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Background The discovery of antibiotics several decades ago was a defining moment in history. They were used to treat previously incurable diseases and save many lives. However, the use of antibiotics is not benign. Antibiotic resistance occurs due to the natural evolution of bacteria and gene transfer between bacteria via vertical and horizontal routes, resulting in protective mechanisms that render antibacterial agents ineffective. Aim of the review To list and describe current, novel pipeline antibiotics indicated for multidrug-resistant gram-negative bacteria. This review discusses the limited number of novel pipeline drugs available to combat the rapidly increasing number of multidrug-resistant bacteria and the need for initiatives to research and discover more novel antibiotics. Method A search of MEDLINE/PubMed using the search terms antibacterial pipeline OR antibiotic pipeline including publications between 1 January 2018 through 23 January 2020 resulted in 230 items. The results obtained were narrowed by adding the search term AND multi-drug resistant which resulted in 12 items. Then, ClinicalTrials.gov was searched for phase 2–3 “interventional” trials registered between 1 January 2018 and 23 January 2020 with the status “recruiting” or “completed” function and including World Health Organization-defined priority pathogens in the “condition or disease” field. The search process was then completed by introducing the term antibacterial agents in the “other terms” field. The trials search and selection resulted in 13 items. Relevant English-language studies and those conducted in humans were considered. Those drugs belonging to new antibiotic classes or to antibiotic classes already known but with new chemical structure were defined as “novel antibiotics”. Results The studies selected and reviewed were those referring to a novel antibiotics. Thus, from MEDLINE/PubMed, we found only 1 item referred to a novel chemical class (Murepavadin n = 1). From ClinicalTrials.gov a total of 4 citations were identified (Ftortiazinon n = 1, Zoliflodacin n = 1, Gepotidacin n = 1, ETX2514 + sulbactam n = 1). Conclusion The antibiotics annually approved by the Food and Drug Administration (FDA) mostly belong to existing classes of antibiotics and have specific indications, limiting their use in many multidrug-resistant infections. There are limited novel drug classes targeting gram-negative infections in the pipeline. Providers must be vigilant with the use of current antibiotics, especially until research and development (R&D) advancements are made.

Summary This study evaluates the variation in population abundance overtime of twenty commercial fish species associated with an artificial reef and a reference site. Mean yearly catch rates were computed from data collected monthly from 1988 to 2012 using trammel nets. The log‐transformed ratios of catches obtained at the reef and the reference site were calculated for each species. Statistical methods employed to study the changes in abundance of such fish species were multidimensional scaling (MDS), Min/Max Auto‐correlation Factor Analysis (MAFA), Dynamic Factor Analysis (DFA) and chronological clustering. The time‐series analyses were performed on three groups of species showing similar patterns of temporal cross‐correlation. These time‐series analytical techniques were utilized to identify common trends, the influence of some environmental variables, and changes in group trends. The analyses indicated a decreasing trend in the catch ratio for two species groups (mostly reef‐dwelling species) while the third species group indicated an inverse pattern. Changes in the trends of abundance in some species were likely related to the general deterioration of the artificial reef modules.

Summary The spatial distribution of fish assemblages was investigated through either hydro‐acoustic surveys (using a Multibeam Echosounder) or fishing surveys (using trammel nets) carried out at increasing distance from two gas extraction structures in the Adriatic Sea and characterized by different building architecture: one, a four‐leg platform; the other a subsea well‐site. Both types of surveys were monthly and performed for 1 year starting after installation of the structures. Primary scope of the study was to evaluate whether the combination of the two methodologies could provide a more comprehensive insight into the fish communities associated with artificial structures. The findings showed that associating the Multibeam Echosounder survey with the fishing survey provided complementary information on the spatial distribution and abundance of fish in the water column surrounding the artificial structures. Both methodologies evidenced the presence of a greater abundance and biomass of fish close to the structures in respect to reference sites. In addition, fish abundance and biomass were generally greater in the surroundings of the four‐leg platform than at the well‐site, a possible consequence of the larger volume of the former.

A study to evaluate quality attributes in muscles Semimembranosus (SM) and Semitendinosus (ST) muscles was performed on 10 entire donkey foals slaughtered at 10 months of age and mean final body weight of 126 kg. Fat content was significantly (P<0.05) higher (1.77%) in SM muscle compared to ST (1.61%); protein, cholesterol and glycogen content were not statistically different between the two muscles examined. Collagen concentration in ST muscle (44.2 µg/mg) was significantly higher (P<0.01) compared to SM muscle (32.1 µg/mg). Polyunsaturated fatty acids were significantly higher (P<0.05) in SM muscle (22.11%) compared to ST muscle (20.61%). [PUBLICATION ABSTRACT]

BackgroundHazard vulnerability analysis (HVA) is a method that provides a systematic approach to identifying the hazards and the direct and indirect effects that they have on the hospital pharmacy.PurposeThe objective of this study was to identify the phases at the greatest risks, to find solutions to reduce the risk level and to enhance patient safety.Material and methodsWe have adapted this method to all the stages of drug compounding. We analysed 45 different events concerning the preparations of drugs. For each process, a score of 0 to 3, has been assigned for the following items: probability of the event happening (0=none/unknown; 1=low; 2=moderate; 3=high); magnitude of impact divided into human impact (probability of death or injury), property impact (physical losses and damages) and business impact (interruption of services) (0=none/unknown; 1=low, 2=moderate, 3=high); and mitigation factors divided into preplanning, internal response and external response (0=none/unknown, 1=high, 2=moderate, 3=low). The severity of the event determined using the difference between the magnitude of impact and the degree of mitigation. The risk was obtained by multiplying the probability by the severity.ResultsOnly 6/45 (13.3%) of all phases showed a risk of more than 50%. The risk related to the lack of prescription and, consequently, preparation made after a doctor’s call, was 52%. The risk related to the preparation of the drug that caused allergy to the patient noted in the electronic medical record was 56%. The risk due to the preparation of the drug that caused interactions with other drugs administered to the patient was 52%. The risk of the wrong quantity of drug prepared was 67%. The risk related to the error in the choice of the solvent to be used was 52%. The risk due to incorrect labelling was 56%.ConclusionBased on these results, we have identified some solutions to reduce the risk: the double-check carried out by two different people could solve the risk due to incorrect labelling; and the software used by pharmacists can be improved to reduce the risk related to the patients’ allergy or cross-reaction. Finally, errors can be reduced through clearer and specific sessions of training for the compounders.References and/or acknowledgementsNo conflict of interest.

According to the EMA, the feasibility of the adaptive licensing depends on the willingness of all parties involved in the process, including patients, to accept a higher level of uncertainty of the product authorised. According to the EMA, it would need to agree in advance the price and terms of repayment of the new drug for different levels of authorisation-that is, after the initial license, after any subsequent license and after the final one. 1 2 Yet, how will the process of adaptive licensing fit with regulatory procedures that allow the off-label use of drugs (eg, law 648/96) or access to experimental therapies (eg, DM 8/5/2003)?

Background and ImportanceThe AWaRe classification of antibiotics, developed by the World Health Organization, is a useful tool for monitoring antibiotic consumption, defining targets and verifying the effects of stewardship policies that aim to optimise antibiotics use and reduce antimicrobial resistances. Antibiotics are classified into three groups, Access, Watch and Reserve, considering the impact on antimicrobial resistance and emphasising the importance of their appropriate use. The ‘Access’ group contains antibiotics used in the first- and second-line treatment of infections. The ‘Watch’ group contains broad-spectrum antibiotics with a higher potential of developing resistance. The ‘Reserve’ group contains last-resort antibiotics used for multidrug-resistant infections.Aim and ObjectivesThe aim of this study was to evaluate and monitor the consumption of antibiotics for parenteral use in the hospital wards, considering the AWaRe classification, during a period of 6 months (from January 2023 to June 2023).Material and MethodsFrom January 2023 to June 2023 all the requests of antibiotics for parenteral use were analysed using an informatic database and classified according to the AWaRe classification and the hospital wards. Moreover, the prescriptions appropriateness was verified by checking the validity of the documentation needed (antibiograms, infectivologist reports).ResultsIn the period considered 110.662 vials of antibiotics for parenteral use were dispensed. Among these, 68.096 vials (61.53%) were antibiotics from the ‘Watch’ group. Meropenem and Ceftriaxone resulted the most administered molecules, especially in Respiratory disease and Emergency wards.26.942 (24.34%) antibiotic vials were dispensed from the ‘Access’ group and 15.624 (14.11%) from the ‘Reserve’ one. Cefazolin and Metronidazole (‘Access’) and Colistimethate (‘Reserve’) resulted the most used antibiotics in their categories, with higher prevalence in Obstetrics and Gynecology, Surgery and Respiratory disease wards, respectively.Conclusion and RelevanceWe found out high antibiotic consumptions, in particular for the ‘Watch’ category, probably due to antibiotic resistance towards the molecules from the ‘Access’ group. These data confirm the importance of the role of the hospital pharmacist, who can promote adherence to guidelines and the correct use of antibiotics, actively contributing to the antimicrobial stewardship programmeReferences and/or Acknowledgements1. Mudenda, et al. Antimicrob Steward Health Epidemiol. 2023;3(1):e84.Conflict of InterestNo conflict of interest.

Background and ImportancePharmacovigilance is an important tool for monitoring drug post-marketing safety. Hospital Pharmacist (HP) plays a primary role in the identification of suspected Adverse Drug Reaction (ADRs) due to his direct contact with the patient. In fact, through the application of indirect pharmacovigilance tools in a real-life context, can lead to the identification of hidden or underestimated ADRs.Aim and ObjectivesThe aim of the study was to evaluate the increase of suspected ADRs reports to biological drugs for the treatment of severe refractory hypereosinophilic asthma (omalizumab, dupilumab, mepolizumab and benralizumab) obtained following the interventions of HP.Material and MethodsA 7-months (October 2022 to May 2023) post-marketing safety study was conducted. The data were collected via a questionnaire consisting of two sections: general data (sex, age, comorbidities, drugs taken and start of therapy) and list reporting the most common side effects where the patient can indicate one or more suspected ADRs among those reported and/or enter any side effect that is potentially linked to the drug. The questionnaire was illustrated and given to the patients at the time of dispensing. The data were also compared with the clinical trials and all adverse reactions reported by patients were entered into the pharmacovigilance network.ResultsInitially there were no reports of ADRs for any of the drugs considered. Following the HP’s interventions, 55% (55/100) of patients reported one or more adverse reactions (Mepolizumab 65%, 26/40; dupilumab 54.5%, 12/22; omalizumab 53.3%, 8/15; benralizumab 39.1%, 9/23) bringing the number of reports to 122 (76 mepolizumab; 14 dupilumab; 16 omalizumab; 16 benralizumab). The study also highlighted ADRs not reported in the trials; for mepolizumab were found diffuse petechiae, haemorrhagic period and frequent urination problems with recurrent cystitis (3.5%; 1/26) while for dupilumab was found a higher incidence of herpetic development and alopecia (4.5%; 1/22). A higher percentage of pyrexia was found for benralizumab compared to trials (3%; 12/320 vs 13%; 3/26).Conclusion and RelevanceThe data analysis confirmed the importance of the HP role in pharmacovigilance. The investigation in a real-world context characterised by a high heterogenicity of patient characteristics (age, comorbidity, adherence) led to an improvement in the incidence of ADRs reports and to the highlighting of side effects not detected during the clinical trials.References and/or AcknowledgementsConflict of InterestNo conflict of interest.

Background and ImportanceInappropriate/unnecessary high-cost antibiotics prescription (such as cefiderecol, ceftazidime/avibactam, meropenem/aborbactam) can lead to development of resistant germs, patient toxicity and increased healthcare-costs. For these antibiotics, Regulatory Authority of our country has decided that, together with request of hospital ward, an official paper form must be sent obligatorily to pharmacy, in which, for each patient, diagnosis, dosage, antibiogram (where applicable) is reported. Hospital pharmacist has the duty of checking exhaustiveness and accuracy of the documentation received, in order to obtain appropriate/complete prescriptions, to ensure success of the clinical purpose, patient safety and containing expenditure.Aim and ObjectivesThe aim of study is to quantify the pharmacist’s interventions in requesting clarifications and/or integrations to the documentation provided by ward, in the period between 01/05/2022–30/04/2023. Without such measures, unnecessary antibiotics would have been dispensed: this would have had negative impact on patient safety and healthcare-costs.Material and MethodsThe analysis was conducted on prescriptions received in hospital pharmacy unit. The data obtained were divided by: active substance, hospital ward, request/not request for clarifications/integrations by pharmacist to ward, type of clarification/integration requested.ResultsAmong 258 requests received (146/258 of ceftazidime/avibactam, 61/258 of cefiderecol, 51/258 of meropenem/vaborbactam) 97/258 were appropriate and complete; 161/258 instead needed to request the ward for clarification and/or integrations. Among the latter, in 48.7% of cases the quantity of vials required didn’t comply with the prescribed dosage; 21.5% didn’t report attached antibiogram, where instead it was mandatory; in 14.8% of cases the official paper form was completely missing and, in 11,4% of cases, it was not complete due to lack of diagnosis and/or duration of therapy. Finally, in 3,6% of cases, the prescription wasn’t performed by the infectious specialist, where necessary.Conclusion and RelevanceThe analysis has revealed a large number of irregular prescriptions: implementations requested by hospital pharmacist were essential to obtain valid requests, to the benefit of both patient safety and the expense for hospital. In fact, through an accurate analysis of the dosage units required and the completeness of attached information, it has been possible to reduce not only economic waste, but also the onset of toxicity and/or antibiotic-resistance deriving from inappropriate prescriptions.References and/or AcknowledgementsConflict of InterestNo conflict of interest.

Background and ImportanceThe cost of unused antiblastic therapies (UAT) has a considerable impact on a General Hospital (GH) budget. In order to optimise resources allocation/limit waste, it is possible to analyse the process that goes from the physician request for patient care to validation carried out by the Hospital Pharmacist, to preparation/distribution/therapy administration for detecting weak points and turn towards a more sustainable company modus operandi.Aim and ObjectivesObjective of the study was to analyse antiblastic drug management process in a GH, by means of Root Cause Analysis, detecting weak links economic consequences and promoting corporate awareness work on the issue.Material and MethodsThe analysis covered the period December 2022 to May 2023. According to data collected, an Excel file was drawn up (showing protocol name/dosage/department/non-administration reason); it was also specified whether therapy was reused for another patient or disposed of and, if so, how much this choice has impacted on GH’s expenditure, making an estimate of the monetary value costs incurred for drug/preparation. An audit composed of physicians/pharmacists/nurses met to investigate non-administration causes for finding a sustainable company policy.ResultsOf 12,150 therapies set up, 97 were UAT; of these, 26/97 were re-used and 71/97 disposed of, for an economic loss of approximately 33,961.82 Euros, considering an estimate of 150 Euros for set-up costs (personnel-resources employed). Root Cause Analysis showed that the main reasons for non-administration were: prescribing errors 7.22% (7/97), inability to reach GH 20.6% (20/97), Adverse Drug Reactions (ADRs) 44.33% (43/97), illness not ADRs related 14.43% (14/97), other factors [anti-Covid test positivity, therapy refusal, falls, etc] 13.40% (13/97).Conclusion and RelevanceFor each non-administration reason corrective actions were identified. It would be desirable for Physician to confirm therapy to Compounding Antiblastic Unit (CAU) only when knows really that patient can receive it, following the visit/assessment of clinical analyses, to direct therapies setting up only towards patients who are truly eligible for conditions/availability/therapeutic reconciliation. Ideal would be the timely communication to CAU of any UAT so that it can be assessed, according to drug’s technical data sheet, whether drug can be reused on the same day or within the stability time. Finally, it would be useful having software alert/constraint system for cycles exceeding numbers permitted, established at the time of protocol coding.References and/or AcknowledgementsConflict of InterestNo conflict of interest.