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).
Trang 1CURRENT SITUATION ABOUT PERFORMANCE OF GOOD
PHARMACY PRACTICE REGULATIONS IN THE CENTRAL CITY AND
THE NORTHERN MOUNTAINOUS AREA
Nguyen Van Thuan 1 ; Nguyen Thanh Binh 2 ; Phan Thi Hoa 3 ; Ngo Xuan Trinh 3
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]
1 175 Military Hospital
2 Hanoi University of Pharmacy
3 Vietnam Military Medical University
Coresponding author: Nguyen Van Thuan (thuanvime@gmail.com)
Date received: 20/10/2019 Date accepted: 26/11/2019
Trang 2However, the professional practice of
drug retailers in our country is still
inadequate, such as selling
over-the-counter 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
1 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 4 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
2 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
Trang 3purpose 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
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
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]
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]
1 Results of investigation on implementing personnel regulations in two areas
Table 1: Implementing personnel regulation
Personnel regulations
Pharmacies of central city area (n = 40) (%)
Pharmacies of mountainous area (n = 40) (%)
(n = 80) (%)
Professional manager
The drug seller wears a
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,
blouse-wearing 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
both groups was higher than the result
of a survey of 371 pharmacies in
3 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
Trang 42 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
Regulations
Pharmacies of central city area (n = 40) (%)
Pharmacies of mountainous area (n = 40) (%)
(n = 80) (%)
Private area for cosmetics,
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
3 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
Pharmacies of central city area (n = 40) (%)
Pharmacies of mountainous area (n = 40) (%)
(n = 80) (%) Regulations
Having (1)
Activity (2)
Having (3)
Activity
40
79 (98.8)
16 (20.0) Hygro-
thermometer
40 (100)
31
24
76 (95.0)
55 (68.8)
Trang 5Tools to
dispense drugs
35 (87.5)
32 (80.0)
38 (95.0)
30
73 (91.3)
62 (77.5) Measures to
avoid sunlight
32
36
68
Of the 4 regulations that maintain the
standards of equipment for storage at
the pharmacy, 3 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
4 Results of investigation on implementing regulations on documents and records at pharmacies in two areas
Table 4: Implementing regulations on books and records
Pharmacies of central city area (n = 40) (%)
Pharmacies of mountainous area (n = 40) (%)
(n = 80) (%) Regulations
Having (1)
Recording (2)
Having (3)
Recording
Patient monitoring
book
38
34
72
Drug receive/deliver
monitoring book
38
37
75
34
67
Temperature,
humidity monitoring
book
35
35
70
Trang 6Of the 4 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)
5 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
Regulations
Pharmacies of central city area (n = 40) (%)
Pharmacies of mountainous area (n = 40) (%)
(n = 80) (%)
Proper arrangement of
Proper arrangement of
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 5 - 7% of pharmacies did not carry out bookkeeping It is necessary to remedy this at pharmacies
6 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)
Trang 7The 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
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
1 Drug Administration, Ministry of Health.
Pharmaceutical Industry Report 2010 Hanoi
2010
2 Ministry of Health. Decision on promulgating principles and standards of "good pharmacy practice" No.11/2007/QD-BYT dated 24/01/2007 Hanoi 2007
3 Ministry of Health. Circular prescribing good practices of drug retail establishments 02/2018/TT-BYT dated January 22, 2018 Hanoi 2018
4 International Pharmaceutical Federation
Guidelines on good pharmacy practice: Standards for quality of pharmacy services 1993
5 Muhammad Haroon Sarwar, Muhammad Farhan Sarwar, Muhammad TaimoorKhalid
pharmacy in providing health care services to the people Research & Reviews in Pharmacy and Pharmaceutical Sciences 2015.
6 Hussain A, Ibrahim M.I. Medication counselling and dispensing practices at community pharmacies: A comparative cross-sectional study from Pakistan J Clin Pharm
2011, 33 (5), pp.859-867