The document discusses best practices in pharmacy legislation and regulation. It notes that realistic laws and regulations are needed to protect public health from issues like ineffective, poor quality, or harmful medicines. When drafting or revising such laws and regulations, it is important to inventory existing policies, determine the appropriate legislative approach, involve legal and healthcare experts, and keep stakeholders informed throughout the process. The goal is to establish a framework that promotes safe, effective pharmaceutical practices for all.

1. Legislation and
Regulation for Best
Practices in Pharmacy

2. Issues to consider
 Pharmacy  Legislation
 Then  Regulation
 Now  Guidelines
 Future
 Ethics
 Best Practices
 Norms
 People
 Places
 Processes
 Products
Remi ADESEUN

3. Pharmacy
Then... Now...
 Combined Honours  Pharmaceutical Care
 Apothecaries  Restoring the original
practised pharmacy & role of looking after
medicine the patient in addition
simultaneously as far to providing the
back as 2000 B.C. medicine
 Separate Profession  Broad Spectrum
 From the 13th  Ensuring optimum drug
Century onwards with therapy through
compounding & production, supply &
control of medicines as
dispensing as main
well as provision of
functions info/advice to patients &
 “Lick, Stick & Pour”! prescribers
Remi ADESEUN

4. Values & Value across the
Value-Chain
 The Future of Pharmacy
 Depends to a great extent on:
 the Pharmacists ability to INNOVATE
 ETHICS, INTEGRITY & PROFESSIONALISM
 Pharmacy’s ability to demonstrate its
RELEVANCE by creating VALUE for
Patients/Consumers/Customers/Chain
members
 ALERTNESS, COHESION, ARTICULATION, &
POLITICAL SAVVY to pre-empt and
counteract unfriendly laws
Remi ADESEUN

5. Who determines best practices?
 Policy Makers
 Regulators
 Professionals
 Academics
 Global Standards
 Peer Review
 Other Team Members
 Public

6. Who determines best practices?
 Policy Makers/Enforcers
 MOH
 Federal
 State
 Legislature
 Exclusive List
 Concurrent
 Judiciary
 Customs/Police

7. Who determines best practices?
 Regulators
 PCN
 NAFDAC
 SON
 FEPA
 EML Committee
 NDLEA
 Opportunity for a “Nigeria Inter-Bank
Settlement System” Model

8. Who determines best practices?
 Professionals
 PSN
 National
 State
 Technical Arms
 ACPN
 NAIP

9. Who determines best practices?
 Academics
 Research
 Training
 Global Standards
 WHO
 FIP

10. Who determines best practices?
 Peer Review/Benchmarking
 ECOWAS
 AU
 COMMONWEALTH
 BRICS
 NEXT 11+1
Bangladesh, Egypt, Indonesia, Iran, Mexico
, (Malaysia) Nigeria, Pakistan, Philippines,
Turkey, South Korea, and Vietnam

11. Who determines best practices?
 Other Team Members
 Doctors
 Nurses
 Others
 Public
 Consumers
 Observers
 Global Citizens

12. Best Practices
 People  Processes
 “Quantity”  Research &
 “Quality” Development
 Spread/Distribution  Manufacturing
 Distribution
 Places
 Manufacturer/Importer
 Products
 Wholesaler  Registration
 Safety & Efficacy
 Retailer
 Formulary
 Hospital
 Marketing & Sales
Remi ADESEUN  Surveillance/Recall

13. Best Practices....People
“Quantity”
Benchmarks Nigeria
 “Quantity” per 100,000  Nigeria Total: 5
 Lower Income  Lagos State:25
Countries: 2-45
 Lower Middle Income  FCT:59
Countries: 7-50  Oyo State:6
 Upper Middle Income  Enugu State:9
Countries: 32-77
 High Income
 Anambra State:6
Countries: 29-206  Zamfara State:0.4
 Yobe State: 0.6
 Ghana: 10
Remi ADESEUN

14. Best Practices....People
“Quality”
 Fitness to Practise
 Pharmacy professionals are considered “fit
to practise” when they can demonstrate the
skills, knowledge, character and health
required to do their job safely and
effectively.
 A pharmacy professional's fitness to practise
can be impaired for a number of reasons
including misconduct, lack of competence,
ill-health and through having been
convicted of a criminal offence.
Remi ADESEUN

15. Pharmacy Best Practices...Here
Pharmacists Council NAFDAC
 People  Process
 Places  Product
Remi ADESEUN

16. Pharmacy Best Practices...There
Regulator=Pharma Society Independent Regulator
 Ireland  UK (GPhC Since
 Northern Ireland 2010)
 USA
 South Africa
 Australia
 Canada
Remi ADESEUN

17. Pharmacy Legislation &
Regulation.....Purpose
 To Protect Public Health
 Governments need to approve comprehensive
laws and regulations and to establish
effective national regulatory authorities to
ensure that the manufacture, trade and
use of medicines are requlated
appropriately and that the public has
access to accurate information on
medicines.
 Should not be simply punitive
 Creating a positive situation tends to be more
effective
Remi ADESEUN

18. Pharmacy Legislation &
Regulation.....Why?
Actions/Omissions leading to Harmful consequence
 Use of medicines  Can lead to:
which are:  Therapeutic Failure
 Ineffective  Exacerbation of Disease
 Resistance to medicines
 Poor Quality
 DEATH!
 Harmful
 Also, undermines confidence
in:
 Health systems, Health
professionals,
manufacturers/importers,
retailers, Govt
Remi ADESEUN

19. Pharmacy Legislation &
Regulation
Legislation Regulation
 Laws are acts passed by a  Regulations are rules
legislative body promulgated by a part of the
 Laws are (should be) usually executive branch of govt,
written in fairly general usually based on a law giving
terms to meet present and the agency statutory
possibly future needs authority for the regulation
 Laws usually have language  After approval, a regulation
that enables the Govt to has the same power as the
issue regulations based on law itself.
the law.  Can be passed more rapidly
 Usually a lengthy process and simply than laws.
with the legislative branch  Can also be altered more
giving final approval. easily.
Remi ADESEUN

20. Pharmacy Legislation &
Regulation
 Guidelines
 Do not carry the force of law, and can be
more easily modified and updated
 Offers information on what the Govt’s
thinking is concerning the best way to
implement regulations
 Following guidelines helps avoid
misinterpretation of and facilitate
compliance with laws and regulations
Remi ADESEUN

21. Pharmacy & Drug Laws
 Poisons and Pharmacy Act (PPA) Cap 535 LFN 1990
 PCN CAP P17 LFN 2004
 PCN Disciplinary Tribunal Rules 2000(Official GazzetteNo 70
Vol 87
 NAFDAC CAP N1 LFN 2004
 Food and Drugs Act Cap S32 2004 LFN
 Food and Drugs Registration etc CAP S33 2004 LFN
 Counterfeit and Fake Drugs and Unwholesome Processed Foods
(Miscellaneous Provisions) Cap C34 LFN 2004
 NDLEA Act of 1989
 Dangerous Drugs Act (DDA) Cap 91 LFN 1990
 National Drug Formulary and Essential Drugs List Act Cap 252
LFN 1990/Essential Drugs Programme
Remi ADESEUN

22. Other Laws affecting Pharmacy
 NHIS Act
 PROCUREMENT ACT 2007
 FEPA Act 1988
 SON Act 1990
 NATIONAL DRUG FORMULARY AND ESSENTIAL DRUGS ACT
 Consumer Protection Council (CPC)
 Trade Malpractices Decree 1992
 National Health Bill
 PROPOSED NATIONAL TRADITIONAL MEDICINE BILL
 PROPOSED NATIONAL PHARMACOVIGILANCE BILL
 HEALTH COMMODITIES AND MEDICINES SUPPLY MANAGEMENT
 PROPOSED TERTIARY HOSPITALS BILL (FMCs)
Remi ADESEUN

23. Evolution of Policy & Law
 Long Process  Key Success
 Informal Factors
Agreement  Clear definition of
 Govt Guidelines what all parties-
 Law manufacturers,
 National Health Policy pharmacists,
doctors are
 National Drug Policy required to do
 Single National Drug  Clarity and
Law? harmony in the
 Federal vs State? roles of regulatory
agencies
Remi ADESEUN

24. Key Questions to ask when
revising/initiating Laws
 What are the most important goals to
achieve in the short, medium & long
term?
 What means are available to achieve
them?
 In which sequence can they best be
tackled?
 What help is available?

25. Considerations in evaluating
the current Pharmacy Laws
 Is incremental change to existing Pharmacy
Laws enough?
 Is a modern, accountable and efficient system
of regulation required?
 fitness to practise provisions for people and
places
 the public interest comes first
 to protect, maintain and promote the health
and safety of the public.
 the issue of conflicts of interest between those
who prescribe and those who dispense drugs

26. Drafting and revising Pharmaceutical
Legislation and Regulations
 Inventory the laws and regulations already in force
 Legal Drafters and Pharma/Health Experts meet to
decide what legislative instrument is required
Assistance available from ICDRA & WHO
(http://apps.who.int.medicinedocs/en/cl/CL1.1.1.1.2/clmd,50.html#hlCL1_1_1_1_2).
 Discuss early drafts of the law with all interested parties:
Health professions, trade/industry groups, concerned
govt depts, consumer groups
 When the law is approved, regulations are developed to
guide the implementation of the law.
 When a regulation is revised, research and take into
account which other laws will be affected by the revision

27. Elements of a Comprehensive
Drug Law
 General Provisions  Powers of
 Control of Enforcement
Availability and  Powers to make
Marketing rules and regulations
 Control of Supply  Repeals and
Mechanisms transitional
 Drug Control provisions
Administration  Exemptions from
provisions of the law
Remi ADESEUN

28. Change Management for New
Laws/Regulations/Guidelines
Neccesity Vision
Sysytems Success
Capabilities Structures

29. New Drug Distribution Guidelines
 Introduced in March 2011
 Sanctions for Non-Compliance expected to
commence with effect from 12th July 2012
 Does it pass the test?
 Necessity & Vision? Probably Yes.
 Are the necessary Structures, Capabilities &
Systems in place to ensure Success? A big
NO!
 What should be the right spirit? Create
Awareness, Interest and Participation of
major stakeholders. Pilot Scheme.

30. Summary
 Realistic and effective laws and regulations are needed for the pharma
sector because:
 Pharmaceuticals concern the whole population
 Many parties are involved: patients, health providers,
manufacturers, etc.
 Serious consequences, including injury and death, can result from
the lack or misuse of medicines
 The consumer has no way to determine product quality
 Informal controls are insufficient
 In drafting or revising legislation, it is important to:
 Inventory the laws and regulations already in force
 Determine what type of legislative is required
 Involve both legal and health experts
 Keep all stakeholders informed

31. Thank You!
Contact Information:
Remi ADESEUN
Chairman
Rodot Group
.Healthcare
.Architecture
.Consulting
08057713769/07065156473
r.adeseun@rodot.org
kojere@yahoo.com