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Background
The COVID-19 pandemic has had a major impact on the organisation of health services worldwide. In the first wave, many therapeutic options were explored, exposing patients to significant iatrogenic risk. In a context in which patient management was not well defined by clear recommendations and in which healthcare professionals were under great stress, was it still relevant to maintain pharmaceutical care or did it bring an additional factor of disorganisation?
Objective The aim of our study was to compare the relevance of pharmaceutical care practices before and during the COVID-19 crisis.
Methods A retrospective, comparative, observational analysis was conducted in two medical units in a French university hospital that were receiving patients with COVID-19 and benefiting from pharmaceutical care prior to the crisis. This study compared clinical pharmacy performance between two 1.5-month periods before and during the COVID-19 crisis. Performance was assessed according to the CLEO scale, rating the clinical, economic and organisational impacts of the accepted pharmaceutical interventions (PIs) performed in these units.
Results Of the 675 accepted PIs carried out in the two medical units over the entire study period, PIs performed during the COVID-19 period had a greater significant clinical impact (72% vs 56%, p˂0.0001), a more positive economic impact (38% vs 23%, p˂0.0001) and a more favourable organisational impact (52% vs 20%, p˂0.0001) than those performed prior to the COVID-19 period.
Conclusions The health crisis generated important changes in care practices. Our study demonstrates the sustained relevance of pharmaceutical care during a health crisis. This local experience confirms the major interest in improving the integration of pharmaceutical expertise within French healthcare teams.
- COVID-19
- PHARMACY SERVICE, HOSPITAL
- Safety
- Quality of Health Care
- Drug Monitoring
Data availability statement
Data are available upon reasonable request.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
The COVID-19 pandemic significantly disrupted healthcare establishments, leading to a notable increase in iatrogenic risk for patients due to the implementation of uncontrolled drug strategies. While the presence of clinical pharmacists in France is known to optimise inpatient care safety as part of routine healthcare, it remains uncertain whether this interprofessional collaboration remains relevant during times of crisis.
WHAT THIS STUDY ADDS
This study demonstrates that maintaining a clinical pharmacist team’s presence during times of stress and disorganisation in a health crisis is a crucial factor in ensuring safe medication management.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
For the future, this research underscores the importance for healthcare establishments to assign clinical pharmacy staff to care units affected by health crises. This proactive measure ensures the preservation of safety and efficiency in patient care within a challenging context.
Introduction
In December 2019, China announced the emergence of a new coronavirus in Wuhan, the capital of Hubei Province. This new virus was responsible for severe pneumonia (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2).1 2 Within a few weeks, the virus spread widely in China and then in the rest of the world. On 11 March 2020, the WHO declared a pandemic.3 In France, containment measures were implemented and a state of health emergency was declared on March 17 and 23 2020.4 5 At that time, 2972 patients were hospitalised, including 771 in intensive care, and 218 deaths were recorded.6 The progression of the pandemic prompted hospitals to reorganise to accommodate the influx of patients with coronavirus-19 (COVID-19).7
Although no specific effective drug has yet been identified for the treatment of COVID-19, many therapeutic solutions were rapidly explored at the beginning of the health crisis. In France, lopinavir/ritonavir, interferon beta, hydroxychloroquine (HC) and remdesivir were positioned as empirical treatments for COVID-19 during the first wave in the first quarter of 20208. The drug–drug interaction and tolerance profile of these treatments,9 the lack of pathophysiological knowledge and the lack of experience of healthcare teams in the management of COVID-19 exposed patients to a significant iatrogenic risk. In addition, there was a risk of drug shortages due to the high supply pressure generated by the global pandemic.10 Combining therapeutic complexity and supply pressure, this health crisis placed hospital pharmacist at the heart of patient management strategies.
Our teaching hospital has a strong interprofessional collaboration model that includes clinical pharmacists in some wards, mainly in high-risk medicine areas.11 12 This daily clinical pharmacy practice is integrated into the operation of the ward and includes medication reconciliation, prescription analysis and medication management.13 The first wave of COVID-19 led to significant reorganisation in the wards. If this reorganisation carried out in the emergency of the first wave seemed to be obvious, we wondered afterwards about its relevance. In a context in which patient management was not well defined by clear recommendations and in which healthcare staff were under high stress level to manage an unknown emergent infectious disease, was it still relevant to maintain a pharmaceutical presence or did it bring an additional factor of disorganisation? The aim of our study was to compare the relevance of pharmaceutical care practices before and during the COVID-19 crisis.
Methods
Study design
A monocentric, retrospective, observational analysis was conducted in the two medical units in a French university hospital that were receiving patients with COVID-19 and benefiting from a pharmaceutical presence prior to the COVID-19 crisis (pulmonology and infectious diseases departments). This study compared clinical pharmacy activity in these units between two 1.5-month periods: from 17 March to 31 April 2020 (corresponding to the first wave of COVID-19 in the geographical area of the study) and from 18 December 2019 to 31 January 2020 (corresponding to before the crisis). This study was approved by the clinical research department of our university hospital.
Description of the clinical pharmacy model
Our university hospital is a 2400-bed facility where most medical units are structured around a classic French healthcare organisation. This “classic” organisation includes a multiprofessional care team, usually including doctors, nurses and physiotherapists. In some medical units of our university hospital an improved model has been developed for many years. This improved model adds to the classical organisation the permanent presence of a clinical pharmacist (resident or senior) in order to reinforce the competence of the healthcare team on the proper use and safety of health products. In clinical units, this service is administered by a resident, along with several fifth-year pharmacy students, under the guidance of a senior clinical pharmacist. The entire scope of pharmaceutical care, in alignment with the French Society of Clinical Pharmacy (SFPC) model, encompasses activities such as medication reconciliation on admission, daily prescription analysis, interprofessional dialogues on therapeutic strategies, involvement in medical rounds and team discussions, patient education initiatives, and participation in relevant therapeutic education programmes. These services are available in clinical units every working day from 8 am to 6 pm. Continuity outside of these hours is ensured through an institutional pharmaceutical on-call service. This reinforced organisation was already in place prior to the COVID-19 crisis, dating back to 2005, within the infectious diseases and pulmonology departments. These departments were extensively engaged in the management of COVID-19 patients during the initial wave. During the study period, both the pulmonology and infectious diseases units each had 27 open beds, resulting in a total of 54 beds. The pharmaceutical team in these units is made up of two residents in pneumology and one resident in the infectious diseases department, supplemented by five pharmacy students in their fifth year. Two senior clinical pharmacists are in charge of supervising the pharmaceutical care activities carried out in these two units.
Organisation setup
During the first wave of COVID-19, our hospital was designated as the main referral hospital for COVID-19 patients in our area. As was the case for many primary care facilities, the COVID-19 pandemic had a strong impact on the organisation of care. The reorganisation of processes with the provision of support resources or the need to coordinate a variety of participants is often necessary.14 In order to cope with this upheaval in the organisation and practice of care, our clinical pharmacy department structured itself to rapidly adapt pharmaceutical care activities to best meet the needs of the care teams and to guarantee safe therapeutic management of patients with COVID-19. This need was reinforced by the fact that patients suffering the most severe forms of COVID-19 are mostly elderly and polymedicated. To meet the increased and specific needs of the COVID-19 crisis, the pharmacy department used a classic PDAC (Plan, Do, Act, Check) methodology structured around an operational crisis cell. In order to guarantee the clinical relevance of pharmaceutical interventions (PIs), the operational crisis unit assigned a clinical pharmacist to carry out permanent documentary monitoring to follow the evolution of medical knowledge regarding COVID-19. This daily monitoring focused in particular on the issue of recommendations specific to COVID-19 from various French and international medical learned societies. From the beginning of the crisis, the clinical pharmacy department decided to cover all the “COVID-19 units” created with the reinforced model, even those that did not previously have a daily pharmaceutical presence. The objective of this implementation was to ensure the safe therapeutic management of these complex patients.
Evaluation criteria
Pharmaceutical care practices before and during the first wave of COVID-19 were assessed from the drug-related problems (DRPs) in relation to the accepted PIs performed in the medical units included in the study and coded according to the SFPC classification.14
PIs that were not accepted were not analysed as, by definition, they did not have an impact on patient management. PIs with unknown status were excluded.
Intervention of the clinical pharmacist
A PI is defined as any action initiated by a pharmacist resulting in a change in the prescriber’s management or in the patient’s treatment.8 All PIs performed in COVID-19 units were traced directly within the medical prescription software: age and sex of the patient, medical unit, status of the pharmacist who performed the PI (senior or resident), international non-proprietary name (INN) and anatomical therapeutic chemical (ATC) of the drug(s) involved, brief description of the clinical context, the DRP (defined as an event or circumstance involving drug therapy that actually or potentially interferes with the desired health outcome15) and the intervention.
Assessing the relevance of PIs
The evaluation of the relevance of clinical pharmacy actions was performed by comparing the impacts of accepted PIs collected according to the CLinical, Economic and Organisational (CLEO) scale. CLEO is a three-dimensional scale validated and developed by the SFPC.16 17 It is the only scale used to evaluate the clinical (not determined (ND), harmful (−1C), null (0C), minor (1C), medium (2C), major (3C), vital (4C)), economic (ND, increased cost (−1E), no change (OE), reduced cost (1E)) and organisational (unfavourable (−1O), null (0O), favourable (1O), ND) impacts of PIs.12 18 19 Each dimension is rated according to the most likely case and with the possibility of a rating for a negative impact. For our study, our focus was on defining the relevance of PIs solely based on their clinical impact using the CLEO scale. We established that interventions with significant relevance would have a clinical impact score ≥2C. The description of interventions rated 2C or higher pertains to those that alter the patient’s clinical trajectory, preventing harm, necessitating intensified monitoring or treatment, potentially extending the patient’s hospital stay, or leading to disability or death. The economic or organisational dimensions are not conventionally used to define relevance, as negative scores in these dimensions do not indicate unfavourable patient management. All accepted interventions underwent retrospective assessment by two experienced clinical pharmacists (two of AT, AG, CC, DL-D, EV, PG or SC) unaffiliated with the relevant units who were familiar with using the CLEO scale.
COVID-19 potentially useful drugs
We identified COVID-19 potentially useful drugs for the management of COVID-19 in order to compare potential changes in PIs related to these drugs. These drugs were defined at the time of the study period according to the COVID-19 management guidelines8 and included: dexamethasone, enoxaparin, heparin calcium, heparin sodium, hydroxychloroquine, lopinavir/ritonavir, methylprednisolone, medical oxygen, prednisolone, remdesivir and tinzaparin.
Statistical analysis
The unit of analysis was the PI. Qualitative variables were described as frequency and percentage, and quantitative variables as mean and SD. Comparison of categorical variables was performed using the Chi-square test or Fisher’s test when appropriate. Statistical analyses were performed using SAS 9.4 statistical software (SAS Institute, Cary, NC, USA).
Results
Description of the pharmaceutical interventions
A total of 788 PIs were performed in the two medical units throughout the study period (table 1). The overall acceptance rate for PIs was 85.7% (n=675) with a rate of 100% (n=232) before the COVID-19 period and a rate of 79.7% (n=443) during the COVID-19 period. A total of 113 PIs were either declined in 38 cases (33.6%) or had an unknown status in 75 cases (66.4%). Accepted PIs covered a total of 207 different molecules. The main therapeutic classes were analgesics (N02; 10.4%), antithrombotic agents (B01; 6.5%), antibacterial drugs for systemic use (J01; 5.6%) and psycholeptics (N05; 5.5%). Of the 675 accepted PIs, 232 (34%) were performed before the COVID-19 period and 443 (66%) during the COVID-19 period. The mean age of patients (±SD) before the COVID-19 period was 71.2±13.8 years and during the COVID-19 period 72.0±15.0 years (p>0.05). Men accounted for 69% (n=161) before the COVID-19 period versus 59% (n=261) during the COVID-19 period (p˂0.05). Before the COVID-19 period, 3% (n=6) of PIs were related to COVID-19 drugs versus 17% (n=74) during the COVID-19 period (p˂0.0001).
Characteristics of pharmaceutical interventions
There were significant differences in the distribution of DRPs between the pre-COVID-19 period compared with the COVID-19 period (table 2). Before the COVID-19 period, non-compliance with guidelines and contraindications were more frequent than during the COVID-19 period (19.8% vs 7.8%, p˂0.0001). In the COVID-19 period, drug–drug interactions (7.4% vs 3.0%, p=0.02) and adverse events (4.1% vs 1.3%, p=0.05) were more often reported.
Description of drug-related problems and pharmaceutical interventions carried out according to COVID-19 period
There was a significant difference between the impacts of PIs before and during the COVID-19 period (p˂0.0001) (table 3). PIs performed during the COVID-19 period had a greater significant clinical impact (≥2C) (72.0% vs 56.5%, p˂0.0001), a more positive economic impact (37.8% vs 23.3%, p˂0.0001) and a more favourable organisational impact (51.6% vs 19.8%, p˂0.0001) than those performed before the COVID-19 period. Ten PIs avoided fatality (4C) during the COVID-19 period versus none before.
Description of the clinical impact of pharmaceutical interventions according to COVID-19 period
Discussion
This study highlights the sustained relevance of pharmaceutical care during a health crisis. Thus, clinical pharmacists ensure the safety of inpatient medication management, both in specific strategies and in the overall management of patients, both in routine periods and in a health crisis context. Significantly, the changes in care practices induced by the health crisis did not jeopardise the improved model implemented in certain departments of our institution, and were even reinforced. The health crisis period did not affect the relevance of the presence of clinical pharmacists in the care units, although the first wave of COVID-19 was a major factor in the disorganisation of care practices and a major generator of stress within the care teams.18 20
Interpretation of results
Our results show the preservation of a good acceptance of interprofessional collaboration (and the strong integration of the clinical pharmacist into medical teams in a health crisis context). The acceptance rate of PIs by physicians was high and maintained during the COVID-19 crisis. The acceptance rates of PIs achieved are consistent with the existing literature for studies conducted during and outside the crisis.12 19 21–23 The rejected PIs do not exhibit any distinctive characteristics except for the commonality of being performed exclusively during the COVID-19 period. The prescription assistance software employed for designing and communicating pharmaceutical interventions lacks the functionality to record the reasons for refusal. The higher number of PIs with an unknown status, denoting cases where it is uncertain whether the physician acknowledged them or not, could be attributed to medical teams dedicating less time to digitally trace their actions on prescriptions during the COVID-19 period. Refusals could stem from undisclosed patient clinical developments or a lack of information concerning the patient’s health status. These uncertainties might arise from incomplete information provided by the pharmacist during the composition of PIs. Additionally, for certain PIs, false refusals might also arise due to errors within the software tool utilised to indicate the acceptance of PIs (such as accidental mouse clicks on the refusal button or incorrect selections in dropdown menus) leading to the incorrect indication of a refusal when the PI was indeed accepted.
For patients for whom PIs were accepted, the average age of the patients before and during the crisis did not differ significantly. COVID-19 has a more severe impact on the elderly,24 therefore the most severe cases of COVID-19 were not managed in the medical units of pulmonology and infectious diseases units but in intensive care units. This explains the lack of change in the average age of the patients before and during the COVID-19 crisis in our study. Similarly, SARS-CoV-2 affects men more severely than women24; therefore,we included more women than men.
There was a significant increase in the number of PIs performed between the pre-COVID period and COVID period, while the pharmaceutical team did not change. This increase illustrates the important need for support from healthcare teams during the COVID-19 crisis. In a period of uncertainty and disorganisation, the care teams relied massively on the pharmaceutical team, which enabled them to ensure greater safety of their intake, particularly for the safety of intercurrent pathologies other than COVID-19. This figure bears witness to the trust placed in the pharmaceutical care work at our institution.
The study identified a significant increase in PIs related to COVID-19 potentially useful drugs. This result supports the relevance of the pharmaceutical team to advocate new therapeutic strategies in times of crisis, which by definition have not yet been mastered by prescribers. These results are linked to the creation during the COVID period by the pharmaceutical crisis unit of a permanent documentary monitoring to follow the evolution of medical knowledge on COVID-19. This daily monitoring was focused in particular on the issuance of specific recommendations on COVID-19 by the various French and international medical societies.
Our study revealed that prior to the COVID-19 period, instances of non-compliance with guidelines and contraindications were more common than during the COVID-19 period, despite the uncertainty surrounding COVID therapeutic strategies, which might have led to the opposite observation. The fundamental objectives of clinical pharmacy primarily involve ensuring the safety of patients' medication management and subsequently optimising and ensuring the effectiveness of the strategies employed. We believe that this outcome reflects the scenario in which before the pandemic, clinical pharmacists were more frequently engaged in matters of efficiency and optimisation regarding medication strategies. However, during the crisis, the focus of prescription analysis shifted towards safety concerns that became predominant amidst the disorganisation and tension associated with the crisis.
During the COVID-19 period we observe PIs related to drug–drug interactions or adverse events. This is largely due to the use of lopinavir/ritonavir or remdesivir during this pandemic period. Indeed, lopinavir/ritonavir has been the cause of numerous pharmacokinetic interactions linked to the powerful inhibitory effect of cytochrome P450 3A4 for which clinical pharmacists have secured numerous prescriptions.9 The culture of prevention of iatrogenic risk carried by the pharmaceutical team has made it possible to reinforce the safety of use of these drugs in a context of stress for the care teams.
Finally, the greater clinical impact observed for PIs performed during the COVID period, when most of these were for non-specific COVID-19 drugs, shows that during the stressful period, medical teams paid less attention to the management of patients' intercurrent treatments and concentrated on the acute management of COVID-19, leaving the clinical pharmacist free to advocate prescriptions in order to guarantee the overall safety of the patients' drug management. As previously mentioned, 10 PIs avoided fatality during COVID-19 period versus none prior to this period. This places the clinical pharmacist as an important participant in the holistic management of the patient. Concerning the other dimensions of the CLEO scale, the benefits observed during the COVID crisis in terms of economic and organisational impacts support the idea of the interest and promotion in France of the strong integration of clinical pharmacists within the healthcare team, in particular at times of tension or disorganisation within the healthcare system.
Study strengths and limitations
Our single-centre, observational, retrospective study is the first to assess the relevance of maintaining the presence of a clinical pharmacist team in the specific context of a health crisis, involving an unknown virus. Recent publications have described the role of the hospital pharmacist during the COVID-19 pandemic, but very few of these studies have been performed in France, where clinical pharmacy is still not fully deployed or recognised, and no study has investigated the relevance of its involvement.23 25–28 The impact of the PIs was assessed in a multidimensional manner using a recent and validated tool already used in the literature.17 The impact of each PI was assessed by an independent pair of senior clinical pharmacists who were not part of the medical unit where the PI was performed in order to ensure impartiality. We acknowledge that we did not use a multidisciplinary group, but the CLEO scale has appropriate inter- and intra-rater reliabilities.16 Our study was performed in a hospital where the practice of clinical pharmacy is well known in the medical community. This inter-professional knowledge may have been a factor in the success of maintaining the relevance of pharmaceutical care activity. The decision to analyse data from the period before the COVID-19 pandemic, specifically December 2019, just before the crisis, allows us to compare data from the same pharmacists and medical teams. In France, the rotation of pharmacy and medical residents occurs in November and May each year. Furthermore, as our hospital is located in a region with a strong winter tourism industry, there is no decrease in activity during the month of December. Finally, it would have been interesting to question the care teams about their perception of the pharmaceutical action during the COVID crisis and its relevance, in particular in terms of the perceived feeling of safety in care practices, which are still not standardised in COVID-19 management.
Conclusions
In the context of a global health crisis involving an emerging virus and uncertain therapeutic strategies, a rapid adaptation of care organisation is essential. Although clinical pharmacists are not experts in health crisis situations or in the specific management of COVID-19, our study suggests that maintaining pharmaceutical care activities in frontline COVID-19 units ensures that safety is maintained in the management of hospitalised patients. It therefore seems appropriate to maintain a pharmaceutical care activity in times of stress for care organisation. Our study shows that clinical pharmacists are health professionals capable of adapting and responding efficiently to the specific challenges of securing patient care in terms of both new specific strategies and overall patient care. This local experience supports a major interest in integrating pharmaceutical expertise into French healthcare teams. Indeed, this expertise contributes to the reinforcement of the safety of the use of health products, the fluidity of care organisations, and the economic efficiency of the care process, particularly in periods of systemic disorganisation.
Data availability statement
Data are available upon reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
Not applicable.
References
Footnotes
EAHP Statement 4: Clinical Pharmacy Services.
Twitter @ArnaudTanty
Contributors AT wrote the manuscript with the supervision of SC. AT and SC participated in data management and conducted the statistical analyses. All authors provided comments, participated in the critical revision of the article, and approved the final version.
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; externally peer reviewed.