A Prospective Real-World Study of Bacillus clausii Evaluating Use, Treatment Habits and Patient Satisfaction in Italian Community Pharmacies: The PEGASO Study.

BACKGROUND: Ailments such as diarrhoea and antibiotic-associated gut symptoms are generally self-managed using probiotics. Real-world data on reasons behind self-medication with over-the-counter (OTC) products and patient-reported outcomes can be investigated strategically by the pharmacists. OBJECTIVE: This study evaluates the use of Bacillus clausii (Enterogermina®) at the Italian community pharmacies among self-medicating patients, their treatment habits and perceived benefits. DESIGN: This is a multicentre, prospective, non-interventional study which included two visits [at screening (T0) and end of the study (T1) when symptoms had subsided, ≤ 30 days from T0]. Patients who were already inclined to buy B. clausii were enrolled and instructed to complete a questionnaire at T0 and T1. The primary objective was to evaluate the reasons for taking B. clausii. Secondary objectives assessed treatment duration, perceived effectiveness, quality of life (QoL), treatment satisfaction and safety outcomes. RESULTS: Overall, 268 patients were enrolled; 99.6% of them were evaluated at T0 and 97.4% at T1, and safety was evaluated in 97.8% who had ≥ 1 dose of B. clausii. At T0, mean age was 50.7 years and majority were females (62.2%). In the interview, main reason stated for using B. clausii at T0 was diarrhoea (56.93%), followed by other gastrointestinal symptoms. Treatment duration was shorter in those with diarrhoea or abdominal pain versus those with constipation or abdominal tension. More than 90% perceived their symptoms to have improved or improved very much. Overall QoL improved in all the aspects measured. Treatment satisfaction was reported by nearly 90% of patients as satisfied, very satisfied or extremely satisfied. No adverse events were reported. CONCLUSION: This is the first pharmacy-based study in Italy that evaluated the real-world usage of an OTC probiotic containing B. clausii among self-medicating adults. Diarrhoea was the most common reason for use, with high-level of perceived effectiveness and patient satisfaction with B. clausii.

Oral Corticosteroid Abuse and Self-Prescription in Italy: A Perspective from Community Pharmacists and Sales Reports before and during the COVID-19 Era.

(1) Background: Corticosteroids are commonly used for a variety of conditions, but their use might come with significant side effects. Self-medication practices increased during the COVID-19 pandemic, potentially favoring corticosteroid misuse. Studies on this topic are lacking, thus we aim to characterize the misuse of corticosteroids in Italy through pharmacists' perspectives and sales reports. (2) Methods: We sent to territorial pharmacists a survey that aimed to investigate corticosteroid misuse before and during the pandemic. In parallel, sales reports of the major oral corticosteroids were obtained from IQVIA. (3) Results: We found that 34.8% of clients demanded systemic corticosteroids without a valid prescription, with a rise to 43.9% during the pandemic (p < 0.001). Adults and patients suffering from upper airway diseases or obstructive airway diseases most frequently asked for corticosteroids without an appropriate prescription. The greatest increase after the beginning of the pandemic was seen for lung diseases. Although sales of the major oral corticosteroids decreased during the pandemic, sales of those used for COVID-19 increased. (4) Conclusions: Self-medication with corticosteroids is common and might lead to avoidable toxicities. This tendency increased during the pandemic probably because of incorrect beliefs about the inappropriate use of corticosteroids for treating COVID-19 itself. The development of shared strategies between doctors and pharmacists is essential in defining protocols guiding appropriate patient referral in order to minimize corticosteroid misuse.

Use, Abuse, and Misuse of Nasal Medications: Real-Life Survey on Community Pharmacist's Perceptions.

BACKGROUND: Medication overuse is an increasing global problem, especially for those rhinology diseases whose management requires over-the-counter drugs. This observational community pharmacy-based study aimed to investigate the actual use of the best-selling topical nasal medications and to characterize the clinical issues underlying their query through the pharmacist's perception. METHODS: In the pilot phase, a preliminary survey was developed by a team of researchers and tested on a small sample of practitioners to assess usability and intelligibility. Eventual amendments were made according to the feedback obtained, and the final version was submitted to practitioners working in 376 pharmacies evenly distributed over the Italian territory. RESULTS: Two groups of customers (18-30 years old and 60-75 years old) were the ones who most frequently purchased topical decongestants. The dosage applied for sympathomimetic amines was higher than recommended in up to 44.4% and the duration of use longer than 5 days in up to 31.9% of the cases. Patients' queries of alpha agonists and topical corticosteroids resulted in significantly higher numbers than practitioners' prescriptions. Allergic rhinitis was the most common disease affecting patients seeking sympathomimetic amines. CONCLUSIONS: The prolonged use of sympathomimetic amines in patients suffering from rhinology diseases is a significant problem that requires greater attention in terms of social education and surveillance.

Impact of 2021 ESC Guidelines for Cardiovascular Disease Prevention on Hypertensive Patients Risk: Secondary Analysis of Save Your Heart Study.

INTRODUCTION: Cardiovascular diseases (CVD) are a leading cause of death worldwide, and several modifiable and unmodifiable risk factors contribute to this burden of disability and mortality. Thus, effective cardiovascular prevention relies on appropriate strategies to control risk factors within the frame of unmodifiable traits. METHODS: We conducted a secondary analysis of treated hypertensive adults aged ≥ 50 years enrolled in Save Your Heart. CVD risk and hypertension control rates based on the 2021 updated European Society of Cardiology guidelines were evaluated. Comparisons with previous standards in terms of risk stratification and hypertension control rates were performed. RESULTS: Among the 512 patients evaluated, with the application of the new parameters for fatal and non-fatal cardiovascular risk assessment, the proportion of individuals at high or very high risk rises from 48.7 to 77.1% of cases. A trend towards lower hypertension control rates was observed based on 2021 European guidelines compared with the 2018 edition (likelihood estimate for difference: 1.76%, 95% CI - 4.1 to 7.6%, p = 0.589). CONCLUSIONS: In this secondary analysis on the Save Your Heart study, the application of the new parameters reported in the European Guidelines for Cardiovascular Prevention 2021 showed a hypertensive population with a very high probability of encountering a fatal or non-fatal cardiovascular event due to failure to control risk factors. For this reason, a better management of risk factors must be the main goal for the patient and all the involved stakeholders.

Developing and piloting a communication assessment tool assessing patient perspectives on communication with pharmacists (CAT-Pharm).

BACKGROUND: Effective communication strategies in health care help to enhance patient empowerment and improve clinical outcomes. OBJECTIVE: Adapt the original Communication Assessment (CAT) instrument for the pharmacist profession (CAT-Pharm) and to test its validity and reliability in two different settings. SETTING: Five hospital pharmacies in Italy and five community pharmacies in Malta. METHOD: Pilot study involving a standardized multi-step process adhering to internationally accepted and recommended guidelines. Corrections and adjustments to the translation addressed linguistic factors and cultural components. CAT-Pharm, compared to the original CAT, maintained 10 out of the 14 items: one was slightly modified; three were changed to better fit the pharmacist role; one was added. MAIN OUTCOME MEASURES: CAT-Pharm development and testing its practicality to assess patient perceptions of pharmacists' interpersonal and communication skills. RESULTS: CAT-Pharm was tested on 97 patients in the Italian setting and 150 patients in the Maltese setting to assess the practicality of the tool and its usefulness in investigating gaps and priorities for improving pharmacist-patient communication. Results Show reliability and internal validity of the CAT-Pharm tool. The analysis of patient perceptions of communication with the pharmacist in Italy indicated differences from that in Malta. The different settings provided insight into the utility of CAT-Pharm. CONCLUSION: This study provided a valid and reliable tool that could be applied to assess patient perception of the pharmacist's communication abilities.

The effect of sucralfate-containing ointment on quality of life in people with symptoms associated with haemorrhoidal disease and its complications: the results of the EMOCARE survey.

BACKGROUND AND AIM: A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease. This survey evaluated the effect of the mentioned sucralfate ointment, on quality of life (QoL) and symptom frequency in participants seeking treatment for haemorrhoidal disease from community pharmacies in Italy. METHODS: EMOCARE was a multicentre prospective survey conducted at community pharmacies in Italy. Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile). A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment. The primary endpoint was the change in HEMO-FISS-QoL scores. RESULTS: Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit. After a mean duration of 13 days, the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: -10.41; 95%CI -11.95, -8.86; P<0.001) and mean scores for all domains of the HEMO-FISS-QoL scale (-11.13 [95%CI -12.95, -9.30] for physical disorders, -6.14 [95%CI -7.42, -4.85] for psychology, -18.79 [95% CI -21.67, -15.90] for defaecation, and -6.46 [95%CI -8.40, -4.51] for sexuality; all P<0.001 versus baseline). At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms and the frequency of all assessed symptoms were reduced significantly from baseline (all P<0.05). CONCLUSIONS: After a mean 13 days of treatment  the sucralfate ointment with herbal extracts improved HEMO-FISS-QoL scores and reduced symptoms in people with haemorrhoidal disease.

Community pharmacist's professional adaptation amid Covid-19 emergency: a national survey on Italian pharmacists.

Background Italy has been the first non-Asian country affected by Coronavirus Disease 19 (COVID-19) pandemic. Community pharmacies are essential services authorized to continue their activity during the emergency. To date, a clear image is lacking of the critical issues Italian community pharmacists had to face and of how they responded in their daily work.. Objective To describe procedures and critical logistical-organizational issues encountered by Italian community pharmacists and to collect the main requests reported by patients to pharmacists. Setting A national survey on Italian community pharmacists. Method A cross-sectional survey using a reasoned questionnaire was sent during the pandemic peak to Italian pharmacies, divided in two groups according to the incidence of COVID-19: "Red Zones" and "non-Red Zones". Main outcome measure Exploring the most frequently adopted measures by the pharmacists. Results 169 community Pharmacists answered the questionnaire. The most frequently adopted measures were the use of gloves, surgical masks and protective barriers at the drug counter. Most implemented services for customers were: booking of prescriptions, delivery of medications and implementation of phone consultations. Overall, the questionnaire highlighted an increase in the number of health-related consultations and requests by customers. In Red Zones, there was a higher use of FFP2 and FFP3 masks by pharmacists, where customers were mainly interested in gaining information about specific classes of medications. Conclusion Community pharmacists adapted to lockdown measures by implementing a number of measures. There was an overall increase in pharmacists' personal protective equipment in Red Zones possibly linked to increased risk perception.

Effect of an educational intervention delivered by pharmacists on adherence to treatment, disease control and lung function in patients with asthma.

BACKGROUND: Lack of therapeutic adherence is a relevant problem in clinical practice and it can be assessed via validated tools such as the Test of Adherence to Inhalers (TAI). Education on the correct use of inhaler devices has been associated with improvement in adherence. Many studies highlighted the pivotal role of pharmacists in promoting therapeutic adherence in the management of respiratory diseases. OBJECTIVE: To evaluate the effectiveness on adherence and clinical parameters of an educational intervention administered by clinical pharmacists (CPs) to patients with asthma on long-term inhalation therapy. METHODS: A prospective comparative study involving 34 community pharmacies in Italy (23 intervention, 11 control). Enrolled subjects were evaluated for adherence to inhalation therapy by TAI, asthma control by "Asthma Control Test" (ACT), and lung function at baseline and after 2 months. The educational intervention at baseline was based on TAI results and administered by specifically trained pharmacists. RESULTS: A total of 242 consecutive subjects (167 intervention, 75 control) were enrolled. There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit. Patients with baseline ACT≥20 maintained disease control more frequently in the intervention group compared to the control arm (95% vs 79.5%, p = 0.004). Conclusions through administration of TAI-driven educational interventions addressing both technical and psychological issues, trained CPs can help improve adherence to treatment and asthma control.

Community Pharmacist's Role in Detecting Low Back Pain, and Patient Attitudes-A Cross-Sectional Observational Study in Italian Community Pharmacies.

BACKGROUND: Low back pain (LBP) is one of the most frequent diseases for which patients seek advice in a community pharmacy. The study aimed to evaluate the feasibility of the administration by community pharmacists of questionnaires to assess the LBP intensity and disability degree in patients entering community pharmacies and the attitudes they have toward pain management by pharmacological and non-pharmacological strategies. METHODS: An explorative, cross-sectional, observational, and quantitative study was performed. Twelve Italian community pharmacists were asked to submit a questionnaire on LBP to patients visiting their pharmacies. The questionnaire included a pain intensity scale, and two validated tools: the Roland and Morris Disability Questionnaire (RMDQ) and the Start Back Screening Tool (SBST) to determine the degree and risk of patient disability, respectively. RESULTS: 872 patients filled out the questionnaires in 6 months. No statistical differences between genders (p > 0.30) were recorded for pain intensity (Female: median score 6, IQR 4-7; Male: median scores 5, IQR 4-7; p > 0.30) and disability associated with LBP (RMDQ high-disability level: Females, 14.7%, Males, 15.0%; p > 0.90). Most of the patients (69%) reported a low degree of disability, but the risk of disability was medium and high in 36% and 18% of them, respectively (p < 0.05). About 14% of patients declare to never seek for physician's advice despite their medium-high degree of disability. CONCLUSION: The study demonstrated the feasibility of validated tools for assessing the degree and risk of disability in LBP patients administrable in community pharmacies. Moreover, the community pharmacy resulted in an important care portal for patients suffering from moderate LBP and for intercepting patients who suffered from severe LBP but had never reported their problem to their physician.

Role of community pharmacists in the detection of potentially inappropriate benzodiazepines prescriptions for insomnia.

BACKGROUND: The appropriate management of chronic insomnia is crucial and prescribing of hypnotic drugs is common. Regular and prolonged use of hypnotics should be avoided because of the risk of tolerance to effects, dependence and an increased risk of adverse events. In 2012, updated Beers criteria for potentially inappropriate medication in older adults suggested to avoid all benzodiazepines in older adults to treat insomnia. In addition, successful discontinuation may result in improvements on cognitive and psychomotor function, particularly in older people. OBJECTIVE: To investigate the appropriateness of benzodiazepines prescription for insomnia and explore the role that community pharmacists can have in identifying signals of potential inappropriate drug prescriptions. SETTING: Community pharmacies in Italy. METHOD: This is an observational study conducted in 8 community pharmacies. Each pharmacist was asked to interview a sample of patients with the prescriptions of at least one benzodiazepine and to complete a minimum data set collecting information about socio-demographic characteristics, drug indication, duration of drug prescription, number of hypnotic-drugs, previous attempt to drug-discontinuation, preference of patients about benzodiazepine withdrawal and modality of drug tapering. Main outcome measure Indications, treatment duration, dosage and drug discontinuation attempts and modalities. RESULTS: A total of 181 participants were interviewed. About half of respondents (n = 81) reported to be treated for insomnia and 62 % were elderly (mean age 68, range 27-93). Fifty-two patients (64 %) were on long term treatment (>3 years) while for thirteen patients (16 %) duration of treatment was comprised between 1 and 3 years. Thirty-three patients were in favour of benzodiazepine-discontinuation but in all cases discontinuation was unsuccessful. CONCLUSION: Use of community pharmacy survey data allowed us to obtain information about incorrect management of insomnia and inappropriate benzodiazepines prescriptions. Stricter adherence to evidence-based guidelines is essential for a rational use of hypnotic and sedatives.