SÚKL information for pharmacies to keep written records in case of recall medicinal products containing addictive substances listed in Annex 1 and 5 of Government Regulation No. 463/2013 Coll., on lists of addictive substances

The State Institute for Drug Control (SÚKL) specifies the procedure and method of keeping records when recalling medicinal products containing addictive substances listed in Annex 1 and 5 of Government Regulation No. 463/2013 Coll., on lists of addictive substances due to quality defects.

When a medicinal product is recalled by the marketing authorization holder (MAH) due to a quality defect, healthcare providers shall follow the instructions of the MAH when handing over unusable medicinal products, the MAH reimburses them for the proven costs incurred in such handing over.

Given repeated questions on the record-keeping procedure in the case of withdrawal of medicinal products containing addictive substances listed in Annex 1 and 5 of the Government Regulation on the lists of addictive substances from the level of healthcare facilities and/or from the level of patients, SÚKL provides below guidance on the correct procedure.

Procedure and record-keeping for the recall of medicinal products issued to healthcare providers

• Packages of the recalled medicinal product returned to the pharmacy by health service providers (hospital wards, outpatient clinics) due to quality defects are considered as unusable medicines according to the Law on Medicines and therefore the pharmacy does not keep a written record of them in the addictive substances register, nor are they subsequently reported in the report on the status and movement of stocks of addictive substances listed in Annex 1 or 5 of the Government Regulation.
• The pharmacy shall take physical possession of the withdrawn packages of the medicinal product, label them accordingly, and store them in a safe separate from other usable medicinal products.
• According to the instructions of the marketing authorization holder, it shall subsequently return them to the distributor, or arrange for their transfer for disposal pursuant to Section 89(1) of Act No 378/2007 Coll. on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals), as amended to persons authorized to dispose of them pursuant to Section 88(3) of the Act on Pharmaceuticals.

Procedure and records of medicines recalled from the patient level and their replacement

• Packages of the recalled medicinal product returned to the pharmacy by health service providers (hospital wards, outpatient clinics) due to quality defects are considered as unusable medicines according to the Law on Medicines, and therefore the pharmacy does not keep a written record of them in the addictive substances register, nor are they subsequently reported in the report on the status and movement of stocks of addictive substances listed in Annex 1 or 5 of the Government Regulation.
• The pharmacy shall take physical possession of the withdrawn packages of the medicinal product, label them accordingly, and store them in a safe separate from other usable medicinal products.
• According to the instructions of the marketing authorization holder, it shall subsequently return them to the distributor, or arrange for their transfer for disposal under Section 89(1) of Act No 378/2007 Coll. on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals), as amended to persons authorized to dispose of them under Section 88(3) of the Act on Pharmaceuticals.
• Procedure and records of medicines recalled from the patient level and their replacement
• complete and incomplete packages of medicines returned by patients to the pharmacy due to quality defects are considered unusable medicines under the Act on Pharmaceuticals. Therefore their receipt from patients is not recorded as receipt in the addictive substances record book. Please note that packages returned by patients are not even included in the reports on the status and movement of stocks of addictive substances listed in Annex 1 or 5 of the Government Regulation.
• The pharmacy will receive the recalled packs and complete an exchange report, which is available on the SÚKL website together with information on the recall. The pharmacy shall hand over the original of the exchange protocol to the distributor together with the withdrawn package, and keep a copy of the exchange protocol within the pharmacy’s documentation on the handling of addictive substances and preparations containing them.
• In the case that a package of a non-defective batch of a medicinal product is dispensed to patients in exchange for the recalled batch, an entry shall be made in the addictive substances record book of the dispensing to the patient. The dispensing record shall include the name and surname of the patient and the patient’s home address, in addition to the date of dispensing and the quantity dispensed.
• The dispensing of the medicine at the exchange is normally based on the presentation of prescription by the patient. A copy of the protocol stored in the record book serves as confirmation of the exchange.

The above methods of recording do not apply to packages of the recalled medicinal product that the pharmacy has in stock (own stock). In this case, the pharmacy returns the recalled medicinal product to the distributor as standard and makes a record of the dispensing in the addictive substances record book as a return. The written proof of the return of the medicinal product, certified by the distributor, shall be stored within the pharmacy’s documentation on the handling of addictive substances and preparations containing them (among the dispensing documents).