Article Text
Abstract
Aims and objective The aim of the European Association of Hospital Pharmacists (EAHP)’s 2023 shortages survey was to collect data on causes and mitigation strategies of shortages of medicines and medical devices and their impact on patient care. The survey targeted hospital pharmacists (HPs), physicians (PHYs), nurses (NRS) and other healthcare professionals (OHCPs). A separate set of questions addressed patients (PTNs).
Methods A 49-question survey was carried out by a team at EAHP, collecting information from European HPs, PTNs, NRS, PHYs and OTHCs on shortages of medicines and medical devices in their respective countries. The survey ran from 27 February to 19 May 2023. The results were analysed by EAHP.
Results There were 1497 HP responses to the 2023 survey. While 95% (n=1429) of HPs and 86% (n=127) of OHCPs consider medicine shortages an ongoing problem, 84% (n=48) of PHYs and 68% (n=15) of NRS also agreed. Shortages of active pharmaceutical ingredients (77%, n=1148), manufacturing (67%, n=1007) and supply chain problems (50%, n=752) are major causes of shortages according to HPs as well as NRS and OHCPs; PHYs (49%, n=18) consider pricing to be the driver. More than 60% (n=765) of HPs, 55% (n=11) of NRS, 57% (n=30) of PHYs and 46% (n=56) of OHCPs experienced shortages of medical devices in 2022. Antimicrobials were most affected, according to all respondent groups, followed by analgesics, anaesthetics, cardiovascular and paediatric medicines. HPs (59%, n=269), NRS (57%, n=4), OHCPs (56%, n=37) and PHYs (54%, n=14) consider delays in care as the main consequence of medication shortages.
Conclusions Shortages of medicines and medical devices affect healthcare services and patient care. Increased transparency and access to information regarding ongoing and emerging shortages as well as better preparedness of healthcare professionals is crucial to their effective management.
- PHARMACY SERVICE, HOSPITAL
- PUBLIC HEALTH
- Quality of Health Care
- HEALTH SERVICES ADMINISTRATION
- Health Care Rationing
- EDUCATION, PHARMACY
Data availability statement
Data are available upon reasonable request.
Statistics from Altmetric.com
- PHARMACY SERVICE, HOSPITAL
- PUBLIC HEALTH
- Quality of Health Care
- HEALTH SERVICES ADMINISTRATION
- Health Care Rationing
- EDUCATION, PHARMACY
WHAT IS ALREADY KNOWN ON THIS SUBJECT?
Medicine shortages occur frequently and affect all pharmacological groups, particularly antibiotics.
The multifaceted nature of shortages makes their effective management difficult.
The major impact of medicine shortages is delayed care, cancellation of care and suboptimal treatment due to therapeutic substitution initiated by medicine shortages.
WHAT DOES THIS STUDY ADD?
Shortages of medical devices occur as frequently as medicine shortages.
Critical medicines are often affected by shortages.
Compared with previous years, the proportion of patients with delayed care, cancellation of care and suboptimal treatment as a major impact of medicine shortages has increased.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY?
The frequency and type of medicine shortages, including shortages of critical medicines, shown by this survey may be indicative of how useful and feasible the existing policy measures are to overcome shortages in Europe.
Feedback given by healthcare professionals on existing mitigating strategies for shortages and their impact on patient care may prove useful for changing the everyday practice and detect gaps in healthcare professionals’ preparedness to respond to future shortages.
This study, developed throughout more than a decade, can be implemented in other healthcare settings across the world where similar surveys on shortages have not yet been conducted.
Introduction
Shortages of medicine and, more recently, of medical devices have been a source of concern for public health globally and across Europe since the 2000s.1 2 The number of medicines affected by shortages grew rapidly throughout the previous decade across European countries, affecting community and hospital pharmacy settings.3 Shortages have increased in severity and persistence, particularly among generic medicines and sterile parenteral medicines. Parenteral antimicrobials, central nervous system, cardiovascular and oncology medicines, and immune modulating agents represent more than 50% of all shortages in Europe.4 Severe and critical medicine shortages result in delaying, cancelling or reallocating treatments or procedures which threaten patient care, and are accompanied by an increased risk of adverse reactions, harm and increased healthcare costs.5
The European Association of Hospital Pharmacists (EAHP) has carried out a series of surveys since 2014 on medicine shortages with the aim of elucidating the main drivers of shortages, their impact on patient care and mitigation pathways that may minimise the effects of the shortages.6 The EAHP’s surveys proved that the number of hospital pharmacists (HPs) facing shortages grew throughout the years with 86% of HPs in 2014 and 95% of HPs in 2023 confirming that shortages are a major burden in delivering the best care to patients.6 7
The policy landscape around medicine shortages in the EU has significantly changed over the last few years, including research initiatives and new legislation mechanisms aimed at mitigating shortages, such as the European Medicines Agency (EMA) extended mandate, the European Commission (EC) study on shortages and the EC-led structured dialogue on security of supply of medicines, including the EC’s pharmaceutical strategy for Europe and the newly established Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).1 8–13 In spite of this, healthcare professionals (HCPs) and patients are facing many challenges in order to mitigate shortages. These include access to information, communication on shortages, alternatives, health risk assessment, continuity of care and follow-up of patients throughout a shortage.14–16
As was the case with previous EAHP surveys, the 2023 EAHP shortages survey has continued to explore the complex nature of shortages in hospitals, including shortages of medical devices for the first time. Moreover, each segment of the management of shortages that may alleviate them was examined, beginning with access to information on shortages and assessment of hospital preparedness to manage a shortage, procurement modalities, conducting risk assessment and creating a list of critical medicines in addition to contingency plans.
Methodology
EAHP created and carried out the 2023 shortage survey using Survey Monkey (https://www.surveymonkey.com/r/EAHP2023ShortageSurvey). The survey questions were made available in Czech, English, French, Hungarian, Romanian, Serbian and Spanish. The online questionnaire along with its objectives and timeline was distributed via a continuous advertising campaign on social media (Facebook, Instagram, Linkedin and X (formerly Twitter)) and via the EU monitor to facilitate engagement of individual HPs, patients (PTNs), physicians (PHYs), nurses (NRS) and other healthcare professionals (OHCPs) across Europe to collect information on shortages in their respective countries. Data from these groups were collected between 27 February and 19 May 2023. A separate set of questions was addressed to PTNs. The results were analysed by EAHP. Where possible, depending on the question, comparisons with the results of the 2014, 2018 and 2019 surveys were carried out.
Results
Responses to EAHP’s 2023 Medicines shortages survey were received from 58 countries, including EAHP’s 36 member countries. The responses from the 22 countries not represented by EAHP, which included many located in Africa, were not taken into account for the analysis of this survey.
HPs submitted 1497 responses to the 49 questions posed by the survey. Information on the response rate per country to EAHP’s medicines shortages surveys in 2014, 2018, 2019 and 2023 is shown in table 1. While the response rate between 2018 and 2019 increased, it decreased between 2019 and 2023.
Medicines shortages and their extent
A large majority (95%, 1429/1497) of the HPs participating in the EAHP’s 2023 shortages survey agreed that medicine shortages are frequently encountered in their hospital compared with 2019 (95%, n=2036) and 2018 (90%, n=1429). While the majority of OHCPs (86%, n=127/148) agreed that medicine shortages are a problem, only 68% of NRS (n=15/22), similarly to 2019 (62%, n=92), shared this view. The number of agreeing PHYs increased from 71% in 2019 to 84% (n=48/57) in 2023.
In comparison to 2019, HPs still perceived the same probable reasons for medicines shortages, such as the global shortage of an active pharmaceutical ingredient (API) (77%, n=1148/1497; 72% in 2019), manufacturing problems (67%, n=1007/1497; 72% in 2019) and supply chain problems (50%, n=752/1497; 49% in 2019) as their top three answers. The top three answers were the same in 2023 as in 2019 for OHCPs, with 74% (n=109/148) choosing global shortage of API as one of the causes of medicines shortages, 58% (n=86/148) selecting manufacturing problems and 55% (n=82/148) opting for supply chain problems. For PHYs, the main drivers of shortages were the price of a medicine (49%, n=18/57) as in 2019, followed by manufacturing problems (46%, n=26/57) and the global shortage of API (39%, n=22/57). Similar to HPs, NRS opted for the global shortage of an API (59%, n=13/22), manufacturing problems (27%, n=6/22) and supply chain problems (27%, n=6/22) as the top three drivers of medicine shortages (figure 1).
More than two-thirds of the HPs (76%, n=790/1037) selected antimicrobial agents as medicines most commonly in short supply in their hospitals, an increase compared with 63% in 2019, followed by analgesics (43%, n=441/1037) and anaesthetic agents (37%, n=384/1037). The latter had been in third place in 2019, while analgesics and oncology medicines that were now ranked fourth (35%, n=368/1037) changed places.
The findings for PHYs, NRS and OHCPs differed from those for HPs. While all identified antibiotics as most affected by shortages (NRS (63%, n=12/19), PHYs (50%, n=22/44) and OHCPs (67%, n=68/101)), anaesthetic agents and blood products (both 32%, n=6/44) ranked second for PHYs, followed by analgesics and cardiovascular medicines (both 26%, n=5/44). For NRS, anaesthetic agents (32%, n=6/19) came in second place. As for PHYs, analgesics and cardiovascular medicines ranked third (both 26%, n=5/19). The second most selected option by OHCPs was analgesics (33%, n=33/101). Paediatric medicines (30%, n=30/101) came third (figure 2).
As the assessment of medicine shortages criticality plays an important role in addressing medicine shortages, in the 2023 Survey a new set of questions on shortages of critical medicines, which should never occur, was introduced. Such a shortage was experienced by 35% of HPs (n=473/1352) 1–3 times in 2022, followed by 29% (n=387/1352) who experienced a shortage at least 4–6 times and 25% (n=336/1352) who experienced a shortage >10 times in 2022. There was a shortage of a critical medicine most often for PHYs (42%, n=24/57) and NRS (50%, n=11/22) 1–3 times in 2022. Only OHCPs (43%, n=64/148) experienced such a scenario >10 times in the same year. Based on the survey responses, lists of critical medicines are not commonly established in hospitals with almost half of the HPs (48%, n=645/1352) reporting not having such of a list, while NRS (50%, n=11/22), OHCPs (49%, n=73/148) and only 37% (n=21/57) of PHYs opted to have such a list in place, which makes the latter equally as unprepared as HPs.
Apart from experiencing shortages of critical medicines, survey respondents also graded the severity of the shortages, with HPs and OHCPs scaling from a moderate impact (HPs (48%, n=303/627); OHCPs (47%, n=31)) to a severe impact (HPs (31%, n=195/627); OHCPs (29%, n=19/66)) and down to a mild impact (HPs (20%, n=124/627); OHCPs (23%, n=15/66)). For NRS, a mild and moderate impact (both 43%, n=3/7) ranked equally high followed by a severe impact (14%, n=2/7). No NRS or PHYs selected ‘no impact’. The scale for PHYs was mild (46%, n=12/26), moderate (38%, n=10/26) and severe (15%, n=4/26) (figure 3).
Medical device shortages
More than 61% (n=765/1251) of HPs and more than 50% of PHYS (n=30/53) and NRS (n=11/20) experienced medical device shortages in 2022 compared with 46% (n=56/121) of OHCPs. HPs consider supply chain problems (53%, n=658/1251) and the shortage or discontinuance of a component, part or accessory of the medical device (48%, n=603/1251) as two main causes of medical device shortages. The same answer was provided by OHCPs with 42% (n=51/121) opting for supply chain problems and 34% (n=41/121) selecting a shortage/discontinuation as the cause. For PHYs (47%, n=25/53) and NRS (45%, n=9/20) the price of the device was considered to be the principal cause of shortages followed by the procurement/tendering procedure (35%, n=7/20) for NRS and supply chain problems (26%, n=14/53) for PHYs (figure 4).
Medical device shortages occurred 1–3 times for the same product for 35% (n=421/1207) of HPs, while 34% (n=409/1207) experienced this problem >10 times for the same device. Communication of medical device shortages seems to be an issue as 37% (n=448/1207) of HPs reported that such problems are only shared if specific questions on the availability of medical devices are asked via email. Interestingly, 33% (n=396/1207) of HPs could not provide feedback, which could be attributed to the fact that HPs are not handling all medical devices in all European countries.
Reporting and managing medicine shortages
For half of the HPs (50%, n=597/1206), NRS (50%, n=10/20) and OHCPs (50%, n=61/121) who participated in the survey, reporting medicine shortages is mandatory in their country, while PHYs were mostly not able to give an answer (44%, n=23/52). The ‘Medicines Agency’ usually manages the shortages reporting system according to 67% (n=779/1160) of HPs in 2023 and 64% in 2019. For those who are familiar with mandatory reporting of medicine shortages, their national reporting systems are found to be useful and regularly updated by 67% (n=41/61) of OHCPs. In 2019 the NRS were the most positive group with regard to reporting systems, but 4 years later they are the most critical with only 20% (n=2/10) agreeing that the national reporting system for shortages is useful and regularly updated. This dissatisfaction with reporting systems is higher among HPs (51%, n=303/597) and PHYs (38%, n=6/16), for both of which the numbers had not changed significantly since 2019. Around one-third of HPs (33%, n=373/1137) reported no feedback on reported shortages from the entity/organisation that is running the reporting systems and 41% (n=468/1137) could not give an answer.
Apart from ‘reporting’ of shortages, the Survey inquired about the existence of a task force group or a team dedicated to managing shortages. Over two-thirds of HPs replied positively to this question. Task forces and/or dedicated teams are mostly situated in the hospital or at the national level. In the hospital they mostly comprise HPs (21%, n=241/1129), while at the national level cooperation plays a role and thus multiple different professions are involved in a task force (18%, n=202/1129), as reported by HPs.
All survey respondents were asked whether the medicine prescribing/dispensing IT system was automatically fed with information on ongoing shortages and potential alternatives in their hospital. The figures for HPs remained exactly the same as in 2019, with 70% (n=780/1112) selecting ‘no’, and OHCPs also having the same opinion (70%, n=83/119). For PHYs (55%, n=28/51) and NRS (45%, n=9/20), around half confirmed that the medicine prescribing/dispensing IT system is not automatically updated with information on ongoing shortages and potential alternatives.
Another aspect of mitigating medicine shortages is in creating protocols and contingency plans. Their existence was confirmed by 32% (n=353/1112) of HPs, 20% (n=4/20) of NRS, 24% (n=12/51) of PHYs and 39% (n=46/119) of OHCPS. Compared with 2019 when this question was only asked to HPs and OHCPs, the availability of protocols and contingency plans increased more for OHCPs (28% in 2019 vs 39% in 2023) than for HPs (29% in 2019 vs 32% in 2023).
Mitigating shortages often implies implementing clinical (changes in conducting standard treatment protocols) and operational (changes in carrying out standard procedures of delivering care) changes into everyday practice of HCPs. The implementation of clinical changes was carried out by 76% (n=843/1112) of HPs, 50% (n=10/20) of NRS, 75% (n=38/51) of PHYs and 67% (n=80/119) of OHCPs, while operational changes were implemented by 55% (n=608/1109) of HPs, 56% (n=67/119) of OHCPs and only 37% (n=7/19) of NRS and 37% (n=19/51) of PHYs. Based on this information, it could be argued that NRS and PHYs are less involved in the management of shortages than other HCPs.
Moreover, the aforementioned changes follow risk assessment, which according to survey responses is conducted only by 15% (n=150/1028) of HPs in case of a shortage. However, compared with 2019 when 69% of HPs did not carry out risk assessment, four years later the percentage of HPs who did not conduct risk assessment was lower at 56% (n=574/1028), which is a slight improvement although risk assessment is still not conducted widely in European hospitals. HPs mainly applied Root Cause Analysis (RCA) (32%, n=48/149) while an equal proportion (24%, n=36/149) used the Failure Mode and Effect Analysis (FMEA) and the Healthcare Failure Mode and Effect Analysis (HFMEA).
Impact of medicine shortages on patient care
As in 2019, HPs identified delays in care or therapy (43%, n=269/627), suboptimal treatment (43%, n=268/627) and cancellation of care (35%, n=220/627) as the main consequences of medicine shortages in their hospitals. Delays in care/therapy in the disease pathway were selected most by NRS (57%, n=4/7) and OHCPs (56%, n=37/66), while PHYs opted for suboptimal treatment/inferior efficacy in addition to delays in care/therapy throughout treatment as their first choice (both 54%, n=14/26). Cancellation of care ranked second for PHYs (35%, n=9/26) and OHCPs (38%, n=25/66). NRS chose this impact as well as increased length of stay in the hospital (both 43%, n=3/7) in second place. The latter came third for PHYs (31%, n=8/26) and OHCPs (36%, n=24/66), while NRS placed medication errors third (29%, n=2/7) (figure 5).
More than half of the HPs (61%, n=633/1037) who participated in the survey indicated that they had experienced shortages which had an impact on patient care in their hospital. A similar response rate was observed for PHYs (59%, n=26/44) and OHCPs (66%, n=67/101), while for NRS the picture was reversed with half (53%, n=10/19) not having experienced shortages that had a patient impact.
Solutions and suggestions to more effectively manage shortages
Among solution proposals that are most likely to be effective and useful in addressing medicine shortages, 47% (n=500/1053) of HPs, 56% (n=25/45) of PHYs, 32% (n=6/19) of NRS and 52% (n=55/105) of OHCPs gave the solution ‘better enforcing the mandatory early notification of a medicine shortage’ a ranking of 5 (very useful). The solution of ‘strengthening collaboration between the European countries and the European institutions’ received more positive feedback compared with the previous survey, with 31% (n=323/1053) of HPs, 49% (n=22/45) of PHYs, 47% (n=9/19) of NRS and 37% (n=39/105) of OHCs giving the proposal a ranking of 5 (very useful). The proposal ‘mandating improved communication among all stakeholders (manufacturers, parallel traders, wholesalers and healthcare professionals)’ received a very positive response, with 54% (n=568/1053) of HPs, 56% (n=25/45) of PHYs, 63% (n=12/19) of NRS and 57% (n=60/105) of OHCPs giving the proposal a ranking of 5 (very useful). The least preferred suggestion in the 2023 Survey was ‘evoking appropriate staffing levels in order to lower the impact that medicine shortages currently have on the overall patient services’.
Patients’ perspective of shortages
Compared with the figures from the EAHP’s 2019 medicines shortages survey, there was a slight increase in the number of PTNs (from 47% in 2019 to 57% in 2023 (n=16/28)) who experienced medicine shortages and 37% (n=7/19) of them reported that the care provided at the hospital was affected by medicine shortages. Most PTNs (38%) received information on the shortages concerning supply chain problems (n=8/21), while others (29%) were informed that the shortage was due to manufacturing problems (n=6/21). Eight of 21 patients who were affected by a medicine shortage received an alternative treatment to solve the problem, while three others were advised to take a lower dose or received the provision of no dose, substitution with suboptimal treatment or finding the medicine in the outpatient setting or even waiting because the treatment was not urgent. The majority of PTNs reported that they had not been affected by a shortage of medical devices (n=13/28). Only 24% (n=5/21) of PTNs stated that they felt that the shortages problem had been correctly handled by HPs/PHYs, while 33% (n=7/21) of them stated that they did not feel that their problem was correctly handled.
Discussion
As in 2019, the 2023 EAHP’s shortages survey showed that 95% of HPs are facing shortages of medicines across Europe, which prevents delivering the best care to PTNs and carrying out everyday tasks in hospital pharmacies, as reported by HCPs and patient organisations.6 17 Compared with 71% of PHYs in 2019 facing the same problem, in 2023 more PHYs (84%) indicated shortages to be a problem in patients’ treatment together with 86% of OHCPs. On the other hand, fewer NRS (68%) seem to share the same perception as in 2019 (62%), which confirms that shortages are mitigated by HPs before they become more visible to HCPs and PTS.18
Similar to 2019, HPs, NRS and OHCPs consider global shortage of an API, manufacturing problems and supply chain problems to be the main causes of shortages in 2023, while for PHYs the price of a medicine is among the top three causes behind the shortages. Manufacturing and supply chain problems depict the multifaceted nature of shortages, which has already been confirmed by a vast body of literature.1 10 14 Global medicine supply chains are becoming more and more of a challenge in an environment of global threats, pandemics, natural disasters, war and energy crises.19 20 On the other hand, medicines pricing and procurement mechanisms play a crucial role in facilitating parallel trade and generating medicine shortages.21
Antimicrobials are considered to be most affected by shortages by all respondent groups, followed by analgesics and anaesthetic agents and blood derivative products. Shortages of antibiotics pose a public threat in the era of growing antimicrobial resistance, especially since inappropriate use of antibiotics, often when there are no appropriate alternatives available, represents the main driver of resistance patterns.22 23 Shortages of antibiotics seem to be on the rise after a short decline in 2019 (63% compared with 77% in 2018), which only underlines the importance of risk assessment in antibiotic substitution in order to optimise health outcomes and prevent rising resistance.15
Since shortages of critical medicines are becoming more frequent leading to detrimental effects on health outcomes, a new question was introduced in the 2023 Survey to explore shortages of critical medicines, which showed that a quarter of HPs experienced shortages of a critical medicine >10 times in 2022, while more than 40% of PHYs and 50% of NRS experienced the same type of shortages up to three times in 2022. As seen in the recently released EU communication on shortages, criticality plays a significant role in medicine shortage assessment and tailoring mitigation mechanisms.8 Taking into account the nature of critical medicines as defined by the EMA and the EC (“Medicines are deemed critical medicines when essential to ensure the continuity of care and the provision of quality healthcare, and to guarantee a high level of public health protection in Europe, and also when their unavailability results in serious harm or risk of serious harm to patients”), it is alarming that these shortages are frequent and necessitate a higher preparedness of HCPs considering the devastating effects on health outcomes. However, the Survey showed that almost 50% of HPs and more than 70% of PHYs do not have a list of critical medicines required in their hospitals. This is quite alarming, considering that lack of preparedness among HPs and HCPs, which is essential in the successful mitigation of shortages and avoiding detrimental effects on patients’ outcomes, as recommended by the EMA in their good practice guidance document.24 The severe impact of shortages experienced among survey respondents by 30% of HPs, 15% of PHYs and 14% of NRS is alarming, knowing that patients are facing deterioration of their health despite all the efforts taken by HCPs. This demonstrates the complexity of both shortages and the limitation of mitigation measures carried out by HCPs, which may not always alleviate the impact of shortages.5 A Drug Shortages Survey conducted in the USA in 2023 showed that more than 50% of health system pharmacists in the USA have experienced shortages of oncology medicines, with severe consequences on patients including cancelled treatment and more than 30% reporting critical impacts.5
Compared with 2019, responses provided by HPs showed an increase in all three categories depicting the impact of shortages on patients. Cancellation of care, less optimal treatment and delayed care as direct consequences of shortages seriously threaten patient outcomes. Similar views are shared by PHYs and OHCPs, where an increase in patient impact is also observed compared with 2019. Increased deteriorating effects of shortages may be attributed to the fact that shortages were first aggravated during COVID-19, then throughout the energy and now war crises.20 On the other hand, an increase in patient impact also shows that mitigation mechanisms for shortages performed by HCPs are not always able to overcome obstacles in carrying out treatment pathways.5 Interestingly, more than half of NRS consider shortages not to have impacted patient care. This can be attributed to the fact that most of the shortages are alleviated by HPs before they are even communicated with the patient or become apparent to PHYs and NRS. However, the EAHP’s 2023 Shortages Survey showed that 33% of PTNs believe that the shortage was not well solved/communicated to them, while 43% were unsure. This should change if HCPs want to increase the awareness of shortages, as suggested by Michael Ganio from the American Society of Health-System Pharmacists who stated that patients should be aware of shortages, even if resolved in a hospital, and consequently they should reach out to the respective legislators informing them of their own experience with a particular shortage.25
For the first time the 2023 EAHP Shortages Survey explored shortages of medical devices and found that 60% of HPs and more than half of PHYs and NRS encountered medical device shortages in 2022. HPs and OHCPs consider supply chain problems to be the major cause of medical device shortages, while PHYs and NRS perceive prices and procurement strategies as major causes of the shortages. Interestingly, the survey findings do not reflect the perspective of EU officials on the main drivers of medical device shortages, such as the capacity of notified bodies to issue certificates according to the new EU Medical Device Regulation and the manufacturers’ preparedness to respond to the new regulation.26
As reported in previous EAHP shortages surveys, HPs reiterated the importance of early notification of a medicine shortage in order to better mange it. This is reflected in the new EU pharma package, where the objective of the proposed reform is to enhance more timely notification of shortages, strengthening information requirements and mandating the marketing authorisation holder to provide shortage prevention and mitigation plans, which would secure the supply of medicines to all EU citizens.27
Compared with 2019, in 2023 the option of strengthening collaboration between European countries and institutions in tackling shortages received a more positive feedback by HPs, reflecting multiple changes in the European shortages policy landscape. The EMA’s extended mandate, creation of the Health Emergency Preparedness and Response Authority (HERA), the EC structured dialogue on shortages and, more recently, the EC communication on shortages prove that, through collaboration between marketing authorisation holders, the industry, the legislators and HCPs, shortages may be managed better.8–11 28 Moreover, improved multi-stakeholder communication on shortages is equally as important as access to the information, which demonstrates that these channels of communication are still not fully functional in many European countries.14
European reporting systems on shortages seem unable to deliver the useful feedback and regular updates needed for the successful management of shortages. Compared with 2019, a lower proportion of HPs see these systems as useful, while NRS completely changed their attitude towards the feedback received from a reporting system as not useful at all. The EMA performed several studies on reporting systems, and a future EMA shortages database, aimed to be established by the end of 2025, specifically targets these drawbacks of existing shortage database reporting systems in terms of accuracy of information and prompt feedback, which is essential to overcome shortages quickly and safely.8
Apart from shortages reporting systems, the survey explored the existence of shortage task force teams at all levels of care which, as in 2019, mostly comprise HPs and are situated in hospitals. However, based on the survey respondents, these task force teams—at least at the hospital level—did not manage to influence modification of hospital IT systems to provide information on shortages and available therapeutic/generic alternatives, which would facilitate medicine substitution as agreed by HCPs and recommended by the EMA.24 29
Only 32% of HPs (a slight increase from 29% in 2019) reported the existence of contingency plans and protocols for overcoming shortages. This is not in line with the best practice for managing shortages and seems to be difficult to implement.8 30
Conclusion
The 2023 EAHP Shortages Survey confirmed that shortages of medicines and medical devices continue to evolve and present a public health threat across Europe. All medicines are affected by shortages, with antimicrobials and oncology medicines leading the long list of shortages. As in previous EAHP surveys on shortages, the main causes remain shortages of API, manufacturing and supply chain problems along with legislative challenges. Medical devices are also affected by shortages due to supply chain, price and procurement issues, which may be exacerbated by introducing the new EU Medical Devices Regulation. Available shortages reporting systems and databases do not seem to fulfil their role due to the quality of available data on shortages and lack of multi-stakeholder engagement. More HPs perform risk assessments in order to mitigate shortages, but still only a small number of them have shortage contingency plans in place in hospitals. Although the policy landscape around shortages in the EU has recently changed significantly, more tangible results driven by HPs’ efforts to overcome shortages smoothly and efficiently for the benefit of their patients are yet to be seen.
Data availability statement
Data are available upon reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
Not applicable.
Acknowledgments
EAHP would like to thank its member associations for participating in the survey.
Footnotes
EAHP Statement 2: Selection, Procurement and Distribution. EAHP Statement 4: Clinical Pharmacy Services. EAHP Statement 5: Patient Safety and Quality Assurance.
Twitter @AndrasSule
Collaborators Not applicable.
Contributors NM, PP, DKP, DM, AS and SK designed and carried out the survey. NM, DLV and SK performed data analysis and interpretation needed for the manuscript. NM, PP, DLV, DKP, DM, AS and SK contributed to critical analysis and interpretation of data as well as revising the manuscript. NM compiled the first draft and the subsequent iterations of the manuscript. All authors read, commented on and contributed to the manuscript for the accuracy of the content. All authors approved the final version to be published and agreed to be accountable for all aspects of the work in terms of its accuracy and integrity. NM is the corresponding author and act as a guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.