Access to medicines Miljković, Nenad; Makridaki, Despina; Kohl, Stephanie
European journal of hospital pharmacy. Science and practice,
09/2023, Letnik:
30, Številka:
5
Journal Article
Recenzirano
Innovative drugs, in particular, place an additional strain on already tight hospital budgets. Besides the constraints faced by public health budgets, there are other barriers to treatment access. In ...its 2016 Conclusions, the Council of the European Union (EU) highlighted the problems that innovative medicinal products present to individual patients and public health systems alike.5 In March 2017, the European Parliament called for national and EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies.6 Since then, different movements—such as the Beneluxa initiative and the Valetta Declaration—have been bringing together countries interested in jointly tackling the issue of unsustainable prices by aiming to improve patient access to innovative medicine, cost containment and pushing for improved price transparency. Producers do not always have the manufacturing capacity to meet the potential need, and vulnerability to the supply chain is added if alternative suppliers drop out of the market due to loss of tender. ...while procurement policies can, on the one hand, have the capability to enable better treatment access, they can, on the other hand, also be perceived as a treatment barrier, especially when their application leads to market concentration and dependency on one single supplier. After years of spearheading the awareness-raising discussion about the influence that medicines shortages have on both patient care and the work of hospital pharmacists, the problem has gained recognition and efforts have finally shifted towards finding preventative and mitigating actions that could help with keeping the growing negative impact of medicines shortages at bay.
Aims and objectiveTo compare antibiotic shortages in Europe between 2013 and 2020 and the views of hospital pharmacists on overcoming shortages via antimicrobial stewardship.MethodsA series of ...European Association of Hospital Pharmacists (EAHP) surveys on medicine shortages, including a survey on the future crisis preparedness of hospital pharmacies, conducted between 2013 and 2020 were compared for the type of antibiotic shortages and respective mitigation strategy. These were analysed taking into account hospital pharmacists’ views on antibiotics provided in the European Centre for Disease Prevention and Control (ECDC) survey on healthcare professionals’ knowledge, attitudes and behaviours about antibiotics, antibiotic use and antibiotic resistance from 2018.ResultsSince 2013 there has frequently been a shortage of antibiotics in European hospitals. In 2014, 67% (347/521) of hospital pharmacists experienced shortages of antimicrobials compared with 77% (1032/1348) in 2018, 63% (1158/1837) in 2019 and 37% (539/1466) in 2020. More than 80% of hospital pharmacists managed antibiotic shortages through substitution in 2014 (284/336) and 2018 (786/946), while this percentage was 40% (63/158) and 42% (620/1466) in 2019 and 2020, respectively. Although 72% (870/1204) of hospital pharmacists received information on how to avoid inappropriate antibiotic prescribing, dispensing and administration, only 37% (450/1204) changed their views and 28% (338/1204) changed their practice in steering antimicrobial treatment.ConclusionAntibiotic shortages affect proper antimicrobial stewardship because of limited appropriate alternatives, taking into account patients’ clinical condition and type of infection. While substitution remains a leading mitigating tool for antibiotic shortages, it carries numerous risks and the potential for antimicrobial resistance and suboptimal health outcomes.
Countries across Africa and Asia have introduced a variety of measures to prevent and treat COVID-19 with medicines and personal protective equipment (PPE). However, there has been considerable ...controversy surrounding some treatments including hydroxychloroquine where the initial hype and misinformation led to shortages, price rises and suicides. Price rises and shortages were also seen for PPE. Such activities can have catastrophic consequences especially in countries with high co-payment levels. Consequently, there is a need to investigate this further.
Assess changes in utilisation, prices, and shortages of pertinent medicines and PPE among African and Asian countries since the start of pandemic.
Data gathering among community pharmacists to assess changes in patterns from the beginning of March until principally the end of May 2020. In addition, suggestions on ways to reduce misinformation.
One hundred and thirty one pharmacists took part building on the earlier studies across Asia. There were increases in the utilisation of principally antimalarials (hydroxychloroquine) and antibiotics (azithromycin) especially in Nigeria and Ghana. There were limited changes in Namibia and Vietnam reflecting current initiatives to reduce inappropriate prescribing and dispensing of antimicrobials. Encouragingly, there was increased use of vitamins/immune boosters and PPE across the countries where documented. In addition, generally limited change in the utilisation of herbal medicines. However, shortages have resulted in appreciable price increases in some countries although moderated in others through government initiatives. Suggestions in Namibia going forward included better planning and educating patients.
Encouraging to see increases in the utilisation of vitamins/immune boosters and PPE. However, concerns with increased utilisation of antimicrobials needs addressing alongside misinformation, unintended consequences from the pandemic and any appreciable price rises. Community pharmacists and patient organisations can play key roles in providing evidence-based advice, helping moderate prices through improved stock management, and helping address unintended consequences of the pandemic.
Results of EAHP's 2019 Medicines Shortages Survey Miljković, Nenad; Batista, Aida; Polidori, Piera ...
European journal of hospital pharmacy. Science and practice,
07/2020, Letnik:
27, Številka:
4
Journal Article
Recenzirano
Odprti dostop
The aim of the 2019 EAHP Medicines Shortages Survey was to collect information on reasons and management strategies for medicines shortages as well as details on their impact on patients. The survey ...targeted hospital pharmacists (HPs), physicians (PHYs), nurses (NRS) and other healthcare professionals (OHCPs). A separate set of questions addressed patients (PTNs).
A 28-question survey was conducted by EAHP, collecting information from European HPs, PTNs, NRS, PHYs and OHCPs on the shortage situation in their respective countries. The survey ran from 7 November 2019 to 13 January 2020. The results were analysed by EAHP.
There were 2136 HP responses to the 2019 survey compared with 1666 in 2018. While 95% of HPs and 89% of OHCPs consider medicine shortages a current problem, only 71% of PHYs and 62% of NRS state the same. Shortages of active pharmaceutical ingredients (72%), manufacturing (72%) and supply chain problems (49%) are leading causes of shortages according to HPs, while PHYs (40%) and NRS (37%) consider the pricing to be their driver. Antimicrobials and oncology medicines were most affected by shortages in 2019. Compared to 2018, the percentage of respondents who reported shortages of oncology medicines increased from 39% to 47% in 2019. HPs (42%), PHYs (36%) and OHCPs (38%) consider delays in care as the main consequence of medication shortages. The satisfaction with reporting systems for medicine shortages decreased from 56% in 2018 to 48% in 2019 for HPs, while they remain low for PHYs (36%).
Medicines shortages affect patient care and healthcare professionals' everyday tasks. Better enforcing of the mandatory early notification of shortages and structured mitigation response is recognised by all respondents as best strategy to tackle shortages.
Introduction:
Medicine shortages result in great risk for the continuity of patient care especially for antimicrobial treatment, potentially enhancing resistance rates and having a higher economic ...impact. This study aims to identify, describe, assess, and assign risk priority levels to potential failures following substitution of antimicrobial treatment due to shortages among European hospitals. Furthermore, the study investigated the impact of corrective actions on risk reduction so as to provide guidance and improve future patient care.
Methods:
Health-care failure mode and effect analysis (HFMEA) was applied to hospitals in Austria (H-AT), Belgium (H-BE), Croatia (H-CR), Greece (H-GR), Spain (H-SP), and Serbia (H-SR). Multidisciplinary teams identified processes, failure modes, causes, and corrective actions related to antibiotic substitution following medicine shortages. Characteristics of study hospitals as well as severity, probability, and hazard scores (HSs) of failure modes/causes were analyzed using Microsoft Office Excel 2010 and IBM SPSS Statistics® via descriptive and inferential statistics.
Results:
Through HFMEA, 74 failure modes were identified, with 53 of these scoring 8 or above on the basis of assigned severity and probability for a failure. Severity of failure modes differed before and after corrective actions in H-CR, H-GR, and H-SR (
p
< 0.005). Their probability differed in all study hospitals (
p
< 0.005) when compared before and after corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in H-CR (46) and the lowest in H-SP (16). Corrective actions can address failure modes and lower HSs; therein, all teams proposed the following: structuring communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement, and increasing effectiveness of the ward stock assessment. These proposed actions led to HS reductions up to 83%.
Conclusion:
There is a lack of structure in addressing risks associated with antibiotic substitution following shortages. Furthermore, lack of communication, data scarcity on availability of antibiotics, non-supportive information technology (IT) systems, and lack of internal substitution protocols hinder quick assessment of alternatives addressing patient needs. Nevertheless, the study shows that health-care professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources.
Abstract
Background
It is known that drug shortages represent a major challenge for all stakeholders involved in the process, but there is little evidence regarding insights into patients′ awareness ...and perspectives. This study aimed to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. Furthermore, we wanted to explore information preferences on drug shortages.
Methods
A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. One hospital (H) from each of this country agreed to participate: Bosnia and Herzegovina (H-BiH), Croatia (H-CR), Germany (H-GE), Greece (H-GR), Serbia (H-SE) and Poland (H-PO). Recruitment and data collection was conducted over 27 months from November 2017 until January 2020. Overall, we surveyed 607 patients which completed paper-based questionnaire. Questions related to: general information (demographic data), basic knowledge on drug shortages, drug shortages experienced during hospitalization and information preferences on drug shortage. Differences between hospital settings were analyzed using Chi-squared test or Fisher’s exact test. For more complex contingency tables, Monte Carlo simulations (N = 2000) were applied for Fisher’s test. Post-hoc hospital-wise analyses were performed using Fisher’s exact tests. False discovery rate was controlled using the Bonferroni method. Analyses were performed using R: a language and environment for statistical computing (v 3.6.3).
Results
6 % of patients reported experiences with drug shortages while hospitalized which led to a deterioration of their health. The majority of affected patients were hospitalized at hematology and/or oncology wards in H-BiH, H-PO and H-GE. H-BiH had the highest number of affected patients (18.1 %, N = 19/105,
p
< 0.001) while the fewest patients were in H-SE (1 %,
N
= 1/100,
p
= 0.001). In addition, 82.5 %, (
N
= 501/607) of respondents wanted to be informed of alternative treatment options if there was a drug shortage without a generic substitute available. Majority of these patients (66.4 %, N = 386/501) prefer to be informed by a healthcare professional.
Conclusions
Although drug shortages led to serious medical consequences, our findings show that most of the patients did not perceive shortages as a problem. One possible interpretation is that good hospital management practices by healthcare professionals helped to mitigate the perceived impact of shortages. Our study highlights the importance of a good communication especially between patients and healthcare professionals in whom our patients have the greatest trust.
Celotno besedilo
Dostopno za:
CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The introduction of the National Surveillance Centre (NSC) has improved the efficiency and effectiveness of managing medicines availability within the public healthcare system in South Africa. ...However, at present, there is limited data regarding the perceptions among users of the NSC and challenges that need addressing. A descriptive quantitative study was performed among all registered active NSC users between August and November 2022. Overall, 114/169 users responded to a custom-developed, self-administered questionnaire (67.5% response rate). Most respondents used the Stock Visibility System (SVS) National Department of Health (NDoH) (66.7% for medicines and 51.8% for personal protective equipment (PPE) or SVS COVID-19 (64.9% for COVID-19 vaccines) or RxSolution (57.0% manual report or 42.1% application programming interface (API)) for reporting medicines, PPE, and COVID-19 vaccines to the NSC and were confident in the accuracy of the reported data. Most respondents focused on both medicines availability and reporting compliance when accessing the NSC, with the integrated medicines availability dashboard and the COVID-19 vaccine dashboard being the most popular. The respondents believed the NSC allowed ease of access to data and improved data quality to better monitor medicines availability and use. Identified areas for improvement included improving internet connectivity, retraining some users, standardising the dashboards, adding more data points and reports, and expanding user adoption by increasing licence limits. Overall, this study found that the NSC in South Africa provides an effective solution for monitoring and improving medicines availability.
According to the European Commission and the European Centre for Disease Prevention and Control (ECDC), the number of patients in the EU who die each year as a result of infections caused by ...resistant bacteria increased from 25 000 in 2017 to 35 000 in 2020.1 2 In the last decades there has been a dramatic growth in the ability of a microorganism to stop an antimicrobial from working against it. Other consequences for patients are that infections persist, which results in longer hospital stays, higher healthcare costs and an increased risk of the infection spreading to others. ...significant inter-professional actions are needed to ensure standard treatments and prevention of serious diseases with effective and safe medicines that are quality assured, used appropriately, and accessible to all who need them. EAHP urges governments to make arrangements so that essential antibiotics in dosage forms and strengths appropriate for both adults and children will be maintained on the market with contingency stock level arrangements and alternative production by hospital pharmacists enabled where necessary. Practice Guidelines based on a new evaluation of the literature including European publications was performed in 2013 and published by an interdisciplinary working group from Austria, Germany and Switzerland.4 The primary goal of AMS is to optimise clinical outcomes while minimising unintended consequences of antimicrobial use.5–7 EAHP calls on national governments and health system managers to use the specialised background and knowledge of the hospital pharmacist in multi-professional antimicrobial stewardship teams or other forms of antimicrobial governance in the hospital and in the community.
Medicines shortages Batista, Aida; Miljković, Nenad; Polidori, Piera ...
European Journal of Hospital Pharmacy. Science and Practice,
09/2019, Letnik:
26, Številka:
5
Journal Article, Book Review
Recenzirano
Odprti dostop
...in 2013 the European Association of Hospital Pharmacists (EAHP) started to analyse in more detail the challenge posed by medicines shortages. ...EAHP advises national governments to evaluate if ...their shortages measures and management systems are fit for purpose and to rectify shortcomings where and when needed. ...EAHP urges national governments and healthcare organisations to evoke appropriate staffing levels in order to lower the impact that medicines shortages currently have on the overall patient services provided by hospital pharmacists. ...a measure would safeguard the timely detection of both temporary and permanent shortages since different signals on potential medicines shortages are being picked up by authorities and hospital pharmacists.6 In addition, national regulatory bodies should ensure action is taken against elements of the supply chain found to be in breach of legal and ethical obligations in relation to supply.7 Consideration should also be given to putting in place more rigorous rules on issuing timely alerts about shortage problems.
Results of EAHP’s 2018 Survey on Medicines Shortages Miljković, Nenad; Gibbons, Nicholas; Batista, Aida ...
European journal of hospital pharmacy. Science and practice,
03/2019, Letnik:
26, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Aims and objectivesThe aim of the 2018 EAHP Survey on Medicines Shortages was to provide a clearer picture on the issue of medicines shortages, including the impact on hospital pharmacists’ time, ...budgets and the effect on patient care.MethodsA survey was conducted by the EAHP, collecting information from European hospital pharmacists on the shortage situation in their respective countries. The survey ran from 19 March 2018 to 11 June 2018. Keele University, UK analysed and compared the results to those of the 2014 survey.ResultsThere were 1666 responses to the 2018 survey, which represented a threefold increase from the 2014 survey which received 607 responses. Ninety per cent of respondents answered ‘Yes’ when asked if shortages of medicines are a current problem in delivering the best care to patients, while only 7% of respondents answered ‘No’, and 3% ’Unsure'.Problems with shortages of antimicrobials were most commonly reported (77% of respondents reporting this as an issue in 2018 vs 57% in 2014), followed by preventative medicines (43% in 2018 vs 20% in 2014) and anaesthetics (39% in 2018 vs 27% in 2014). Fifty-nine per cent of respondents have seen care delayed as a consequence of medication shortages, with cancellations of care (31% of respondents), medication errors (25% of respondents) and suboptimal treatment for patients (25% of respondents) also being frequently reported.Sixty-three per cent of respondents reported having had to pay a higher price to procure from alternate sources most of the time or always when there was a shortage of a medicine.ConclusionsMedicines shortages is an increasing problem across Europe and is having an adverse impact on patient care. Medicines shortages are adding to hospital pharmacists’ time pressures and have an adverse budgetary impact. More timely information about impending shortages and how long they will last is seen as necessary to help manage the problem.
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