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The patient has the right to choose – instead of the original drug, he can buy a replacement. It is the pharmacist’s duty to propose this to him.
The Act on the Reimbursement of Medicines, Foodstuffs for Special Nutritional Purposes and Medical Devices provides for an obligation to inform about the possibility of purchasing a drug covered by a reimbursement, other than the drug prescribed on the prescription, with the same international name, dose, pharmaceutical form that does not cause therapeutic differences, the same therapeutic indication. The retail price of such a drug should not exceed the limit of public funding and the retail price of the drug prescribed on the prescription.
In many cases, patients react with suspicion and do not wish to receive an equivalent (replacement) for the drug prescribed on the prescription. There are, however, those who consciously demand it. It depends on the quality of the pharmacist’s contact with the patient whether the specialist will be able to convince the patient to use a substitute, e.g. in a situation where a prescription drug is not currently available for sale or it is too expensive for the patient.
The simplest definition of a substitute-equivalent is that it is a drug containing the same active substance (with the same international name), with the same dosage and pharmaceutical form. In the case of reimbursed drugs, it is important for which indications they have been registered. Substitute drugs are called generics or generics; in a nutshell, we can call them copies of original drugs, that is, invented and originally introduced to the market. After the expiry of patent protection, generic manufacturers can place substitutes on the market after having registered them in accordance with the regulations.
Copy or original?
The patient should be aware that a drug is the result of a technology that includes not only basic and technological pharmaceutical and medical knowledge, but also the complex, costly process of approving and developing the drug. Every part of this chain (knowledge, work and investment) costs money. Individual interactions of the substitute in a patient may vary, and a physicochemical change in the patient’s body may have an influence on the action of the drug – depending on the characteristics of the organism. You can hear many times from patients that they feel worse after switching to an equivalent drug or, as they themselves believe, the drug is not working. Such observation may result from many aspects, but it is certainly important to inform the pharmacist about any doubts. The use of substitutes requires a case-by-case analysis, and the margin for the patient’s taste should be minimal. Pharmacist knowledge is the only rational basis for accepting a substitute.
The substitutes are recreational drugs. They contain the same active substance in the same dose, they may only differ in excipients. It can be said that they must work the same as the original drugs. Pursuant to the Act, the pharmacist is obliged to inform the patient about the possibility of issuing a cheaper alternative. A very important matter is the form of providing this information. In my opinion, persuading the patient to use a substitute and justifying it for economic reasons is not very elegant. On the other hand, in a calm manner, devoid of emotions and behaviors typical of a salesperson, informing him about such a possibility is on the spot and should not arouse suspicions in the patient.
The person filling the prescription at the pharmacy can always ask the pharmacist for a cheaper alternative, and he should always dispense the drug if possible (the drug has a cheaper counterpart and the price is lower). The act makes it impossible to replace a drug with an equivalent if the doctor has noted this information on the prescription. I would also be cautious about offering substitutes for individual medications, such as insulins.
When there is no replacement
Another important issue is the existence of a large group of original drugs that have no substitutes. It happens for two main reasons: patent protection or economic reasons. No generic form will introduce a substitute for a drug that is not sold at a sufficiently high level in terms of its massiveness. A given generic drug is placed on the market as a result of an economic analysis. If sales of the originator drug are too low, no replacement is produced. A legitimate question arises as to whether the economic calculation does not in this case eliminate the chance for the development of new drugs. However, we must realize that each stage of drug production is the result of many research efforts and the ability to use the knowledge we have.
The last of the elements mentioned here is the most valuable and is slowly regaining its rank. A generic company can largely save itself serious costs because it uses the experience of the company producing the original drug. Sometimes it seems that the companies producing the substitutes only drink all the cream, because they invest in drugs that have already been tested on the market.
However, the additional value of the original drug is the work of scientists and research teams put into its creation, the financial resources invested and the potential development of medicinal products. What would happen if original medicines were no longer produced? Generic companies would have nothing to copy and we would be at a standstill. Only the action and coexistence of both types of drugs and the companies producing them give us real hope for the development of pharmacy and competitiveness.
Personally, I am closer to original drugs. Due to their influence in the development of the treatment process and the work put into their creation. Experience, information and, as a final product, a new quality of the drug are important.
Tekst: MSc farm. Michał Stalony-Dobrzanski