How pen needles influence compliance and wellbeing of …static.livemedia.gr/ngda/documents/al17350_us63_20151113170230... · How pen needles influence compliance and wellbeing of

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How pen needles influencecompliance and wellbeingof the diabetic patient

Thessaloniki, November 13 2015

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• Intro – key facts

• Factors influencing compliance and

wellbeing:

o Innovation

o Technology

o Quality

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Headquarter: Grandate (Como)Turnover 2014: 1.218 Mio €Branches : 24 worldwide, 15 in Europe and4 in emerging countries

Distributors: over 100 worldwideBusiness units: 6 in EuropePoints of Sale : over 400 worldwideEmployees: 6.600

KEY FACTS

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OUR BRANDS

Baby care Health & beauty

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Source: IMS sep 15

Thermometers Health CareNebulizers Venipuncture

BPMs WoundcareDiabetes

32%32% 14%14% 20%20%

28%28% 24%24% 77%77% 26%26%

MARKET SHARES - ITALY

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wellbeing:

o Innovation

o Technology

o Quality

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Pen needle technical terminology

1. Primary container

2. Needle shield

3. Cannula

4. Transparent glue

5. Needle hub

6. Medical paper

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2

3

4

5

6

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Tip

Bevels

Heel


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Patient tip:• enters patient’s skin• entirely covered of silicone to ensure

smooth sliding

Cartridge tip:• enters the cartridge piercing its rubber

lid


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Insupen innovation

1. Extr3me triple sharpening

2. External diameter

3. Internal diameter

4. Length

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1) Triple sharpening

The top of the cannula (patient tip) undergoes 3grinding treatments:• one central sharpening (A)• two side sharpening (B)

All main Insupen pen needles are sharpenedaccording to the new Extr3me technology,ensuring a more comfortable penetration.

A

BB

Designed for an Extr3me comfort

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Designed for an Extr3me comfort

1) Triple sharpening – Extr3me

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1) Extr3me: thinner profile

The new PiC’s Extreme 3 needle geometry makes the needle profilethinner, thus reducing the material that penetrates into the skin.

Insupen«traditonal» vs.new Insupen

Extreme: lessmaterial

penetrates intothe skin.

Insupen 32Gx4. Data on file.

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1) Extr3me: longer bevels

The new geometry makes the tip even sharper: bevels are longer andless inclined while the length of the cannula doesn’t change. Thisleads to a reduced penetration force.

7,5°

11°

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Heel penetrationforce

-10%Tip penetration

force-21%

1) Extr3me: penetration force

31G

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32G

Tip penetrationforce-20%

Heel penetrationforce

-12%

1) Extr3me: penetration force

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All Insupen 32G and 31G pen needles feature the new Extremesharpening.

1) Triple sharpening – The new Extreme range

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External diameter(GAUGE)

2) External diameter of the needle

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Fear and pain of injections:

• 94% of insulin users show symptoms of anxiety, distress or

phobia around blood and injury from injections (1)

• 33% of insulin users are afraid of their injections (2)

• 75% of newly diagnosed children < 9 years old have a fear of

injections (3)

• 47% of people with diabetes say they would be more likely to

follow their prescribed insulin regimen if a product easing pain

and discomfort of injections was available (4)

2) External diameter: patient’s attitude

(1) Berlin I, Bisserbe JC, Eiber R, Balssa, N, Sachon C, Bosquet F, Grimaldi, A: Phobic symptoms, particularly the fear ofblood and injury, are associated with poor glycemic control in type 1 diabetic adults. Diabetes Care 1997;20:176–178

(2) Peyrot M, Rubin RR, Kruger DF, Travis LB: Correlates of insulin injection omission. Diabetes Care 2010;33:240-245(3) Howe CJ, Ratcliffe SJ, Tuttle A, Dougherty S, Lipman TH: Needle anxiety in children with type 1 diabetes and their

mothers. AM J Matern Child Nurs 2010;36:25-31(4) AADE Injection Impact Survey, 2007

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2) External diameter:more comfortable injections

There is a significant correlation between needle diameter andfrequency of painful injections.

Pain following controlled cutaneous insertion of needles with different diameters. Lars Arendt-Nielsen, Henrik Egevist & PeterBjerring. Somatosensory and Motor Reserch, March/June 2006; 23(1/2) : 37-43 (from page 3-4)

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The first 32G pen needle on the market (2007).

2) External diameter

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Doc Leader - Evaluation of acceptability of Insupen 32G pen needle

Main results of a customer satisfaction survey* involving 350patients who tried Insupen 32G

Does Insupen 32G make injections morecomfortable and less painful?

Would you recommend Insupen 32Gto another diabetic patient?

2) External diameter: Insupen 32G customersurvey

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Internal diameter

Cannula wall

3) Internal diameter: the wall of the cannula

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3) Internal diameter: the wall of the cannula

According to the ISOnorm, the cannula canbe:

NORMAL WALLED

or

THIN WALLED.

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3) Internal diameter: ISO Norm

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3) Internal diameter: thin wall cannula

* Comparison of usability and Patient Preference for insulin Pen Needles produced with different production Techniques:”Thin-Wall” Needles compared to “Regular-Wall” Needles: An Open-Label Study, Thorsten Siegmund, M.D., Hannes Blankenfeld,M.D., and Petra-Maria Schumm-Draeger,M.D., Diabetes Technology & Therapeutics. August 2009,11 (8):523-528. doi:10.1089/dia. 2009. 0048. Published in Volume: 11 Issue 8: August 21, 2009

THIN WALL BENEFITS*:• less pain• less bleeding• less skin irritation• less injection strain• less residual insulin leakage

from the patients skin afterinjection

• less needle occlusion

The whole Insupen range is thin walledaccording to ISO 9626.

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1. drug flows easier through the needle, for a faster injection2. more comfortable injection

3) Internal diameter: High Flow Thin Wall

Insupen 32G 4mm goes even beyond:

Super thin wall features a wall thickness of 0,045 mm, still complying with the ISO Normsrequirements (such as cannula stiffness).

HIGH FLOWTHIN WALL

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32Ginner diameter = 0,12 mm

32G HIGH FLOWinner diameter = 0,14 mm

Inner diameter 16% increased

3) Internal diameter: High Flow

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Q = flow rateΔP = pressureR = cannula inner radiusL = cannula lengthk = constant

ΔPL

R4

Q = kHagen–Poiseuilleequation

The equation below describes the flow rate of liquids insideany tube.

Flow rate is highly affected by inner diameter (R4).This means that a slight increase in the inner diameter allowsa big increase in the flow rate.


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3) Internal diameter:High Flow Thin Wall technology

Insupen 32G 4mmnormal wall

Insupen 32Gx4 High Flow vs Insupen 32Gx4 traditional.Data on file.

+70%insulin flow

+70%insulin flow

vs.

Insupen 32G 4mmHigh Flow Thin Wall

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ISO 11608-2:2012 minimum flow rate expected

PiC G32x4Minimum flow rate expected = 2,2 [ml/min]

PiC G32x4 HIGH FLOWMinimum flow rate expected = 4,3 [ml/min]


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3) Internal diameter: the Insupen range

Thin Wall

HIGH FLOWTHIN WALL

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• In a 2004 study, blinded assessments of pain showed no significantdifference in pain scores for the 2 needle lengths tested (6mm and12.7mm). This observation would indicate that, at least under theconditions of needle testing in this clinical trial, the discomfort ofpuncturing dermal tissues did not differ materially for the 2 lengths.

• The questions specifically comparing patient perception toward the 2needles showed however a marked preference for the shorter, finerneedle: when specifically asked about needle preference, patientsindicated that they considered the shorter needle (6mm) easier touse.

4) Length: pain and ease of use

A Multicenter, Open-Label, Randomized,Two-Period Crossover Trial Comparing Glycemic Control, Satisfaction, and Preference Achievedwith a 31 Gauge × 6 mm Needle versus a 29 Gauge × 12.7 mm Needle in Obese Patients with Diabetes Mellitus. Sherwyn Schwartz, MD,1 David Hassman, DO, 2 John Shelmet, MD, 3 Richard Sievers, MD, 4 Richard Weinstein, MD, 5 John Liang, PhD, 6 and William Lyness,PhD 6. CLINICAL THERAPEUTICS®/VoL. 26, No. 10, 2004

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4) Length: dermis thickness

* Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injection: implication for needlelength recommendation, Michael A. Gibney, Christina H. Arce, Karen J. Byron, Laurence J. Hirsch”.

The thickness of the dermis is unrelated to BMI and fluctuates, onaverage, between 1.8 and 2.5 mm according to the injection site*.

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4) Length: suitable needle

* New injection recommendations for patients with diabetes, A Frid, L. Hirsch, R. Gaspar, D. Hicks, G. Kreugel, J. Liersch, C.Letondeur, J.P. Sauvanet, N. Tubiana-Rufi, K. Strauss - Diabetes & Metabolism 36 (2010) S3-S18

The new guidelines for insulin injections recommend to use shortneedles (4 to 6mm) for all patients, including those with a sturdyphysical build, because they can pass through the dermis layer andreach the subcutaneous tissue.

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We have decided however to have a wide32G range in order to let freedom ofchoice:

• to the patient, who can choose acomfortable pen needle (32G) in avariety of lengths matching his/her ownfavorite injection technique (90°, 45°,with pinch etc)

• to the professional, who –according tohis/her own experience- may prescribea specific pen needle for each patient

4) Length: Insupen’s choice

The above injection techniques are recommended in the Clinical Study “New injection recommended for patients with diabetes”, AndersFrid, Ruth Gaspar, Debbie Hicks, Larry Hirsch, Gillian Kreugel, Jutta Liersch, Corinne Letondeur, Jean-Pierre Sauvanet, Nadia Tubiana-Rufi, Kenneth Strauss - Vol.36 – 2010, Diabetes & Metabolism.”

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A larger range

4) Length: the Insupen range

for a wider choice.

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wellbeing:

o Innovation

o Technology

o Quality

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Insupen technology

1. Anti-coring

2. Electrochemical polishing

3. Silicon

4. Compatibility

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In order to get the heel surface smooth, tiny glass microspheres are “shot” at the heel to round off its surface andremove all eventual spikes/burrs left after the sharpening.

Closer look

500x magnifying

BEFORE TREATMENT

1) Anti-coring treatment: purpose & process

AFTER TREATMENTHEEL

Comparative scanning microscope examination (Breda Scientific Institute – Milan)

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CARTRIDGE TIP:• effective piercing of the cartridge

rubber lid• prevention of fragments fall into insulin no cannula obstruction

1) Anti-coring treatment: benefits

NO ANTICORING:POSSIBILE FRAGMENTS

ANTICORING:NO FRAGMENTS

PATIENT TIP:• smoother sliding into the skin• no risk of abrasions/grazes• further reduction of discomfort

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2) Electrochemical polishing

Both tip and bevels are treated in an electrochemical acid bath givinga final finishing that:• removes any remaining spikes• gets a surface finish (absence of micro-imperfections on the tip)

Comparative scanning microscope examination (Breda Scientific Institute – Milan)

INSUPEN needle Untreated needle

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Special Medical grade silicone is laid evenly all over the entire needlesurface.

3) Silicone

In combination with a precisesharpening and polishing of theneedle, this ensures its smoothsliding into the skin.

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4) CompatibilityThe updated ISO 11608 norm (ISO 11608-2:2012) prescribes that thecompatibility between pen needles and pen injector has to be assessedthrough testing the needles with every single pen.The list of the compatible pens is listed on the packs and it’s periodicallyupdated.The previous revision (EN ISO 11608-2:2000) instead stated that each “Type A”pen needle was compatible with each “Type A” pen injector.

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Using a needle more than once may cause:

• Inaccurate dosage 1

• Insulin crystallization 2

• Lipodystrophies 3

• Sterilisation 4

• Damage of needle tip 5

• Lubricant removal 6

1. Ginsberg BH, Parkes JL, Sparacino C., The kinetics of insulin administration by insulin pens, Horm Metab Res. 1994Dec;26(12):584-7. - The Importance of Good Insulin Injection Practices in Diabetes Management - Richard Dolinar, MD,2009l

2. Hanas R. (1998), Insulin-Dependent Diabetes in Children, Adolescents and Adults. Uddevalla, Sweden, Piara HB.3. I.V. Misnikova, A.V. Dreval, V.A Gubkina, E.V. Rusanova ; The Risks of Repeated Use of Insulin Pen Needles in Patients with

Diabetes Mellitus; Journal of Diabetology, 2011. - Bahar Vardar, Sevgi Kızılcı; Factors influencing lipohypertrophy; TITAN2009

4. I.V. Misnikova, A.V. Dreval, V.A Gubkina, E.V. Rusanova ; The Risks of Repeated Use of Insulin Pen Needles in Patients withDiabetes Mellitus; Journal of Diabetology, 2011. - Insulin Administration; DIABETES CARE, VOLUME 27, supplement 1, 2004.

5. I.V. Misnikova, A.V. Dreval, V.A Gubkina, E.V. Rusanova ; The Risks of Repeated Use of Insulin Pen Needles in Patients withDiabetes Mellitus; Journal of Diabetology, 2011 . - King L (2003) Subcutaneous insulin injection technique. NursingStandard. 17, 34, 45-52.

6. The Importance of Good Insulin Injection Practices in Diabetes Management - Richard Dolinar, MD, 2009

Single use device

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These data suggest that if participants reuse pen needles, they have just as muchchance of having lipohypertrophy as not, but if they do not reuse pen needles theyhave a modest (and significant) reduction in the risk of lipohypertrophy, eventhough many of those who do not reuse pen needles still develop lipohypertrophy.

Results and analysis of the 2008–2009 Insulin Injection Technique Questionnaire survey. Carina DE CONINCK, AndersFRID,Ruth GASPAR,Debbie HICKS,Larry HIRSCH,Gillian KREUGEL,Jutta LIERSCH,Corinne LETONDEUR,Jean-PierreSAUVANET,Nadia TUBIANA1and Kenneth STRAUSS. Journal of Diabetes 2 (2010) 168–179

Single use device:reuse and lypohypertrophy

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wellbeing:

o Innovation

o Technology

o Quality

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Quality levels-Q

UAL

ITY

+

Excellence

Innovative features & quality controls

Voluntary technical Standards

COMPLIANCE WITH UNI ENISO PRODUCT STANDARDS

(e.g. UNI EN ISO 7886) High QualityCOMPLIANCE WITH UNI

EN ISO PROCESS STANDARDS(e.g. UNI EN ISO 13485)

COMPLIANCE WITHDIR. 93/42

ESSENTIAL SAFETY AND MARKETSUITABILITY REQUISITES

PHARMACOPOEIAREGULATIONS

Compulsory Standards

Minimum Quality

NO USE OF ALLERGENS INMANUFACTURING

Additional, voluntaryQUALITY CONTROLS

HIGH FLOWTHIN WALL

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The ISO 9626 Stiffness Test is made in order to verify that thenormal bending of the needle stays inside the parameters set by

the ISO.

Quality Control process:stiffness test

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Quality Control process:cannula pull test

The ISO 7864 pull test,consisting in pulling thecannula with a certainforce, is performed toverify that it does not

detaches from the hub.

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The ISO 9626 Breakage Test, consisting in bending right andleft several times a cannula, is performed to verify that it does

not break.

Quality Control process:cannula breakage test

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Quality Control process:dislocation test

This test verifies that thecannula is straightly mounted

onto the hub (ISO 11608)

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This test, performed accordingto ISO 11608, verifies that thestrength necessary to screw

and unscrew a pen needle on apen stays inside ISO

parameters.

Quality Control process:torque test

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Quality Control process: cannula length

This test, performedaccording to ISO 11608,

verifies that the real lengthof the needle stays inside

ISO tolerances.

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The tolerance set as agoal by Insupen is

narrower:

+/-0,5mm

Quality Control process:length and tolerance

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A ray of light enters the cannula on one side; if the «quantity oflight» coming out the other side is smaller it means that the

cannula is not straight and it’s discarded.

Additional voluntary quality control, not required by ISOstandard.

Quality Control process:cannula straightness

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Additional voluntary qualitycontrol not required by ISO

standard.

Three different checks are performed to ensure that cannulas are notstuck:

1. Automatic control during cannula manufacturing2. Random control at the end of the cannula manufacturing stage3. Automatic control during assembly stage (100% of the production)

Quality Control process:cannula obstruction

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Polyurethanefilmaccording toISO TC 84SC1 n.252

We check the penetrationforce of Insupen pen needlesusing a special polyurethanefilm that reproduces asclosely as possible thefeatures of the human skin.

The output is then comparedwith our internal database toverify that it stays inside theestablished parameters.

Additional voluntary qualitycontrol not required by ISOstandard.

Quality Control process:needle penetration test

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Main needle controls

Technical file available on demand

REFERENCE STANDARD AIM OF TEST IMPACT ON QUALITY

SHEAR RESISTANCEUNI EN ISO 7864

(validation control – internal procedure

no. 10.05.01.00 no. 6)

Check cannulas’ shear

resistance under cyclic

stress

Guarantee maximum needle quality

NEEDLE DIMENSIONSISO 7864 (routine control - internal

procedure no. 10.05.01.00 no. 3)

Check cannula and needle

dimensions

(internal/external diameter

- wall/angle/tip thickness

Ensure most painless penetration

possible

FLEXINGISO 9626 (routine control - internal

procedure no. 10.05.01.00 no. 4)

Check needle’s flex

resistance

Ensure utmost needle quality and

safety during use

INTERNAL/EXTERNAL

CANNULA CLEANLINESS

ISO 7864 – ISO 8537 (routine control -

internal procedure no. 10.05.01.00 no.

5)

Exclude contamination by

foreign bodies

Ensure maximum patient health

and safety

62Technical file available on demand

REFERENCE STANDARD AIM OF TEST IMPACT ON QUALITY

CANNULA/BARREL

TRACTION

ISO 7864 - ISO 8537 (routine

control - internal procedure no.

10.05.01.00 no. 10)

Check force needed to

detach cannula from its

support

Ensure perfect needle-support

(barrel) adhesion and

maximum device safety

NEEDLE COVER/

NEEDLE TRACTION

routine control - internal procedure

10.05.01.00 no. 11

Check force needed to

detach needle cover from

its support

Ensure adequate needle

protection and sterility

PLASTIC MATERIAL

ACCEPTANCE

(acceptance control - internal

procedure 10.05.02.00 no. 4)

Check plastic product

properties (cleanliness,

transparency)

SILICONE OIL

ACCEPTANCEcorrespondence with specifications

Check silicone polymer

propertiesEnsure user’s maximum safety

Main product controls

63Technical file available on demand

CHEMICAL/BIOLOGICAL TEST REFERENCE STANDARD AIM OF TEST IMPACT ON QUALITY

FARMACOPEA-REQUIRED TESTSFarmacopea (routine control - internal

procedure 10.05.02.00 no. 13)

Check parameters such as syringe

non-pyrogenicity and non-toxicityEnsure product safety

QUANTITATIVE SILICONEFarmacopea (routine control - internal

procedure 10.05.02.00 no. 1)Check lubricant content

Prevent excess of silicone, which

is not broken down if introduced

into body

RESIDUAL ETHYLENE OXIDE CONTENTFarmacopea (routine control - internal

procedure 10.05.02.00 no. 2)

Check that EO content is less than 10

ppm as per standard

Check that residual EO is below

Artsana standard of 2 ppm (less

than Farmacopea limit) to ensure

greater patient safety.

BACTERIAL ENDOTOXIN DETECTION

(GEL-CLOT METHOD)

Farmacopea (routine control - internal

procedure 10.05.03.00 no. 7)Exclude risk of pyrogen contamination

Respect patient’s health and avoid

irritation

BACTERIAL ENDOTOXIN

QUANTIFICATION (LAL TEST)

Farmacopea (routine control - internal

procedure 10.05.03.00 nos. 5 and 8)Exclude risk of pyrogen contamination

Respect patient’s health and avoid

irritation

ELASTOMER CLOSURESFarmacopea (routine control - internal

procedure 10.05.02.00 no. 22)

Evaluate conformity of closures for

aqueous preparations for parenteral

use

Ensure product safety

STERILITYFarmacopea (routine control - internal

procedure 10.05.04.00 no. 1)

Correspondence with safety

requisitesEnsure product safety

Main biochemical controls

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Automatic, 100% check stations during assembly, impacting ontoproduct quality:

• Vision system checking useful length of the cannula• Vision system checking presence of the glue• Vision system checking patient tip integrity (absence of hooks)• Vision system checking patient tip bending after placing shield• Vision system checking cartridge tip bending• Vision system checking printing of data on the box• Sensor checking non-obstruction of the cannula• Sensor checking integrity of primary container• Sensor checking correct positioning of needle shield• Sensor checking box weight (100 pen needles per box)

The non-complying pieces are automatically discarded.

Assembling process:quality controls

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KEY FACTS

• More than 50 years of experience in cannula and needles

manufacturing

• More than 5.500 millions pen needles manufactured so far

• Integrated, made in Italy production (ISO and FDA compliant)

• Innovation (32G, Extr3me sharpening, High Flow Thin Wall)

• 32G pen needle in 3 lengths

• Over 60 quality control tests

• Additional quality restrictions and quality level parameters

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Ευχαριστώ!

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means:

ExpertiseInnovationTechnology

Quality

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• These new recommendations come from a 2-steps process:o the results of the second Injection Technique Questionnaire (ITQ)

survey (2008-2009), involving more than 4.300 insulin-injectingpatients with diabetes from 171 centers in 16 countries, making it one ofthe largest multi-center studies of its kind in diabetes. The outcomeswere then presented for review and revision to 127 experts from 27countries at the TITAN workshop in September 2009.

o a systematic literature analysis conducted for all peer-reviewedstudies and publications on injections in diabetes: an international groupof experts met regularly over a two-year period to review this literatureand draft the recommendations. Of 292 articles reviewed, 157 werefound to meet the criteria of relevance to the recommendations.

Injection techniques: the latest guidelines

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• Many studies show that to safeguard normal tissue one mustproperly and consistently rotate sites

• Patients should be taught an easy-to-follow rotation pattern fromthe onset of injection therapy

• The below scheme with proven effectiveness involves dividing theinjection site into quadrants (or halves when using the thighs orbuttocks), using one quadrant per week and moving alwaysclockwise, as shown by figures below

• Injections within any quadrant or half should be spaced at least1cm from each other in order to avoid repeat tissue trauma

Where to inject: site rotation

New injection recommendations for patients with diabetes, A Frid, L. Hirsch, R. Gaspar, D. Hicks, G. Kreugel, J.Liersch, C. Letondeur, J.P. Sauvanet, N. Tubiana-Rufi, K. Strauss - Diabetes & Metabolism 36 (2010) S3-S18

Abdominal rotationpattern by quadrants

Thigh and Buttocks rotational pattern by halves

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The choice of the injection site is anessential element for the glycaemiacontrol, since there is (especially withfast insulin) a relevant variability of theabsorption speed (= passage intoblood) for non-analogue insulins.

From fastest to slowest:

abdomen, shoulder, buttock, thigh

Absorption speed depends also on thetype of insulin (human, analogues,rapid- or slow-acting). For example,soluble human insulins may have aslower absorption profile than rapid-acting analogs. The most rapidabsorption of soluble human insulins isin the abdomen, which should be thepreferred site.

Where to inject: absorption speed

Recommended injection sites


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Clinical evidences and literature varies onto this subject.

Several healthcare professionals suggest to make the skinfold inorder to reduce the risk of IM injections, which can lead to a too fastinsulin absorption and therefore hypoglycaemia.

Here below general recommendations for adults.

How to inject: the appropriate technique


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• Lifting a skin fold and/or injecting at a 45-degree angle are especiallyimportant in slim or normal weight patients and in those injecting into thelimbs or into slim abdomens, particularly when using needles ≥8 mm.

• Skin folds are essential when the distance from skin surface to the muscleis less than the length of the needle.

• Lifting a skin fold is an easy and effective means for ensuring SCinjections.

• A proper skin fold is made with the thumb and index finger (possibly withthe addition of the middle finger). Lifting the skin by using the whole handrisks lifting muscle with the SC tissue and can lead to IM injections.

How to inject: the skin fold

• The skin fold should not besqueezed so tightly that it causesskin blanching or pain.


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• Lipohypertrophy is a thickened, ‘rubbery’ lesion that appears in the SCtissue of injecting sites in up to 50% of patients who inject insulin.

• Patients should not inject into areas of lipohypertrophy since insulinabsorption can be delayed or made erratic.

• Detection of lipohypertrophy requires both visualization and palpation ofinjecting sites, as some lesions can be more easily felt than seen.

• Figure 1 illustrates visible lipohypertrophy in a woman who had injected inthe same two locations below the umbilicus for twelve years.

Lipohypertrophy

Figure 1

Figure 2

• Figure 2 illustrates the detection ofpalpable lipohypertrophy bycomparing a fold of normal skin(left) with lipohypertrophic tissue(right). Normal skin can bepinched tightly together, whilelipohypertrophic lesions cannot.


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• Inject slowly and ensure that the plunger (syringe) or thumbbutton (pen) has been fully depressed.

• When using a pen, wait another 10 seconds after dose deliverybefore removing the needle in order to avoid leakage/reflux; thisensures full delivery of the injected dose.

• Massaging the site before or after injection may speed upabsorption and is generally not recommended.

• Tips for making injections less painful include:o Keeping insulin in use at room temperature, since cold

insulin can be more painful when injected;o If using alcohol, injecting only when the alcohol has dried

out;o Not injecting at hair roots;o Using a new needle at each injection.

Other recommendations


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Fear and pain of injections:

• 94% of insulin users show symptoms of anxiety, distress or

phobia around blood and injury from injections (1).

• 75% of newly diagnosed children < 9 years old have a fear of

injections (3).

• 47% of people with diabetes say they would be more likely to

follow their prescribed insulin regimen if a product easing pain

and discomfort of injections was available (4).

• 33% of insulin users are afraid of their injections (2).

(1) Berlin I, Bisserbe JC, Eiber R, Balssa, N, Sachon C, Bosquet F, Grimaldi, A: Phobic symptoms, particularly the fear ofblood and injury, are associated with poor glycemic control in type 1 diabetic adults. Diabetes Care 1997;20:176–178

(2) Peyrot M, Rubin RR, Kruger DF, Travis LB: Correlates of insulin injection omission. Diabetes Care 2010;33:240-245(3) Howe CJ, Ratcliffe SJ, Tuttle A, Dougherty S, Lipman TH: Needle anxiety in children with type 1 diabetes and their

mothers. AM J Matern Child Nurs 2010;36:25-31(4) AADE Injection Impact Survey, 2007

Insulin injection and patient’s compliance

76

Polonsky WH, Fisher L, Guzman S, Villa-Cabellero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: thescope of the problem. Diabetes Care 2005;28(10):2543-2545.

“Willing” and “unwilling” refer to patients’ willingness to begin insulin therapy.

Insulin injection and patient’s compliance

77

UK data from the 2009 Injection Technique Questionnaire (ITQ)survey of people with diabetes using insulin (*) showed that:• 75% did not follow any site rotation routine.• 60% had not changed their needle size since starting therapy.• 54% reported lipohypertrophy at some time in their life.• 45% experienced bleeding or bruising.• 43% released the skin fold too soon.• 41% failed to re-suspend their cloudy insulin adequately.• 28% admitted injecting into areas of lipohypertrophy.• 17% were using an incorrect technique for lifting a skin fold.• Only 41% reported frequent and adequate inspection of their

injection sites.

The importance of the education:patients’ mistakes

• D. Hicks, The UK & Ireland experience, TITAN 2009 congress

78

A 2010 survey* asked participants about the education and trainingthey had received relating to injection technique. Many did notremember receiving any education on particular topics.

The importance of the education:information retention

*Frid A, Hirsch L, Gaspar R et al (2010) The Third Injection Technique Workshop in Athens (TITAN). DiabetesMetab 36(Suppl 2): S19–29

Documents

How pen needles influence compliance and wellbeing of …static.livemedia.gr/ngda/documents/al17350_us63_20151113170230... · How pen needles influence compliance and wellbeing of