Transcript Introduction The regulation in Sri Lanka do not limit

DOES REGISTRATION OF SEVERAL
GENERICS TRANSLATE INTO MORE
AND CHEAPER DRUGS FOR THE
PATIENTS’ IN SRI LANKA?
Fernandopulle BMR
Senarathna SMDKG
Department of Pharmacology, Faculty of Medicine, Colombo
Does registration of several generics translate into more and cheaper drugs for the patient?
Fernandopulle BMR, Senarathna SMDKG.
Department of Pharmacology, Faculty of Medicine, Colombo.
 Problem statement -The regulations in Sri Lanka do not limit the registration of the products of a drug. This
predictably has resulted in a large number of products of the same drug with variable prices. As in other countries in
Sri Lanka the fundamental principle of market economy does not regulate prices of pharmaceuticals merely through
open competition, although import duty and VAT are not imposed on drugs. Furthermore there is some evidence that
the prices of generics vary between geographical regions in Sri Lanka (1). But little is known regarding variability of
prices and availability of drugs within a geographical region.
 Objectives –To study the registration and availability of some selected essential drugs and to determine variation in
costs within Colombo.
 Design –Descriptive study(2)
 Setting - Pharmacies located around the National Hospital of Sri Lanka, Colombo.
 Study population – 13 pharmacies including private and semi governmental outlets.
 Methodology – Pre-designed structured questionnaires were interviewer administered. The availability and prices of
30 drugs (selection criteria, local burden of disease and inclusion in the Essential Drug List) were inquired. The
number of products for each category, market leader, most sold generic equivalent and the cheapest generics were
studied. The market leader, the most sold generic equivalents were predetermined (2). The cheapest generic drugs
were determined on the spot (2). The Management Sciences for Health (MSH) reference prices 2002 was selected as
the standard.
 Outcome Measures- No of registered products, availability in pharmacies and price.
 Results-All 30 drugs were available at variable prices. When median prices were compared, only 3 (Erythromycin
116 %, Salbutamol inhaler 109% and Beclomethasone inhaler 112 %) of the cheapest generics were higher than the
International Median Price (IMP). Although there were many registered products (2-36) for each drug, the
availability at pharmacies varied from 1–5. Greater than 75% availability of the cheapest generic was 46%, most
sold 46%, and market leader 20%. Cheapest generic was not always the most sold, but eleven of the most sold was
also the cheapest. In most sold, 55% were less and 25% were 100-199 % and 18%were 200 -499 % were higher than
the IMP. No market leader was less than the IMP, 25% were 100 -199 % higher; 25 % were 200 -499 % higher; and
50 % were 500-3500 % higher than the IMP.
 Conclusions- Although 90 % of the cheapest generics are less than IMP, they are not always available and
prescribed. Market leader is always more than the IMP. Thus although cheap drugs are available, they are not
necessarily being prescribed.
 References 01). Essential Drug Monitor; WHO: No32,2003,Page05
02). Medicine Prices a new approach to measurement, WHO, 2003
Introduction and background
YEAR 2002
Population: 19 million
Life Expectancy : males 70.7y
females 75.4y
Literacy Rate : 90.1%
Poverty Level: population < USD1/day: 6.6%
< USD2 /day: 45.4%
Wages of lowest paid worker :USD35/M
Total govt. health expenditure :
USD 256.91/1.6% GDP
Total drug budget :USD 51.49 Million
Contribution to total health expenditure :
Govt: 48%, Households 46%, Employers 3%,
Private insurance 1%, NGOs 2%
Doctor : Patient ratio: 1: 2300
PHARMACEUTICALS
Imported drugs dominate, local manufacture contribution minimal.
Import Expenditure: USD 105 million
Price structure
 Imported pharmaceuticals
 Locally manufactured pharmaceuticals
F.P.
1). Imported price
100
Cost of drug
100
P.P.
100
P. only
100
(including marketing cost)
( including CIF and fiscal levies)
2). Price to wholesaler
130.8
Price to wholesaler
120
117.5 115
3). Price to retailer1
141.9
Price to retailer
130.2
127.5 124.8
4). Price to public
165.0
Price to public
152
149
Mark up in semi govt. outlets 162.0
146
F.P. - Fully processed , P.P. - Partially processed , P.
only - Packing only
Objectives –To study the registration and availability of some
selected essential drugs and to determine variation in costs within
Colombo
Study design –Descriptive study carried out in accordance with
the methodology described in the manual of Medicine prices: A new
approach to measurement(WHO/HAI,2003).
Setting & study population - 13 pharmacies including
private and semi governmental outlets located in Colombo (Within
2km radius from the National hospital)
Method







Pre-designed standardized structured questionnaires on prices and availability
of 30 pre – selected drugs were interviewer administered
Drugs were selected on following criteria.
 Local burden of disease and Inclusion in the Essential Drug List
The Innovator (INO), the most sold generic equivalents (MSG) were
predetermined. The most sold generic drugs were selected using IMS health
data (July to June 2003). The cheapest generic (CG) drugs were determined on
the spot (2).
The International median prices (IMP) were selected from the Management
Sciences for Health reference prices 2002.(Http://erc.msh.org)
The Median price for each drug category was calculated and converted into US
dollars (Exchange rate, middle value = 1$ = 97.10 on 1st July 2003)
Median Price Ratio( MPR) = Median medicine price to patient : Medicine’s
IMP
The availability of drugs in the retail pharmacies were compared with the total
registered (Drug Index Sri Lanka 2003, Total = innovator, branded generics and
generics ).
Results
Table- 1 Indicates the number registered and availability
TR. -Total number registered under each chemical entity according to drug index
2003, AV. - Number available in pharmacies
Name of the dug
TR
N=
AV
N=
Availability as %
INO
MSG
CG
Ranitidine 150mg
10
4
69
62
8
Omeprazole cap 20mg
18
3
38
31
77
Domperidone 10 mg
12
5
77
85
15
ORS 27.9mg
2
2
0
85
85
Metformin 500mg
12
4
69
38
85
Glibenclamide 5mg
11
5
85
85
8
Furosemide 40 mg
6
2
69
38
38
Hydrochlorothiazide25mg
1
1
0
62
62
Propranolol 10mg
3
2
31
69
38
Atenolol 50mg
21
4
38
38
38
Nifedipine Retard 20 mg
8
3
0
77
46
Verapamil 40mg
4
1
0
92
92
Enalapril 5mg
9
4
46
38
77
Table- 1 continued
Name of the dug
TR
N=
AV
N=
Availability as %
INO
MSG
CG
Simvastatin 10 mg
7
5
15
23
38
Prednisolone 5mg
10
1
0
92
92
Carbimazole 5mg
2
1
15
77
77
Amoxicillin 250mg
36
4
69
85
38
Cefalexin 250 mg
15
5
31
54
62
Cloxacillin 250 mg
14
2
0
85
85
Erythromycin 250mg
9
5
54
77
77
Ciprofloxacin 250mg
21
3
0
23
38
Aciclovir 200mg
10
2
23
62
31
Carbamazepine 200 mg
7
2
62
77
77
Diazepam 5mg
7
2
23
85
85
Amitriptyline 25mg
5
2
31
38
31
Metronidazole 200 mg
18
2
92
31
77
Mebendazole 100mg
14
3
92
62
31
Diethycarbamazine 50mg
8
2
85
62
62
Salbutamol Inhaler 100µg
6
2
85
85
85
Beclometasone inhaler 50mg
2
2
46
46
31
Table - II
Variation in price between pharmacies
For some innovator products ( shown below) there was a variation between the
maximum and the minimum prices. However for most of the INO and all of the
MSG and CG the variation was less than Sri Lankan rupees one.
Innovator drug
Percentage variation in price between
max. and min. prices in pharmacies
Carbamazepine
34.2
Enalapril
4.36
Omeprazole
7.35
Cefalexin
8.79
Median drug prices compared to the IMP(MSH)
Table- III
Innovator
100 – 199%
Ranitidine(199)Propranolol(122) Cefalexin (195)
Diethycarbamazine(172),Beclometasone inhaler(164)
200-499 %
Metformin(298), Glibenclamide(372), Furosemide(358),
Erythromycin(271) ,Salbutamol Inhaler(209)
500-3500 %
Omeprazole(569),Atenolol(2003),Enalapril(933),Amoxicillin(621)
Aciclovir(1483),Carbamazepine(790),Diazepam(3213)
,Amitryptyline(563),Metronidazole(681),Mebendazole(2670)
Table- IV
Cheapest
generic
Less than
IMP
Omeprazole(9.5) Metformin(22) , Furosemide (78)Hydrochlorothiazide(54)
Propranolol(12) Atenolol(45) NifedipineR(43) Verapamil(62) Enalapril(42)
Prednisolone(82) Carbimazole(47) Amoxicillin(98) Cefalexin(55)
Cloxacillin(88) Ciprofloxacin(7.3) Aciclovir(53) Carbamazepine(73)
Diazepam(21) Amityiptyline(54) Metronidazole(81) Mebendazole(48)
Carbimazole 5mg (47)
100 -199%
Erythromycin(116)Salbutamol Inhaler(109)
Beclometasone inhaler (112)
Table- V
Less than
IMP
Most sold generic
Ranitidine(78),Furosemide(89)Hydrochlorothiazide(54),Propra
nolol(30) Atenolol (45) ,Verapamil (62) Enalapril (74)
Prednisolon (82) Carbimazole(47) Cloxacillin(88)
Ciprofloxacin(26) Carbamazepine (73) Diazepam(21)
Amitriptyline(69) Diethycarbamazine(49)
100 –199% Metformin(144) Nifedipine R(181)Amoxicillin(104)
Cefalexin(199)Erythromycin(116)Mebendazole(175),Beclomet
asone inhaler(164)
200-499%
Omeprazole(332) Glibenclamide(372) Aciclovir(271)
Metronidazole(457),Salbutamol inhaler(209)
Discussion & conclusions




All 30 pre- selected drugs were available at variable prices in the retail pharmacies.
Many products registered (2-36) for each drug. But, availability varied from 1–5.
Price variations between pharmacies were seen mainly with some INO.
90 % of the CGs were less than IMP but availability was 46%. This probably is due
to non prescribing of CGs owing to concerns on quality.
 Greater than 75% availability was 20% for INO, and 46% for MSG.
 11 MSG was also the CG, were locally manufactured and for 9/11 the availability
was > 75%.
 Greater than 75% availability of some of the CG is probably linked to the Price.
When the MPR for the MSG is much higher than the CG , it appears that the
availability of CG is above 75% and MSG below 50%.
Table- VI
Name of the drug
MSG
MPR
Omeprazole 20mg
3.32
Metronidazole 200mg 4.575
Metformin 500mg
1.44
CG
Availability
MPR
31
31
38
0.097
0.807
0.22
Availability
% variation in price
77
97%
77
82.6%
85
101%
•None of the INO was less than the IMP, 4 of the 7 unavailable INO products were in
the ATC category C.
•The widest difference between INO and CG was found to be 150 times for diazepam.
•The lowest paid government worker would have to work for 5 1/4 days to pay for
monthly course of INO Metformin where as less than half a day for the CG.
•The non availability of certain INOs probably indicates that they do not a have
market share to survive.
•The availability of generics seems to have a impact on the price of the innovator.
•Table 4 shows the change in prices between 2000(Essentails drug monitor No 32–Page 6) and
2003. In the year 2001 ranitidine was under the patent cover.
Table- VII
Drug name
Ranitidine
Drug type
INO
Colombo (2001)
Colombo (2003)
MPR
TR
MPR
5.65
1
1.99 10
% change in
MPR
TR
- 50.25
.
Recommendations
 When several products of drug are registered, the Drug
Regulatory Authority should have a mechanism to ensure that it
is available to the consumer.
 From our study if availability is indicated as demand, it could be
interpreted that prescribers prefer locally manufactured generics
(when available) over imported generics. Hence the presently
limited local manufacture of drugs should be actively
encouraged.
 The patent protection should be limited as competition with
generics seems to bring down prices.
 It seems that doctors prescribe generics if they perceive them to
be of good quality, hence the quality of generics should be
ensured to gain the overall confidence of the prescriber.