According to article of the Federal Law No. 55 “On the Circulation of Medical Devices”, the rules for the sale of prescription drugs in pharmacies for their use in hospitals and clinics that are licensed to engage in pharmaceutical activities have been approved.
Key Points
Regulation on the licensing of pharmaceutical activities No. 1081 of December 22, 2011 is a key document that defines the list of requirements and the conditions presented by the state to licensees. Licensees are legal entities that carry out retail sale of drugs intended for medical use, for example, pharmacy chains and individual entrepreneurs who have the right to this activity. There is a specific list of prescription drugs.
What threatens violation?
All of these persons must comply with the rules for the release of these funds, which are intended for medical use. The same provision defines the concept of gross violation of licensing conditions and requirements, which include issues related to the dispensing of medicines. In the event that the established rules for dispensing drugs are violated, the regulatory authorities have the right to regard the detected crime as gross with all the ensuing consequences, from serious penalties to suspension of the licensee.
So, how to release a prescription drug?
Regulatory framework for drug dispensing
Federal Law No. 55 “On the Circulation of Medicines” provides for the rules for dispensing drugs for medical use by pharmacies, as well as by individual entrepreneurs.
In addition to this law, the following regulatory documents have been approved that regulate the procedure for dispensing medicines:
- Law No. 323 “On the Basics of Health Care".
- Law No. 2300 on the Protection of Consumer Rights.
- Order of the Ministry of Health No. 647 "On approval of the rules of pharmacy practice of medical products."
- A number of departmental regulations.
Who is responsible?
The process of dispensing prescription drugs involves close collaboration between medical and pharmaceutical workers. Doctors are responsible for prescribing drugs as part of the compliance with the necessary requirements. Pharmacy workers must conduct a pharmaceutical examination before dispensing a prescription. Therefore, an important requirement is the presence of feedback between medical and pharmaceutical structures. That is, regulatory requirements involve the regular sending of information about all incorrectly written prescriptions to a medical institution. A similar process of regular feedback eliminates questions about prescription drug abuse issues.
Who, according to the rules, has the right to write prescriptions?
To date, five forms of prescription forms are valid. At the beginning of 2016, some changes were made to the forms of prescription forms. In order to use for intended purposes the reserves of long-purchased prescription forms, it was allowed to use the old model until the entry of the order of the Ministry of Health of Russia No. 385 into force. Now pharmacy workers are required to require those versions of forms, the structure of which is changed in accordance with current regulatory documents.
Government Order No. 1175 brought a lot to the prescribing and prescribing procedures. An important place in the significance of changes should be given directly to the paradigm of prescribing drugs. Previously, the health worker had the right to use any name of the drug, that is, group or commercial. But in connection with the entry into force of Order No. 1175, the prescription of drugs according to the international nonproprietary name is now set as a priority. In the event that it is absent, the group option should be used. If both names are missing, then by trade type.
Who is added to the list?
In the list of those who have the right to prescribe and write prescriptions, there are workers with secondary medical education, in particular, midwives and paramedics, but only if such powers are assigned to them by a corresponding decree of the head of the medical institution. Individual entrepreneurs also traditionally have the right to prescribe medicines and prescriptions, however, under certain restrictions. For example, the nuances are related to the fact that these entrepreneurs who carry out private medical practice cannot prescribe psychotropic and narcotic drugs from the pharmaceutical lists “2” and “3”. There are also cases where prescription non-prescription drugs are dispensed.
What about a recipe that comes under a brand name? Is it possible to reject it or is it believed that it was written out correctly? An explanation of this issue is in the order of the Ministry of Health No. 1175. The bottom line is that the medical officer has the right to use when issuing a trade name subject to individual intolerance or according to vital indications. True, such a decision should be approved by the medical commission, which confirms the presence of a stamp on the back of the prescription.
Prescription rules and form differences
What is the difference in the form of the forms and how should they be issued to medical personnel in order to avoid incorrect pharmaceutical expertise? And also what are the basic rules for dispensing drugs? Forms of recipes can be distinguished by the purpose of use, their structure and composition of details, as well as the duration and storage. Let us cite as an example several options for prescription forms.
Special Prescription Form
It is the most complex in terms of details and structure. However, from the point of view of use, there is only one case in which the health care provider must apply it. This form of strict accounting is protected and is intended for prescribing psychotropic and narcotic drugs. Any such prescription must be certified by the personal signature of the doctor and his seal. On the form must be indicated the name, surname and patronymic of an authorized specialist, which may be the head or deputy medical institution. Also, this person may be an authorized representative who certifies the forms. In addition, the seal of the medical organization must be certified. Next, in the prescription form, there is a mark of the pharmacy structure about the release of the medicine. In the event that the pharmacy employee is happy with everything in terms of prescribing, he will indicate information about what is released, what dosage and packaging of the medicine is. The recipe is certified by indicating the full name, date of vacation, and also the seal of the pharmacy.
Recipe form No. 107
It is a simplified form compared to the above special form. According to regulatory documents, this option can be used when prescribing, as well as writing out a list of prescription drugs that contain small doses of psychotropic and narcotic substances. This form must contain the stamp of the medical organization, its full name along with the address, phone number and date. In addition, a mark is placed on the age category of the patient: children or adults. The name of the patient is also indicated, the name of the drug in Latin according to the international non-proprietary name along with packaging and dosing. In this prescription form, you can enter up to three names of medicines, which can not be done in other versions. On the form, among other things, a personal signature is put with the seal of the attending physician. Such a prescription is valid for up to sixty days, and for patients with chronic diseases an extension of up to one year is allowed. What are the rules for prescription drugs?
Additional Rules
The legislation provides for the following rules:
- Holidays in medical institutions are subject to medicines that are registered in the Russian Federation in accordance with the established procedure.
- The dispensing of medicines in medical organizations, including preferential prescriptions, is carried out in accordance with the procedure that was approved by order of the Ministry of Health. What else prescribes prescription drugs?
- Medical institutions can dispense drugs that are sold without a doctor’s prescription, as well as drugs that are subject to quantitative accounting and are prescribed on forms of established forms.
- In the departments of medical institutions, conditions must necessarily be ensured for the preservation of prescriptions for drugs that are subject to quantification.
- Prescriptions for drugs subject to quantitative accounting should be transferred from separate departments to medical organizations every month for further separate storage. At the end of the storage period, all recipes must be destroyed in accordance with the current legislation of the Russian Federation. The rules for dispensing prescription drugs must be followed without fail.
- An employee of a pharmaceutical institution that dispenses medicines must inform buyers about the rules for using the drugs, the regimen for their administration, daily and single doses, and must also pay attention to the need to read and familiarize themselves with the information about the medication.
- At the request of the buyer, an employee of a medical institution that dispenses medicines must provide information on documents that will reflect the price and expiration date of the product, as well as papers confirming its quality.
- At the request of the buyer, it is necessary to provide a sales receipt, which must indicate the name and dosage, as well as the total number of medicines dispensed, their price and date with the signature of the dispenser.
- The person in charge of conducting and organizing the work on dispensing medicines is the head of the medical institution.
What are the prescription drugs?
This list is fixed by order of the Ministry of Health No. 403 of July 11, 2017.
Prescription drugs are subject to combined medications containing:
- ergotamine hydrotartrate in an amount of up to five mg;
- ephedrine hydrochloride up to 100 mg;
- pseudoephedrine hydrochloride 30 mg;
- pseudoephedrine hydrochloride 30 mg; dextromethorphan hydrobromide 10 mg;
- dextromethorphan hydrobromide 10 mg;
- codeine or its salts 20 mg;
- pseudoephedrine hydrochloride 30 mg;
- pseudoephedrine hydrochloride from 30 mg to 60 mg, dextromethorphan hydrobromide in an amount of 10 mg;
- dextromethorphan hydrobromide 200 mg;
- ephedrine hydrochloride 100 mg;
- phenylpropanolamine 75 mg.