“It’s the most wonderful time of the year“, sung Andy Williams for the first time in 1963. And so it should be, were it not for the remarkable fact that I find myself penning these end-of-year reflections between the latest FMD Implementation Workshop and the debate in the House of Commons of the United Kingdom on the Brexit withdrawal agreement and the framework for the future relationship between the European Union and the United Kingdom.
These two major issues have commanded considerable attention within the pharmaceutical and healthcare community for some months now, with certainly one principal reason for this being the impact that these concurrent events will have on the medicines supply chain and hence, inevitably, on the accessibility and availability of medicines. These are also matters that continue to be a source of great concern for all stakeholders, with equality of access to innovative medicines being just one from amongst the many healthcare topics that, only a few days ago, Romanian Health Minister Sorina Pintea outlined as objectives for the upcoming Romanian Presidency of the European Council.
Yet in the midst of all of these challenges, a troubling behavioural trend threatens to emerge – one that is by no means unique to the pharmaceutical sector, or even to our times – although the increased visibility afforded by the digital world and online social media would make it seem to be the case. It is the positioning of those who, in preparation for a potential perfect storm that is yet to develop, are already seeking to point the finger of blame to ensure that they are exculpated from the consequences in the aftermath of the storm.
J’accuse? No – not at all. After all, it is part of the quality culture that forms an integral part of the pharmaceutical sector to perform an honest root cause analysis and shoulder one’s responsibilities, but it should also be imbued in this culture to adopt the appropriate mentality as part of any preventive action to move forward in the right direction.
In these times, I find inspiration in the words – coincidentally also uttered in 1963 – of former United States President John F. Kennedy, who said “I also believe that we must re-examine our own attitude … for our attitude is as essential as theirs.”
So, in this spirit of self-reflection, which is particularly apt for this time of the year, I choose to believe. I believe that we are not perfect, and that even with the best intentions, objectives and planning, we sometimes make honest mistakes, or do not quite achieve our objectives. I believe that no matter how great the challenges and the difficulties, if we unite our efforts, instead of building walls, we can find solutions to any problem. Above all, I believe that if we remember that our ultimate common aim is to ensure the well-being of patients through continued accessibility and availability of medicines to cure their illnesses, we can all work together to achieve this goal.
Last, but certainly not least, I believe that the ability to reach out in friendship is key to this mutual understanding and collaboration. Therefore, in friendship, I extend to all of you and your loved ones my personal best wishes, and those of EIPG, for a serene Christmas Season and a fruitful New Year.
Survey on satisfaction from EIPG’s monthly newsletter
It was a pleasure to have you with us during the whole-year journey we made in the pharmaceutical world with our monthly newsletter. This newsletter gave us the opportunity for a regular communication with you and allowed your national pharmaceutical associations to promote their outstanding issues to the rest of the European pharmaceutical community.
Now comes the time to also give voice to each individual member of EIPG to help us improve this newsletter and take it to the next level. Following this link, you will be prompted to invest a couple of minutes of your time to give us your feedback, allowing this newsletter to cater more to your needs.
Advisory Group on the Education of Industrial Pharmacists
Modern and contemporary education on industrial pharmacy, as well as the competencies and know-how of students are really important matters for EIPG. We want to open discussion and support universities and other educational stakeholders to develop studies of industrial pharmacy.
We have been talking about the competencies that are needed when working as a professional in pharma industry, which is a constantly evolving environment and how students must be able to respond to the needs of this hectic and changing environment.
The pharma industry constantly needs new skills to cover all the main aspects of the roles requested in the pharma industry (not only regulatory, research & development and the QP but also market access, pharmacovigilance, operations, quality management, procurement, warehousing, distribution (GDP), financial and legal aspects). We have an understanding and concern that only a part of these fields is covered by current university degrees and frequently a specific Masters degree is needed in order to get deeper and more comprehensive knowledge.
We would like to express concerns that developments in the pharmaceutical industry are proceeding at a very fast rate and that consequently current emphasis devoted to such aspects of education of the profession in pharmacy curricula run the risk that future graduates in pharmacy may no long acquire the necessary knowledge and skills to ensure the adequate knowledge that training for pharmacists should provide, and that may furthermore hinder the access of pharmacists to professional activities in the pharmaceutical industry without the acquirement, not only of additional professional experience but also additional higher education. In view thereof, we confirm our interest in an advisory group on seeking a way forward to ensure the continued future role of pharmacists in the pharmaceutical industry.
EIPG hereby announces an interest in an Advisory Group that would work with EAFP (European Association of Faculties of Pharmacy). We need the support of more members and experts besides those from the EIPG Bureau to have a wider and more pan-European input. It would also be best if the Advisory Group could be put in place soon.
Would YOU be interested to join to this Group and give your input to this important initiative? If yes, please email to Vice-President of Education and Careers, Anni Svala (firstname.lastname@example.org).
EIPG contribution to Moglynet Summer School
MOGLYNET (“Modulation of glycolytic flux as a new approach for treatment of atherosclerosis and plaque stabilization: a multidisciplinary study”) is led by a Consortium of Universities, in cooperation with a few pharmaceutical companies and professional associations. It is a Horizon 2020 joint doctoral project. The programme was launched in 2015 with the aim of providing 12 early stage researchers with innovative PhD training in Drug Discovery and Development.
It aims to define a new joint PhD educational model in Drug Discovery and Development and to promote institutional cooperation and mobility. The research methodologies and approaches proposed by the MOGLYNET Consortium are strongly multidisciplinary and involve a number of different state-of-the-art technologies and methodologies. An active contribution of industry in training activities is an important feature of the programme.
EIPG was invited to support the project and to offer training by industrial pharmacists from its network. In September, a “Summer School on Pharma Skills” was organized in Varese (Italy) with the purpose of training the PhD candidates on three main topics:
- Working in a team
- Intellectual property and technology transfer
- Pharmaceutical quality system
Fifteen qualified professionals, with specific experience in human resource management, intellectual property rights and quality management were invited to this summer school which was organized in three sessions over four days, including either lessons and working groups.
EIPG was invited to contribute to this initiative with speakers on pharmaceutical quality topics, focusing on GMP of active substances and on the supply chain of medicinal products.
Piero Iamartino (EIPG Vice-President Technical and Professional Development) and Maurizio Battistini (EIPG Vice-President of European Affairs) attended the event and made presentations on behalf of EIPG.
At the opening session, Piero Iamartino and Maurizio Battistini introduced the PhD students to EIPG and its activities, highlighting the important role played by industrial pharmacists operating in the different areas of the European pharma industry. They emphasised the current actions taken by EIPG to promote the professional education of young pharmacists through collaborating with EPSA (European Pharmacy Students Association) in organising discussion meetings and webinars to help students better understand the present industrial requirements.
In the Quality Session, Piero Iamartino gave a presentation on “GMP in the production of Active Pharmaceutical Ingredients (APIs)”, with the purpose of explaining the main features of active substance manufacture and the interaction with medicinal product manufacture.
In introducing the topic, a comparison between API production and dosage form manufacture was presented, highlighting the different criticalities in terms of process steps, unit operations, plant configurations, equipment used, safety and environmental impact of manufacturing activities. Attention was drawn to the purification and finishing process steps of an API production, where the final chemical and physical profile is determined.
Reference was made to the current GMPs for APIs and the main requirements and actions to be taken in order to comply with these guidelines.
The critical issue of the choice of the API starting material and the principles of quality were presented, emphasising the adoption of risk management, which should to be applied from the development phase in order to manage all critical steps at the industrial level.
The safety issues in API manufacture were discussed, including the frequent use of containment systems for operator protection, resulting from the increased number of highly potent APIs to be handled.
The main features of crystallization were presented as the most common purification step, with reference to the official requirements for impurity profile.
The final part of the presentation was focused on the finishing steps (milling, micronisation, sieving), where the API physical characteristics are defined and become a critical quality attribute. Thus, the interaction between the API and medicinal product manufacturers is to be promoted to ensure a successful drug product manufacture.
Maurizio Battistini presented “The Supply Chain for Medicines” in order to illustrate the peculiarities and different management aspects that characterize the pharmaceutical supply chain.
He highlighted that the supply chain of medicines has two significant aspects which influence all operating steps: the goods which are treated (medicines) and the final customer (patient). All main steps (procurement – manufacturing – storing – supplying – importing – exporting) require qualified actors, whose performance is based on specific authorizations and the compliance with pharmaceutical guidelines.
The aforementioned aspects are associated with the principles of traceability, correct preservation and the availability of data and their integrity.
The complexity of the medicine distribution chain was underlined, considering the multiplicity of actors involved (manufacturers of active ingredients, excipients, packaging materials – manufacturers of medicines – warehouses – distributors – hospitals – pharmacies – patients) and the fact that all of them, while pursuing the same purpose, have different backgrounds and are located in different places, often far from each other.
The main challenges of this chain were illustrated, with reference to: licences, authorizations and other regulatory aspects, complexity and diversification of the product portfolio and their characteristics, price regulation, systems for traceability / serialisation of products, complaints and recalls from the market.
An analysis of the vulnerability of the process was provided, presenting some practical cases that have occurred and referring to major problems to be considered in managing the distribution chain.
Good Distribution Practices (GDP) were introduced as the regulatory tool to keep the pharmaceutical supply chain under control, thus avoiding the risks reported in the introduction: “GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorized or entitled to supply medicinal products to the public”. It was emphasized that the two main pillars of GDP are the correct conservation/distribution of medicines (and their precursors) and traceability throughout the entire distribution process.
A more detailed description of the concept of falsified medicine serialisation was presented (end to end model and full traceability) and the various actors involved in the supply chain (suppliers, manufacturers, warehouses, wholesalers, hauliers, hospitals, community pharmacies).
The introduction of these elements illustrated the main processes (receipt of drugs, control and storage, customer order management, preparation and shipping) and ancillaries processes (management of “returned” products and “recalls”, self-inspections and external audits, qualification of premises and equipment, management of complaints and non-compliance) that qualify the primary distribution. In the pharmaceutical field this is characterised by: adequate infrastructure – responsible person – suitable documentation system and quality system / certification.
Given the characteristics of the pharmaceutical sectors distribution chain, the ten chapters of GDPs were presented with the purpose of providing the PhD candidates with the key elements of each chapter and the motivations behind them.
The session ended with a description of some of the main risks to be taken into account in the distribution chain of medicines (supply continuity – vendors qualification and compliance issues – management of second tier suppliers – pest control in warehouses – temperature control during warehousing and transportation – change control – Fraudulent Activities in the Supply Chain). A reference was made to the Security Tool Kit recently issued by FDA for a more secure and rigorous control of the pharmaceutical supply chain.