ORIGINAL ARTICLE

Generic medicine substitution practices among communitypharmacists: a nationwide study from Malaysia

Chee Ping Chong & Mohamed Azmi Hassali &Mohd Baidi Bahari & Asrul Akmal Shafie

Received: 13 January 2010 /Accepted: 14 June 2010 /Published online: 18 July 2010# Springer-Verlag 2010

AbstractAims This study aims to assess generic medicine substitu-tion practices among Malaysian community pharmacists.Method A cross-sectional nationwide descriptive studyusing a specific mailing data collection form was conductedfrom May 2007 through December 2007. A sample of1,419 community pharmacies was involved in this study.Data were collected across the brand name medicinerequests encountered on 14 working days and for whichan equivalent generic product was available. Pharmacists’generic substitution rate, physicians’ and patients’ accep-tance of substitution and cost saving achieved fromsubstitution were assessed.Results Responses were received from 157 pharmacies(response rate 11.1%). The pharmacists recommendedgeneric substitution for 84.7% (1,538/1,815) of the brandname medicine requests. While suggesting substitution, thepharmacists voluntarily consulted the physicians for 13.1%(91/695) of the recommendations which involved prescrip-tion orders. The majority of the physicians (87.9%) whenconsulted by the pharmacists accepted the recommendationfor substitution. Meanwhile, 88.9% (1,368/1,538) of thepharmacists’ substitution suggestions were accepted by thepatients. The overall patients’ expenditure on medicineswas reduced by a total of 57.4% (Malaysian ringgit

27,266.30 or US $7,369.30; US $1.00 = Malaysian ringgit3.70) through acceptance of substitution.Conclusion The Malaysian community pharmacists active-ly recommended generic substitution for brand namemedicine requests which they encountered. Both thephysicians and patients highly accepted the substitutionrecommendation and this contributed to significant reduc-tion in patients’ medicines expenditure.

Keywords Generic substitution . Community pharmacist .

Physician . Patient . Cost saving

Introduction

Equitable and timely access to efficacious medicines at anaffordable cost can ensure effective treatment of manyailments and avoid patients’ non-compliance to medicines(Kennedy et al. 2004; MOH 2007). Globally, genericmedicines are effective in treating many of today’s ailmentsand their use contributes to substantial savings in medicinesexpenditure (Andersson et al. 2007; Fischer and Avorn2004; King and Kanavos 2002). Consequently, a genericsubstitution policy that aims to encourage the utilization ofgeneric medicines has been legislated in various developed(Heikkila et al. 2007; McManus et al. 2001; Simoens andDe Coster 2006; Simoens 2009) and developing countries(Gossell-Williams 2007; Homedes and Ugalde 2005;NAPM 2009). This policy allows pharmacists to substitutebrand name medicines with bioequivalent generics, provid-ed if allowed by the prescribing physicians and consentedto by the patients.

Generic medicines provide the opportunities for sav-ings in the health care system due to their cheaper pricethan the innovator medicines (King and Kanavos 2002).

C. P. Chong (*) :M. B. BahariDiscipline of Clinical Pharmacy, School of PharmaceuticalSciences, Universiti Sains Malaysia,Minden, Penang 11800, Malaysiae-mail: jjueping@gmail.com

M. A. Hassali :A. A. ShafieDiscipline of Social and Administrative Pharmacy,School of Pharmaceutical Sciences, Universiti Sains Malaysia,Minden, Penang 11800, Malaysia

J Public Health (2011) 19:81–90DOI 10.1007/s10389-010-0349-3

The average price difference between innovator andgeneric medicines could range from 20 to 90% (Kingand Kanavos 2002; Shafie and Hassali 2008). Savingsfrom the use of generic medicines could free up thegovernment’s financial resources for the funding ofexpensive patented medicines or developing new servicesfor patients (Ess et al. 2003; McGavock 1997, 2001;Smeaton 2000). From the patients’ perspective, genericsubstitution could improve affordability of medicinesparticularly among disadvantaged groups and chronicpatients with multiple drug treatments (MOH 2007).

In countries with a generic substitution policy, thecommunity pharmacists play a crucial role in encouragingthe uptake of generic medicines (Allenet and Barry 2003;McManus et al. 2001; Suh 1999). The pharmacists areresponsible for advising the prescribers about the qualityand safety of generic medicines and educating patients onissues pertaining to generic substitution, such as avoidanceof confusion arising from brand switching and compliancewith therapy (Kirking et al 2001; Mott and Cline 2002;Scuderi 2002). In Malaysia, the community pharmacistslack chances to perform generic substitution as there iscurrently no separation of prescribing and dispensingfunction between private doctor clinics and pharmacies.Besides, currently there is no guideline on how genericsubstitution should be undertaken at community pharma-cies. The main opportunity for pharmacists to substitutegenerics is when they encounter patients who walk inwithout a prescription and request a Class C Poison.According to the Malaysian Poison Act of 1952, a Class CPoison can be dispensed by a registered pharmacist in alicensed pharmacy outlet without a prescription (LegalResearch Board of Malaysia 2006). There is a trend inMalaysia where consumers often consult the pharmacistsfor guided self-treatment of minor ailments such as simplecold symptoms. In this regard, the pharmacists mightdispense some of those poisons classified as a Class CPoison such as common antihistamine-containing prepa-rations. However, under the National Medicines Policy,the Malaysian Government is planning to implement botha dispensing separation and a generic substitution policyin the future (MOH 2007). Subsequently, Malaysianpharmacists will have a greater role in promoting genericmedicines utilization.

An evaluation of the pharmacists’ current genericsubstitution practices and patients’ acceptance are essentialfor planning a generic substitution policy. As genericsubstitution involved modification in the physicians’ choiceof treatment, a study is needed to evaluate the extent ofcommunication between the pharmacists and physicianswith regard to substitution and the physicians’ acceptanceof substitution recommendations. Currently, there is also alack of national data on cost saving resulting from the use

of generic medicines under a free market system inMalaysia, where the government does not control the pricesof both innovator and generic medicines. Therefore, thisstudy aims to assess the Malaysian community pharmacists’generic substitution practices, physicians and patients’acceptance of substitution and cost saving achieved fromsubstitution. The outcome of this study would providebaseline data to support the implementation of a genericsubstitution policy in the future.

Methods

This was a cross-sectional nationwide descriptive studyusing a self-completed anonymous data collection form.The data form was tested for face and content validity bytwo experts and ten registered pharmacists and was furtheradjusted after pilot testing with 34 community pharmacists(Ping et al. 2008).

This study involved the community pharmacists inMalaysia. The sampling unit was the community pharmacyand the sampling frame was a list of 1,419 communitypharmacies in Malaysia which was obtained from all of thestate governments. Assuming 80% of the pharmacists werein favour of generic substitution (Ping et al. 2008), a total of155 pharmacies would provide a representative sample sizewith 5% margin of error and 90% confidence level. Thedata form was mailed to the entire 1,419 pharmacies in thesampling frame as the response rate was estimated to below. Two invitation and two follow-up reminder letterswere used to improve the response rate. The participation inthis survey was strictly voluntary. The informed consents ofthe respondents were obtained and no personal data of therespondents were reported. Data were collected from 1 May2007 to 31 December 2007.

The inclusion criteria were any request for brand namemedicines encountered on 14 consecutive working days andfor which an equivalent generic product was available. Theexclusion criteria were medications which are not suitableto be substituted according to British National Formulary(BNF) (Royal Pharmaceutical Society of Great Britain2006). The BNF was chosen as the reference because it waswidely used among the Malaysian pharmacists. Thepharmacists were requested to record the details of thebrand name medicine request and relevant generic substi-tution, including the product name, dose, quantity supplied,cost to the pharmacist, price to the patient, consultationwith the physician, physician acceptance and patientacceptance.

The data analysis was performed by using SPSS®version 11.5. The chi-square statistic was used to determinedifferences in the pharmacists’ substitution recommenda-tion rate, pharmacists’ consultation rate with the physicians,

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physicians’ and patients’ acceptance of substitution, be-tween different types of brand name medicine requests,geographical areas, types of diseases and poison classes. Ap value of less than 0.05 was set to determine statisticalsignificance. Odds ratios and 95% confidence intervals(95% CI) were calculated for variables which demonstratedsignificant differences based on chi-square analysis.

The pharmacists’ and patients’ total cost savingsachieved through the acceptance of generic substitutionwere calculated. The pharmacists’ cost saving was deter-mined based on the stated pharmacy procurement costs forbrand name medicines and relevant generic substitute. Thereduction in patients’ expenses was calculated by compar-ing the prices of brand name medicines to the price ofgeneric products actually dispensed to the patients. Themonthly cost saving (per 30 days) was calculated forsubstitution involving medicines to treat chronic diseases.The percentages of cost savings (per item) achievedthrough generic substitution according to diseases, poisonsand therapeutic classes were calculated.

Results

Demographic data

Upon completion of this study, responses were receivedfrom 157 pharmacies (response rate 11.1%) with 1responding pharmacist from each outlet. As described inTable 1, 61.8% of the respondents were female and themajority (31.8%) were aged between 25 and 30 years. Morethan half (57.9%) of the respondents either fully or partlyowned their pharmacies. The majority of the respondentswere from urban areas (73.9%) (Table 1).

Brand name medicine requests

A total of 1,815 brand name medicine requests (eachrequest involved one item) were received by the respond-ents. On average, each pharmacy received 12 requestswithin the study period. Among the requests, 43.2% wereunder prescription orders and 56.8% were without prescrip-tion orders. The majority (70.7%, n=554) of the brandname prescription orders were asking for Class B Poison(prescription only medicines), followed by Class C Poison(28.6%, n=224) and non-poison (0.7%, n=6). Conversely,94.2% (n=971) of the non-prescription requests were forClass C Poison and 5.8% (n=60) were non-poison.

Only 37.3% of the requests were for chronic diseaseswhich needed long-term treatment. The requests were mostlyfor drugs in the therapeutic class of respiratory system(23.3%) and therapeutic subclasses of anti-inflammatory andantirheumatic products (12.1%) (Table 2).

Generic substitution recommendations

The pharmacists recommended generic substitution for 84.7%of the brand name medicine requests (Table 2). There wassignificantly (p<0.001) higher generic substitution recom-mendation rate for brand name medicines with prescription(88.6%) compared to those without prescription (81.8%).The recommendation rate for pharmacists in urban areas(86.1%) was significantly (p=0.004) higher than rural areas(80.4%). Nevertheless, the recommendation rate did notdiffer significantly between patients with acute and chronicdiseases and across different poison classes. Of the differenttherapeutic classes, the substitution offering rate was lowestfor medicines for the nervous system (63.2%) and highestamong anti-infectives for systemic use (89.5%). Among theten most common therapeutic subclasses, the highestsubstitution rate occurred in topical anti-infectives withcorticosteroid (93.4%), whereas the lowest rate was fordrugs to treat obstructive airway diseases (80.0%).

Table 1 Demographics and practice characteristics of the respondingpharmacists

Characteristic n (%)

Gender

Male 60 (38.2)

Female 97 (61.8)

Age group, years

25–30 50 (31.8)

31–35 48 (30.6)

36–40 24 (15.3)

41–50 26 (16.6)

>50 9 (5.7)

Employment position

Self or part owner 91 (57.9)

Employee or license holder 64 (40.8)

Missing data 2 (1.3)

Type of pharmacy where practicing

Single-outlet independent pharmacy 93 (59.2)

Multi-outlet independent pharmacy 49 (31.2)

Chain pharmacy 15 (9.6)

Number of prescriptions received per month

Nil 20 (12.7)

1–5 72 (45.9)

6–10 20 (12.7)

11–20 15 (9.6)

21–50 8 (5.1)

>50 12 (7.6)

Missing data 10 (6.4)

Area where pharmacy situated

Urban 116 (73.9)

Rural 41 (26.1)

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Table 2 Brand name medicine requests, pharmacists’ generic substitution recommendations and patients’ acceptance of substitution

Brand name medicinerequests, No. of cases (%)

Generic substitution recommendations,No. of cases (%)/recommendation rate, %

Patient acceptance, No. ofcases (%)/acceptance rate, %

Total 1,815 (100.0) 1,538 (100.0)/84.7 1,368 (100.0)/88.9

Request classifications

1. Request under prescription order 784 (43.2) 695 (45.2)/88.6a 613 (44.8)/88.2

2. Request without prescription order 1,031 (56.8) 843 (54.8)/81.8a 755 (55.2)/89.6

Area where pharmacy situated

1. Urban 1,381 (76.1) 1,189 (77.3)/86.1b 1,063 (77.7)/89.4

2. Rural 434 (23.9) 349 (22.7)/80.4b 305 (22.3)/87.4

Type of disease

1. Acute disease 1,138 (62.7) 978 (63.6)/85.9 881 (64.4)/90.1

2. Chronic disease 677 (37.3) 560 (36.4)/82.7 487 (35.6)/87.0

Poison class

1. Class B Poison (prescription medicines) 554 (30.5) 465 (30.2)/83.9 419 (30.6)/90.1

2. Class C Poison (pharmacist onlymedicines)

1,195 (65.8) 1,011 (65.7)/84.6 893 (65.3)/88.3

3. Non-poison 66 (3.7) 62 (4.1)/93.9 56 (4.1)/90.3

Therapeutic classc

1. Respiratory system 423 (23.3) 351 (22.8)/83.0 312 (22.8)/88.6

2. Alimentary tract & metabolism 403 (22.2) 353 (23.0)/87.6 311 (22.7)/88.1

3. Cardiovascular system 290 (16.0) 242 (15.7)/83.4 218 (15.9)/90.1

4. Musculoskeletal system 255 (14.1) 213 (13.8)/83.5 188 (13.7)/88.3

5. Dermatologicals 229 (12.6) 204 (13.3)/89.1 177 (12.9)/86.8

6. Anti-infectives for systemic use 95 (5.2) 85 (5.5)/89.5 78 (5.7)/91.8

7. Blood & blood forming organs 44 (2.4) 36 (2.3)/81.8 35 (2.6)/97.2

8. Nervous system 38 (2.1) 24 (1.6)/63.2 24 (1.8)/100.0

9. Genitourinary system & sex hormones 28 (1.6) 23 (1.5)/82.1 18 (1.3)/78.3

10. Sensory organs 6 (0.3) 4 (0.3)/66.7 4 (0.3)/100.0

11. Systemic hormonal preparations,excluding sex hormones & insulins

4 (0.2) 3 (0.2)/75.0 3 (0.2)/100.0

Therapeutic subclassc

1. Anti-inflammatory & antirheumaticproducts

219 (12.1) 183 (11.9)/83.6 164 (12.0)/89.6

2. Antihistamines for systemic use 195 (10.7) 165 (10.7)/84.6 148 (10.8)/89.7

3. Drugs used in diabetes 151 (8.3) 128 (8.3)/84.8 106 (7.7)/82.8

4. Drugs for acid-related disorders 149 (8.2) 131 (8.5)/87.9 122 (8.9)/93.1

5. Cough & cold preparations 123 (6.8) 102 (6.6)/82.9 93 (6.8)/91.2

6. Antifungals for dermatological use 114 (6.3) 104 (6.8)/91.2 90(6.6)/86.5

7. Lipid-modifying agents 114 (6.3) 99 (6.4)/86.8 90(6.6)/90.9

8. Drugs for obstructive airway diseases 105 (5.8) 84 (5.5)/80.0 71 (5.2)/84.5

9. Beta blocking agents 62 (3.4) 56 (3.6)/90.3 49 (3.6)/87.5

10. Topical anti-infectives withcorticosteroid

61 (3.4) 57 (3.7)/93.4 51 (3.7)/89.5

Others (33 therapeutic subclasses) 522 (28.7) 429 (28.0)/82.1 384 (28.1)/89.5

Chi-square analysis showed significant differences between:a Requests under prescription order and without prescription order (p<0.001; odds ratio=1.74; 95% CI: 1.33–2.29)b Urban and rural area (p=0.004; odds ratio=1.51; 95% CI: 1.14–2.00)c Based on Anatomical Therapeutic Chemical (ATC) classification

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Extent of communication between pharmacistsand physicians

The pharmacists consulted the physicians for 13.1% of thegeneric substitution recommendation cases which involvedprescription orders. The pharmacists in urban and ruralareas did not differ significantly in their consultation rateswith the physician [14.0% (73/523) versus 10.5% (18/172)]. The recommendations were more frequently (oddsratio=1.71; 95% CI: 1.08–2.69) discussed with the physi-cian when recommending substitution for patients withacute diseases than chronic diseases [17.6% (37/210) versus11.1% (54/485), p=0.020]. Only 14.0% (65/465) and10.3% (23/224), respectively, of the Class B and Class CPoison cases involved consultation with the physician andthe difference was not significant.

Physicians’ acceptance

The physicians accepted 87.9% of the pharmacists’ genericsubstitution recommendations. The physicians in urban areashad a higher acceptance of substitution compared to those inrural areas although the difference was not statisticallysignificant [89.0% (65/73) versus 83.3% (15/18)]. Thephysicians’ acceptance of substitution cases which involvedacute or chronic diseases did not differ significantly [86.5%(32/37) versus 88.9% (48/54)]. Nevertheless, the physicianswere more likely to accept the substitution of a Class B Poisonthan a Class C Poison [96.9% (63/65) versus 69.6% (16/23),p<0.001; odds ratio=13.78; 95% CI: 2.61–72.8).

Patients’ acceptance

The patients generally accepted 88.9% of the genericsubstitution recommendations. There were no significant

differences in the patients’ acceptance of substitutionrecommendations which involved prescription orders orwithout prescription orders, between patients in urban andrural areas, acute or chronic diseases and across poisonclasses (Table 2).

Pharmacists and physicians’ influence on the patients’acceptance of substitution

The majority [95.6% (87/91)] of the substitution recom-mendations with prescription orders and for which thepharmacists consulted the prescriber were accepted bythe patients. Further analysis showed that 98.8% of thesubstitution recommendations which were agreed to bythe physicians were accepted by the patients. Interestingly,most of the patients (72.7%) chose to accept the genericsubstitution despite the disagreement by the physicians withthe recommendation. Meanwhile, 87.1% of the genericsubstitution recommendations for which the pharmacists didnot consult the prescriber were agreed to by the patients(Table 3).

Generic products involved in substitution

Table 4 shows the most frequently requested brand namemedicines and their generic substitutes. The brand namemedicines were predominantly substituted by genericproducts which were manufactured by Malaysian pharma-ceutical companies.

Cost saving

A total of 105 (66.9%) pharmacists disclosed the procure-ment costs and selling prices of the branded and genericmedicines involved in 846 (61.8%) of successful substitu-

Table 3 Consultation between pharmacists and physicians and physicians’ and patients’ acceptance of generic substitution

Generic substitution recommendationinvolved items under prescription order,No. of cases (%)

Generic substitution recommendationinvolved items without prescription order,No. of cases (%)

Total (%)

Pharmacist consulted physician 91 (13.1) - 91 (5.9)

Physician accepted 80 (87.9) - 80 (87.9)

Patient accepted 79 (98.8) - 79 (98.8)

Patient did not accept 1 (1.2) - 1 (1.2)

Physician did not accept 11 (12.1) - 11 (12.1)

Patient accepted 8 (72.7) - 8 (72.7)

Patient did not accept 3 (27.3) - 3 (27.3)

Pharmacist did not consult physician 604 (86.9) 843 (100.0) 1,447 (94.1)

Patient accepted 526 (87.1) 755 (89.6) 1,281 (88.5)

Patient did not accept 78 (12.9) 88 (10.4) 166 (11.5)

Total 695 (100.0) 843 (100.0) 1,538 (100.0)

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tion cases. The costs and prices were generalized to theremaining 480 successful cases. Another 42 cases (includ-ing 14 chronic diseases cases) were excluded because thequantity and/or the brand of the generic medicines

dispensed were not provided. Thus, the cost saving wascalculated for 1,326 (96.9%) of successful cases.

Of these successful cases, the total procurement cost forbranded products was Malaysian ringgit (MYR) 36,511.45

Table 4 Most frequently requested brand name medicines and relevant generic substitutiona

Brand name medicine(generic name)

Manufacturer (countryof origin)

Generic substitute Manufacturer (countryof origin)

No. of cases (%)

1. Zyrtec® (cetirizine) tablet UCB Pharma (Belgium) 1. Adezio® Xepa-Soul (local) 26 (34.2)

2. Simtec® CCM Pharmaceutical (local) 23 (30.3)

3. Cetirizin Stada® Stadapharm (Germany) 9 (11.8)

4. Others (8 products) 18 (23.7)

2. Zantac® (ranitidine) tablet GlaxoSmithKline (UK) 1. Histac® Ranbaxy (India) 43 (71.7)

2. Apo-Ranitidine® Apotex (Canada) 10 (16.7)

3. Hyzan® Xepa-Soul (local) 3 (5.0)

4. Others (3 products) 4 (6.6)

3. Voltaren® (diclofenac Na)tablet

Novartis (Switzerland) 1. Zolterol® CCM Pharmaceutical (local) 12 (19.4)

2. Olfen® Mepha (Switzerland) 10 (16.1)

3. Remethan® Remedica (Cyprus) 9 (14.5)

4. Voren® YSP Industries (local) 9 (14.5)

5. Difnal® Ranbaxy (India) 9 (14.5)

6. Others (5 products) 13 (21.0)

4. Zocor® (simvastatin) tablet Merck Sharp & Dohme(Australia)

1. Vascor® CCM Pharmaceutical (local) 14 (23.7)

2. Simvor® Ranbaxy (India) 13 (22.0)

3. Pharmaniaga Simvastatin® Pharmaniaga (local) 8 (13.6)

4. Others (7 products) 24 (40.7)

5. Ventolin Evohaler®(salbutamol) inhaler

GlaxoSmithKline (UK) 1. Asthalin Inhaler® Cipla (India) 43 (91.4)

2. Butahale Inhaler® Dr. Reddy's Lab (India) 2 (4.3)

3. Salvent HFA Inhaler® Medispray Lab (India) 2 (4.3)

6. Clarityne® (loratadine) tablet Schering-Plough (USA) 1. Ezede® Xepa-Soul (local) 19 (40.4)

2. Loradine® YSP Industries (local) 10 (21.3)

3. Carin® CCM Pharmaceutical (local) 5 (10.6)

4. Others (10 products) 13 (27.7)

7. Glucophage® (metformin)tablet

Merck (USA) 1. Diabetmin® Hovid (local) 17 (48.6)

2. Upha Metformin® CCM Pharmaceutical (local) 10 (28.6)

3. Dyna Metformin® Dynapharm (local) 6 (17.1)

4. Others (2 products) 2 (5.7)

8. Diamicron® (gliclazide) tablet Servier (France) 1. Glimicron® Hovid (local) 21 (61.8)

2. Glyade® Alphapharm (Germany) 12 (35.3)

3. Others (3 products) 1 (2.9)

9. Tenormin® (atenolol) tablet AstraZeneca (UK/Sweden) 1. Normaten® Xepa-Soul (local) 14 (41.2)

2. Apo-Atenol® Apotex (Canada) 11 (32.4)

3. Noten® Alphapharm (Germany) 6 (17.6)

4. Others (3 products) 3 (8.8)

10. Clarinase Repetab®(loratadine/pseudoephedrine)tablet

Schering-Plough (USA) 1. Carinox® CCM Pharmaceutical (local) 32 (97.0)

2. Allerpid® China Chemical &Pharmaceutical (Taiwan)

1 (3.0)

11. Others (188 brand namemedicines)

881 (64.4)

Total 198 brand name medicines 1,368 (100.0)

a Data are presented for successful generic substitution cases which were accepted by the patients

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(US $9,867.95; US $1.00 = MYR 3.70). The total costdeclined by MYR 25,184.25 (US $6,806.55) to MYR11,327.20 (US $3,061.40) after substitution. Thus, thepharmacists’ expenses on stocks were reduced by 69.0%.

Monthly cost saving (per 30 days) was calculated for473 of successful cases which involved chronic diseases.The pharmacists’ total monthly cost for branded medi-cines was MYR 23,261.10 (US $6,286.80). The totalcost decreased by 68.8% (MYR 16,004.60 or US$4,325.60) to MYR 7,256.50 (US $1,961.20) aftersubstitution.

Of 1,326 successful cases, the total patients’ expenseswere MYR 47,503.50 (US $12,838.80) before substitution.Total patients’ expenses were reduced to MYR 20,237.20(US $5,469.50) through acceptance of substitution and thiscorresponded to a medicines expenditure reduction of57.4% (MYR 27,266.30 or US $7,369.30).

Of 473 chronic cases, the total patients’ monthlyexpenditure for branded medicines was MYR 29,475.50(US $7,966.35). After substitution, the total expendituredeclined by 57.9% (MYR 17,054.90 or US $4,609.45) toMYR 12,420.60 (US $3.356.90). The average cost savingper item per month was MYR 36.06 (US $9.75).

The average percentage of cost saving (per item) wascalculated based on 846 of successful cases for which thecosts and selling prices were disclosed. The average costsavings achieved from substitution involving acute diseases(68.3%) was marginally higher than chronic diseases(65.1%). The average cost savings from Class B Poisons(70.6%) was found to be higher than Class C Poisons(66.5%) and non-poisons (57.2%) (Table 5).

Discussion

This study revealed that under the present medicine policywhereby doctors are allowed to dispense, the Malaysiancommunity pharmacists seldom received prescriptionorders that allowed an opportunity for generic substitution.Although there was no legislation of a generic substitutionpolicy, the surveyed pharmacists actively recommendedgeneric substitutes for most of the brand name medicinerequests. This finding suggested that the implementation ofa generic substitution policy in the future may receivetremendous support from the pharmacists. However, thegeneric substitution rate observed in this study was lowerthan in countries with a generic substitution policy in place.For instance, in New Jersey, USA where a mandatorygeneric substitution policy was legislated, a previous studyfound that the generic substitution rate by the pharmacistswas 96% (Suh 1999).

The pharmacists were highly confident in recommendinggeneric counterparts for brand name medicines which were

used for either acute or chronic diseases. This clearly isreflected by the high substitution rate of medicine for bothacute and chronic diseases. This finding was in contrastwith a study result from the USA where pharmacists weresignificantly less likely to perform generic substitution forpatients with chronic diseases than acute conditions (Mottand Cline 2002). Additionally, no significant differenceswere found in the pharmacists’ substitution recommenda-tion rates across the poison classes in the present study.This suggested that the pharmacists were generally confi-dent in recommending generic medicines for both mild tomoderate diseases (non-poison and Class C Poison) andmore severe diseases (Class B Poison). Nevertheless, therewere certain therapeutic classes and subclasses whichdemonstrated relatively lower substitution recommendationrates, namely medicines affecting the nervous system anddrugs for obstructive airway diseases. This finding indicat-ed that the pharmacists may perceive these groups ofmedicines as less appropriate for generic substitution as itmay place the patients’ health at risk. There were studiesthat found similar trends where pharmacists viewed genericsubstitution as less suitable for certain medicine classessuch as narrow therapeutic index medicines (Banahan andKolassa 1994) and dry powder inhalers (Williams andChrystyn 2007).

Currently, there is no policy that requires Malaysianphysicians to indicate generic substitution’s permissibilityon the prescription. There is also no requirement forpharmacists to obtain consent from the prescribers whenperforming substitution. Within this context, the pharma-cists’ decision to consult the prescriber is voluntary andbased on their professional judgment. This study showedthat the Malaysian pharmacists seldom consult physicianswhen substituting generics for brand name medicines underprescription orders. The majority of the substitutions wereperformed without consent from the prescriber. TheMalaysian Government needs to consider the level ofgeneric substitution rights under the future generic substi-tution policy. Pharmacists may have wide substitutionrights, whereby they can substitute generics freely withoutauthorization from the prescriber (King and Kanavos 2002).Otherwise, the government can adopt the generic substitu-tion policy in effect in many countries like Australia,Denmark, Finland, France, Germany, Italy, Poland, Swedenand the USA, which allow pharmacists to perform genericsubstitution without consulting the prescribers, provided theprescribers do not designate on the prescriptions thatsubstitution is not permissible (Simoens and De Coster2006; McManus et al. 2001; Suh 1999; Andersson et al.2005). Nevertheless, the Malaysian Government needs toevaluate the opinions of relevant stakeholders regarding thisissue before the legislation on generic substitution rightscan come into practice.

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The physicians seldom restricted generic substitutionrecommendations by the pharmacists in this study. Thisfinding was consistent with study results from severalcountries that have implemented a generic substitutionpolicy. A survey involving physicians in the USA reportedthat 78% of respondents supported generic substitution inmost cases and 17% supported substitution in all caseswhere equivalent generics were available (Barrett 2005).Studies from Finland (The Social Insurance Institution ofFinland 2009) and Sweden (Andersson et al. 2005) foundthat the physicians only opposed generic substitution in

0.4% and 1–8%, respectively, of the prescriptions whichwere eligible for substitution.

The consumers’ acceptance of generic substitution wasgenerally high in the present study. The Malaysianconsumers’ acceptance of generic medicines was compara-ble with findings from a few developed countries. Studiesfrom Denmark (Andersen et al. 2000) and Norway(Kjoenniksen et al. 2006) found that 84 and 78%,respectively, of the consumers were in favour of genericsubstitution. In the USA, a previous national survey foundthat 91% of the consumers were satisfied with generic

Table 5 Mean percentage of cost saving (per item) achieved through generic substitution according to disease, poison and therapeuticclassificationa

No. of cases (%) Pharmacists’ cost saving,% (95% CI)b

Patients’ cost saving,% (95% CI)b

Type of disease

1. Acute disease 544 (64.3) 68.3 (66.9–69.8) 51.1 (49.5–52.7)

2. Chronic disease 302 (35.7) 65.1 (62.9–67.4) 54.1 (51.7–56.4)

Poison class

1. Class B Poison (prescription medicines) 237 (28.0) 70.6 (68.5–72.7) 57.5 (55.0–60.0)

2. Class C Poison (pharmacist only medicines) 568 (67.1) 66.5 (65.0–68.0) 50.6 (49.0–52.2)

3. Non-poison 41 (4.9) 57.2 (50.5–63.9) 42.6 (37.7–47.5)

Therapeutic class

1. Alimentary tract & metabolism 194 (22.9) 72.6 (70.3–74.8) 58.1 (55.0–61.2)

2. Respiratory system 189 (22.3) 66.7 (64.3–69.1) 48.4 (46.3–50.4)

3. Musculoskeletal system 123 (14.5) 69.8 (66.3–73.2) 50.6 (46.9–54.3)

4. Cardiovascular system 116 (13.7) 68.2 (64.6–71.9) 56.7 (52.9–60.5)

5. Dermatologicals 103 (12.2) 56.4 (53.4–59.5) 48.8 (45.8–51.7)

6. Anti-infectives for systemic use 71 (8.4) 66.5 (62.3–70.6) 50.2 (45.4–55.1)

7. Blood & blood forming organs 18 (2.1) 65.8 (61.3–70.3) 60.2 (54.7–65.7)

8. Nervous system 17 (2.0) 69.4 (61.5–77.3) 44.3 (34.4–54.1)

9. Genitourinary system & sex hormones 9 (1.1) 39.2 (27.5–50.9) 18.3 (11.3–25.2)

10. Sensory organs 4 (0.6) 57.7 (-) 41.5 (-)

11. Systemic hormones, excluding sex hormones &insulins

2 (0.2) 85.2 (-) 78.3 (-)

Therapeutic subclass

1. Anti-inflammatory & antirheumatic products 105 (12.4) 70.0 (66.4–73.5) 50.9 (47.1–54.6)

2. Antihistamines for systemic use 91 (10.8) 75.1 (73.0–77.3) 50.9 (48.4–53.5)

3. Drugs used in diabetes 74 (8.8) 71.7 (67.7–75.8) 59.4 (54.5–64.3)

4. Drugs for acid-related disorders 73 (8.6) 76.9 (74.8–79.0) 66.3 (63.5–69.1)

5. Antifungals for dermatological use 61 (7.2) 67.2 (62.9–71.5) 53.1 (49.1–57.1)

6. Drugs for obstructive airway diseases 50 (5.9) 58.6 (54.6–62.7) 47.4 (43.9–50.9)

7. Cough & cold preparations 48 (5.7) 59.3 (53.2–65.3) 44.6 (39.1–50.0)

8. Lipid-modifying agents 41 (4.8) 71.3 (66.5–76.0) 58.0 (51.7–64.3)

9. Topical anti-infectives with corticosteroid 36 (4.3) 59.3 (54.4–64.2) 49.8 (45.3–54.2)

10. Beta blocking agents 26 (3.1) 77.8 (73.0–82.6) 67.9 (62.5–73.4)

Others (33 therapeutic subclasses) 241 (28.4)

Total 846 (100.0)

a Data are presented for 846 of successful generic substitution cases for which the costs and selling prices were disclosed by the pharmacistsb 95% CI for mean percentage of cost saving

88 J Public Health (2011) 19:81–90

medicines (Anonymous 1990). In addition, the Malaysianconsumers’ acceptance of generic substitution was general-ly high regardless of the types and severity of the diseasesinvolved. This result differed from a previous researchundertaken in the USA which found that the consumersshowed more preference for using innovator medicines thangeneric products in treating severe medical conditions(Himmel et al. 2005). Interestingly, in cases involvingpharmacists’ consultation with the physicians, nearly all ofthe substitution recommendations were accepted by thepatients if the doctor approved the change. Nonetheless,when the prescribers disagreed with the substitution, sevenof ten patients ignored the physicians’ decision andaccepted the generic medicines. This implied that althoughphysicians’ consent can improve the patients’ acceptance,disagreement with the physicians might not always befollowed by the patients. As currently there is no policywhich mandates Malaysian pharmacists to supply brandname medicines if the prescribers disagree with substitu-tion, the pharmacists in this study chose to follow thepatients’ final decision in accepting the substitution. Thepatients’ ability to afford the medication may be the mainconcern of the pharmacists in doing so.

Through generic substitution, pharmacists saved 69.0%of their cost in stock purchasing. This significant costreduction may be one of the factors which encouraged thepharmacists to offer substitution. Studies from othercountries also showed that incentive was one of the mainfactors which influenced the pharmacists to recommendgeneric medicines (Allenet and Barry 2003; Banahan andKolassa 1994; Hassali et al. 2005). Additionally, thepharmacists may actively offer substitution because of thesignificant cost saving to the consumers (Banahan andKolassa 1994; Babar and Awaisu 2008). As highlighted inthis study, the patients’ expenses for medicines werereduced by 56.0%. This indicated that the price differencebetween generic and brand name medicines in Malaysialeads to significant cost saving. The percentage of costsaving observed in this study was higher than in severalcountries where reference pricing systems were imple-mented. For example, the potential savings from genericsubstitution in France, Italy and the Netherlands were 35,31 and 41%, respectively (Simoens et al. 2005). Thereference pricing system in these countries involvesgrouping together similar medicine products and defininga reference price that will be reimbursed by medicalinsurance funds (King and Kanavos 2002). If a medicineproduct is priced higher than the reference price, the insuredmust paid the difference in price. Conversely, in countrieswith a free market system like the USA, the average pricedifferential between innovator and generic medicines was50–90% (King and Kanavos 2002), which was almostsimilar to the findings in this study.

Study limitations

The cost saving calculated in this study was only estimatedas the real costs and selling price disclosed by 105pharmacies were generalized to the cases in the remaining52 pharmacies which did not provide the information onmedicine prices. In addition, this study did not directlyassess the reasons for pharmacists, physicians and patientsto support or oppose generic substitution, especially wheninvolving certain groups of medicines. A follow-upqualitative interview would be the solution to overcomethis limitation.

Conclusion

The Malaysian community pharmacists actively recom-mended generic substitution for brand name medicinerequests which were eligible for substitution. However,most of the substitution recommendations involving pre-scription orders were performed without consent from theprescribers. This showed that there is an urgent need todevelop a generic substitution policy in order to overcomethis problem. The majority of the prescribers agreed withthe generic substitution suggestions made by the pharma-cists. The patients highly accepted the generic substitutionrecommendations and this contributed to significant reduc-tions in patients’ medicines expenditure.

Conflict of interest The authors declare that they have no conflict ofinterest.

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