survey Archives - European Industrial Pharmacists Group (EIPG)

Environmental sustainability: the EIPG perspective

Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

How AI is Changing the Pharma Industry and the Industrial Pharmacist's Role

Svala Anni, Favard Théo, O´Grady David The pharmaceutical sector is experiencing a major transformation, propelled by groundbreaking drug discoveries and advanced technology. As development costs in the pharmaceutical industry exceed $100 billion in the U.S. in 2022, there is a Read more

Generative AI in drug development

by Giuliana Miglierini Generative AI is perhaps the more advanced form of artificial intelligence available today, as it is able to create new contents (texts, images, audio, video, objects, etc) based on data used to train it. Applications of generative Read more

PGEU annual medicine shortages report

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The situation of medicine shortages is getting worse, with many countries which in 2023 experienced more issues than the previous years, according to the PGEU annual report on medicine shortages. Community pharmacists are on the front line to find suitable solutions to provide patients with the products they need to treat their diseases.

“Despite pharmacists continued best efforts to find solutions, shortages still leave many patients without their prescribed treatment – said PGEU President Aris Prins. – This situation causes frustration and inconvenience for patients and erodes their trust in pharmacists and in the healthcare system. They also cause stress for pharmacy staff and impose an additional administrative burden on pharmacies daily work”.

The main outcomes of the yearly survey
As every year, PGEU (the association representing community pharmacists at the European level) run a survey among its members to assess the current situation of medicine shortages. The survey was run between 4 December 2023 and 17 January 2024; 26 PGEU’s members provided their contribution to the 15 questions (1 answer per country).

All respondent countries experienced medicines shortages in 2023. Only three respondents reported positive improvements over the previous year (Cyprus, Greece and North Macedonia, representing 12% of the total), some other a stable situation (23%). In the great majority of cases (65%), shortages increased with respect to 2022, confirming the already known trend. Among the more significant data, the Netherlands reported 2.292 medicine shortages in 2023 (in comparison the 1.514 registered in 2022), a negative trend that impacted on 5 out of 13 million medicine users. A similar situation was reported by Sweden, where 2.457 packages were reported to be in shortage in September 2023, compared to the 1.615 in 2022. Spain also reported an increase in 36% of medicine shortages compared to the previous year.

The time spent by community pharmacies to deal with shortages almost tripled over the last 10 years, reaching an average of 10 hours per week in 2023.

The lack of anti-infective for systemic use (i.e. antibiotics) is particularly worrying, as it was experienced in 100% of the respondent countries. Slightly lower are data on shortages of medicines for the respiratory system (96% of countries impacted) and cardiovascular systems (92%). Other therapeutic classes often impacted at a European level are medicines for alimentary tract and metabolism, the nervous system, and antineoplastic and immunomodulating agents (77% of countries impacted, respectively). It is significant to note that, according to the report, there are no categories of medicinal products exempt from shortage issues.

The worsening of this trend is also acknowledged by the fact that in many responding countries (27%) the list of medicines facing shortages exceeded 600 references at the time of the survey, and was between 500-600 references in another 15% of countries.

The problem is not only referred to medicines: medical devices are also concerned, with shortages in community pharmacies reported by 69% (+3% vs 2022) of the countries participating to the survey. In this case too, all classes of medical devices are touched by the problem, with higher percentages for Class I (low risk devices – e.g. bandages, thermometers, surgical face masks) (27%) and Class IIa (medium risk devices – e.g. lancets, needles, short-term contact lenses) (23%). In the case of medical devices, only two countries reported the existence of a specific system to monitor shortages.

The impact for patients and community pharmacies
Patients are hardly impacted by medicine shortages. According to the PGEU report, distress (100% of respondent countries) and interruption of therapeutic treatments (88%) are the more frequent inconvenience. In many cases, patients have no other alternative than to buy other more expensive or non-reimbursable medicines (73%), thus increasing the rate of private expenditure for co-payments. The survey also highlights the occurrence of suboptimal treatment with reduced efficacy (73%), a practice that might negatively impact on patients’ health.

These issues can also lead to patients losing trust in the pharmacy, a negative effect reported by 77% of participating countries; employee satisfaction may be also impacted (73%). A very high percentage of countries (92%) indicated that community pharmacies may experience financial losses linked to medicine shortages, due to the dedicated amount of time needed and increased administrative responsibilities.

According to the report, disruption/suspension of the manufacturing process (65%), national pricing and procurement strategies (62%), and unexpected/high increase in demand of medicines (50%) are the main causes identified by pharmacists leading to medicine shortages. In the majority of countries (69%) there are already reporting systems in place for community pharmacists to report shortages.

Different solutions for different countries
It is worthwhile to note that only 46% of countries participating to PGEU’s survey have a commonly accepted definition of medicine shortages at the national level. This definition is incorporated in the national legislation in 19% of cases. Significantly, 35% of respondent countries still do not apply a standardised definition for shortages.

The PGEU annual report also assessed the solutions available to community pharmacists in different countries. Generic substitution is a very diffuse practice across Europe (92% of respondent countries), while far less often encountered are the preparation of compounding formulations (50%), or the adjustment of therapy and posology with a different strength of the same medicine (50%). Both these practices may require the issuing of a new prescription by the doctor in charge of the patient. Some countries are experiencing new approaches to simplify the process. In Germany, for example, a new legal basis was created to allow pharmacists to deviate from the medical prescription without consulting the prescribing doctor upon certain conditions in case of a shortage.

PGEU also calls the European and national institutions to adopt urgent and ambitious measures to better address medicine shortages. The availability of a timely and adequate supply of medicines to patients should be the first priority, to be included in the ongoing revision of the pharmaceutical legislation. This last one should put patients’ interests over commercial ones. An improved compliance to public service obligations of supply chain actors would be also required, as well as the impact of pricing policies on medicines availability and on the security of the supply chain.

Shared electronic communication tools between pharmacists and prescribers (i.e. electronic health records) may prove important to possibly expand the role of pharmacists to handle shortages, by allowing them to substitute the missing product with the most appropriate alternative. Reporting, monitoring, and communication on medicine shortages should be also improved according to PGEU, with action to be taken both at the central (EMA) and national level, e.g. working at increasing the efficiency and effectiveness of joint notification and assessment practices. A greater transparency on shortages data would be also appreciated by community pharmacists, to be achieved in each country through the connection of all medicine supply chain actors and national competent authorities in consistent reporting systems. Last, but not least, PGEU asks for a better recognition and valorisation of investments made by pharmacists and pharmacies to manage shortages.

Trends for the future of the pharmaceutical manufacturing

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

By Giuliana Miglierini

The technological evolution of pharmaceutical manufacturing towards the full implementation of the Industry 4.0 paradigm is rapidly advancing. Digitalisation of productions is supported by the wide spread of automation, devices connected to the Internet of Things, and machine learning algorithms able to keep entire processes under control. Looking at pharmaceutical development, new types of treatments are emerging, also requiring a retuning of current approaches. Results from a survey among experts and industry insiders (56 respondents from 13 different countries) run by Connect in Pharma show new challenges are to be faced in the incoming years by the pharmaceutical industry in order to maintain its market position.

The combined value of the global pharmaceutical market in 2022 is estimated to be approx $650 billion. The main component reflects pharmaceutical manufacturing (US$ 526 billion in 2022, data Insight Slice), while the global pharmaceutical packaging market value is roughly US$131 billion (data Fact.MR).

Many different factors supporting the transformation of pharmaceutical manufacturing have been identified by Connect in Pharma, ranging from ageing of population to Covid19 and Ukraine crisis, to climate change and pressures on energy costs, up to the shortage of healthcare professionals. The final conclusions and opportunities identified by the report indicate new partnerships and collaborations (mainly with startups, and small and medium-sized companies) will remain fundamental to support competitiveness, together with growing investments in tech-driven innovations. Involvement of patients and healthcare professionals in identifying unmet needs and optimal solutions is another item to be considered in order to increase adherence to therapy, suggests the report.

Digitalisation still waiting to full exploit its potential

Innovation in automation and digitalisation of processes has been introduced in the pharmaceutical sector at a slower pace compared to other industrial sectors, due to its higher regulatory barriers. About one third (28%) of respondents to the survey indicated their companies are developing artificial intelligence (AI) or other digital tools for application in the manufacturing and packaging process. The main drivers towards the implementation of such systems are more efficient data collection, reduction of manufacturing down times and human errors, and the use of machine learning to support continuous manufacturing. Better workflow integration and anticounterfeiting, and the ability to share supply chain data with regulators are also relevant. These are all objectives that would need to provide new specific training to the workforce, e.g. on AI or tools for augmented reality.

One of the main barriers that, according to the report, is still slowing down the full potential of AI and digitalisation in the pharmaceutical industry is represented by the need to comply to regulations, including data integrity and security. The human factor may also prove relevant, as many people (including top management) may be reluctant to accept this change in technology. The availability of data scientists with a deep knowledge of the pharmaceutical sector is another critical point to be addressed.

Advances in drug delivery technologies

Connect in Pharma’s report also shed light on some drug delivery technologies that, despite not being an absolute novelty, are gaining relevance for the development of new products and treatments.

The moving of pharmaceutical pipelines towards a continuously increasing number of new biologic / biosimilar products, including mRNA-based and gene therapies, requires the availability of manufacturing and packaging capacities able to accommodate the specific needs of such often very unstable macromolecules. New drug delivery systems have been developed in recent years to provide answers to this need, among which is inhalation technology.

Dry powder inhalers and nasal delivery devices are the preferred formulations for the 50% of respondents to the survey that indicated actions are ongoing to develop new products using inhalation technologies. According to the report, these devices might prove particularly useful to deliver drugs that need to rapidly pass the blood-brain barrier in order to become effective, as well as for the delivery of vaccines. Fast absorption and higher bioavailability compared to other routes of administration are other elements of interest for inhalation technologies, which is also believed to be able to contribute to the reduction of carbon footprint.

Once again, the regulatory environment resulting from the entry into force of the EU Medical Devices Regulation (especially for drug-device combination products), together with the need to demonstrate patient safety and satisfactory bioavailability of these devices, are among the main barriers to their development, says the report. Inhalation technologies may also give rise to a new generation of delivery devices connected to the Internet of Medical Things (IoMT).

Another major trend identified by Connect in Pharma refers to the development of new drug delivery systems for injectable medicines (50% of respondents). This area is greatly impacted by the entry into force of the revised Annex 1 to GMPs, on 25 August 2023, that will increase the requirements for aseptic manufacturing. According to the report, main areas of innovation in this field may include new devices for injectable drug delivery, namely targeted to diabetes (the leading area of innovation), intravitreal ocular injection, autoimmune diseases, oncology, respiratory therapy, and pain management.

Connected devices

Diabetes is a highly relevant field of innovation also with respect to the implementation of connected devices, those embedded sensors and electronics allow for the real-time collection of data on self-administration of the therapy by patients, and their forwarding to health professionals. AI algorithms further enhance the potential of connected devices delivering diabetes treatments, as they support the real-time monitoring of insulin concentration in blood, and the consequent level of insulin delivered by the device. According to Connect in Pharma, other positive characteristics arising from the use of connected devices refer to the possible increase of patient adherence and compliance to treatment, resulting in improved patient outcomes and more personalised treatment.

Regulatory barriers are once again a main burden to the wider spread of connected devices, says the report, due for instance to the ultimate control over the sharing of data, and the choice if to implement single-use or reusable devices. Manufacturing costs, cybersecurity, and patient hesitancy are other hurdles identified by respondents to the survey.

The challenges for sustainability

The green policies put in place especially in the EU are calling industry to revise its processes and products to decrease their environmental impact, improve sustainability of manufacturing and packaging processes, so to eventually meet the climate targets fixed for 2050. According to the report, the global healthcare sector would be responsible for 4.4% of global net emissions. Connect in Pharma’s survey indicates 66% of involved companies are working to implement more sustainable practices. These may include for example the use of recycled materials in secondary packaging, the implementation of energy efficient technologies, and the development of more ecofriendly drug delivery systems. Costs have been identified as the main barrier to transition, together with the lack of common definitions. According to some of the experts, a wider use of data to monitor manufacturing systems and processes may help in improving the overall efficiency and in lowering the carbon footprint. Transport, for example, has a great impact on the sustainability of packaging.