Industry can support clinicians with prescribing decisions

Market Access
ABPI guide

The ABPI has launched a new guide to how the pharmaceutical industry can help healthcare professionals with complex prescribing decisions.

When faced with a difficult prescribing decision, approaching the pharmaceutical company that developed the medicine can be a helpful source of information and advice, alongside other guidance from professional bodies.

What do we mean by appropriate prescribing?

Appropriate prescribing means prescribing the right medicine, in the right dose, for the right duration, for the right patient.

Companies want to support ethical and evidence-based prescribing to help healthcare professionals and patients reach proportionate decisions about the best course of treatment in different situations. This might be no treatment at all in some cases.

It is in the interests of patients, the NHS, and the life sciences industry for patients to be prescribed only the medicines they need, only for as long as they need them; no more, no less.

Why are companies so expert and what can they offer?

The pharmaceutical industry is very highly regulated. Before any medicine ever reaches a patient, companies must have robust evidence to convince regulators that it works and will be developed and manufactured to extremely high safety and quality standards. This responsibility does not end with the approval of the medicine, but continues with ongoing safety monitoring for as long as the medicine is in use.

The companies are, therefore, experts on their medicines, how they work and who they work best for. Although manufacturers cannot provide direct clinical advice to patients, they can draw on a wide range of information, data, and expertise to help clinicians, including the Summary of Product Characteristics (SmPC), in-house pharmacovigilance experts, as well as medical advisers who can provide in-depth information and data.

Most pharmaceutical companies in the UK have a Medical Information Service (MIS) for healthcare professionals and the public via telephone or email. MIS advisers are trained to provide balanced information and advice on all clinical aspects of medicines. These resources should be used by prescribers if needed.

Can the pharmaceutical industry be trusted to provide impartial advice?

Companies are required by the ABPI Code of Practice to provide fair, balanced, and verifiable information on medicines to support high-quality healthcare. The ABPI Code reflects and goes beyond the law. Signing up to the ABPI Code is a condition of ABPI membership.

Any information a company provides also has to be signed off by a responsible in-house medical professional. In the UK, these people are usually NHS-trained doctors or pharmacists.

The pharmaceutical industry also has a vital role in ensuring that, when working with healthcare professionals on the development and distribution of medicine, this relationship does not lead to an inappropriate bias in prescribing.

A case study example

A patient was receiving a medicinal product to help with an inflammatory bowel condition. Following three months of successful treatment, the patient fell pregnant and needed to make an informed decision about whether to continue with treatment.

The treating physician contacted the Medical Service Liaison (MSL) within the company to request further information on use in pregnancy in order to be able to counsel the patient appropriately and enable that decision. While use in pregnancy was not contraindicated, there was limited information within the current product label and use in pregnancy was not recommended.

The pharmacovigilance team reviewed the Periodic Safety Update Report – a report supplied to regulatory authorities that provides the worldwide safety experience of a product within a defined timeframe, as well as information on pregnancy-related outcomes through the pharmacovigilance database – and had a discussion with the global medical safety lead. Following this, the pharmacovigilance team created a medical safety review report of data from pregnant patients, which was provided to the physician.

This also provided the team with an opportunity to highlight to the physician the importance of completing the related pregnancy follow-up forms, as well as how this information is then used in the aggregate reporting process and how it can impact on the product label in the future.

Provision of this data enabled the physician to discuss the information with their patient and, in this case, the patient decided to continue with treatment, informed of the benefits and risks of continued treatment.

The ABPI and the pharmaceutical industry are committed to enhancing and promoting transparency and disclosure in healthcare professionals and industry relationships. Our guide sets out the continued progress in that area, which helps to underpin and support better patient outcomes.

Amit Aggarwal
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Dr Amit Aggarwal
16 February, 2024