According to the 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.
Basics
Regulation on licensing activities in the field of pharmaceuticals No. 1081 dated December 22, 2011 is a key document that defines the list of requirements, as well as the conditions imposed by the state on licensees. Licensees are legal entities that carry out retail trade in 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 the violation?
All listed 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 license conditions and requirements, includinginclude issues related to the dispensing of medicines. In the event that the established rules for dispensing medicines are violated, the regulatory authorities have the right to regard the identified crime as gross, with all the ensuing consequences, ranging from serious pen alties to suspension of the licensee.
So what's the right way to dispense a prescription drug?
Regulatory regulation of drug dispensing rules
Federal Law No. 55 “On the Circulation of Medicines” provides for the rules for dispensing drugs for medical use by pharmacies, as well as individual entrepreneurs.
In addition to this law, the following legal documents have been approved that regulate the procedure for dispensing medicines:
- Law No. 323 “On the Fundamentals of He althcare.”
- Law 2300 on Consumer Protection
- Order of the Ministry of He alth No. 647 "On Approval of the Rules for the Pharmacy Practice of Medicines".
- A number of departmental regulations.
Who is responsible?
The prescription drug dispensing process involves close collaboration between medical and pharmaceutical professionals. Physicians are responsible for prescribing drugs within the framework of compliance with the necessary requirements. Pharmacy workers, before dispensing a drug by prescription, must conduct a pharmaceutical examination. Therefore, an important requirement is the presence of feedbackbetween medical and pharmaceutical structures. That is, regulatory requirements imply the regular sending of information about all incorrectly written prescriptions to a medical institution. This regular feedback process eliminates questions about prescription drug abuse.
Who, according to the rules, has the right to write prescriptions?
To date, five prescription forms are valid. At the beginning of 2016, some changes were made to the forms of prescription forms. In order to use stocks of long-purchased prescription forms for their intended purpose, it was allowed to use the old model until Order No. 385 of the Ministry of He alth of Russia came into force. Now pharmacy workers are required to demand those versions of the forms, the structure of which has been changed in accordance with the current regulatory documents.
Government Order No. 1175 introduced a lot of new things into the procedure for prescribing and prescribing drugs. An important place in terms of the significance of changes should be given directly to the paradigm of prescribing medicines. Previously, the he alth worker had the right to use any name of the remedy, that is, group or trade. But in connection with the entry into force of Order No. 1175, the priority is now set to prescribing drugs under the international non-proprietary name. 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?
On the list of those whohas the right to prescribe and issue prescriptions, workers with a secondary medical education have appeared, in particular midwives and paramedics, but only if such powers are vested in them by the relevant decree of the head of the medical institution. Individual entrepreneurs also traditionally have the right to prescribe drugs and write prescriptions, albeit with 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 pharmaceutical lists “2” and “3”. There are also cases where over-the-counter prescription drugs are dispensed.
What about a prescription that comes under a brand name? Is it possible to reject it or is it considered to be issued correctly? An explanation to this issue is in the order of the Ministry of He alth No. 1175. The bottom line is that the medical officer has the right to use the trade name when prescribing, subject to individual intolerance or according to vital indications. True, such a decision must be approved by the medical commission, which confirms the presence of a stamp on the back of the prescription.
Prescription drug dispensing rules and differences in forms
What is the difference between the forms of the forms and how should they be correctly drawn up by medical workers in order to avoid incorrect pharmaceutical expertise? And also what are the basic rules for dispensing drugs? Formsrecipes can be distinguished by the purpose of use, their structure and composition of details, as well as by the period of validity and storage. Here are some examples of prescription forms.
Special Prescription Form
It is the most complex in terms of the composition of the details, as well as the structure. True, in terms of use, there is only one case in which a he alth worker should use 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. The form must necessarily indicate the surname, name and patronymic of the authorized specialist, which may be the head or deputy of the medical institution. Also, this person can be an authorized representative who certifies the forms. In addition, certification by the seal of a medical organization is required. Further in the prescription form there is a mark of the pharmacy structure on the release of the medicine. In the event that the pharmacy employee is satisfied with everything in terms of issuing a prescription, then he indicates information about what is dispensed, what is the dosage and packaging of the medicine. The prescription is certified by indicating the full name, the date of issue, as well as the seal of the pharmacy.
Prescription form 107
This is a simplified form compared to the special form described above. According to regulatory documents, this option can be used when prescribing, as well as writing out a list of prescription drugs that contain smalldoses of psychotropic and narcotic substances. This form must contain the stamp of the medical organization, its full name along with the address, telephone number and date. In addition, a mark is made on the age category of the patient: child or adult. 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 types of medicines, which cannot be done in other options. On the form, among other things, a personal signature with the seal of the attending physician is put. Such a prescription is considered valid for up to sixty days, and for patients with chronic diseases, an extension of up to one year is allowed. What other rules are involved in prescription drug dispensing?
Additional rules
The legislation provides for the following rules:
- Medicines that are registered in the Russian Federation in accordance with the established procedure are subject to leave in medical institutions.
- Distribution of medicines in medical organizations, including on preferential prescriptions, is carried out in accordance with the procedure approved by the order of the Ministry of He alth. What else does prescription drug dispensing involve?
- Medical institutions can dispense medicines that are sold without a doctor's prescription, as well as drugs that are subject to subject-quantitative accounting and are written out on prescribed forms.
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In medical departmentsinstitutions must be provided with conditions for the safety of stored prescriptions for drugs that are subject to quantitative accounting.
prescription drugs without prescriptions - Prescriptions for medicines subject to subject-quantitative accounting must be transferred every month from separate divisions to medical organizations for further separate storage. At the end of the storage period, all prescriptions must be destroyed in accordance with the current legislation of the Russian Federation. Prescription drug dispensing rules must be followed.
- An employee of a pharmaceutical institution that dispenses medicines must inform customers about the rules for using drugs, their regimen, daily and single doses, and also must 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 about the 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 should indicate the name and dosage, as well as the total number of drugs dispensed, their price and date signed by the dispenser of the medicines.
- The head of themedical facility.
What are prescription drugs?
This list is fixed by order of the Ministry of He alth No. 403 dated July 11, 2017.
Combination medicines containing:
- ergotamine hydrotartrate up to five mg;
- ephedrine hydrochloride up to 100 mg;
- pseudoephedrine hydrochloride 30mg;
- pseudoephedrine hydrochloride 30mg, dextromethorphan hydrobromide 10mg;
- dextromethorphan hydrobromide 10mg;
- codeine or its s alts 20 mg;
- pseudoephedrine hydrochloride 30mg;
- pseudoephedrine hydrochloride 30 mg to 60 mg, dextromethorphan hydrobromide 10 mg;
- dextromethorphan hydrobromide 200mg;
- ephedrine hydrochloride 100mg;
- Phenylpropanolamine 75 mg.
