Responsibilities of Pharmacy Responsible Managers Regarding the Preparation of Magistral Products<\/p>\n
Abstract:<\/strong><\/p>\n Personalised medicines prepared, packaged, labeled, and presented to the patient by a pharmacist in the pharmacy laboratory in accordance with a doctor’s prescription are called compounded products. Compounded products are formulations that are individually prescribed and prepared, where the dosage of active substances in terms of volume or weight is determined by the physician based on the severity of the patient’s condition. Pharmacists are obliged to know their responsibilities and the laws and regulations they must comply with when preparing compounded formulations. <\/p>\n INTRODUCTION<\/strong><\/p>\n As a result of their education, the pharmacist is the sole individual authorized to prepare medicines, and the pharmacy profession is one of those that leaves no room for error regarding human life and health. This is because even the smallest error can often lead to irreversible consequences such as non-recovery, disability, or death. Should such a situation arise, every conscientious pharmacist will inevitably face a profound moral responsibility. Preventing such an outcome requires not relying solely on the knowledge acquired in faculty, but actively following all professional developments, exercising diligence while providing service, refraining from delegating duties that one should perform personally, and striving to avoid even the slightest mistake. <\/p>\n Compounded medicines must be at least as effective, safe, and high-quality as proprietary medicinal products, and they must be prepared in appropriate premises under proper conditions. The Regulation on the Licensing of Human Medicinal Products, which aims to ensure efficacy, safety, and quality in pharmaceuticals, states that all products designated as compounded are exempt from its scope. Similarly, the production facilities for compounded medicines fall outside the scope of the Regulation on Manufacturing <\/strong>Facilities for Human Medicinal Products, which regulates the procedures and principles regarding manufacturing in accordance with Good Manufacturing Practices <\/strong>(GMP) and relevant standards. To ensure that this privilege\u2014granted as a result of the trust placed in pharmacists both in our country and worldwide\u2014is not abused, we must show the necessary care and attention to our laboratories. <\/p>\n Serving individual and public health, the pharmacist must prioritize respect for life and humanity while carrying out this duty. While acting in accordance with professional ethics in their relations with professional organizations, public institutions and organizations, universities, and the industry, the pharmacist’s fundamental approach must be professional rather than commercial. <\/p>\n As in other countries, the practice of the pharmacy profession in our country is determined by laws and regulations. The definition of the pharmacy profession was established in Law No. 6197 on Pharmacists and Pharmacies, which was enacted on December 18, 1953,<\/strong> and published in the Official Gazette No. 8591 on December 24, 1953.<\/p>\n Pharmacy is a healthcare service involving the preparation and delivery to the patient of medicines in various pharmaceutical forms derived from natural and synthetic drug raw materials used in the diagnosis, treatment, and prevention of diseases; the analysis of medicines, and their monitoring in terms of continuity of pharmacological effect, safety, efficacy, and cost; the provision of standardization and quality assurance related to drugs, as well as informing patients about problems associated with drug use and reporting any arising issues. It is mandatory to be a pharmacist to open and operate a pharmacy, or to serve as a responsible manager in a pharmaceutical warehouse. A pharmacist may establish establishments such as pharmaceutical manufacturing facilities, cosmetic production sites, and pharmaceutical R&D centers, or serve as a responsible manager in such official or private institutions. <\/p>\n In addition; <\/strong>The third section of the Law includes explanations regarding pharmaceutical and chemical substances.<\/p>\n SECTION THREE Pharmaceutical and chemical substances;<\/p>\n Article 21 \u2013 Pharmaceutical and chemical substances included in the Turkish Codex kept in establishments shall possess the qualities and conditions specified in the Turkish Codex.<\/p>\n Article 22 \u2013 The owners and responsible managers of pharmacies, pharmaceutical warehouses, and laboratories are responsible for the impurity and improper preservation of opened medical pharmaceutical and chemical substances.<\/p>\n Article 23 \u2013 The preservation of toxic and potent pharmaceuticals and their sale to consumers shall be carried out in accordance with the relevant laws and regulations.<\/p>\n Article 24 \u2013 (Amended: 2\/1\/2014-6514\/36 Art.) Wholesale sales of toxic and potent substances and pharmaceuticals cannot be made from pharmacies, and pharmacies cannot participate in tenders. Inter-pharmacy drug swaps are not considered wholesale sales; it is mandatory to report to the Pharmaceutical Track and Trace System during the processes of drug sales, returns to the pharmaceutical warehouse from which they were purchased or to other warehouses in case of force majeure, swaps between pharmacies, and the destruction of expired or deteriorated products. Pharmaceuticals cannot be sold over the internet or any other electronic environment. Websites cannot be opened on behalf of pharmacy pharmacists and pharmacies. Pharmacists cannot engage in open or covert cooperation, in any manner whatsoever, with institutions, physicians, other healthcare institutions and organizations, or third parties for the purpose of having prescriptions sent to them; they cannot employ brokers, couriers, or similar directing personnel, collect or direct prescriptions, or accept prescriptions originating through such means. If these acts are detected, an administrative fine ranging from five thousand Turkish Liras to fifty thousand Turkish Liras shall be imposed on the pharmacist and the mediating person or institution. In the event of repetition of the acts, the administrative fine to be imposed shall be applied as twice the previously imposed fine. <\/p>\n Article 25 \u2013 It is mandatory that prescriptions left at the pharmacy for preparation be made without modification or alteration, and the delivery of medicines and prescriptions (by writing their prices on them) to the buyer shall be carried out according to the principles determined and announced by the Ministry of Health and Social Assistance<\/sup>. The responsible manager of the pharmacy is directly responsible for any errors or similar issues found in the medicines of prescriptions prepared in pharmacies. Pharmacists cannot prepare prescriptions whose contents they suspect to be incorrect, or prescriptions containing pharmaceutical substances in excess of the amounts written in the codex unless they are underlined with two lines and separately signed, without contacting the attending physician. However, in cases where it is not possible to contact the attending physician, they shall prepare the prescription according to the maximum amounts written in the codex and notify the highest local health authority of the situation. <\/p>\n In SECTION FOUR of the REGULATION ON PHARMACISTS AND PHARMACIES, published by the Turkish Medicines and Medical Devices Agency in the Official Gazette No. 28970 on Saturday, April 2, 2014, there are explanations regarding Pharmacy Locations and Sections.<\/strong><\/p>\n (3) The laboratory sections of pharmacies shall be separated in a manner that prevents direct contact with customers or patients. Pharmacists who hold a licensed pharmacy operating prior to natural disasters such as earthquakes, floods, and fires, but can document that the workplace used as a pharmacy was significantly damaged and rendered unusable due to these disasters, may be issued a license to operate a pharmacy in premises of a minimum 20 square meters or in temporary structures for a period not exceeding two years. <\/p>\n (5) The pharmacy may have more than one door, provided that it is specified in its project submitted to the relevant authorities. None of these doors may open into another shop or store. The pharmacy laboratory cannot have direct access to the outside. <\/p>\n Laboratory section<\/p>\n ARTICLE 21 \u2013 (1) Chemical substances, galenical preparations, and crude drugs used in the preparation of compounded medicines shall be stored in glass bottles, while light-sensitive substances shall be kept in colored bottles in a separate cabinet.<\/p>\n (2) In pharmacies, the surface of the counter designated for drug preparation shall be made of heat-resistant glass, marble, or materials that will not cause microbiological contamination. Precision, centigram, or kilogram scales shall be kept on the counter or on a separate special table in a manner that prevents calibration disturbance. It is mandatory to obtain an inspection certificate for the scales from the relevant authority every two years. <\/p>\n (3) Mains water supply is mandatory in laboratories.<\/p>\n Cabinets for toxic substances<\/p>\n ARTICLE 22 \u2013 (1) All toxic substances shall be separated according to the Pharmacopoeia and kept in separate cabinets. The door of one of the cabinets shall be colored red with the inscription “severe poisons” on it, and the other shall be green with the inscription “poisons to be kept separately”. It is mandatory that these cabinets be kept locked at all times and that the key remains with the responsible manager of the pharmacy. Depending on the type of poison to be placed in these cabinets, their names shall be written on red or green labels on the medicine bottles placed inside them. Additionally, labels bearing the inscription “severe poison” or “poison to be kept separately” shall be affixed. Drugs subject to a red prescription shall be stored in a steel safe. <\/p>\n Compounded medicines, label and packaging<\/p>\n ARTICLE 31 \u2013 (1) A label shall be affixed to the packaging of compounded medicines in a manner that prevents it from falling off. The names of the pharmacy, the physician, and the patient, as well as the directions for use of the medicine, shall be written on these labels. <\/p>\n (2) Labels for medicines for internal use shall be white, while labels for medicines for external use shall be red.<\/p>\n (3) Compounded medicines to be prepared in pharmacies shall be placed in unused, new, and appropriate packaging.<\/p>\n Prescriptions related to compounded medicines<\/p>\n ARTICLE 32 \u2013 (1) It is prohibited to show or provide the original or copy of any prescription, including those left at pharmacies to be prepared, to anyone other than the prescribing physician and the patient or the patient’s relative.<\/p>\n In SECTION SIX, explanations regarding Pharmaceutical and Chemical Substances, the properties of pharmaceutical substances, and responsibilities are included.<\/p>\n ARTICLE 39 \u2013 (1) All pharmaceutical substances present in pharmacies must comply with the specifications in the Pharmacopoeia. The owner and responsible manager of the pharmacy are responsible for these matters. <\/p>\n Storage of pharmaceutical substances<\/p>\n ARTICLE 40 \u2013 (1) All raw chemical pharmaceutical ingredients, ready-made medicines, vaccines, and serums shall be stored appropriately, taking into account the specifications in the Pharmacopoeia and the storage conditions on the packaging. For this reason, the temperature and humidity of the pharmacy environment must comply with the storage conditions. <\/p>\n (2) The labels of bottles containing materials that damage labels, such as bromine, iodine, acid, and alkali, must be made in a way that prevents them from detaching or deteriorating. Damaged and soiled labels shall be renewed. The batch number, manufacturing and expiration dates, place of production, and storage conditions shall be specified on the packaging of chemical substances. <\/p>\n (3) Food supplements<\/sup>, medicines used in pharmacy and agriculture, chemical substances, other health products, and veterinary medicinal products\u2014excluding veterinary biological products\u2014that are produced or imported by obtaining permission, a license, or a price from the relevant ministry, must be kept in separate cabinets so that they do not affect one another.2<\/p>\n <\/p>\n In the GUIDELINES ON GOOD PHARMACY PRACTICE included in Article 50 of the Regulation on Pharmacists and Pharmacies, which entered into force upon publication in the Official Gazette dated 12.04.2014 and numbered 28970, it is stated that: “It is aimed to increase the quality and continuity of the services provided in pharmacies, to ensure access to safe, effective, and high-quality medical products and quality healthcare services, to enable patients to adhere to treatment, to be effective in raising patient awareness in order to prevent issues arising from incorrect drug and dosage selection as well as drug-drug and drug-food interactions, adverse drug effects, and irrational drug use, to cooperate with physicians regarding the use of drugs correctly, in appropriate doses, and for a sufficient duration, and to develop Good Pharmacy Practices.”<\/strong><\/p>\n The Guidelines cover pharmacies, the pharmacists and other personnel working in these pharmacies, and pharmacy services. The philosophy of Good Pharmacy Practice is to provide services related to the products kept in the pharmacy, to help the public benefit from these services in the best possible way, and to engage in activities aimed at increasing efficiency by evaluating the expected benefit versus the actual benefit obtained from medicines. <\/p>\n In the Guidelines, Compounded Medicine is defined as “a medicine or medicines specially prescribed for a patient by a physician and prepared in the pharmacy according to this formula,” while Section 7 defines the “Pharmacy laboratory section” in detail. <\/p>\n 7.1. The laboratory section of pharmacies may be located on a mezzanine or basement floor, but it shall be separated in a manner that prevents direct contact with individuals or patients and direct connection to the outside.<\/p>\n 7.2. The counter dedicated to preparing medicines shall be made of heat-resistant glass, marble, or materials that will not cause microbiological contamination.<\/p>\n 7.3. The laboratory shall be prepared as an appropriately designed, clean area where potential errors are minimized and conditions facilitating the preparation of compounded medicines are ensured.<\/p>\n 7.4. The laboratory shall be designed in a manner that does not lead to contamination and cross-contamination.<\/p>\n 7.5. Precision, centigram, or kilogram scales shall be kept on the counter or on a separate special table in a way that prevents their calibration from being altered. A calibration control certificate shall be obtained from the relevant institution every two years for the scales. Calibration dates and the next calibration date shall be specified on the label on the device. Calibration records of all devices present in the pharmacy shall be stored to include the latest calibration record of the device to be presented during inspections. <\/p>\n 7.6. Chemical substances, galenical preparations, and crude drugs used in the preparation of compounded medicines shall be kept in glass bottles and\/or their original packaging, while substances susceptible to deterioration by light shall be kept in colored bottles, properly labeled, in a separate cabinet.<\/p>\n 7.7. Laboratories shall have city water supply.<\/p>\n 7.8. Laboratories shall not be used for any other purpose, and appropriate humidity and temperature conditions shall be provided to prevent the deterioration of chemical substances.<\/p>\n Furthermore, Section 10 of the Good Pharmacy Practice Guidelines also includes definitions regarding the Preparation of Compounded Medicines, as well as the Supply, Storage, Dispensing to the Patient, and Disposal of Medicines.<\/p>\n 10.a. Preparation of Compounded Medicines<\/p>\n 10.a.1. The pharmacist shall ensure that compounded medicines are prepared and dispensed in a safe, effective, and high-quality manner.<\/p>\n 10.a.2. The pharmacist shall carefully read the information written on the prescription and, if there are any incomplete, incorrect, or incomprehensible points on the prescription, must contact the doctor.<\/p>\n 10.a.3. Multiple compounded medicines cannot be prepared simultaneously in the laboratory.<\/p>\n 10.a.4. After the preparation of medicines in the laboratory, the necessary cleaning procedures shall be performed.<\/p>\n 10.a.5. Compounded medicines shall be prepared by the responsible manager\/assistant\/second pharmacist, and medicines prepared by assistant and second pharmacists shall be dispensed to the patient under the supervision of the responsible manager pharmacist.<\/p>\n 10.a.6. Written standard operating procedures shall be prepared for all operations performed, and tasks and procedures shall be carried out accordingly. In the event of any changes to the information in the documents, they shall be signed and dated. Such changes shall be made in a manner that still allows the original information to be read. Where deemed appropriate, the reason for the change shall be recorded. <\/p>\n 10.a.7. Compounded medicines may be prepared in the pharmacy. Apart from this, the manufacture of cosmetics, medicines, and medical devices for commercial purposes shall not be carried out. <\/p>\n 10.a.8. Bulk manufacturing and sending of medicines to doctors’ offices shall not be permitted.<\/p>\n 10.a.9. Compounded medicines cannot be prepared upon the request of patients.<\/p>\n 10.a.10. Invoices from the suppliers of chemical substances used in the preparation of compounded medicines shall be retained to enable retrospective traceabilities and to be presented during inspections.<\/p>\n 10.b. Packaging and Labeling of Compounded Medicines<\/p>\n 10.b.1. Labels shall be affixed to the packaging of compounded medicines in a manner that will not fall off. These labels shall include the name of the pharmacy and the preparing pharmacist, the names of the doctor and the patient, instructions for use of the medicine, date of preparation, contained substance\/substances and their quantities, storage conditions of the medicine, and warnings, if any. In cases where multiple compounded medicines are presented to the patient at the same time, distinctive designations shall be included on the labels. <\/p>\n 10.b.2. Labels for internal use medicines shall be white, and labels for external use medicines shall be red.<\/p>\n 10.b.3. Medicines to be prepared in pharmacies shall be placed in unused, new, and appropriate packaging.<\/p>\n In this manner, it is included.<\/sup><\/p>\n The criminal liability of pharmacists should be examined in two parts: criminal liability according to the new Turkish Penal Code, and criminal liability according to other laws and regulations (CRIMINAL LIABILITY ACCORDING TO THE TURKISH PENAL CODE NO. 5237 – CRIMINAL PROCEDURE CODE NO. 5271).<\/strong><\/p>\n CRIMINAL LIABILITY ACCORDING TO THE TURKISH PENAL CODE NO. 5237<\/strong><\/p>\n Manufacturing or selling drugs in a manner that endangers people’s lives and health<\/strong><\/p>\n Article 187 – (1) Any person who manufactures or sells medicine in a manner that endangers the life and health of individuals shall be sentenced to imprisonment for a term of one year to five years and a judicial fine.<\/p>\n (2) If this crime is committed by a physician or a pharmacist, or within the scope of the execution of a profession or trade carried out based on official permission, the penalty to be imposed shall be increased by one-third.<\/p>\n ACCORDING TO OTHER LAWS AND REGULATIONS<\/strong> The penal sanction set forth in Article 32 of the Law on Misdemeanors No. 5326 is applied. <\/p>\n These briefly include:<\/sup> failure of pharmacies to comply with duty days and hours, non-compliance with pharmacy opening and closing hours, operation of collusive (collusion-based) pharmacies, breach of confidentiality, using intermediaries for medical prescriptions, selling medical preparations and compounded formulas above the prices determined by the Ministry of Health, selling controlled drugs without a prescription, non-attendance at General Assembly Meetings, possessing or selling expired or spoiled medicines, performing medical treatment procedures, failing to keep in-stock commercially available medicines used in emergency treatment, failing to display an illuminated duty roster board, advertising on behalf of the pharmacy, and creating a website on behalf of the pharmacist or pharmacy.<\/p>\n Disciplinary responsibilities of pharmacists;<\/strong> Article 30 \u2013 The Disciplinary Board shall impose the following disciplinary penalties depending on the nature of the acts and actions contrary to professional etiquette and dignity committed by members who fail to join the chamber or fail to fulfill other obligations imposed on them by this law, as well as those members whose files are referred to it:<\/p>\n a) Written warning,<\/p>\n b) (Amended: 23\/2\/1995 – Art. 4078\/4) A fine ranging from four to fifteen times the chamber’s annual membership fee as of the date the act was committed,<\/p>\n c) (Amended: 23\/2\/1995 – Art. 4078\/4) Prohibition from practicing the profession from three days to 180 days,<\/p>\n d) Prohibiting those<\/sup> who have received the penalty of prohibition from practicing the profession three times in a region from working in that area. Disciplinary boards shall exercise their discretion without following a specific order in imposing these penalties. However, if a member temporarily prohibited from practicing the profession under paragraph (c) needs to be prohibited again due to the recurrence of previous acts and actions, the maximum limit of the penalty specified in this paragraph shall be imposed. (Added: 23\/2\/1995 – Art. 4078\/4) Chamber disciplinary boards are required to finalize the files referred to them within a maximum of three months. <\/p>\n In our country, <\/strong>the rules that pharmacists must comply with are set forth in the Turkish Pharmacists Association Deontology <\/strong>Regulation. Pharmacists registered with the Turkish Pharmacists Association are subject to the provisions of this Regulation. Article 7 of the Regulation pertains to magistral formulas. <\/p>\n Article 7 – A<\/strong> pharmacist cannot be blamed for the lack of healing efficacy of magistral formulas prepared in accordance with pharmaceutical <\/sup>rules or medicines dispensed as proprietary medicinal products.<\/p>\n When evaluated<\/strong> from the perspective of the TURKISH CODE OF OBLIGATIONS; it should not be forgotten that while serving at the pharmacies where they are responsible managers, their relationship with the patient is a purchase-and-sale relationship. (Relevant articles of the Code of Obligations No. 6098) <\/p>\n In the event that a damage occurs to the purchasing patient as a result of using the medicine supplied and the medical aid rendered within the patient-pharmacist relationship, caused by the fault of the pharmacist or their employee, the pharmacist is required to compensate for the damage suffered by that person, depending on the nature of the harm.<\/p>\n In the event of death, the incurred damage consists of “loss of support compensation,” “moral damages,” and funeral expenses that the relatives of the deceased may claim; in the event of disability, compensation for the loss of earning capacity and moral damages; and in the event of causing the illness to be prolonged, wage loss resulting from absence from work, additional expenses spent on treatment, and depending on the situation, moral damages.<\/p>\n Moral damages are explained in Article 56 of the Code of Obligations. According to the article, the judge may award non-pecuniary damages to the injured party in the event of bodily harm to a person, and to their family in cases of severe bodily harm or death, depending on the facts and circumstances. <\/p>\n For same-type<\/sup> incidents occurring in hospitals, both the pharmacist who caused the incident and the employing institution are held liable. The institution’s liability is determined according to the principles of “strict liability” (liability without fault). The institution has a right of recourse against the pharmacist. (Code of Obligations Article 66). <\/p>\n CONCLUSION<\/strong><\/p>\n The relevant articles in the Laws and Regulations set forth above emphasize that the duty performed by pharmacists is a sacred and honorable profession requiring maximum diligence, just like that of physicians, and that pharmacists must act under immense responsibility while carrying out their profession.<\/p>\n The general responsibilities of pharmacists are defined across multiple laws rather than a single legislation, taking the form of specific prohibitions or mandatory duties.<\/p>\n In conclusion, pharmacists face CONSCIENTIOUS, LEGAL, PENAL, and DISCIPLINARY liabilities in relation to their profession.<\/strong><\/p>\n \u201cNemo censetur ignorare legem\u201d REFERENCES<\/strong><\/p>\n 1- LAW ON PHARMACISTS AND PHARMACIES Law Number: 6197 Date of Enactment: 18\/12\/1953 Published Official Gazette: Date: 24\/12\/1953 Issue: 8591 Published Code: Edition: 3 Volume: 35 Page: 83<\/p>\n 2- REGULATION ON PHARMACISTS AND PHARMACIES From the Turkish Medicines and Medical Devices Agency 12 April 2014 SATURDAY \/ Official Gazette \/ Issue: 28970<\/p>\n
\nPENAL RESPONSIBILITIES<\/strong><\/p>\n
\nActing in violation of the matters and rules specified in the Turkish Pharmacists Association Law No. 6643, the Law on Pharmacists and Pharmacies No. 6197, and the Turkish Pharmacists Deontology Regulation, as well as the decisions of the General Assembly and the Board of Directors, constitutes a disciplinary offense in addition to the relevant penal provisions.<\/p>\n
\nIgnorance of the law is no excuse.<\/strong><\/p>\n