Providing timely, evidence-based information on the safe and effective use of medicines, facilitating changes to healthcare practices, supporting risk minimization behavior.

2. Module XV-Safety communications
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2
 Communicating safety information to patients and healthcare professionals is a public health
responsibility and is essential for achieving the objectives of pharmacovigilance in terms of
promoting the rational, safe and effective use of medicines, preventing harm from adverse
reactions and contributing to the protection of patients‘ and public health.
 Safety communication is a broad term covering different types of information on medicines,
including statutory information as contained in the product information ( SmPC, PL and the
labelling of the packaging), But we focuses on the communication of new or emerging safety
information‘, which means new information about a previously known or unknown risk of a
medicine which has or may have an impact on a medicine‘s benefit-risk balance and its
condition of use.
 To support public confidence in the regulatory system.

3. Module XV-Safety communications
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 Safety communication should deliver clear, concise, precise to the point messages and reach
the right audiences at the right time for them to take appropriate action.
 Safety communication should be tailored to the appropriate audiences (e.g. patients and
healthcare professionals) by using appropriate language and taking account of the different
levels of knowledge and information needs whilst maintaining the accuracy and consistency of
the information conveyed.
 Safety communication should address the uncertainties 3 months related to a safety concern.
This is of particular relevance for emerging information which is often communicated while
medicines authorities are conducting their evaluations; the usefulness of communication at this
stage needs to be balanced against the potential for confusion if uncertainties are not properly
represented.

4. Module XV-Safety communications
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 Patients and healthcare professionals should, where possible, be consulted and messages pre-
tested early in the preparation of safety communication, particularly on complex safety concerns
“User tested in advance”
 Safety information should Not include any material or statement which might constitute
advertising.
 The primary target audiences for safety communication issued by RAs and MAH should be:-
 healthcare professionals Post marketing practice + Clinical practice
 Patients – Consumer and HCP organisations.
 Media written communication Not verbal communication

5. Module XV-Safety communications
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 The preparation of DHPCs involves cooperation between the MAH and the RAs.
 Agreement between these two parties should be reached before a DHPC is issued by the
marketing authorisation holder.
 The agreement will cover Four Issues.
 + Disseminatingcontent
communication
plan
List
Mechanism
Timeframe
(1st week,..)

6. Module XV-Safety communications
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 A DHPC should be disseminated in the following situations when there is a need to take
immediate action or change current practice in relation to a medicinal product:
 Suspension, withdrawal or revocation of a marketing authorisation for safety reasons.
 an important change to the use of a medicine due to the restriction of an indication, a new
contraindication, or a change in the recommended dose due to safety reasons;
 a restriction in availability or discontinuation of a medicine with potential detrimental effects
on patient care.

7. Module XV-Safety communications
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 Communication material in lay language (e.g. using a questions & answers format) helps
patients and the general public to understand the scientific evidence and regulatory actions
relating to a safety concern.
 Lay language documents should contain the recommendations agreed by the RAs and advice
for risk minimization for patients and healthcare professionals in relation to the safety concern,
and should be accompanied by relevant background information. (as: Cidophage)
“User tested in advance”
-Patient
-Patient caregiver

8. Module XV-Safety communications
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 Press communication includes press releases and press briefings which are primarily intended
for journalists.
 Interaction with the media is an important way to reach out to a wider audience as well as to
build trust in the regulatory system.
 Press releases may also be prepared and published by MAH. and should prior agreed on the
display from the authority.
 In cases where a DHPC is also prepared, healthcare professionals should ideally receive it prior
to or around the same time of the publication or distribution of a press release so that they
are better prepared to respond to patients.
 written communication Not verbal communication

9. Module XV-Safety communications
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 A website is a key tool for members of the public (including patients and HCPs) actively
searching the internet for specific information on medicinal products.
 RAs as well as MAH should ensure that important safety information published on websites
under their control is easily accessible and understandable by the public.
 Information on websites should be kept up-to-date, with any information that is out-of-date
marked as such or removed. (as: EMA)

10. Module XV-Safety communications
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 Online safety information may also be disseminated via other web tools.
 When using newer, more rapid communication channels, special attention should be paid
to ensure that the accuracy of the information released is not compromised.
 Communication practices should take into account emerging communication tools used by the
various target audiences.

11. Module XV-Safety communications
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 Bulletins and newsletters provide at regular intervals new information about medicines and their
safety and effectiveness. (as: PharmaTimes Magazine)
 When one RA takes regulatory action on a particular safety concern, other authorities may need
to respond to enquiries or communicate on the same issue such as lines-to-take should be
considered.

12. Module XV-Safety communications
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 RAs and MAH should have systems in place for responding to enquiries about medicines
from individual members of the public. Responses should take into account the
information which is in the public domain and should include the relevant recommendations
to patients and HCPs issued/agreed by national medicines authorities.
 Where questions relate to individual treatment advice, the patient should
be advised to contact a healthcare professional.
 There are other tools and channels such as publications in scientific journals and journals
of professional bodies.

13. Module XV-Safety communications
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With National
medicines
authorities
With Marketing
authorization
holders
With patients‘
and healthcare
professionals‘
organizations
till reach to end
users

14. Module XV-Safety communications
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 As soon as a MAH intends to make a public announcement relating to information on PV
concerns in relation to the use of a medicinal product:
 MAH shall inform the medicines authority before public announcement.
 Whenever a MAH becomes aware that a third party (e.g. scientific journals, learned
societies, patients‘ organizations) intends to issue communication that could
potentially impact the benefit-risk balance of a medicinal product authorized in Arab
countries, the MAH should inform the medicines authorities concerned and make every
effort to share the content of the communications with the relevant authorities.

15. Module XV-Safety communications
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 Disseminated by: One or Group of MAHs.
 Disseminated at: Request of RAs or on the MAHs own initiative.
 MAH should seek the agreement of the relevant RAs prior to dissemination regarding the:-
 Content of a DHPC
 Communication plan.

16. Module XV-Safety communications
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 The content of DHPC:-
 Date
 Title….indicate the safety concern. (Full Message).
 Summary paragraph....brief description of the safety concern.
 Further information on the safety concern …...important details.
 Further information on recommendations to HCP…...If needed.
 Call for reporting….communication details. (QPPV + EPVC).
 Annexes.
 Signature
Header +
Footer
Full letter 1 or 1.5
page as max.
 No paragraph
 Bullet points (NMT 2 rows
 Take home messages
Precise, concise
to the point + No
promotional
notice

17. Module XV-Safety communications
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 The MAH should submit to medicine authority for approval:-
 Draft DHPC.
 The communication plan The dissemination list “Intended recipient list”
Timetable for disseminating the DHPC {Urgency should be
considered (usually max. of 15 calendar days is consider appropriate)}
Dissemination mechanism (e.g. by Postal mail, express
mail….) – The mechanism should be appropriate to meet the disseminating timetable.
One full original hard copy. 2 working days
 The MAH should submit these documents Return to MAH after stamped with approval
One soft copy. Retained at the authority
Name
Specialty
Geographic distribution
Telephone no.

18. Module XV-Safety communications
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 Any significant event or problem occurring during the DHPC dissemination which reveals
a need to change the Communication Plan or a need for further communication to
Healthcare Professionals, this should be notified in a timely manner to national medicines
authority to be approved.
 After dissemination of a DHPC, a “closing review” should be performed by the MAH, a
“progress report” may be submitted upon request of the national medicines authority
 The usual language for preparing the DHPCs will be English (unless other language is
requested by the RAs e.g. Arabic suitable to (part of) the intended receipts (e.g. nurses).
 The RAs may publish the final DHPC on their official websites