This chapter is divided into 6 main sections. The first section is an introduction regarding the scenario, discussed in this chapter. Section two will highlight the objectives of this chapter. Section three is the detailed methodology of the study. Section four consists of the results. Section five will discuss the results in light of previous studies and objectives of this study and section six will be the conclusion of the study.
Introduction and Background
Updated information about medicines is the primary need of doctors for practicing medicine and to ensure appropriate prescription. There are many information sources available which are considered potential to update doctors' knowledge on existing and new medicines (Mali et al., 2010). These sources are of both commercial and non-commercial origin. Pharmaceutical industry is the most widely used commercial source of drug information by the doctors. Although the primary object of pharmaceutical industry is developing and marketing medicines, but at the same time they also put a lot of efforts in gathering, generating and disseminating drug information (Collier and Iheanacho, 2002). Many authors have shown concerns about accuracy and validity of the drug information disseminated by pharmaceutical companies. Studies have identified misleading and manipulated claims in the brochures and advertisement regarding medicines by the pharmaceutical companies (Rohra et al., 2008; Rohra et al., 2006; Islam and Farah, 2007; Islam and Farah, 2008a; Othman et al., 2010a; Roughead et al., 1998). The current part of the study evaluated the various sources of drug information used by the doctors in Pakistan and Malaysia. The study also evaluated the drug brochures for accuracy and consistency of information keeping WHO, IFPMA, PhAMA DCO,MOH (Pakistan) as standards (WHO, 1986; IFPMA, 2007; Pharmaceutical Association of Malaysia, 2008; Drug Control Organization, 1996).
Study Objectives
General objectives
The study was generally aimed to explore and document the drug information sources in Pakistan and Malaysia used by doctors and to evaluate the brochures used by medical representatives to present drug information to healthcare providers, for its accuracy and consistency. Make sure you really measure accuracy and consistency !!
Specific objectives
In order to achieve the aim mentioned above, the study was designed for the following specific objectives:
To audit the drug brochures for accuracy and consistency of information, using the criterion defined by WHO, FIPMA, DCOMOH (Pakistan) and PhAMA
Methodology
Study design
In order to document the commonly adopted drug information sources by doctors in Pakistan and Malaysia and as well as to evaluate the drug brochures collected from the doctors' clinics, a cross sectional study design was adopted (Mann, 2003; Cardarelli et al., 2006).
Study population and sampling
What is the diff of 6.3.2 and 6.3.3???? should combine, this is not the way to write population and sample and sampling; should mention what is your population of study, then sample size if appropriate and how they were chosen; rewrite The doctors were interviewed in 4 cities of two provinces of Pakistan and GPs working in all states of Malaysia (please refer to Ch. 3, Section 3.5.1; page; Ch.4, Ch. 5). The drug brochures were collected from the doctors interviewed in Pakistan, while in Malaysia, 473 brochures were collected from the selected GP clinics in Penang state.
Sampling method why mentioning survey methods etc here; it should focus on how subjects/elements are selected
A total of 250 doctors of different practice status and 250 medical representatives of MNCs and PNCs were interviewed in four cities of two provinces of Pakistan. In Malaysia the data was collected from 1702 GPs practicing in Malaysia by adopting postal survey methods (please refer to Ch. 3, Section 3.4 page and Section 3.5.1; page). For the detailed demographic information of doctors interviewed in Pakistan, please refer to Ch.4, section 4.4 and for detailed demographic information of GPs, surveyed in Malaysia, please refer to Ch.5, section 5.4.
How many different elements of study in this chapt? Divide accordingly using paragraph and do not confuse readers As far as drug brochures are concerned, a total of 500 brochures were collected from the clinics of interviewed doctors (two from each clinic) in Pakistan while in Malaysia, 473 brochures were collected from 5 selected GP clinics in Penang state. After comprehensive scrutiny and filtration as shown in Figure 6.1, a total of 498 broachers were included and evaluated for the study. If you justified that in the form of flow diagram given below, please mention the figure and its number what is this?
Data collection method and procedure what is the diff bet method and proc?
The data collection for this study was done via data collection tools 1, 3 and 4. The tools were pre tested for validity and reliability (please refer to Ch. 3, Section 3.7.1.a, page; and Section 3.7.1.b, page). The Cronbach's coefficient Alpha value for tool 4 was 0.729 (n=50). This statement should be in the tool dev section
What variables are collected and measured here? Did you explicitly mention criteria used for evaluation?
Final selection of brochures for evaluation
Figure 6.: Diagrammatic illustration of the process adopted for the selection of the brochures for evaluation check cap vs small letters in the figure
Data management and analysis
All the data was analyzed using SPSS version 15 and Microsoft Office Excel, 2003. To summarize the data, descriptive statistics (frequencies, percentages, mean standard deviation and cross tabulation) were calculated. To evaluate reliability and internal consistency of the data collection tools, Cronbach's Alpha was applied for the initial 10% of the total sample (De Bourdeaudhuij et al., 2005; Bonett, 2002; Oyvind et al., 2007) (for Cronbach's Alpha values, please refer to Chapter 4, section …; page… and Chapter 5, section…; page…..). The Cronbach's coefficient Alpha value for tool 4 was 0.729 (n=50) you mentioned earlier !Chi-square test was applied as inferential statistics (delete) to analyze association between independent variables (company, country and practice status) and different dependent variables what they are?. A P value of less then 0.05 was considered as statistical significance for all the tests.
Results
Sources of drug information used by doctors in Pakistan and Malaysia
Do you have these results/section in the previous chapt?
Preferred sources of drug information used by doctors in Pakistan the target or focus is on drug brochures and why this section is here?
Table 6.1 shows that majority of the doctors (n=222; 88.8%) in Pakistan are dependent on medical representatives as major source of drug information. Slightly less than half of the doctors use peer reviewed journals (n=109; 43.6%) as source of drug information. Other potential sources of drug information, used by doctors in Pakistan include medical text books (n=89; 35.6%), medicine index/guides (n=57; 22.8%) and non-reviewed journals (n=53; 21.2%). One fifth of the doctors (n=50; 20.0%) were dependent on pharmaceutical companies' sponsored symposiums and lectures. A small number of doctors were dependent on various other drug information sources which included CME programs (n=40; 16%), product monographs (n=24; 9.6%), advertisements of medicines in medical journals (n=11; 4.4%) and meetings of the professional associations of doctors (n=8; 3.2%).
Table 6. Preferred sources of drug information used by doctors in Pakistan
Sources of Information
Responses
Percent
Medical REPs
222
88.8
Peer Reviewed Journals
109
43.6
Books
89
35.6
Medicine Index/Guides
57
22.8
Non-Reviewed Journals
53
21.2
Co. Sponsored Symposia/Lectures
50
20.0
CME
40
16.0
Product Monograph
24
9.6
Journal Ads
11
4.4
Association Meetings
8
3.2
Preferred sources of drug information used by GPs in Malaysia
Medical representatives are also considered as top source of drug information by majority (n=1471; 86.8%) of GPs in Malaysia as shown in Table 6.2. CME programs and pharmaceutical companies' sponsored symposia/lectures were adopted by GPs as second (n=1177; 69.4%) and third (n=1021; 60.2%) potential source of drug information respectively. More than half (n=943; 55.6%) of the GPs consulted medical index/guide as source of drug information. Reasonably high numbers of GPs depend on advertisements in medical journals (n=661; 39%), peer reviewed journals (n=654; 38.6%), product monographs (n=638; 37.6%) and medical text books (n=528; 31.2%). Meetings of the professional associations of doctors also served as source of drug information for slight more than one fourth of the GPs (n=473; 27.9%) in Malaysia. Another source of drug information used by GPs in Malaysia was non-reviewed journals which is considered as least preferred source and is adopted by a very small number of GPs (n=72; 4.3%).
Table 6. Preferred sources of drug information used by doctors in Malaysia
Sources of Information
Responses
Percent
Medical REPs
1471
86.8
CME
1177
69.4
Co. Sponsored Symposia/Lectures
1021
60.2
Medicine Index/Guides
943
55.6
Journal Ads
661
39.0
Peer Reviewed Journals
654
38.6
Product Monograph
638
37.6
Books
528
31.2
Association Meetings
473
27.9
Non-Reviewed Journals
73
4.3
Comparison of the preferred sources of drug information used by doctors in Pakistan and GPs in Malaysia
Medical representatives were found to be the primary source for doctors in both countries Pakistan and Malaysia (P=0.332). Use of CME programs as source of drug information was found significantly higher (P <.001) in Malaysian GPs as compared to doctors in Pakistan (Table 6.3). Similarly, pharmaceutical companies' sponsored symposia/lectures (P <.001) and medical index/guides (P <.001) also used as sources of drug information were found to be significantly higher in Malaysian GPs. There was no significant association (P =0.129) noticed in use of peer reviewed journals as sources of drug information by the doctors of both countries. Advertisements in medical journals (P <.001) and product monographs (P <.001) were also adopted significantly higher number of GPs in Malaysia. No statistical significance (P =0.149) was found in use of medical text books as source of drug information in both countries. Considering meetings of doctors' professional associations as source of drug information was significantly higher (P <.001) among the GPs in Malaysia. Use of non reviewed medical journals as drug information source was found significantly higher (P <.001) among the doctors in Pakistan.
Table 6. Comparison of the preferred sources of drug information used by doctors in Pakistan and GPs in Malaysia
Sources of Drug Information
Country
Total
N=1945
P value
Pakistan
N=250
Malaysia
N=1695
Medical REPs
222 (88.8)
1471 (86.8)
1693 (87.0)
.332
CME
40 (16.0)
1177 (69.4)
1217 (62.6)
<.001
Co. Sponsored Symposia/Lectures
50 (20.0)
1021 (60.2)
1071 (55.1)
<.001
Medicine Index/Guides
57 (22.8)
943 (55.6)
1000 (51.4)
<.001
Peer Reviewed Journals
109 (43.6)
654 (38.6)
763 (39.2)
.129
Journal Ads
11 (4.4)
661 (39.0)
672 (34.5)
<.001
Product Monograph
24 (9.6)
638 (37.6)
662 (34.0)
<.001
Books
89 (35.6)
528 (31.2)
617 (31.7)
.149
Association Meetings
8 (3.2)
473 (27.9)
481 (24.7)
<.001
Non-Reviewed Journals
53 (21.2)
73 (4.3)
126 (6.5)
<.001
How this part is measured? What kind of measurement? Did you mention in methods section?
Evaluation of the drug brochures what is the relationship between the part above and this part?
Classification of the brochures according to the therapeutic uses of the drugs
The collected brochures were classified into 11 classes according to their therapeutic uses as presented in Figure 6.2. The majority of the brochures (n=130; 26.5%) were from antibiotics class which included antibacterial, anti fungal and antivirus. The second largest numbers of brochures (n=91; 18.6%) were related to blood and cardiovascular system (CVS) medicines. Brochures of supplement (electrolytes, minerals, elements, vitamin etc) and NSAIDS were at third (n=51; 10.4%) and fourth (n=47; 9.6%) number, respectively. The other classes included antihistamines and respiratory tract (n=41; 8.4%), gastrointestinal tract (GIT) related medicines (n=37; 7.6%), central nervous system (CNS) related medicines (n=33; 6.7%), endocrinology (n=25; 5.1%), dermatology (n=12; 2.4%), and steroids (n=9; 1.8%). Fourteen (2.8%) brochures represented miscellaneous therapeutic classes.
Figure 6. Classification of the brochures according to the therapeutic uses of the drugs
Brochures' evaluation for critical drug information as per standard criteria
All the brochures (n=497; 100%) collected from Pakistan and Malaysia had the trade name of the particular medicine. Generic name of the medicines was also present in almost all (n=480; 96.6%) of the brochures. Dosage form of the medicine (n=486; 97.8%), potency of the medicine per dose (n=454; 91.3%) and indications (n=466; 93.8%) were also present in majority of the brochures. The names of the excipients were missing in more than ninety percent of the brochures. Only a very small number (n=43; 8.7) of brochures presented the names of the excipients. The patient safety information like side effects, major drug interactions, major precautions, expected adverse drug reactions (ADRs) and contraindications were missing in most of the brochures. Only 128 (25.8%) brochures had mentioned side effects, only one third (n=183; 36.8%) had information about drug interactions, slightly less than half (n=246; 49.5%) mentioned about precautions. Almost half (n=243; 48.9%) of the brochures cited contraindications of respective drugs and almost two fifth (n=191; 38.4%) of brochures provide information about expected ADRs. Most of the claims (n=352; 70.8%) made in the brochures were supported by scientific references but the element of factual comparison was missing in exactly half (n=249; 50%) of the brochures. Almost all (n=472; 95%) of the brochures had the contact information of manufacturer or/and marketers.
Table 6. Evaluation of the brochures for the critical drug information
Criteria for evaluation
Frequency
Percentage
Trade Name
497
100.0
Generic Name
480
96.6
Dosage Form
486
97.8
Potency Per Dose
454
91.3
Indications
466
93.8
Name Excipients
43
8.7
Side Effects
128
25.8
Major Interactions
183
36.8
Major Precautions
246
49.5
ADRs
191
38.4
Contraindications and Warnings
243
48.9
Scientific Support to Claims
352
70.8
Factual comparison
249
50.0
Contact information of manufacturer or/and marketers.
472
95.0
Figure 6. A brochure presenting detail prescribing information in very small unreadable font size
Figure 6. A brochure in which the difference between trade and generic name of the medicine presentation is highlighted
The study found that the dosage form was presented significantly (P=.009) less in national companies' (NCs) brochures as compared to MNCs. The brochures of national companies were found significantly better (P=.016) in terms of presenting the names of the excipients as compared to MNCs. MNCs were found significantly adherent to the standard criteria for brochures as compared to NCs for presenting drug interactions (P<.001), precautions (P<.001) and expected ADRs (P<.001). National companies were found significantly (P<.001) more adherent to the standard criteria in terms of presenting contraindications and warnings. In terms of including contact information in the brochures, MNCs were significantly better (P=.009) as compared to NCs (Table 6.5).
Table 6. Comparison of MNCs and NCs for adherence to criteria of providing critical information in drug brochures
Criteria for evaluation
Responses
Company
Total
N=493
P Value
MNC
NC
Trade Name
Yes
224 (100)
269 (99.6)
493 (99.8)
1.00*
No
0 (0.0)
1 (0.4)
1 (0.2)
Generic Name
Yes
217 (96.9)
259 (95.9)
476 (96.4)
.575
No
7 (3.1)
11 (4.1)
18 (3.6)
Dosage Form
Yes
223 (99.6)
259 (91.5)
482 (97.6)
.009
No
1 (0.4)
11 (8.5)
12 (2.4)
Potency Per Dose
Yes
204 (91.1)
247 (93.0)
451 (91.3)
.872
No
20 (8.9)
23 (7.0)
43 (8.7)
Indications
Yes
211 (94.2)
251 (11.5)
462 (93.5)
.579
No
13 (5.8)
19 (88.5)
32 (6.5)
Name Excipients
Yes
12 (5.4)
31 (24.8)
43 (8.7)
.016
No
212 (94.6)
239 (75.2)
451 (91.3)
Side Effects
Yes
61 (27.2)
67 (27.4)
128 (25.9)
.542
No
163 (72.8)
203 (72.6)
366 (74.1)
Major Interactions
Yes
108 (48.2)
74 (38.9)
182 (36.8)
<.001
No
116 (51.8)
196 (61.1)
312 (63.2)
Major Precautions
Yes
140 (62.5)
105 (29.6)
245 (49.6)
<.001
No
84 (37.5)
165 (70.4)
249 (50.4)
ADRs
Yes
111 (49.6)
80 (41.1)
191 (38.7)
<.001
No
113 (50.4)
190 (58.9)
303 (61.3)
Contraindications and Warnings
Yes
131 (58.5)
111 (69.3)
242 (49.0)
<.001
No
93 (41.5)
159 (30.7)
252 (51.0)
Scientific Support to Claims
Yes
162 (72.3)
187 (92.6)
349 (70.6)
.457
No
62 (27.7)
83 (7.4)
349 (29.4)
Factual comparison
Yes
109 (48.7)
139 (51.5)
248 (50.2)
.532
No
115 (51.3)
131 (48.5)
246 (49.8)
Contact information of manufacturer or/and marketers.
Yes
219 (97.8)
250 (92.6)
469 (94.9)
.009
No
5 (2.2)
20 (7.4)
25 (5.1)
Note: * P value for Fisher Exact test (50% cells have expected count less than 5) you did not mention this test in method section !; put yes/no in the center of the cells
The brochures collected from Malaysia were found significantly more adherent to the guidelines in terms of providing patient safety information as compared to Pakistan. Table 6.6 shows significantly higher number of Malaysian brochures providing information about drug interactions (P<.001), precautions (P<.001), expected ADRs (P<.001) and contraindications (P<.001).
Table 6. Comparison of countries for adherence to criteria of providing critical information in drug brochures write n ? for the country out of 498; yes/no in the ctr
Criteria for evaluation
Responses
Country
Total
N=498
PValue
Pakistan
Malaysia
Trade Name
Yes
254 (100)
243 (99.6)
497 (99.8)
.307*
No
0 (0)
1 (0.4)
1 (0.2)
Generic Name
Yes
247 (97.2)
233 (95.5)
480 (96.4)
.295
No
7(2.8)
11(4.5)
18(3.6)
Dosage Form
Yes
246 (96.9)
240 (98.4)
486 (97.6)
.272
No
8(3.1)
4(1.6)
12(2.4)
Potency Per Dose
Yes
234 (92.1)
220 (90.2)
454 (91.2)
.441
No
20(7.9)
24(9.8)
44(8.8)
Indications
Yes
242 (95.3)
224 (91.8)
466 (93.6)
.114
No
12(4.)
20(8.2)
32(6.4)
Name of Excipients
Yes
28 (11.0)
15 (6.1)
43 (8.6)
.053
No
226(89.0)
229(93.9)
455(91.4)
Side Effects
Yes
72 (28.3)
56 (23.0)
128 (25.7)
.168
No
182(71.7)
188(77.0)
370(74.3)
Major Interactions
Yes
64 (25.2)
119 (48.8)
183 (36.7)
<.001
No
190(74.8)
125(51.2)
315(63.3)
Major Precautions
Yes
90 (35.4)
156 (63.9)
246 (49.4)
<.001
No
164(64.6)
88(36.1)
252(50.6)
ADRs
Yes
58 (22.8)
133 (54.5)
191 (38.4)
<.001
No
196(77.2)
111(45.5)
307(61.6)
Contraindications and Warnings
Yes
98 (38.6)
145 (59.4)
243 (48.8)
<.001
No
156(61.4)
99(40.6)
255(51.2)
Scientific Support to Claims
Yes
185 (72.8)
167 (68.4)
352 (70.7)
.282
No
69(27.2)
77(31.6)
146(29.3)
Factual comparison
Yes
117 (46.1)
132 (54.1)
249 (50.0)
.073
No
137 (53.9)
112 (45.9)
249 (50.0)
Contact information of manufacturer and/or/ marketers.
Yes
241 (94.9)
231 (94.7)
472 (94.8)
.916
No
13(5.1)
13(5.3)
26(5.2)
Note: * P value for Fisher Exact test (50% cells have expected count less than 5)
Evaluation of the visual and related contents, presented in the drug brochures
The brochures were also evaluated for the illustrations, misleading photos, and endorsements by some celebrities or use of HCP opinion presented in the brochures for promotional purpose. Most of the brochures were found adherent to the standard guidelines except few brochures with the illustrations showing effect of the product (n=99; 19.9%), misleading photos (n=51; 10.2), endorsement by the celebrities (n=14; 2.8%) and a very small number (n=6; 1.2%) of brochures mentioned opinion of the HCP as presented in Table 6.7.
Table 6. Evaluation of the visuals and related contents, presented in the drug brochures
Criteria
Frequency
Percent
Illustration Showing Effect of Product
99
19.9
Misleading Photos
51
10.2
Endorsement by Celebrity
14
2.8
Opinion of HCP
6
1.2
No statistically significant difference was found between MNCs and NCs in terms of presenting illustrations, misleading photos, endorsement by celebrities or use of HCP opinion for promotional purpose (Table 6.8).
Table 6. Comparison of companies for the visuals and related contents, presented in the drug brochures mention n? for MNC and NC - check all tables
Criteria for evaluation
Responses
Company
Total
PValue
MNC
NC
Illustrations Showing Effect of Product
Yes
39 (17.4)
57 (21.2)
96 (19.5)
.291
No
185 (82.6)
212 (78.8)
397 (80.5)
Misleading Photos
Yes
27 (12.1)
22 (8.2)
49 (9.9)
.152
No
197 (87.9)
247 (91.8)
444 (90.1)
Endorsement by Celebrity
Yes
7 (3.1)
7 (2.6)
14 (2.8)
.728
No
217 (96.9)
262 (97.4)
479 (97.2)
Opinion of Health Care Professionals (HCP)
Yes
5 (0.0)
1 (2.5)
6 (1.2)
.097*
No
219 (100)
268 (97.5)
487 (98.8)
Note: * P value for Fisher Exact test (50% cells have expected count less than 5)
Table 6.9 shows that brochures collected from Pakistan had significantly higher number of illustrations showing effects of medicines (P= .035) and HCP opinion (P= .013) for promotional purpose while brochures from Malaysia had significantly higher number of misleading photos (P= .003) and endorsements by celebrities (P= .024) with intentions of promoting medicinal product.
Table 6. Comparison of countries for the visuals and related contents, presented in the drug brochures n?
Criteria for evaluation
Responses
Country
Total
PValue
Pakistan
Malaysia
Illustrations Showing Effect of Product
Yes
60 (23.6)
39 (16.0)
99 (19.9)
.035
No
194 (76.4)
204 (84.0)
398 (80.1)
Misleading Photos
Yes
16 (6.3)
35 (14.4)
51 (10.3)
.003
No
238 (93.7)
208 (85.6)
446 (89.7)
Endorsement by Celebrity
Yes
3 (1.2)
11 (4.5)
14 (2.8)
.024
No
251 (98.8)
232 (95.5)
483 (97.2)
Opinion of Health Care Professionals (HCP)
Yes
5 (2.2)
1 (0.4)
6 (1.2)
.013*
No
219 (97.8)
268 (99.6)
487 (98.8)
Evaluation of claims' text in brochures for compliance with the standards
The statements and claims mentioned in brochures were evaluated for accuracy, clarity, and objectivity as defined by various regulations and codes. Slightly less than one third (n=143; 29.0%) of brochures were found with theoretical projections of therapeutic evidences. A reasonable number of brochures (n=104; 21.1%) had used exaggerated statements using words "excellent", "best", "only" etc. Some brochures (n=70; 14.1%) also mentioned the word "safe" without any scientific evidence or support. Few brochures (n=15; 3.0%) had statements which indicated efforts to hide the real nature of the claims. A small number (n=8; 1.6%) of brochures had such type of statements which may lead to illegal use of that medicine. Seven (1.4%) brochures advertised skills and services and only two of the (0.4%) brochures extrapolated the data from animal studies (Table 6.10).
Table 6. Evaluation of claims' text for compliance with the standards
Criteria
Frequency
Percent
Theoretical Projection of Evidences
143
29.0
Use of Exaggerated Word i.e. excellent, best
104
21.1
Use of Word "Safe"
70
14.1
Content to Hide Real Nature of Claims
15
3.0
Statements Leading to Illegal Use of Drug
8
1.6
Adv of Skills and Services
7
1.4
Extrapolated Data from Animal Studies
2
0.4
The use of word "safe" was found significantly higher (P=.011) in the brochures of the national companies as mentioned in the Table 6.11. Exaggerated claims were also found significantly higher (P=.001) in the brochures of national companies. The advertisement of skills and services was found significantly higher (P=.004) in the brochures of MNCs. The contents which may hide the real nature of the claims were also found significantly more (P=.028) in the brochures of MNCs. Brochures of the national companies were found having theoretical projections of the claims significantly higher (P=.001) as compared to MNCs rather than using scientific facts and figures.
Table 6. Evaluation of claims' text on the basis of companies for compliance with the standards
Criteria for evaluation
Responses
Company
Total
PValue
MNC
NC
Use of Word "Safe"
Yes
22 (9.8)
48 (17.8)
70 (14.2)
.011
No
202 (90.2)
221 (82.2)
423 (85.8)
Use of Exaggerated Word
Yes
32 (14.3)
72 (26.8)
104 (21.1)
.001
No
192 (85.7)
197 (73.2)
389 (78.9)
Statements Leading to Illegal Use of Drug
Yes
3 (1.3)
5 (1.9)
8 (1.6)
.734*
No
221 (98.7)
264 (98.1)
485 (98.4)
Adv of Skills and Services
Yes
7 (3.1)
0(0.0)
7 (1.4)
.004*
No
217 (96.9)
269(100)
486 (98.6)
Content Real Nature of Claim
Yes
11 (4.9)
4 (1.5)
15 (3.0)
.028
No
213 (95.1)
265 (98.5)
478 (97.0)
Theoretical Projection of Evidences
Yes
49 (21.9)
94 (34.9)
143 (29.0)
.001
No
175 (78.1)
175 (65.1)
350 (71.0)
Extrapolated Data From Animal Studies
Yes
2 (0.9)
0 (0.0)
2 (0.4)
.206
No
222 (99.1)
269 (100)
491 (99.6)
The study found that the brochures collected from Pakistan had word "safe" (P<.001), exaggeration (P<.001) and theoretical projection (P<.001) of the claims significantly higher as compared to the brochures collected from Malaysia (Table 6.12).
Table 6. Evaluation of claims' text on the basis of countries for compliance with the standards
Criteria for evaluation
Responses
Country
Total
PValue
Pakistan
Malaysia
Use of Word "Safe"
Yes
60 (23.6)
10 (4.1)
70 (14.1)
<.001
No
194 (76.4)
233 (95.9)
427 (85.9)
Use of Exaggerated Word
Yes
85 (33.5)
19 (7.8)
104 (20.9)
<.001
No
169 (66.5)
224 (92.2)
393 (79.1)
Statements Leading to Illegal Use of Drug
Yes
4 (1.6)
4 (1.6)
8 (1.6)
1.00*
No
250 (98.4)
239 (98.4)
489 (98.4)
Adv of Skills and Services
Yes
1 (0.4)
6 (2.5)
7 (1.4)
.063*
No
253 (99.6)
237 (97.5)
490 (98.6)
Content Real Nature of Claim
Yes
7 (2.8)
8 (3.3)
15 (3.0)
.727
No
247 (97.2)
235 (96.7)
482 (97.0)
Theoretical Projection of Evidences
Yes
109 (42.9)
36 (14.8)
145 (29.2)
<.001
No
145 (57.1)
207 (85.2)
352 (70.8)
Extrapolated Data From Animal Studies
Yes
0 (0.0)
2 (0.8)
2 (0.4)
.239*
No
254 (100)
241 (99.2)
491 (99.6)
Check previous comments on tables and check other tables
Evaluation of the quality of references' presentation in the brochures
On average 3 (median) (mean=4.59+5.99) references were used in the brochures out of which on average 2 (median) (mean=3.34+4.29) references were understandable. The references having enough information to access particular study were considered understandable. The publication name, volume, issue, year of publication and page numbers were considered as the minimum information to term the reference as understandable.
Discussion
There are various commercial and non-commercial sources of drug information, available to doctors for updating their knowledge regarding existing and upcoming medicines (Shetty and Karve, 2008; Layton et al., 2007; Stimson, 1977). In a study, doctors were asked to rank sources of drug information according to their importance. The ranking done by the doctors from 1 to 10 included drug bulletins, medical journal articles, monthly index of medical specialties (MIMS), British National Formulary (BNF), non-sponsored clinical meetings, primary care colleagues, consultants/ hospital recommendations, pharmaceutical representatives, sponsored meetings and direct mails respectively (McGettigan et al., 2001). However, the ranking for the drug information sources did not seem practically adopted by the doctors as per the current study findings and also revealed by many other studies (Prosser et al., 2003; McGettigan et al., 2001; Thomson et al., 1994). According to the findings of the current study, medical representatives were the most used source of drug information for doctors, both in Pakistan and Malaysia, which is not surprising at all. All over the world, medical representatives are considered practically as a common source of drug information by majority of the prescribers. In some developing countries they serve as only source of drug information (Shankar, 2008; Norris et al., 2004; Islam and Farah, 2008a). Although medical representatives are adopted as primary source of drug information by the practitioners, the authenticity of the information obtained through commercial sources is questionable as highlighted by many authors (Ziegler et al., 1995; Villanueva et al., 2003; Santiago et al., 2008; Cardarelli et al., 2006). It is also pointed out by many studies that medical representatives are basically trained to promote their medicines when you are writing many studies you need to cite at least three references not one) (Fugh-Berman and Ahari, 2007; Lexchin, 1995). The drug information they present to the physicians may not be complete but the way they present it is very effective to induce prescription. Due to influential tendency of the detailing by medical representatives, Shaughnessy and Slawson had pronounced them as "stealth bombers" (Shaughnessy and Slawson, 1996).
The second widely used source of drug information by Malaysian GPs was CME programs while Pakistani doctors consider peer reviewed journals as second most important source of drug information (Manning and Deson, 1980). CME programs are a good source of drug information but increasing involvement of the pharmaceutical industry in such programs turns it into a controversial source. Participation of an industry which has an inherent vested interest in professional development of healthcare providers can not be seen as a sole objective thus raises many questions on such ventures. Therefore, it is very important to maintain the credibility of CME programs, (it seems like some word is missing in between two) it should be solo responsibility of the profession (Relman, 2001). Peer reviewed journals were also found as one of the key source for drug information among Malaysian GPs. Medical journals are always considered as credible accurate and credible source of drug information and are always ranked by physicians as the most important source of drug information. The findings of the current study are not much different in terms of medical journals. Although journals are not used as first preferred source by doctors in Pakistan and Malaysia,. This is probably because of the non availability of independent drug information sources in developing countries like Pakistan (Pakenham-Walsh et al., 1999; Hafeez and Mirza, 1999). Still a considerable majority adopted it for updating their knowledge regarding medicines.
The main aim of the pharmaceutical companies is to induce prescription and uses all the available means of promotion including drug information and is directed to influence the prescribing decisions of the physicians (Islam and Farah, 2008b; Stimson, 1975; Mali et al., 2010). In order to achieve their targets, pharmaceutical companies can resort to any unfair means including data manipulation in their brochures (Day, 2006). In order to design effective brochures for drug promotion, companies very carefully decides to present the information in their brochures and this puts the company's integrity in doubt (Shetty and Karve, 2008). According to the findings of the current study, the drug information which can help to induce prescription like trade name, generic name, dosage form, dosage and indications were merely presented in almost all the brochures. This is evident also in a previous study which evaluated journal advertisements in Malaysian medical journals (Othman et al., 2010a). Interestingly, the information crucially required to ensure patients' safety like name of the excipients, side effects, drug interactions precautions, ADRs and contraindications were absent in majority of the brochures (Othman et al., 2010a). Overall the brochures were lacking in providing evidence based scientific information (Tomson and Weerasuriya, 1990). Even the information provided was not according to the standards i.e. the codes demand that the generic or International Nonproprietary Name (INN) (WHO, 1986) should be equally prominent as trade name but none of the evaluated brochures satisfied such criteria. Likewise, other information was also presented in such small font size which was not readable with naked eye (please refer to Figure 6.3 and Figure 6.4). The regulations and self regulatory codes recommend appropriate size of font to present the information in the brochures (Drug Control Organization, 1996; Pharmaceutical Association of Malaysia, 2008). The readability is very important to ensure the proper understanding of the information presented in drug brochures and in terms using it for clinical decision making (Silver and Braun, 1993; Weih et al., 2008; Timothy and Stephen, 1997). The companies follow this rule only to present the most important information like patient safety while the unnecessary theoretical projections and off label promotion of prescription medicine is prominently presented especially in developing countries (Islam, 2008).
Majority of the studies conducted to evaluate drug brochures and advertisement in medical journals were focused on evaluating validity of claims and their influences on doctors' prescribing behavior (Rohra et al., 2008; Rohra et al., 2006; Othman et al., 2010b; Orlowski and Wateska, 2007). Very few studies have evaluated the readability and completeness of the references cited in the advertisements (Cardarelli et al., 2006; Keng and Coley, 1994; Cooper and Schriger, 2005). Very few studies with a limited scope have evaluated the visual accuracy of the data and claims given in the brochures (Cardarelli et al., 2006). The current study also evaluated the pictures, illustrations and endorsements from celebrities and/or healthcare professionals (HCP), presented in text or pictures. The illustration showing effect of medicines without any scientific reference were observed in a considerable number of brochures. Such illustrations were found more in the brochures collected from Pakistan. Illustrious presentation without scientific evidence is against the criteria given by various regulations and codes of conducts.
Another problem found in the visuals was the misleading photos which were observed more in the brochures collected from Malaysia. Presenting such visuals indicates irresponsible behavior of the pharmaceutical companies. By such behavior it seems that companies are handling pharmaceutical promotion like promotion of fast moving consumer goods (FMCGs) which is inadvisable due to its direct possible effects on human health and economy. The study also evaluated brochures text for some prohibited words like "safe" and exaggeration of the claims and it was observed that words "safe", exaggerated words like "excellent", "only" and theoretical projection of claims were practiced more by the companies in Pakistan without any substantial scientific support and most of them were national companies. Many other studies also found that pharmaceutical companies' advertisement in various forms cannot be trusted without counter check. They commonly try to exaggerate the claims in their brochures and advertisements and try to hide the real nature of the medicine effects (Rohra et al., 2008; Rohra et al., 2006; Othman et al., 2010b; Othman et al., 2010a; Islam and Farah, 2008a; Cardarelli et al., 2006; Santiago et al., 2008; Islam and Farah, 2007) even they do not hesitate to change the data in their brochures. Such practices are not limited to developing countries only. Doctors in developed countries also face same challenge of claims' exaggeration and change of data in the brochures (Day, 2006; Cardarelli et al., 2006; Santiago et al., 2008).
It is required by all regulations and codes of conduct for drug promotion that the claims regarding therapeutics of medicines must be supported with scientific evidence. Most of the claims in the brochures evaluated for current study were supported with scientific references (Keng and Coley, 1994) but a considerable number of references were not understandable. Most of the references, cited in brochures were within minimum acceptable limits of completeness (Lexchin and Holbrook, 1994). Either the cited references did not have enough information to access the particular study or they were referring to such type of data which was not accessible like "data on file". It is clearly mentioned in the codes and regulations that the "scientific data in the public domain should be made available to prescribers and any other person entitled to receive it" (WHO, 1986). In majority of the brochures with incomplete references, a phrase was mentioned at the end before the address of company "for further information, please contact…….." The companies' responses to the requests for further information are usually not encouraging. Studies have assessed the responses of companies on sending them request especially for "data on files" and the response rate against such requests from the pharmaceutical companies was disappointing (Hafeez and Mirza, 1999; Cooper and Schriger, 2005).
Conclusions
The current part of the study documented medical representatives as major source of drug information in both the Pakistani and Malaysian settings. In terms of evaluation of drug brochures for accuracy and consistency of information, discrepancies are observed mainly in drug safety related information as well as inappropriate and incomplete citation of references.
