Rights and obligations of regulators, drug manufacturers, doctors, pharmacists, patients, and insurance companies in the case of off label use of medicinal products

Abstract

For many years, the off-label use of drugs has been a debated issue for healthcare administrators, regulators, pharmaceutical manufacturers, doctors, pharmacists, insurance companies, and patients. The mechanism for monitoring and regulating the off-label use of drugs must have sound scientific evidence and principles that provide for discouraging their use in the absence of convincing and evidence-based clinical justification and the availability of alternatives. Regulatory authorities (FDA and others) are very strict about manufacturing standards and documentation of the safety and efficacy of drugs, but they do not regulate the way they are prescribed. Thus, doctors can prescribe drugs off-label if their medical knowledge and the patient's condition allow it. The decision to use the drug off -label is not illegal if the doctor does not abuse his official position and does not violate the rules for its prescription.