only
B. Email and hard copy
C. Fax (facsimile) and email
D. Hard copy and fax (facsimile)
A

A. Hard copy only

20
Q

Which of the following statements about relative and absolute risk claims in promotional material is correct?

Select one:
A. In order to assess the clinical impact of an outcome, the reader needs to know the relative risk involved; therefore absolute risk should never be referred to without also referring to the relative risk

B. In order to assess the clinical impact of an outcome, the reader needs to know the absolute risk involved; therefore relative risk should never be referred to without also referring to the absolute risk.

C. In order to assess the clinical impact of an outcome, the reader needs to know the absolute risk involved; therefore absolute risk should never be referred to without also referring to the relative risk

D. In order to assess the clinical impact of an outcome, the reader needs to know the relative risk involved; therefore absolute risk should never be referred to without also referring to the relative risk

A

B. In order to assess the clinical impact of an outcome, the reader needs to know the absolute risk involved; therefore relative risk should never be referred to without also referring to the absolute risk.

21
Q

A company is preparing promotional material in both printed and electronic form.
When can the electronic form be released?

Select one:
A. When all parties have agreed that there will be no subsequent amendments.

B. When the final electronic form has been certified by the nominated signatory

C. When the final electronic form has been certified by the author of the material

D.When the final forms of both electronic and printed material have been certified by the nominated signatory

A

B. When the final electronic form has been certified by the nominated signatory

22
Q

Which of the following visits to a prescriber is permissible?

Select one:
A. A fourth visit within a year
B. To follow up a report of an adverse reaction
C. To drop off a room rental fee prior to a meeting
D. To leave a product sample with the practice secretary

A

B. To follow up a report of an adverse reaction

23
Q

A health professional has incorrectly introduced you to a colleague as someone working for a company which is not your employer.

You should

Select one:
A. ignore it and proceed as originally planned
B. clarify that you work for a different company.
C. save embarrassment by giving a neutral response
D. ensure that the health professional knows your name

A

B. clarify that you work for a different company

24
Q

Which one of the following statements concerning the disclosure of transfers of value to health professionals is correct?

Select one:
A. Disclosures must be made every six months
B. The company must ensure that recipients are aware of the process for disclosure
C. Disclosed information must remain in the public domain for a minimum of five years.
D. Disclosures are to be made on the company’s website and should be accessed via a clearly labelled link

A

B. The company must ensure that recipients are aware of the process for disclosure

25
Q

The following question relates to a company providing samples of a product.

In the context of having a marketing authorisation as an extension of an existing medicine, a product would be regarded as a ‘new medicine’ if it is to be supplied:

Select one:
A. for an existing indication in larger pack sizes
B. for a new indication in larger pack sizes of an existing dose
C. for an existing indication that includes new strengths and/or dosage forms
D. for a new indication that includes new strength and/or dosage forms

A

D. for a new indication that includes new strength and/or dosage forms

26
Q

Promotional materials may, on occasion, contain reference to:

  1. The medicines and products of other pharmaceutical companies.
  2. The activities of other pharmaceutical companies
  3. The health professions
  4. The clinical and scientific opinions of health professions

According to the ABPI Code of Practice, which of the above must never be disparaged in such references?

Select one:
A. 1 and 2 only
B. 2 and 3 only
C. 2, 3 and 4 only
D. 1, 2, 3 and 4
A

D. 1, 2, 3 and 4

27
Q

The following warning may appear on patient information supplied with prescribed medicines:

‘This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.’

Which of the following symbols must also be included on the printed material?

A

Upside down black triangle.

28
Q

In the first 6 months following the launch of a new medicine a health professional may be sent in total no more than

Select one:
A. 2 mailings 
B. 3 mailings
C. 4 mailings
D. 6 mailings
A

C. 4 mailings

29
Q

Which line of the table shows facts that must be taken into consideration in product promotion when one pharmaceutical company’s product is being compared favourably with that of another company?

Accurate? Fair? Able to be sustained?

A

It must be accurate, fair and able to be sustained.

30
Q

Promotional material may be sent in which forms without prior permission from the recipient?

Select one:
A. Hard copy only
B. Email and hard copy
C. Fax (facsimile) and email
D. Hard copy and fax (facsimile)
A

A. Hard copy only

31
Q

Which of these three statements about hiring consultants are correct?

  1. A legitimate need for the services must be clearly identified in advance of requesting the services.
  2. The criteria for selecting consultants must be directly related to the identified need.
  3. The number of consultants retained must not be greater than the number reasonably necessary to achieve the identified need.
Select one:
A. 1 and 2 only
B. 1 and 3 only
C. 2 and 3 only
D. 1, 2 and 3
A

D. 1, 2 and 3

32
Q

Prescribing information must be provided with audio-visual (AV) promotional materials such as:

  1. audio-only recordings e.g. CDs
  2. DVDs
  3. interactive data systems
  4. the Internet

In which of the above may the prescribing information be provided either by way of a document made available to all who access the material, or by inclusion within the AV material itself?

Select one:
A. 1 only
B. 1 and 2 only 
C. 2 and 3 only
D. 2, 3 and 4 only
A
  1. DVDs

3. interactive data systems

33
Q

Payments for room rental may be

Select one:
A. made to a practice manager if they are receipted
B. made to postgraduate medical centres and the like
C. in the form of a donation to a practice-based charity
D. in the form of a donation in lieu of refreshments

A

B. made to postgraduate medical centres and the like

34
Q

Which regulatory body is responsible for the professional standards of pharmacy technicians?

Select one:
A. The General Medical Council
B. The Nursing and Midwifery Council
C.
The General Pharmaceutical Council
D. The Prescription Medicines Code of Practice Authority
A

C.

The General Pharmaceutical Council

35
Q

Companies must submit annual reports of their financial results to Companies House each year and these reports may include information relating to existing medicines and those not yet marketed.
Whose information needs should be considered when drafting this report?

Select one:
A. Patients
B. Financial investors
C. Healthcare professionals
D. The Association of the British Pharmaceutical Industry
A

B. Financial investors

36
Q

Promotional information about a company’s new products might be supplied to health professionals in a number of forms:

  1. In envelopes with a handwritten name and address
  2. In envelopes carrying a label such as ‘Important Safety Update’
  3. In print resembling independent editorial matter in journals
  4. In promotional information packs provided during declared sponsored activities

According to the ABPI Code of Practice, which of the above would be considered to be disguised promotion?

Select one:
A. 1 only
B. 1, 2 and 3 only
C. 2, 3 and 4 only
D. 3 and 4 only
A

B. 1, 2 and 3 only

37
Q

The list of patient organisations that companies support must be made publicly available.

How often and in what time period must this list be disclosed?

Select one:
A. Annually within six months of the end of the calendar year in which the transfer of value was made
B. Every two years within a year of the end of the second year of the two years in which the transfer of value was made
C. Annually within three months of the end of the calendar year in which the transfer of value was made
D. Every two years within six months of the end of the second year of the two years in which the transfer of value was made

A

A. Annually within six months of the end of the calendar year in which the transfer of value was made

38
Q

The items specified below refer to items a company may or may not provide with respect to promotions to health professionals and other decision makers:

  1. Notebooks, pens and pencils given out at exhibition stands
  2. Notebooks, pens and pencils given in conferences at bona fide meetings organised by a third party provided that no individual receives more than one notebook and one pen or pencil and that they do not bear the name of the donor company or the name of any medicine or any information about medicines
  3. Modest donations to reputable charities in return for health professionals’ attendance at company stands at meetings
  4. Modest donations to reputable charities in return for the grant of an interview with a health professional

Which of the following responses is correct?

Select one:
A. 1 and 2 may be provided; 3 and 4 may not be provided Incorrect
B. 1 and 3 may be provided; 2 and 4 may not be provided
C. 2 and 3 may be provided; 1 and 4 may not be provided
D. 2 and 4 may be provided; 1 and 3 may not be provided

A

C. 2 and 3 may be provided; 1 and 4 may not be provided

39
Q

A company may make a donation to a charity nominated by a doctor

Select one:
A. in return for attendance at a company stand during a meeting
B. of any amount, provided the money is for a reputable charity
C. which buys equipment for a surgical practice
D. in return for being granted an interview

A

A. in return for attendance at a company stand during a meeting

40
Q

Prescribing information must be provided with audio-visual (AV) promotional materials such as:

  1. audio-only recordings, e.g. CDs
  2. DVDs
  3. interactive data systems
  4. the Internet

In which of the above must the prescribing information be provided as a document made available to all persons who access the material?

Select one:
A. 1 only
B. 1 and 2 only
C. 3 and 4 only
D. 1, 2, 3 and 4
A

A. 1 only

41
Q

Which sample of a prescription medicine was supplied in accordance with the Code of Practice?

Select one:
A. A was sent to a nurse who had sent an email
B. B was sent to a doctor in response to a signed and dated email
C. C was sent to a doctor after a request during a telephone conversation
D. D was sent to a pharmacist in response to a written and signed request

A

B. B was sent to a doctor in response to a signed and dated email

42
Q

In the first 6 months following the launch of a new medicine a health professional may be sent in total no more than

Select one:
A. 2 mailings
B. 3 mailings
C. 4 mailings
D. 6 mailings
A

C. 4 mailings