March 4, 2024
adequate supply of medicines, adjustment of therapy and posology, alternative treatments, Annual Report, anti-infective for systemic use, antineoplastics, Aris Prins, Class I medical devices, Class IIa medical devices, co-payments, compliance to public service obligations, compounding formulations, data transparency, definition of medicine shortages, Electronic Health Records, employee satisfaction, financial losses, generic substitution, immunomodulating agents, increase in demand of medicines, interruption of therapeutic treatments, joint notification, medicine shortages community pharmacists, medicines for alimentary tract and metabolism, medicines for the cardiovascular systems, medicines for the nervous system, medicines for the respiratory system, national pricing, non-reimbursable medicines, patients distress, PGEU, pricing policies, private expenditure, procurement strategies, reduced efficacy, reporting systems for medicine shortages, revision of the pharmaceutical legislation, security of the supply chain, shared electronic communication tools, shortage of medical devices, suboptimal treatment, survey, suspension of the manufacturing process, trust in the pharmacy, valorisation of investments
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.