Prescriptions: Health ministry amends regulations to solve dosage problem

Currently, it is not possible for the prescriber to improve or supplement the dosage unit form or the use of a medicinal product, foodstuff for special nutritional purposes or medical device, based on the person's knowledge.

In addition, the problem of too small a quantity of a medicinal product, foodstuff for special nutritional use or medical device, which the previous provisions of the Regulation of the Minister of Health of December 23, 2020 on prescriptions (Journal of Laws of 2023, item 487, as amended) allowed to issue, is resolved in the event that the person issuing the prescription does not specify in the prescription the dosage or use of the product or device. Currently, the regulations allow, in this type of situation, the issuance of at most two of the smallest packages of the product or device in question - depending on the case reimbursed from public funds, or available for sale in the territory of the Republic of Poland, which, in the opinion of the designer, is too small.

Also resolved is the fact that in the event that different amounts of a medicinal product, foodstuff for special nutritional use or medical device result from the numbers, package sizes, number of dosage units and dosage method stated in the prescription, the dispensing person is obliged to dispense the smallest of these as the amount prescribed by the prescriber. This regulation was intended as a safeguard for the patient for this circumstance, so that he would not purchase (and, as a result, use) a quantity of the drug that the prescriber did not intend to prescribe for him, or, to put it another way, so that he would not use a quantity that was too large in relation to the prescriber's intention, which could reflect on the patient's health.

Nevertheless, the scale of cases where, based on the aforementioned requirement, patients received too little of a medicinal product in relation to their actual needs is too large. Although the Ministry of Health does not have accurate statistics in this regard, it knows that this is a common and all too frequent phenomenon. Therefore, the designer decided, based also on the signals and expectations of the self-government of the pharmacy profession in this regard, which have been reported for a long time, to take legislative action to level out this problem.

It is recommended to allow the person filling the prescription at the pharmacy or pharmacy point of sale:

1) determine the form of the dosage unit of the medicinal product, foodstuff for special nutritional use or medical device, based on the knowledge;

2) dispense twice the number of packages of a medicinal product or medical device, if the dosage method is not specified on the prescription in the required manner;

3) to dispense a larger quantity of a medicinal product, foodstuff for special nutritional use or medical device, where the number, package size, number of dosage units and dosage method stated in the prescription result in different quantities of this product, agent or device to be dispensed.

Source: RCL