ABPI Code of Practice 2021

Questions and Answers

What is specifically excluded from the Code for the Scottish Medicines Consortium (SMC)?

Information that is misleading

Factual and accurate information (correct)

Over-the-counter medicines

Information that is not factual

Who does the term 'other relevant decision maker' refer to?

A health professional involved in patient care

An NHS role with no influence on medicines

Only pharmaceutical company representatives

Anyone who can influence the use of medicines (correct)

Which type of medicine is defined as being primarily aimed at the public for self-medication?

Prescription medicine

Prescription-only medicine

Over-the-counter medicine (correct)

Controlled substance

What is the main focus of the epidemiological methods mentioned?

To analyze collected data Signup and view all the answers

Which organizations are mentioned as receiving information from pharmaceutical companies?

National Institute for Health and Care Excellence (NICE) Signup and view all the answers

When did the new edition of the Code of Practice come into operation?

1 July 2021 Signup and view all the answers

What is the role of the Prescription Medicines Code of Practice Authority (PMCPA)?

To operate the Code of Practice independently Signup and view all the answers

Which of the following is true about submitting complaints to the PMCPA?

Complaints are directed to the Code of Practice Panel Signup and view all the answers

What is the transition period for companies wishing to continue with ongoing Medical and Educational Goods and Services?

Until 31 December 2021 Signup and view all the answers

What type of organization is the Association of the British Pharmaceutical Industry (ABPI)?

A company limited by guarantee Signup and view all the answers

Where can reports on cases under the Code be accessed?

Available on request and on the Authority's website Signup and view all the answers

What is the phone number provided for contacting the PMCPA?

020 7747 8880 Signup and view all the answers

What is the purpose of the template for disclosure agreed for the 2021 Code?

To submit data to Disclosure UK Signup and view all the answers

What is defined as a 'company' in this context?

A legal entity organizing or sponsoring promotion within Europe Signup and view all the answers

What must companies publicly disclose regarding fees and expenses?

Fees and expenses for contracted services with patient organizations Signup and view all the answers

What does Clause 30 entail regarding clinical trials?

Disclosure must align with the Joint Position on Clinical Trial Information Signup and view all the answers

How should companies handle international events?

They must notify local representatives in advance Signup and view all the answers

Which of the following statements about conflict of requirements is true?

More restrictive requirements must be followed Signup and view all the answers

What is the purpose of the EFPIA Code mentioned in the content?

To establish limitations on subsistence compensations Signup and view all the answers

Where should information about clinical trials be included by companies?

On the home page of their website Signup and view all the answers

Which of the following is NOT mentioned as part of the fees that need to be disclosed?

Funds allocated for marketing campaigns Signup and view all the answers

What must companies publish regarding non-interventional studies of marketed medicines?

Summary details and results Signup and view all the answers

In the absence of other formal arrangements, who is assumed to be the responsible person in a company?

Managing Director or Chief Executive Signup and view all the answers

What is required concerning clinical trial details?

They must be registered within 21 days of patient enrolment Signup and view all the answers

Which of the following statements about scientific services in companies is true?

Responsibilities can be separated or combined in one scientific service Signup and view all the answers

Which entities are companies responsible for regarding the information issued about their products?

All agencies they work with Signup and view all the answers

What must companies take reasonable steps to ensure concerning other parties commissioned for studies?

They comply with the Code’s requirements Signup and view all the answers

How soon must details of ongoing clinical trials be registered after patient enrolment begins?

Within 21 days Signup and view all the answers

What is the purpose of having a scientific service within a company?

To compile and collate information about marketed medicines Signup and view all the answers

What is prohibited when stating information about adverse reactions of a product?

Stating that a product has no adverse reactions Signup and view all the answers

Which of the following statements about price comparisons is correct?

Valid price comparisons must be based on similar indications. Signup and view all the answers

What should be avoided when using the term 'new' in marketing?

Describing a product that has been available for over a year Signup and view all the answers

Which of the following statements regarding statistical information in marketing is true?

Only statistically significant differences should be highlighted. Signup and view all the answers

How should emerging clinical or scientific opinions be communicated?

They should be referred to in a balanced manner. Signup and view all the answers

Which statement correctly represents the use of comparisons in marketing?

Comparisons should include relevant information about both products. Signup and view all the answers

Which of the following is prohibited regarding the representation of other pharmaceutical companies?

Disparaging the products of other companies Signup and view all the answers

When using the term 'safe' in product marketing, what is necessary?

It must always be qualified to provide context. Signup and view all the answers

Study Notes

ABPI Code of Practice Overview

Implemented on 1 July 2021 with no transition period except for ongoing Medical and Educational Goods and Services until 31 December 2021.
Requires the use of a specific template for data submission to Disclosure UK in 2022.

Prescription Medicines Code of Practice Authority (PMCPA)

Established by the Association of the British Pharmaceutical Industry (ABPI) in 1993.
Operates independently to manage the Code of Practice for the Pharmaceutical Industry.
Complaints are directed to the PMCPA’s Director via established contact information.
Cases are reviewed by the Code of Practice Panel and potentially the Appeal Board; reports are publicly available.

Definitions and Terms

"Other relevant decision maker": Includes NHS roles influencing medicine use, excluding health professionals.
"Over-the-counter medicine" (OTC): Primarily advertised for self-medication, subject to specific advertising regulations.

Company and Service Definitions

A "company" refers to any legal entity involved in pharmaceutical promotion within Europe, which may include parent or subsidiary organizations.
Companies must document and publicly disclose fees and expenses paid to individuals for contracted services, especially those related to patient organizations.

Clinical Trials and Research

Companies must disclose clinical trial details in line with Joint Position on Disclosure and Publication of Clinical Trial Results.
Summary details and results from non-interventional studies must also be published, reflecting obligations tied to clinical trials.
Ongoing clinical trials must be registered within 21 days of patient enrollment initiation.

Advertising and Claims Regulations

Claims about adverse reactions must be substantiated by clinical evidence; ambiguous language about safety is prohibited.
The term "new" cannot be used without specifying available duration; products must not be falsely represented in comparisons.
Disparagement of products, services, or professionals is not allowed; comparisons must be fair and statistically valid.

Responsibility and Compliance

Companies must maintain a scientific service for compiling medicine information and emerging clinical opinions.
Definitions clarify that companies are accountable for third-party communications and advertising related to their products.

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Description

Explore the ABPI Code of Practice for the Pharmaceutical Industry as established in 2021. This quiz covers the key principles, roles, and responsibilities as outlined in the guidance. Test your understanding of ethical standards and practices within the pharmaceutical sector.