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An undesirable effect (UE) of a cosmetic product is a harmful reaction attributable to its normal or reasonably foreseeable use. However, the knowledge of UEs, at the population level, is limited by the absence of formal and reliable cosmetovigilance systems, which nevertheless are characterized by underreporting. To test the feasibility of the collection of UEs in our territory we have carried out a pilot project aimed to assess either the notification procedures or the validation/evaluation of the collected forms in our territory. As reporting categories, we have chosen dermatologists and community pharmacists who were asked to notify UEs to cosmetics through a reporting form we have set up. During the period July 2006-December 2007, we have registered 76 reporting forms. Dermatologists who have sent 47 reporting forms represented the main reporting category, followed by community pharmacists (15 reports), other health professionals (9 reports) and consumers (5 reports). Several drawbacks, mainly represented by the incompleteness and inaccuracy of the filled in forms, affected the validation process. Thus, on receipt, we could validate only 34 forms and only after a careful check with each single reporter, we could include in the study other 36 forms. The validation of the collected reports has stressed the importance of a well-structured reporting form, an easy access to notification procedures as well as education and training programme. The evaluation of the validated forms has revealed the need of a controlled term vocabulary for the classification of the observed events and diagnosis, especially with regard to cutaneous reactions that represented almost the totality of the reported events (95.7%). Among the events (n=45) reported by dermatologists, 22 were diagnosed as allergic contact dermatitis (ACD) and 18 as irritant contact dermatitis (ICD). Facial care products (19.7%), followed by body care products (16.9%), perfumes (12.7%) and eye care products (11.3%) were the cosmetics mainly suspected to be responsible for the observed events. Correspondingly, face (n=37), including periorbital and perioral area, forehead, ocular mucous membrane and lips, followed by entire body (n=9) were the body sites reported as more involved. In conclusions, our experience allowed us to identify the main pitfalls of the system we have experienced. These are setting/formulation of the reporting form, notification step, description of the event and diagnosis. A careful settlement of these aspects could substantially contribute to the establishment of an efficient reporting system, although the bias due to underreporting is difficult to eliminate.

The most frequent cause of mortality and morbidity in industrialized countries is coronary artery disease (CAD), which in Europe alone is responsible for around two million deaths per year. In 2001 it accounted for about 260,000 hospital discharges in Italy. The costs of CAD treatment in Italy--which were borne by the Italian state, the third-party payer--amounted to 800 million euros. We propose to assess the pharmacoeconomic implications of using amlodipine besylate treatment in Italy for patients with coronary artery disease. The study is based on a post-hoc cost-effectiveness analysis that compared standard care supplemented by amlodipine besylate with ordinary standard care over a 36-month time horizon. The clinical outcome data were based on the prospective randomized evaluation of vascular effect of norvasc trial (PREVENT). Direct medical costs referred to the purchase costs of amlodipine besylate and the cost of National Health Service (NHS) hospitalization. The costs were discounted back at an annual rate of 5%. Patients administered amlodipine besylate exhibited a significant risk reduction with respect to any major vascular event or procedure when compared to the placebo group. The reduction mainly referred to unstable angina events and revascularization procedures. We estimated that the total cost of adding amlodipine besylate to standard care amounted to 139,050 euros per 1000 patients treated for 36 months. This represents a cost of 1780 euros per patient remaining free of any vascular event. Results were sensitive to both clinical and economic variables. The incremental costs of the alternative therapy ranged from 296 euros to 5066 per patient free of any event in, respectively, the best and worst scenario. Amlodipine besylate therapy can be a cost-effective strategy for CAD treatment in Italy. Our economic evaluation demonstrated, first, that by reducing vascular events and the need for revascularization procedures savings were achieved in hospital expenditure, and, second, that such savings could significantly offset drug costs.

In Italy, revascularization interventions increased from 44,600 in 1996 to more than 100,000 in 2001. In particular, the occurrence of percutaneous transluminal coronary angioplasty (PTCA) increased from 239 cases per million population in 1994 to about 1300 cases per million population in 2001. This trend has caused a concomitant increase in revascularization costs, which have doubled in few years, rising from Euro 421 millions in 1996 to Euro 850 millions in 2001. In 2001, PTCA amounted to 55% of total cost of revascularizations. The aim of this study was to assess the pharmacoeconomic consequences of amlodipine besylate therapy administered in patients at high risk of restenosis after PTCA. We conducted a cost-effectiveness analysis comparing therapy with amlodipine besylate added to standard care versus standard care alone. Information on clinical outcomes was drawn from the Coronary Angioplasty Amlodipine Restenosis Study (CAPARES). Medical costs were estimated with reference to drug therapy and hospitalizations for coronary events and revascularization procedures. The study was conducted from the perspective of the Italian third party payer (National Health Service). The analysis was applied to a time horizon of 4 months. Amlodipine besylate resulted less expensive and more effective than standard care. It reduced mortality, morbidity for coronary reasons and the need of revascularization procedures. The cost per 1000 patients was estimated at Euro 1,166,000 in the placebo and Euro 950,000 in the amlodipine besylate group, resulting into a cost saving of Euro 216,000, that is 18.5% of total cost of standard care. Results are sensitive to the cost of amlodipine besylate and the cost of hospitalizations, but therapy with amlodipine besylate resulted dominant even in the most unfavorable hypothesis.