On 27th November 2020 took place the AFI symposium “Pharmacovigilance and quality session”, dedicated to the quality system and complaints management, in which field experts shared their experiences within their companies, all different from each other.

The webinar began with a double interview by the presenter Dr. Andrea Oliva of Mylan to Dr. Delia Valsecchi and Dr. Viviana Riccardi, respectively head of pharmacovigilance and head of the quality department of Mundipharma Italia.

They were asked questions mainly concerning the management of some specific cases by their respective departments:

“In case of a complaint from a patient who bought a package of a psoriasis drug and she complains that she has found an extra pill and claims that this package has poor efficacy, how does the quality fare? And what about pharmacovigilance? “

Dr. Riccardi, Quality Department: As per the procedure, there is the obligation to send the complaint report within 24 hours to the production site, to which an investigation is requested. Internally, the information is reported in the report form to be sent to the production site.
The complaint is identified through the reference number and other necessary data, such as the medical specialty, the dosage, the pharmaceutical form, the expiry date, the batch and pack number and the description of the complaint, the type of complaint: damage to the package, counterfeiting or forgery.
Is identified the classification of the complaint: critical, minor, or major.
Everything is then reported into the database indicating a link to an adverse event. The communication is sent to the production site which reports the reference number.
If there is not all the information to carry out the investigation, it is necessary to contact the patient to ask for information such as photos or any useful details. It is reported to the pharmacovigilance since it has reported a lack of therapeutic efficacy.

Dr. Valsecchi, Pharmacovigilance Department: Since there is a lack of efficacy, it is a case of adverse event, so therefore the reporter’s contacts are requested from Quality Assurance as it will be necessary to ask the patient for additional information. The CIOMS is then filled in and the info is sent to global, whose pharmacovigilance department will insert it in the global database; therefore, it must submit the case to EudraVigilance. Then it continues with local storage keeping in mind the processing of sensitive data. The case is marked as coming from a product complaint and therefore needs to be reconciled with the Quality Assurance database. The Drug Safety team will continue to monitor the case for any follow up.
Read the insight: The KPIs from the point of views af a branch

Following there was the intervention of Dr. Marika Ciappa, Patient Safety & GVP Quality Lead of AstraZeneca Italy, who illustrated the use of KPIs for monitoring the performance of the pharmacovigilance quality system in a reality where there isn’t a dedicated department to Quality Assurance, but all quality processes are divided into the various functions within the pharmacovigilance team itself and beyond.
Read the insight: KPIs as a tool for relationships between global and local

Dr. Federica Varoli of Bausch & Lomb – IOM Spa subsequently analyzed the management of KPIs from the point of view of the relationship between the branch and the headquarter, asserting them as a necessary tool not only for the local quality system, but for the whole company in its entirety as the parent company, with a detailed internal analysis of each branch, will be able to discover anomalies and weaknesses.

To conclude this first part dedicated to the quality system and the relations between internal departments and between the branch and the headquarter, a round table in which the speakers answered the questions posed by the participants, including:
“What are the advantages and disadvantages of realities like yours? It is better to have separate pharmacovigilance and qualities rather than united, or to have a relationship reality between global and local?”

Each participant found the positive side of their reality:
Dr. Riccardi and Dr. Valsecchi find it very practical to have separate quality and pharmacovigilance, as they can find a comparison in each other;
Dr. Varoli finds her dual role within both the parent company and the branch very useful: in this way she can understand what are the real difficulties both in setting the KPIs by local and then in the calculation by of global;
Finally, Dr. Ciappa considers a great point in favor of having the quality already inserted in the pharmacovigilance as the team already has a focus on quality, for example in the insertion of a case, as staff already know that that case will likely be reviewed later. The only point against the consequent amount of work and time spent.

“A follow-up can be considered only for pharmacovigilance or only for quality if there is no significant information for the other department?”

Dr. Varoli answers the question by giving a practical example: “One of our branches took a finding because the result of a quality survey had not been communicated as a fundamental aspect in the documentation archive within the pharmacovigilance database. If there is a complaint associated with an adverse event both departments must have the two investigations in parallel in the report and these must be mutually contaminated with the results of the individual assessments “.

“From the point of view of quality, does the lack of efficacy always require an analytical test?”
Dr. Riccardi answered affirmatively.

Dr. Eleonora Corbetta of ACS Dobfar opened the second part of the webinar, illustrating the steps to follow for the complaint managing by bringing some practical examples of her company that produces sterile products.
Read the insight: Management of complaints and their impact on safety

Finally, Dr. Donata Saddemi and Dr. Barbara Belloni of Recipharm showed how the complaint is handled both by the production and by the pharmacovigilance.
Read the insight: Collaboration between pharmacovigilance and quality

Here too, at the end, there was a round table in which various questions emerged from the participants such as: ““Internally we place the customer complaint as detrimental or non-detrimental to the customer, is that correct or should we categorize as major, minor and critical? “ Dr. Belloni replies: “There is no single rule, it is certain that the explanation of what is meant by this classification and what are the subsequent tests in order to support it in audits must be very well detailed in the procedure: there are often auditors who have a more classical view and therefore they are expected to see the classical nomenclature of minor, major and critical. Furthermore, there are indications, also from AIFA, which refer to this classification. So, let’s say that maintaining the classical criticality classification helps, but I wouldn’t necessarily discard my idea if it is well managed and rationalized “.

“Can I enter multiple complaints of the same categories received at different times in the same open investigation, or do I have to open a separate investigation for each one?”
All the doctors agree that it is always better to open separate complaints, which can then eventually be reconnected, but separate complaints are useful for doing the trend analysis.
Even if the complaint is the same, received by the same customer, it is still advisable to insert both of them in the same investigation where any further details will be added to make a single investigation including everything.

“For an adverse event report listed in the leaflet, is the verification of the batch record of the product still required?”
In this case too, the doctors agree that it should always be done: the batch record review is a basic review for each type of complaint as it tracks all the activities carried out in the production of the batch and therefore implies in itself a source of any problems.

What emerges at the end of the session is that each company has its own reality, its own organization and its own procedures, sometimes there is complete diversity in the management of pharmacovigilance, but in conclusion, the ultimate goal of everything is always the patient safety.