The generic drug is a drug is not più, covered by patent, that instead of the trade name has the name of the active ingredient followed by the name of the pharmaceutical company that produces it.
The generic drugs have the same therapeutic indications, posology and perhaps the same efficacy and safety of the drug “brand-name”.
Small technical glossary just to be more clear. active Ingredient:
the active substance present in any medication, that is; the product that causes the pharmacological effect. The name of the active ingredient often makes reference to its chemical characteristics, and is attributed to the time of the discovery. the
the name of imagination, which is attributed to the drug by the company that produces it. Often the trade name alludes, or to the activitiesà pharmacology or to the physical and chemical characteristics. Products with the same active ingredient may have different trade names, e.g. the ac. Acetyl salicylic acid (active ingredient) has several trade names: aspirin, cardioaspirina, bufferin, aspirinetta…).
Patent on the medicines:
The cover about the patents of the drugs, 15 years in Italy, is the interval of time within which the company that patented the drug keeps the exclusivenessà marketing.
This does not exclude that the company that holds the patent, not to be able to give a fee (royalty) production for other pharmaceutical companies.
Biodisponibilità capacità, which has a dosage form to achieve a certain plasma concentration of the active ingredient in a given time
the Cost of generic drugs:
The generic drugs they cost at least 20% less compared to the medications of the “brand name”. This lower cost is due to the fact that these drugs contain active ingredients not più covered by a patent, then the companies producing the generic drugs should support the costs of production, and not those of the search.
Bioequivalenza, controllo qualità, reperibilità
The effectiveness of a drug depends on the dosage of active ingredient is from biodisponibilità. The control of quality; or, the production, and allow, if applied effectively, have a product with standard qualityà constants.
The secure twenty-fourà in the pharmacy is an important factor to meet the needs of both the prescribing physician and the patient. A generic drug should have the same bioequivalence, a secure control of qualityà and an excellent distribution to be the height of the drug “brand-name”.
The case of Ratiopharm. The Ratiopharm è the più large German pharmaceutical company, and the più important reality; the european commission for the development and production of generic drugs.
From the brochures, the company says that più of the 10% of the human resources is involved in the control of qualityà, with the intent that the generic drugs Ratiopharm can boast the absolute bioequivalence with respect to the corresponding drugs “brand name”.
The company in a bioequivalence study of his medications showed that the average values of plasma concentrations are perfectly superimposed to drugs in “brand name”.
The studies presented concern the following drugs:
|Generico Ratiopharm||Corrispondente farmaco di “marca”|
|Verapamil 80 mg Ratiopharm||Isoptin 80|
|Propafenone 150 mg Ratiophatm||Rytmonorm 150|
|Diltiazem 60 mg Ratiopharma||Tildiem 60|
|Atenololo 100 mg Ratiopharm||Tenormin|
|Ranitidine 150 mg Ratiopharm||Ranidil 150|
the Advice of the pharmacist
The generic medicines are born with the intent to save money to the National Health Service and to patients. It is calculated that on average an Italian family, using generic drugs may save € 60 for the year. If the use of these products spread most, the savings to the coffers of the state would be significant.
A greater diffusion of generic drugs, it would be desirable, but there are several factors that prevent it: the natural distrust of the italians, the lack of information for physicians and citizens, the name “generic drug”. Remove the distrust which they have of the citizens to the noveltyà in the field of health care is very difficult.
The continuous scams organized by pharmaceutical companies, the doctors, the pharmacists, the employees of the Ministry of Health, to S. S. N. not tempt the citizens to have trust in the innovations. The manufacturers of generic drugs do not play with enough, except for a few notable exceptions, a capillary work of information technical science.
The generic name is a synonym of non-specific, this può to induce the people of the più simple to think that generic drugs are identical to the brand name ones.
it Would have been desirable to call them by their true name: “drugs without a patent”. My final advice is: generic drug sì, but qualityà. The only firm that at this time provides all the necessary guarantees is the Ratiopharm.
Legislation of generic drugs.
medicinal products not covered by the patent on the active ingredient, having equal composition in active principles, form pharmaceutical, route of administration, modeà of the release, the number of unità dosing and dose unit are the same, are reimbursed to community pharmacists with S. S. Regional up to the competition of the price più the bottom of the corresponding product available in the normal distribution cycle region.
pharmacist in the absence of the indication of non-provisionà of the medicine prescribed by the doctor and after having informed the patient, the delivery to the latter of the medication with the price of the più low or lower than or equal to the reference indicated in the annex.
In the case in which the doctor to place on the prescription with the indication of not provisionà or the citizen does not accept the replacement, the difference between the reference price indicated in the annex “List of active principles with reference prices” and the price of the prescribed drug is the responsibility of the assisted, with the exception of pensioners of the war holders of retirement annuity.
Rules of protection (are the standards that may vary from region to region, that the following is in force in the Lazio region). In case it is not possible to deliver the assisted the drug having a price lower than or equal to the reference becauseé not available in the distribution cycle, the pharmacist dispenserà the drug is available with a price immediately higher than the reference price (the più low as possible).
On this medication, the assistance is not to get acquainted with; to correspond to the difference from the reference price, while sarà the due share of € 1,00 when the medication has price of more than € 5,00. Will continue to be excluded from the payment of revenue share at € 1.00 for the categories which are exempt.
Dr: Cesare Augusto De Silvestri