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Thanks to their distribution throughout the territory and extended opening hours, community pharmacists are among the healthcare specialists most easily accessible to the public and often represent the first point of consultation both for the treatment of acute health conditions and, more generally, for health and therapy advice. The objective of the present study was to evaluate whether post-graduate courses/further training courses for pharmacists might influence the quality of patient management and care and, consequently, the satisfaction of the users who entered the pharmacy. We used the revenues of the pharmacies (Group A) in which these pharmacists are employed as a performance indicator. We compared the data for this group with the national averages for Italian pharmacies (Group B) and with those of a group (Group C) of selected pharmacies as similar as possible to the pharmacies in Group A based on a number of well-defined parameters. The comparison of revenues, year-on-year changes, and the average number of sales by the pharmacies in the three groups indicates that the pharmacies in Group A had the best performance, not only when compared with the national average but especially compared with the control group, specifically selected to make the comparison as significant as possible.

Introduction It is not possible to recover from chronic diseases; however, a healthy lifestyle and correct adherence to therapy can avoid complications and co-morbidities. The aim of this study was the cross-sectional evaluation, by means of a questionnaire, of real-world data on the prevalence of non-adherence to metformin and atorvastatin oral therapies in a sample of patients that attend community pharmacies in the Piedmont Region. The secondary aim was to evaluate the presence of correlations between non-adherence and a number of variables detected by the questionnaire. Materials and methods Data were gathered from face-to-face interviews in six community pharmacies in Piedmont. The questionnaire was divided into two sections: the first included the Morisky, Green and Levine Medication Adherence Questionnaire (MAQ) (to assess therapy adherence); the second included questions on gender, age, level of education and the pharmacy in which the questionnaire was administered. Comparisons between proportions and mean values were performed using the χ2 test. Modified Poisson regression with robust standard errors was used for multivariate analysis. The level of significance was fixed at 0.05, CI at 95%. Results The sample analysed was composed of 408 subjects (receiving either metformin or atorvastatin). According to MAQ, 62 patients were non-adherent (15% of the total cohort). Crude and multivariate analysis did not show any statistically significant correlation between gender, age, level of education and non-adherence. It emerged that there was a correlation between non-adherence and being a customer of two of the pharmacies involved [PR = 3.31 (p=0.028) and PR = 3.11 (p=0.027)]. Conclusions Community pharmacies can be an appropriate setting to identify non-adherent patients. Therefore, healthcare professionals could realize an integrated and structured intervention to improve adherence. However, MAQ could underestimate the number of non-adherent patients. Further studies to test the association between non-adherence prevalence and being the customer of a specific pharmacy should be performed.

Bevacizumab (BVZ) is a monoclonal antibody that binds to human vascular endothelial growth factor A (VEGF-A) and inhibits the interaction between VEGF-A and VEGF receptors, thus blocking the angiogenesis. Repeated intravitreal injections of BVZ for the treatment of ocular pathologies that present an excessive proliferation results in a low patience compliance. BVZ is specially indicated for the treatment of diabetic and degenerative retinopathy. In the present study, we designed lipid nanoparticles (NPs) as a BVZ sustained drug delivery system for reducing the frequency of administration. We used a simple and highly efficient procedure, “Cold dilution of microemulsions”, to obtain spherical NPs with mean diameters of 280–430 nm, Zeta potentials between −17 and −31 mV, and drug entrapment efficiencies between 50 to 90%. This study focused on the biochemical and biophysical stabilities of BVZ after entrapment in NPs. SDS-PAGE electrophoretic analysis and circular dichroism, dynamic light scattering, and scanning electron microscopy were used to characterize BVZ-loaded NPs. The biocompatibility was assessed by in vitro cell compatibility studies using the ARPE-19 cell line. Thus, in this work, a stable BVZ-loaded system was obtained. In addition, several studies have shown that BVZ is released slowly from the lipid matrix and that this system is biocompatible. The results are promising and the developed NPs could be exploited to create a new, potentially effective and minimally invasive treatment of intraocular diseases.

Introduction Type 2 diabetes is an important public health issue, yet adherence to drugs and regular clinical follow-up is still suboptimal. This study aims to evaluate a community pharmacy programme for monitoring and enhancing adherence to prescribed pharmacological therapies and recommended examinations among patients with confirmed diabetes. Methods The intervention was conducted in different Italian areas between April 2017 and January 2018. All adult patients who entered a pharmacy with a personal prescription for any antidiabetic drug and agreed to participate, were interviewed. Those found to be non-adherent received counselling from the pharmacists. All patients were invited for a follow-up interview after 3 months. Results Overall, 930 patients were enrolled and completed the baseline interview. We found low rates of non-adherence, ranging from 8% to 13% for prescribed pharmacological therapies, and 11–29% for the recommended clinical examinations. Non-adherence to oral therapies was higher among younger and recently diagnosed patients; that to clinical examinations was higher in men, those with an intermediate duration of diabetes and less educated patients. Large geographical differences persisted after the adjustment for individual factors. Only 306 patients (32.9%) returned for the follow-up interview, most of whom were already adherent at baseline. Conclusions Poor adherence to drugs or clinical examinations is not easy to identify in the usual operating setting of community pharmacies. Furthermore, the majority of patients did not return for follow-up, making it impossible to evaluate the efficacy of the pharmacists’ counselling. It might be more effective to plan interventions addressed to specific subgroups of patients or areas.

The field of Cannabis sativa L. research for medical purposes has been rapidly advancing in recent decades and a growing body of evidence suggests that phytocannabinoids are beneficial for a range of conditions. At the same time impressing development has been observed for formulations and delivery systems expanding the potential use of cannabinoids as an effective medical therapy. The objective of this review is to present the most recent results from pharmaceutical companies and research groups investigating methods to improve cannabinoid bioavailability and to clearly establish its therapeutic efficacy, dose ranges, safety and also improve the patient compliance. Particular focus is the application of cannabinoids in pain treatment, describing the principal cannabinoids employed, the most promising delivery systems for each administration routes and updating the clinical evaluations. To offer the reader a wider view, this review discusses the formulation starting from galenic preparation up to nanotechnology approaches, showing advantages, limits, requirements needed. Furthermore, the most recent clinical data and meta-analysis for cannabinoids used in different pain management are summarized, evaluating their real effectiveness, in order also to spare opioids and improve patients’ quality of life. Promising evidence for pain treatments and for other important pathologies are also reviewed as likely future directions for cannabinoids formulations.

Objective To evaluate the efficacy of a reinforcement message (RM) administered by a hospital pharmacist on adherence, through a randomised study involving patients undergoing oral chemotherapy from which an objective outcome measure and patients' subjective opinions were collected. A secondary aim was to detect which psychological or clinical factors influence adherence. Methods Forty patients were enrolled and randomised to an experimental group (EG) or a control group (CG). The EG received a 10-minute RM provided by a hospital pharmacist with a doctor and a nurse. The CG received the standard of care. To measure adherence, plasma drug concentration and subjective evaluation were taken during the visits, in addition to a psychological assessment (coping strategies, psychological distress and personality traits). Results The EG reported higher drug levels and a statistically significant higher mean score on the subjective evaluation. A linear regression model highlighted statistically significant differences in the plasma drug concentration, after considering toxicity and dose reduction and controlling for the Reward Dependence Scale of the Temperament and Character Inventory between the EG and the CG. Conclusion Adequate information and education on the therapy, using an RM strategy provided by a hospital pharmacist, seems to positively influence adherence to the treatment.

Hypertension is a risk factor for renal, cardiovascular and cerebrovascular diseases. It is responsible for a large proportion of overall morbidity and mortality every year. Hypertension-mediated organ damage is largely not reversible. For these reasons, prevention has primary importance: sensibilization of population on hypertension-related consequences is essential for therapeutic adherence and reduction of unhealthy lifestyle behaviour. This study aimed to evaluate awareness about hypertension among community pharmacies customers.A questionnaire about hypertension was collected by 2731 customers from 94 community pharmacies in North West Italy, during a hypertension screening program. Hypertension awareness was unsatisfactory in a large proportion of the sample, with only 15% of subjects having an overall good level of knowledge. Furthermore, lower awareness was associated to higher blood pressure values (132/79 ± 19/11 mmHg vs 128/78 ± 18/10 mmHg, p 0.001) and subjects resulted hypertensive or uncontrolled despite antihypertensive therapy, presented worse questionnaire scores (4.7 ± 1.9 vs 4.9 ± 2.0, p = 0.03).Knowledge about hypertension is largely unsatisfactory among population. Community pharmacies may play as a setting for health education and hypertension screening.

Background and aims Given the paucity of symptoms in the early stages of type 2 diabetes, its diagnosis is often made when complications have already arisen. Although systematic population-based screening is not recommended, there is room to experience new strategies for improving early diagnosis of the disease in high risk subjects. We report the results of an opportunistic screening for diabetes, implemented in the setting of community pharmacies. Methods and results To identify people at high risk to develop diabetes, pharmacists were trained to administer FINDRISC questionnaire to overweight, diabetes-free customers aged 45 or more. Each interviewee was followed for 365 days, searching in the administrative database whether he/she had a glycaemic or HbA1c test, or a diabetologists consultation, and to detect any new diagnosis of diabetes defined by either a prescription of any anti-hyperglycaemic drug, or the enrolment in the register of patients, or a hospital discharge with a diagnosis of diabetes. Out of 5977 interviewees, 53% were at risk of developing diabetes. An elevated FINDRISC score was associated with higher age, lower education, and living alone. Excluding the number of cases expected, based on the incidence rate of diabetes in the population, 51 new cases were identified, one every 117 interviews. FINDRISC score, being a male and living alone were significantly associated with the diagnosis. Conclusions The implementation of a community pharmacy-based screening programme can contribute to reduce the burden of the disease, particularly focusing on people at higher risk, such as the elderly and the socially vulnerable.

Community pharmacies are among the most easily accessible health services. Considering the major impact of COVID-19 in social terms, the purpose was to analyse the evolution of the relationship between community pharmacies and customers during the pandemic in 2020 and to understand which strategies should be implemented in the future. The data have been collected from May to December 2020. Pharmacists administered a questionnaire, also available online, to all customers that agreed to participate. The total number of respondents was 502. The results obtained confirm a generally high level of satisfaction with pharmacies among customers and appreciation for the role of community pharmacies. For the future, the priority is to monitor the situation to break down social inequalities. A task that can be entrusted to the branch of the healthcare service ideally suited to this end: local medicine, of which the community pharmacy is an essential element. The post-pandemic pharmacy will need to have the skills to provide accurate and reliable information on issues, including broad topics such as prevention and lifestyle to fight “syndemic” (two or more factors that work together to make a disease worse) and “infodemic” (too much information including false or misleading information during a disease outbreak).

Migraine is a disabling neurovascular syndrome which affects 12-15% of the global population and it represents the third cause in years lived with disability in both males and females aged 15-49 years. Among migraineurs, the symptomatic drug abuse may be a risk factor in the development of medication overuse headache (MOH). Detecting cases of MOH is not straightforward; community pharmacists may, therefore, be in a strategic position to identify individuals who self-medicate, particularly with respect to prevent the development of MOH. In 2014, our group published the results of a survey conducted in Piedmont, Italy, on the patterns of use and dispensing of drugs in patients requesting assistance from pharmacists for relief of a migraine attack. We decided, now, to expand the scope of the model to a national level. The study is based on cross-sectional face-to-face interviews using questionnaires, presented in this paper, consisting of a first part regarding the socio-economic situation and a second part which aimed to classify the disease and any excessive use of drugs. Of the 610 pharmacists trained with an online course, 446 gathered a total of 4425 correctly compiled questionnaires. The participation of community pharmacies has highlighted various criticalities especially of an organisational nature; however, it also revealed the power of this method as a means of gathering epidemiological data with a capillarity which few other methods can match. The objective was also to identify each territory's requirements and facilitate the decision-making process in terms of understanding what patients/citizens actually require.

Pyridoxamine, a structural analog of vitamin B6 that exerts antiglycative effects, has been proposed as supplementary approach in patients with initial diabetic nephropathy. However, the molecular mechanism(s) underlying its protective role has been so far slightly examined. C57Bl/6J mice were fed with a standard diet (SD) or a diet enriched in fat and fructose (HD) for 12 weeks. After 3 weeks, two subgroups of SD and HD mice started pyridoxamine supplementation (150 mg/kg/day) in the drinking water. HD fed mice showed increased body weight and impaired glucose tolerance, whereas pyridoxamine administration significantly improved insulin sensitivity, but not body weight, and reduced diet-induced increase in serum creatinine and urine albumin. Kidney morphology of HD fed mice showed strong vacuolar degeneration and loss of tubule brush border, associated with a drastic increase in both advanced glycation end products (AGEs) and AGEs receptor (RAGE). These effects were significantly counteracted by pyridoxamine, with consequent reduction of the diet-induced overactivation of NF-kB and Rho/ROCK pathways. Overall, the present study demonstrates for the first time that the administration of the antiglycative compound pyridoxamine can reduce the early stages of diet-dependent kidney injury and dysfunction by interfering at many levels with the profibrotic signaling and inflammatory cascades.

Italy is the last European country to adopt policies on the liberalization of pharmacy ownership. In August 2017, the Italian government approved the law n. 124 (annual market and competition law), despite the opposition of some stakeholders. This law extended the ownership of pharmacies to non-pharmacist business partners. Law n. 124 is an important turning point for pharmacists in Italy and could lead to a general reorganization of the Italian pharmaceutical system. As has already happened in several European countries, the removal of barriers to pharmacy ownership incentivizes finance companies and pharmaceutical wholesalers to make significant investments in this sector, leading to the emergence of commercial pharmacy chains. The future of community pharmacies is uncertain and is closely linked to the fate of the current government. However, progressive polarization between independent pharmacies and pharmacies that are part of chains can already be observed.

Headache disorders are the third among the worldwide causes of disability, measured in years of life lost to disability. Given the pharmacies' importance in general in headache patient and, in particular in migraine patient management, various studies have been carried out in recent years dealing with this issue. Indeed, in 2014, our research group first analysed publications on a number of studies conducted worldwide. As five years have passed since our first analysis of the literature and having carried out a number of specific studies in Italy since 2014, we wish to analyse once again the studies carried out globally on this topic to evaluate how the situation has evolved in the meantime. The key words used for the bibliographic search were "community pharmacy" and "headache"; we considered articles published between 2014 and 2018. The selected studies regarded Sweden USA, Belgium, Ireland, Jordan and Ethiopia. From the analysis of the international research papers, it is evident that, despite the time that has passed since the previous analyses and the general agreement that pharmacists find themselves in an ideal position to offer adequate levels of counselling to headache patients, the knowledge of pharmacists is not yet sufficient. Clearly, there is a strong need to develop training programmes specifically focused on this subject. Regarding Italy, a national study, commenced in 2016, was designed as a cross-sectional survey employing face-to-face interviews between pharmacist and patient using a questionnaire drawn up by experts in compliance with best practice from scientific literature. Six hundred ten pharmacists followed a specific training course; 4425 questionnaires were correctly completed. The use of pharmacies as epidemiological sentinels, given their capillarity and daily contact with the local population in Italy, enabled us to obtain an epidemiological snapshot closer to the real-life situation compared to specialist headache centres. Over the course of this study, data on headaches were gathered in Italian pharmacies with the highest levels of numerosity in the world.

Background: vaccines are one of the greatest medical discoveries. In various countries, pharmacists are authorised to administer vaccines directly in pharmacies; thus, leading to an increase in the immunisation rate and a notable gain in consensus amongst the population. The main objective was to evaluate the opinion of pharmacy customers regarding the proposal to authorise pharmacies to administer vaccines. Results: 85% of the respondents were in favour of the introduction of a vaccinating pharmacist. The data show more positive attitudes to the introduction of this service amongst subjects with an elderly dependant relative (PR = 1,10; p = 0.025). Furthermore, it can be noticed a higher probability of positive attitudes to the establishment of the vaccinating pharmacist amongst those with positive attitudes to vaccines (PR = 1,15; p = 0.039). Moreover, the pharmacist is seen as a reference on the subject of vaccines by only 8% of interviewees. Discussion: The data highlight the particularly positive feedback regarding the subject of pharmacists being authorised to administer vaccines. This service may, however, encounter obstacles such as economic problems and opposition from other health professionals. Materials and methods: Data were gathered through a face-to-face interview by means of questionnaires in eight pharmacies in the north-west of Piedmont (Italy). Descriptive statistics were performed. The comparison between the proportions and average values was performed by χ(2) and t-test. The indicator used for the associations was the Prevalence Ratio (PR). The PR was calculated using a modified Poisson regression with robust standard errors. The level of significance was fixed at 0.05; IC at 95%.

Pharmacists in the community and the essential requirement to safeguard their own health have become fundamental since the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The aims of this paper were (I) to analyze the directives provided to pharmacists in 2020 regarding preventative safety measures to be adopted, (II) to determine the number of pharmacists who came into contact with SARS-CoV-2 in North-West Italy and relate this to the adopted preventative measures. The first aim was pursued by conducting a bibliographic research, consulting the principal regulatory sources. The second one was achieved with an observational study by administering a questionnaire and performing a serological test. The various protection measures imposed by national and regional legislation were analyzed. Two hundred and eighty-six pharmacists (about 8% of the invited ones) responded to the survey. Ten pharmacists reported a positive result to the serological test. Of the subjects who presented a positive result, three declared that they had not used a hand sanitizer, while two stated that they had not scheduled the cleaning and decontamination of surfaces. Two interviewees had not set up a system of quota restrictions on admissions. In four cases, a certified cleaning company had decontaminated the premises. The results of our study show that during the coronavirus disease 2019 (COVID-19) pandemic, the most pressing challenge for community pharmacists has been the protection of staff and clients inside the pharmacy, the challenge to be faced in the near future will probably be the management of new responsibilities.

Current legislation in Italy provides that medical Cannabis may be administered orally or by inhalation. One of the fundamental criteria for the administration of oral formulations is that they deliver a known consistent quantity of the active ingredients to ensure uniform therapies leading to the optimisation of the risks/benefits. In 2018, our group developed an improved Cannabis oil extraction technique. The objective of the present work was to carry out a stability study for the oil extracts obtained by this method. Furthermore, in order to facilitate the consumption of the prescribed medical Cannabis therapy by patients, a standard procedure was defined for the preparation of a single-dose preparation for oral use (hard capsules) containing the oil extract, thereafter, the quality and stability were evaluated. The hard capsules loaded with the oil extract were analysed and found to be uniform in content. The encapsulation process did not alter the quantity of the active molecule present in the oil. The stability tests yielded excellent results. Since the capsule dosage form is easily transported and administered, has pleasant organoleptic properties and is stable at room temperature for extended periods of time, this would facilitate the adherence to therapy by patients in treatment.

Background. D-tagatose is an isomer of fructose and is ~90% as sweet as sucrose with less caloric value. Nowadays, D-tagatose is used as a nutritive or low-calorie sweetener. Despite clinical findings suggesting that D-tagatose could be beneficial in subjects with type 2 diabetes, there are no experimental data comparing D-tagatose with fructose, in terms of metabolic derangements and related molecular mechanisms evoked by chronic exposure to these two monosaccharides.Materials and methods. C57Bl/6j mice were fed with a control diet plus water (CD), a control diet plus 30% fructose syrup (L-Fr), a 30% fructose solid diet plus water (S-Fr), a control diet plus 30% D-tagatose syrup (L-Tg), or a 30% D-tagatose solid diet plus water (S-Tg), during 24 weeks.Results. Both solid and liquid fructose feeding led to increased body weight, abnormal systemic glucose homeostasis, and an altered lipid profile. These effects were associated with vigorous increase in oxidative markers. None of these metabolic abnormalities were detected when mice were fed with both the solid and liquid D-tagatose diets, either at the systemic or at the local level. Interestingly, both fructose formulations led to significant Advanced Glycation End Products (AGEs) accumulation in mouse hearts, as well as a robust increase in both myocardial AGE receptor (RAGE) expression and NF-κB activation. In contrast, no toxicological effects were shown in hearts of mice chronically exposed to liquid or solid D-tagatose.Conclusion. Our results clearly suggest that chronic overconsumption of D-tagatose in both formulations, liquid or solid, does not exert the same deleterious metabolic derangements evoked by fructose administration, due to differences in carbohydrate interference with selective proinflammatory and oxidative stress cascades.

BACKGROUND Antioxidants effectiveness in prostate cancer (PCa) chemoprevention has been severely questioned, especially after the recent results of the Selenium and Vitamin E Cancer Prevention Trial. We present the results of a double-blind randomized controlled trial (dbRCT) on the pharmacokinetic, clinical, and molecular activity of dietary supplements containing lycopene, selenium, and green tea catechins (GTCs) in men with multifocal high grade prostatic intraepithelial neoplasia (mHGPIN) and/or atypical small acinar proliferation (ASAP). METHODS From 2009 to 2014, we conducted a dbRCT including 60 patients with primary mHGPIN and/or ASAP receiving daily lycopene 35 mg, selenium 55 µg, and GTCs 600 mg, or placebo for 6 months. Pharmacokinetic analysis were performed with UV–Visible spectrophotometric assay under standard (SC) and accelerated (AC) conditions. Upon plasma lycopene concentrations falling within the expected range (1.2–90 mcg/l) and no side-effects of grade >1, study proceeded to phase II (n = 50). After unblinding of results, eight men (4 per arm, 2 without and 2 with PCa, respectively) were randomly selected and totRNA extracted from “non-pathological” tissues. MicroRNA profiling was performed with the Agilent platform. Raw data processing used R-statistical language and linear models for microarray analysis. RESULTS Samples were stable except for lycopene, showing significant degradation (SC = 56%, AC = 59%) and consequently stabilized under vacuum in a dark packaging. Mean plasmatic lycopene concentration was 1,45 ± 0,4 μM. At 6 months, 53 men underwent re-biopsy and 13 (24.5%) were diagnosed with PCa (supplementation n = 10, placebo n = 3 [P = 0.053]). At a mean 37 months follow-up, 3 additional PCa were found in the placebo group. No significant variations in PSA, IPSS, and PR25 questionnaires were observed. Stronger modulation of miRNAs was present on re-biopsy in the supplementation group compared to the placebo, including: (i) overexpression of miRNAs present in PCa versus non-cancer tissue; (ii) underexpression of miRNAs suppressing PCa proliferation; (iii) detection of 35 miRNAs in PCa patients versus disease-free men, including androgen-regulated miR-125b-5p and PTEN-targeting miR-92a-3p (both upregulated). CONCLUSION Administration of high doses of lycopene, GTCs, and selenium in men harboring HGPIN and/or ASAP was associated with a higher incidence of PCa at re-biopsy and expression of microRNAs implicated in PCa progression at molecular analysis. The use of these supplements should be avoided. Prostate 75: 1177–1186, 2015. © 2015 Wiley Periodicals, Inc.

Sirt2 is a target for the treatment of neurological, metabolic, and age-related diseases including cancer. Here we report a series of Sirt2 inhibitors based on the 1,2,4-oxadiazole scaffold. These compounds are potent Sirt2 inhibitors active at single-digit μM level by using the Sirt2 substrate α-tubulin-acetylLys40 peptide and inactive up to 100 μM against Sirt1, -3, and -5 (deacetylase and desuccinylase activities). Their mechanism of inhibition is uncompetitive toward both the peptide substrate and NAD(+), and the crystal structure of a 1,2,4-oxadiazole analog in complex with Sirt2 and ADP-ribose reveals its orientation in a still unexplored subcavity useful for further inhibitor development. Tested in leukemia cell lines, 35 and 39 induced apoptosis and/or showed antiproliferative effects at 10 or 25 μM after 48 h. Western blot analyses confirmed the involvement of Sirt2 inhibition for their effects in NB4 and in U937 cells. Our results provide novel Sirt2 inhibitors with a compact scaffold and structural insights for further inhibitor improvement.

Headaches are among the most common disorders of the nervous system. On a global level, it is estimated that the prevalence of headache disorder in adults is 47 %. A proper treatment of headaches requires training of health care personnel, careful diagnosis and recognition of the condition, appropriate treatment with cost-effective drugs, simple changements in lifestyle and patient education. Unfortunately, a large number of people suffering from headache disorders are not diagnosed and treated. The unsatisfied needs in migraine can be faced by involving the pharmacist in the management of the pathology. To really understand which are the activities and the potential of community pharmacies in the management of patients with headache or migraine we took into account studies conducted around the world during the last 5 years. Based on the data collected it is clear that the role of the community pharmacist may be crucial in managing patients with headache or migraine but only if he receives an adequate and continuous education both on the management of therapies and maintains a stable relationship with the medical doctor and/or patient. In Piedmont a specific study to identify migraine sufferers has involved the community pharmacies in the administration of a questionnaire, specially crafted by the Italian Headache Foundation (FICEF non-profit association).

Headache disorders are considered the second leading cause of years lived with disability worldwide, and 90% of people have a headache episode at least once a year, thus representing a relevant public health priority. As the pharmacist is often the first and only point of reference for people complaining of headache, we carried out a survey in a nationwide sample of Italian pharmacies, in order to describe the distribution of migraine or non-migraine type headaches and medicines overuse among people entering pharmacies seeking for self-medication; and to evaluate the association, in particular of migraine, with socio-demographic and clinical characteristics, and with the pathway of care followed by the patients. A 14-item questionnaire, including socio-demographic and clinical factors, was administered by trained pharmacists to subjects who entered a pharmacy requesting self-medication for a headache attack. The ID Migraine™ Screener was used to classify headache sufferers in four classes. From June 2016 to January 2017, 4424 people have been interviewed. The prevalence of definite migraines was 40%, significantly higher among women and less educated people. About half of all headache sufferers and a third of migraineurs do not consider their condition as a disease and are not cared by any doctor. Among people seeking self-medication in pharmacies for acute headache attacks, the rate of definite or probable migraine is high, and a large percentage of them is not correctly diagnosed and treated. The pharmacy can be a valuable observatory for the study of headaches, and the first important step to improve the quality of care delivered to these patients.

In 2014 our group published the results of a survey conducted in Piedmont, Italy, on the patterns of use and dispensing of drugs in patients requesting assistance from pharmacists for relief of a migraine attack. Epidemiological studies on migraine have consistently shown that migraine is far more common among women than men. This gender difference is also reflected in the higher percentage of women visiting a pharmacy to obtain treatment or advice for headache attacks. In this study, we further explored gender differences in healthcare-seeking behavior and use of migraine medications. The aim of the study was to determine whether women made better selective use of migraine medications and whether visiting a headache center for consultation and treatment reflected awareness of how best to manage their condition. Among the drugs usually taken for relieving head pain, there was no statistically significant difference between men and women in the routine use of NSAIDs (55.6 vs. 51.6 %) or ergot derivatives (8.7 vs. 9.3 %). Statistically significant differences emerged between men and women (27.9 vs. 35.4 %) in the use of triptans (p = 0.003; OR 1.41, 95 % CI 1.12–1.78) and in the use of combined medications (8.5 vs. 12.2 %) (p = 0.029; OR 1.49, 95 % CI 1.04–2.14) but not in the use of simple OTC non-NSAIDs. Less men than women sought professional medical care for managing migraine (65.7 vs. 72.4 %) (p = 0.003; OR 0.71, 95 % CI 0.57–0.89); more women than men sought treatment at a headache center (21.7 vs. 17.4 %) (p = 0.044; OR 1.31, 95 % CI 1.07–1.72).

Antioxidants effectiveness in prostate cancer (PCa) chemoprevention has been severely questioned, especially after the recent results of the Selenium and Vitamin E Cancer Prevention Trial. We present the results of a double-blind randomized controlled trial (dbRCT) on the pharmacokinetic, clinical, and molecular activity of dietary supplements containing lycopene, selenium, and green tea catechins (GTCs) in men with multifocal high grade prostatic intraepithelial neoplasia (mHGPIN) and/or atypical small acinar proliferation (ASAP).From 2009 to 2014, we conducted a dbRCT including 60 patients with primary mHGPIN and/or ASAP receiving daily lycopene 35 mg, selenium 55 µg, and GTCs 600 mg, or placebo for 6 months. Pharmacokinetic analysis were performed with UV-Visible spectrophotometric assay under standard (SC) and accelerated (AC) conditions. Upon plasma lycopene concentrations falling within the expected range (1.2-90 mcg/l) and no side-effects of grade1, study proceeded to phase II (n = 50). After unblinding of results, eight men (4 per arm, 2 without and 2 with PCa, respectively) were randomly selected and totRNA extracted from "non-pathological" tissues. MicroRNA profiling was performed with the Agilent platform. Raw data processing used R-statistical language and linear models for microarray analysis.Samples were stable except for lycopene, showing significant degradation (SC = 56%, AC = 59%) and consequently stabilized under vacuum in a dark packaging. Mean plasmatic lycopene concentration was 1,45 ± 0,4 μM. At 6 months, 53 men underwent re-biopsy and 13 (24.5%) were diagnosed with PCa (supplementation n = 10, placebo n = 3 [P = 0.053]). At a mean 37 months follow-up, 3 additional PCa were found in the placebo group. No significant variations in PSA, IPSS, and PR25 questionnaires were observed. Stronger modulation of miRNAs was present on re-biopsy in the supplementation group compared to the placebo, including: (i) overexpression of miRNAs present in PCa versus non-cancer tissue; (ii) underexpression of miRNAs suppressing PCa proliferation; (iii) detection of 35 miRNAs in PCa patients versus disease-free men, including androgen-regulated miR-125b-5p and PTEN-targeting miR-92a-3p (both upregulated).Administration of high doses of lycopene, GTCs, and selenium in men harboring HGPIN and/or ASAP was associated with a higher incidence of PCa at re-biopsy and expression of microRNAs implicated in PCa progression at molecular analysis. The use of these supplements should be avoided.

The A.P.P.A. ® Project is the result of the cooperation between the University of Turin (Italy) and Italian Community Pharmacists and it is in agreement with the International Health Cooperation principles. The Project is structured in six steps through which it is possible to obtain an effective and functional galenic laboratory in hospitals located in developing Countries: from a preliminary study of local needs up to a constantly and accurate control of the prepared galenics by analysis in the laboratories of the University of Turin. The proposed pharmaceutical dosage forms are liquids, capsules, ointments, pessaries, suppositories, parenteral solutions. For each laboratory, a specific handbook has been studied to comply with the local needs. For each preparation, specific tests have been performed to verify the stability under different environmental conditions (EMA guidelines). Several Projects are working on: two in Cameroon, Madagascar and Angola; one in Chad and one in Haiti.

After an initial screening of ingredients and production methods, nanoemulsions for ocular administration of timolol containing the drug as maleate (TM) or as ion-pair with AOT (TM/AOT) were prepared. The physico-chemical characterization of nanoemulsions, regarding mean diameter, pH, zeta potential, osmolarity, viscosity and surface tension, underlined their feasibility to be instilled into the eyes. Single components and emulsions were tested ex vivo on rabbit corneas to evaluate corneal irritation, that was measured according to opacity test. A marked decrease in corneal opacity was observed using the drug formulated in nanoemulsions rather than in aqueous solutions. Drug permeation and accumulation studies were performed on excised rabbit corneas. An increase in drug permeation through and accumulation into the corneas were observed using TM-AOT compared to TM due to an increase of lipophilicity of the drug as ion-pair. The introduction of chitosan (a positive charged mucoadhesive polymer) into emulsions allowed to increase TM permeation probably due to the interaction of chitosan with corneal epithelial cells.

Aim To investigate the diffusion of counterfeit medicines in developing countries and to verify the stability of galenic dosage forms to determine the stability of galenics prepared and stored in developing countries. Methods We purchased 221 pharmaceutical samples belonging to different therapeutic classes both in authorized and illegal pharmacies and subjected them to European Pharmacopoeia, 7th ed. quality tests. An UV-visible spectrophotometric assay was used to determine the galenics stability under different conditions of temperature (T) and relative humidity (RH). Results A substantial percentage of samples was substandard (52%) and thus had to be considered as counterfeit. Stability tests for galenics showed that the tested dosage forms were stable for 24 months under “standard” (t = 25 ± 2°C, RH = 50 ± 5%) conditions. Under “accelerated” (t = 40 ± 2°C, RH = 50 ± 5%) conditions, samples were stable for 3 months provided that they were stored in glass containers. Stability results of samples stored in “accelerated” conditions were similar to those obtained by on site in tropical countries and could so supply precious information on the expected stability of galenics in tropical countries. Conclusion This study gives useful information about the presence of counterfeit medicinal products in the pharmacies of many developing countries. This should serve as an alarm bell and an input for the production of galenics. We recommend setting up of galenic laboratories in developing countries around the globe.