Current situation about performance of good pharmacy practice regulations in the central city and the Northern mountainous area

To describe the status of compliance with a number of good pharmacy practice regulations of pharmacies in the central cities and the Northern mountainous area (2017 - 2018).

Journal of military pharmaco-medicine no9-2019 CURRENT SITUATION ABOUT PERFORMANCE OF GOOD PHARMACY PRACTICE REGULATIONS IN THE CENTRAL CITY AND THE NORTHERN MOUNTAINOUS AREA Nguyen Van Thuan1; Nguyen Thanh Binh2; Phan Thi Hoa3; Ngo Xuan Trinh3 SUMMARY Objectives: To describe the status of compliance with a number of good pharmacy practice regulations of pharmacies in the central cities and the Northern mountainous area (2017 2018) Subjects and methods: Cross-sectional description The sample size included 80 pharmacies (40 pharmacies in central cities and 40 pharmacies in mountainous area) Collect data on evaluating compliance with a number of good pharmacy practice regulations through observation of designed checklists Results: The implementation of personnel regulations: The proportion of pharmacies in two regions reached a low rate (5.0 - 56.3%) Pharmacy facilities reached a good rate (57.5 - 98.8%) Equipment stored at drugstores had a low use rate (with equipment: 85.0 - 98.8%; active equipment: 20.0 - 77.5%) Books and records at drugstores reached low use rate (records: 85.9 - 96.2%; complete records and tracking: 17.9 - 96.2%) Arrangement in display and storage areas had a low rate (37.5 - 63.8%) The average point of implementing some good pharmacy practice regulations of central pharmacies (16.1 ± 2.89) was higher than that of mountainous pharmacies (14.73 ± 2.43) The difference was statistically significant (p < 0.05) Conclusion: The percentage of pharmacies in two regions that complied with good pharmacy practice was generally low Central city pharmacies complied with regulations on good pharmacy practice higher than those in mountainous areas Therefore, when building measures to improve good pharmacy practice scores, more attention should be paid to pharmacies in mountainous areas * Keywords: Good pharmacy practice; Mountainous areas; Central cities INTRODUCTION The retail pharmacies in the community can be considered as a "grassroots health unit", play an important role in the system of direct drug supply to the people, meeting the rising needs of the community about primary health care Besides, when people have health problems, most of them choose pharmacy is the first place to go [5] According to the report of the Vietnam Drug Administration in 2010, when people suffered from any health problems, especially common diseases, 60 - 85% of them often have visited drugstores to seek help and medication, before coming to other types of health services [1] 175 Military Hospital Hanoi University of Pharmacy Vietnam Military Medical University Coresponding author: Nguyen Van Thuan (thuanvime@gmail.com) Date received: 20/10/2019 Date accepted: 26/11/2019 188 Journal of military pharmaco-medicine no9-2019 However, the professional practice of drug retailers in our country is still inadequate, such as selling over-thecounter medicines, substance abuse, antibiotics, corticosteroids, vitamins To overcome the inadequacies in the quality of pharmacy practice, since 2007, the Vietnam Ministry of Health had published a document of Decision No.11/2007/QD-BYT promulgating the principles and standards of "Good pharmacy practice” (GPP) [2] Nevertheless, there are currently many opinions that the granting of GPP in our country is only "formal" outside The question is whether pharmacies will continue to be guaranteed as the result of the initial GPP assessment? The maintenance of facilities, drug storage conditions as prescribed, the monitoring and supervision of the quality of drugs purchased at drugstores as well as the quality of drug supply to people and what is the difference between pharmacies in the central cities and mountainous areas? Therefore, this research was conducted with main objective: To describe the current situation about performance of good pharmacy practice regulations in the central cities and the northern mountainous area (2017 - 2018) SUBJECTS AND METHODS Subjects, location and time of study - Subjects: Pharmacies meet GPP standards and are still doing business (excluding private pharmacies within hospitals, district health stations, general clinics in the study area; not belonging to pharmacies that sell traditional medicines and medical materials) - Location of study: The study was conducted in provinces and cities: Hanoi and Haiphong represented for the central cities; Tuyenquang and Dienbien represented for the Northern mountainous area - Time of study: From 01 - 2017 to 01 - 2018 Methods * Study design: The cross-sectional descriptive method * Sample size and sample selection: 20 pharmacies were chosen in each province/city Specific pharmacies in each province/city were selected by using the simple random method from the list of pharmacies which was provided by the Department of Health of the studied provinces/cities Total: 80 pharmacies * Methods and techniques for data collection: Investigators observe directly at drugstores (drug retailers) and use checklists to assess facilities, equipment and practice regulations (personnel, prescription, and labeling) follow the GPP principle * Data processing methods: The information collection forms were checked, cleaned, processed and entered by using Excel software Information was analyzed by descriptive statistical technique Compare the differences between the two ratios via the index p * Research ethics: The study was reviewed and approved of the Department of Health in researched provinces Owners of pharmacies were fully explained about the content and 189 Journal of military pharmaco-medicine no9-2019 purpose of the study All study subjects confirmed voluntary participation All pharmacy informations were kept confidentially and were for research purposes only, not for other purposes RESULTS AND DISCUSSION Subsequently, the International Federation of Pharmaceuticals had developed a GPP guide on the basis of drawing on practical experiences in the use of drugs by countries throughout the territory and by international pharmaceutical organizations [4] The concept of GPP was first conceived at the Conference in Tokyo (1993) by the International Pharmaceutical Federation (FIP): A good practice drugstore is a pharmacy that does not consider benefits profits of their own business but also interested in the interests of buyers, the common interests of the whole society In Vietnam, GPP is a document that sets out basic principles and standards in professional practice at pharmacies of pharmacists and pharmaceutical personnel on a voluntary basis adhere to ethical and professional standards at a level higher than the minimum legal requirements [3] Results of investigation on implementing personnel regulations in two areas Table 1: Implementing personnel regulation Pharmacies of central city area (n = 40) (%) Pharmacies of mountainous area (n = 40) (%) p Total (n = 80) (%) Professional manager presents at the pharmacy (22.5) (10) 0.225 13 (16.3) The drug seller wears a blouse 26 (65.0) 19 (47.5) 0.176 45 (56.3) The drug seller wears a signboard (10.0) 0.116 (5.0) Personnel regulations One of the first contents of the pharmacy good practice standard is personnel The results of our research showed that the proportion of professional managers present at drugstores, blousewearing drug sellers and drug vendors wearing signboards of pharmacies in central city area was higher than that in the moutainous area However, this difference was not statistically significant (p > 0.05) The percentage of professionals present at the pharmacy for 190 both groups was higher than the result of a survey of 371 pharmacies in major cities of Pakistan in 2012, when the authors pointed out, 2.2% of pharmacies had pharmacists who sold directly [6] Based on this, it can be seen that pharmacists or professional staff present at pharmacies was very low, which can cause many difficulties for customers such as not buying the right medicine or not being consulted carefully Journal of military pharmaco-medicine no9-2019 Results of investigation on implementing regulations on maintaining material facility standards at pharmacies in two areas Table 2: Implementing on maintaining material facility standards at pharmacies Pharmacies of central city area (n = 40) (%) Pharmacies of mountainous area (n = 40) (%) p Total (n = 80) (%) Consulting area 34 (85.0) 37 (92.5) 0.481 71 (88.8) Hand-washing area 25 (62.5) 21 (52.5) 0.498 46 (57.5) Dispensing drug area 33 (82.5) 38 (95.0) 0.154 71 (88.8) Private area for cosmetics, functional foods 39 (97.5) 40 (100) 0.241 79 (98.8) Regulations Among the four regulations to maintain standards of drugstores' facilities and regulations, the private areas for cosmetic and functional foods to be served was the highest proportion; regulations for hand-washing was the lowest incidence (57.5%) The difference in the compliance rate between the two regions was not statistically significant (p > 0.05) The results showed that the proportion of drugstores in mountainous areas maintained standards in counseling areas, drug dispensing areas and separate areas for cosmetics and functional foods were very high, even higher than pharmacies in the central city area Only hand-washing area in pharmacies of central cities had a higher rate of maintaining standard of facilities than that in mountainous area However, these differences were not statistically significant (p > 0.05) Of all areas, hand-washing areas had the lowest rates of pharmacies upholding the standard This was also a point to be noted for improvement, because adequate and proper hand hygiene was one of the measures to prevent cross-contamination from person to person Results of investigation on implementing regulations on maintaining storage equipments standards at pharmacies in two areas Table 3: Implementing on maintaining storage equipments standards at pharmacies Regulations Pharmacies of central city area (n = 40) (%) Pharmacies of mountainous area (n = 40) (%) Total (n = 80) (%) p Having (1) Activity (2) Having (3) Activity (4) p (1-3) p (2-4) Having Activity Air conditioner 39 (97.5) (17.5) 40 (100) (22.5) 1.00 0.781 79 (98.8) 16 (20.0) Hygrothermometer 40 (100) 31 (77.5) 36 (90) 24 (60.0) 0.116 0.147 76 (95.0) 55 (68.8) 191 Journal of military pharmaco-medicine no9-2019 Tools to dispense drugs 35 (87.5) 32 (80.0) 38 (95.0) 30 (75.0) 0.432 0.790 73 (91.3) 62 (77.5) Measures to avoid sunlight 32 (80.0) - 36 (90.0) - 0.348 - 68 (85.0) - Of the regulations that maintain the standards of equipment for storage at the pharmacy, regulations (air conditioners, hygro-thermometers and dispensers) were subjected (both equipment and operating at the time of study) However, the ratio of setting up equipment was not commensurate with the proportion of equipment in operation mode The proportion of central cities and mountainous drugstores with air-conditioners, hygrometer sets, retailing devices, measures to avoid the sunlight was quite high (≥ 80%) However, with the current status of operation, the regulation of operation in pharmacies in mountainous areas was higher than pharmacies of central city area, but the rate was quite low The rate of operation of hygro-thermometer, and the number of retail dispensers of central city pharmacies was higher than in the mountainous areas However, the difference was not statistically significant (p > 0.05) As for the method of avoiding sunlight, 85% of pharmacies were equipped but all pharmacies did not use this method Preserving facilities is very important and necessary to avoid adverse effects from the environment A situation that can be seen in pharmacies was that even though they had such equipments, the rate of operation was quite low Therefore, pharmacies should have regular maintenance and repair to ensure the operation of drug storage equipment Results of investigation on implementing regulations on documents and records at pharmacies in two areas Table 4: Implementing regulations on books and records Regulations Pharmacies of central city area (n = 40) (%) Having (1) Patient monitoring book Drug receive/deliver monitoring book ADR tracking book Temperature, humidity monitoring book 192 38 (95.0) 38 (95.0) 33 (82.5) 35 (87.5) Recording (2) 27 (67.5) 38 (95.0) (22.5) 28 (70.0) Pharmacies of mountainous area (n = 40) (%) Having (3) 34 (85.0) 37 (92.5) 34 (85.0) 35 (87.5) Total (n = 80) (%) p Recording p (1-3) (4) p (2-4) Having Recording (22.5) 0.263 < 0.001 72 (92.3) 36 (46.2) 37 (92.5) 1.00 1.00 75 (96.2) 75 (96.2) (12.5) 1.00 0.378 67 (85.9) 14 (17.9) 29 (72.5) 1.00 1.00 70 (89.7) 57 (73.1) Journal of military pharmaco-medicine no9-2019 Of the regulations on documents and records at the drugstore, 96.2% of the pharmacies fully implemented both regulations (monitoring books and full records) Regulations on ADR monitoring books had the lowest percentage of pharmacies Regarding the regulations on patient monitoring book, there was a clear difference in the percentage of pharmacies that complied with the full record between the two areas The difference was statistically significant (p < 0.001) Results of investigation on implementing regulations on display and storage zones arrangement at pharmacies in two areas Table 5: Implementing display and storage zones at pharmacies Pharmacies of central city area (n = 40) (%) Pharmacies of mountainous area (n = 40) (%) p Total (n = 80) (%) Proper arrangement of cosmetics, functional foods 30 (77.0) 21 (52.5) 0.787 51 (63.8) Proper arrangement of over-thecounter/prescription medications 19 (47.5) 11 (27.5) 0.105 30 (37.5) Regulations The proportion of central pharmacies that properly arranged functional food cosmetics and the right arrangement of over-the-counter/prescription drugs was higher than that of the drugstores in mountainous areas The difference in the proportion of pharmacies that complied with regulations between the two regions was not statistically significant (p > 0.05) It can be seen that pharmacies in mountainous areas were currently not implemented Our results were similar to a study conducted on some of the Northern provinces such as Hanoi, Vinhphuc, Nghean and Thanhhoa Assessments of the practice of pharmacies have shown that in practice, according to the inspection results at GPP pharmacies in Hanoi in the period of 2010 - 2012, there were still many inadequate bookkeeping: there were more than 50% of pharmacies recording incomplete books, not according to regulations Between - 7% of pharmacies did not carry out bookkeeping It is necessary to remedy this at pharmacies Average score of the GPP regulations implementation at two pharmacy groups in two areas Figure 1: Average score of implementing some GPP regulations (p = 0.024) 193 Journal of military pharmaco-medicine no9-2019 The average point of implementing a number of GPP regulations of the pharmacies in central city was 16.1 ± 2.89, higher than that in the mountainous area (14.73 ± 2.43) The difference was statistically significant (p < 0.05) As can be seen, pharmacies in mountainous areas tend to comply with regulations on good pharmacy practice not yet equal to those of the central city Therefore, when developing measures to improve GPP points, more attention should be paid to pharmacies in mountainous areas CONCLUSION The pharmacies of the two regions had complied with regulations on GPP: The proportion of personnel was low (5.0 to 56.3%), in terms of pharmacy facilities the rate was quite good (57.5 to 98.8%), about the equipment used in drugstores storage at the low actual utilization rate (with storage facilities: 85.0 - 98.8%; operating equipment: 20.0 - 77.5%), records at the drugstore achieved a low rate of use (with records: 85.9 - 96.2%; complete records and tracking: 17.9 96.2%), the rate of arrangement in the display and storage area was low (37.5 63.8%) The average point of implementing 194 some GPP regulations of central city pharmacies (16.1 ± 2.89) was higher than that of mountainous pharmacies (14.73 ± 2.43) The difference was statistically significant (p < 0.05) REFERENCES Drug Administration, Ministry of Health Pharmaceutical Industry Report 2010 Hanoi 2010 Ministry of Health Decision on promulgating principles and standards of "good pharmacy practice" No.11/2007/QD-BYT dated 24/01/2007 Hanoi 2007 Ministry of Health Circular prescribing good practices of drug retail establishments 02/2018/TT-BYT dated January 22, 2018 Hanoi 2018 International Pharmaceutical Federation Guidelines on good pharmacy practice: Standards for quality of pharmacy services 1993 Muhammad Haroon Sarwar, Muhammad Farhan Sarwar, Muhammad TaimoorKhalid et al The roles of pharmacy and clinical pharmacy in providing health care services to the people Research & Reviews in Pharmacy and Pharmaceutical Sciences 2015 Hussain A, Ibrahim M.I Medication counselling and dispensing practices at community pharmacies: A comparative crosssectional study from Pakistan J Clin Pharm 2011, 33 (5), pp.859-867  ... describe the current situation about performance of good pharmacy practice regulations in the central cities and the northern mountainous area (2017 - 2018) SUBJECTS AND METHODS Subjects, location and. .. pharmacies in the central city area Only hand-washing area in pharmacies of central cities had a higher rate of maintaining standard of facilities than that in mountainous area However, these differences... pharmacies of central city area, but the rate was quite low The rate of operation of hygro-thermometer, and the number of retail dispensers of central city pharmacies was higher than in the mountainous