A National Conference for Health Care Professionals
Tuesday 29th October 2013
The Westin Dragonara Resort, St Julian’s
For medicines you can trust Improving medication use in older persons
D
Dr Patricia Vella Bonanno
Superintendence of Public Health
29th October 2013
Industry
Monitoring & Evaluation
Rational Medicines
Use
National Medicines
Policy
Essential Medicines
Human Resources
Legislation
Medicines Financing
Medicines Regulation
EU Pharmaceutical
Legislation
NationalLegislation
Research
Supply systems
Medicines Policy
NationalStakeholders
HealthcareProfessionals
Patients and Patient Organisations
Pharmacies
Importers
Policy Makers
Consumers
Affordability
Wholesale Dealers
Manufacturers
The National Pharmaceutical Framework
3
Policy makers & regulators
Healthcareprofessionals
Patients & consumers
The Medicines Supply Chain, regulation and policies
4
All stakeholders together for medicines you can trust
Policy makers&
Regulators
Industry
Patients and consumers
Healthcare professionals
5
6
Clinical trials in Malta
Regulated since 2005
Authorisation is based on:� evaluation of scientific information (Medicines Authority)� ethical approval (Health Ethics Committee)
Regulation is primarily aimed at protecting clinical trial subjects
Clinical trials produce information required for the evaluation of marketing authorisations and changes to authorisations
List of clinical trials authorised is published on www.clinicaltrialsregister.eu 6
Licensing of medicinal products
Benefits• Efficacy• Use of
medicines
Risks•Safety•Side effects•Adverse drug reactions•Contra-indications
Quality of productsExpiry dates
Active Ingredients (API)Inactive ingredientsStorage conditions
•Classification (P/nonP)•Labelling•Patient information leaflet•Summary of Product Characterisitics (SPC)
Evaluation
7
Authorised medicinal products
Source : Medicines Authority
0
500
1000
1500
2000
2500
3000
3500
4000
4500
2004 2005 2006 2007 2008 2009 2010 2011 2012
Year
No
. of
Pro
du
cts
Au
tho
rise
d
126a
National (MT)
MRP/DCP
PMA/MA
PMA
Cumulative Number of Authorised Medicinal Products in Malta (excluding products authorised through the centralised procedure) 8
0 4 8 12 16 20 24 28
Years
Originator medicines and generic medicines
Originator Medicines
Evaluation:QualitySafetyEfficacy
Generic Medicines
Evaluation:QualityBioequivalence
Research
Clinical studies
Development
AUTHORISATION
Only originator products on the market
Exclusivity
Originator and generic products on the market
Competition
AUTHORISATION
AUTHORISATION
Originator and generic products on the market
Competition
9
Active ingredient/s
Essentially similar
There can be minor differences between originator products and generic products, but these are considered to have the same active ingredient, as long as these do not significantly impact on the properties with respect to safety and/or efficacy.
Dosage formsThe same
Can have different shape, colour and size of unit and different packaging and pack size.
ExcipientsCan be different
Inactive substances usually do not effect the patient, but patients maybe allergic to certain inactive substances
Standards
The same
Evaluated in line with EU legislation. The requirements for the supply chain are the same.
Name of product
Different
Different names. The name can be unique (proprietary) or it can be based on the active ingredient and the name of the company (non-proprietary).
Comparison between originator and generic medicines
10
Information on medicines authorised in Malta
http://medicinesauthority.gov.mtwww.maltamedicineslist.com
Medicines • trade name • chemical name• license holder• therapeutic class
Summary of Product Characteristics
Patient information leaflet
Safety information11
Summary of Product Characteristics (SPC)
Product Summary
Clinical Particulars4.1 Therapeutic Indications4.2 Posology and Method of Administration4.3 Contraindications 4.4 Special Warnings and Precautions for Use 4.5 Interactions 4.6 Pregnancy and Lactation4.7 Effect on Ability to Drive and Use Machines 4.8 Undesirable Effects4.9 Overdose
Pharmacological Properties
Pharmaceutical Particulars
Administrative Data 12
Patient information leaflet
13
14
Presentation and labelling of medicinal products
15
Pharmacovigilance
New legislation on pharmacovigilance S.L.458.35
Centralised EU database for ADRs and ME
Products subject to ‘additional monitoring’
Black triangle scheme for new medicines and vaccinesProducts subject to EU–wide additional close monitoring
Doctors and HCPs encouraged to report ADRs‘It shall be the duty of doctors and other HCPs to immediately report to the Medicines Authority any suspected adverse drug reaction to a medicinal product in Malta’ S.L.458.35 Sub-regulation 3(4)
Patients can report ADRs and Medication Errors to HCPs or directly
Marketing authorisation holders remain responsible for products on the local market 15
Adverse Drug Reaction and Medication Error Report Form
16
Reporting of adverse drug reactions and medication errors
‘Adverse drug reaction (ADR)’- a response to a medicinal product which is noxious and unintended
Safety issues post-authorisation
17
Risk Benefit
pharmacovigilance data and activities
evaluation of the risk/benefit balance
Variations to marketing authorisations
Withdrawal or suspension of marketing authorisations
Quality of medicinal products on the market
• Monitoring of quality of medicinal products on the market
• Sampling of products from the market
• New legislation on falsified medicinal products (Jan 2013)
- defines falsified
medicinal products
- strengthens the
legal supply chain
- regulates sales over
the internet (authorised sites)18
Source: Priority Medicines for Europe and the World, Update 2013 Report, cited from Data from the World Bank
Europe is ageing
19
Use of medicines in older persons
• Medicines play an expanding role inhealth care as patients grow older
• Increased incidence of diseasessuch as dementia and osteoporosis
• Need for clinical trials in the older persons- 39% of RCTs excluded older persons - 81% of RCTs also excluded people with
co-morbidities
• Initiatives to increase studies in older persons
20
Factors affecting use of medicines in older persons
• Changed pharmacokinetics and pharmacodynamics
• Changed physiology
• Changed spectrum of diseases
• Older persons are prescribed more than one kind of medicine (many take three or more) – polypharmacy
• Increased risk of:- medicines interactions, - mix-ups - potential for side-effects
• Interaction with alcohol and food 21
Accessibility of medicines in older persons
• Age-related changes like - memory loss - poor eyesight
- arthritis - Parkinsons disease
• Difficulties with taking medicines:
- opening of packaging and dividing tablets
- calculation of doses
- swallowing of oral medication
- reading and understanding information
• Mobility may affect accessibility
• Older persons reside in different care settings depending on the level of care needed 22
Affordability of medicines
• Financial difficulties may affect access to medicines
23
Prescribing for older persons
• Prescribe in accordance with SPC
• Note special precautions for use
• Monitor treatment for indications and for adverse effects
• Keep updated list of all medicines including non-prescription and herbal medicines and supplements
• Review of medication, not just add-on
• Pre-define and review length of treatment
• Be aware whether patients have access to their medicines
• Ensure that patients/carers understand and follow regimen • Address non-concordance
• Minimise risk factors, find remedial action for problems24
Dispensing of medicines to older persons
• Review treatment and maintain list of all medicines being taken (prescription/ non-prescription, herbal)
• Explain any changes in medicines prescribed and in products dispensed to patient/carer
• Ensure that clear directions for taking medicines are given, labelling is clear and is understood by patients
• Include special warnings about interaction with alcohol, other medicines and food
• Ensure that patients can open packaging
• Ensure that dosage form is appropriate
• Advise on ways to ensure concordance
• Help patients to access and store medicines 25
All stakeholders together for medicines you can trust
Policy makers&
Regulators
Industry
Patients and consumers
Healthcare professionals
26
Thank you
27
A National Conference for Health Care Professionals
Tuesday 29th October 2013
The Westin Dragonara Resort, St Julian’s