Implementing National Drug Policies

1
Implementing National Drug Policies
2
What have we learned about this topic based on
evidence?

• NDPs are most successful when they include
• Implementation plan that involves all
  stakeholders,
• capacity development.
• Evaluation and measurement as an integral part of
  the plan.
• Keep telling the story to all

3
Recommendations

• Develop measurement systems (indicators/outcomes)
  
• Identify small, easy and potentially
  successful targets to address in early
  interventions
• Talk to the Minister and the media, and the
  health professionals, and the consumer.
• Plan budgets and strategies to convert projects
  to programs
• Plan a long term strategy to reinforce and renew
  political and professional support -

4
Key NDP research questions

• What are the best /possible and sustainable data
  systems for measuring and monitoring policies in
  different settings?
• What are effective strategies for converting
  policy into effective programs?
• Using the media in NDP implementation how, what
  for, what works (best), what doesnt work?
• Research into behaviour and attitudes of doctors,
  health professionals and consumers?
• What strategies are effective in sustaining
  capacity development?

5
Regulation on drug quality and use
6
What have we learned about this topic?

• Regulation without enforcement does not assure
  quality
• There is little evidence of the impact of global
  and regional initiatives and tools (e.g. use of
  WHO Certification Scheme, GMP, GPP guidelines) on
  country efforts to assure the quality of
  essential medicines.
• Despite having UN list of banned substances, many
  of these products are in the market.

7
Recommendations

• Regulatory bodies, procurement agencies, and
  other national stakeholders should critically
  assess the performance of current operational
  quality assurance strategies.
• WHO and development assistance agencies should
  support country initiatives to assure the quality
  of medicines, including strengthening
  enforcement.
• The UN list of banned and restricted substances
  should be acted upon in all member states
• Banning should be accompanied by suggested
  alternative treatments, be publicized, monitored
  and drugs be recalled from the market.

8
Key regulatory research questions

• How can different strategies contribute to assure
  quality, including combating counterfeit
  products?
• Regional surveys of what, was done in the
  different countries to follow up decisions to
  include substances in the UN list of banned
  substances and if nothing was done, why not.
• Qualitative research as to why regulations are
  not enforced.

9
Strategies for Improving Pharmaceutical Promotion
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What knowledge do we currently have about this
topic?

• Inappropriate promotion continues to be very
  widespread
• Compliance to, and awareness of WHO EC is
  generally poor
• Voluntary guidelines and Self-regulation are
  rarely effective on their own
• Many regulations exist that are not effectively
  enforced

11
Recommendations

• Develop networking opportunities for regions
• Report your research and experiences to the
  WHO/HAI drug promotion database
• Enforce existing regulations and publicize
  enforcement actions
• Develop and implement training/awareness programs
  for professionals and consumers

12
Recommendations (Cont.)

• Every country needs to develop an effective and
  realistic strategy for controlling drug promotion
• Develop and implement free access to good,
  unbiased drug and therapeutics information, both
  for professionals and the public
• Develop funding mechanisms to monitor/enforce,
  possibly including a levy on promotional spending
  by the pharmaceutical industry
• Educating children about medicines, and awareness
  of pharmaceutical promotion

13
Key promotion research questions

• What is the extent and impact of drug promotion
  and regulation in developing countries?
• What new tools are needed for improved monitoring
  and evaluation?
• What is the impact of Internet drug
  promotion/sales? How can they be controlled?
• What effect does drug promotion have on
  childrens perceptions of medicine taking?

14
Injection safety
15
What knowledge do we currently have about this
topic?

• Significant progress has occurred in this area.
• Better communication between patients and
  providers can reduce injection overuse
• Increased access to single use injection devices
  improves injection safety
• Managerial approaches can improve injection
  practices

16
Recommendations

• Combine interventions using various methods to
  improve effectiveness
• Monitor injection use and injection safety using
  standardized indicators
• Explore ways to test the Interactive Group
  Discussion approach in various other settings
• Empower patients to express a preference for
  oral medications and demand single use injection
  equipment
• Ensure injection device security

17
Key injection research questions

• What financial incentives for prescribing
  injections can be identified to show how the
  problem could be addressed?
• How can we study "positive deviants" who
  prescribe fewer injections?
• Will the reduction of injection use in the
  formal, public sector drive patients to use the
  informal, private sector?

18
Role of DTC in Improving Use
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What have we learned about this topic?

• DTCs need nurturing, members must be motivated to
  work and often need skills training (See new
  manual and existing course)
• DTCs are an essential link between the National
  Drug Policy and the periphery
• Process variables can show progress before
  outcome or impact effects can be detected

20
Recommendations

• Establish clear hierarchy of responsibility for
  DTCs in the country
• Establish national/ regional centres to support
  DTCs
• Give DTC members protected time for their work
• Develop institutional support for DTC, including
  influencing clinicians locally relevant data,
  incentives for DTC members food, training

21
Recommendations (Cont.)

• Introduce culture and practice of DTCs into
  undergraduate education for medicine pharmacy
• Establish regular training for actual and
  potential DTC members
• Employ and recognize clinical pharmacists and
  clinical pharmacologists in health service
• Develop DTCs in private sector in combination
  with other clinical meetings?

22
Key DTC research questions

• What are the characteristics of a successful DTC?
  Including structure, process outcome indicators
  for DTCs?
• Can we evaluate the impact of DTCs on drug use
  costs saved from improved use of drugs?
• What are the influences of procurement factors,
  consumer pressure, and industry pressure on
  decisions of DTCs?

23
Encouraging Prescribing of Generic Drugs in
Hospitals
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What have we learned about this topic?

• Generic prescribing and substitution may be
  influenced by financing mechanisms.
• A multi-method intervention can increase generic
  prescribing and reduce costs for the targeted
  therapeutic products.
• Generic prescribing and generic substitution
  (generic dispensing) reduce costs but may not
  improve prescribing.
• Drug quality must be assured to promote generic
  prescribing/substitution.

25
Recommendations

• Disseminate findings on impact of generic
  prescribing and generic substitution policies.
• Create incentives through the financing
  mechanisms to enable generic prescribing and
  generic substitution.
• Every hospital should design and implement
  comprehensive approaches that include appropriate
  formulary, generic prescribing and substitution
  policies.

26
Key generic prescribing research questions

• What works to promote generic prescribing and
  generic substitution policies?
• What are the effects on health outcomes of
  cost-containment interventions?
• How can the impact of educational interventions
  for generic prescribing be sustained?

27
Procurement and Hospital Economics

• (combined)

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What knowledge do we currently have about these
topics?

• Knowledge must be shared with all stakeholders
  health providers, politicians, warehouse workers.
  
• All procurement interventions must be
  self-sustainable.
• Training is not the only intervention to improve
  procurement systems
• Simple economic indicators can be developed for
  each facility. Should be used for trend
  monitoring.
• A matrix of ABC and VED (vital, essential, and
  desirable) can be an effective monitoring and
  management tool for each facility
• Available information technology is fine for
  performing procurement management

29
Recommendations

• Develop case studies of effective procurement
  management
• Develop a good procurement manual, handbook, and
  training (such as how to use ABC/VED data)
• Need a new periodicals for procurement and supply
  management of pharmaceuticals
• Focus on training and staffing levels, for
  effective procurement management
• Develop financial management indicators that
  relate to health outcomes.

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Key procurement and economics research questions

• After supervision, what are the best
  interventions to improve procurement?
• What financial incentives improve procurement
  performance?
• What is the goal of Quality Control in the
  procurement system?
• How has decentralization and the HIV/AIDS and TB
  epidemics impacted drug supply management
  systems?
• How can forecasting be improved?
• How do we measure and value the rational use of
  drugs in hospitals?
• What is the impact of stock outs on rational use?

31
Innovative Public Private Sector Strategies to
Improve Drug Use in Primary Care
32
What knowledge do we currently have about this
topic?

• Private systems need to be competitive and
  profitable to be sustainable
• Buy-in/consensus of stakeholders is critical to
  program development

33
Recommendations

• Develop programs/interventions based on consensus
  building of stakeholders
• Develop information systems to support decision
  making in private care initiatives
• Explore IT/communications strategies to support
  pharmaceutical management and improved drug use
• Increase focus on quality of care aspects of
  private sector initiatives

34
Key public-private innovation research questions

• What can be done using incentives to improve the
  quality of care in the private sector?
• How can the issue of commercial competition,
  which may decrease the quality of service, be
  addressed?

35
Microeconomic Issues in Drug use User fees and
Physician incentives
36
What have we learned about this topic

• Dispensing doctors or prescribing dispensers
  perform less well
• Self regulation does not work
• Fee structure influences medicines use and
  prescribing, cost, quality of care, availability,
  and cost effectiveness
• Regulations have been effective in reducing
  antibiotic use.

37
Recommendations

• Need for agreed indicators to monitor and
  evaluate RDU, pharmacy practices and care to
  monitor the effect of for-profit dispensing and
  other financial incentives
• WHO should develop guidelines and take a position
  on the issue of prescribing and dispensing (for
  profit) by the same person.

38
Key microeconomics research questions

• What are the determinants of prescriber behavior?
  
• What guides the patient in their choice of
  services?
• How do pharmacy practice and quality of care for
  dispensers and prescribing dispensers differ and
  change among countries?
• What interventions are effective to improve use
  through changing physician fees and financial
  incentives?

39
Community RDFs, Drug Franchises and RUD
40
What have we learned about this topic?

• Alternative drug distribution channels have a
  role in improving access and RUD
• To be viable these alternative channels need
  active effective supervision, good financial
  management, motivated staff, active DTC
  technical training
• In some cases financial incentives may cause
  adverse effect on RUD

41
Recommendations

• An informed community is essential which means
  that community education and involvement are
  mandatory
• These systems should be part of the overall
  health system and not parallel or separate
• Regulatory and policy framework should be
  balanced with reality
• Private providers such as itinerant drug sellers
  may be brought into system

42
Key RDF research questions

• Can the performance of itinerant drug sellers be
  improved?
• How do the different drug distribution schemes
  affect equity?
• How will improved access affect use of drugs?

43
International Pharmaceutical Pricing
44
What knowledge do we currently have about this
topic?

• An area of considerable progress since ICIUM1
• Prices vary greatly
• Almost all developed countries have some form of
  price mechanism
• WHO/HAI methodology is a major advance

45
Recommendations

• All countries should do a WHO/HAI pricing survey
  though this methodology needs to be extended.
• A drug pricing network--involve pricing
  directorates, health insurance groups,
  researchers and activists--should be established.
  Submit a grant proposal for a 2 day meeting of
  collaborators

46
Recommendations(cont.)

• Survey public sector procurement systems to
  evaluate efficiency, cost, best practices.
• All countries should develop price monitoring
  systems
• In order to encourage the uptake of generic
  medicines, develop mechanisms for QC to provide
  confidence for all

47
Key pricing research questions

• What pricing policies and mechanisms are used and
  what are their features?
• Impact of pricing policies on use, health
  outcomes access by level and sector

48
Impacts of Insurance Coverage on Use and Cost
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What have we learned about this topic?

• Health insurance scheme can be established in
  resource-poor settings.
• HIS can use leverage with various stakeholders to
  promote rational use of medicines-- through
  reimbursement policies tied into treatment
  guidelines, provider accreditation, contracts
  with pharmaceutical companies.
• Claims data can help us understand medication
  use, cost, and outcomes
• USE AVAILABLE DATA NOW.

50
Recommendations

• Start implementing drug benefits in a systematic
  manner with continuous monitoring and evaluation.
• Develop standardized coding IT system from the
  beginning.
• Develop capacity to enable people to routinely
  use insurance data for monitoring, evaluation,
  evidence-based decision-making.
• Develop network to share experiences
• Develop manual and training modules on using
  claim data for monitoring drug use and cost.

51
Key insurance research questions

• What are the requirements for establishing and
  sustaining a drug benefit program in a HIS?
• What are the effects of providing drug benefits
  through a HIS on (a) equity (b) affordability
  and finances (c) quality and (d) health
  outcomes?
• What indicators and data structures are needed
  to measure these effects?