Requirements applied for writing of prescriptions of other EU countries and dispensing of medicinal products

REQUIREMENTS FOR THE SALE OF MEDICINES AND MEDICINAL PRODUCTS (MP) PRESCRIBED IN ANOTHER EU/EEA COUNTRY

Medicinal products are prescribed using prescription forms and are dispensed (sold) in the pharmacies of the Republic of Lithuania following the Rules on writing of prescriptions and dispensing (sale) of medicinal products and reimbursed means of medical aids to inhabitants, approved by the Order No 112 of the Minister of Health of the Republic of Lithuania of 8 March 2002 (Official Gazette, 2002, No 28-1013; Official Gazette, 2013, No 93-4658) (hereinafter – the Rules).

Implementing the provisions of the Directive 2012/52/EU of the Commission by which means of facilitation of recognition of medicinal products prescriptions issued in other Member States are set forth, the Rules have been supplemented with the requirements applied for writing of prescriptions and dispensing of medicinal products (came into force on 25 October 2013).

Herewith the requirements of the Rules are provided which are important to the citizens of other countries wishing to obtain medicinal products in the pharmacies of the Republic of Lithuania:

Following these Rules, prescription-only medicinal products are dispensed (sold) only according to prescriptions issued by the person possessing qualification of health care professional providing health care services in the other country and having the right to administer medicinal products and (or) medical devices.

Please note that the following items cannot be purchased in Lithuania with prescriptions issued by healthcare professionals of other EEA countries: narcotic pharmaceuticals, extemporaneous preparations made in pharmacies, and medicinal products that are supplied on Patient Named Basis.

Requirements for paper prescriptions:

• The original prescription form signed by a healthcare professional must be presented
• The prescription must contain the following information:

Name (-s), last name (-s) of a patient (written in words without abbreviations), date of birth of a patient;

Date of issue of the prescription;

Information about the healthcare professional legally authorized to issue prescriptions in the country where the prescription was issued: surname, first name (written in full, without abbreviations), professional qualification, email address or telephone number (with international code), workplace address, including the name of the EU country;

• Information about the prescribed medicine:

International Nonproprietary Name (INN) of medicine;

If a biological medicinal product is prescribed and this is necessary for medical reasons – the brand product name (if a brand product name was indicated for medical reasons, additionally the reason why it was indicated);

Pharmaceutical form;

Strength;

Quantity of dosage units;

Dosage size or package, its size, package description (if available), and the number of packages if more than one package is prescribed;

Dosage regimen;

• If a medical device (MP) is prescribed: its name, quantity, dimensions (if applicable), and other data;

If the pharmacy specialist has no doubts regarding the information provided in the prescription, and alongside the INN name the brand medicine name is also indicated, where a biological medicinal product is prescribed, or the prescription of a specific medicine name is additionally justified by stating the medical reasons for prescribing that specific medicine, the pharmacy specialist may dispense only the medicine with the brand name indicated in the prescription.

If several medicines are prescribed and one or more prescription medicines, for which the paper prescription according to the Rules must remain stored in the pharmacy, are unavailable in the pharmacy, the medicines may be dispensed separately only if the pharmacy is able to keep a copy of the prescription (paper or stored electronically).

Requirements for electronic prescriptions

• Applies to electronic prescriptions issued in EU countries belonging to the My Health@EU

 eHealth Digital Service Infrastructure (eHDSI) network, with which Lithuania exchanges e-prescription data

The prescription must contain the following information:

• Name (-s), last name (-s) of a patient (written in words without abbreviations), date of birth of a patient;
• Date of issue of the prescription;
• Information about the healthcare professional legally authorized to issue prescriptions in the country where the prescription was issued: surname, first name (written in full, without abbreviations), professional qualification, email address, telephone number (with international code), workplace address, including the name of the EU country;
• Information about the prescribed medicine:

International Nonproprietary Name (INN) of the medicine (if the electronic prescription specifies a brand product name, there must be an indication: whether the medicine may/may not be dispensed under another brand name (“Yes” or “No”));

Pharmaceutical form;

Strength;

Quantity of dosage units;

Dosage size or package, its size, package description (if available), and the number of packages if more than one package is prescribed;

Dosage regimen;

If the e-prescription field “Is substitution with another brand medicine name allowed?” is marked “Yes”, it is permitted to dispense a medicine under a different brand name than the one indicated in the prescription, marking that “The medicine name was changed”.

If the pharmacy specialist has no doubts regarding the information provided in the prescription, and alongside the INN brand medicine name is indicated with the field “Is substitution with another brand medicine name allowed?” marked “No”, the pharmacy specialist may dispense only the medicine with the brand name indicated in the prescription.

A pharmacist is prohibited from changing:

the active substance, strength, pharmaceutical form, route of administration (regardless of the value indicated in the field “Is substitution with another brand name allowed?”).

A pharmacy specialist may change:

package size, number of packages (regardless of the value indicated in the field “Is substitution with another brand name allowed?”).

REQUIREMENTS FOR DISPENSING MEDICINES AND MEDICAL PRODUCTS (MP) PRESCRIBED IN A COUNTRY OUTSIDE THE EU/EEA

Dispensing is only possible with paper prescriptions

• The original prescription form signed by a healthcare professional must be presented;
• It is prohibited to dispense narcotic and psychotropic medicinal products, medicinal products that are supplied on Patient Named  Basis, medicinal products included in the List of Medicinal Products and Medicinal Substances Subject to Quantitative Accounting in Pharmaceutical Companies, Institutions and Healthcare Institutions (hereinafter – medicinal products subject to quantitative accounting), as well as extemporaneous medicines if their composition contains narcotic and/or psychotropic substances and/or quantitatively accounted medicines, i.e. ethanol, chloramphenicol (powders only), clonidine, nandrolone, narcotic medicines.
• If several medicines are prescribed and one or more prescription medicines, for which the paper prescription according to the Rules must remain stored in the pharmacy, are unavailable in the pharmacy, the medicines may be dispensed separately only if the pharmacy is able to keep a copy of the prescription (paper or stored electronically).
• After dispensing the medicine or medical device, or dispensing part of the prescribed quantity: a copy of the prescription and the original prescription intended to be returned to the patient must include the information specified in Annex 2 of the Rules.