Nel corso del convegno organizzato dall’Osservatorio nazionale sulla salute della donna (Onda), in collaborazione con DOC Generici, e voltosi a Milano presso NH Hotel Touring di via Targhetti 7, sono stati presentati i risultai di una studio condotto su un campione di oltre 14.500 pazienti dell’ASL di Bergamo e Pavia, che ha analizzato 6 patologie/aree terapeutiche – diabetologia, cardiologia, dislipidemia, reumatologia, psichiatria e ipertensione – per indagare la relazione esistente tra lo switch tra farmaci equivalenti e l’aderenza alla prescrizione del medico, thus studying the effects of replacing a generic drug with another equivalent in terms of adherence and persistence to the current therapeutic treatment.

I dati sono stati discussi dal Prof. Alberico Catapano, Presidente della Società Europea dell’Aterosclerosi, il Prof. Claudio Mencacci, Presidente della Società Italiana di Psichiatria, il Prof. Enrico Agabiti Rosei, Presidente della Società Europea dell’Ipertensione, il Prof. Carlomaurizio Montecucco, Direttore SC di Reumatologia, Policlinico San Matteo di Pavia, il Prof. Alberto Margonato, Direttore della Divisione di Cardiologia Clinica, IRCCS Ospedale San Raffaele di Milano, il Prof. Roberto Trevisan, Direttore dell’Unità di Malattie Endocrine e Diabetologia dell’A.O. Papa Giovanni XXIII di Bergamo ed il Prof. Giorgio L. Colombo del Dipartimento di Scienze del Farmaco dell’Università degli Studi di Pavia. I lavori del convegno sono stati introotti e condotti dalla Dott.ssa Nicoletta Orthmann, Referente medico-scientifico dell’Onda.

Lo scorso febbraio abbiamo presentato i dati di una nostra survey, condotta su un campione di 445 donne, con l’obiettivo di esplorare le modalità di approccio al farmaco generico e il grado di soddisfazione, con particolare riferimento alle conseguenze di un eventuale switch da un farmaco a un altro sulla prosecuzione della terapia. – ha affermato Nicoletta Orthmann, Referente medico-scientifico di Onda – Three women

out of four reported that substituting one generic for another was a problem, which in 19% of cases resulted in lower adherence to therapy (errors of hiring, suspension or termination). The preliminary results of the study that we are presenting today constitute the 'evidence based' confirmation of what emerged in our investigation: the more the number of substitutions between generics increases, the lower the adherence to the therapeutic program in progress. For chronic pathologies, such as those taken into consideration in the research, it is, however, crucial to maintain therapeutic continuity, even after the achievement of positive results, to ensure greater efficacy and safety of the treatment and reduce the risk of complications and hospitalization

The data presented at the Milanese conference follow a previous study published in PlosOne in 2013, which compared generic and branded medicines with expired patents, from which the clinical equivalence between brand and generic had emerged and in which persistence and compliance were higher for the equivalent drug.

The study presents several aspects worthy of attention. – ha dichiarato il professor Enrico Agabiti Rosei, Presidente della Società Europea dell’Ipertensione – First of all data confirm that the practice of substituting a generic with another equivalent drug is very commonaffecting more than half of the patients. Furthermore, the 'switch' often occurs repeatedly, with a frequency between one change every 3 and one every 5 prescriptions, in relation to the different therapeutic areas. The results also show that in patients with repeated 'switches' there is a clear fall in treatment adherence and persistence, and this draws attention to the possible risks associated with frequent changes in the drug dispensed.

In all 6 areas examined by the study, a progressive trend of reduction in compliance was found following a drug change: on average, if one generic prescription out of two is replaced with another equivalent, for dyslipidemia and diabetes shows the highest percentage of decrease in adherence (48% and 36% respectively), followed by rheumatology (21%) and psychiatry (19%) and hypertension (10%).

The greater the number of generic drug substitutions, the lower the compliance.

Adherence to therapy and the horizontal replacement of equivalent medicines are inversely proportional: as the switch from one generic to another of the same molecule increases, in fact, the patient's adherence to the therapeutic prescription decreases, with a value equal to 28% if the substitution affects half of the prescriptions. The decline in adherence to drug prescription therefore implies a lower efficacy and safety of therapeutic treatments, with a consequent increase in the risk of complications and a worsening of the patients' health conditions.

Even in the area of psychiatry – ha sostenuto il professor Claudio Mencacci, Presidente della Società Italiana di Psichiatria e Direttore del Dipartimento di Neuroscienze dell’Ospedale Fatebenefratelli di Milano – the study demonstrated that as horizontal substitution between generic drugs increases, adherence and persistence to therapy decrease. It is essential, as demonstrated by the AIFA Guidelines of 2014, that, regardless of the antidepressant used, the treatment lasts at least 6 months in patients suffering from depression, by virtue of the high risk of recurrence, to which a large part of the economic costs are attributed and social aspects of the pathology. Previous observational studies have shown that almost 50% of patients on therapy discontinue treatment in the first 3 months and 70% in the first 6 months. It is therefore important to reduce the factors that can affect adherence to treatment and also those biological factors that can interfere with the good clinical outcome achieved.

Therefore, the advice is to always keep the same 'generic brand' with which the treatment was started and the positive results were achieved.

Bioequivalent drugs do not present criticalities in clinical use both by specialists and by general practitioners – ha affermato il professor Alberico Catapano, Presidente della Società Europea dell’Aterosclerosi – demonstrating, in a large series of studies, fully equivalent to the so-called 'branded' in clinical efficacy, measurable in the population treated also through studies of 'real life' use. They also represent an opportunity to contain pharmaceutical expenditure, without prejudice to the concept of citizens' freedom of choice. There remain some 'psychological' barriers that originate from the incomplete understanding by healthcare professionals (doctors, pharmacists, etc.) of the concept of bioequivalence, in addition to the non-uniformity of the packaging which, in the case of elderly people, can be a problem and lead to relevant therapeutic discontinuities.

The entry of equivalent (or generic) medicines into the world pharmaceutical market is a phenomenon of considerable interest in economic and social terms, which has significantly changed both company strategies and the behavior of all the players involved in healthcare spending and in the prescription of drugs. – ha sottolineato il Professor Giorgio L. Colombo del Dipartimento di Scienze del Farmaco, Università degli Studi di Pavia – Among the numerous "cost-containment" tools adopted by all modern healthcare systems, those that aim not so much to block consumption, impose discounts or cut prices, but to increase the allocative efficiency of the system, deserve particular interest. restoration of market competitiveness obtainedto stimulating the "price competition" of the producers, as in the case of equivalent drugs.

OFF patent medicines (patent expired) represent, to date, almost half of territorial consumption in Italy, even if the greatest prescription is still concentrated on branded products, unlike what happens in other European countries where favors the pure equivalent drug (unbranded). However, the presence of a significant share of the market for pure equivalent medicines (unbranded) is a necessary condition for price competition in the sector to unfold and companies, upon expiry of the patent, begin to compete on price with strong reductions and with simultaneous benefits for the public health system.

Furthermore, when the patient buys the generic branded product, he must pay a co-payment fee at his expense, while this does not happen for the pure generic product, which is completely paid for by our public health service.

In conclusion – ha ribadito il Professor Alberto Margonato, Direttore Divisione di Cardiologia Clinica, IRCCS Ospedale San Raffaele, Milano –

once a generic drug has been prescribed, the doctor must ensure that it is not replaced with an equivalent drug from a different manufacturer.

Variation in the characteristics of the packaging, shape and color of the tablets can invalidate these results.

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