The adoption of the rules of good pharmacy practice in the pharmaceutical sector began to be discussed back in 2016. It was widely believed that this document will become a key industry act in 2017. And so it happened. Let us briefly review the contents of the act on good pharmacy practice with comments .
General information
Order 647 , containing a new procedure, was registered by the Ministry of Justice on January 9, 2017. This document entered into force on March 1 of the specified year.
Order 647n provides a set of requirements, the non-fulfillment of which entails the corresponding consequences, including administrative liability under the Code of Administrative Offenses. Of course, this document does not cancel other orders, decrees, laws. The order of the Ministry of Health, however, accumulates a number of their provisions. All of them are now contained in a single legal act.
Good Pharmacy Practices: Discussion
Prior to the entry into force of the document, it was suggested that it would become the most used act in pharmaceuticals. And the heads of pharmacies, and pharmacists, and pharmacists, and other employees will open exactly the Rules of Good Pharmacy Practice to clarify how to take this or that product, how to organize paperwork, how to properly advise the buyer, and so on. Simply put, it was expected that the act would be the No. 1 benefit in the work of pharmacies.
The Rules of Good Pharmacy Practice contain new recommendations and standards. Their use, of course, will slightly change the daily activities of pharmacy structures.
The Rules of Good Pharmacy Practice , enshrined in the Order of the Ministry of Health, contain, among other things, a detailed description of the actions, mechanisms, and processes of pharmacies. For example, they contain details of the implementation of acceptance control of products.
International practice
It is worth saying that work on the Code of Practice has been going on for quite some time. So, in 1993, the IFF (International Pharmaceutical Federation) developed a document whose name is translated into Russian as “ Good Pharmaceutical Practice”.
In 1997 and 2001, this document was revised. At the same time, not only the IFF, but also WHO participated in the revision of Good Pharmacy Practice .
It is worth saying that the NAP was not a specific guide. The document did not have a detailed description of all procedures and aspects of pharmacy work. “ Good pharmacy practice ” is a general basic scheme, on the basis of which the Rules should be developed in different countries, taking into account the specifics of a particular state. National NAPs, in turn, must be detailed.
Preconditions for the adoption of the document
The implementation of the Rules of Good Pharmacy Practice is determined, according to experts, for two reasons.
First of all, the Ministry of Health and Roszdravnadzor significantly intensified their activities to improve the regulatory framework of the pharmaceutical sector.
Secondly, experts believe that the emergence of the Rules of Good Pharmacy Practice in the Russian Federation is associated with participation in the EAEU. The fact is that Russia's partners in this organization have long had their own NAPs. One of the areas of work of the authorized structures of the EAEU is to bring the pharmacological legislation of member countries into a single form.
Structure
The rules of good pharmacy practice are divided into 8 sections:
- The first and second are general provisions and terms.
- Third, fourth - reveal the features of the quality management system and management processes.
- The fifth - highlights issues related to resources (personnel, equipment, infrastructure, and so on).
- In the sixth, there is a description of various processes within the framework of the pharmacy organization. For example, operations for the purchase, acceptance, storage, sale of goods are detailed.
- The seventh section is devoted to introspection - an assessment of the performance of a pharmacy.
- In the eighth, it refers to a continuous increase in work efficiency.
Terminology Innovations
The new Rules of Good Pharmaceutical Practice disclose the concept of “pharmaceutical service”. Under it is understood the service provided by the pharmacy organization and aimed at meeting the needs of the buyer in medicines and other products of the pharmacy assortment. As part of its provision, consumers and health workers should receive information about the availability, storage, use of products.
Counseling is aimed at ensuring responsible self-medication. In turn, it should be understood as the reasonable use by the buyer of non-prescription drugs. According to the Rules of NAP, they should be used to prevent mild health disorders before providing medical care. From this we can conclude that the independent use of prescription drugs, for example antibiotics, is regarded as irresponsible self-medication.
Article 2.4 discloses the concept of “pharmacy assortment goods”. It is believed that this term is first fixed at the regulatory level. However, it can be called an innovation formally, since the definition almost completely duplicates paragraph 7 of article 55 of the " Retail Order ". The goods of the pharmacy assortment are listed in it in sufficient detail.
Showcase
One of the Good Pharmacy Practices short stories is the provision for storing medicines. It is present in the section containing information about the equipment.
Attention should be paid to the wording that prescription drugs can be stored on display windows, in open, glass cabinets if consumers do not have physical access to them. This provision has caused a lot of controversy even before the adoption of standards of good pharmacy practice .
In international practice, three approaches are used to dispense and lay out prescription drugs. In some countries, leave is carried out exclusively according to prescriptions, and such funds are not laid out on the windows. In other states, there are no restrictions on this issue.
The provisions of Good Pharmacy Practice in Russia are called by experts the third approach. The conditions must be met:
- Strict adherence to prescription drugs.
- The display is allowed if the buyer is guaranteed to have no access to medicines.
Indication of open and glass cabinets is aimed, inter alia, at ensuring that pharmacy organizations do not face penalties for funds that are on display windows behind the first-time manager (pharmacist serving consumers) who do not have access to the pharmacy hall but are facing it . Auditors often consider the glass "facade" a display case, as it is visible from the hall. Accordingly, claims are made to the pharmacy. Now everything will depend on strict observance of the set conditions.
It is worth noting that the phrase “can be stored” does not mean “necessary”.
Experts predicted that the likelihood of expansion of prescription calculations in pharmacies is very small. The fact is that some organizations do not have sufficient space, employees of other structures seek to minimize contacts with consumers who saw the medicine on the window and demand or ask to sell it without a prescription.
Product reception
This process is as detailed as possible in the new Rules. Experts, and representatives of the pharmaceutical sector themselves, respond positively to this innovation.
The goods acceptance procedure is covered in article 6.2. It details acceptance control. In particular, there are indications on which details of the primary and secondary packaging, accompanying documentation, marking should be paid attention to.
The acceptance process is detailed not only for pharmacological substances and drugs. It is also said in detail about dietary supplements, dietetic, children's, medical nutrition products, products and items for caring for children, perfumes and cosmetics, mineral waters, and medical products.
Experts recommend that you print out the rules of acceptance control and keep it in a conspicuous place as a visual aid.
Counseling Features
Article 6.4 states that the sale of products in pharmacy organizations involves not only direct sales and sales, but also the provision of information within the competence of pharmaceutical workers. Of particular note are the provisions of the norm, such as:
- At the request of the buyer, the employees of the pharmacy organization must familiarize the citizen with a certificate or declaration of conformity of the goods of interest to him.
- Non-drug products may be sold by specialists who do not have a pharmaceutical education.
- To provide consulting and other pharmaceutical services, it is advisable to allocate a zone for personal conversation. This can be done by installing special limiters, applying a bright color border for waiting, the organization of places, etc.
According to experts, this situation is certainly correct. After all, every buyer has the right to get advice in a private conversation on their own health issues, including with a pharmacist. Experts emphasize that these rules are advisory rather than mandatory. The fact is that within the framework of the current legislation and prevailing pharmaceutical practice, far from all pharmacies it is possible to isolate such zones purely technically, and not everywhere it will be advisable.
In small pharmacies there is no place, but on large objects, on the contrary, the area allows you to conduct a private conversation without separating a special zone.
Annexes to Article 6.4
There are only two of them. Applications consolidate the simplest counseling schemes in cases where the consumer:
- Asks for the goods.
- Needs symptom counseling. For example, a person comes to a pharmacy and says that his stomach hurts, a runny nose, or something else.
The Rules note that for each symptom, the pharmacy should have a separate survey scheme. However, the NAP does not explain where to get at least a sample.
Controversial moment
Experts focus on another provision of article 6.4. It stipulates that the pharmaceutical worker must make every effort to ensure that the buyer who made the decision to purchase the medicine has a sufficient picture of:
- its action;
- duration and method of application;
- probable adverse reactions;
- storage rules at home;
- cost;
- combination with other medicines and food products;
- contraindications;
- the need to consult a doctor while maintaining symptoms;
- the inability to return the medication of inadequate quality and so on.
Of course, most of this information is present in the instructions for the tool. However, about her in Art. 6.4 does not say.
When analyzing the wording, many questions arise. For example, what does "do your best" mean? How to measure the "sufficiency" of the buyer about the product?
Experts note the vagueness, subjectivity of the wording. Some experts suggest that these gaps provide an additional reason for supervisory authorities to apply sanctions to pharmacies.
The first-runner is certainly able to answer all questions of interest to the buyer (within his competence, of course), provide reliable information and so on. However, the pharmacist, even with all this, cannot guarantee the formation of a "sufficient idea" with the client about the product. What if a person didn’t listen very carefully or didn’t get enough sleep today? In addition, it is possible that the consumer generally came to the pharmacy to file a claim.
In addition, you need to understand that such a detailed consultation may take some time. What if you do with other customers in line? After all, they also have the right to get a "sufficient idea" of the product of interest to them.
Staff
To fulfill the requirements set forth in the Rules, the head of the pharmacy must approve the staffing table. It must include:
- Names of posts, specialties, professions, information about qualifications.
- Data on the number of staff units.
- Information about the payroll fund.
Each employee must be familiarized with his duties and rights under signature.
Employees with the necessary qualifications and experience may be allowed to engage in activities affecting product quality.
Actually, all these rules are also present in other industry normative acts, standards, etc.
Adaptation program
It is being implemented for newly hired employees. After passing the program, knowledge, qualifications, and work experience are periodically checked.
The adaptation program includes:
- Induction training.
- Preparation at the immediate place of work (primary and repeated).
- Updating knowledge of regulatory acts on the circulation of medicines, public health, protection of consumer rights, the procedure for the provision of pharmaceutical services, including advice on the use of medical products at home; hygiene rules.
- Development of communication and conflict prevention skills.
- Health and Safety Training (Occupational Safety and Health).
The requirements for the experience and qualifications of the head and employees of a pharmacy organization are enshrined in the Regulation on licensing pharmaceutical activities.
Training Issues
The head of the pharmacy organization provides training on the rules of vacation:
- medicines for medical use;
- narcotic / psychotropic drugs;
- medicines in respect of which subject-quantitative accounting is conducted;
- medicines containing a small amount of narcotic compounds.
In the course of the training, employees are also explained questions regarding:
- The procedure for storing recipes.
- Compliance with minimum assortment requirements.
- Application of the marginal sizes of retail allowances to the selling prices of medicines included in the list of vital drugs, the procedure for the formation of their value.
- Compliance with the requirements for storage and transportation of medicines.
- Compliance with the requirements when working with falsified, counterfeit, substandard goods.
- Compliance with the restrictions provided for pharmaceutical workers in the performance of their professional duties.
- Improving knowledge of medicines, including reproduced and interchangeable products, the ability to provide comparative information on drugs and prices.
- Methods of processing information received from consumers about the use of drugs, side effects, bringing this information to interested parties.
Performance Assessment
First of all, it is carried out by the head of the pharmacy organization. The assessment is aimed at checking the completeness of compliance with the requirements enshrined in the Rules of the NAP, to determine corrective actions.
Analysis of issues related to personnel, facilities, equipment, compliance with the rules for the sale of products of the pharmacy assortment, documentation, measures for working with offers and consumer reviews, activities for the detection of counterfeit, falsified, substandard goods, internal audit, is carried out by the head in accordance with the schedule approved in the prescribed manner.
Internal audit
He must be independent and thorough. An internal audit is conducted by persons from among the employees specially authorized by the head of the pharmacy organization. It is allowed to attract third parties on a contractual basis.
The results of the audit should be documented. The documentation includes all the information obtained during the audit, as well as proposals for corrective actions, if there is a need for them.
Measures taken as a result of the audit are also recorded by acts.
The audit is also aimed at detecting shortcomings in the process of compliance with the requirements of the law and the formulation of recommendations for preventive and corrective actions.
The internal audit program should take into account the results of previous audits, including those carried out by regulatory authorities.
An entity designated as responsible for the audited direction of the pharmacy organization must ensure the immediate implementation of preventive and corrective measures.