Pharmaceutical Packaging Forum

1
Pharmaceutical Packaging Challenges and
Requirements From an European View

• Pharmaceutical Packaging Forum

2

• Topics of the Presentation
• CR Senior Friendly
• The Fight against Counterfeits
• Effectiveness of Healthcare Adherence
  Supporting Packaging

3
CR Senior Friendly
4

• CR Senior Friendly
• European Standards
• Legislation
• Context
• Future

5

• CR Senior Friendly
• European Standards
• EN ISO 8317 2004 European Standard for rigid
  packaging
• EN 14375 2003 European Standard for flexible
  packaging of medicines (does not include
  Toxicity)
• EN 862 2001 European Standard for flexible
  packaging for non-medicines

6

• CR Senior Friendly
• Legislation
• Germany 1979 based on Standard DIN 55559
• Italy 1984 (prohibiting Child Tests)
• NL following Germany 1985
• UK 2003 based on BS 8404

7
CR Senior Friendly Context
8

• CR Senior Friendly
• Context
• European CR Standards include Adult Tests Age
  50 to 70 excluding infirm People
• Demographic Reality is Different
• Acc. to the Survey Living in Vienna 7.9 of Men
  and 11.4 of Women older than 70 years are in
  Need of Care ? Conclusion 92.1 of Men and 88.6
  of Women take care of their daily Medication
  Themselves.

9

• CR Senior Friendly
• Future
• New Standard for Openability of Packs (all
  Packaging) pr EN WI 00261368 Packaging Ease of
  Opening currently undergoing Public Inquiry
• Test Panel draft EU Standard either 60 80 or
  70 89

10

• CR Senior Friendly
• Future New Standard for Openabiliy
• Test Procedure
• Panellists will be given only such Instructions
  as to how to open the Pack as will be Printed on
  the Pack when Supplied to the Consumer.
• No Tools other than Integrated in the Pack
• No Demonstration

11

• CR Senior Friendly
• Future New Standard for Openabiliy
• Test Procedure Criteria
• Effectiveness of Opening 5 to familiarize
• Efficiency of Opening as fast as possible 1 max
• Satisfaction with Opening Satisfaction Score has
  to be gt 5 on a scale from 0 ( not at all
  satisfied) to 10 (
  very satisfied)
• The Pack passes the Test if 80 and more of the
  Panellists succeed to Open it within the Given
  Time (1) and Score it 5

12
The Fight against Counterfeits
13

• The Fight against Counterfeits
• The Size of the Problem
• The Technological Approach
• The Holistic Approach
• The Legal Situation
• The Logistic Approach
• Conclusions

14
The Fight against Counterfeits The Size of the
Problem
WHO Fact Sheet N 275, revised 14 Nov. 2006.
Counterfeit medicines represent an enormous
public health challenge. Anyone, anywhere in the
world, can come across medicines seemingly
packaged in the right way, in the form of tablets
or capsules that look right, but which do not
contain the correct ingredients and, in the worst
case scenario, may be filled with highly toxic
substances. In some countries, this is a rare
occurrence, in others, it is an everyday reality.

15
The Fight against Counterfeits The Size of the
Problem
WHO Fact Sheet N 275, revised 14 Nov.
2006. Counterfeit medicines range from random
mixtures of harmful toxic substances to inactive,
useless preparations. Occasionally, there can be
high quality fakes that do contain the declared
active ingredient. In all cases, contents of
counterfeits are unreliable because their source
is unknown or vague and always illegal. Fake
drugs can cause harm to patients and sometimes
lead to death.

16
The Fight against Counterfeits The Size of the
Problem

• A Press Report of June 28, 2008 The other drug
  traffic
• Aprox. 15 of all pharmaceutical products sold
  worldwide are fake
• worldwide trade with counterfeit drug exceeds
  30 billion
• profits resulting from trade with counterfeit
  medicines are higher than those from what is
  usually called drug trafficking

17
The Fight against Counterfeits The Size of the
Problem

• The EU Commission notes
• A Sharp Increase in Seized Counterfeit Medicines
  EU statistics report the seizure of a total of
  2.711.410 medicinal products (articles) at EU
  Customs in 2006. This is an increase of 384
  compared to 2005.(2)

2) http77ec.europa.eu/taxation_customs/resources/
documents/customs/customs_controls/counterfeit_pir
acy /statistics/counterf_comm_2006_en.pdf
18
The Fight against Counterfeits The Size of the
Problem

• The EU Commission notes
• A Trend towards Counterfeiting of Life Saving
  Drugs originally focussed on lifestyle
  medicines, now targeting heart diseases and
  psychiatric disorders
• with significantly less or no active substance

19
The Fight against Counterfeits The Size of the
Problem

• The EU Commission notes
• A Trend towards targeting the classical supply
  chain
• A blurred line between counterfeit and
  sub-standard active substances.

20
The Fight against Counterfeits The Technological
Approach

• Secure the Pack
• Bring anti counterfeit features as close to the
  product as possible
• Increase the hurdles for any potential
  counterfeiters
• use more complex and sophisticated technology
• Introduce track and trace systems such as coding,
  electronic track and trace, RFID, mass
  serialisation, universal and uniform pedigrees

21
The Fight against Counterfeits The Technological
Approach

• Overt Security Features
• Holograms
• OVI
• Guilloches

22
The Fight against Counterfeits The Technological
Approach

• Overt Security Features
• Watermarks
• Embossing
• (Micro text)

23
The Fight against CounterfeitsThe Technological
Approach

• Overt Security Features
• High pressure surface treatment of aluminium foils

24
The Fight against Counterfeits The Technological
Approach

• Covert Security Features
• Taggants
• UV reflecting inks
• IR reflecting inks

25
The Fight against Counterfeits The Technological
Approach

• Track and Trace
• Fingerprint scanning, such as
• Ingenia Technology U.K.
• Signoptic France

26
The Fight against Counterfeits The Technological
Approach

• Track and Trace
• Bar Codes EAN13, EAN 128
• 2D Codes
• RFID

27
The Fight against Counterfeits The Technological
Approach

• Track and Trace
• 2005, Italy introduced the Bollini a label
  featuring the Italian product license number and
  a sequential number.
• Belgium requires each medicine pack to feature
  sequentially numbered labels.
• France also requires two bar codes to be applied
  to each medicine pack.

28
The Fight against Counterfeits The Technological
Approach
Track and Trace May 2007, EFPIA issued a
guidance document entitled Packaging Standard
for Counterfeit Resistant Packaging and its
Implementation into International Supply Chains
in Europe. EFPIA indicates support for
applying unit level, randomized 2D serial
barcodes. 

29
The Fight Against Counterfeits The Legal Situation

• The EU Commission considers (amongst other
  measures)
• to turn GMP guidelines into a legally binding
  Directive,
• to ban repacking,
• require GDP certificates to be issued after each
  inspection of a wholesaler,
• to establish a Community Database of Wholesalers

30
The Fight Against Counterfeits Conclusion

• There is a sharp increase of counterfeit drugs
  penetrating the market
• There is no silver bullet solution to fight
  counterfeits
• The pharmaceutical industry, their suppliers and
  the distributors of medicinal products have to
  assume their responsibility
• The best technology is useless without stringent
  controls of the supply chain

31
Adherence Effectiveness of Healthcare
32
Adherence Effectiveness of Healthcare

• Non Compliance / Adherence extends Illness
• Non Compliance / Adherence results in Unnecessary
  Suffering
• Non Compliance / Adherence costs Billions

• WHO Report. Adherence to long-term therapies
  evidence for action. 2003
• World Health Organisation Infectious disease
  report. Publication Code WHO CDS99.1, 1999
• Berg et al., Medication Compliance A Healthcare
  Problem. The Annals of Pharmacotherapy 1993
• Johnson J.A., Bootman J.L. Drug related
  morbidity and mortality impact of pharmaceutical
  care. Arch. Intern,Med. Vol 155/1995

33
Adherence Effectiveness of Healthcare

• The Size of the Problem
• Adherence Key to Outcomes
• How Pack Design can Support Patients to Follow
  their Regimen
• How Pack Design can Support/Prevent Patients to
  Follow their Regimen
• Case Study
• The Pharma Industrys Benefit of Adherence
  Supporting Packaging
• Conclusions

34
Adherence Effectiveness of Healthcare The Size
of the Problem

• WHO
• .populations are ageing and increasingly, people
  are living with one or more chronic conditions
  for decades.
• .they will become the most expensive problems
  faced by our healthcare systems.

35
Adherence Effectiveness of Healthcare The Size
of the Problem

• Each and Everyone of us
• IS
• WAS
• or WILL BE
• a Patient at Some Point in Time and for Some Time
  of his Life!

36
Adherence Effectiveness of Healthcare The Size
of the Problem

• Each and Everyone of us
• DID
• DOES
• or WILL
• Depend on Medicines and their Correct
  Application.

37
Adherence Effectiveness of Healthcare The Size
of the Problem

• Each and Everyone of us has been Struggling with
• poorly designed Medication Packs
• inappropriate Information
• or Accessibility of the Contents

38
Adherence Effectiveness of Healthcare The Size
of the Problem

• Each and Everyone of us is at Risk
• of Medication Errors
• of Over dosing/Under dosing
• or involuntary Medication Holidays

39
Adherence Effectiveness of Healthcare The Size
of the Problem

• Each and Everyone of us Pays the Bill
• For Lost Productivity
• For Unnecessary Acute Care / Interventions
• For Unnecessary High Cost of Public Health

40
Adherence Effectiveness of Healthcare Key to
Outcomes by the Example of HIV
WITH VIROLOGIC FAILURE
PRESCRIBED DOSES TAKEN
Paterson, et al., Ann Int Med 133 21-30, 2000
41
Adherence Effectiveness of Healthcare How Pack
Design can Support Patients to Follow their
Regimen
Healthcare is delivered in many different
contexts and patients sensory, physical and
mental capabilities vary greatly. Design
solutions have to address these factors.
Source Information Design for Patient Safety,
National Patient Safety Agency 2006
42
Adherence Effectiveness of Healthcare How Pack
Design can Support/Prevent Patients to Follow
their Regimen
Following the NHS report Building a safer NHS
for Patients. The UK Dispensing Error Analysis
Scheme revealed that 33 of errors were linked to
look/sound alike drug names.
43
Adherence Effectiveness of Healthcare How Pack
Design can Support Patients to Follow their
Regimen

• Packaging
• serves to Bring the Correct Medicine to the
  Patient
• Packaging
• serves to Convey Information
• Packaging
• serves to Improve Compliance, Adherence
  

44
Adherence Effectiveness of Healthcare How Pack
Design can Support Patients to Follow their
Regimen

• Tools that help Compliance
• Optical (69)
• Ritual (26)
• Control by a third person (6)

Source Arnet I, Schoenenberger RA, Spiegel R,
Haefeli WE. Überzeugung als Fundament der
Compliance und Techniken zur Compliance -
Optimierung, Schweiz Med. Wochenschrift 1999
1291477-86
45
Adherence Effectiveness of Healthcare How Pack
Design can Support Patients to Follow their
Regimen
Stora Ensos DDS and DDSi Winner of the HCPC
Europe Packaging Award 2008
46
Adherence Effectiveness of Healthcare How Pack
Design can Support Patients to Follow their
Regimen
SIMpill Smart
47
Adherence Effectiveness of Healthcare How Pack
Design can Support Patients to Follow their
Regimen
Protomeds Biodose
48
Adherence Effectiveness of Healthcare Case Study
49
Adherence Effectiveness of Healthcare Case Study
50
Adherence Effectiveness of Healthcare Case Study
51
Adherence Effectiveness of Healthcare Case Study

Scenario 1Use of 3 Distinct Packages for PPI,
AB1 and AB2 in Parallel
52
Adherence Effectiveness of Healthcare Case Study

Scenario 2Use of a Combination Package for PPI,
AB1 and AB2
53
Adherence Effectiveness of Healthcare The
Pharma Industrys Benefit of Adherence Supporting
Packaging

Since its introduction more than 50 of all
physicians in Germany prescribe ZacPac for the
eradication of helicobacter pylori ZacPac Winner
of the HCPC-Europe Packaging Award 2007
54
Adherence Effectiveness of Healthcare Conclusion

WHO User-friendly packaging of drugs is a
low-cost way of increasing compliance with (.)
drug therapy.
World Health Organisation Infectious disease
report. Publication Code WHO CDS99.1, 1999
55

Adherence Effectiveness of Healthcare Conclusion

• Improved Compliance/Adherence
• Benefit the Patients
• Benefit Public Health
• Benefit the Tax Payers
• Benefit the Healthcare Businesses

56

• Thank you for your attention
• hcpc-europe_at_tkm.co.at
• www.hcpc-europe.org