COMBAT METHAMPHETAMINE EPIDEMIC ACT, PACKAGE INSERTS & MEDGUIDES, & EMERGENCY CONTRACEPTION

What is the Purpose of the Combat Methamphetamine Epidemic Act?

Combat Methamphetamine Epidemic Act of 2005 bans OTC sales of cold medicines that contain ingredients that are commonly used to make methamphetamine such as pseudoephedrine (federal & PA same)

What it is the Scope of Ban?

• Pseudoephedrine

• Phenylpropanolamine; &

• Ephedrine

What are the Requirements?

• The Act allows for the sale of pseudoephedrine only from locked cabinets or behind the counter

• The law:

  • Limits the amount any individual could purchase

    • Daily Sales

      • Daily sales of regulated products not to exceed 3.6 grams w/o regard to the # of transactions

    • 30 Day Purchase

      • 30 day purchase limit not to exceed 9 grams of pseudoephedrine base in regulated products

    • Mail Order

      • 30 day (not monthly) sales limit not to exceed 7.5 grams if sold by mail-order to ‘mobile retail vendor’

  • Requires individuals to present a photo identification card issued by the State or Federal Government or a document that is considered acceptable by the seller

  • Requires retailers to keep a written or electronic “logbook” (PA requires all retailers to electronically report transactions to NPLEx) listing sales & identifies the following:

    • Name of product

    • Quantity sold

    • Name & address of purchase

    • Dates & times of the sales, &

    • Verified signature of pt

  • Requires Certification & Training

    • Retailers must train each applicable individual & certify to the Attorney General that they understand the requirements that apply

  • Requires Record to be kept for 2 years

What are Patient Package Inserts?

• Required for:

  • Oral Contraceptives

  • Estrogen containing products

• Institutional Distribution

  • Institutions may provide PPIs w/ each prescription or w/ first dose & again every 30 days

What are MedGuides?

• Different from Patient Package Inserts

• FDA requires that MedGuides be issued w/ certain prescription medications & biologicals

• When required MedGuides must be issued w/ ALL new & refill prescriptions

What is Medwatch?

• MEDWATCH is currently the FDA Safety & Information & Adverse Event Reporting Program

What is the Availability of Emergency Contraception?

• Plan B One Step has been approved by the FDA as an OTC form of emergency contraception

• Original FDA regulations required women ages 16 & younger to obtain a doctor’s prescription in order to receive Plan B One Step. However, a recent federal court ruling has voided this requirement. As the law currently stands, Plan B One Step is available OTC to any female

• Pharmacies are no longer required to store Plan B One Step behind the counter

What is Emergency Contraception in Hospitals?

• Hospitals providing emergency medical care to victims of sexual assault must:

  • Supply written information about emergency contraception

  • Orally inform victims of the availability of emergency contraception, &

  • Administer emergency contraception onsite upon the victim’s request

    • Hospital may choose not to provide emergency contraception onsite if doing so may be contrary to the stated religious or moral beliefs of the hospital

    • If a hospital claims a religious or moral exemption, that hospital must still provide written information about emergency contraception, & arrange for a victim who requests it, to be transported to a facility which provides emergency contraception

  • Ensure that each member of the hospital personnel that provides sexual assault emergency services is provided w/ written informational materials about emergency contraception