E-DRUG: South African Health Review 1997, Chapter 10: Drug Policy

["Halima Rooplall" <halima@healthlink.org.za>]

E-drug: South African Health Review 1997, Chapter 10: Drug Policy
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Chapter 10: DRUG POLICY

Full text:  http://www.healthlink.org.za/hst/sahr/97/chap10.htm    or
Portable Document Format: 
ftp://www.healthlink.org.za/pubs/SAHR/1997/Chap10.pdf

INTRODUCTION

The National Drug Policy (NDP) is the South African Government's macro
plan for the rational and economic use of drugs in the country.1 If
carefully and appropriately implemented the NDP will assist in the
improvement in the health status of the population of South Africa.

A glance at the 1996 Review

The 1996 Review addressed the key issues of both the NDP and the South
African Drug Action Programme (SADAP).2 This programme (SADAP) was
envisaged to ensure the implementation of the NDP over the next four
years through three phases: 

* Phase one would comprise those aspects for which no regulatory or
   legislative alterations were necessary, such as the preparation of
   essential drugs lists. 
* Phase two would involve the amendment of regulations issued in 
   terms of current legislation (eg. proposed regulation R.1150 of 12 
   July 1996) 
* Phase three would be the major changes to legislation such as to 
   the Pharmacy Act and the Medicines and Related Substances Control 
   Act . 

This chapter will focus on six key areas of the NDP and will assess
the degree to which the policy has been implemented, and consider the
success of the phased approach.

LEGISLATION AND REGULATION

Policy directives

The aim of ensuring that drugs reaching patients are safe, effective
and meet approved standards and specifications entails amendment of
two areas of legislation and their attendant regulations. The
Medicines and Related Substances Control Act, No 101 of 1965 requires
strengthening in order to aid the Medicines Control Council in its
regulatory role. In addition, a number of Acts governing the
dispensing of drugs by various service providers require consolidation
(eg. Nursing Act).

Progress to date

The proposed regulation R.1150 dealing with, amongst other things the
labelling of medicines, licensing and the use of non-proprietary
name-prescribing, was published for comment in the Government Gazette
in July 1996. After inputs from many interested parties, this
regulation was withdrawn for further technical attention. Inputs were
also gathered by the Parliamentary Portfolio Committee on Health.3
Most of the inputs were subjective in nature and were concerned with
issues around the proposed further training of health professionals
(such as dispensing doctors) for licensing purposes. A sub-committee
was convened by the portfolio committee and briefed with the task of
investigating pertinent case studies dealing with dispensing and
trading doctors, their interaction with the public and financial
analysis. The study has to date not delivered a report and some key
players have effectively withdrawn. 

The Medicines and Related Substances Amendment Bill was withdrawn
following its First Reading in Parliament. In particular, Government's
intention to allow for the possible parallel importation of medicines
has provoked vigorous response in the press from the pharmaceutical
manufacturing sector, even though the intention was clear in the
policy and had been reported widely.4,5 (See chapter 3 on
legislation).

Considerable progress has been made with regard to the amendment of
the Pharmacy Act. The Amendment Bill, which was tabled in Parliament
in early May 1997, provides for a new composition of the Pharmacy
Council, taking into account the impact of the Forum for Statutory
Health Councils and the need to have more representation from
provincially employed pharmacists who provide pharmaceutical services
to some 80% of the population.6 The imperatives of the National
Qualifications Framework have also been accommodated in the Bill, but
these may still be affected by developments in Education policy. The
Bill sets out to enable the Pharmacy Council to introduce lay
ownership of retail pharmacies, in support of the NDP. Specifically,
allowance is made for multi-professional practices for private
hospital pharmacies, and for the licensing of all pharmacies by the
Department of Health. This Bill was also withdrawn. It is envisaged
that both Bills, after minor technical revisions will be resubmitted
to Parliament in the second half of 1997.

DRUG PRICING

Policy directives

The NDP plans to curb the increase in drug acquisition costs by
rationalising drug pricing and by promoting the use of generic drugs.
In terms of rationalising pricing, the policy suggests replacement of
the wholesale and retail mark-up system with one based on a
professional fee. A Pricing Committee was suggested at a national
level to monitor and regulate drug prices and to introduce
transparency into the pricing process in the private pharmaceutical
sector. 

Progress to date

The Department of Health has taken a very significant step in the
provision of health care where drugs are now supplied free of charge
to patients at the primary health care (PHC) level. It is policy that
in time all of these drugs will comply with the Essential Drugs List
(EDL). 

In late January 1997 agreement was reached between the Pharmaceutical
Society of South Africa and the Representative Association of Medical
Schemes on a new pricing structure for retail pharmacy. This would be
based on an acquisition cost (a disclosed non-discriminatory net unit
price ex-manufacturer to which distribution fees, inventory-related
costs and practice costs would be added) and a professional fee (based
on a tariff per hour, with unit times for specific procedures). 

Following a meeting of the National Consultative Drug Policy Forum, an
implementation date of 1 April 1997 was agreed upon.7 This system has,
however, been attacked in the press by the Pharmaceutical
Manufacturers Association (PMA)8 and was not implemented on the agreed
date. The implementation of generic and/or therapeutic substitution,
is dealt with in the Amendment Bill to the Medicines and Related
Substances Control Act. International experience has shown that these
measures, combined with efficient logistics and a degree of
international tendering can reduce drug costs. Such a system was shown
to reduce unit costs by more than 50% in its first procurement cycle
in a group of nine Eastern Caribbean countries.9 

DRUG SELECTION

Policy directives

The NDP endorses the application of the Essential Drug concept and
proposes an Essential Drug List (EDL) Committee and a three-tier set
of EDLs.

Progress to date

The first Standard Treatment Guidelines and EDL for Primary Care was
released in March 1996. 10 However, application of the list has been
patchy. Some provincial and local authorities have had problems with
the availability of some drugs on the list . A lack of input from
primary care practitioners was also noted. Providers of primary care
training programmes lamented the disease orientation of the list,
preferring a syndromic or presenting problem approach. This list is
currently being reviewed, and a second list is expected before the end
of 1997.11

The process being followed with the preparation of the secondary and
tertiary EDLs is quite different. A list of "systems", with disease
states within each system has been drawn up.12 Each section has been
allocated to a recognised specialist in that field. However, progress
on this "hospital list" has been slow.

PROCUREMENT AND DISTRIBUTION

Policy directives

The NDP suggests measures to improve the cost-effectiveness of public
sector distribution facilities and to use private sector facilities
where applicable. The public sector co-ordinating body for procurement
(COMED) was to have been strengthened.

Progress to date

Attention is being given to increasing the efficiency of COMED. COMED
has obtained prices substantially lower than those of the private
sector but they are still 23% higher than the international generic
market. Also COMED continues to have no say over the selection or the
quantities of drugs bought by the Provinces. There has been a hint of
Provinces taking over their own "COMED" activities. Development of
information and accounting systems is slow. As a result there is an
absence of exact data of drug expenditure at national level.

The Northern Province and Mpumalanga no longer have access to
centralised pharmaceutical stores as a result of boundary changes and
have used private sector suppliers. An innovative system has been
developed in the Free State, where private pharmacies have been
supplied with state medicines, via a private wholesaler, for
dispensing to District Surgeons' patients.13 While successful in that
setting, the high cost of this system militates against its
introduction in many other areas. Private sector initiatives in drug
distribution are on the increase. The impact of managed care will be
felt in the private sector, with many schemes adopting similar tender
processes to those used by the State, in an attempt to reduce
expenditure on drugs. For example, in February 1997, the South African
Managed Care Coalition (SAMCC) persuaded 50 pharmaceutical
manufacturers to tender for supply of medicines at significantly lower
prices on the basis of a formulary prepared by SAMCC members.14

In an effort to control shrinkage, the DoH included in regulation
R.1150 its intention to implement a Central Mark Control System for
all medicines. Implementation is awaited of this system whereby each
medicine pack will be labelled with an unique bar code identifying its
origins. 

Another area addressed by the policy was that of the promotion of
local manufacture of drugs. To address this issue, the Department of
Trade and Industry has established an initiative for the
pharmaceutical sector. This attempts to bring together all relevant
stakeholders in order to devise strategies for the strengthening of
this sector of the economy. In an effort to encourage local industry,
local tenders are considered even if up to 15% higher than the lowest
tender of international companies.

RATIONAL DRUG USE

Policy directives

This policy aims to promote rational prescribing, dispensing and use
of drugs by all health workers and the public. Emphasis is placed on
education and training, on the provision of drug information and on
appropriate prescribing and dispensing. The body entrusted with this
task is the South African Drug Action Programme (SADAP), which has
received external funding for a period of 4 years after which the
essential programmes it develops will be institutionalised within the
Department of Health.

Progress to date

In November 1996, the Co-ordinating Committee for the Training of
Prescribing Personnel in the Effective Use of Medication at the
Primary Health Care Level arranged a workshop in Pretoria.15 This
workshop can be seen as the first evidence of the SADAP process which
officially appointed its Director, Dr Wilbert Bannenberg, on a
full-time basis from January 1997. Another area of development has
been the appointment of Provincial Essential Drugs Co-ordinators
(PEDCOs) who are to form the link between SADAP and the Provincial
authorities. For example, in the North West Province the PEDCO was
able to already claim some progress, in that a trainer pharmacist post
for the Province had been approved.16

HUMAN RESOURCE DEVELOPMENT

Policy directives

The National Drug Policy (NDP) emphasises the need for strengthening
drug supply management skills. Two aspects can be delineated: the
efforts to bring health professional curricula into line with the NDP
and the changes to provincial organograms to support implementation.

Progress to date

On the curriculum front, some progress has been made in defining a new
approach to the training of pharmacists and pharmacy support
personnel. A training system which complies with the National
Qualifications Framework is being developed. Initial documents on the
competencies of entry-level pharmacists and support personnel are in
the final stages of validation.17 SADAP has confirmed the need to
define the competencies of all personnel involved in drug prescribing
and management and to co-ordinate training efforts in this regard.

New drug training projects and courses

The Rational Drug Prescribing Training Project of the Universities of
Durban-Westville and UCT. This project has produced a training manual
for primary level prescribers and initiated a regional drug
information centre.18,19

The WHO Collaborating Centre on Drug Policy, Information and Safety
Monitoring at the University of the Western Cape (UWC, School of
Pharmacy) and UCT (Department of Pharmacology) runs short courses such
as The Essential Drugs course for a District Health Care System.

A series of training courses promoting Aspects of Rational Drug Use
are offered by MEDUNSA, both alone and in collaboration with the
Boston-based consultancy Management Sciences for Health (MSH).

Almost all provincial Health Departments are understaffed with
pharmaceutical personnel. Exact figures on the number of active
pharmacists or support personnel posts are unknown. The scale of the
challenge can be seen in the figures from the Free State (Figure 1).
In January 1997, only 35% of a total of 148 pharmacist posts in the
Province were filled. Notably, only 1 of 8 Chief Pharmacist posts was
filled. Efforts have been made to improve the human resources
situation in some provinces and Mpumalanga has approved a position for
a district pharmacist in each District Health Management Team.20
However approval of a position does not mean the post will be filled!

Attempts to draw pharmacists to provincial services are seriously
hampered by flawed appointment measures, which do not allow for
starting salaries commensurate with prior experience. No incentives to
work in rural areas have been developed.

A recent Health Systems Trust publication has reported on a large
scale evaluation of pharmaceutical services in the Northern
Province.21 The authors advocate intensive training for all staff in
drug supply management and rational prescribing. The study
demonstrated a number of areas of concern. These included:

* no clinic staff were aware of the NDP 
* only 60% of hospitals had at least one qualified pharmacist 
* 55% of all clinic attenders received at least one antibiotic 
* only 50% of hospitals had a thermometer in the refrigerator used to 
   store vaccines (no hospitals recorded fridge temperatures). 

SUMMARY
Implementation of the NDP has been slow over the last year which is
directly related to the lack of legislative support. In terms of phase
one implementation, not all the essential drugs lists have been
compiled. The Primary Health Care List is being reviewed, and cannot
really be regarded as having been implemented. Initiation of phase two
implementation has met with opposition and has resulted in delays
while the regulations are being rewritten or the Acts which will
enable promulgation of such regulations are being amended. Phase three
implementation is dependent on the parliamentary timetable, and the
amendment bills of relevance to the NDP are among the legislation
which need to be enacted in the 1997 session if significant progress
is to be made. 

SADAP, now fully operational with adequate funding and staffing, is
expected to impact significantly on the implementation process. The
1996 Review chapter ended with the following observation: "the degree
of opposition by vested interests to the implementation of such
progressive policies cannot be overemphasised".1

It remains to be seen in 1997 whether new legislation will be enough
to significantly speed up the implementation of the NDP against this
background of continued opposition based on vested interests.

It is crucial that significant changes to the drug policy arena be
implemented before the political capital of the change of government
is lost. This effect was elegantly demonstrated in the political
handling of drug policy reform after the Aquino government came to
power in the Philippines.22 Failure to achieve fundamental drug policy
changes might result in considerable expenditure on infrastructural
development without the wherewithal to supply essential drugs.23

This challenge was well put by the Minister of Health, Dr Zuma: "There
were problems in the development process and I'm sure there are going
to be problems in implementation. In fact, there are going to be
problems all the time".5

Authors: Andy Gray, Department of Pharmacy, University of
Durban-Westville;  Peter Eagles, Department of Pharmacy, University of
the Western Cape 

REFERENCES:
1. Department of Health. National Drug Policy for South Africa.
Pretoria, 1996.

2. Summers R, Suleman F. Drug Policy and Pharmaceuticals. In The South
African Health Review 1996. Health Systems Trust and the Henry J
Kaiser Family Foundation, Durban, 1996.

3. National Portfolio Committee on Health. Report on Public Hearings
on Proposed Regulations on the Dispensing of Drugs. November 1996.

4. The Mercury. Zuma plans cheap drug imports. 7 May 1997.

5. Fresle D. South Africa's new National Drug Policy. Essential Drugs
Monitor 1996; 21: 17-18.

6. Minister of Health. Pharmacy Amendment Bill. 

7. Minutes of National Consultative Drug Policy Forum, 26 February
1997, Pretoria.

8. The Star. New pricing structure for drugs under attack, 18 February
1997.

9. Huff-Rouselle M, Burnett F. Cost containment through pharmaceutical
procurement: a Caribbean case study. International Journal of Health
Planning and Management 1996; 11: 135-15 7.

10. Department of Health. Essential Drugs List and Standard Treatment
Guidelines for Primary Health Care, Pretoria, 1996.

11. Minutes of the Essential Drugs Programme Implementation Meeting,
20 February 1997, Durban.

12. Department of Health. Common Conditions of Patients for Hospital
EDL, 23 September 1996.

13. H. Marais. Head, Pharmaceutical Services, Free State Department of
Health (personal communication)

14. Sunday Independent. Drug companies help to cut cost of medicine.
16 February 1997.

15. Report of the First Workshop for the Training of Prescribing
Personnel in the Effective Use of Medication. 5/6 November 1996,
Pretoria.

16. Jordan M. EDL Implementation in North West Province, February
1997.

17. Interim Pharmacy Council of South Africa. Draft Unit Standards for
Pharmacists' Assistants and for Entry-level Pharmacists.

18. Orrell C, Kishuna A. Rational Drug Prescribing Training Course -
Training Manual. Health Systems Trust, 1997.

19. Kishuna A, Orrell C. Rational Drug Prescribing Training Project .
Progress Report. 31 January 1997

20. Department of Health, Welfare and Gender Affairs. Primary Health
Care in Mpumalanga. Guide to District-Based Action. Health Systems
Trust, Durban, 1996.

21. Moller H, Summers RS. Evaluation of the Transformation of
Pharmaceutical and Related Services in the Northern Province. Health
Systems Trust, Durban, 1997.

22. Lee MB. The politics of pharmaceutical reform: the case of the
Philippine National Drug Policy. International Journal of Health
Services 1994; 24(3): 477-494.

23. Sunday Independent. New clinics are little use when their
dispensaries have no medicine. 20 April 1997.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Halima Rooplall
Health Systems Trust     Tel: 27 31 3072954
PO Box 808               Fax: 27 31 3040775 
Durban, 4000             halima@healthlink.org.za
http://www.healthlink.org.za

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