BOARD UPDATE WINTER, 2017

Susan Alverson

OUR PRESENT AGENDA

• Legislation

• DEA consideration of pharmacists as having corresponding liability

• Our meetings with other groups

• Office changes

• FDA meeting March 16th at Samford

LEGISLATION

ADD WORDS “A HEALTH CARE PROVIDER” TO THE DEFINITION OF A PHARMACIST.

LEGISLATION

DRUG SUPPLY CHAIN SECURITY ACT

•Boards of Pharmacy must create separate licenses for Manufacturers, Wholesale/Distributers, Repackagers, 3PLs (Third Party Logistics), Private Label Distributers. (virtual manufacturer)

•Feds have license for Manuf. Repack, working on Wholesale and 3PL.

DEFINITIONS

• Manufacturer: develop, make, store and sell product. Possess product

– They OWN the product– hold the NDA or the ANDA. Responsible for quality.

• Wholesaler – buys product already made and will resell. Do not hold an NDA or ANDA. Possess product.

• 3PL – Take possession of product, but do not own. Warehouse or ship.

DEFINITIONS

• Repackager – Buys drug product or ingredients, takes possession, repacks the product for a buyer

• Private Label Distributer – Contracts out to have a product manufactured with their NDC and label. PLD owns the NDA or ANDA.

– Owns but never possesses the product

– Responsible product release & quality

RISK TO PHARMACY

• Do not buy if seller is not licensed in Alabama.

– We are not licensing companies out of the country.

• Be sure the drug is approved.

Potassium Chloride Powder

Manufacturer for:

Virtus

Tampa, Fl

Manufactured for

Virtus

Nashville TN

• NDC Code(s): 76439-343-10, 76439-343-30

• Packager: Virtus Pharmaceuticals OpCo II

• Category: HUMAN PRESCRIPTION DRUG LABEL

• DEA Schedule: None

• Marketing Status: unapproved drug other

• DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

CHANGE TITLE OF INSPECTORS

• We are asking to change title to inspector.

• It will not change authority.

• Will make it easier to obtain documents.

AUTHORITY TO CHARGE TECHNICIAN LATE FEE

• We have charged technicians a $10 fee for late renewal of registration.

• Statute says we have the authority to manage registration of technicians.

• Sunset committee wanted us to spell out that authority.

Rewrite compounding regs, to recognize USP standards

• We have spelled out the requirements for sterile and non-sterile compounding.

• We will replace all those pages with the statement that we will recognize USP and FDA regulations.

DIFFERENCE IN MOLECULES VERSUS BIOLOGIC

MOLECULE CHOLESTEROL IMAGE COENZYME Q

SO WHAT IS THE PROBLEM?

• Biologics are not molecules which are always the same in structure, and while cholesterol is cholesterol is cholesterol.

• Biologics are grown, and involve protein folding

• Biologics are never really exactly the same from lot to lot

Manufacturers want to be able to substitute

• How do you allow substitution of one drug for the other when they are not the same?

• FDA is preparing a reference called the “Purple Book” which will identify what is interchangeable

• We do not want the legislation to say to use FDA interchange list OR therapeutic equivalence.

WHAT IS YOUR CR?

CR = CORRESPONDING RESPONSIBILITY

•DEA regulations state that the pharmacist should know and recognize when controlled drugs are being abused.

•The pharmacist should question inappropriate prescribing and usage.

•And the pharmacist should refuse to fill the prescription if it appears to be over usage.

• To protect yourself, be sure to document on or with the record that you contacted prescriber for explanation of reason for prescribing such dose or multiple drugs.

• If you receive pushback, you should refuse to fill; protect yourself.

• If prescriber is rude, call the medical Board, or call us and we will call the medical board.

SUBSYS

SUBSYS

• CII aerosol Fentanyl

• HIGH risk of respiratory depression.

• MD must do REMS training

• RPh must do REMS training.

• Use ONLY for cancer pain!

• Use ONLY for breakthrough pain NEVER for maintenance

• RPh. MUST council patient.

• Must explain drug disposal.

CAUTION! Suboxone.

• Suboxone and Subutex for addiction.• Physician must register and complete online

training. Will be given an “X” ID number.

• Prescriber may only have 275 addict patients.

• MD office must send HIPAA release signed by pt. before you may communicate by phone

• Pharmacy may not compound copy of drug.

• If you add extra ingredient, you have created a product which is not approved for addiction and may not be used.

OFFICE CHANGES

• Mitzi Ellenburg and Diane Decker retired

• Wendy Passmore is now responsible for scheduling appearances before the Board– Communication on legal cases between our office and

the people in the cases

• New employees

– Ashley Huntley: full-time receptionist

– Twalla Jackson: in-state and out-of-state pharmacies

• Transitioning to online

CONTACT INFO

Name Area of Specialty

Rhonda Cokerrcoker@albop.com

Licensing Supervisor

Lynn Martinlmartin@albop.com

Pharmacists

Terry Lawrencetlawrence@albop.com

Technicians

Kim Pickettkpickett@albop.com

Pharmacy Businesses

Twalia Kingtking@albop.com

In-State PharmaciesOut-of-State Pharmacies

Wendy Passmorewpassmore@albop.com

Legal CommunicationsAgenda and Board Hearings

CHANGES TO USP 800WINTER 2017

Susan Alverson

Enforceability

• USP 800 may subject pharmacies to both state board and FDA inspections.

• Goes into effect July of 2018

List of Hazardous Drugs

• Each institution must have a list

– Type of HD

– Dosage form

– Risk of exposure

– Packaging

– Manipulation

NIOSH HDs

• Six categories:

– Carcinogenic drugs

– Teratogenic drugs

– Reproductive toxins

– Drugs with organ toxicity at low doses

– Genotoxic drugs

– Drugs that mimic existing HDs

• Updated every two years

– New list expected this year

Receiving & Storage

• Receipt and unpacking of antineoplastic HDs must occur in a negative pressure or neutral pressure area.

• Capsules and tablets or closed liquids do not have to meet this requirement.

• Storage: For open or manipulated drugs– Negative pressure room

– At least 12 air changes per hour

– Must be in a separate refrigerator from non-HDs

Preparation

• HD preparation must be performed in a separate area from non-HDs.

– Separate negative pressure room

– Separate primary engineering controls

• No compounding small volumes of HDs in areas where non-HDs are routinely prepared.

– Eliminates exception rule in USP 797.

Equipment

• Sterile HDs:

– Class II biologic safety cabinet

– CACIs Certified Aseptic Containment Isolator

• Nonsterile HDs:

– Externally vented Class I BSCs

– Containment-ventilated enclosures (CVEs)

• Class I BSCs and CVEs do not guarantee product sterility.

Environment

• HD preparation must always occur in a negative pressure environment.

• Clean room

• Negative pressure containment segregated compounding area

– Vented to the outside

– At least 12 air changes per hour

– Do not need to meet standards of the International Organization for Standardization.

– May have a shorter BUD (12 hours) than products prepared in a clean room.

Administration

• Use of CSTDs:– recommended for preparing HDs in the pharmacy

– required for administering HDs to patients

COPIES OF DRUGS

• May not make a copy of a product on the market, whether it is branded or generic.

• May make a copy, if need for patient in a different form. Be sure to document.

• Warning about Viagra 20 mg.

QUESTIONS