GPP Assessment in Lebanese Pharmacies
GPP Assessment in Lebanese Pharmacies
Original Research
Good pharmacy practice assessment among
community pharmacies in Lebanon
Danielle A. BADRO , Hala SACRE , Souheil HALLIT , Ali AMHAZ, Pascale SALAMEH .
Received (first version): 11-Nov-2019 Accepted: 23-Feb-2020 Published online: 16-Mar-2020
Abstract
Objective: This study aims to assess good pharmacy practice (GPP) aspects and compare GPP scores among community pharmacies in
Lebanon, using a tool developed jointly by the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO)
to improve and maintain standards of pharmacy practice.
Methods: Data collection was carried out between July and October 2018 by a team of 10 licensed inspectors who work at the
Lebanese Order of Pharmacists (OPL) and visited community pharmacies across Lebanon. The questionnaire was adapted to the
Lebanese context and included 109 questions organized under five sections: socio-demographics, Indicator A (data management and
data recording), Indicator B (services and health promotion), Indicator C (dispensing, preparation and administration of medicines),
and Indicator D (storage and facilities). The value of 75% was considered as the cutoff point for adherence to indicators.
Article distributed under the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 Unported (CC BY-NC-ND 4.0) license
Results: Out of 276 pharmacies visited, a total of 250 (90.58%) pharmacists participated in the study with one pharmacist being
interviewed in every pharmacy. Results showed that 18.8% of pharmacists were generally adherents to GPP guidelines (scores above
the 75% cutoff): 23.3% were adherent to indicator A, 21.6% to indicator B, 14.8% to indicator C and 13.2% to indicator D. Moreover,
comparison of GPP scores across geographical regions revealed a higher adherence among community pharmacists working in the
Beirut region compared to the North region, the South region, Mount Lebanon, and the Bekaa.
Conclusions: Our study shows that community pharmacists in Lebanon do not fulfill GPP criteria set by FIP/WHO, and that this poor
adherence is a trend across the country’s geographical regions. Therefore, efforts should be made to raise awareness among
pharmacists about the necessity to adhere to GPP guidelines and standards, and train them and support them appropriately to reach
that goal. This is the first indicator-based comprehensive pilot assessment to evaluate GPP adherence in community pharmacies across
Lebanon. Working on the optimization of this assessment tool is also warranted.
Keywords
Pharmacies; Professional Practice; Quality of Health Care; Pharmacists; Pharmaceutical Services; Health Promotion; Goals;
Management Audit; World Health Organization; Reference Standards; Lebanon
resulting spread of communicable diseases are only a few in the Decree No. 2622 issued in 1992 that briefly describes
among numerous other critical aspects that have severely the location, inner layout, fixtures, materials, and
11-13 20
impacted community health. All these roles have to be supplies.
practiced within well-managed settings to guarantee
In Lebanon, as in many developing countries, law
quality of medications and pharmaceutical services while
enforcement is limited, and the introduction of new laws is
minimizing errors and malpractice. In Lebanon, to be
slow and thus laws of 1950 are still enforced. Moreover,
allowed to practice, pharmacists must register with the
inspection visits to community pharmacies are sporadic and
Lebanese Order of Pharmacists (OPL, is the official
penalties differ according to the breach of the law
pharmacists’ association), as per the Lebanese law of
14 identified. Consequently, and to improve the quality of
1950. To maintain their registration, pharmacists should
pharmacy practice and practice evaluation, GPP standards
pay an annual fee and enroll in the mandatory continuing
14,15 were suggested by the OPL and published in 2019. These
education program. Moreover, pharmacists’ practice is
standards were based on those suggested by the FIP/WHO
overseen by inspectors from the OPL in collaboration with
and those in application in the United States, Europe, and
inspectors from the Ministry of Public Health (MOPH);
regional countries, and adapted to the Lebanese context.
however, a standardized tool for pharmacy practice
The GPP requirements applicable to Lebanon were defined
evaluation is not yet available in the country.
and categorized into fifteen sections that set standards for
Figures retrieved from the OPL indicate that at the end of various aspects of pharmacy practice, including pharmacy
2017, 2,968 pharmacies, harboring 3,762 pharmacists settings, handling of stock, supply of non-prescription
(employers and employees), were distributed across a medicines, health promotion, and research and
2 21
territory of 10,452 Km as follows: 232 (7.8%) in Beirut, 431 professional development.
(14.5%) in the North region, 553 (18.7%) in the South
The leading authority entitled to evaluate GPP is the MOPH
region, 463 (15.6%) in the Bekaa region, and 1,289 (43.4%)
in collaboration with the OPL. However, the process of
in the Mount Lebanon region. The evaluated ratios of
monitoring pharmacists’ professional activities is neither
pharmacies and community pharmacists were 6.61 and
16 standardized nor quantitative and might be subjective due
8.36 per 10,000 inhabitants, respectively. The latter was
to the lack of a quantitative tool. A pre-requisite for
higher than the mean density of 3.73 pharmacists per
efficient and fair evaluation of GPP in the community is the
10,000 inhabitants identified within the WHO Eastern
establishment of an indicator-based tool that can be used
Mediterranean region in a study conducted by the FIP in
reliably for the assessment. Studies conducted among
2016. Moreover, the average density of community
community pharmacists in Lebanon have already reported
pharmacists per 10,000 inhabitants in Lebanon (8.36) was
about GPP performance; however, these studies were
higher than the mean ratio (3.31 per 10,000 inhabitants)
limited in number and focused on some but not all aspects
across all WHO regions and in the higher range of the ratios 9
of GPP.
(1.92 to 11.82) found in some neighboring WHO countries
17
(United Arab Emirates, Bahrain, Jordan, Egypt, Kuwait). In To implement the GPP standards already defined by the
Lebanon, the easy access to pharmacies and familiarity OPL, and since no validated tool is available in Lebanon, it is
with pharmacists, the distant location of hospitals, essential to start by assessing the current situation using
particularly in remote regions, the expensive international tools. Thus, the objective of this pilot study
clinical/medical consultation fees, and the possibility to was to assess GPP aspects as recommended by the FIP and
obtain medication without prescription are all contributing the WHO, and compare GPP scores among community
factors that have made pharmacists the first healthcare pharmacists in Lebanon based on pharmacies’ geographical
18
professionals to be consulted by patients. distribution and pharmacists’ characteristics, using a
1
FIP/WHO-developed tool.
In this context, the aspects of pharmacy practice that
require particular attention or urgent intervention are not
clearly identified, in particular the common practice in METHODS
Lebanon of dispensing medications without prescription or
Data collection
appropriate indications of use. This haphazard practice that
started during the Lebanese civil war still prevails, despite Data collection was carried out between July and October
efforts of regulatory authorities to enforce article 43 of law 2018. Data were prospectively collected by a team of 10
367/94 of 1994, requiring that the dispensing of licensed OPL inspectors who were designated by the OPL
19
medications be done upon physician’s prescription. In and visited community pharmacies across all Lebanese
fact, the only two classes of medications strictly regulated geographic areas, namely Beirut, Mount Lebanon, North,
in Lebanon are psychotropic agents and narcotics, where South, and Bekaa. Based on the list of pharmacies available
the pharmacist is required by law to keep the physician’s in the OPL, inspections were scheduled by the OPL
prescription and record it in specifically designed registers; administration in regular rounds, following specific routes
other medications are not subject to law enforcement. of visits outside of their district of origin.
Other practice items are also addressed in the law (such as
the prohibition to perform any medical act or injecting In preparation for data collection, OPL inspectors received
medications and vaccines); however, no mention is made a one-day training session on the use of the inspection tool.
about the majority of other practice issues, such as Pharmacies to be visited were randomly selected and were
counseling to the patient, medication therapy not informed beforehand of the OPL inspector’s visit. In
management, reporting adverse effects, etc. Regarding the every visited pharmacy, only one licensed community
technical specifications of the pharmacy, they are featured pharmacist (employer or employee) was approached; if
more than one was on duty at the time of the visit, then All 35 questions administered by OPL inspectors were
the OPL inspector would choose one of them randomly. excluded from their specific indicator section and grouped
Those who refused to participate were excluded from the into an “OPL-administered group” (OAG). Those questions
study. No unlicensed staff were approached. It is were considered as indicators and taken into account when
noteworthy to highlight that in Lebanon, pharmacists have estimating Cronbach’s alpha.
the legal obligation to comply with OPL inspectors’
The questionnaire was available in both Arabic and English
demands during visits; however, this does not include filling
languages, and participants chose their preferred language.
out surveys.
It was initially developed in English, then translated into
Institutional Review Board (IRB) approval was granted by formal Arabic language and reverse translated into English
the American University of Science and Technology to [See Online appendix 1 for the questionnaire].
conduct the study (IRB request number AUST-IRB-
Specific items of the FIP/WHO document were purposefully
20180518-01). The study was anonymous and verbal
excluded from our questionnaire, such as the role of
approval of participation was obtained from all
pharmacists in vaccination campaigns, in the writing of
participating pharmacists. Anonymity was ensured by
standard operating procedure for referral to appropriate
analyzing the data after removing any pharmacist related
healthcare providers, and in the implementation of new
identifier.
technologies in pharmacy services. Those aspects of
Indicators and scale pharmacy practice were not used to evaluate GPP scores
since they do not rely on the professional capacities of the
The FIP/WHO document described four roles in pharmacy
pharmacist or their standard of practice solely and require
services and identified 15 functions under those roles.
support by other healthcare professionals as well as
Using the FIP/WHO document and the questions published
ministries. Therefore, our indicator-based tool specifically
by Trap et al. (2010), a 109-item questionnaire was
focused on the items of the FIP/WHO document that
designed; it included one section detailing demographics
evaluated efficacy and standards of practice for the items
and characteristics of the community pharmacist, and four
22 that can be managed by the pharmacists unilaterally in the
indicators. Indicator A was labeled “Data management
Lebanese context and where no external intervention or
and data recording” and was designed to evaluate data
support is required or needed.
management and data recording, such as the systems used
to record medications dispensed. Indicator B was labeled Statistical analyses
“Services and facilities” and measured items related to
Data entry was performed by two people not involved in
services and health promotion, including health campaigns
the data collection process. Data were analyzed using IBM
and services available to patients such as vaccinations.
SPSS Software version 23. After weighting for the
Indicator C evaluated “Dispensing, preparation,
community pharmacists’ geographical distribution
administration and distribution of medicines” by assessing
according to the OPL official figures, frequencies were
the quality of dispensing, preparation and administration of
calculated for all categorical variables, while means and
medicines by pharmacists. Indicator D focused on “Storage”
standard deviations were calculated for continuous
and addressed power supply, contingency plans, and other 23
variables. GPP indicators were analyzed as continuous
storage-related aspects. Additional questions about facility
variables and as dichotomous variables, where adherence
details and medication disposal were added to indicator D.
to an indicator was considered positive in case the score
24
The questionnaire was designed to fit requirements and was above the passing grade set at 75%.
standards of pharmacy practice in Lebanon. Some of the
Since our sample included more than 100 participants, the
questions were self-administered by the community
data was considered normally distributed, whereby non-
pharmacist, while others were answered by the OPL
normal distributions have no significant consequences in
inspector since they required direct observation and visual 25
the case of samples greater than 100. The Student’s t-test
verification. All of the eight questions under Indicator A
was used to investigate differences between two groups,
were self-administered. Eight of the 20 questions under
while ANOVA was used to compare means of adherence
Indicator B were self-administered, while 12 were
scores between three groups or more. A post-hoc analysis
answered by the OPL inspector after direct observation.
using the Bonferroni test was also applied to study
Thirty-two of the 33 questions under Indicator C were self-
differences between variable modalities taken two by two.
administered, while one was assessed by the OPL inspector,
No multivariable analyses were conducted since the
and 14 of the 36 questions under Indicator D were self-
majority of bivariate tests were non-significant. A p-value
administered, while 22 were answered by the OPL
of 0.05 was considered significant and 95% confidence
inspector. The maximum possible score is 26, 32, 55 and 16
intervals were used.
for indicators A, B, C, and D, respectively. The Cronbach’s
alpha was 0.833, 0.301, 0.119, and 0.526 for indicators A, B,
C and D, respectively. The GPP adherence total score was RESULTS
calculated by summing the scores of the four indicators. In
A total of 250 pharmacies participated in the study,
addition, overall adherence to an indicator was assessed
whereby one pharmacist was surveyed in every pharmacy.
using a cut-off value of 75%: for every indicator, the
Most pharmacies were located in the Mount Lebanon
pharmacist had to have appropriate behavior/answer on
region (44.50%), while Beirut included the lowest
more than 75% of items to be considered adherent to the
percentage (12.60%). Across demographic regions, 138
FIP/WHO indicator.
(57.20%) participating pharmacists were females and most
Table 1. Sociodemographic and other characteristics of the Finally, most pharmacies offered services such as flu
participants.
vaccination, blood pressure, and glycemia checks (Online
Variable N (%)
appendix 2 - Table 2).
Gender
Male 103 (42.80%) All pharmacists had dispensed more than one prescription
Female 138 (57.20%) per day (Online appendix 2 - Table 3), and almost all of
Level of education
them had encountered prescription errors and provided
BS Pharmacy 145 (60.60%)
PharmD 76 (31.60%)
information regarding adherence to treatment and
Master’s 14 (5.70%) antibiotic resistance (98%). Less than half of them had to
PhD 5 (2.10%) call back patients because of a wrong delivery of
Governorate medication or wrong dosage prescription after patients had
Beirut 31 (12.60%) left the pharmacy (41%), while 88% acknowledged
Mount Lebanon 109 (44.50%) dispensing medications without prescription. Those
North 32 (13.20%) medications included NSAIDs (95%), antibiotics (60%),
South 41 (16.70%) steroids (27%), benzodiazepines (14%), gastrointestinal
Bekaa 32 (13.10%)
drugs (67%), hormones and contraceptives (48%).
Number of patients per day
<50 106 (45.20%) Moreover, 88% declared explaining to patients the purpose
50-100 95 (40.30%) of switching to a generic and less than 40% made
>100 34 (14.50%) extemporaneous preparations in a suitable area using
Years of practice appropriate equipment. The vast majority did not have a
Less than a year 8 (3.20%) clear recall procedure for dealing with products suspected
1 year to less than 3 years 28 (11.20%) to be adulterated, unlicensed, spurious, falsely labeled,
3 years to less than 6 years 37 (14.90%) falsified, or counterfeit, while almost all pharmacists
6 years to less than 12 years 72 (29.50%)
declared that patients could consult them for unusual
12 years or more 101 (41.20%)
adverse events. Most of the pharmacists interviewed had
Hours of work per week
Less than 31 hours 19 (7.60%) access to documentary and information resources, mainly
32-40 hours 31 (12.40%) through the internet (63%). More than 90% counseled
>40 hours 199 (79.90%) patients and checked medications before dispensing, while
Position in the pharmacy one-quarter did not check for contraindications, drug
Owner/Employer 197 (80.50%) interactions, or prescribed doses (Online appendix 2 - Table
Staff/Employee 48 (19.50%) 3).
Family monthly income *
<1000 USD 8 (4.20%) With regard to the management of medication stock
1000-2000 USD 58 (30.20%) (Indicator D), around 7% of pharmacists stated that there
2000-3000 USD 51 (26.60%) was no electric power supply available overnight, 9%
>3000 USD 75 (39.10%) indicated that they did not have adequate inventory
Mean (SD) management and expiration date monitoring systems, 85%
Age (in years) 39.01 (10.19) did not encourage patients to return expired or unwanted
House crowding index 0.94 - 0.47
products, and 68% did not have a specific procedure to
*The mean family income in Lebanon is 1833 USD
dispose of expired products (Online appendix 2 - Table 4).
had at least 12 years of experience in pharmacy practice Regarding items that were directly checked by OPL
(41.20%). The mean age of pharmacists was 38.88 years (SD inspectors, the evaluation of Indicator B showed that
10.06), with 64.80% having a Bachelor of Science (BS) around 60% of community pharmacies did not have
degree and most (77.30%) working more than 40 hours a drinking water or toilet facilities available for customers.
week. Additional descriptive results are summarized in The evaluation of Indicator D showed that 3% of
Table 1. pharmacists did not protect their stock of medications from
Descriptive results related to indicators’ items are direct sunlight. However, most pharmacies were equipped
presented in Online appendix 2 - Tables 1 to 5. Almost all with cooling and heating systems, 88% had a refrigerator
pharmacists made use of a computerized data where, in 22% of cases, products other than medications
management system (99%) mainly for stock management were stored. In 52% of pharmacies, pharmacists did not
(92%), but rarely for clinical services and medication label shelves, and in 58% of the cases medicine
management. Around one-quarter (27%) of the bottles/containers were stored on the floor in the storage
pharmacists interviewed used log books, but only a few area (Online appendix 2 - Table 5). Finally, half of the
used them for clinical services. Three-quarters of pharmacists surveyed declared that they did not use pest
pharmacists kept copies of prescriptions for non-controlled control services at the pharmacy (Online appendix 2 - Table
medications (76%) (Online appendix 2 - Table 1). 5).
The majority of pharmacies (83%) employed a licensed The mean GPP adherence score was 4.62 (SD 1.36) for
pharmacist for patient services and health promotion, and indicator A, 9.39 (SD 4.05) for indicator B, 14.02 (SD 2.27)
offered a suitable place to discuss confidential information for indicator C, and 9.35 (SD 2.02) for indicator D; for the
(93%). Furthermore, less than a third of pharmacists full scale, the results were 33.90 (SD 3.95) (Figure 1).
declared participating in awareness campaigns against Moreover, in the absence of a cutoff point for the GPP
most common diseases, and half of them made information adherence total scale score, the value of 75% was adopted
24
of various types and health resources available for patients. as the cutoff point. Results were presented as percentage
Figure 1. Spidograph depicting mean score and percentage of adherence per indicator and for the full scale
of adherence to GPP; 41 (18.80%) of the pharmacists were and the Bekaa regions. Doctor of Pharmacy (PharmD)
considered adherent to GPP guidelines (all scores above holders demonstrated better adherence to GPP guidelines
75%), 57 (23.30%) were considered adherent to indicator A, in comparison with BS Pharmacy holders. All other
53 (21.60%) to indicator B, 36 (14.80%) to indicator C, and characteristics did not affect the adherence to GPP
32 (13.20%) to indicator D (Figure 1). guidelines (Table 3).
The bivariate analysis was used to examine GPP adherence
for each of the demographics and characteristics of the DISCUSSION
pharmacists (Table 2). The results of the ANOVA test
This study sought to assess the level of adherence to GPP
showed significantly higher adherence score to indicator D
guidelines of community pharmacists in Lebanon. The
in Beirut (11.25; SD 0.50); also the highest GPP overall
results showed that 18.80% of pharmacists were generally
adherence score (37.75; SD 0.50) for the four indicators
adherent to GPP guidelines (scores above the 75% cutoff):
altogether was found in Beirut (Table 2). Post-hoc analysis
23.30% were adherent to indicator A, 21.60% to indicator
results identified a significantly higher mean GPP
B, 14.80% to indicator C, and 13.20% to indicator D. The
adherence total score in Beirut compared o other regions.
use of indicators rather than other measurement tools was
Concerning indicator D, a significantly higher mean score
deemed most appropriate because, despite its limitations,
was found in Beirut compared to the Bekaa (p=0.036), in
it is a well-accepted “measurable element of practice
the Mount Lebanon compared to the Bekaa (p=0.010), and
performance for which there is evidence or consensus that
in the North compared to the Bekaa (p=0.024).
it can be used to assess the quality, and hence change in
26-28
No significant difference was found between the GPP the quality of care provided”.
adherence total score and all indicators and gender, years
of practice, number of weekly working hours, and total Moreover, comparison of GPP scores across geographical
family income per month (p>0.05 for all variables). A regions revealed a higher adherence among community
significantly higher indicator D score was found in pharmacists working in the Beirut region compared to the
employees compared to employers (p=0.049), whereas North region, the South region, Mount Lebanon, and the
there was no significant difference between the two groups Bekaa. The data collected can be used as a baseline in
and the GPP total score, indicators A, B, and C. Finally, a future GPP evaluations over the years, across geographical
significantly higher indicator A mean score was found in locations, and according to the demographic characteristics
pharmacists receiving between 50 and 100 patients per of pharmacists, particularly if the assessment tool is
day, whereas significantly higher indicators C and D mean improved in future studies.
scores were found in pharmacists receiving more than 100 Furthermore, it is important to point out that FIP
patients per day (Table 2). encourages national pharmacy professional associations to
In the multivariable analysis, a significantly lower evaluate pharmacy practice by adapting the FIP/WHO
adherence was found in the South as compared to Beirut guidelines to the national context. Indeed, they state that
Table 2. Mean scores and standard deviations for all indicators univariate analysis
GPP adherence
Indicator A Indicator B Indicator C Indicator D
total score
Region
Beirut 37.75 (0.50) 5.50 (0.57) 12.50 (4.36) 14.25 (2.22) 11.25 (0.50
Mount Lebanon 34.78 (3.07) 4.52 (1.37) 9.51 (3.77) 13.61 (2.25) 9.35 (2.13
North 30.00 (9.90) 4.71 (0.99) 9.36 (4.84) 14.35 (2.24) 10.07 (1.77
South 31.00 (3.84) 4.57 (1.29) 8.77 (3.86) 14.57 (2.30) 9.19 (1.82
Bekaa 34.01 (4.58) 4.70 (1.71) 9.04 (4.21) 14.48 (2.35) 8.37 (1.75
p-value <0.001 0.318 0.403 0.076 <0.001
Gender
Male 33.79 (4.08) 4.67 (1.51) 9.43 (4.20) 14.33 (2.33) 8.99 (2.07)
Female 33.40 (4.22) 4.57 (1.41) 9.14 (3.88) 14.05 (2.33) 9.09 (1.87)
p-value 0.483 0.627 0.575 0.354 0.700
Years of practice
Less than 6 months 31.16 (3.06) 4.50 (1.73) 10.00 (1.15) 13.25 (1.50) 9.50 (2.38)
6 months to less than a year 33.62 (6.67) 4.25 (1.71) 11.50 (3.42) 15.00 (2.00) 9.50 (1.73)
1 year to less than 3 years 33.09 (4.44) 4.86 (1.24) 9.46 (3.78) 13.75 (2.34) 9.39 (2.02)
3 years to less than 6 years 34.23 (4.36) 4.62 (1.59) 9.70 (3.98) 14.51 (2.43) 9.19 (2.09)
6 years to less than 12 years 34.18 (3.49) 4.64 (1.32) 9.52 (4.34) 14.21 (2.44) 8.98 (2.05)
12 years or more 33.92 (3.95) 4.53 (1.56) 8.74 (4.02) 14.10 (2.25) 9.01 (1.89)
p-value 0.644 0.927 0.569 0.708 0.919
Hours of work/week
1-16 hours 32.67 (2.59) 5.33 (0.52) 9.00 (1.41) 14.67 (0.82) 9.00 (0.89)
17-31 hours 31.20 (4.88) 5.00 (1.00) 8.92 (3.25) 14.62 (2.10) 10.23 (1.88)
32-40 hours 34.65 (3.25) 4.52 (1.61) 9.10 (4.02) 13.97 (2.85) 9.03 (2.14)
>40 hours 34.01 (3.99) 4.58 (1.47) 9.31 (4.17) 14.13 (2.28) 9.03 (1.97)
p-value 0.052 0.543 0.978 0.799 0.205
Position in pharmacy
Owner/Employer 33.72 (3.82) 4.64 (1.46) 9.16 (3.93) 14.14 (2.29) 8.98 (1.88)
Staff/Employee 34.61 (4.41) 4.57 (1.39) 9.89 (4.71) 14.19 (2.56) 9.68 (2.40)
p-value 0.186 0.794 0.313 0.892 0.049
Family income/month
<1000 USD 32.54 (4.46) 4.12 (1.73) 7.75 (2.60) 12.62 (1.51) 9.13 (1.64)
1000-2000 USD 33.46 (4.13) 4.64 (1.45) 9.19 (4.50) 14.14 (2.35) 9.22 (1.99)
2000-3000 USD 34.83 (3.70) 4.59 (1.69) 9.53 (3.91) 14.04 (2.46) 8.78 (1.84)
>3000 USD 34.17 (3.78) 4.60 (1.35) 9.76 (3.96) 14.40 (2.24) 9.48 (1.88)
p-value 0.256 0.839 0.557 0.218 0.254
Number of patients per day
<50 2.32 (1.14) 1.78 (0.75) 2.26 (1.02) 2.11 (0.99) 2.18 (1.08)
50-100 2.30 (1.13) 2.04 (0.73) 2.48 (1.08) 2.38 (0.94) 2.29 (1.03)
>100 2.76 (1.01) 1.76 (0.77) 2.34 (1.25) 2.60 (1.17) 2.85 (0.85)
p-value 0.106 0.026 0.375 0.027 0.005
“The minimum national standards for each activity are into” the “system”. Therefore, instead of evaluating them
based on processes that need to be relevant and defined on their ability to control quality of products at the time
appropriately according to the local needs of the pharmacy they are allowed into the system, community pharmacists
practice environment and national profession aspirations. were evaluated on their readiness to report in case of
All national pharmacy professional associations should also suspicion over the quality of products beyond the time
adapt these roles and functions in accordance with their point when those medications were allowed into the
own requirements. The activities listed below can be system, which is the time those products are being
further defined and measured by setting indicators of good delivered to patients (see questions C16-C18 in Online
practice within a national context and can be weighted by appendix 1).
1
actual practice-setting priorities”. Accordingly, items of our
The geographical distribution of pharmacies into Beirut,
indicator-based tool were adapted to the Lebanese
Mount Lebanon, Bekaa, North, and South was
context. For instance, in the FIP/WHO joint document,
representative of the OPL distribution of pharmacies.
under Role 1/Function B/2nd requirement, it is indicated
Expectedly, pharmacists were predominantly females
that “Pharmacists who are responsible for procurement
(57.2%) and overall, degrees earned were BS (60.6%),
should ensure that procurement is supported by strong
Pharm.D. (31.6%), Master’s (5.7%), and PhD (2.1%). These
quality assurance principles to assure that substandard,
findings are contradictory with the data published recently
adulterated, unlicensed and spurious/falsely-
by Bizri et al., possibly due to the slightly varying
labelled/falsified/counterfeit medicines are not procured or 29
1 geographical distribution of the participating pharmacists.
allowed into the system”. While we trust in the MOPH and
Nevertheless, our data are in line with the official national
their strict control of the pharmaceutical products
figures available in the OPL databases, thus our study
imported into the country, we believe that pharmacists, as sample can be considered representative of Lebanese
healthcare providers, do not have any tangible power in 23
community pharmacists. However, some confidence
assuring that counterfeit medicines are not being “allowed intervals are extremely wide, showing that for some
Table 3. Univariate analysis of different factors associated with the adherence vs. non-adherence to the GPP guidelines.
Variables p-value Unadjusted OR Confidence Interval
Age 0.310 1.02 0.99 1.04
Gender (males* vs females) 0.063 0.60 0.36 1.03
Education level 0.094
BS Pharmacy - 1
Pharm.D. 0.048 1.89 1.01 3.56
Master’s degree 0.274 0.57 0.21 1.56
PhD 0.581 0.60 0.10 3.69
Governorate <0.001
Beirut 1
Mount Lebanon 0.859 1.08 0.46 2.53
North Lebanon 0.492 0.50 0.07 3.61
South Lebanon <0.001 0.15 0.05 0.43
Bekaa 0.730 0.83 0.30 2.35
Years of experience 0.213
Less than 6 months - 1
6 months to less than a year 0.178 9.00 0.37 220.92
1 year to less than 3 years 0.706 1.59 0.14 17.56
3 years to less than 6 years 0.268 3.80 0.36 40.34
6 years to less than 12 years 0.251 3.87 0.38 39.05
12 years or more 0.197 4.54 0.46 45.22
Number of working hours / week 0.241
1-16 hours - 1
17-31 hours 0.711 0.67 0.08 5.68
32-40 hours 0.278 2.77 0.44 17.46
>40 hours 0.252 2.73 0.49 15.30
Position in the pharmacy (employer* vs employee) 0.791 1.10 0.53 2.28
House crowding index 0.788 0.92 0.51 1.66
Number of patients per day 0.169
<50 - 1
50-100 0.802 0.93 0.51 1.69
>100 0.089 2.11 0.89 4.97
*Reference group
analyses, the sample size was small. Studies with larger solutions yet to be approved and implemented by the
30
sample are recommended to overcome this drawback. MOPH.
Overall, our results showed that pharmacy practice in Indicator B served to identify services and facilities
Lebanon is not compliant with GPP standards, with less available at the pharmacies. A licensed pharmacist was
than a fifth of pharmacists meeting the requirements of all employed at most pharmacies (83%) for patient services
four indicators. The highest adherence score detected was and health promotion, which means that 17% are
for indicator A (23.3% of pharmacists). It is noteworthy that breaching the law by not having a pharmacist on a
indicator A consisted of eight questions in total and that continuous basis (besides during the interview where the
none of those questions were subjected to direct pharmacist was present); thus, it is suggested to enforce
verification by the OPL inspectors, thus possibly allowing the law on the pharmacist's continuous presence in the
the pharmacists to have a better adherence score for that pharmacy. There was a suitable place to discuss
indicator specifically. Pharmacists scored poorly on confidential information in almost all pharmacies.
indicators C and D, with less than 15% of pharmacists However, less than a third of pharmacists declared
properly adhering to GPP standards, respectively. Those engaging in awareness campaigns about most common
indicators are critical in a healthcare context since they diseases. In fact, the participation of pharmacists in
relate to the dispensing, preparation, and storage of outreach activities organized by the MOPH is still weak, and
medications. Importantly, the adherence levels were not higher levels of collaboration between the OPL and the
related to the pharmacy or the pharmacists’ characteristics. MOPH are recommended to improve pharmacists’
involvement. Nevertheless, half of the pharmacists had
The analysis of Indicator A showed that almost all information of various types and sources available to
pharmacists surveyed used a computerized system for data patients, which impact on patients’ health needs to be
management (99%), mainly for stock management (92%), assessed in future studies. The majority of pharmacists
and rarely for clinical services and medication offered services such as flu vaccination, blood pressure,
management. Since the electronic patient profile is not and glycemia checking; these activities can be considered
mandatory yet, this result was expected but not in as a satisfactory involvement in health promotion and their
8,21
accordance with the suggested Lebanese GPP guidelines. extension to other preventive measures would be
Moreover, only three-quarters of pharmacists kept copies encouraged to optimize pharmacists’ implication in health
of prescriptions for non-controlled medications, although awareness.
31
dispensed more than one prescription per day, most of dispose of expired products. This is another major issue
them identified errors in prescriptions, and engaged in that the competent authorities must address, because of its
awareness by providing information about adherence to environmental and health consequences, particularly in
treatment and antibiotic resistance. These figures are Lebanon where pollution of ecosystems linked to the waste
41,42
considered appropriate. Less than half of the pharmacists crises has been lasting for years.
had to call back patients after leaving the pharmacy, which
With regard to the items confirmed by the interviewer,
is relatively low, while almost all pharmacists declared that
serious hygiene problems were identified, with half of the
patients could consult for unusual adverse events.
pharmacists declaring that they do not use pest control
Although more than 90% declared counseling patients and
services. In addition, 88% had a refrigerator (confirmed by
checking medications before dispensing, one-quarter did
the interviewer), but 22% used it to store products other
not check for contraindications, drug interactions, or
than medications. Another major issue is that 7% of
prescribed doses; more efforts should be deployed by
pharmacists stated that the pharmacy was not supplied
relevant authorities to optimize these practices through
32 with electrical power during the night, while 3% did not
continuing professional development.
store medication stocks away from direct sunlight, which
43
Moreover, although the majority of pharmacists have may alter their quality. GPP adherence scores by region
access to literature and information resources for their own were low for each of the four indicators except for
education, mainly through internet, pharmacists should Indicator D (Storage) in Beirut.
broaden their knowledge and acquire better dispensing
33 Comparison across regions revealed a higher overall GPP
practices. They should also be encouraged to maintain
adherence score in Beirut. The underlying explanation is
effective communication with their patients, and follow up
34 yet to be identified and requires confirmation by larger
on their treatments to improve health outcomes. Indeed,
studies. It is hypothesized that an urban status of Beirut
a study in Lebanon had revealed that 40 to 50% of
dwellers (and thus pharmacists) would allow pharmacist to
Lebanese patients were asking for better communication
have more assets and better apply standards that require
with pharmacists, and enhanced pharmacy services.
resources at the human or financial levels, which may not
Pharmacists are also encouraged to improve their
be the case in other regions. This finding corroborates
communication with prescribing physicians in cases of
18,35,36 those of a previous situation analysis of pharmacists in
identified unnecessary medical prescriptions.
Lebanon conducted recently, showing that a substantial
Additional questions within Indicator C showed that almost percentage of Lebanese pharmacists have financial
44
all pharmacists declared dispensing medications without difficulties and cannot afford hiring assistant pharmacists.
prescription (NSAIDs [95%], antibiotics [60%], steroids
While pharmacists may proactively and actively work on
[27%], benzodiazepines [14%], gastrointestinal drugs [67%],
improving their adherence to GPP guidelines, the quality of
hormones and contraceptives [48%]), despite laws
pharmacy practice can be affected by involuntary factors
prohibiting it. This high rate of dispensing medications
unrelated to the pharmacist’s skills or standards of practice,
without prescription was found across all geographical
such as the patients’ load or the educational level of
areas. The undermining reasons found in previous studies
patients in the geographical area of the pharmacy. Indeed,
were mainly patients’ inability to visit a physician due to
2,37 a heavy load of patients means that the pharmacist can
financial constraints and lack of time. Therefore, it is
only dedicate a limited amount of time explaining to each
imperative to strengthen law enforcement through
patient the proper use of medications, or providing health
collaborative actions between the OPL and the MOPH,
awareness information to patients with a possibly low level
taking appropriate measures to improve the system,
of knowledge. Therefore, patient load, patient education
protect patients’ health, and reduce antibiotic
38,39 level, and the socioeconomic status of the pharmacist must
resistance. Furthermore, 88% of pharmacists declared
be included in GPP assessment tools to ensure a fair
explaining to patients the purpose of switching to a generic,
evaluation of pharmacists’ adherence to GPP. Our results
knowing that there are no evidence-based guidelines in
revealed that most pharmacies were visited daily by 10 to
Lebanon (similar to the book Approved Drug Products with
50 patients (44.66%) and many were visited by 50 to 100
Therapeutic Equivalence Evaluations, commonly known as
patients (40.30%). Moreover, the majority of pharmacists
the Orange Book in the US) to drive the pharmacist’s choice
(79.90%) declared working more than 40 hours per week.
and define a clear legal framework; the OPL had already
Taken altogether, these data indicate that the load of visits
suggested to the MOPH appropriate guidelines for safe
does not always provide enough room for the pharmacist
substitution of medications, allowing pharmacists to use
30,40 to discuss with every patient and abide by the
generic substitution whenever adequate and safe.
requirements of the FIP/WHO to explain the purpose of use
Within Indicator D, results showed an obvious problem of medication and indications of use, collect information
with the disposal of expired medications and about their medical history and provide health habits tips,
pharmaceutical waste. Moreover, the vast majority of especially if the pharmacist is not assisted by an additional
pharmacists did not have a clearly designed recall staff at the pharmacy. Adherence to GPP requires further
procedure for products they suspected to be adulterated, study since the multivariable analysis did not demonstrate
unlicensed, spurious, falsely labeled, falsified, or that the number of weekly working hours and the daily
counterfeit. In addition, 9% did not have an adequate stock patient load were associated with poor adherence to GPP
management and expiry date monitoring system, 85% did standards; this could be due to a lack of power in the
not encourage patients to return expired or unwanted analysis, or to a real absence of association in the Lebanese
products, and 68% did not have a specific procedure to context. Since previous studies in both developed and
developing countries had demonstrated the importance of national study will be important for statistical significance
the adequacy of the number of pharmacists compared to and appropriate comparison across geographical regions
the patients load in terms of quality of care, future studies over time. Finally, the validity was not assessed and
28,45,46
are warranted to further assess this issue. reliability results of the standardized tool we used was
suboptimal; this may be due to the fact that respondents
It is suggested that competent authorities, mainly the
better understood the question in one indicator than the
MOPH and the OPL, discuss solutions to improve the
others. We suggest further studies to better adapt the tool
financial situation of community pharmacists by
to the Lebanese context and prove its validity and improve
remunerating the services they might provide (particularly
its reliability characteristics, particularly in a constantly
the ones that were shown to be cost-effective), such as 51
changing healthcare system. Since the tool we used was
medication therapy management, medication
8 not previously validated, using it in a standardized way
reconciliation, and others. Improving the situation of
might still lead to a non-differential information bias,
pharmacists might allow them to better adhere to GPP
underestimating some associations. Improving the tool may
standards, which is expected to improve patients’ health as
show additional associations and further precise the
demonstrated in developed countries; additional studies
results, although we do not have reasons to believe that
are necessary to confirm these ideas. Furthermore,
the overall direction (i.e., suboptimal pharmacy practice)
continuing education related to this topic would also
would change. Another limitation is related to the
consolidate pharmacists’ knowledge, improve their attitude
assessment of Indicators B, C, and D since those were
towards the importance of GPP, and motivate them to
measured by combining together two distinct
spend resources towards improving the quality of their
47,48 measurement methods namely, self-reporting and visual
services. In addition to education, research has shown
evaluation by OPL inspectors. We suggest that in future
that multi-interventions might improve pharmacy practice
studies only one measurement method is used or that self-
in developing countries: regulatory enforcement,
reported items are evaluated separately from items
education, and peer influence were useful in specific
49 evaluated by OPL inspectors. Finally, for the accurate
aspects of pharmacy practice, when applied together.
assessment of those GPP items that are of critical
Finally, our results and recommendations could be importance for patients’ health, we could envisage using
52
extrapolated to other developing low- and middle-income specific measurement models.
countries; they can however be also useful for high-income
countries in rural areas, where several pharmaceutical
CONCLUSIONS
services are not available. This point was clearly highlighted
by the WHO European region report on legal and This study aimed at designing an indicator-based tool to
regulatory framework for community pharmacy in assess the level of adherence to GPP among community
50
Europe. pharmacists in Lebanon, and compare scores across
geographical regions. To our knowledge, this is the first
Limitations and strengths of the study indicator-based comprehensive pilot assessment study that
This pilot study has several limitations including a evaluates GPP adherence in community pharmacies across
possibility of information bias. Indeed, 80.5% of the Lebanon. It showed that community pharmacies in
pharmacists interviewed owned the pharmacy: they may Lebanon do not fulfill GPP criteria. Efforts should be made
have feared sanctions or penalties by the visiting OPL to support pharmacists with appropriate measures, make
inspector and may have altered their answers to meet GPP them aware of the importance of GPP adherence, and train
standards and protect the interests of their businesses. them on GPP guidelines and standards. Working on the
Therefore, we suggest evaluating pharmacists anonymously optimization of the assessment tool is also imperative. It
and have all answers pooled by geographical location. must be validated and adapted to the Lebanese context,
Similarly, items that require direct evaluation by the OPL thus leading to more precise assessment results and better
inspector would be answered electronically on site, which implementation of GPP standards in community practice.
decreases the risk of errors. However, we note that the
inspectors involved in this validation study were selected CONFLICT OF INTEREST
based on their experience; in addition, there was a high
number of completed questionnaires that were returned. Prof. Pascale Salameh was Chair of Scientific Committee at
the OPL at the time of this research work.
Moreover, there is a risk of error during data entry that was
done electronically and checked at three different time
points by three different individuals. Therefore, we believe FUNDING
that data entry mistakes are minimal if not absent. Also, None.
increasing the population size for the purpose of a cross-
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The low adherence of community pharmacies in Lebanon to Good Pharmacy Practice (GPP) standards can be attributed to several factors. Only a small proportion of pharmacists adhere to all four GPP indicators, with less than 15% meeting the standards for indicators C and D, which are crucial for the proper dispensing, preparation, and storage of medications . Contributing factors include inadequate facilities, lack of inventory management systems, and a failure to engage sufficiently in health promotion activities, such as awareness campaigns. Additionally, nearly 9% of pharmacies lack adequate inventory management and expiration monitoring systems . These practices impact public health negatively by potentially leading to medication mismanagement, increased medication errors, and limited public access to necessary health information, ultimately affecting overall healthcare quality . Strengthening these pharmacy practices through better regulatory enforcement and increased pharmacist education could improve compliance and public health outcomes.
Lebanese pharmacists contribute significantly to enhancing patient knowledge by identifying prescription errors and providing information on treatment adherence and antibiotic resistance . More than 90% of pharmacists counsel patients and check medications before dispensing, which supports patient understanding and adherence to treatment regimens . These educational efforts aim to reduce medication errors, improve treatment outcomes, and mitigate issues related to antibiotic resistance. Potential outcomes include enhanced patient safety, reduced incidence of antibiotic-resistant infections, and overall improvement in health literacy within the population. Strengthening these efforts further could amplify positive health outcomes in the community.
Community pharmacists in Lebanon play a potentially significant role in public health through outreach activities, such as enhancing public knowledge on medication use and promoting health screenings. However, less than a third of pharmacists engage in awareness campaigns about common diseases . Barriers to their participation include a lack of collaboration between the Order of Pharmacists of Lebanon (OPL) and the Ministry of Public Health (MOPH), as well as limited encouragement for pharmacists to participate in these activities . Addressing these barriers could involve enhancing inter-organizational collaboration and providing incentives or clear frameworks for pharmacists to engage in public health initiatives, thereby expanding their role beyond dispensing medications to include active participation in community health education.
Economic factors, such as family income levels, surprisingly do not show a significant direct correlation with adherence to Good Pharmacy Practice (GPP) standards in Lebanon, as indicated by p-values ranging from 0.218 to 0.839 across different GPP indicator scores . This suggests that economic standing may not be a primary motivator for compliance. However, it indicates that economic incentives, such as financial support for infrastructure improvements or continuing education, could still be strategically used to indirectly encourage higher adherence levels by alleviating operational burdens on pharmacists. Tailoring such support could enhance overall compliance with GPP standards, ultimately benefiting public health outcomes.
The study shows that the role of ownership in adherence to Good Pharmacy Practice (GPP) standards is not statistically significant, with ownership status showing no substantial effect on compliance . This finding suggests that pharmacy ownership, whether employer or employee, does not inherently affect the adherence to GPP standards. The implications for future pharmacy regulations in Lebanon could involve shifting focus from ownership-based interventions to more universal policies that target all pharmacists regardless of ownership status. This might include mandatory continuing education, improved infrastructure, and systematic enforcement of GPP standards, aimed at enhancing compliance across the board.
Socio-demographic factors like gender and years of experience have varying influences on adherence to Good Pharmacy Practice (GPP) standards in Lebanon. Although the study did not find a statistically significant correlation between gender and adherence (p-value 0.063), there is a trend where male pharmacists have a lower odds ratio for adherence compared to females . Regarding years of experience, although no conclusive statistical correlation was found (p-value 0.213), older pharmacists, with more experience, tend to have higher adherence (odds ratios increase with years of service). These findings indicate that factors outside of socio-demographics, such as ongoing education and practical training, might better explain GPP adherence than gender or experience alone.
Collaboration between the Order of Pharmacists of Lebanon (OPL) and the Ministry of Public Health (MOPH) could be strengthened by establishing formal agreements outlining joint responsibilities and objectives, which include structured participation in outreach activities and health campaigns. The current low involvement level in awareness campaigns reflects a need for better strategic coordination and communication . Enhanced collaboration might involve creating shared platforms for training, resource-sharing, and policy development. Additionally, clearly defined roles and incentives for pharmacists to engage in public health activities could improve participation, facilitating a joint effort towards addressing public health challenges and enhancing community health services.
Lebanese pharmacies encounter significant challenges in inventory and stock management, particularly concerning expired and unwanted medications. Approximately 85% of pharmacists do not encourage returning expired or unwanted products, and 68% lack a specific procedure for disposing of expired medications . These challenges reflect broader issues within pharmacy practices related to inventory management and adherence to safety standards. The limited use of advanced inventory systems contributes to these issues, risking the mismanagement of pharmaceuticals, which can lead to public health hazards and environmental concerns. Effective strategies, such as the adoption of standardized inventory management systems and staff training on safe disposal practices, are essential to enhance pharmacy operations and safeguard public health.
Education level among Lebanese pharmacists shows a correlation with adherence to GPP standards. A Pharm.D. degree was associated with higher adherence (odds ratio 1.89), suggesting that higher educational attainment could improve GPP compliance . This implies that enhancing pharmaceutical education to a higher level, like Pharm.D. programs, might positively impact adherence to professional standards in the pharmacy practice. This points to the necessity for educational institutions and policymakers in Lebanon to consider comprehensive curriculum revisions that emphasize practical and regulatory aspects of pharmacy practice to meet GPP standards effectively.
Infrastructural deficiencies in Lebanese pharmacies include the absence of adequate facilities such as drinking water and toilet facilities for customers, found in around 60% of community pharmacies . Additionally, 52% of pharmacies do not label shelves, and in 58% of cases, medication containers are stored on the floor . These deficiencies suggest significant challenges in maintaining the sanitary and organizational standards necessary for compliance with GPP guidelines. Such infrastructural shortcomings can adversely affect both the safety and efficacy of pharmaceutical services, as poor environmental conditions and inadequate label use can lead to errors in medication storage and dispensing, ultimately affecting public health outcomes.