Cannabis-Based Oral Formulations for Medical Purposes: Preparation, Quality and Stability.

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.

Community Pharmacy Practice in Italy during the COVID-19 (SARS-CoV-2) Pandemic: Regulatory Changes and a Cross-Sectional Analysis of Seroprevalence.

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.

Knowledge on arterial hypertension in general population: Results from a community pharmacy screening program.

BACKGROUNDS AND AIMS: 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. METHODS AND RESULTS: 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). CONCLUSION: Knowledge about hypertension is largely unsatisfactory among population. Community pharmacies may play as a setting for health education and hypertension screening.

The 2017 deregulation of pharmacies in Italy: Introducing non-pharmacist ownership.

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.

Assessment of a non-physician screening program for hypertension and cardiovascular risk in community pharmacies.

BACKGROUND AND AIMS: The strategic role of prevention in hypertension setting is well known but, with the only exception of annually events promoted by international scientific societies, no other screening campaigns are available. Aim of this study was to assess the feasibility of a non-physician pharmacy-based screening program and to describe the cardiovascular risk and the BP status of participating subjects. METHODS AND RESULTS: 2731 costumers participated to the screening program, answering to a questionnaire about personal cardiovascular risk and measuring their BP with an Omron HEM 1040-E. Since no threshold for hypertension diagnosis is currently available for community pharmacies BP measurements, we assessed high BP prevalence according to 3 different cut-offs (≥140/90, ≥135/85 and ≥ 130/80 mmHg) and compared normotensives and hypertensives on major cardiovascular risk factors. According to the proposed cut-offs, prevalence of hypertension was respectively of 31%, 45% and 59.5%, and it increased among younger subjects (31-65 y) when the lowest cut-offs were applied. High BP was found in a large percentage of subjects self-declared on-/not on-treatment (uncontrolled hypertensives) or normotensives (presumptive hypertensives) and among those not aware of their own BP values (presumptive hypertensives). Prevalence of CV risk factors was higher in hypertensives than in normotensives. CONCLUSIONS: Our findings demonstrated that a community pharmacy-based screening is feasible and attracts the interests of many subjects, improving awareness on their BP status. The screening was also showed to be useful in order to detect potentially uncontrolled and/or suspected new hypertensives, especially among young adults, to refer to general practitioners for confirmatory diagnosis or further evaluation.

Development of Standard Operating Protocols for the Optimization of Cannabis-Based Formulations for Medical Purposes.

Under current legislation in Italy, Cannabis for medical purposes may be administered orally in the form of decoction or Cannabis oil extract. The scientific literature reports a number of preparation methods, mainly for oils, but no study is available that compares thoroughly, from a technological viewpoint, the Cannabis-based formulations currently administered to patients. With this in mind, this research work aimed to carry out specific formulation studies to design standard operating procedures for the preparation and optimization of Cannabis-based galenic formulations. Both decoctions and oils were prepared under different operating conditions to identify the most efficient process for the production of formulations with a high concentration of decarboxylated delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Regarding Cannabis oil, a new procedure has been developed that allows significantly higher recovery rates for THC and CBD compared with those for water-based extraction methods (decoction) and those for oil-based methods currently in use. Moreover, based on the results, it is possible to affirm that the prescription of Cannabis-based decoctions should not be the recommended first-choice solution for therapy, considering the low concentration of THC and CBD and, consequently, the high volume of decoction that the patient would have to ingest.

How to promote vaccinations: a pilot study in the North-West of Italy.

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 χ2 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%.