Triptans utilization in Italian population: A real-life study in community pharmacies.

The term Headache Disorders (HD) refers to a number of nervous system pathologies characterised by recurrent headaches. Despite the serious impact HD have on the health system, society, and the economy, these are an underestimated, underdiagnosed, and, hence, undertreated phenomenon. Triptans are the first-line therapy for the acute treatment of moderate to severe migraine but their utilization is still inadequate, perhaps also because in Italy no triptan can be bought without a medical prescription. In this article, the data from a 2016-2017 study has been further analysed with the aim of evaluating any associations between the use of triptans and the other series of variables identified in the questionnaire. This further analysis has been connected to the role that community pharmacies could play on this issue. The questionnaire was administered to 4,424 pharmacy users by 610 purposely trained pharmacists working in 514 pharmacies. The survey was carried out in 19 of the 20 Italian regions. The data shows that only 25% of patients suffering from HDs are prescribed triptans. Older patients, those with definite migraines, and those with a chronic disorder resort more frequently to this class of pharmaceuticals, as do those patients in care at a specialist headache centre. The multivariable analysis also confirmed these results. Our study, which performed a direct detection, in real life, on patients requesting pharmacological treatment for a migraine headache, therefore confirmed the need to investigate the reasons behind the low use and prescription of triptans in the Italian population. Moreover, any future studies should take advantage of community pharmacies, plan actions that would allow a series of evaluations over time of the requirements of migraineurs, and establish a process to put these patients under the care of the pharmacy to ensure adherence to therapy.

Opportunistic screening for type 2 diabetes in community pharmacies. Results from a region-wide experience in Italy.

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.

Prevention, education and counselling: the worldwide role of the community pharmacist as an epidemiological sentinel of headaches.

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.

Self-medication for migraine: A nationwide cross-sectional study in Italy.

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.

Community pharmacies as epidemiological sentinels of headache: first experience in Italy.

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.

[Community pharmacy; towards a new model.] / La Farmacia dei Servizi: verso un nuovo modello per la prevenzione delle patologie croniche.

In recent years, even in Italy, a new model of "Community pharmacy" is being developed, which identifies the pharmacist as the most accessible health care professional for citizens, and recognizes his role in preventing chronic diseases. A project started in Piedmont (Italy) in 2012 has aimed at applying and evaluating this model of pharmacy in the prevention of diabetes, through the early detection of individuals with undiagnosed diabetes or at high risk of developing the disease, or with counselling to diabetic patients not adhering to the optimal therapeutic pathway. The results suggest that the pharmacy might be able to implement an effective preventive action, particularly among socio-economically disadvantaged people, thereby helping to reduce inequalities in care. The cost/effectiveness evaluation of long-term outcomes, based on the use of existing health information systems, will provide more accurate information on the value of the model.

Thiopurine S-methyltransferase pharmacogenetics in a large-scale healthy Italian-Caucasian population: differences in enzyme activity.

AIMS: To investigate the influence of genotype, age and gender on the thiopurine S-methyltransferase (TPMT) phenotype in healthy Italian-Caucasian subjects. MATERIALS & METHODS: The study investigated the TPMT genotype and the TPMT phenotype of 943 healthy Italian-Caucasian subjects of different age and gender (age range: 0.08-68 years; 623 males 320 females). TPMT red blood cell activity was measured in all samples and genotype was determined for the TPMT alleles *2, *3A, *3B and *3C. RESULTS: TPMT activity levels in our whole population ranged from 1.6 up to 75.2 U/gHb. Significant TPMT activity differences between wild-type and heterozygous subjects were observed. We divided our TPMT activity into four categories according to our frequency distribution: low (0.1%), intermediate (32.9%), normal (60%) and high (7%), with arbitrary cut-off values of 8.0, 19.4 and 37.0 U/gHb, respectively. The whole population had a total of 94.5% of homozygous wild-type subjects, 5.4% heterozygous variants and one (0.1%) compound heterozygous variant TPMT*3B/*3C. The overall concordance rate between TPMT genotypes and phenotypes was 71.6%. The TPMT activity was significantly higher in wild-type children (0.08-17 years) than in wild-type adults (aged 18-68 years). Moreover, it was noted that wild-type infants from 0.08 to 5 years had a 9% higher average TPMT activity than the other wild-type groups, and only in children from 0.08 to 2 years was the TPMT activity higher in males than in females. CONCLUSION: The data obtained in this study show that genetic factors seem to be the major aspect in TPMT phenotype variability in adults, whilst, in children, other physiological factors should be taken into consideration when assessing the TPMT phenotype, such as age and gender.

Flow cytometric evaluation of circulating CD34+ cell counts and apoptotic rate in children with acquired aplastic anemia and myelodysplasia.

OBJECTIVE: Identification of a rapid and noninvasive test for the follow-up of aplastic anemia (AA) patients during immunosuppressive therapy (IST) to evaluate its functional effect on hematopoietic progenitors (HPC) and for early detection of progression to myelodysplasia or relapse. MATERIALS AND METHODS: Absolute count and apoptotic rate (AR) of peripheral blood (PB) CD34+ cells were evaluated by three-color flow cytometry for CD45, CD34, and annexin V in cord blood (CB), normal children, and adults, as well as in pediatric patients with AA at diagnosis and during IST, Fanconi anemia (FA), chronic immune cytopenia, and refractory anemia with excess blasts (RAEB). RESULTS: In normal subjects, the AR of PB CD34+ cells showed a progressive increase (p < 0.05), while their counts decreased (p < 0.05) from birth to adulthood. In very severe AA (vSAA) and severe AA (SAA) at diagnosis, the AR was 91.6% +/- 2.8%, higher than controls (p < 0.05), and PB CD34+ cell count was 2.6 +/- 2.4/microL. In FA patients, the PB CD34+ AR was again significantly increased (54.2% +/- 13.7%) with an absolute count of 3.7 +/- 1.2/microL. Conversely, in RAEB the AR was 11.7% +/- 3.5% and the absolute count 85.1 +/- 48.2/microL (p < 0.05). Chronic immune cytopenias did not significantly differ from controls. CONCLUSIONS: Flow cytometry evaluation of PB CD34+ AR and counts is a noninvasive and feasible first-step method for the differentiation of AA and myelodysplasia (MDS), and it might be useful for monitoring AA during IST to secure the early detection of relapse or transformation to MDS.