Pharmacy Industry Leadership: An Overview of USP - February 22, 2014 10:30 - 11:30 AM
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February 22, 2014
10:30 – 11:30 AM
Pharmacy Industry Leadership: An
Overview of USP
Jeanne Sun, Pharm.D.
Associate Scientific Liaison
Healthcare Quality Standards
USP’s Beginning
USP was founded in 1820 by
11 physicians, in Washington, D.C.
2
The first Pharmacopeia (1820)
The first Pharmacopoeia of the United States contained 217 of the
“most fully established and best understood” medicines in the
U.S. It was published “by the authority of the medical societies
and colleges.”
3
About USP
Scientific non-profit
organization that sets
standards for the identity,
strength, quality, and purity of
medicines, food ingredients,
and dietary supplements
USP Headquarters
Rockville, MD
USP’s Mission:
To improve global health through public standards and related
programs that help ensure the quality, safety, and benefit of
medicines and foods.
4
About USP
What We Do Today
– Establish and disseminate public written standards for the quality,
purity, identity, strength, and labeling of medicines
– Provide recommendations to practitioners on the safe use of
medicines
– Work with international health agencies to improve the quality of
medicines worldwide
– Educate practitioners, producers and others seeking information on
quality and USP standards
5
Council of Experts
6
USP Standards
The United States Pharmacopeia National
Formulary (USP–NF)
Food Chemicals Codex (FCC)
USP Dietary Supplements
Compendium (DSC)
USP on Compounding
USP Medicines Compendium (MC)
Herbal Medicines Compendium (HMC)
Reference Standards
Other Resources
– Pharmacopeial Forum (PF)
– FCC Forum (FCCF)
– USP Dictionary
– Chromatographic Columns
7
Legal Recognition Around the World
USP standards are used in more than 140 countries around the
world.
Medicines Food Ingredients
– Exportation of medicines to The Food Chemicals Codex (FCC)
the U.S. should abide by U.S. compendium are recognized in:
law and U.S. FDA Canada – food additive must
regulations, which specify comply with specifications in
USP–NF standards. FCC
Australia and New Zealand –
primary source of identity and
purity specifications for
substances added to food
Brazil – FCC standards are
recommended, along with
other standards.
Israel – food additive must
comply with FCC or iJECFA.
8
Legal Recognition in the US
1848 Drug Import Act 1994 Dietary Supplement
recognized USP standards to Health Education Act
stop the dumping of drugs by recognize USP standards for
Europeans dietary supplements
1906 Pure Food and Drugs Act
enforced USP and NF standards
for strength, quality, and purity
1938 Food, Drug and
Cosmetic Act recognized USP
& NF standards for strength,
quality, purity, packaging, and
labeling
9
9
Legal Recognition in the US
1997FDA Modernization Act 2013Drug Quality and
Sec. 503A stated that Security Act recognize USP
compounding must comply with monographs for bulk drug
USP-NF standards and chapter substances and USP chapters
on pharmacy compounding on pharmacy compounding
2003Medicare Modernization
Act requested USP to develop
and revise the Model Guidelines
for Medicare Formularies
2010Affordable Care Act
recognizes USP Model
Guidelines to assess coverage
of Essential Health Benefits
10
10USP Healthcare Quality Standards
Expert Committees (2010-2015)
– Nomenclature, Safety and Labeling Expert Committee
• Scientific Liaison: Andrzej Wilk, Ph.D.
• Scientific Liaison: Donna Bohannon, R.Ph.
– Compounding Pharmacy Expert Committee
• Scientific Liaison: Rick Schnatz, Pharm.D.
• Scientific Liaison: Jeanne Sun, Pharm.D
– Therapeutic Information and Formulary Support
• Scientific Liaison: Jami Earnest, Pharm.D
Expert Panels and Advisory Groups
– Prescription Container Labeling
– Compounding with Hazardous Drugs
– Pharmaceutical Compounding – Sterile Preparations
11Nomenclature, Safety and Labeling Expert Committee
Monograph Titles
1. Substance monograph
Amlodipine Besylate
2. Product monograph
Amlodipine Besylate
Tablets
3. Compounded Preparation
monograph
Amlodipine Oral
Suspension
13USP Dictionary
Entry Components
– U.S. Adopted Name (USAN)
– Pronunciation Guide
– Molecular formula and weight
– Chemical Name
– CAS registry number(s)
– Other nonproprietary names
– Pharmacologic and/or therapeutic activity
– Brand name(s)
– Name(s) of manufacturer
– Graphic formula
14Reference Tables
Container for Dispensing Capsules and Tablets
– Relevant tight (T)
– Well-closed (W)
– Light-resistant (LR)
Solubility
Atomic weights
15Prescription Container Labeling
Purpose
– To develop standards for prescription container labels as they are the
patient’s best source. The prescription container label must be able to
fulfill the professional obligations of the healthcare provider to give
the patient all the information needed to understand how to safely
use the medication
Official May 2013
Take:
2 tablets in the morning
2 tablets in the evening
16Physical Environments that Promote
Safe Medication Use
Purpose
– To describe optimal physical environment standards to promote
accurate medication use and improve performance since the work
environment has been identified as one of the most commonly
reported factors contributing to medication errors
Physical Environments addressed:
– Illumination
– Sound and Noise
– Interruptions and Distractions
– Physical Design and Organization
of Workspace
17Safety Focused Labeling Initiatives
Ferrules and Cap Overseals
Strength and Total Volume
Prescription Container Labeling
18USP Pictograms
Standardized graphic images that help convey medication
instructions, precautions, and/or warnings to patients and consumers.
– Deliver important information to patients with a lower level reading ability and
patients for whom English is a second language.
– Reinforce printed or oral instructions.
Currently USP offers 81 pictograms
– Tested for comprehension
Available for download (free of
charge)
– http://www.usp.org/usp-healthcare-
professionals/related-topics-resources/
usp-pictograms
19Compounding Expert Committee
Compounding
Definition
– The preparation of a drug in accordance with a licensed practitioner’s
prescription or medication order based on the triad relationship.
Why compound? Viable Alternatives?
– Pediatric patients – Crushing Tablets
– Geriatric patients – Splitting Tablets
– Animal patients – IV Solutions
– Non-standard doses
– Allergen-free medication
– HRT
– Sports Injuries
– Pain management
– Drug Shortages
– Discontinuation by manufacturer
21
21Compounding General Chapters
Pharmaceutical Compounding – Nonsterile Preparations
Pharmaceutical Compounding-Sterile Preparations
Quality Assurance in Pharmaceutical Compounding
Pharmaceutical Calculations in Prescription Compounding
Prescription Balances & Volumetric Apparatus
22Hazardous Drugs – Handling in
Healthcare Settings
Purpose
– To clearly identify the requirements for handling of hazardous drugs
to protect the patient, healthcare personnel, and environment.
– Processes intended to provide containment of HDs to as low a limit
as reasonably achievable
– Harmonization of OSHA , NIOSH,
ASHP, and ONS guidelines
– Addresses receipt, storage, mixing,
preparing, compounding (sterile and
nonsterile), dispensing, and
administration of hazardous drugs
23Compounding for Investigational
Studies
Purpose:
– To guide compounding practitioners in the extemporaneous compounding of
drugs used in investigational studies.
– Should be in compliance with all the appropriate USP general chapters
and USP–NF standards pertaining to compounding
– Chapter provides additional standards for compounding for investigational
preclinical and early phase I investigations
New chapter proposal for PF39(5) Sept-Oct 2013
– Targeted publication in USP37-NF32 (2nd Supplement)
24Compounded Preparation Monographs
COMPOUND PILLS OF JALAP
Take of Jalap in powder;
Rhubarb in powder;
Castile soap, each one ounce.
Submuriate of mercury six drachms
and two scruples.
Tartarized antimony, twenty eight
grains.
With water form a mass and divide into four
hundred pills.Components of a Compounded Preparation
Monograph
Title
Definition
- Lists the range of labeled amount
of active ingredient
Formula
- Ingredients and quantities
Compounding Procedures
Stability-indicating Assay
pH
Packaging and Storage
Labeling
Beyond-use dates
- Stability studies
- Chapters or
26Clinical Case
S: Malnourished white male
At 3 months, developed “cradle cap”
O: At 6 months, weighed 4 pounds
Widespread weeping cutaneous lesions covering body
Seizures and Impaired digestion
A:
P:
Acrodermatitis enteropathica is an autosomal recessive metabolic
disorder affecting the uptake of zinc, characterized by periorificial and acral
dermatitis, alopecia, and diarrhea. Fatal if untreated.
27Clinical Case
Zinc Sulfate 44 mg/mL
123
Pharmacy
Road
Rockville,
MD
Solution
(123)555-‐0123
Zinc sulfate, granular 4.4 g
Name:
Baby Johnson Age:
(heptahydrate)
6 months
Date:
June 26, 2013 Cherry syrup, NF 45 mL
Purified Water, NF, a 100 mL
Zinc Sulfate 44 mg/mL
sufficient quantity to
Oral Solution
make
Sig: 3.5 mL/day of zinc Note:
Elemental
zinc
1
mg
is
equivalent
(equiv 154 mg/day Zinc) to
zinc
sulfate
2.47
mg
or
zinc
sulfate
Disp: 50 mL heptahydrate
4.4
mg.
ReLills: 3
Signature:
Dr. SmithTherapeutic Information and
Formulary Support Expert
Committee
29Medicare Modernization Act (MMA) 2003
Section 1860D-4(b)(3)(C) defines role of USP:
“(ii) MODEL GUIDELINES The [HHS] Secretary shall request the United States
Pharmacopeia to develop, in consultation with pharmaceutical benefit managers
and other interested parties, a list of categories and classes that may be used by
prescription drug plans under this paragraph and to revise such classification
from time to time to reflect changes in therapeutic uses of covered part D drugs
and the additions of new covered part D drugs.”
Section 1860D-11(e)(2)(D) creates “safe harbor”:
“(ii) USE OF CATEGORIES AND CLASSES IN FORMULARIES. The Secretary
may not find that the design of categories and classes within a formulary violates
clause (i) if such categories and classes are consistent with guidelines (if any) for
such categories and classes established by the United States Pharmacopeia.”USP Medicare Model Guidelines
Development
USP MMG v1.0 (2005)
involved:
– Expert Committee
– Environmental scan
– Public advisory meetings
– Public comment process
Revision from “time to
time”
– USP MMG v2.0 (2006)
– USP MMG v3.0 (2007)
– USP MMG v4.0 (2008)
– USP MMG v5.0 (2011)
– USP MMG v6.0 (2014)
Arch Intern Med 2006; 145:448-453.
31USP Medicare Model Guidelines
USP MMG are…. USP MMG are not….
√Structural model of categories ≠ Formulary or list of essential
and classes medications
√Part of a CMS Part D formulary ≠ Mandated in their entirety (plans
check that requires 2 drugs from can adjust their formulary
each category/class category/class names)
√Therapeutically driven by FDA ≠ Drug classification based solely
indications xxxxxxxxxx upon pharmacology/chemistry
√Specific to Part D drugs and ≠ Inclusive of all medications or
Medicare Beneficiaries patients
32ACA Essential Health Benefits
ACA requires health plans to cover “Essential Health Benefits” (EHB)
within 10 benefit categories, including prescription drugs
HHS Final Rule (2/25/13) cites USP Medicare Model Guidelines
– “…in order to comply with the requirement to cover EHB, a plan would cover
at least the greater of:
(1) One drug in every USP category and class; or
(2) the same number of drugs in each category
and class as the EHB-benchmark plan. “
For 2014-2015, HHS makes use of
USP Medicare Model Guidelines v5.0
33Looking ahead….
Expert Panels to address therapeutic information needs
expressed by USP Convention membership
• Information and decision support for drug shortages
• Biologic products
• Precision medicine
Data collected by the University of Utah Drug Information
Service. Data for 2012 are through Dec 31, 2012.
34Opportunities at USP
35Council of Experts & Expert Committees
Council of Experts
– oversees USP's scientific and standards-setting decisions
Expert Committees
– responsible for developing and revising USP standards that comprise its
seven compendia
Expert Panel
– formed to provide additional expertise on a particular compendial topic,
thereby supplementing Expert Committee expertise
Call for Candidate for 2015-2020 Convention Cycle
– Deadline for Application: Jan 1, 2015
– http://uspgo.to/call-candidates.
36Summer Internship Program
Offers students of chemistry, pharmaceutical sciences, and related science
disciplines, the fulfilling opportunity to work on a defined project that expands
and enhances USP's core strategic initiatives focusing on the following areas:
– Healthcare Quality Standards
– Reference Standards Laboratory—Quality of Manufactured Medicines
– Global Health Impact Program—Quality of Medicines
– Excipients
Duration: 12 weeks, 37.5 hour work week
Location: U.S. Pharmacopeia Headquarters (Rockville, MD)
Dates: May 26, 2014 – August 15, 2014
More information can be found at
http://www.usp.org/about-usp/careers/internship-fellowship-programs
37Global Fellowship Awards Program
Promotes research in areas relating to standards for medicines, foods, and
dietary supplements and their use
USP Global Fellowship Awards of up to $50,000 are presented to the students
whose proposed research directly address a specific USP scientific or research
need.
Eligibility
– Have been accepted for full-time study in a Ph.D. or Pharm.D. program
– Have been accepted to a Fellowship Program;
– Or have been awarded a postdoctoral research (non-faculty) appointment.
Application Deadline: May 2, 2014
More information can be found at
http://www.usp.org/about-usp/careers/internship-fellowship-programs
38Career Opportunities
Being a part of USP means belonging to a diverse culture made up of more than
800 talented professionals working together at five international locations.
We share our expertise in science, IT, human resources, quality assurance,
communications, administrative management, and more...all to support an
overall mission dedicated to making a difference by providing standards and
programs that help improve the quality of medicines, dietary supplements, and
foods worldwide.
Current openings can be found at:
https://uspcareers.silkroad.com/
uspext/EmploymentListings/
EmploymentListingsUSP.html
39My pathway to USP
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