The Role of a Pharmacist

Last week I attended the annual main event for pharmacists in Finland, Farmasianp?iv?t at Messukeskus in Helsinki. While the majority of the time was spent on catching up with old colleagues and networking with other pharmacists, it was also a possibility for me to learn about the latest advancements in the field of pharmacy. It also made me think about the role of pharmacists at Tepsivo and the roles in general.

The educational background thought process started when I had to decide who should I ask if they want to attend Farmasianp?iv?t. Tepsivo currently has four pharmacists but also a couple of colleagues who are not pharmacists in Finland. Farmasianp?iv?t is aimed at pharmacists, but the entry is not prohibited from non-pharmacists.

Different Kinds of Pharmacists

In the end I decided to invite pharmacists only as I was thinking the event would be most relevant for them. But even that was not clear cut, because there are different kinds of pharmacists in the world.

If you have a pharmacy education from another country in the EU it might not be exactly the same training you would receive in Finland, but you should be able to get a pharmacist license (if you pass the language test, which is another story) to work as a pharmacist in a Finnish pharmacy. If you have a degree outside of the EU, the courses and training you have passed, might not be eligible for being licensed as a pharmacist in Finland, even if you managed to learn the language. For the purpose of this particular event, there was not a big difference, but there was a small area accessible only for pharmacists that were licensed to dispense in Finland.

Does the Educational Background Matter?

In a company like Tepsivo the educational background and profession of people often does not matter that much. There are no strict educational requirements for specific roles. We have more skill based requirements in our job descriptions. Pharmacists, doctors, economists, engineers, lawyers and all kinds of other professionals work together in specific roles that are not necessarily related to the educational background or the professional degree one possesses. Most people have multiple roles and job descriptions meaning that from a traditional point of view you could think they have multiple jobs because the employees are required to possess multiple skillsets.

I can easily see an analogy between running a company like Tepsivo and running a pharmacy in Finland (I can also see a long list of differences). The number of employees is in the same range, the annual turnover is in the similar figures and most importantly you are working with medicinal products, medical devices and products that are similar to these and can slip into the usual processes, but are actually somehow different, for example herbal and homeopathic products.

One of the big differences is that Tepsivo does not consist only of pharmacists and pharmaceutical technicians. This adds an additional challenge, because you might not be able to fully understand and utilize the educational and professional background of all the employees. In a pharmacy, it is much easier because the pharmacist knows what the freshly graduated pharmacists have learned in the university, and they can also tell what the senior pharmacists knows based on the years of experience and previous specialty tasks they have held at a pharmacy.

Identity of a Pharmacist in the Outside World

The true professional identity of a pharmacist or a doctor in a pharmacovigilance organization like Tepsivo is a thing that does not come up much except maybe during Teams calls where the people introduce themselves very thoroughly and you might mention that you are a pharmacist who has worked in the industry for 10 years in these and those companies. This can be a subtle way of communicating to a future colleague or a stakeholder that you two have a similar background and it is much easier for you two to get on the same page, even if your companies, nationalities and other backgrounds are completely different.

Some Organizations Need a Pharmacist

Service Provider companies like Tepsivo can legally be owned and managed by anyone. There are no legal requirements (related to the profession) to become a managing director or to own a pharmacovigilance service provider company. However, because we operate in a highly regulated field, the requirements for certain types of roles and people in management positions can be easily required, if the company ventures off from pharmacovigilance to regulatory affairs and starts to dabble in marketing authorization applications and transfers, for example.?

According to the Finnish legislation a pharmacy license can be owned only by a licensed pharmacist. In practice there is much more to actually getting the license. You have to compete for the license (often for years) against other pharmacists in a competition where your educational and professional background are the game chips.?

There are other kinds of companies that can only be managed by a pharmacist or they must have a pharmacist in a management role: Hospital pharmacy can be managed only by a pharmacist. The qualified person of a pharmaceutical manufacturer must be a licensed pharmacist or have another suitable higher education degree. The qualified person of a pharmaceutical wholesaler must be a licensed pharmacist.

Pharmacist in the Industry

The EU Directive Directive 2001/83/EC states that one of the requirements for acquiring manufacturing authorization is to have a qualified person, who has a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by one of the EU Member States, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.

In the pharmacovigilance sector, it is easy to confuse the requirements for a Qualified Person (QP) for pharmaceutical manufacturing with a qualified person for pharmacovigilance, especially if you are researching the requirements of a country whose legislation and guidelines you are unfamiliar with. The EU Regulation No 726/2004 states that the holder of an authorisation for a medicinal product for human use? (marketing authorization holder) shall have permanently and continuously at their disposal an appropriately qualified person responsible for pharmacovigilance (QPPV). But the same regulation does not define any professional or educational requirements for the QPPV.

The requirements for QPPV role are defined in the Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC. According to the implementing regulation, if the QPPV has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC (At least six years of study or 5 500 hours of theoretical and practical training provided by, or under the supervision of, a university), the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance is assisted by a medically trained person. The implementing regulation also states that the marketing authorization holders shall ensure that the QPPV has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities.

Other countries and other processes in the pharmaceutical industry might have legislative requirements related to the educational background of the person appointed to the role. In some companies it might be a practice, that certain internal roles or positions have a requirement that the person is a pharmacist or a doctor, to ensure that they have a certain level of knowledge and competence without having to test this in job interviews or having to go through year-long training programs. And of course there are also companies that give their employees the possibility to use some of their time to go through extra-curricular courses to gain additional knowledge or certifications.These certifications for people then act as a short-cut to better positions.?

I guess my main point is that Farmasianp?iv?t was once again more educational and useful event than I would have thought. Attending the event made me think about the different kinds of roles that one can have and what those roles mean to me and others, both at work and outside of work. Pharmacist is definitely one of those roles I'll have my whole life, even if I never identified with the role very strongly. Thinking too much about roles and their meaning to us as individuals might take anyone down a rabbit hole but sometimes they are really useful and even required.