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Comparative Analysis of National Drug Policies - Second Workshop Geneva, 10-13 June 1996 - EDM Research Series No. 025
(1997; 175 pages) View the PDF document
Table of Contents
View the documentExecutive summary
View the documentI. Introduction
Open this folder and view contentsII. Background on the research project
Open this folder and view contentsIII. Second workshop
Open this folder and view contentsIV. Preliminary findings
Open this folder and view contentsV. Conclusions of the workshop and follow-up plans
Open this folder and view contentsAnnex 1: Research proposal
View the documentAnnex 2: List of participants
View the documentAnnex 3: Agenda
View the documentAnnex 4: Questionnaire on NDP performance assessment
Open this folder and view contentsAnnex 5: Achievements of the national drug policies in the 12 countries
View the documentAnnex 6: Consolidated tables
View the documentOther documents in the DAP Research Series
 

Annex 6: Consolidated tables

This annex contains the results of the indicators exercise in the 12 countries which participated in the workshop. These results are presented following the list of indicators and in two sets: the first one from page 85 to 99 covers Bulgaria, Chad, Colombia, Guinea, India and Mali; the second one from page 100 to page 114 covers the Philippines, Sri Lanka, Thailand, Viet Nam, Zambia and Zimbabwe.

Most of these data were presented during the workshop. They were then scrutizined for relevance, consistency, and reliability by Mrs K. Timmermans and Mrs P. Brudon, who received answers to their queries from the principal investigators of each country. The new consolidated tables were sent again to the country teams which reviewed them and finally a double check took place in Geneva using the consolidated table and the report for each country. However, it should be noted that some of these results are preliminary (Chad and Zambia). Some are incomplete (Sri Lanka); some are difficult to present in a table as they are structured differently (Colombia). Finally, in a number of cases, data alone do not provide a sufficiently clear picture, and there is a need to revert to country reports which will be available at a later stage.

The data were collected mainly at the end of 1995 and beginning of 1996. For data related to background information (BG1 to BG31), most of them refer to 1994

NATIONAL DRUG POLICY - BACKGROUND INFORMATION

na = not available
nr = not relevant

PRIVATE 1. COUNTRY INFORMATION:

Bulgaria 1994

Chad

Colombia 1995

Guinea

India* Andhra Pradesh

Mali

Population data







BG1: Total population (in millions)

8.4

6.6

37.5

6.3

70.5

8.8

BG2: Average annual growth of the population (%)

-0.38

2.4

2.2

2.8

2.4

3.5

BG3: Percentage of population living in urban areas (%)

67.8

21

73.8

30

36.71

24

BG4: Life expectancy (years)

70.9

50.3

69

47

67.1 F/U2
60.7 F/R2
61.5 M/U2
57.3 M/R2

62 F2
59 M2

Economic data







BG5: GNP per capita (USD)

11863

169

1260

450

61

168

BG6: Average annual rate of inflation (%)

121.94

(na)

23

4

13

25

2. HEALTH INFORMATION:

Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

Health status data







BG7: Infant mortality rate (per 1,000)

16.3

145

27.3

136

60

103

BG8: Maternal mortality rate (per 100,000)

20

800

64

623

259

1000

* NB: Figures for one state (Andhra Pradesh) only, unless when indicated that the answer applies to India
1 1991 census
2 F = female, M = male, U = urban, R = rural
3 Official statistical data
4 In a country with huge fluctuations like Bulgaria, trends are more important than annual figure

NATIONAL DRUG POLICY - BACKGROUND INFORMATION


Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

Health system data







BG13: Total number of prescribers

40,3901

1,487

33,000

2,604

33,835

3,102

BG14: Total public health budget (million USD)

392

6.6

721

10.91

136.03

6.5

BG15: Total value of international aid for the health sector (million USD)

2.68

42.2

26

(na)

(na)
(187.4 India)

125
(1991)

BG16: Total health expenditure (million USD)

431

46.42

1,604

(na)

(na)

1035
(1991)

3. DRUG SECTOR INFORMATION:

Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

Economic data







BG17: Total public drug expenditure (million USD)

69.23

0.3

200

1.72
(1994)

9.263

1.22

BG18: Total value of international aid for drugs (cash + kind) (million USD)

0.20

5.2

(nr)

(na)

0.023

4.8

BG19: Total drug expenditure (public + households + international aid) (million USD)

105

8.3

1000

16.90
(1994)

83.254

34.2

BG20: Total value of local production (ex-factory price) sold in the country (million USD)

66.6

0.2

980

0

657.1

4.9

BG21: Total value of drug imports (CIF) (million USD)

29.44

11.6

20

(na)

(na)
(285.2 India)

11.7

1 Beside physicians (28,094), dentists and physician assistants are entitled to prescribe
2 Household expenditures are not included (not known); public health expenditures < budget.
3 Data from financial year '93/'94.
4 Data from 1992.
5 Figure from before the devaluation of the Franc CFA.

NATIONAL DRUG POLICY - BACKGROUND INFORMATION


Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

BG22: Total value of drugs under generic name (CIF and ex-factory prices) sold in the country (million USD)

(na)

6

250

1.73
(1994)

(na)

3.3
(1994)

Human resources







BG23: Total number of pharmacists

4,500

31

5,000

401

1,746

313

BG24: Total number of pharmacy technicians or other aides/assistants

4,000

(na)

1,000

769

20,076

1,500

Drug sector organization







BG25: Total number of drug manufacturing units in the country

641

1

300

0

977

1

BG26: Total number of wholesalers in the country

480

2

90

7

7,827

5

BG27: Total number of pharmacies and drug outlets in the public sector (including health facilities and hospitals that dispense drugs)

1,180

(na)

3,250

399

1,817

77

BG28: Total number of pharmacies and drug outlets in the private sector

2,200

172

13,000

199

14,703

468

BG29: Total number of private pharmacies and drug outlets in the three major urban areas

1,002

103

5,400

116

1,844

139

Number of drugs







BG30: Total number of registered drugs (in dosage forms and strengths)

5,000

(nr)2

14,000
(6,500 actually in the market)

1,446

(na)
(60-80,000 India)

2,000

BG31: Total number of drugs on the national essential drugs list (in dosage forms and strengths)

(nr)

(240 INN)

435

207
(165 INN)

2354

313
(223 INN)

1 Important drug manufacturers are only 12 to 14.

2 Formal registration procedures not yet in place; 1,231 drugs are registred at Pharmat (largest supplier for the private sector)

3 Estimation; data from NGOs, bi- and multilateral cooperation are not included.

4 Figure concerns EDL for tertiary level; primary and secondary level have separate, shorter essential drugs lists.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Bulgaria 1995

Chad

Colombia '95/'96

Guinea

India Andhra Pradesh

Mali

Legislation and regulation







ST1: Is there an official national drug policy document updated in the past ten years?

N1

N

N

Y

Y

N

ST2: Is there drug legislation updated in the past ten years?

Y

N

Y

Y

Y

Y

ST3: Have regulations based on the drug legislation been issued?

Y

Y

Y

Y

Y

Y

ST4: Is there a drug regulatory authority whose mandate includes registration and inspection?

Y

Y

Y

Y

Y

Y

ST5: Is there a licensing system to regulate the sale of drugs (wholesalers, pharmacists, retailers)?

Y

Y

Y

Y

Y

Y

ST6: Are pharmacists legally entitled to substitute generic drugs for brand name products?

Y

N

Y

Y

N

N

ST7: Are there legal provisions for penal sanctions?

Y

Y

Y

Y

Y

Y

ST8: Is there a check-list for carrying out inspections in different types of pharmaceutical establishments?

Y

N

N

Y

N

Y

ST9: Are there any institutions within or outside the country where quality control is carried out?

Y

N

Y

N

Y

Y

ST10: Is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce used systematically?

Y

N

Y

N

Y

Y

ST11: Are there controls on drug promotion based on regulations and consistent with the WHO ethical criteria for medicinal drug promotion?

Y

N

Y

N

Y

N

1 Drug policy issues briefly discussed in the official national health policy document.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

Essential drugs selection and drug registration







ST12: Is there a national essential drugs list (EDL)/formulary using INN officially adopted and distributed countrywide?

N

N2

Y

Y

N

Y

ST13: Is there an official drug committee whose duties include updating the national essential drugs list (EDL)?

(nr)

Y

Y

Y

Y
(N India)4

N

ST14: Has the national essential drugs list (EDL)/formulary been updated and distributed countrywide in the past five years?

(nr)

N2

Y

Y

Y
(N India)4

Y

ST15: Do drug donations comply with the national essential drugs list (EDL)?

N1

N

(nr)

N

Y

N

ST16: Are there formal procedures for registering drugs?

Y

N

Y

Y

Y

Y

ST17: Is there a drug registration committee?

Y

Y3

Y

Y

N

Y

ST18: Is drug registration renewal required at least every five years?

Y

Y3

N

Y

N

Y

Drug allocation in the health budget/public sector financing policy







ST19: Is the public drug budget spent per year more than 20% of the MOH operating budget spent per year for the last three years?

N

Y

(nr)

N

N

N

ST20: Is the public drug expenditure per capita more than US$1.00 per year for the last three years?

Y

N

Y

N

N

N

1 There is no national EDL; but a list of drugs needed which is not followed by donors.

2 EDL 1994 adopted but not distributed countrywide; EDL revision 1995 has been adopted, but is not yet distributed largely.

3 Legal provisions exist, but are not yet operational.

4 India does not have a national EDL, but A.P. State has.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

ST21: Is the public drug budget spent for national hospitals less than 40% of the total public drug budget spent for the last three years?

Y

(na)

(nr)

Y

N

N

ST22: Has the public drug budget spent per capita increased in the last three years?

N

(na)

N

N

N

Y

ST23: Are there any financing systems in addition to the public drug budget that contribute to the provision of drugs in the public sector?

N

Y

Y

Y

Y

Y

Public sector procurement procedures







ST24: Are drugs usually procured in the public sector through competitive tender?

Y

N

Y

Y

Y

Y

ST25: Is there a system for monitoring supplier performance?

Y

N

Y

N

Y

Y

ST26: Are tenders done under INN?

Y

Y

Y

Y

Y

Y

ST27: Does the procurement unit receive foreign currency in less than 60 days (from request to release)?

Y

N

(nr)

Y

(nr)

N

ST28: Is procurement in the public sector limited to drugs on the national essential drugs list (EDL)?

N1

N

Y2

Y

N

N

ST29: Is the average lead time (from order to receipt at central level) less than 8 months?

Y

Y

Y

N

Y

(-)
(6-18 months)

ST30: Is procurement based on a reliable quantification of drug needs?

Y

N

Y

N

Y

N

1 There is no national EDL; to answer this question, the Bulgarian team used the WHO model list.
2 However, 30% of drugs purchases made by public hospitals with resources from fiscal revenues are not on EDL.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

Public sector distribution and logistics







ST31: Are good storage practices observed in the central procurement/distribution unit and/or major regional warehouses?

Y1

N

Y

Y

N

N

ST32: Is the information recorded on the stockcards for a basket of drugs the same as the quantity of stock in store?

Y1

N

Y

N

Y

Y

ST33: Are the stocks for a basket of drugs within their expiry dates in the central procurement/distribution unit and/or major regional warehouses?

Y1

Y

Y

Y

Y

N

ST34: Have all incoming products been physically inspected for the last three deliveries in the central procurement/distribution unit and/or in the major regional warehouses?

Y1

N

Y

Y

Y

Y

ST35: Are only drugs which are on the national essential drugs list (EDL) in stock in the central procurement/distribution unit and/or in the major regional warehouses?

N1

Y

N

Y

N

Y

ST36: Are 80% or more of the vehicles of the central procurement/distribution unit and/or major regional warehouses in working condition?

(nr)

(na)

(nr)

Y

N

N

Pricing policy







ST37: Are drug prices regulated in the private sector?

Y

Y2

N

Y

Y

Y

ST38: Is there at least one major incentive for selling essential drugs at low cost in the private sector?

N

N

Y

N

N

Y

ST39: Is the total margin used by wholesalers and retailers less than 35% of the CIF price?

Y

N

(na)

N

Y

Y (brand)
N (INN)

1 No central or major warehouse exists, but many regional ones; this answer is valid for the vast majority of regional warehouses/stores.

2 However, regulations are being violated, and there is no control.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

ST40: Is there a system for monitoring drug prices?

Y

N

Y

N

Y

N

ST41: Are essential drugs under INN or generic name sold in private drug outlets?

Y

Y

Y

Y

N

Y

Information and continuing education on drug use







ST42: Is there a national publication (formulary/bulletin/manual, etc.), revised within the past five years, providing objective information on drug use?

Y

N1

Y

Y

N

Y

ST43: Is there a national therapeutic guide with standardized treatments?

Y

N

N

N

N

Y

ST44: Is the concept of essential drugs part of the curricula in the basic training of health personnel?

N

N

N

N

N

N

ST45: Is there an official continuing education system on rational use of drugs for prescribers and dispensers?

N

N

N

N

N

Y

ST46: Is there a drug information unit/centre?

Y

Y

Y

N

N

N

ST47: Does the drug information unit/centre (or another independent body) provide regular information on drugs to prescribers and dispensers?

Y

N

Y

N

N

N

ST48: Are there therapeutic committees in the major hospitals?

Y

N

N2

N

N

N

ST49: Are there public education campaigns on drug use?

(na)

N

Y
(not systematically)

N

N

Y

ST50: Is drug education included in the primary/secondary school curricula?

N

N

N

N

N

N

1 A formulary exists for HC level only, but it is not yet distributed countrywide.

2 In some hospitals yes, but not in all hospitals.

NATIONAL DRUG POLICY - PROCESS INDICATORS*


'ideal' value**

Bulgaria 1995 (survey 1996)

Chad

Colombia '95/'96

Guinea

India Andhra Pradesh

Mali

Legislation and regulation








PR1: Number of drug outlets inspected, out of total number of drug outlets in the country.

not <50%

68

0

(-)

0

65

6 (private)
< 1 (public)

PR2: Number of drug outlets in violation, out of total number of drug outlets inspected.

0%

27

(0)

(-)

(0)

9

60

PR3: Number of sanctions and administrative measures implemented, out of total number of violations identified.

100%

34

(-)

(-)

(-)

100

100

PR4: Number of samples routinely collected, out of total number of planned collected samples.

100%

(indicator
changed)

(-)

(-)

(-)

78

(-)
210 samples collected

PR5: Number of samples tested, out of total number of samples collected.

100%

100

(-)

(-)

100

93

100

PR6: Number of advertisements in violation of regulations on the ethical promotion of drugs, out of total number of advertisements monitored.

0%

(nr)1

(-)

(-)

(0)

5

100
(1 case)

PR7: Number of sanctions implemented for advertisements in violation of regulations, out of total number of violations identified.

100%

(nr)1

(0)

(-)

(-)

21

100
(1 case)

Essential drugs selection and drug registration








PR8: Value of drugs from the national essential drugs list (EDL) procured in the public sector, out of total value of drugs procured in the same sector.

- >100%

26

(-)

65

100

85

(-)

PR9: Number of drugs from the national essential drugs list (EDL) prescribed, out of total number of drugs prescribed.

- >100%

332 70

53 (private)
91 (public)

61 (private)
69 public

28 (private)
87 (public)
39 (market)

39 (private)
98 (public)

26 (private)
56 (public)

PR10: Number of drugs from the national essential drugs list (EDL) sold, out of total number of drugs sold.

- >100%

40

62 (private)

63

28 (private)
44 (market)

49 (private)

60 (private)
100 (public)

* All Process Indicators are percentages.
** - > 100% = the 'ideal' value should approach 100%, but does not necessarily have to reach 100%.

1 Regulations just introduced
2The first figure is based on drugs included in non reimbursable prescriptions, the 2nd in reimbursable prescriptions.

NATIONAL DRUG POLICY - PROCESS INDICATORS


'ideal' value

Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

PR11: Number of locally manufactured drugs sold in the country from the national essential drugs list (EDL), out of the total number of drugs from the national essential drugs list.

- >100%

41

2

95

0
(no local drug production)

100

6

PR12: Number of combination drugs newly registered, out of total number of newly registered drugs.

- >0%

14

(-) 1

(-)

33

11

(0)
(no new registration)

PR13: Number of registered drugs which are banned in other countries, out of total number of registered drugs.

- >0%

0.5

(-)

(-)

2

(na)

(0)
(no new registration)

Drug allocation in the health budget/public sector financing policy








PR14: Value of public drug budget spent per capita in the last year, out of average value of the same budget during the past three years.

>100%

119

(-)

100

89

86

(-)

PR15: Value of public drug budget spent by major hospitals, out of value of public drug budget spent.

not >40%

37,5

(-)

12

37

76

29

PR16: Value of international aid received for drugs, out of value of public drug budget.

*

0.3

95

(nr)

(na)

0.2

395

PR17: Value of revenue generated for drugs through additional financing system, out of value of public drug budget.

*

0.03

(-)

0-102
20-602

(na)

11

(-)

PR18: Public drug budget spent, out of public drug budget allocated.

100%

115

86

(-)

99.8

83

50

Public sector procurement procedures








PR19: Value of drugs purchased through competitive tender, out of value of drugs purchased.

- >100%

0,04

0

100

65

100

44

PR20: Value of drugs purchased from local manufacturers through competitive tender, out of value of drugs purchased through competitive tender.

- >100%

(na)

(-)

(-)

0

100

17

* No ideal value, depends on country situation
1 No registration yet.
2 Depending on income level (0-10% for part of population with annual income < 3,500 US$; 20-60% for population with annual income > 3,500 US$).

NATIONAL DRUG POLICY - PROCESS INDICATORS


'ideal' value

Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

PR21: CIF/ex-factory value of a basket of drugs, out of average CIF/ex-factory value of the same basket the year of reference.

<100%

1811

178 (private)
234 (public)
(1995/1993)

100

(na)

114

103

PR22: CIF/ex-factory value of a basket of drugs, out of "reference" value on the international market of the same basket.

<100%

100

69
(?)

153

119

(na)

(-)

PR23: Average lead time for a sample of orders in the last year, out of average lead time during the past three years.

<100%

60

(-)

100

(na)

100

(-)

PR24: Average time period of payment for a sample of orders, out of average time period of payment stated in contract.

100%

178

(-)

188

(-)

100

200

PR25: Number of drugs/batches tested, out of number of drugs/batches procured.

100%

100

0

3

0

93

(-)

PR26: Number of drugs/batches that failed quality control testing, out of number of drugs/batches tested.

0%

9.52

(0)

4

(0)

7

(-)

Public sector distribution and logistics








PR27: Average time between order and delivery from central store to remote facilities in the last year, out of average time between order and delivery in the past three years.

<100%

33

(-)
(14 days)

(-)
(10 days)

39

75

(-)
(1-6 months)

PR28: Average stockout duration for a basket of drugs in the central and/or regional stores in the last year, out of average stockout duration for the same basket in the past three years.

<100%

1193

(-)

(-)

0

79

(-)

PR29: Average stockout duration for a basket of drugs in a sample of remote facilities in the last year, out of average stockout duration for the same basket in the past three years.

<100%

1253

(-)
(59 days)

(-)

294

81

(-)

1 When comparing 1996 to 1994: 181% - when comparing 1996 to 1995: 114%.
2 This figure is only for drugs tested on suspicion of non conformity.
3 Problems linked to the economic crisis rather than lack of management skills.

NATIONAL DRUG POLICY - PROCESS INDICATORS


'ideal' value

Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

Pricing policy








PR30: Value of a basket of drugs, out of CIF/ex-factory value of the same basket.

*

139

153 (private)
177 (public)

425

225 (private)

117 (private)
45 (public)


146 (public)

PR31: Average expenditure per prescription, out of average expenditure per prescription in the past three years.

<100%

(na)

(-) 1

(-)

103 (pr/CKY)5
226 (public)6

106 (private)
104 (public)

(-) 7

PR32: Value of a basket of drugs, out of value of the same basket the year of reference.

<100%

141
(1996/1994)

156 (private)2
192 (public)2
161 (market)2

100
(1995/1992)

112
(1995/1992)

131 (private)
100 (public)

(-)

Information and continuing education on drug use








PR33: Number of prescribers having direct access to a (national) drug formulary, out of total number of prescribers surveyed.

100%

25

52(prescribers)
44(dispensers)

503

33(prescribers)
12(dispensers)

21(prescribers)

15.2 (prescribers)

PR34: Number of training sessions on drug use for prescribers in the last year, out of average number of training sessions organized in the past three years.

>100%

(na)

0


(na)

0

(-)

PR35: Number of prescribers who have attended at least one training session in the last year, out of total number of prescribers surveyed.

100%

0(prescriber)
0(dispenser)

33(prescribers)
36(dispensers)

254

13(prescribers)
15(dispensers)

4 (prescribers)

11 (prescribers)

PR36: Number of issues of independent drug bulletins published in the last year, out of average number of issues of independent drug bulletins published per year in the past three years.

>100%

205

0

143
(1996/1995)

0

0

50
(1995/1994)

PR37: Average number of copies of independent drug bulletins sent to prescribers, out of total number of prescribers.

not<100%

11

0

3

(na)


(-)

PR38: Amount spent on public education campaigns on drug use, out of total amount spent on public health education campaigns.

*

(na)

(0)

(na)

(-)


(-)

Note to previous table:

* No ideal value, depends on country situation

1 Average expenditures are (in USD): 8.7 private; 1.4 public; 4.1 parallel market.

2 1995/1993.

3 More than 50% of prescribers had direct access in 43% of the hospitals assessed.

4 According to the level of care provided in the facility where the prescribers work (1st level 19%, secondary 25% and tertiary 28%).

5 Figure valid for the private sector in the capital (Conakry) only.

6 Average figure. In fact, for drugs authorized at health center level, the indicator is 94% (so a slight decrease in prices).

7 Average expenditure in private sector: 7.2 USD.

NATIONAL DRUG POLICY - OUTCOME INDICATORS*


'ideal' value

Bulgaria 1996

Chad

Colombia '95/'96

Guinea

India Andhra Pradesh

Mali

Availability of essential drugs








OT1: Number of drugs from a basket of drugs available in a sample of remote health facilities, out of total number of drugs in the same basket.

100%

85

80

(-)

93

66

(-)

OT2: Number of drugs at the lowest price from a basket of drugs, out of total number of drugs in the same basket.

100%

85

(-)

49

334 (private)
464 (market)

57

(-)

Affordability of essential drugs








OT3: Average retail price of standard treatment of pneumonia, out of the average retail price of a basket of food. (NB: basket of food for a family (6-8 persons) for 1 day)

(low)

2791

85 (private)
19 (public)

45 (private)3
34 (public)

166(private)
26 (public)
29 (market)

100 (private)
76 (public)

(-)

OT4: Value of a basket of drugs, out of the value of the same basket with the cheapest drugs.

- >100%

(na)

(-)

183

134 brand
490 INN

169

(-)

Quality of drugs








OT5: Number of drugs/batches that failed quality control testing, out of the total number of drugs/batches surveyed.

0%

9.62

92 (private)
65 (public)

4

19 (private)
23 (public)
24 (market)

19

(-)

OT6: Number of drugs beyond the expiry date, out of the total number of drugs surveyed.

0%

0

0 (private)
2 (public)

2

0 (private)
0.7 (public)
0 (market)

0

0

Rational use of drugs








OT7: Average number of drugs per prescription.

1.00-2.00

1.95

1.95 (private)
2.00 (public)
1.88 (market)

2.39

2.08 (private)
2.40 (public)
2.53 (market)

1.93 (private)
2.27 (public)

2,33

* All Outcome Indicators are percentages, except OT7.
1 NB: Basket of food for 1 person, 1 month.
2 Quality testing only in case of suspicion
3 NB: Basket of food for 3-5 persons, 1 month
4 Values for generic drugs; if brand name products are taken, the % available in pharmacies was 69% and in the market 32%.

NATIONAL DRUG POLICY - OUTCOME INDICATORS


'ideal' value

Bulgaria

Chad

Colombia

Guinea

India Andhra Pradesh

Mali

OT8: Number of prescriptions with at least one injection, out of the total number of prescriptions surveyed.

(low)

9.75

30 (private)
23 (public)
26 (market)


61 (public)1

21 (private)
20 (public)
34 (market)

5 (private)2
66 (public)

30.7

OT9: Number of children under five with diarrhoea receiving antidiarrhoeal drugs, out of the total number of children under five with diarrhoea surveyed.

- >0%

(nr)

29

9

15

78

(-)

OT10: Number of drugs from the national essential drugs list (EDL), out of the 50 best selling drugs in the private sector.

100%

46

50

60

26

42

303

1 This figure does not seem to reflect the reality, probably some problems happen when coding or transcribing data.

2 These data should be interpreted with caution as many private doctors administer injections at their clinics and then write prescriptions for drugs to be purchased outside. Consequently, the prescriptions studied at the retail outlet do not capture the injection prescription habits.

3 Out of the 30 best selling drugs.

NATIONAL DRUG POLICY - BACKGROUND INFORMATION


na = not available
nr = not relevant

1. COUNTRY INFORMATION:

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Population data







BG1: Total population (in millions)

68

17.6

59

72.5 (74.0)1

9.3

11.5

BG2: Average annual growth of the population (%)

2.4

1.2

1.98

2.16 (1.86)1

3.2

3.14

BG3: Percentage of population living in urban areas (%)

(na)

25
(1990)

23

19.8 (20.2)1

42

30.6

BG4: Life expectancy (years)

65

75
F 71 M

69.6

65

55
F 50 M

61

Economic data







BG5: GNP per capita (USD)

952

588

1650

220 (279.5)1

350

438

BG6: Average annual rate of inflation (%)

9.1

11.7

5.8

14.4

40

22.5

2. HEALTH INFORMATION:

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Health status data







BG7: Infant mortality rate (per 1000)

56

17.2

25.95

46

123.3

61

BG8: Maternal mortality rate (per 100,000)

80

30

14


220

395

1 Figures for 1995.

NATIONAL DRUG POLICY - BACKGROUND INFORMATION


Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Health system data







BG13: Total number of prescribers

483,275

6,127

13,6291

63,947


15,819

BG14: Total public health budget (million USD)

308
(1993)

151

1,985.4

168
(228.5)4


1432

BG15: Total value of international aid for the health sector (million USD)

69
(1990)

3

14.25

35.8
(47.4)4


392

BG16: Total health expenditure (million USD)

870
(1991)


5,938.2

231
(323)4


...

3. DRUG SECTOR INFORMATION:

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Economic data







BG17: Total public drug expenditure (million USD)

41
(1993)

23.5

93.15

33.6
(64.6)4


51.62

BG18: Total value of international aid for drugs (cash + kind) (million USD)

(na)

0.5

(na)

7.2
(9.6)4


9.252/3

BG19: Total drug expenditure (public + households + international aid) (million USD)

888
(1993)


2,000

239
(266)4


89.942

BG20: Total value of local production (ex-factory price) sold in the country (million USD)

(na)

5.5
(1994)

481.3

87


42.62

BG21: Total value of drug imports (CIF) (million USD)

171
(1992)

50
(1992)

187.3

152


44.72

1 Medical doctors. Data from government published statistics, but likely to be underestimated.
2 Fiscal year 1994/1995.
3 Figure for fiscal year 1995/1996 is 20.56 million US dollars.
4 Figures for 1995.
5 Hospitals under Ministry of Public Health only.

NATIONAL DRUG POLICY - BACKGROUND INFORMATION


Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

BG22: Total value of drugs under generic name (CIF and ex-factory prices) sold in the country (million USD)

84.6
(1994)


(nr)

(na)


59.933

Human resources







BG23: Total number of pharmacists

1,498

3,966

4,7214

7,500

101

485

BG24: Total number of pharmacy technicians or other aides/assistants

(na)

643

(na)

16,376

200
(estimation)

224

Drug sector organization







BG25: Total number of drug manufacturing units in the country

244

12

177

84

7

20

BG26: Total number of wholesalers in the country

693

150

(496
importers)

132

47

35

BG27: Total number of pharmacies and drug outlets in the public sector (including health facilities and hospitals that dispense drugs)

363

922

9,648

22,4001

877

1,037

BG28: Total number of pharmacies and drug outlets in the private sector

9,985

1,541

23,842

4,300
(ph´cy)
15,000(outl.)

288
36 (ph´cies)

922

BG29: Total number of private pharmacies and drug outlets in the three major urban areas

3,513

673

(na)

3,100

2

429

Number of drugs







BG30: Total number of registered drugs (in dosage forms and strengths)

15,050
(6,377 brands)

5,550

29,461

6,000

750

2,235
(1,135 INN)

BG31: Total number of drugs on the national essential drugs list (in dosage forms and strengths)


(536 INN)

350

389

188

354

592

1 Includes all kind of public drug outlets.
2 Almost all private pharmacies are in urban areas.
3 Fiscal year 1994/1995.
4 Data from government published statistics, but likely to be underestimated.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Legislation and regulation







ST1: Is there an official national drug policy document updated in the past ten years?

Y

N

Y

N (94)
Y (95)

N

Y

ST2: Is there drug legislation updated in the past ten years?

Y

N

Y

Y

N

Y

ST3: Have regulations based on the drug legislation been issued?

Y

Y

Y

Y

N

Y

ST4: Is there a drug regulatory authority whose mandate includes registration and inspection?

Y

Y

Y

Y

Y

Y

ST5: Is there a licensing system to regulate the sale of drugs (wholesalers, pharmacists, retailers)?

Y

Y

Y

Y

Y

Y

ST6: Are pharmacists legally entitled to substitute generic drugs for brand name products?

Y

N

N

N

N1

Y

ST7: Are there legal provisions for penal sanctions?

Y

Y

Y

Y

Y
(but low)

Y

ST8: Is there a check-list for carrying out inspections in different types of pharmaceutical establishments?

Y

N

Y

N

Y

Y

ST9: Are there any institutions within or outside the country where quality control is carried out?

Y

Y

Y

Y

Y

Y

ST10: Is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce used systematically?

N

Y

N

N

Y

N

ST11: Are there controls on drug promotion based on regulations and consistent with the WHO ethical criteria for medicinal drug promotion?

N

Y

Y

N (94)
Y (95)

N

Y

1 The Draft Act is silent on this issue; at the University Teaching Hospital pharmacists are allowed to issue generics when a brand name is prescribed.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Essential drugs selection and drug registration







ST12: Is there a national essential drugs list (EDL)/formulary using INN officially adopted and distributed countrywide?

Y

Y

Y

Y

Y

Y

ST13: Is there an official drug committee whose duties include updating the national essential drugs list (EDL)?

Y

N

Y

N (94)
Y (95)

Y

Y

ST14: Has the national essential drugs list (EDL)/formulary been updated and distributed countrywide in the past five years?

Y

Y

Y

N (94)
Y (95)

N

Y

ST15: Is it mandatory that drug donations comply with the national essential drugs list (EDL)?

N

N

N

N

N

Y

ST16: Are there formal procedures for registering drugs?

Y

Y

Y

Y

Y

Y

ST17: Is there a drug registration committee?

N1

Y

Y

Y

Y2

Y

ST18: Is drug registration renewal required at least every five years?

Y

Y

N

Y

N
(but annual retention fee)

Y

Drug allocation in the health budget/public sector financing policy







ST19: Is the public drug expenditure more than 20% of the MOH operating budget spent per year for the last three years?

N

N

Y

N

N

Y

ST20: Is the public drug expenditure per capita more than US$1.00 per year for the last three years?

N

Y

Y

N

N

Y

1 No specific committee but a well-organized procedure conducted by BFAD.
2 No specific committee; the secretariat of the Pharmacy, Medicine and Poisons Board is taking on this function.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

ST21: Is the percentage of the public drug expenditure for national hospitals less than 40% for the last three years?

(na)

Y

Y

N


Y

ST22: Has the public drug expenditure per capita increased in the last three years?

(na)

Y

Y

Y

N

Y/N4

ST23: Are there any financing systems in addition to the public drug budget that contribute to the provision of drugs in the public sector?

Y

N

Y

Y

N

N

Public sector procurement procedures







ST24: Are drugs usually procured in the public sector through competitive tender?

Y

Y

Y1

N

Y

Y

ST25: Is there a system for monitoring supplier performance?

N

Y

Y

N

Y
(partly)

N

ST26: Are tenders done under INN?

Y

Y

Y

N

Y

Y

ST27: Does the procurement unit receive foreign currency in less than 60 days (from request to release)?

(nr)

Y

(nr)

Y

N

Y

ST28: Is procurement in the public sector limited to drugs on the national essential drugs list (EDL)?

Y

N

N

N

Y

Y

ST29: Is the average lead time (from order to receipt at central level) less than 8 months?

Y

N

(nr)

Y

N

Y

ST30: Is procurement based on a reliable quantification of drug needs?

N

Y

Y/N2

N

Y/N3

N

1 Only when the value exceeds 2000 US dollars.

2 Practices vary in different hospitals.

3 There is a model to calculate drug needs based on consumption figures, but due to insufficient funds the calculated figures have to be reduced, which is often done on an 'ad hoc' basis.

4 It went up, then down.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Public sector distribution and logistics







ST31: Are good storage practices observed in the central procurement/distribution unit and/or major regional warehouses?

Y

N

Y/N1

N
Y (central)

Y

59%

ST32: Is the information recorded on the stockcards for a basket of drugs the same as the quantity of stock in store?

Y


Y/N1

Y


88%

ST33: Are the stocks for a basket of drugs within their expiry dates in the central procurement/distribution unit and/or major regional warehouses?

Y


Y/N1

Y


Y

ST34: Have all incoming products been physically inspected for the last three deliveries in the central procurement/distribution unit and/or in the major regional warehouses?

(na)

N

Y/N1

N

Y

Y

ST35: Are only drugs which are on the national essential drugs list (EDL) in stock in the central procurement/distribution unit and/or in the major regional warehouses?

Y

N

Y

Y


Y

ST36: Are 80% or more of the vehicles of the central procurement/distribution unit and/or major regional warehouses in working condition?

(nr)


Y

Y

Y

Y

Pricing policy







ST37: Are drug prices regulated in the private sector?

N

Y

N

N

N

N

ST38: Is there at least one major incentive for selling essential drugs at low cost in the private sector?

N

N

N

N

N

(Y)2

ST39: Is the total margin used by wholesalers and retailers less than 35% of the CIF price?

(na)

Y

N

N

N2

N

1 Individual hospitals usually purchase directly from manufacturers/importers; for most individual hospitals the answer is 'no'.

2 There is one incentive: the Medical Aids Society refunds only the generic price; + 25% of population is member, but the number is increasing.

NATIONAL DRUG POLICY - STRUCTURAL INDICATORS


Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

ST40: Is there a system for monitoring drug prices?

Y

N

N

N

N

Y

ST41: Are essential drugs under INN or generic name sold in private drug outlets?

Y

Y

Y

Y

Y1

Y

Information and continuing education on drug use







ST42: Is there a national publication (formulary/bulletin/manual, etc.), revised within the past five years, providing objective information on drug use?

Y

Y

Y

Y

Y

N

ST43: Is there a national therapeutic guide with standardized treatments?

Y

Y

Y

Y

Y
(partly)

Y

ST44: Is the concept of essential drugs part of the curricula in the basic training of health personnel?

N
(starting to do this)

Y

Y

N


Y

ST45: Is there an official continuing education system on rational use of drugs for prescribers and dispensers?

N

N

Y

N

N

N

ST46: Is there a drug information unit/centre?

Y

N

Y

Y

N

Y

ST47: Does the drug information unit/centre (or another independent body) provide regular information on drugs to prescribers and dispensers?

N

N

Y

N

N

N

ST48: Are there therapeutic committees in the major hospitals?

Y

Y

Y

Y

Y2

N

ST49: Are there public education campaigns on drug use?

Y

N

Y

N (94)
Y (95)
(on antibiotics only)

N3

Y2

ST50: Is drug education included in the primary/secondary school curricula?

N

N

Y

N


N

1 Although there is no specific policy on this.
2 In process.
3 Partly.

NATIONAL DRUG POLICY - PROCESS INDICATORS*


'ideal' value**

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Legislation and regulation








PR1: Number of drug outlets inspected, out of total number of drug outlets in the country.

not <50%

110
(NCR)

100

59.8

27.5


15

PR2: Number of drug outlets in violation, out of total number of drug outlets inspected.

0%

10

35

7.6

84.2


36

PR3: Number of sanctions and administrative measures implemented, out of total number of violations identified.

100%

7

17.5

23.3

65.5

(3 licences
revoked '94)

16

PR4: Number of samples routinely collected, out of total number of planned collected samples.

100%

(-)
(3,758 samples collected)


45.9

79


(nr)

PR5: Number of samples tested, out of total number of samples collected.

100%

93


60.4

92.1


(-)
(153 samples tested)

PR6: Number of advertisements in violation of regulations on the ethical promotion of drugs, out of total number of advertisements monitored.

0%

3


2.5

(na)


36

PR7: Number of sanctions implemented for advertisements in violation of regulations, out of total number of violations identified.

100%

100


23.3

(na)


33

Essential drugs selection and drug registration








PR8: Value of drugs from the national essential drugs list (EDL) procured in the public sector, out of total value of drugs procured in the same sector.

- >100%

100

69

53.3

40
(estimation)

100

1002

PR9: Number of drugs from the national essential drugs list (EDL) prescribed, out of total number of drugs prescribed.

- >100%

79 (private)
91 (public)


76.81
(public)

36.2 (priv.)
40.5 (pub)


70 (private)
99 (public)

PR10: Number of drugs from the national essential drugs list (EDL) sold, out of total number of drugs sold.

- >100%

77

50.4

42.1

33.3

69 (private)
80 (public)

(-)

Note to previous table:

* All Process Indicators are percentages.

** - > 100% = the 'ideal' value should approach 100%, but does not necessarily have to reach 100%.

1 Data from 2 hospitals.

2 GMS procures only from EDL; Hospitals can procure other drugs; figures are not available, but % non-EDL drugs is expected to be small.

NATIONAL DRUG POLICY - PROCESS INDICATORS


'ideal' value

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

PR11: Number of locally manufactured drugs sold in the country from the national essential drugs list (EDL), out of the total number of drugs from the national essential drugs list.

- >100%

(nr)

17

(na)

56.9


53

PR12: Number of combination drugs newly registered, out of total number of newly registered drugs.

- >0%

5

16.2

14.2

25.7


22

PR13: Number of registered drugs which are banned in other countries, out of total number of registered drugs.

- >0%

4



(na)


0

Drug allocation in the health budget/public sector financing policy








PR14: Value of public drug budget spent per capita in the last year, out of average value of the same budget during the past three years.

>100%

(na)

126

(na)

184


100

PR15: Value of public drug budget spent by major hospitals, out of value of public drug budget spent.

not >40%


35

(na)

90.7


21

PR16: Value of international aid received for drugs, out of value of public drug budget.

(-)

(-)

2

(na)

20.4


17.9

PR17: Value of revenue generated for drugs through additional financing system, out of value of public drug budget.

(-)



(na)

42.8

1

2.9

PR18: Public drug budget spent, out of public drug budget allocated.

100%

100

100

(na)

100


144

Public sector procurement procedures








PR19: Value of drugs purchased through competitive tender, out of value of drugs purchased.

- >100%

100

100

100



53.7

PR20: Value of drugs purchased from local manufacturers through competitive tender, out of value of drugs purchased through competitive tender.

- >100%

(nr)

< 20
(estimation)

(nr)

(nr)
(no tender)


682

1 A cost recovery system exists; its total value is < 1% of the total public health budget.

2 Estimation; this figure was calculated for 1992 (65%), and is believed to have remained about the same.

NATIONAL DRUG POLICY - PROCESS INDICATORS


'ideal' value

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

PR21: CIF/ex-factory value of a basket of drugs, out of average CIF/ex-factory value of the same basket the year of reference.

<100%

(-)


(na)

(na)


110

PR22: CIF/ex-factory value of a basket of drugs, out of "reference" value on the international market of the same basket.

<100%

(-)


(na)

(na)


100

PR23: Average lead time for a sample of orders in the last year, out of average lead time during the past three years.

<100%

(-)


(na)

33.3


98

PR24: Average time period of payment for a sample of orders, out of average time period of payment stated in contract.

100%

(-)


(na)

133


150

PR25: Number of drugs/batches tested, out of number of drugs/batches procured.

100%

95


27

14.26

0

7.7

PR26: Number of drugs/batches that failed quality control testing, out of number of drugs/batches tested.

0%

1.5

221

23.5

0


10

Public sector distribution and logistics








PR27: Average time between order and delivery from central store to remote facilities in the last year, out of average time between order and delivery in the past three years.

<100%

(-)
(12 days in 1995)

99

(excluded)

(-)
(4.8 days)

2

115

PR28: Average stockout duration for a basket of drugs in the central and/or regional stores in the last year, out of average stockout duration for the same drug basket in the past three years.

<100%

(-)


(excluded)

(na)

60 MSL3
2 OMS 3

(-)
(24.5 days)

PR29: Average stockout duration for a basket of drugs in a sample of remote facilities in the last year, out of average stockout duration for the same drug basket in the past three years.

<100%

(-)
(173 days in 1995)


(excluded)

(-)
(2.6 days)


(-)

1 Average figure; 32% of 'complaint-samples' and 13% of randomly collected samples failed.
2 Drug kits are delivered automatically, without order.
3 MSL = Medical Stores Limited; OMS = Old Medical Stores.

NATIONAL DRUG POLICY - PROCESS INDICATORS


'ideal' value

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Pricing policy








PR30: Value of a basket of drugs, out of CIF/ex-factory value of the same basket.

(-)

(-)

165
(CIF)

(excluded)

(na)


213 (private)
115 (public)

PR31: Average expenditure per prescription, out of average expenditure per prescription in the past three years.

< 100%

(-) 1


(excluded)

95.6 (private)
96.6 (public)


110 (private)
101 (public)

PR32: Value of a basket of drugs, out of value of the same basket the year of reference.

< 100%

(-)


(excluded).

98.4 (private)
122.2 (public)


112 (private)
110 (public)

Information and continuing education on drug use








PR33: Number of prescribers having direct access to a (national) drug formulary, out of total number of prescribers surveyed.

100%

42

3

(excluded)

31.5
82.5 (95)

41.3

91

PR34: Number of training sessions on drug use for prescribers in the last year, out of average number of training sessions organized in the past three years.

> 100%

(-)


(na)

360


300

PR35: Number of prescribers who have attended at least one training session in the last year, out of total number of prescribers surveyed.

100%

27

21

(excluded)

69.5

29

5(prescribers)
56(dispensers)

PR36: Number of issues of independent drug bulletins published per year, out of average number of issues of independent drug bulletins published per year in the past three years.

> 100%

200

120

(excluded).

154.5


40
(Pharmanews)

PR37: Number of copies of independent drug bulletins sent to prescribers, out of total number of prescribers.

not < 100%

35

95

(excluded)

78.5


25
(Pharmanews)

PR38: Amount spent on public education campaigns on drug use, out of total amount spent on public health education campaigns.

(-)-

(-)


(na)

6


3

1 Average expenditure per prescription in 1995: private sector = 5.81 USD, public sector = 3.75 USD.

NATIONAL DRUG POLICY - OUTCOME INDICATORS*


'ideal' value

Philippines

Sri Lanka

Thailand

Viet Nam

Zambia

Zimbabwe

Availability of essential drugs








OT1: Number of drugs from a basket of drugs available in a sample of remote health facilities, out of total number of drugs in the same basket.

100%

54

100

(excluded)

80.5

54.8

70

OT2: Number of drugs at the lowest price from a basket of drugs, out of total number of drugs in the same basket.

100%

66


(excluded)

53

17

64

Affordability of essential drugs








OT3: Average retail price of standard treatment of pneumonia, out of the average retail price of a basket of food. (NB: basket of food for a family (6-8 persons) for 1 day)

low

16 (private)
9 (public)


(excluded)

188.6(private)5
179.5 (public)


38 (private)
28 (public)

OT4: Value of a basket of drugs, out of the value of the same basket with the cheapest drugs.

- >100%

(-)


(excluded)

262

1796

135

Quality of drugs








OT5: Number of drugs/batches that failed quality control testing, out of the total number of drugs/batches surveyed.

0%

5

13

21.8

25


10

OT6: Number of drugs beyond the expiry date, out of the total number of drugs surveyed.

0%

0


(excluded)

0.16

0 (private)
2 (public)

3

Rational use of drugs








OT7: Average number of drugs per prescription.

1.00-2.00

2.63 (private)
1.73 (public)

1.92 (private)
(data partly analysed)

3.054

4.3 (private)
4.5 (public)

2.0 (pr.clin.)
1.5 (pr.outlet)
2.3 (public)

1.72(private)
1.65 (public)
1.80 (RHC)1

OT8: Number of prescriptions with at least one injection, out of the total number of prescriptions surveyed.

low

12 (private)
6 (public)

12

2.64

17.3 (private)
31.9 (public)

24 (pr.clin.)
9.6 (pr.outlet)
20 (public)

3 (private)
13 (public)

OT9: Number of children under five with diarrhoea receiving antidiarrhoeal drugs, out of the total number of children under five with diarrhoea surveyed.

- >0%

0.4 (private)
2.96 (public)

03

95.58

10.5

58 (pr.clin.)7
54 (pr.outlet)
30 (public)

(-)

OT10: Number of drugs from the national essential drugs list (EDL), out of the 50 best selling drugs in the private sector.

100%

52


(excluded)

78

94

50

Note to the previous table:

* All Outcome Indicators are percentages, except OT7.

1 RHC = rural health center (public sector).

2 Data partly analysed; injections often provided directly by prescriber, and therefore 'not prescribed'.

3 No paediatric antidiarrhoeal drugs in the market.

4 Data from 2 provincial hospitals.

5 The average retail price of a basket of food is calculated in Viet Nam for one person/day.

6 Provisional figure; the importance of the different drugs in the basket has not yet been taken into account.

7 pr.clin. = private clinic/dispensary; pr.outlet = private drug outlet; public = public drug outlet.

8 Private drugstores only.

 

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The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: August 29, 2014