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