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

INFORMATION ABOUT ELEMENTS TO BE INCLUDED INTO PRESCRIBTIONS WHICH ARE ISSUED IN THE MEMBER STATE OTHER THAN THE MEMBER STATE IN WHICH MEDICINAL PRODUCT, MEDICAL DEVICE OR MEANS OF MEDICAL AID ARE BEING SOLD
 

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 (coming 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:

                      Requirements applied for dispensing (sale) of prescription only medicinal products according to the prescriptions issued in other country

                      Following these Rules, prescription-only medicinal products are dispensed (sold) only according to prescription 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. 

Prescription-only medicinal products (with exception of narcotic medicinal products) and medical devices can be sold according to the prescriptions issued in the other EU country on the condition that no doubts occur regarding provided information in the prescription and if the prescription contains at least the following data:

• Name (-s), last name (-s) of a patient (written in words without abbreviations),
• Date of birth of a patient,
• Date of issuance of the prescription,
• Last name (-s), name (-s) of health care professional who issued a prescription (written in words without abbreviations),
• Professional qualification,
• Electronic mail address and telephone or fax number (with international codes),
• Working address (also name of related EU country),
• In case of medicinal product – international name or brand name of medicinal product; in case of administration of biological medicinal product or if it is necessary due to medical reasons (in such case brand name of medicinal product must be indicated by providing a ground due to which medical reasons specific medicinal product is prescribed),
• Pharmaceutical form (tablet, solution, etc.),
• Strength,
• Quantity
• Dosage regimen,
• In case of prescribed medical device – name of medicinal device. Prescribing medical devise the measurements or other data shall be indicated if available,
• Prescription must be signed (in hand written or electronic signature taking into account the form of the issued prescription).

Prescription-only medicinal products are sold if no doubt occurs regarding information provided in the prescription issued in non EU country with exception of psychotropic medicinal products, medicinal products included into the list of Medicinal products and medicinal substances which are subject of quantitative accounting in pharmaceutical enterprises and institutions and public health care institutions, also with exception of extemporal medicinal products with the composition of medicinal substances included into the list of Medicinal products and medicinal substances which are subject of quantitative accounting in pharmaceutical enterprises and institutions, narcotic and (or) psychotropic substances included into the list of II and III Schedule of Narcotic and Psychotropic substances approved by the Minister of Health of the Republic of Lithuania.

In those cases when doubts occur regarding the information provided in the prescription issued by the person possessing qualification of health care professional providing health care services in the other EU country and having the right to administer medicinal products and when besides the international name also brand name of medicinal product is indicated or medicinal product is indicated by the brand name, and the administration of the medicinal product is additionally proved by indicating due to which medical reasons the specific medicinal product is administered – the pharmacy specialist sells only the medicinal product with indicated brand name.

In case of doubt regarding name of medicinal product, means of medical aids or medical device, strength of medicinal product, compatibility of medicinal products prescribed in the prescription, the pharmaceutical specialist is obliged to clarify doubts with the physician or the other person possessing qualification of health care professional providing health care services and having the right to administer medicinal products or medical devices who has issued the prescription.

If that is not possible the pharmacist decides for himself/herself whether to dispense medicinal products, means of medical aid or medical devices. If pharmacist assistant (pharmacist technician) is not successful in clarifying uncertainties with the physician or the other person possessing qualification of health care professional providing health care services and having the right to administer medicinal products or medical devices who has issued the prescription, the pharmacist assistant (pharmacist technician has to consult with supervising pharmacist regarding dispensing of medicinal products, means of medical aid and (or) medical devices.

In case if validity time of prescription has not yet commenced or expired, medicinal products, means of medical aid and medical devices are not dispensed (sold).

The pharmacy retains and keeps prescription forms or prescription forms issued by other countries if on the ground of which medicinal products indicated in these Rules have been dispensed:

• Medicinal products included into the List of medicinal products and substances which are subject for quantitative control in pharmaceutical enterprises, institutions and health care institutions;
• Extemporal medicinal products with the composition of medicinal substances included into the list of Medicinal products and medicinal substances which are subject of quantitative control in pharmaceutical enterprises and institutions (with exception of narcotic medicinal products);
• Psychotropic medicinal products;
• Prescription-only medicinal products containing precursors of narcotic and psychotropic substances of the first category;
• Nominal medicinal products (applicable in Lithuania only);
• Chloramphenicol drops, with exception of composite;
• Anti-infectious medicinal products for systemic use grouped in J group by the first level of the code according to Anatomic therapeutic chemical index approved by the World Health Organization;
• Antidepressants grouped in N06A subgroup by the third level of the code according to Anatomic therapeutic chemical index approved by the World Health Organization;
• Antipsychotic medicinal products grouped in N05A subgroup by the third level of the code according to Anatomic therapeutic chemical index approved by the World Health Organization;
• Peroral diphenhydramine preparations;
• Prescription-only medicinal products administered through primary health care institutions (medical centre), non regulated by other provisions of the points of these Rules (applicable in Lithuania only);
• Antibiotics and prescription-only chemotherapeutic medicinal products indicated for dermatologic usage, products grouped in D06 subgroup by the second level of the code according to Anatomic therapeutic chemical index approved by the World Health Organization.

List of medicinal products and medicinal substances subject to quantitative accounting in pharmaceutical enterprises, institutions and health care institutions

1. Ethanol.

2. Chloramphenicol powder.

3. Clonidine*.

4. Nandrolone*.

5. Narcotic medicinal products *, included into the II list of the lists of narcotic and psychotropic substances approved by the Order of the Minister of Health – Narcotic and psychotropic substances permitted to use for medical purposes.

* All forms of medicinal product are quantitatively controlled.

Information about medicinal products authorized in the Republic of Lithuania is accessible here: http://extranet.vvkt.lt/paieska/index.php?thislanguage=lang_en