Buying drug substitutes is not always beneficial. Even if the substitute is made up of the same substances, its effect may depend on how it was produced.
IRENA REJ, President of the Polish Pharmaceutical Chamber of Commerce:
Substitution of drugmust be justified. Just as the legitimacy of the functioning of generic drugs cannot be questioned, they should not be used as substitutes for original drugs. One cannot without reservations translate into the practice of using this drug in the form of generic preparations. Even though generics contain the same active ingredient, with the same international name, in the same dose and are bioequivalent to the original.
When determining the bioequivalence status of a drug substance, a difference with the original of up to 20% is allowed. The effect of the drug may depend on the method of production. It is important whether the medicine contains an active substance, the standard of which has been registered in the office, or whether the manufacturer bought the same theoretically from a cheap supplier - in China, India, Korea. Then the question arises whether such a substance has parameters identical to that in the original drug or not. It is about the degree of purification, method of synthesis, production technology.
And one more thing: the active substance must be suspended in something. By definition, substitutes may differ from innovative drugs in the content of excipients that are not actually tested. Take, for example, drugs to lower cholesterol - some can cause muscle aches and pains, others not. If they were identical, they would not differ in their side effects. The effect of the substitute on the patient's body may be different, and the physicochemical change in the body may affect the drug's performance.
In a word, not every restorative drug is good for everyone. In the interests of the good quality of generic drugs and the harmonization of their production standards, in accordance with the new EU directive, from June 2013, it is not possible to market an active substance purchased outside Europe without a European certificate for a given substance. Pharmaceutical companies must obtain such a certificate, which costs a lot, or switch to European substances, much more expensive.
monthly "Zdrowie"