At the pharmacy: the option of substitution
The concept of substitution is closely connected to that of bioequivalence; if a medicine is bioequivalent to the original medicine the pharmacist can substitute the latter with a corresponding equivalent that has the same therapeutic efficacy.
Definition
The option of substitution, aimed at encouraging the dissemination of equivalent medicines in the population and at reducing the costs for the Italian National Health Service (SSN - Sistema Sanitario Nazionale), was introduced by legislative decree 347 of 18/09/2001, converted by law 405 of 16/11/2001 and modified by law 178/02 (conversion of legislative decree 138/02) which establishes that:
"For medicines having the same composition in terms of active ingredients, as well as the same pharmaceutical form, administration route, mode of release, number of posological units and same dose units, the pharmacist will be reimbursed by the SSN the lowest price of the corresponding product available on the normal regional distribution networks (the so-called reference price) in compliance with the appropriate directives of the Region; this disposition is not applicable to medicines covered by patents related to their active ingredient".
When to substitute
When the patent protection for a medicine reimbursed by the SSN expires and one or more equivalent medicines are authorised, the Agenzia Italiana del Farmaco (AIFA) includes both the original medicine and its equivalents in a list, which is up-dated monthly, called the "Transparency List". In this list the original medicine and its corresponding equivalents are listed together with their reference price. The reference price corresponds to the lowest price on the market for that medicine and is also the price reimbursed by the SSN. If a medicine appears on the Transparency List and the prescribing doctor does not specify on the prescription that the medicine "cannot be substituted", the pharmacist is obliged to offer the patient an equivalent medicine at the reference price. Should a prescribing doctor add the instruction "cannot be substituted" or should the patient not accept the substitution, the difference in price between the reference price and the retail price is borne by the patient.
Finally, if a doctor omits to specify on the prescription the Marketing Authorization Holder, the pharmacist may provide any medicine equivalent in composition and strength to the one that was prescribed.
Substitution of non reimbursed medicines
The concept of substitution was also extended to medicines not reimbursed by the SSN (class C medicines, paid for completely by the patient), including the so-called "medicines available without prescription"(*) and "over the counter" medicines (OTCs), by legislative decree 87/05 converted into law 149/05. The law provides that even in this case the pharmacist must inform the patient of the availability of equivalent medicines that may be purchased at a lower price.
This norm was introduced to further encourage the culture of equivalent medicines in Italy, less widespread than in the rest of Europe, especially as compared to Northern Countries.
(*)An Italian class of medicines similar to OTCs, with the only difference that no publicity to the public is allowed.
Definition
The option of substitution, aimed at encouraging the dissemination of equivalent medicines in the population and at reducing the costs for the Italian National Health Service (SSN - Sistema Sanitario Nazionale), was introduced by legislative decree 347 of 18/09/2001, converted by law 405 of 16/11/2001 and modified by law 178/02 (conversion of legislative decree 138/02) which establishes that:
"For medicines having the same composition in terms of active ingredients, as well as the same pharmaceutical form, administration route, mode of release, number of posological units and same dose units, the pharmacist will be reimbursed by the SSN the lowest price of the corresponding product available on the normal regional distribution networks (the so-called reference price) in compliance with the appropriate directives of the Region; this disposition is not applicable to medicines covered by patents related to their active ingredient".
When to substitute
When the patent protection for a medicine reimbursed by the SSN expires and one or more equivalent medicines are authorised, the Agenzia Italiana del Farmaco (AIFA) includes both the original medicine and its equivalents in a list, which is up-dated monthly, called the "Transparency List". In this list the original medicine and its corresponding equivalents are listed together with their reference price. The reference price corresponds to the lowest price on the market for that medicine and is also the price reimbursed by the SSN. If a medicine appears on the Transparency List and the prescribing doctor does not specify on the prescription that the medicine "cannot be substituted", the pharmacist is obliged to offer the patient an equivalent medicine at the reference price. Should a prescribing doctor add the instruction "cannot be substituted" or should the patient not accept the substitution, the difference in price between the reference price and the retail price is borne by the patient.
Finally, if a doctor omits to specify on the prescription the Marketing Authorization Holder, the pharmacist may provide any medicine equivalent in composition and strength to the one that was prescribed.
Substitution of non reimbursed medicines
The concept of substitution was also extended to medicines not reimbursed by the SSN (class C medicines, paid for completely by the patient), including the so-called "medicines available without prescription"(*) and "over the counter" medicines (OTCs), by legislative decree 87/05 converted into law 149/05. The law provides that even in this case the pharmacist must inform the patient of the availability of equivalent medicines that may be purchased at a lower price.
This norm was introduced to further encourage the culture of equivalent medicines in Italy, less widespread than in the rest of Europe, especially as compared to Northern Countries.
(*)An Italian class of medicines similar to OTCs, with the only difference that no publicity to the public is allowed.
