legislation and regulation for best practices in pharmacy ra psn
TRANSCRIPT
Legislation and Regulation for Best Practices in Pharmacy
Issues to consider
Pharmacy
Then
Now
Future
Best Practices
People
Places
Processes
Products
Legislation
Regulation
Guidelines
Ethics
Norms
Remi ADESEUN
Pharmacy
Then...
Combined Honours
Apothecaries practised pharmacy & medicine simultaneously as far back as 2000 B.C.
Separate Profession
From the 13th Century onwards with compounding & dispensing as main functions
“Lick, Stick & Pour”!
Now...
Pharmaceutical Care
Restoring the original role of looking after the patient in addition to providing the medicine
Broad Spectrum Ensuring optimum drug
therapy through production, supply & control of medicines as well as provision of info/advice to patients & prescribers
Remi ADESEUN
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
Who determines best practices?
Policy Makers
Regulators
Professionals
Academics
Global Standards
Peer Review
Other Team Members
Public
Who determines best practices?
Policy Makers/Enforcers
MOH
Federal
State
Legislature
Exclusive List
Concurrent
Judiciary
Customs/Police
Who determines best practices?
Regulators
PCN
NAFDAC
SON
FEPA
EML Committee
NDLEA
Opportunity for a “Nigeria Inter-Bank Settlement System” Model
Who determines best practices?
Professionals
PSN
National
State
Technical Arms
ACPN
NAIP
Who determines best practices?
Academics
Research
Training
Global Standards
WHO
FIP
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
Who determines best practices?
Other Team Members
Doctors
Nurses
Others
Public
Consumers
Observers
Global Citizens
Best Practices
People
“Quantity”
“Quality”
Spread/Distribution
Places
Manufacturer/Importer
Wholesaler
Retailer
Hospital
Processes
Research & Development
Manufacturing
Distribution
Products
Registration
Safety & Efficacy
Formulary
Marketing & Sales
Surveillance/Recall
Remi ADESEUN
Best Practices....People “Quantity”
Benchmarks
“Quantity” per 100,000
Lower Income Countries: 2-45
Lower Middle Income Countries: 7-50
Upper Middle Income Countries: 32-77
High Income Countries: 29-206
Nigeria
Nigeria Total: 5
Lagos State:25
FCT:59
Oyo State:6
Enugu State:9
Anambra State:6
Zamfara State:0.4
Yobe State: 0.6
Ghana: 10
Remi ADESEUN
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
Pharmacy Best Practices...Here
Pharmacists Council
People
Places
NAFDAC
Process
Product
Remi ADESEUN
Pharmacy Best Practices...There
Regulator=Pharma Society
Ireland
Northern Ireland
Independent Regulator
UK (GPhC Since 2010)
USA
South Africa
Australia
Canada
Remi ADESEUN
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
Pharmacy Legislation & Regulation.....Why?
Actions/Omissions leading to
Use of medicines which are:
Ineffective
Poor Quality
Harmful
Harmful consequence
Can lead to:
Therapeutic Failure
Exacerbation of Disease
Resistance to medicines
DEATH!
Also, undermines confidence in:
Health systems, Health professionals, manufacturers/importers, retailers, Govt
Remi ADESEUN
Pharmacy Legislation & Regulation
Legislation
Laws are acts passed by a legislative body
Laws are (should be) usually written in fairly general terms to meet present and possibly future needs
Laws usually have language that enables the Govt to issue regulations based on the law.
Usually a lengthy process with the legislative branch giving final approval.
Regulation
Regulations are rules promulgated by a part of the executive branch of govt, usually based on a law giving the agency statutory authority for the regulation
After approval, a regulation has the same power as the law itself.
Can be passed more rapidly and simply than laws.
Can also be altered more easily.
Remi ADESEUN
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
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
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
Evolution of Policy & Law
Long Process
Informal Agreement
Govt Guidelines
Law
National Health Policy
National Drug Policy
Single National Drug Law?
Federal vs State?
Key Success Factors Clear definition of
what all parties-manufacturers, pharmacists, doctors are required to do
Clarity and harmony in the roles of regulatory agencies
Remi ADESEUN
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?
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
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
Elements of a Comprehensive Drug Law
General Provisions
Control of Availability and Marketing
Control of Supply Mechanisms
Drug Control Administration
Powers of Enforcement
Powers to make rules and regulations
Repeals and transitional provisions
Exemptions from provisions of the law
Remi ADESEUN
Change Management for New Laws/Regulations/Guidelines
Vision
Success
Structures Capabilities
Sysytems
Neccesity
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.
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
Thank You!
Contact Information:
Remi ADESEUN
Chairman
Rodot Group
.Healthcare
.Architecture
.Consulting
08057713769/07065156473