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-Swathi kiran Sarihaddu
What is an Insulin pen?
• Insulin pens are pen-shaped injector devices that contain a disposable
needle and either an insulin reservoir (or) an insulin cartridge designed for
self medication purposes. Used by patients with diabetes.
What is the need for it?
• It is accurate and timely insulin dosing is a vital
piece of a comprehensive plan, then why not?
Why is it now important?
• Because current statistics show that about 422 million people are
suffering from Diabetes worldwide. And the number is increasing year
by year!
Classification
• Insulin pens are regulated as Class II devices under 21 CFR 880 by
CDRH. Prefilled Insulin injector pens falls under Combination
products category.
Types of Insulin pens
• Techniques for dosing and insulin delivery are similiar for both types of
pen devices:
─ Prefilled pens
─ Reusable (cartridge) pens
• Both long-acting or basal insulin and rapid-acting or bolus insulin are
available in pens
How d0 they work?
• The insulin is injected by depressing the dose button which via
mechanical coupling causes the piston in the insulin cartridge to move
forward thereby expelling the intended dose.
•In simple language, Injected into
fat layer under skin, rotate sites.
•Common sites: abdomen,
thigh buttocks, upper arms
Advantages
• Insulin pens are portable, discreet, and convenient for injections away
from home.
• They save time because there is no need to draw up insulin from a
bottle - it is already pre-filled in the self-contained cartridge.
• They usually let you set an accurate dose by the simple turn of a
dosage dial, and that may make it easier to set an accurate dose for
people who have vision or dexterity problems.
Disadvantages
• Insulin in pens and cartridges is often more expensive than insulin in
bottles for use in syringes.
• Not all insulin types are available for use in insulin pen cartridges.
• Insulin pens do not let you mix insulin types, which means that if the
insulin mixture you need is not available as a pre-mix, two injections
must be given - one for each type of insulin.
FDA Guidance Documents
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm081324.htm
• http://www.fda.gov/downloads/RegulatoryInformation/Guidances/U
CM147095.pdf
• http://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.h
tm
Thank you!

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Presentation

  • 2. What is an Insulin pen? • Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir (or) an insulin cartridge designed for self medication purposes. Used by patients with diabetes. What is the need for it? • It is accurate and timely insulin dosing is a vital piece of a comprehensive plan, then why not?
  • 3. Why is it now important? • Because current statistics show that about 422 million people are suffering from Diabetes worldwide. And the number is increasing year by year! Classification • Insulin pens are regulated as Class II devices under 21 CFR 880 by CDRH. Prefilled Insulin injector pens falls under Combination products category.
  • 4. Types of Insulin pens • Techniques for dosing and insulin delivery are similiar for both types of pen devices: ─ Prefilled pens ─ Reusable (cartridge) pens • Both long-acting or basal insulin and rapid-acting or bolus insulin are available in pens
  • 5. How d0 they work? • The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. •In simple language, Injected into fat layer under skin, rotate sites. •Common sites: abdomen, thigh buttocks, upper arms
  • 6. Advantages • Insulin pens are portable, discreet, and convenient for injections away from home. • They save time because there is no need to draw up insulin from a bottle - it is already pre-filled in the self-contained cartridge. • They usually let you set an accurate dose by the simple turn of a dosage dial, and that may make it easier to set an accurate dose for people who have vision or dexterity problems.
  • 7. Disadvantages • Insulin in pens and cartridges is often more expensive than insulin in bottles for use in syringes. • Not all insulin types are available for use in insulin pen cartridges. • Insulin pens do not let you mix insulin types, which means that if the insulin mixture you need is not available as a pre-mix, two injections must be given - one for each type of insulin.
  • 8.
  • 9. FDA Guidance Documents • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm081324.htm • http://www.fda.gov/downloads/RegulatoryInformation/Guidances/U CM147095.pdf • http://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.h tm

Editor's Notes

  1. First Insulin pen was introduced by the Danish Company Novo Nordisk in 1985 and it was marketed as Novopen.
  2. Pre-filled pens Pre-filled pens contain a built-in, insulin cartridge. Because this device requires no loading by the student/parent/guardian, it is especially convenient and easy to use. Reusable pens With the reusable pen, an insulin cartridge is inserted into the pen's delivery chamber.