PIPA GUIDANCE DOCUMENT:

RESPONDING TO PATIENT ENQUIRIES

Introduction
Increasing awareness of, and involvement in, their own medical care, has given
rise to the “informed patient”. As a result, pharmaceutical medical information
departments can expect to receive calls from patients who have an in-depth
understanding of their condition and treatment.
Guidance about how enquiries from patients should be handled is included in section 1.4 of the PIPA UK
Guidelines for the Pharmaceutical Industry Medical Information Departments (Revised 2018), accessible
via https://www.pipaonline.org/UK-Guidelines-on-Standards-in-Medical-Information.

All responses to enquiries originating from members of the public / patients must conform with the
Association of the British Pharmaceutical Industry (ABPI) Code of Practice (specifically clause 26).
Historically, this often meant that pharmaceutical companies gave little or no information in answer to
such enquiries.

However, with an increasing number of trusted and reliable sources of information in the public domain
that can be accessed by patients, responses to such enquiries can, and should, go much further in
providing helpful information to patients without either contravening the Code of Practice or interfering
with the important patient-doctor relationship.

PIPA has created this document to help medical information (MI) departments provide informative and
helpful responses to patient enquiries that include:

• Appropriate factual information relevant to the question being posed and the understanding
of the patient, presented in a clear and unambiguous manner
• Sign posts to other relevant sources of information (e.g. patient organisations)
• A clear explanation of the limitations placed on the pharmaceutical industry regarding what
information can and cannot be shared, and why these limitations exist (for example, why the
industry cannot give medical advice)
• A statement referring the patient back to their doctor / appropriate healthcare professional
(HCP) for further advice and information, also stating that their HCP can contact MI for
further specialist information if necessary, which they can then discuss with the patient.

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It is important that MI professionals use their professional judgement when selecting which sources of
information would be appropriate for the enquirer they are dealing with.
Some patients will have a high level of scientific knowledge and understanding about their medical
condition and / or the medicine they have been prescribed, while others will have relatively little
knowledge. It is important that the MI professional identifies the patient’s level of understanding to
ensure they provide a useful and beneficial response to the customer whilst remaining compliant with
the Code of Practice.
The following table provides guidance on how to gauge the level of scientific knowledge the
patient has.

Patient with a low level of scientific Patient with a high level of scientific
understanding around their medicine, disease understanding around their medicine, disease or
or therapy area therapy area

Patient: Patient:

• Is not aware of the information in the • Is already aware of the information in

Patient Information Leaflet (PIL) the PIL and/or Summary of Product
• Has not used the product yet or not used it Characteristics (SmPC)
for very long • Has used the product for many years
• Has limited or no knowledge around the • Has good knowledge of the product and
product and/or disease area. the disease area
• Has done their own research online and still
cannot locate answer
• Confidently and accurately uses scientific /
medical terms
• States that they are / were a healthcare
professional / work in healthcare.

Subject: {Product}® {Active ingredient} { }

Written responses to patients –
examples of wording We recommend that if a product is subject to
additional monitoring, then the black triangle
The following information is for guidance only. should be included next to the product name.
We have included examples and suggestions We would also recommend including an
for text you can use, but we recommend that explanation using the wording from clause 26.3
you adapt the wording, and order of the text, to of the Code:
fit with your company’s policies, internal style
and the level of scientific understanding of the
patient. You may also find some of the wording “ This medicine is subject to additional
helpful when communicating with patients / monitoring. This will allow quick
members of the public by telephone. identification of new safety information. You
can help by reporting any side effects you
Introductory sentence: may get. See www.mhra.gov.uk/yellowcard
for how to report side effects.”
Include an appropriate introduction, for
example: Continue with an expression of empathy and
“Thank you for contacting us regarding X. I understanding of the question (if appropriate).
understand you have requested X.”
Examples of wording include:
You may wish to include a subject line at the
start of the letter, for example: “I am sorry to hear that….”
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 “I understand this must be difficult for you…” available information to share – and outline
“I understand it must be frustrating that…” why the pharmaceutical industry cannot give
medical advice.
“I can see that you are concerned…”
Sample wording is provided below, which can
You may wish to change the use of ‘I’ to ‘we’ be modified, as appropriate, to your response:
depending on your company’s internal style,
and whether the response signature is a “Like most pharmaceutical companies in the
department rather than an individual. UK, <Company name> is a member of the
Association of the British Pharmaceutical
Explain what information is provided Industry (ABPI - https://www.abpi.org.uk/).
in the response: The ABPI upholds a Code of Practice for the
Pharmaceutical Industry (the Code) (http://
To engage the enquirer with your response, use www.pmcpa.org.uk/thecode/Pages/default.
this part of the letter to provide a top-level aspx) which sets various standards, including
explanation of what is included in the email specifying what information can ethically
/ letter. Sample wording is provided below be shared with patients and members of the
which can be modified, as appropriate, to your public about prescription medications.
response:
Although the Code permits us to provide you
“In this email (/letter) I/we have included with factual and reliable information in the
information and links to resources available public domain that may help to answer your
in the public domain that I/we feel would be question, it does not permit us to provide
helpful to you in response to your enquiry. I/ medical advice to patients, comment on
we have also explained the limitations placed
their personal medical matters, or suggest
on the pharmaceutical industry regarding
the most appropriate medicine for their
what information we can provide to patients,
treatment. This is to ensure that we do not
and why these limitations exist.”
interfere with the valuable patient-doctor
relationship.”
Provide any relevant information
available in the public domain that Refer the patient back to their
could help answer their enquiry: prescriber:
Build an appropriately worded response
using any applicable resources from the list The previous section naturally leads on to
of suggestions in the table at the end of this wording that refers the enquirer back to the
document, depending on the customer’s level healthcare professional (HCP) that prescribed
of scientific understanding. Ensure you put the medication for them.
the information provided in the context of the Sample wording is provided below, which can
question asked and make sure you don’t go be modified, as appropriate, to your response:
beyond the scope of the enquiry. Include links
to where the information can be found for “As a healthcare professional, your GP - or
future reference. other prescribing physician - can use his/
If the patient is already taking the medication her clinical judgement, knowledge of
they are enquiring about, provide a link to the your medical history and available clinical
PIL or, if speaking to them directly, advise them information to make informed decisions
where this can be found. about your treatment.
They are also able to request further specialist
Explain the limitations on the data clinical data or technical information from us
provided: to support their decision, which they can then
discuss with you.
Here, clearly explain about the ABPI Code
of Practice and why this means that there We would therefore always advise you to
are limitations on the information provided. discuss any concerns or questions that
Explain why you have been able to share you have about your medication with your
some information – or explain why there is no doctor.”
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Adverse event statement & Review of patient responses
disclaimer: To satisfy the requirements of the
supplementary information for clause 14.3
If the patient’s enquiry included an adverse “Examination of other material” of the ABPI
event, or you suspect there is an adverse Code, ensure written patient responses are
event involved, include a suitable statement examined or peer reviewed.
here, including any requests for follow-up
information. For example:
• for when the enquirer reported an adverse
event within their enquiry:
“All pharmaceutical companies are obliged
to follow up on any reports of side effects
involving their products, in order to make
a proper safety assessment. It is important
that we investigate all possible side effects,
and obtain a medical report where possible,
as this enables us to maintain accurate
information about our medicines for
prescribers and patients. As you have told us
about a side effect that you have experienced
whilst taking <PRODUCT>, I have copied your
enquiry to our Drug Safety department who
may contact you to ask for your permission to
request further details from your doctor. This
is a routine process and your details will not
be used for any other purpose.”
• for suspected adverse events:
“Reporting side effects
If you experience side effects with any
medication you are taking, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in the
information leaflet that comes in the pack.
You can report side effects via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide
more information on the safety of your
medication.”

Other company disclaimers

Companies may require other disclaimers to
be included in correspondence with patients,
including:
• product quality complaints (where
applicable)
• data protection (GDPR) and confidentiality
• copyright
• company-specific disclaimers etc.

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Summary and examples of resources to be used

Patient with a low level of scientific Patient with a high level of scientific
understanding around their medicine, disease understanding around their medicine, disease
or therapy area or therapy area

- Confirm question and include introductory - Confirm question and include introductory
sentence sentence

- Provide any relevant information that - Provide any relevant information that
addresses their enquiry, e.g. addresses their enquiry, e.g.

• Provide information from PIL (or SmPC • Re-iterate the information from PIL
in those cases where info is in SmPC and (or SmPC in those cases where info is in
not PIL) SmPC and not PIL)

• Provide information from relevant • Confirm information that they are

sources listed below already aware of (own research)
• Provide information from relevant
sources listed below
- Include link to PIL or advise patient where
this can be found • Ensure to only direct customers to
more complex sources if they have
demonstrated a high level of scientific
- Explain the limitations on the data knowledge or have confirmed they are
provided (e.g. Code of Practice) healthcare professionals (e.g. PubMed,
IDAPs)
- Refer patient back to their healthcare
professional (HCP) and advise them that - Ensure to STILL include link to PIL or advise
their HCP can contact us if they would like patient where this can be found
to discuss this further

- Explain the limitations on the data

- Include AE statement & other relevant provided (e.g. Code of Practice)
company disclaimers as appropriate

- Refer patient back to their healthcare

professional (HCP) and advise them that
their HCP can contact us if they would like
to discuss this further

- Include AE statement & other relevant

company disclaimers as appropriate

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Sources of information in the public domain Sources of information in the public domain
that patients in this category can be referred that patients in this category can be referred
to include: to include:

Electronic Medicines Compendium (eMC) Electronic Medicines Compendium (eMC)

for Patient Information Leaflet (PIL) and / or for Patient Information Leaflet (PIL) and / or
Summary of Product Characteristics (SmPC): Summary of Product Characteristics (SmPC):
• www.medicines.org.uk (UK) • www.medicines.org.uk (UK)
• www.medicines.ie (IRELAND) • www.medicines.ie (IRELAND)

ClinicalTrials.gov: https://clinicaltrials.gov/ European Public Assessment Reports (EPARs):

https://www.ema.europa.eu/en/medicines/
EU clinical trials register: https://www. download-medicine-data#european-public-
clinicaltrialsregister.eu/ assessment-reports-(epar)-section

ClinicalTrials.gov: https://clinicaltrials.gov/
UK Clinical Trials Gateway: https://www.
ukctg.nihr.ac.uk/
EU clinical trials register: https://www.
clinicaltrialsregister.eu/
NHS website: https://www.nhs.uk/
UK Clinical Trials Gateway: https://www.ukctg.
NHS “behind the headlines” website: https:// nihr.ac.uk/
www.nhs.uk/news/
UK Teratology Information Service (UKTIS)
bumps: http://www.medicinesinpregnancy.org/

NHS website: https://www.nhs.uk/

NHS “behind the headlines” website: https://

www.nhs.uk/news/

Interactive Drug Analysis Profiles:* https://

yellowcard.mhra.gov.uk/iDAP/

PubMed:* https://www.ncbi.nlm.nih.gov/
pubmed

Patient Groups: Internally agreed patient

groups relevant to the therapy area.

*To be shared only with patients who are

HCPs or have demonstrated a high degree
of scientific understanding. We recommend
informing patients that if do their own
literature searches, the results may not give a
balanced view of all available data.