Background
Methods
Study design
Participants, setting and sampling procedure
Sample size
Data collection form
Statistical analysis
Ethical approval
Results
Demographic characteristics of participant pharmacists
Variable |
N (%) |
---|---|
Gender | |
Male | 158 (52.3) |
Female | 144 (47.7) |
Age | |
20–29 | 128 (42.4) |
30–39 | 81 (26.8) |
40–49 | 59 (19.6) |
50–59 | 20 (6.6) |
>59 | 14 (4.6) |
Education level | |
Bachelor degree | 260 (86.1) |
Pharm D | 28 (9.3) |
Master degree | 11 (3.6) |
PhD | 3 (1.0) |
University of graduation | |
Local | 179 (59.3) |
Regional | 84 (27.8) |
International | 39 (12.9) |
Years of experience | |
5 or less | 118 (39.1) |
6–10 | 55 (18.2) |
11–15 | 44 (14.6) |
16–20 | 42 (13.9) |
>20 | 37 (12.3) |
Years of practice in Palestine | |
5 or less | 124 (41.1) |
6–10 | 55 (18.2) |
11–15 | 44 (14.6) |
16–20 | 42 (13.9) |
>20 | 37 (12.3) |
Location of the pharmacy | |
City | 193 (63.9) |
Village | 99 (32.8) |
Palestinians refugee-camps | 10 (3.3) |
Job title | |
Owner | 151 (50.0%) |
Employee | 151 (50.0%) |
Pharmacists’ knowledge about generic medicine
Characteristic | Median (Q1-Q3) | Mean ± SD |
P-value |
---|---|---|---|
Gender | |||
Male | 6 (5–7) | 5.92 ± 1.30 | 0.971 |
Female
| 6 (5–7) | 5.91 ± 1.24 | |
Age | |||
20–29 | 6 (5–7) | 5.86 ± 1.22 | 0.734 |
30–39 | 6 (5–7) | 5.93 ± 1.31 | |
40–49 | 6 (5–7) | 6.03 ± 1.19 | |
50–59 | 6 (5–6.75) | 5.75 ± 1.29 | |
>59 | 7 (5_7.25) | 6.07 ± 1.77 | |
Academic degree | |||
B.Sc. | 6 (5–7) | 5.92 ± 1.28 | 0.975 |
Pharm D | 6 (5–7) | 5.93 ± 1.12 | |
M.Sc. | 6 (5–7) | 6.00 ± 1.18 | |
Ph.D. | 6 (3) | 5.00 ± 1.73 | |
University of graduation | |||
Locally | 6 (5–7) | 5.94 ± 1.16 | 0.235 |
Regional | 6 (5–7) | 5.74 ± 1.46 | |
Internationally | 6 (5–7) | 6.18 ± 1.30 | |
Years of experience | |||
5 or less | 6 (5–7) | 5.84 ± 1.21 | 0.737 |
6–10 | 6 (5–7) | 5.87 ± 1.26 | |
11–15 | 6 (5–7) | 5.96 ± 1.38 | |
16–20 | 6 (5–7) | 6.07 ± 1.24 | |
More than 20 | 6 (5–7) | 5.98 ± 1.37 | |
Years of practice | |||
5 or less | 6 (5–7) | 5.85 ± 1.21 | 0.715 |
6–10 | 6 (5–7) | 5.85 ± 1.30 | |
11–15 | 6 (5–7) | 6.14 ± 1.29 | |
16–20 | 6 (5–7) | 5.90 ± 1.28 | |
More than 20 | 6 (5–7) | 5.95 ± 1.41 | |
Location of pharmacy | |||
City | 6 (5–7) | 5.86 ± 1.36 | 0.664 |
Village | 6 (5–7) | 6.04 ± 1.09 | |
Palestinians Refugees Camps | 5.5 (5–7) | 5.70 ± 1.06 | |
Job title | |||
Pharmacy owner | 6 (5–7) | 5.95 ± 1.23 | 0.691 |
Pharmacist assistant | 6 (5–7) | 5.87 ± 1.30 |
Knowledge item | Correct response N (%) | Incorrect response N (%) | I don’t know N (%) |
---|---|---|---|
1. The term generic medicine is a drug product marketed under the drugs non-proprietary approved name or a product marketed under a different brand name (proprietary) name. (T) | 192 (63.6) | 93 (30.8) | 17 (5.6) |
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. (T) | 280 (92.7) | 9 (3.0) | 13 (4.3) |
3. Product quality data are NOT required before a generic product can be registered in such countries that require bioequivalent data. (F) | 21 (7.0) | 239 (79.1) | 42 (13.9) |
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. (T) | 286 (94.7) | 13 (4.3) | 3 (1.0) |
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. (T) | 251 (83.1) | 23 (7.6) | 28 (9.3) |
6. For 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%. (F) | 156 (51.7) | 38 (12.6) | 108 (35.8) |
7. A generic medicine is usually manufactured without a license from the innovator company, but marketed after expiry of patent or other exclusivity rights. (T) | 179 (59.3) | 87(28.8) | 36 (11.9) |
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%. (T) | 68 (22.5) | 94(31.1) | 140 (46.4) |
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. (F) | 263 (87.1) | 23 (7.6) | 16 (5.3) |
10. If a generic medicine is bioequivalent to a branded medicine, it means that it is also therapeutically equivalent. (T) | 231 (76.5) | 56(18.5) | 15 (5.0) |
Pharmacists’ attitudes toward generic medicines
Attitudinal item | Strongly agree N (%) | Agree N (%) | Neutral N (%) | Disagree N (%) | Strongly disagree N (%) |
---|---|---|---|---|---|
1. I support generic substitution for brand name drugs in all cases where a generic is available. | 66 (21.9) | 122 (40.4) | 17 (5.6) | 85(28.1) | 12 (4.0) |
2. Wider use of generic medicines will mean that less money will be spent for research and development of new pharmaceuticals. | 38 (12.6) | 130(43.0) | 58 (19.2) | 69(22.8) | 7 (2.3) |
3. Wider use of generic medicines will result in decrease in health care expenditure by the government of Palestine. | 51 (16.9) | 155 (51.3) | 46 (15.2) | 43(14.2) | 7 (2.3) |
4. Switching a patient from branded medicine to a generic medicine may change the outcome of the drug therapy. | 16 (5.3) | 75 (24.8) | 54 (17.9) | 132(43.7) | 25 (8.3) |
5. Therapeutic failure is a serious problem with most generic products. | 13 (4.3) | 27 (8.9) | 35 (11.6) | 176(58.3) | 51 (16.9) |
6. All products approved as generic drugs by the health authorities in the state of Palestine can be considered therapeutically equivalent to their branded counterparts. | 48 (15.9) | 171 (56.6) | 35 (11.6) | 42(13.9) | 6 (2.0) |
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 Palestine. | 57 (18.9) | 147 (48.7) | 18 (6.0) | 68(22.5) | 12 (4.0) |
8. Patients should be given enough explanations about the reasons for choosing generic medicines for them. | 75 (24.8) | 171 (56.6) | 17 (5.6) | 31(10.3) | 8 (2.6) |
9. Community pharmacists in Palestine should be given generic substitution right. | 117 (38.7) | 147 (48.7) | 16 (5.3) | 17 (5.6) | 5 (1.7) |
10. The intensity of promotional activities by medical representatives plays an important role in dispensing generics. | 99 (32.8) | 174 (57.6) | 9 (3.0) | 16 (5.3) | 4 (1.3) |
11. Health authorities in Palestine should implement policies such that bioequivalence data are mandatory before a generic product is marketed. | 135 (44.7) | 153 (50.7) | 7 (2.3) | 6 (2.0) | 1 (0.3) |
12. Community pharmacists should be allowed to perform generic substitution without consulting the prescribing physician. | 91 (30.1) | 119 (39.4) | 30 (9.9) | 49(16.2) | 13(4.3) |
13. Community pharmacists must consult the prescribing physician when performing generic substitution. | 23 (7.6) | 97 (32.1) | 34 (11.3) | 121(40.1) | 27 (8.9) |
14. Community pharmacists should only be required to consult the prescribing physician when substituting certain categories of drugs, such as those with narrow therapeutic index. | 65 (21.5) | 130 (43.0) | 39 (12.9) | 62(20.5) | 6 (2.0) |
15. In general, I would not dispense generic medicine to my patients. | 19 (6.3) | 67 (22.2) | 44 (14.6) | 122(40.4) | 50 (16.6) |
Influencing factors linked to selection and dispensing of generic medicines
Factor | Important influencing factor N (%) | Neutral N (%) | Unimportant influencing factor N (%) |
---|---|---|---|
Lack of belief in generic medicines | 217 (71.9) | 50 (16.6) | 35 (11.6) |
Availability of policies,law and regulations | 188 (62.3) | 76 (25.2) | 38 (12.6) |
Legal implication | 167 (55.3) | 98 (32.5) | 37 (12.3) |
Cheaper cost to the customer | 241 (79.8) | 34 (11.3) | 27 (8.9) |
Having no other choice | 217 (71.9) | 59 (19.5) | 26 (8.6) |
Consumer preference /demand | 217 (71.9) | 51 (16.9) | 34 (11.3) |
Availability of stock | 219 (72.5) | 43 (14.2) | 40 (13.2) |
Customer’s appearance or nationality | 84 (27.8) | 76 (25.2) | 142 (47.0) |
Cost effectiveness of generic medicines | 254 (84.1) | 26 (8.6) | 22 (7.3) |
Data or information about proven bioequivalence to original brand | 216 (71.5) | 55 (18.2) | 31 (10.3) |
Personal faith in the product | 260 (86.1) | 23 (7.6) | 19 (6.3) |
Substitution agreement with prescriber | 228 (75.5) | 51 (16.9) | 23 (7.6) |