Int J Clin Pharm DOI 10.1007/s11096-013-9909-2
RESEARCH ARTICLE
Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar Ahmed Awaisu • Nadir Kheir • Mohamed Izham Mohamed Ibrahim Maguy El-Hajj • Huda Hazi • Nada Khudair • Raja Barazi
•
Received: 2 September 2013 / Accepted: 26 December 2013 Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014
Abstract Background The practice of generic medicines prescribing, dispensing and substitution in developing countries has been controversial among healthcare professionals, particularly due to issues on quality, safety and efficacy. These controversies are as a result of inter-country differences in policies and laws as well as individualized knowledge and attitudes of pharmacists pertaining to generic medicines. Objective This study primarily aims to assess the knowledge, attitudes, and practices of community pharmacists in Qatar towards generic medicines. Setting Community pharmacy settings throughout the State of Qatar. Method A cross-sectional study using a pretested paper-based survey was conducted among a random sample of community pharmacists in Qatar. The data were analyzed using IBM-SPSS version 20. Both descriptive and inferential statistical analyses were applied. Main outcome measure Knowledge, attitudes, and practices of generic medicines pertaining to regulatory standards, safety, efficacy, quality, and future policies. Results A total of 160 surveys were distributed to community pharmacists of which 118 were returned (response rate, 74 %). The mean total score of generic medicines knowledge among the pharmacists was 6.8 ± 1.6 (maximum possible score
was 10). Years of practice as well as place of obtaining academic degree did not influence knowledge score. Approximately 72 % of the pharmacists supported generic substitution for brand name drugs in all cases where a generic medicine is available and the majority (93 %) agreed that pharmacists should be given generic substitution right. Nearly 61 % of the pharmacists considered lack of proven bioequivalence to original brands as an important barrier for selecting generic medicines and 55 % rated ‘‘lack of policy for directing the practice of generic medicine’’ as an important barrier. Conclusion In order to enhance the quality use of and to promote the practice of generic medicines in Qatar, an educational program should be implemented. A national generic medicine policy and guidelines are warranted in the State of Qatar. Keywords Community pharmacists Generic medicines Qatar Substitution
Impact of the findings on pharmacy practice •
• A. Awaisu (&) N. Kheir M. I. M. Ibrahim M. El-Hajj H. Hazi N. Khudair R. Barazi College of Pharmacy, Qatar University, P.O. Box 2713, Doha, Qatar e-mail: [email protected] A. Awaisu N. Kheir M. I. M. Ibrahim M. El-Hajj Clinical Pharmacy and Practice Section, College of Pharmacy, Qatar University, P.O. Box 2713, Doha, Qatar
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There is a need to develop educational intervention programs that target community pharmacists to promote the rational utilization of generic medicines in Qatar. Policymakers should establish a generic medicine policy and guidelines for the State of Qatar. There is a need to improve pharmacists’ knowledge about the pharmaceutical impact of generic substitution, including possible allergy to ingredients. There is a need to assess the knowledge, attitudes, and practices on generic substitution, and the need for educational interventions of physicians and other healthcare professionals in Qatar.
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Introduction Escalating healthcare costs are a global concern, and pharmaceutical expenditures represent a considerable portion of these costs [1–3]. Pharmaceutical expenditure is considered a significant factor that leads to rising health care costs in many countries, and cost-containment strategies for developed countries, such as New Zealand, have been well-described in the literature [1–3]. In Qatar, reports have indicated that spending on prescription drugs has increased sharply with a faster growth rate than other major components of the health care system [4]. In 2009, the value of Qatar’s drug expenditure at consumer prices was estimated to be QR 848 Million (US$ 233 Million), having posted double-digit growth in relation to the previous year [4]. Prescription drugs continued to dominate the market, accounting for close to 90 % of sales by value, supported by generous and high quality public-sector provision. By 2014, drug expenditure is expected to increase by a compound annual growth rate of 11.16 %, in US dollars and in local currency terms to reach QR 1.44 Billion (US$ 400 Million) [4]. The healthcare system in Qatar is broadly divided into public and private health sectors. The public health sector, which is financed predominantly by government revenues and regulated by the Supreme Council of Health (SCH) [5], provides full primary healthcare coverage supplemented by general hospitals and specialist referral hospitals, while the private health insurance covers health services at private hospitals and clinics. Employers (both government and private) usually provide coverage through the public sector and might provide private insurance for selected employees. Hamad Medical Corporation (HMC) is the primary provider for health care in the country, and it is comprised of eight public hospitals [6]. Most patients in Qatar currently receive their medications from these hospitals. Medicines are provided almost free, with a nominal charge of QR 2.0–10.0, through government outlets comprising of HMC hospitals and other primary healthcare clinics. If an individual has private health insurance, medicines are fully covered and are provided through privately owned community pharmacies and pharmacies in clinics and hospitals. The private health sector, including hospitals, general practitioner clinics, and community pharmacies, plays an increasingly important role, and individuals without private health insurance fully pay for services and products. The pharmaceutical market in Qatar is highly import-dependent, with only one drug manufacturing company in the country (Qatar Pharma), which is a private company that mainly produces intravenous solutions. Imported drug products are invariably more expensive than locally manufactured products. Until recently, when the medicine pricing law was changed, the Pharmacy and Drug Control
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Department under the SCH was the sole authority to fix the prices of medicines in Qatar. Retailers were getting the stocks from wholesalers with the prices printed on each pack of medicines. With the abolishment of Law No. 7 in 1990, government control over retail prices of all the medicines sold in Qatar allows importers to establish their own prices. One of the goals of the National Health Strategies 2011–2016 [7] is to improve the health services to the level of international standards. Under this premise, Qatar envisions to provide world-class health care standard services and the best healthcare in the Middle East region (NHS 2011–2016). Within this goal, there is a community pharmacy strategy project aiming to adopt and implement international community pharmacy services and best practices as a benchmark [8]. Patients in future may have to obtain medications from private community pharmacies, which will host a range of expanded and specialist pharmaceutical care services in addition to the regular medication dispensing. An important strategy to control the skyrocketing healthcare costs is to promote the use of more affordable but comparably safe and effective generic drugs instead of the more expensive branded equivalents [1, 9–14]. The use of generic medicines results in significant cost savings and increased access to medicines, and generic substitution is widely encouraged by many government authorities across the world as a cost-containment strategy for patients, healthcare systems and society at large [1, 11–13, 15–17]. A focus on cost-containment through the adoption of the generic drug prescribing and dispensing policy and a focus on promoting the quality use of these products in Qatar could provide substantial savings in the health care budget without compromising the therapeutic effects of the prescribed medicines or the quality of care [9, 11, 13, 14, 18, 19]. The concepts of generic prescribing and generic substitution have been controversial, and questions remain regarding the acceptance and promotion of generic practices among healthcare professionals [18, 20–24]. This controversy surrounds issues of quality, safety and efficacy of the generic medicines [14, 20–27]. There is an apparent lack of knowledge pertaining to the quality, safety, and efficacy of generic medicines among healthcare professionals. Currently, there are no national generic medicine prescribing and dispensing policies in Qatar, and the obligation of prescribing and dispensing brand-name or generic products, especially in community practices, lies with the general practitioner and the pharmacist, respectively. To our knowledge, no studies have been conducted to evaluate the knowledge, attitudes, and practices of healthcare professionals pertaining to generic medicines in the State of Qatar. Pharmacists are key players in the chain of medication distribution because one of their core
Int J Clin Pharm
professional roles is to ensure the manufacture, supply, and distribution of safe, effective, and quality medicines. Pharmacists can assist patients with obtaining the most cost-effective medicines, and this is considered a pharmaceutical care intervention that improves the access to medicines, adherence to therapy and healthcare outcomes. Understanding generic medicine practices and perceptions held regarding these issues is very important in establishing a sound generic medicine policy that will eventually lead to substantial savings in the government’s health care expenditure and will improve access to essential medicines in this country [1, 10, 21, 28–31].
Aim of the study This study aims to (1) determine the current knowledge of community pharmacists in Qatar regarding generic medicines; (2) explore the attitude and perceptions of community pharmacists towards generic drug products, including quality, safety, and efficacy issues and; (3) evaluate the pharmacists’ current generic substitution practices and views about potential generic medicine policies that could be adopted in the future.
Ethical considerations and approval This study was approved by the Qatar University Institutional Review Board (QU IRB). For the purpose of receiving ethical approval, the study protocol, the survey instrument, and informed consent (each in English and Arabic) were submitted to the QU IRB for review. A participant information sheet containing the objectives and general description of the study was provided to each randomly selected participant. Only the participants who provided written informed consent were recruited into the study. The questionnaire was anonymous, and no names or identity numbers were required.
Method Study design and participants This was a cross-sectional, descriptive study using a selfadministered paper-based survey that was conducted between December 2012 and February 2013. The study targeted currently practicing community pharmacists in the state of Qatar. A random sample of 160 community pharmacists was selected from the entire population of community pharmacists practicing in Qatar (N = 500) to participate in the study.
Study setting This study involved all the community pharmacy outlets (including chain and independent pharmacies) in Qatar with its seven governorates of Doha, Al Shamal, Al Khor, Al Rayyan, Al Wakra, Umm Salal, and Al Daayen. Eligibility criteria Participants were eligible to be included if they: (1) were registered/licensed by the Supreme Council of Health as pharmacists in Qatar; (2) speak the English and/or Arabic language and; (3) have been in practice for at least 12 months in Qatar. The community pharmacists who did not meet these criteria were excluded from the study. Study sample and sampling technique The estimation of sample size was performed using the Raosoft online calculator, and the researchers took into account a 20 % non-response rate. There were approximately 500 registered community pharmacists practicing in Qatar. To achieve a confidence level of 95 % and a 5 % margin of error, the study targeted 160 community pharmacists who were randomly selected to participate in the study from the list of community pharmacists in Qatar (sampling frame). A simple random sampling technique was applied in the sample selection. Survey instrument development and implementation The questionnaire used in this study was developed through an extensive review of available literature pertaining to knowledge, attitudes and practices of pharmacists and other healthcare professionals regarding generic medicines. In addition to questions on the demographic and professional characteristics, the questionnaire was comprised of three sections to evaluate: (1) the participants’ knowledge and views regarding generic medicines; (2) perceptions, attitude, and practices towards generic medicines, including generic substitution; (3) factors influencing generic medicine practices, including generic substitution. The domain assessing knowledge was comprised of 10 factual questions regarding the definition of generic medicines, bioequivalence and therapeutic equivalence issues, generic products quality/safety/efficacy in relation to innovator brands, and patent and exclusivity right issues. The respondents were required to choose ‘‘True’’ or ‘‘False’’ or ‘‘Unsure’’ for each of the knowledge questions. A respondent was given one point for each correct response and zero points for each incorrect or unsure response. The maximum possible score was 10 points. Fifteen attitudinal items anchored on a fivepoint Likert scale (from strongly agree to strongly
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disagree) were used to assess the participants’ perceptions and attitudes towards using generic medicines and the implication on government pharmaceutical expenditure, their current practice of generic substitution, profitability, perception of quality/safety/efficacy, support and nature of future generic medicine policies. Twelve items were used to ascertain the pharmacists’ views regarding the importance of certain factors influencing the practice of generic medicines (response choices ranged from important to unimportant factor). The face and content validity of the questionnaire was conducted by three persons identified as experts in generic medicine research and survey instrument development. The readability, clarity and completion time of the modified survey were determined among 10 purposively selected community pharmacists who were eventually excluded from the data analysis. The survey was developed initially in English and translated into Arabic using standardized forward—backward and reconciliation processes. An explanatory statement and an informed consent were distributed with the questionnaire to inform each participant about the purpose and objectives of the study and about the confidentiality of the survey results. Upon fulfillment of the eligibility criteria, each participant was given a copy of the questionnaire by the researchers after signing the written informed consent.
of the community pharmacists were male (n = 63; 58.9 %), in the middle-age group, i.e., between the age 30–39 years old (n = 54; 50.9 %), with BSc degree (n = 99; 92.5 %), and had 5 or less years of practice in Qatar (n = 65; 60.7 %) (Table 1). Nearly one-third of the respondents (n = 34; 31.8 %) graduated from India, and approximately 28 % (n = 30) had between 11 and 15 years of work experience (n = 30; 28.3 %). More details regarding the demographic and professional characteristics of the community pharmacists are provided in Table 1.
Table 1 Demographic characteristics of community pharmacists in Qatar (n = 108) Characteristica
Frequency (%)
Gender Male
63 (58.9)
Female
44 (41.1)
Nationality Non-Qatari
107 (100)
Age 20–29
33 (31.1)
30–39
54 (50.9)
40–49
19 (17.9)
Academic degree
Data analyses The data collected were analyzed using the IBM Statistical Package for Social Sciences (IBM SPSS Software) version 20. Both descriptive and inferential statistics were applied for the data analyses. All the categorical variables, including the respondents’ socio-demographic and professional characteristics, items assessing knowledge and practices on generic medicines, and other attitudinal items, were expressed as frequencies and percentages. The knowledge scores were calculated as the mean (±SD) and the median (±IQR). The influence of respondents’ professional and demographic factors on knowledge was tested using the Mann–Whitney U and Kruskal–Wallis tests as appropriate. The level of significance was set a priori at p B 0.05.
Results Sociodemographic and professional characteristics of the respondents Of the 160 surveys distributed, 118 community pharmacists returned the surveys (73.8 % response rate), and 108 surveys were analyzed (91.5 % useable rate). The majority
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BSc
99 (92.5)
Master
7 (6.5)
PharmD
1 (0.9)
Country of graduation India
34 (31.8)
Egypt
31 (29.0)
Philippines
21 (19.6)
Sudan
8 (7.5)
Jordan
5 (4.7)
Pakistan
4 (3.7)
Syria
2 (1.9)
Iraq
1 (0.9)
Palestine
1 (0.9)
Years of experience 5 or less
29 (27.4)
6–10
27 (25.5)
11–15
30 (28.3)
16–20
15 (14.2)
More than 20 Years of practice in Qatar
a
5 (4.7)
5 or less
65 (60.7)
6–10
22 (20.6)
11–15
17 (15.9)
16–20
3 (2.8)
There were some missing data across all the variables
Int J Clin Pharm Table 2 Knowledge of community pharmacists in Qatar on generic medicines (n = 108) knowledge item
n (%) Correct response
Incorrect response
1. The term ‘generic medicine’ is a drug product marketed under the drug’s nonproprietary approved name or a product marketed under a different brand name (proprietary) name
94 (87.0)
14 (13.0)
2. Generic products must be bioequivalent to the innovator brand before they can be approved to be marketed in many developed and some developing countries
95 (88.0)
13 (12.0)
3. Product quality data are NOT required before a generic product can be registered in such countries that require bioequivalent data 4. Provided that a generic product conforms to bioequivalence and product quality requirements, it is assumed that its efficacy, quality and safety are similar to the original branded product
65 (60.2)
43 (39.8)
94 (87.0)
14 (13.0)
5. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same
95 (88.0)
6. For a generic drug to be bioequivalent to its innovator brand or other generics, the 90 % confidence intervals for the ratio of each pharmacokinetics parameters (i.e. Cmax and AUC), must lie within the range of 90–110 %
73 (67.6)
35 (32.4)
7. A generic medicine is usually manufactured without a license from the innovator company, but marketed after expiry of patent or other exclusivity rights
74 (68.5)
34 (31.5)
8. When two pharmaceutical products are bioequivalent, it means that the Cmax and AUC ratios estimated for each formulation can vary by -20 to ?25 %
27 (25.0)
81 (75.0)
9. Where there is a ‘generic substitution’ policy, the community pharmacists is allowed to dispense a different brand of the drug, but may or may not refer back to the prescriber depending on the jurisdiction/law
80 (74.1)
28 (25.9)
10. If a generic medicine is bioequivalent to a branded medicine, it means that it is also therapeutically equivalent
41 (38.0)
67 (62.0)
(range from 60.2 to 88.0 %; average of 77.6 %). Between 87 and 88 % of the respondents were able to define the terms ‘generic medicine’ and ‘bioequivalence’, identify the bioequivalence requirement for generic products in developed and some developing countries, the comparable safety, efficacy and quality of generic drugs that are bioequivalent to branded products. Over 30 % of the respondents lacked knowledge of the standard pharmacokinetic parameter recommendations to establish bioequivalence between the innovator and generic drug products. Most of the respondents could not answer item 8 (i.e., when two pharmaceutical products are bioequivalent, it means that the Cmax and AUC ratios estimated for each formulation can vary by -20 to ?25 %) and item 10 (i.e., if a generic medicine is bioequivalent to a branded medicine, it means that it is also therapeutically equivalent); only 25.0 and 38.0 % provided correct answers for these items, respectively. Effect of community pharmacists’ characteristics on their knowledge of generics
13 (12.0)
Knowledge of the community pharmacists on generic medicines The knowledge on generic medicines among the community pharmacists in Qatar is presented in Table 2. Out of the 10 knowledge items tested, more than 60 % of the respondents answered 8 out of the 10 questions correctly
The study further analyzed the respondents’ knowledge of generic medicines based on their demographic profiles and professional characteristics (Table 3). Due to the nonnormality of the data (i.e., the knowledge score), the Mann–Whitney U and Kruskal–Wallis nonparametric tests were used. Out of the six characteristics tested, only gender had an effect on the knowledge score (p = 0.035), and male community pharmacists had significantly higher knowledge scores compared with their female counterparts (mean ± SD: 7.08 ± 1.7 vs. 6.41 ± 1.5, respectively). Though one would expect that older community pharmacists with more years of practice since graduation would score higher on the knowledge of generic medicines than the younger and less experienced pharmacists, this did not reach statistical significance in this sample (p [ 0.05). Attitude and perceptions on generic medicines and generic substitution practices Table 4 illustrates the community pharmacists’ attitudes and perceptions the utilization of on generic medicines in Qatar. Fifteen items on perceptions were assessed on a 5-point Likert scale: strongly agree to strongly disagree. Regarding the attitudinal statement ‘‘I support generic substitution for brand name drugs in all cases where a generic is available’’, almost three-quarter (72.3 %) of the respondents agreed (strongly agree ? agree; SA ? A) with the statement. The majority of the respondents (SA ? A; 71.3 %) were in agreement with the following statement: Wider use of generic medicines will result in decrease in health care expenditure by the government of
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Int J Clin Pharm Table 3 Influence of Qatar community pharmacists’ demographic and professional characteristics on knowledge Characteristic
n
Median knowledge score (IQR)
Mean knowledge score ± SD
p value
0.035
Gender Female
44
7 (3)
6.41 ± 1.49
Male
63
7 (2)
7.08 ± 1.716
Age in years 20–29
33
7 (3)
6.73 ± 1.663
30–39
54
7 (3)
6.69 ± 1.53
40–49
19
8 (3)
6.81 ± 1.663
0.141
Highest academic degree 99
7 (2)
6.86 ± 1.654
Master
Bachelor
7
6 (3)
6.29 ± 1.704
PharmD
1
5
5
56
7 (3)
6.61 ± 1.614
More than 10 years 50 Practice duration in Qatar
7 (2)
7 ± 1.702
0.377
Experience in years 10 years or less
5 or less
65
7 (3)
6.71 ± 1.558
6–10
22
7 (3)
6.68 ± 1.961
11–15
17
8 (2)
7.24 ± 1.678
16–20
3
7
7.33 ± 1.528
0.196
0.557
Region of getting the highest academic Middle east
48
7 (2)
6.79 ± 1.543
Asia
59
7 (3)
6.81 ± 1.757
0.682
p values were calculated using Kruskal–Wallis and Mann–Whitney U tests as appropriate
Qatar. For the statement ‘‘Switching a patient from branded medicine to a generic medicine may change the outcome of the drug therapy’’, the respondents had mixed perceptions or opinions; 37.1 % agreed (SA ? A), and 35.2 % disagreed (strongly disagree ? disagree; SD ? D) with the statement. The community pharmacists showed a diverse opinion on the following statement: ‘‘Therapeutic failure is a serious problem with most generic products’’; 37.0 % agreed (SA ? A) and 37.9 % disagreed (SD ? D). Exactly three-quarters (75.0 %) of the respondents admitted (SA ? A) that ‘‘All products approved as generic drugs by the health authorities in the state of Qatar can be considered therapeutically equivalent to their branded counterparts’’. The majority of the respondents (80.6 %) agreed that patients should be given enough information about the reasons for generic substitution of their medicines. A very high proportion (93.4 %) of the community pharmacists surveyed in Qatar believed that they should be given generic substitution rights. The majority of the community pharmacists (88.7 %) agreed that ‘‘Health
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authorities in Qatar should implement policies such that bioequivalence data are mandatory before a generic product is marketed’’. Generally, the respondents (82.7 %) believed that ‘‘Community pharmacists should be allowed to perform generic substitution without consulting the prescribing physician’’. Almost half of the respondents disagreed (SD ? D) and 41.0 % were undecided for the following statement: ‘‘Community pharmacists must consult the prescribing physician when performing generic substitution’’. Most of the respondents (82 %) agreed (SA ? A) that ‘‘Community pharmacists should only be required to consult the prescribing physician when substituting certain categories of drugs, such as those with narrow therapeutic indices’’. The majority (82.0 %) of the community pharmacists disagreed (SD ? D) with the statement that ‘‘In general, I would not dispense generic medicine to my patients’’. Factors influencing generic medicines practices Table 5 shows possible influencing factors related to the selection and dispensing of generic medicines for patients. Twelve factors were identified ab initio, and the following is the list of top 6 important influencing factors in descending order according to the respondents’ opinions: ‘‘Cheaper cost to the customer’’ (82.4 %), ‘‘Consumer preference or demand’’ (67.3 %), ‘‘Cost-effectiveness of generic medicines’’ (66.0 %), ‘‘Availability of stock’’ (64.3 %), ‘‘Data or information about proven bioequivalence to original brands’’ (60.6 %), and ‘‘Legal implications’’ (60.2 %).
Discussion Community pharmacists play a pivotal role in the medication use process and have a professional responsibility to help patients in the selection of quality, safe, effective, and affordable drug products. Having sound knowledge, positive attitudes and practices towards generic medicines could influence the selection of pharmaceutical products and promote access to medicines [19, 28]. The pharmacist should have a clear understanding of what are ‘‘generic medicines’’ and of generic prescribing and substitution policies. It was evident that the majority of the respondents (over 85 %) in the current study correctly identified the definition of ‘‘generic medicines’’ and the criteria and regulatory requirements underlying the approval of a generic product to be marketed in developed nations. These findings are consistent with previous studies that have been reported from other developing nations, such as Malaysia and Pakistan [25, 32, 33].
Int J Clin Pharm Table 4 Community pharmacists’ attitudes on generic medicines utilization in Qatar (n = 108) Attitudinal item
n (%) Strongly agree
Agree
Neutral
Disagree
1. I support generic substitution for brand name drugs in all cases where a generic is available.
29 (26.9)
49 (45.4)
16 (14.8)
12 (11.1)
2 (1.9)
2. Wider use of generic medicines will mean that less money will be spent for research and development of new pharmaceuticals.
35 (32.4)
39 (36.1)
17 (15.7)
14 (13)
3 (2.8)
3. Wider use of generic medicines will result in decrease in health care expenditure by the government of Qatar.
33 (30.6)
44 (40.7)
16 (14.8)
14 (13)
1 (0.9)
4. Switching a patient from branded medicine to a generic medicine may change the outcome of the drug therapy.
11 (10.2)
29 (26.9)
30 (27.8)
34 (31.5)
4 (3.7)
5 (4.6)
35 (32.4)
27 (25)
32 (29.6)
9 (8.3)
6. All products approved as generic drugs by the health authorities in the state of Qatar can be considered therapeutically equivalent to their branded counterparts.
19 (17.6)
62 (57.4)
12 (11.1)
15 (13.9)
0 (0)
7. The price difference between generic and branded drugs is often so great that I feel I must dispense prescriptions with generic substitution, especially for people who do not have prescription drug benefits in Qatara 8. Patients should be given enough explanations about the reasons for choosing generic medicines for them
36 (33.6)
57 (53.3)
8 (7.5)
5 (4.7)
1 (0.9)
23 (21.3)
64 (59.3)
17 (15.7)
3 (2.8)
1 (0.9)
9. The intensity of promotional activities by medical representatives plays an important role in dispensing generics.
19 (17.6)
64 (59.3)
17 (15.7)
7 (6.5)
1 (0.9)
10. Community pharmacists in Qatar should be given generic substitution righta
47 (44.3)
52 (49.1)
6 (5.7)
0 (0)
1 (0.9)
11. Health authorities in Qatar should implement policies such that bioequivalence data are mandatory before a generic product is marketeda
39 (36.8)
55 (51.9)
8 (7.5)
4 (3.8)
0 (0)
12. Community pharmacists should be allowed to perform generic substitution without consulting the prescribing physiciana
38 (36.5)
48 (46.2)
16 (15.4)
2 (1.9)
0 (0)
13. Community pharmacists must consult the prescribing physician when performing generic substitutiona
2 (1.9)
9 (8.6)
14. Community pharmacists should only be required to consult the prescribing physician when substituting certain categories of drugs, such as those with narrow therapeutic indexa
22 (20.8)
65 (61.3)
11 (10.4)
8 (7.5)
15. In general, I would not dispense generic medicine to my patientsa
2 (1.9)
3 (2.8)
14 (13.2)
49 (46.2)
5. Therapeutic failure is a serious problem with most generic products.
a
43 (41)
41 (39)
Strongly disagree
10 (9.5) 0 (0)
38 (35.8)
Missing data
A clear understanding of the key concepts associated with generic medicines and specific regulatory standards for products to be registered as generics [18, 24, 34] is critical, and there are important determinants of knowledge, attitudes, and practices. Of particular attention are the pharmacokinetic parameters and bioequivalence concepts, such as peak plasma drug concentration (Cmax) and area under the concentration–time curve (AUC), that determine systemic drug delivery [18, 24, 34]. Three-quarters of the community pharmacists provided incorrect responses to the question regarding the technical definition of bioequivalent
products, and nearly one-third of the respondents did not know the cutoff limits of Cmax and AUC for two products (a branded and a generic product) to be considered bioequivalent. These findings suggest a need for interventions to improve pharmacists’ knowledge on these important issues underlining the efficacy, safety, and quality of generic medicines. Over 60 % of the pharmacists did not know that bioequivalence does not necessarily mean therapeutic equivalence. There was no statistically significant difference between the pharmacists who had more working experience and the
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Int J Clin Pharm Table 5 Possible influencing factors related to selection and dispensing of generic medicines among the community pharmacists Factora
n (%) Unimportant influencing factor
Neutral
Important influencing factor
Lack of belief in generic medicines
11 (10.8)
47 (46.1)
44 (43.1)
Availability of policies, laws and regulations Legal implications
6 (6.0)
39 (39.0)
55 (55.0)
4 (4.1)
35 (35.7)
59 (60.2)
Cheaper cost to the customer
3 (2.9)
15 (14.7)
84 (82.4)
Having no other choice Consumer preference/ demand Availability of stock
10 (10.4)
32 (33.3)
54 (56.3)
6 (5.9)
27 (26.7)
68 (67.3)
3 (3.1)
32 (32.7)
63 (64.3)
14 (14.4)
40 (41.2)
43 (44.3)
Cost effectiveness of generic medicines
4 (4.0)
30 (30.0)
66 (66.0)
Data or information about proven bioequivalence to original brands
2 (2.0)
37 (37.4)
60 (60.6)
Personal faith in the product
5 (5.0)
38 (37.6)
58 (57.4)
13 (13.0)
28 (28.0)
59 (59.0)
Customer’s appearance or nationality
Substitution agreement with prescriber a
There were some missing data across all the variables
others in terms of the overall knowledge score (p [ 0.05). Babar and colleagues found a significant difference in New Zealand pharmacists’ knowledge of generic medicines depending on the length of time in practice; the pharmacists with less than 5 years in practice had a better understanding of generic medicines than those with greater than or equal to 5 years in practice [21]. The place of training, practice environment, and years since graduation might influence generic medicine knowledge and practices, as is evident from these two distinct scenarios. The lack of differences in the current study could most likely be explained by lack of introducing sufficient contents related to these issues in Asian and Middle Eastern pharmacy schools curricula. There is a significant migration of the pharmacy workforce from South Asia to the Middle East countries, and there are a high number of generic drug companies in Asia. Hence, there are opportunities for positive curricula changes pertaining to generic products in Asian pharmacy schools. The community pharmacists’ perceptions on generic medicines in the current study are similar to previous studies where pharmacists were positively inclined to generic substitution as they view it as a recognition of their
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role as medication therapy experts [35–41]. This idea was reflected by 72 % of the participants agreeing on the statement ‘‘I support generic substitution for brand name drugs in all cases where a generic is available’’ and by 93 % of the participants agreeing with the statement ‘‘Community pharmacists in Qatar should be given generic substitution right’’. The respondents further demonstrated positive attitudes towards the economic benefits of a wider use of generic medicines by agreeing that such practices will result in a decrease in healthcare expenditure by the government. Appreciating the benefit of generic medicine practices is a crucial step in the process of implementing a national systematic effort for establishing a generic medicine policy in the State of Qatar [30, 31, 36]. One finding was that 89 % of the respondents agreed on the statement that ‘‘Health authorities in Qatar should implement policies such that bioequivalence data are mandatory before a generic product is marketed’’, a finding that is consistent with previous studies in which concern about using generic drugs that are not bioequivalent to the innovator or other reference standards was the most significant risk that pharmacists reported [23, 24, 26, 27]. Although the pharmacists were positively inclined towards generic medicine use, they might exhibit some reservations pertaining to the attainment of world standard regulatory requirements [18, 35]. Due to the fact that the majority of the respondents agreed that ‘‘Community pharmacists should be allowed to perform generic substitution without consulting the prescribing physician’’ and that almost half of the respondents disagreed with the statement that ‘‘Community pharmacists must consult the prescribing physician when performing generic substitution’’, it is essential to take into account the conclusion of previous studies about the slow rate of gaining acceptance of generic substitution by physicians and the importance of educating physicians about the benefits of generic prescribing [42– 44]. One must consider the unresolved issues and concerns surrounding generic substitution of some therapeutic agents, such as antiepileptic drugs (AEDs) and cardiovascular agents [20, 24, 45]. The rights and integrity of the prescriber must be preserved when establishing new policies. If the prescriber does not wish a prescribed brand to be substituted with a generic equivalent because of concerns of safety or efficacy, they should have the right to indicate so on the prescription or on an exempt form [45]. Greater than one-third of the community pharmacists disagreed that switching therapy from a brand to a generic product could alter drug therapy outcomes. It is a wellknown fact that bioequivalence, as defined by the regulatory authorities, might not necessarily guarantee therapeutic equivalence, especially for some therapeutic agents such as AEDs and other agents with narrow therapeutic indices like warfarin and digoxin [20, 24, 45–47]. Generic
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substitution for some therapeutic agents could be associated with potentially serious consequences, including therapeutic failures, adverse events and variability of responses [20, 24, 45, 47]. There could be potential adverse effects associated with the excipients used in different products. In some developed counties such as New Zealand and Canada, there are a limited number of medicines that are considered non-interchangeable medicines, and these products are exempt from generic substitution. Pharmacists and prescribers need to be well versed about these issues to avoid compromising the outcomes of patient care while trying to contain costs. The most important factors influencing the pharmacists’ generic drug substitution practices according to the respondents include the cheaper cost to the customer, consumer demand, and cost-effectiveness of the generic medicines. These factors have equally been reported by similar studies [35, 48]. Having no other choices was the most important factor rated by 60 % of participants in a study that was conducted in New Zealand [21], and this was comparable to our finding of 56 % of the participants identifying this as an important influencing factor. Similar economic, policy-related, scientific, and regulatory-related considerations have been reported by other investigators and likely remain relevant issues of consideration among practitioners [35]. The authors strongly believe that this reflective evaluation of Qatar pharmacists’ knowledge, perceptions, and practices on generic medicines is an essential step prior to the development and implementation of any policy for change [19, 25, 30, 31, 36, 49]. The findings of this study have implications for promoting the quality use of generic medicines and for establishing a sound generic medicine policy in the context of a transition economy [30]. This will ensure a continuous supply of quality, safe, and effective generic and branded drug products in Qatar and will ultimately help health authorities and government in decreasing healthcare costs. The current findings call for educational intervention programs to improve the knowledge of healthcare professionals, particularly pharmacists and physicians [50]. In particular, if generic medicine policies were to be implemented in Qatar, there would be a need for nationwide education campaigns to update all the pharmacists and prescribers. An additional potential benefit of such educational interventions will be to demystify the longstanding misconceptions and perceptions created by manufacturers of branded products through aggressive marketing strategies to convince healthcare professionals about the inferiority of generics compared with branded drugs. The need to improve pharmacists’ knowledge about the pharmaceutical impact of generic substitution including allergies to ingredients is equally important. Pharmacy educators in Qatar, the larger Middle East and Asia should incorporate
and reinforce content related to generic medicines, bioequivalence and therapeutic equivalence concepts in pharmacy schools curricula. The anticipated improvement in knowledge, practices and positive attitudes pertaining to generic medicines will improve the quality use of generics, decrease the escalating costs incurred to healthcare budgets and improve the accessibility to and affordability of medicines in the country [11–13, 19, 28, 29]. Pharmacists are uniquely positioned to be more sensitized and enlightened regarding these significant issues. Similar studies on generic medicine knowledge, attitudes, and practices should be conducted among physicians and other prescribers in Qatar to ascertain if there are needs for educational interventions. Some of the major strengths of the study include the use of an objective method of knowledge assessment instead of subjective self-assessed ability of the participants and the relatively high response rate. The study has some important limitations inherent to most survey-type studies. The survey was administered using hardcopy questionnaires, which are prone to the subjects using educational resources for answering the knowledge questions and the possibility of information exchange among respondents. There is a possibility of social desirability bias on the attitude issues, where the respondents might tend to give more favorable responses toward generic medicine practices. Another limitation was that a scoring system was not established for the attitudes and practice domains during the study instrument development; therefore, it was not possible to run a correlation analysis to determine an association between the dependent variables (i.e. the knowledge, attitudes, and practice). Lastly, the findings might not be generalized to all pharmacists in Qatar because hospital practices might be totally different from community pharmacies.
Conclusions A large proportion of community pharmacists in Qatar had basic knowledge regarding generic medicines but lacked knowledge of the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters. A national systematic effort should be adopted to establish a generic medicine policy and guidelines, either independently or as part of a comprehensive national medicine policy in the State of Qatar. An educational program should be developed and conducted to enhance the quality of and promote the practice of generic medicines in Qatar. Acknowledgments The authors thank all community pharmacists who voluntarily participated in this study. Funding This publication was made possible by a UREP award [UREP11-068-3-012] from the Qatar National Research Fund (a member of The Qatar Foundation).
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Int J Clin Pharm Conflicts of interest Statements made in this article are the sole responsibility of the authors. There are not other conflicts of interest. 22.
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RESEARCH ARTICLE
Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar Ahmed Awaisu • Nadir Kheir • Mohamed Izham Mohamed Ibrahim Maguy El-Hajj • Huda Hazi • Nada Khudair • Raja Barazi
•
Received: 2 September 2013 / Accepted: 26 December 2013 Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014
Abstract Background The practice of generic medicines prescribing, dispensing and substitution in developing countries has been controversial among healthcare professionals, particularly due to issues on quality, safety and efficacy. These controversies are as a result of inter-country differences in policies and laws as well as individualized knowledge and attitudes of pharmacists pertaining to generic medicines. Objective This study primarily aims to assess the knowledge, attitudes, and practices of community pharmacists in Qatar towards generic medicines. Setting Community pharmacy settings throughout the State of Qatar. Method A cross-sectional study using a pretested paper-based survey was conducted among a random sample of community pharmacists in Qatar. The data were analyzed using IBM-SPSS version 20. Both descriptive and inferential statistical analyses were applied. Main outcome measure Knowledge, attitudes, and practices of generic medicines pertaining to regulatory standards, safety, efficacy, quality, and future policies. Results A total of 160 surveys were distributed to community pharmacists of which 118 were returned (response rate, 74 %). The mean total score of generic medicines knowledge among the pharmacists was 6.8 ± 1.6 (maximum possible score
was 10). Years of practice as well as place of obtaining academic degree did not influence knowledge score. Approximately 72 % of the pharmacists supported generic substitution for brand name drugs in all cases where a generic medicine is available and the majority (93 %) agreed that pharmacists should be given generic substitution right. Nearly 61 % of the pharmacists considered lack of proven bioequivalence to original brands as an important barrier for selecting generic medicines and 55 % rated ‘‘lack of policy for directing the practice of generic medicine’’ as an important barrier. Conclusion In order to enhance the quality use of and to promote the practice of generic medicines in Qatar, an educational program should be implemented. A national generic medicine policy and guidelines are warranted in the State of Qatar. Keywords Community pharmacists Generic medicines Qatar Substitution
Impact of the findings on pharmacy practice •
• A. Awaisu (&) N. Kheir M. I. M. Ibrahim M. El-Hajj H. Hazi N. Khudair R. Barazi College of Pharmacy, Qatar University, P.O. Box 2713, Doha, Qatar e-mail: [email protected] A. Awaisu N. Kheir M. I. M. Ibrahim M. El-Hajj Clinical Pharmacy and Practice Section, College of Pharmacy, Qatar University, P.O. Box 2713, Doha, Qatar
•
•
There is a need to develop educational intervention programs that target community pharmacists to promote the rational utilization of generic medicines in Qatar. Policymakers should establish a generic medicine policy and guidelines for the State of Qatar. There is a need to improve pharmacists’ knowledge about the pharmaceutical impact of generic substitution, including possible allergy to ingredients. There is a need to assess the knowledge, attitudes, and practices on generic substitution, and the need for educational interventions of physicians and other healthcare professionals in Qatar.
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Introduction Escalating healthcare costs are a global concern, and pharmaceutical expenditures represent a considerable portion of these costs [1–3]. Pharmaceutical expenditure is considered a significant factor that leads to rising health care costs in many countries, and cost-containment strategies for developed countries, such as New Zealand, have been well-described in the literature [1–3]. In Qatar, reports have indicated that spending on prescription drugs has increased sharply with a faster growth rate than other major components of the health care system [4]. In 2009, the value of Qatar’s drug expenditure at consumer prices was estimated to be QR 848 Million (US$ 233 Million), having posted double-digit growth in relation to the previous year [4]. Prescription drugs continued to dominate the market, accounting for close to 90 % of sales by value, supported by generous and high quality public-sector provision. By 2014, drug expenditure is expected to increase by a compound annual growth rate of 11.16 %, in US dollars and in local currency terms to reach QR 1.44 Billion (US$ 400 Million) [4]. The healthcare system in Qatar is broadly divided into public and private health sectors. The public health sector, which is financed predominantly by government revenues and regulated by the Supreme Council of Health (SCH) [5], provides full primary healthcare coverage supplemented by general hospitals and specialist referral hospitals, while the private health insurance covers health services at private hospitals and clinics. Employers (both government and private) usually provide coverage through the public sector and might provide private insurance for selected employees. Hamad Medical Corporation (HMC) is the primary provider for health care in the country, and it is comprised of eight public hospitals [6]. Most patients in Qatar currently receive their medications from these hospitals. Medicines are provided almost free, with a nominal charge of QR 2.0–10.0, through government outlets comprising of HMC hospitals and other primary healthcare clinics. If an individual has private health insurance, medicines are fully covered and are provided through privately owned community pharmacies and pharmacies in clinics and hospitals. The private health sector, including hospitals, general practitioner clinics, and community pharmacies, plays an increasingly important role, and individuals without private health insurance fully pay for services and products. The pharmaceutical market in Qatar is highly import-dependent, with only one drug manufacturing company in the country (Qatar Pharma), which is a private company that mainly produces intravenous solutions. Imported drug products are invariably more expensive than locally manufactured products. Until recently, when the medicine pricing law was changed, the Pharmacy and Drug Control
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Department under the SCH was the sole authority to fix the prices of medicines in Qatar. Retailers were getting the stocks from wholesalers with the prices printed on each pack of medicines. With the abolishment of Law No. 7 in 1990, government control over retail prices of all the medicines sold in Qatar allows importers to establish their own prices. One of the goals of the National Health Strategies 2011–2016 [7] is to improve the health services to the level of international standards. Under this premise, Qatar envisions to provide world-class health care standard services and the best healthcare in the Middle East region (NHS 2011–2016). Within this goal, there is a community pharmacy strategy project aiming to adopt and implement international community pharmacy services and best practices as a benchmark [8]. Patients in future may have to obtain medications from private community pharmacies, which will host a range of expanded and specialist pharmaceutical care services in addition to the regular medication dispensing. An important strategy to control the skyrocketing healthcare costs is to promote the use of more affordable but comparably safe and effective generic drugs instead of the more expensive branded equivalents [1, 9–14]. The use of generic medicines results in significant cost savings and increased access to medicines, and generic substitution is widely encouraged by many government authorities across the world as a cost-containment strategy for patients, healthcare systems and society at large [1, 11–13, 15–17]. A focus on cost-containment through the adoption of the generic drug prescribing and dispensing policy and a focus on promoting the quality use of these products in Qatar could provide substantial savings in the health care budget without compromising the therapeutic effects of the prescribed medicines or the quality of care [9, 11, 13, 14, 18, 19]. The concepts of generic prescribing and generic substitution have been controversial, and questions remain regarding the acceptance and promotion of generic practices among healthcare professionals [18, 20–24]. This controversy surrounds issues of quality, safety and efficacy of the generic medicines [14, 20–27]. There is an apparent lack of knowledge pertaining to the quality, safety, and efficacy of generic medicines among healthcare professionals. Currently, there are no national generic medicine prescribing and dispensing policies in Qatar, and the obligation of prescribing and dispensing brand-name or generic products, especially in community practices, lies with the general practitioner and the pharmacist, respectively. To our knowledge, no studies have been conducted to evaluate the knowledge, attitudes, and practices of healthcare professionals pertaining to generic medicines in the State of Qatar. Pharmacists are key players in the chain of medication distribution because one of their core
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professional roles is to ensure the manufacture, supply, and distribution of safe, effective, and quality medicines. Pharmacists can assist patients with obtaining the most cost-effective medicines, and this is considered a pharmaceutical care intervention that improves the access to medicines, adherence to therapy and healthcare outcomes. Understanding generic medicine practices and perceptions held regarding these issues is very important in establishing a sound generic medicine policy that will eventually lead to substantial savings in the government’s health care expenditure and will improve access to essential medicines in this country [1, 10, 21, 28–31].
Aim of the study This study aims to (1) determine the current knowledge of community pharmacists in Qatar regarding generic medicines; (2) explore the attitude and perceptions of community pharmacists towards generic drug products, including quality, safety, and efficacy issues and; (3) evaluate the pharmacists’ current generic substitution practices and views about potential generic medicine policies that could be adopted in the future.
Ethical considerations and approval This study was approved by the Qatar University Institutional Review Board (QU IRB). For the purpose of receiving ethical approval, the study protocol, the survey instrument, and informed consent (each in English and Arabic) were submitted to the QU IRB for review. A participant information sheet containing the objectives and general description of the study was provided to each randomly selected participant. Only the participants who provided written informed consent were recruited into the study. The questionnaire was anonymous, and no names or identity numbers were required.
Method Study design and participants This was a cross-sectional, descriptive study using a selfadministered paper-based survey that was conducted between December 2012 and February 2013. The study targeted currently practicing community pharmacists in the state of Qatar. A random sample of 160 community pharmacists was selected from the entire population of community pharmacists practicing in Qatar (N = 500) to participate in the study.
Study setting This study involved all the community pharmacy outlets (including chain and independent pharmacies) in Qatar with its seven governorates of Doha, Al Shamal, Al Khor, Al Rayyan, Al Wakra, Umm Salal, and Al Daayen. Eligibility criteria Participants were eligible to be included if they: (1) were registered/licensed by the Supreme Council of Health as pharmacists in Qatar; (2) speak the English and/or Arabic language and; (3) have been in practice for at least 12 months in Qatar. The community pharmacists who did not meet these criteria were excluded from the study. Study sample and sampling technique The estimation of sample size was performed using the Raosoft online calculator, and the researchers took into account a 20 % non-response rate. There were approximately 500 registered community pharmacists practicing in Qatar. To achieve a confidence level of 95 % and a 5 % margin of error, the study targeted 160 community pharmacists who were randomly selected to participate in the study from the list of community pharmacists in Qatar (sampling frame). A simple random sampling technique was applied in the sample selection. Survey instrument development and implementation The questionnaire used in this study was developed through an extensive review of available literature pertaining to knowledge, attitudes and practices of pharmacists and other healthcare professionals regarding generic medicines. In addition to questions on the demographic and professional characteristics, the questionnaire was comprised of three sections to evaluate: (1) the participants’ knowledge and views regarding generic medicines; (2) perceptions, attitude, and practices towards generic medicines, including generic substitution; (3) factors influencing generic medicine practices, including generic substitution. The domain assessing knowledge was comprised of 10 factual questions regarding the definition of generic medicines, bioequivalence and therapeutic equivalence issues, generic products quality/safety/efficacy in relation to innovator brands, and patent and exclusivity right issues. The respondents were required to choose ‘‘True’’ or ‘‘False’’ or ‘‘Unsure’’ for each of the knowledge questions. A respondent was given one point for each correct response and zero points for each incorrect or unsure response. The maximum possible score was 10 points. Fifteen attitudinal items anchored on a fivepoint Likert scale (from strongly agree to strongly
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disagree) were used to assess the participants’ perceptions and attitudes towards using generic medicines and the implication on government pharmaceutical expenditure, their current practice of generic substitution, profitability, perception of quality/safety/efficacy, support and nature of future generic medicine policies. Twelve items were used to ascertain the pharmacists’ views regarding the importance of certain factors influencing the practice of generic medicines (response choices ranged from important to unimportant factor). The face and content validity of the questionnaire was conducted by three persons identified as experts in generic medicine research and survey instrument development. The readability, clarity and completion time of the modified survey were determined among 10 purposively selected community pharmacists who were eventually excluded from the data analysis. The survey was developed initially in English and translated into Arabic using standardized forward—backward and reconciliation processes. An explanatory statement and an informed consent were distributed with the questionnaire to inform each participant about the purpose and objectives of the study and about the confidentiality of the survey results. Upon fulfillment of the eligibility criteria, each participant was given a copy of the questionnaire by the researchers after signing the written informed consent.
of the community pharmacists were male (n = 63; 58.9 %), in the middle-age group, i.e., between the age 30–39 years old (n = 54; 50.9 %), with BSc degree (n = 99; 92.5 %), and had 5 or less years of practice in Qatar (n = 65; 60.7 %) (Table 1). Nearly one-third of the respondents (n = 34; 31.8 %) graduated from India, and approximately 28 % (n = 30) had between 11 and 15 years of work experience (n = 30; 28.3 %). More details regarding the demographic and professional characteristics of the community pharmacists are provided in Table 1.
Table 1 Demographic characteristics of community pharmacists in Qatar (n = 108) Characteristica
Frequency (%)
Gender Male
63 (58.9)
Female
44 (41.1)
Nationality Non-Qatari
107 (100)
Age 20–29
33 (31.1)
30–39
54 (50.9)
40–49
19 (17.9)
Academic degree
Data analyses The data collected were analyzed using the IBM Statistical Package for Social Sciences (IBM SPSS Software) version 20. Both descriptive and inferential statistics were applied for the data analyses. All the categorical variables, including the respondents’ socio-demographic and professional characteristics, items assessing knowledge and practices on generic medicines, and other attitudinal items, were expressed as frequencies and percentages. The knowledge scores were calculated as the mean (±SD) and the median (±IQR). The influence of respondents’ professional and demographic factors on knowledge was tested using the Mann–Whitney U and Kruskal–Wallis tests as appropriate. The level of significance was set a priori at p B 0.05.
Results Sociodemographic and professional characteristics of the respondents Of the 160 surveys distributed, 118 community pharmacists returned the surveys (73.8 % response rate), and 108 surveys were analyzed (91.5 % useable rate). The majority
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BSc
99 (92.5)
Master
7 (6.5)
PharmD
1 (0.9)
Country of graduation India
34 (31.8)
Egypt
31 (29.0)
Philippines
21 (19.6)
Sudan
8 (7.5)
Jordan
5 (4.7)
Pakistan
4 (3.7)
Syria
2 (1.9)
Iraq
1 (0.9)
Palestine
1 (0.9)
Years of experience 5 or less
29 (27.4)
6–10
27 (25.5)
11–15
30 (28.3)
16–20
15 (14.2)
More than 20 Years of practice in Qatar
a
5 (4.7)
5 or less
65 (60.7)
6–10
22 (20.6)
11–15
17 (15.9)
16–20
3 (2.8)
There were some missing data across all the variables
Int J Clin Pharm Table 2 Knowledge of community pharmacists in Qatar on generic medicines (n = 108) knowledge item
n (%) Correct response
Incorrect response
1. The term ‘generic medicine’ is a drug product marketed under the drug’s nonproprietary approved name or a product marketed under a different brand name (proprietary) name
94 (87.0)
14 (13.0)
2. Generic products must be bioequivalent to the innovator brand before they can be approved to be marketed in many developed and some developing countries
95 (88.0)
13 (12.0)
3. Product quality data are NOT required before a generic product can be registered in such countries that require bioequivalent data 4. Provided that a generic product conforms to bioequivalence and product quality requirements, it is assumed that its efficacy, quality and safety are similar to the original branded product
65 (60.2)
43 (39.8)
94 (87.0)
14 (13.0)
5. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same
95 (88.0)
6. For a generic drug to be bioequivalent to its innovator brand or other generics, the 90 % confidence intervals for the ratio of each pharmacokinetics parameters (i.e. Cmax and AUC), must lie within the range of 90–110 %
73 (67.6)
35 (32.4)
7. A generic medicine is usually manufactured without a license from the innovator company, but marketed after expiry of patent or other exclusivity rights
74 (68.5)
34 (31.5)
8. When two pharmaceutical products are bioequivalent, it means that the Cmax and AUC ratios estimated for each formulation can vary by -20 to ?25 %
27 (25.0)
81 (75.0)
9. Where there is a ‘generic substitution’ policy, the community pharmacists is allowed to dispense a different brand of the drug, but may or may not refer back to the prescriber depending on the jurisdiction/law
80 (74.1)
28 (25.9)
10. If a generic medicine is bioequivalent to a branded medicine, it means that it is also therapeutically equivalent
41 (38.0)
67 (62.0)
(range from 60.2 to 88.0 %; average of 77.6 %). Between 87 and 88 % of the respondents were able to define the terms ‘generic medicine’ and ‘bioequivalence’, identify the bioequivalence requirement for generic products in developed and some developing countries, the comparable safety, efficacy and quality of generic drugs that are bioequivalent to branded products. Over 30 % of the respondents lacked knowledge of the standard pharmacokinetic parameter recommendations to establish bioequivalence between the innovator and generic drug products. Most of the respondents could not answer item 8 (i.e., when two pharmaceutical products are bioequivalent, it means that the Cmax and AUC ratios estimated for each formulation can vary by -20 to ?25 %) and item 10 (i.e., if a generic medicine is bioequivalent to a branded medicine, it means that it is also therapeutically equivalent); only 25.0 and 38.0 % provided correct answers for these items, respectively. Effect of community pharmacists’ characteristics on their knowledge of generics
13 (12.0)
Knowledge of the community pharmacists on generic medicines The knowledge on generic medicines among the community pharmacists in Qatar is presented in Table 2. Out of the 10 knowledge items tested, more than 60 % of the respondents answered 8 out of the 10 questions correctly
The study further analyzed the respondents’ knowledge of generic medicines based on their demographic profiles and professional characteristics (Table 3). Due to the nonnormality of the data (i.e., the knowledge score), the Mann–Whitney U and Kruskal–Wallis nonparametric tests were used. Out of the six characteristics tested, only gender had an effect on the knowledge score (p = 0.035), and male community pharmacists had significantly higher knowledge scores compared with their female counterparts (mean ± SD: 7.08 ± 1.7 vs. 6.41 ± 1.5, respectively). Though one would expect that older community pharmacists with more years of practice since graduation would score higher on the knowledge of generic medicines than the younger and less experienced pharmacists, this did not reach statistical significance in this sample (p [ 0.05). Attitude and perceptions on generic medicines and generic substitution practices Table 4 illustrates the community pharmacists’ attitudes and perceptions the utilization of on generic medicines in Qatar. Fifteen items on perceptions were assessed on a 5-point Likert scale: strongly agree to strongly disagree. Regarding the attitudinal statement ‘‘I support generic substitution for brand name drugs in all cases where a generic is available’’, almost three-quarter (72.3 %) of the respondents agreed (strongly agree ? agree; SA ? A) with the statement. The majority of the respondents (SA ? A; 71.3 %) were in agreement with the following statement: Wider use of generic medicines will result in decrease in health care expenditure by the government of
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Int J Clin Pharm Table 3 Influence of Qatar community pharmacists’ demographic and professional characteristics on knowledge Characteristic
n
Median knowledge score (IQR)
Mean knowledge score ± SD
p value
0.035
Gender Female
44
7 (3)
6.41 ± 1.49
Male
63
7 (2)
7.08 ± 1.716
Age in years 20–29
33
7 (3)
6.73 ± 1.663
30–39
54
7 (3)
6.69 ± 1.53
40–49
19
8 (3)
6.81 ± 1.663
0.141
Highest academic degree 99
7 (2)
6.86 ± 1.654
Master
Bachelor
7
6 (3)
6.29 ± 1.704
PharmD
1
5
5
56
7 (3)
6.61 ± 1.614
More than 10 years 50 Practice duration in Qatar
7 (2)
7 ± 1.702
0.377
Experience in years 10 years or less
5 or less
65
7 (3)
6.71 ± 1.558
6–10
22
7 (3)
6.68 ± 1.961
11–15
17
8 (2)
7.24 ± 1.678
16–20
3
7
7.33 ± 1.528
0.196
0.557
Region of getting the highest academic Middle east
48
7 (2)
6.79 ± 1.543
Asia
59
7 (3)
6.81 ± 1.757
0.682
p values were calculated using Kruskal–Wallis and Mann–Whitney U tests as appropriate
Qatar. For the statement ‘‘Switching a patient from branded medicine to a generic medicine may change the outcome of the drug therapy’’, the respondents had mixed perceptions or opinions; 37.1 % agreed (SA ? A), and 35.2 % disagreed (strongly disagree ? disagree; SD ? D) with the statement. The community pharmacists showed a diverse opinion on the following statement: ‘‘Therapeutic failure is a serious problem with most generic products’’; 37.0 % agreed (SA ? A) and 37.9 % disagreed (SD ? D). Exactly three-quarters (75.0 %) of the respondents admitted (SA ? A) that ‘‘All products approved as generic drugs by the health authorities in the state of Qatar can be considered therapeutically equivalent to their branded counterparts’’. The majority of the respondents (80.6 %) agreed that patients should be given enough information about the reasons for generic substitution of their medicines. A very high proportion (93.4 %) of the community pharmacists surveyed in Qatar believed that they should be given generic substitution rights. The majority of the community pharmacists (88.7 %) agreed that ‘‘Health
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authorities in Qatar should implement policies such that bioequivalence data are mandatory before a generic product is marketed’’. Generally, the respondents (82.7 %) believed that ‘‘Community pharmacists should be allowed to perform generic substitution without consulting the prescribing physician’’. Almost half of the respondents disagreed (SD ? D) and 41.0 % were undecided for the following statement: ‘‘Community pharmacists must consult the prescribing physician when performing generic substitution’’. Most of the respondents (82 %) agreed (SA ? A) that ‘‘Community pharmacists should only be required to consult the prescribing physician when substituting certain categories of drugs, such as those with narrow therapeutic indices’’. The majority (82.0 %) of the community pharmacists disagreed (SD ? D) with the statement that ‘‘In general, I would not dispense generic medicine to my patients’’. Factors influencing generic medicines practices Table 5 shows possible influencing factors related to the selection and dispensing of generic medicines for patients. Twelve factors were identified ab initio, and the following is the list of top 6 important influencing factors in descending order according to the respondents’ opinions: ‘‘Cheaper cost to the customer’’ (82.4 %), ‘‘Consumer preference or demand’’ (67.3 %), ‘‘Cost-effectiveness of generic medicines’’ (66.0 %), ‘‘Availability of stock’’ (64.3 %), ‘‘Data or information about proven bioequivalence to original brands’’ (60.6 %), and ‘‘Legal implications’’ (60.2 %).
Discussion Community pharmacists play a pivotal role in the medication use process and have a professional responsibility to help patients in the selection of quality, safe, effective, and affordable drug products. Having sound knowledge, positive attitudes and practices towards generic medicines could influence the selection of pharmaceutical products and promote access to medicines [19, 28]. The pharmacist should have a clear understanding of what are ‘‘generic medicines’’ and of generic prescribing and substitution policies. It was evident that the majority of the respondents (over 85 %) in the current study correctly identified the definition of ‘‘generic medicines’’ and the criteria and regulatory requirements underlying the approval of a generic product to be marketed in developed nations. These findings are consistent with previous studies that have been reported from other developing nations, such as Malaysia and Pakistan [25, 32, 33].
Int J Clin Pharm Table 4 Community pharmacists’ attitudes on generic medicines utilization in Qatar (n = 108) Attitudinal item
n (%) Strongly agree
Agree
Neutral
Disagree
1. I support generic substitution for brand name drugs in all cases where a generic is available.
29 (26.9)
49 (45.4)
16 (14.8)
12 (11.1)
2 (1.9)
2. Wider use of generic medicines will mean that less money will be spent for research and development of new pharmaceuticals.
35 (32.4)
39 (36.1)
17 (15.7)
14 (13)
3 (2.8)
3. Wider use of generic medicines will result in decrease in health care expenditure by the government of Qatar.
33 (30.6)
44 (40.7)
16 (14.8)
14 (13)
1 (0.9)
4. Switching a patient from branded medicine to a generic medicine may change the outcome of the drug therapy.
11 (10.2)
29 (26.9)
30 (27.8)
34 (31.5)
4 (3.7)
5 (4.6)
35 (32.4)
27 (25)
32 (29.6)
9 (8.3)
6. All products approved as generic drugs by the health authorities in the state of Qatar can be considered therapeutically equivalent to their branded counterparts.
19 (17.6)
62 (57.4)
12 (11.1)
15 (13.9)
0 (0)
7. The price difference between generic and branded drugs is often so great that I feel I must dispense prescriptions with generic substitution, especially for people who do not have prescription drug benefits in Qatara 8. Patients should be given enough explanations about the reasons for choosing generic medicines for them
36 (33.6)
57 (53.3)
8 (7.5)
5 (4.7)
1 (0.9)
23 (21.3)
64 (59.3)
17 (15.7)
3 (2.8)
1 (0.9)
9. The intensity of promotional activities by medical representatives plays an important role in dispensing generics.
19 (17.6)
64 (59.3)
17 (15.7)
7 (6.5)
1 (0.9)
10. Community pharmacists in Qatar should be given generic substitution righta
47 (44.3)
52 (49.1)
6 (5.7)
0 (0)
1 (0.9)
11. Health authorities in Qatar should implement policies such that bioequivalence data are mandatory before a generic product is marketeda
39 (36.8)
55 (51.9)
8 (7.5)
4 (3.8)
0 (0)
12. Community pharmacists should be allowed to perform generic substitution without consulting the prescribing physiciana
38 (36.5)
48 (46.2)
16 (15.4)
2 (1.9)
0 (0)
13. Community pharmacists must consult the prescribing physician when performing generic substitutiona
2 (1.9)
9 (8.6)
14. Community pharmacists should only be required to consult the prescribing physician when substituting certain categories of drugs, such as those with narrow therapeutic indexa
22 (20.8)
65 (61.3)
11 (10.4)
8 (7.5)
15. In general, I would not dispense generic medicine to my patientsa
2 (1.9)
3 (2.8)
14 (13.2)
49 (46.2)
5. Therapeutic failure is a serious problem with most generic products.
a
43 (41)
41 (39)
Strongly disagree
10 (9.5) 0 (0)
38 (35.8)
Missing data
A clear understanding of the key concepts associated with generic medicines and specific regulatory standards for products to be registered as generics [18, 24, 34] is critical, and there are important determinants of knowledge, attitudes, and practices. Of particular attention are the pharmacokinetic parameters and bioequivalence concepts, such as peak plasma drug concentration (Cmax) and area under the concentration–time curve (AUC), that determine systemic drug delivery [18, 24, 34]. Three-quarters of the community pharmacists provided incorrect responses to the question regarding the technical definition of bioequivalent
products, and nearly one-third of the respondents did not know the cutoff limits of Cmax and AUC for two products (a branded and a generic product) to be considered bioequivalent. These findings suggest a need for interventions to improve pharmacists’ knowledge on these important issues underlining the efficacy, safety, and quality of generic medicines. Over 60 % of the pharmacists did not know that bioequivalence does not necessarily mean therapeutic equivalence. There was no statistically significant difference between the pharmacists who had more working experience and the
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Int J Clin Pharm Table 5 Possible influencing factors related to selection and dispensing of generic medicines among the community pharmacists Factora
n (%) Unimportant influencing factor
Neutral
Important influencing factor
Lack of belief in generic medicines
11 (10.8)
47 (46.1)
44 (43.1)
Availability of policies, laws and regulations Legal implications
6 (6.0)
39 (39.0)
55 (55.0)
4 (4.1)
35 (35.7)
59 (60.2)
Cheaper cost to the customer
3 (2.9)
15 (14.7)
84 (82.4)
Having no other choice Consumer preference/ demand Availability of stock
10 (10.4)
32 (33.3)
54 (56.3)
6 (5.9)
27 (26.7)
68 (67.3)
3 (3.1)
32 (32.7)
63 (64.3)
14 (14.4)
40 (41.2)
43 (44.3)
Cost effectiveness of generic medicines
4 (4.0)
30 (30.0)
66 (66.0)
Data or information about proven bioequivalence to original brands
2 (2.0)
37 (37.4)
60 (60.6)
Personal faith in the product
5 (5.0)
38 (37.6)
58 (57.4)
13 (13.0)
28 (28.0)
59 (59.0)
Customer’s appearance or nationality
Substitution agreement with prescriber a
There were some missing data across all the variables
others in terms of the overall knowledge score (p [ 0.05). Babar and colleagues found a significant difference in New Zealand pharmacists’ knowledge of generic medicines depending on the length of time in practice; the pharmacists with less than 5 years in practice had a better understanding of generic medicines than those with greater than or equal to 5 years in practice [21]. The place of training, practice environment, and years since graduation might influence generic medicine knowledge and practices, as is evident from these two distinct scenarios. The lack of differences in the current study could most likely be explained by lack of introducing sufficient contents related to these issues in Asian and Middle Eastern pharmacy schools curricula. There is a significant migration of the pharmacy workforce from South Asia to the Middle East countries, and there are a high number of generic drug companies in Asia. Hence, there are opportunities for positive curricula changes pertaining to generic products in Asian pharmacy schools. The community pharmacists’ perceptions on generic medicines in the current study are similar to previous studies where pharmacists were positively inclined to generic substitution as they view it as a recognition of their
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role as medication therapy experts [35–41]. This idea was reflected by 72 % of the participants agreeing on the statement ‘‘I support generic substitution for brand name drugs in all cases where a generic is available’’ and by 93 % of the participants agreeing with the statement ‘‘Community pharmacists in Qatar should be given generic substitution right’’. The respondents further demonstrated positive attitudes towards the economic benefits of a wider use of generic medicines by agreeing that such practices will result in a decrease in healthcare expenditure by the government. Appreciating the benefit of generic medicine practices is a crucial step in the process of implementing a national systematic effort for establishing a generic medicine policy in the State of Qatar [30, 31, 36]. One finding was that 89 % of the respondents agreed on the statement that ‘‘Health authorities in Qatar should implement policies such that bioequivalence data are mandatory before a generic product is marketed’’, a finding that is consistent with previous studies in which concern about using generic drugs that are not bioequivalent to the innovator or other reference standards was the most significant risk that pharmacists reported [23, 24, 26, 27]. Although the pharmacists were positively inclined towards generic medicine use, they might exhibit some reservations pertaining to the attainment of world standard regulatory requirements [18, 35]. Due to the fact that the majority of the respondents agreed that ‘‘Community pharmacists should be allowed to perform generic substitution without consulting the prescribing physician’’ and that almost half of the respondents disagreed with the statement that ‘‘Community pharmacists must consult the prescribing physician when performing generic substitution’’, it is essential to take into account the conclusion of previous studies about the slow rate of gaining acceptance of generic substitution by physicians and the importance of educating physicians about the benefits of generic prescribing [42– 44]. One must consider the unresolved issues and concerns surrounding generic substitution of some therapeutic agents, such as antiepileptic drugs (AEDs) and cardiovascular agents [20, 24, 45]. The rights and integrity of the prescriber must be preserved when establishing new policies. If the prescriber does not wish a prescribed brand to be substituted with a generic equivalent because of concerns of safety or efficacy, they should have the right to indicate so on the prescription or on an exempt form [45]. Greater than one-third of the community pharmacists disagreed that switching therapy from a brand to a generic product could alter drug therapy outcomes. It is a wellknown fact that bioequivalence, as defined by the regulatory authorities, might not necessarily guarantee therapeutic equivalence, especially for some therapeutic agents such as AEDs and other agents with narrow therapeutic indices like warfarin and digoxin [20, 24, 45–47]. Generic
Int J Clin Pharm
substitution for some therapeutic agents could be associated with potentially serious consequences, including therapeutic failures, adverse events and variability of responses [20, 24, 45, 47]. There could be potential adverse effects associated with the excipients used in different products. In some developed counties such as New Zealand and Canada, there are a limited number of medicines that are considered non-interchangeable medicines, and these products are exempt from generic substitution. Pharmacists and prescribers need to be well versed about these issues to avoid compromising the outcomes of patient care while trying to contain costs. The most important factors influencing the pharmacists’ generic drug substitution practices according to the respondents include the cheaper cost to the customer, consumer demand, and cost-effectiveness of the generic medicines. These factors have equally been reported by similar studies [35, 48]. Having no other choices was the most important factor rated by 60 % of participants in a study that was conducted in New Zealand [21], and this was comparable to our finding of 56 % of the participants identifying this as an important influencing factor. Similar economic, policy-related, scientific, and regulatory-related considerations have been reported by other investigators and likely remain relevant issues of consideration among practitioners [35]. The authors strongly believe that this reflective evaluation of Qatar pharmacists’ knowledge, perceptions, and practices on generic medicines is an essential step prior to the development and implementation of any policy for change [19, 25, 30, 31, 36, 49]. The findings of this study have implications for promoting the quality use of generic medicines and for establishing a sound generic medicine policy in the context of a transition economy [30]. This will ensure a continuous supply of quality, safe, and effective generic and branded drug products in Qatar and will ultimately help health authorities and government in decreasing healthcare costs. The current findings call for educational intervention programs to improve the knowledge of healthcare professionals, particularly pharmacists and physicians [50]. In particular, if generic medicine policies were to be implemented in Qatar, there would be a need for nationwide education campaigns to update all the pharmacists and prescribers. An additional potential benefit of such educational interventions will be to demystify the longstanding misconceptions and perceptions created by manufacturers of branded products through aggressive marketing strategies to convince healthcare professionals about the inferiority of generics compared with branded drugs. The need to improve pharmacists’ knowledge about the pharmaceutical impact of generic substitution including allergies to ingredients is equally important. Pharmacy educators in Qatar, the larger Middle East and Asia should incorporate
and reinforce content related to generic medicines, bioequivalence and therapeutic equivalence concepts in pharmacy schools curricula. The anticipated improvement in knowledge, practices and positive attitudes pertaining to generic medicines will improve the quality use of generics, decrease the escalating costs incurred to healthcare budgets and improve the accessibility to and affordability of medicines in the country [11–13, 19, 28, 29]. Pharmacists are uniquely positioned to be more sensitized and enlightened regarding these significant issues. Similar studies on generic medicine knowledge, attitudes, and practices should be conducted among physicians and other prescribers in Qatar to ascertain if there are needs for educational interventions. Some of the major strengths of the study include the use of an objective method of knowledge assessment instead of subjective self-assessed ability of the participants and the relatively high response rate. The study has some important limitations inherent to most survey-type studies. The survey was administered using hardcopy questionnaires, which are prone to the subjects using educational resources for answering the knowledge questions and the possibility of information exchange among respondents. There is a possibility of social desirability bias on the attitude issues, where the respondents might tend to give more favorable responses toward generic medicine practices. Another limitation was that a scoring system was not established for the attitudes and practice domains during the study instrument development; therefore, it was not possible to run a correlation analysis to determine an association between the dependent variables (i.e. the knowledge, attitudes, and practice). Lastly, the findings might not be generalized to all pharmacists in Qatar because hospital practices might be totally different from community pharmacies.
Conclusions A large proportion of community pharmacists in Qatar had basic knowledge regarding generic medicines but lacked knowledge of the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters. A national systematic effort should be adopted to establish a generic medicine policy and guidelines, either independently or as part of a comprehensive national medicine policy in the State of Qatar. An educational program should be developed and conducted to enhance the quality of and promote the practice of generic medicines in Qatar. Acknowledgments The authors thank all community pharmacists who voluntarily participated in this study. Funding This publication was made possible by a UREP award [UREP11-068-3-012] from the Qatar National Research Fund (a member of The Qatar Foundation).
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Int J Clin Pharm Conflicts of interest Statements made in this article are the sole responsibility of the authors. There are not other conflicts of interest. 22.
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