Drug substitution in the community pharmacy during the COVID-19 pandemic

Abstract

Drug substitution in a pharmacy consists in replacing a preparation — originally prescribed by an entity authorized to do so — by a person authorized to dispense a medicinal product. This process takes place when one buys medicine in a community pharmacy. It involves the patient and a pharmacist or pharmacy technician. The legal issues of drug substitution are regulated by the Act on the reimbursement of drugs, foodstuffs intended for particular nutritional uses, and medical devices of 12 May 2011. In Poland, it is possible to substitute an original drug for a generic drug, a generic drug for an original drug, or a generic drug for another generic drug. An original drug is one which was first introduced to the market and was initially subject to patent protection. According to the World Health Organization, generic medicines are substitutes for the original ones. They do not have a patent and can be introduced only after the patent protection of the original drug has expired. The marketing authorization process is simplified compared to the original drug.

The reasons for replacing a drug in a pharmacy are most often economic, i.e., a lower price of the substitute, or the originally prescribed drug being unavailable in the pharmacy. The COVID-19 pandemic has contributed to drug shortages in pharmacies, especially at the beginning. The reasons for the deficits, apart from supply exceeding demand, are assumed to include the fact that both drugs and raw materials are largely imported from China and India. The following considerations are limited to prescription drugs only.

The aim of the article is to present the phenomenon of drug substitution in a community pharmacy which can be observed during the COVID-19 pandemic. The author analyzes the market data provided for the purposes of this work by PEX PharmaSequence Ltd.

During the COVID-19 pandemic, there was an increase in the scale of substitution. In 2019, 3.73% of all prescription drugs were switched, compared to 5.50% in 2020. The conclusions indicate the need for further observation of the phenomenon of drug substitution in pharmacies by persons authorized to dispense medicinal products and to constantly address the problem from the perspective of various scientific disciplines.