Pharmacovigilance shifts toward patient-centred approaches amid growing advocacy and education

Best practices in integrating patient insights

Mitan: 

I think in this respect, I can really talk a little bit about the work that I have seen in Europe, but also in the US, where we get involved directly with the patients, patient advocacy groups, and speak with them through the forum of DIA, where we bring the industry, regulators, and academia. Also, health technology assessments, the organisations that are important in Europe, come together to really talk about those elements of patient involvement. One other element that is very important in the European landscape, and also in the US landscape, is the direct involvement of patients in the scientific advice that the pharma industry is going through. So, you actually have patients or patient organisations being invited to the discussions between the regulators and the industry, having a direct say in the important elements and discussing what matters to them.

Prof Moin: 

From an Indian perspective, this has been a little different because the awareness of pharmacovigilance among Indians, and I’m not talking about the masses, even among healthcare professionals, is very, very poor. And that’s why we have been trying, through DIA and some other forums, to create pharmacovigilance awareness, because it directly impacts patient safety and well-being. We have been taking every possible opportunity to develop and hold workshops with pharmacy colleges. For instance, I have been associated with Jamia Hamdard, so I have conducted a lot of workshops there.
So, people who are coming out of medical and paramedical colleges are being sensitised to what pharmacovigilance is all about and what their roles and obligations are, which will really help us reach the stage where Europe and the US are today. And also, during certain weeks, like pharmacovigilance week or pharmacy weeks, we try to hold lectures in most pharmacy or medical colleges, so that, we create this type of awareness.

Drivers behind the shift to patient-centric pharmacovigilance

Prof. Moin:

The key driver previously was that it was known and felt that we were concentrating too much on the drug molecules and medical treatment itself, and patients were somewhat put on the back burner. So now, with all these new initiatives, we are ensuring that pharmacovigilance and drug safety are more patient-centric.

And that’s why when we talk about real-world evidence, patient safety programs, and all that, the patients are actually the focus of all these programs. And we make sure that their well-being, adherence to regimens, and any safety issues they might experience while using a particular molecule are brought upfront and in real-time, rather than pharmacovigilance depending entirely on spontaneous reports. And you don’t have any control over spontaneous reports.

So, these types of programs, like PSPs and registries, give you real-time safety issues with the drugs for which these PSPs are being run. So, that’s why we say this is now more patient-centric than drug-centric. And more proactive than reactive.

Mitan:

And if I can add to that, I believe that one of the major factors in the changes in pharmacovigilance, with patients really being at the centre, is patient education. I think patients today have access to so much information that they very rarely take medication without familiarising themselves with what it is.

And therefore, I think they also demand that the industry and healthcare professionals be considerate of the patient. So, I think there is a lot of proactivity from the patient side. And, you know, that certainly created a certain pressure on healthcare professionals. But I think it’s a good dynamic. What really comes to my mind, specifically with regards to DIA, when you look at the creation of DIA, it was created because of thalidomide, which brought the focus on patient safety and well-being.

And so, that is really at our core. That’s why one of the key elements for us is always to have patients, patient organisations, and advocacy groups at the discussions where DIA is present. Because patients are not just the object of discussion. They need to be a vital part, and determine, “Do I want the drug that causes so many side effects, or do I prefer three more years of life without these side effects?” So, I think patients are really becoming much more vocal and demanding.

Prof Moin:

And I think the knowledge available today, through Google and social media, is also increasing awareness. In fact, many times it happens that when they go to doctors, they are very well informed about the drug, its side effects, and adverse effects. So, that’s all because of social media.

Challenges in adopting patient-centric approaches in India

Prof Moin:

Patient awareness in India is still not low. But if you see the entire Europe, there are risk minimisation measures for certain molecules which have known risk. So, you cannot give this particular drug to the patient and doctors cannot prescribe until and unless the marketing authorisation holder has got an education program in place. 

So, they have to provide all the education material to doctors and patient. Patients are being told that these are the risks involved with this particular molecule and they are supposed to report back and the marketing authorisation holder is supposed to track all the patients and all the doctors whom they have given the training through education material. So, that’s how this is again becoming a patient centric.

For example, isotretinoin is normally used by young girls for acne. Now, in Europe, you will not get isotretinoin until and unless you fill an informed consent form. There is a post-marketing surveillance form, which has an informed consent form, which clearly states that it has got teratogenic effects, you should not get pregnant while using this drug and have to use very strong contraception. And before starting taking this drug, you have to have a pregnancy test done to ensure that you are not pregnant at this point of time. 

In India, you can get any drug from the pharmacy shop. Isotretinoin is a very trivial drug for India. So, that is the type of measures that advanced countries have put in place. Unfortunately this is not happening in India because of our literacy level and the burden of population. 

The influence of patient advocacy groups on policy

Mitan:

I think it is not only that. I believe that it is patient advocacy groups. I think this is coming because we are observing that we have been asked, can you connect us with the patient advocacy groups around the world. We had a meeting in Singapore last year. The first thing they wanted, is can you connect us with the patient advocacy groups. I believe that, and I see that in Europe, there are so many patient advocacy groups for say, breast cancer. Just imagine how many support groups there are for women. They are becoming very vocal and they educate themselves before they go and talk to the regulators, before they go and talk to the industry. They really come equipped with the latest knowledge and they demand that they are being put at the centre.

So, I think this will come also in the parts of the world. Maybe this is not yet the case. But the treatments are getting more progressive. Patients will also want to be more and more in control of what they are actually getting.

Prof Moin:

 In India, we hardly hear of any patient advocacy groups. They are very rare. So, I think through you people (media), we will have to really promote this particular culture, right to awareness, and people, patient advocacy groups and things like that, which will ultimately result in these types of measures coming up into the regulations itself. Actually, we are talking about the scenario where patient advocacy groups are kind of pushing for policy changes. Then they will push pharma companies, med device companies, etc. So, it’s actually then changing policies. 

Mitan:

Patient advocacy groups will also then put pressure on the regulators, who then in turn put pressure on the industry through the risk management plans, for example. You cannot launch the molecule if you don’t have a risk management plan for certain molecules that are high risk. So, I think the dynamic is certainly very good. 

Prof Moin: 

It’s a pressure group, a pressure lobby by the patient. But in India, the pressure lobby is the pharma company, and they lobby for their molecules. And there are many, many examples which I don’t want to go into. There are some of the drugs which were withdrawn, and because of the pressure lobby from the industry, those drugs were again introduced into India. 

Mitan:

And that might be one of the things for the next year for the DIA forum. We can think about inviting patient groups in India to talk about their issues, for example. 

Educating healthcare professionals on pharmacovigilance

Prof Moin:

Pharmacovigilance has not been included into medical syllabus, not even paramedical syllabus. Nurses are the first ones to interact between patients and drugs. Now, this year, Mumbai University has introduced one elective model on pharmacovigilance, in the final year. And that too is an elective module, meaning that if you want to take it, otherwise don’t take it. So, I think we have been talking to ICMR, and we have been talking at every platform, that medical and paramedical staff, those who are coming out, and those who are going to be the next generation of healthcare professionals, should know what pharmacovigilance is all about. 

So, until and unless they are sensitised, because they are the bridge between the patient, pharma industry and regulators. More than the doctors, it is the paramedical staff. 

Role of Regulatory Bodies in Supporting Patient-Centric Pharmacovigilance:

Mitan: 

Going back to my first comment, which is they directly bring patients into the scientific advice. When the industry is coming, either industry will bring the patients, or the regulators will invite patients. Patient advocacy, usually, these are not just the single patients from the street, but there are organisations where the patients are being trained on the subject, they are being trained on the regulatory frameworks, they have the right vocabulary. So, there are training programs for patient advocacy groups, for spokespeople, where they really ensure that the patient voice is at the table. 

Prof Moin:

With any regulations or something like that, they put it in front of all the stakeholders to comment. So, there again, they are open to comments. So, this again is they are reaching out to all the stakeholders. As a patient or as a patient’s lobby, you can definitely comment and you can propose some changes and all that.

Mitan:

In Europe, this is a normal thing. So, the European legislation is basically open call for any comments and contributions.

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