Pharmacy issues 2004
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Pharmacy Issues: 2004. Elizabeth Curry-Galvin, DVM Assistant Director, Scientific Activities AVMA-Schaumburg [email protected] Topics Compounding Ethical Products Internet Pharmacies. Context Business Legal Ethical Reminder Allegations, No Names Policy vs. Not

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Pharmacy issues 2004

Pharmacy Issues: 2004

Elizabeth Curry-Galvin, DVM

Assistant Director, Scientific Activities

AVMA-Schaumburg

[email protected]


Pharmacy issues 20041

Topics

Compounding

Ethical Products

Internet Pharmacies

Context

Business

Legal

Ethical

Reminder

Allegations, No Names

Policy vs. Not

State laws and rules vary-check Colorado

Pharmacy Issues: 2004


What s compounding

What’s Compounding?

  • Definition

    • Simply, the preparation of custom medication for a particular patient (manipulation--> unapproved drug)

    • Pharmacists or Veterinarians

  • Fills a niche

    • No drug approved for condition

    • Approved drug needs modification

  • Examples

    • Mixing two pre-anesthetics

    • Tablets into suspension

    • Diluting

    • Flavoring


Be precise

Be Precise

  • Avoid generalizing when discussing “compounding”

    • DRUG

      • Approved drug (AMDUCA) vs. bulk drug [raw drug ingredient or chemical] (not legal)

    • VCPR

      • Custom medication prescribed for one animal vs. purchases outside of a VCPR

    • SCALE

      • Individual animal (compounding) vs. manufacturing / wholesaling (piracy)

    • ANIMAL

      • Food vs. non-food animal (different risks, differences in regulatory discretion)


2 compounding issues

2 Compounding Issues

  • Address Piracy

  • Compounding from bulk drugs is not legal

    • Need regulatorydiscretion from states and FDA when veterinarians compound medically necessary drugs from bulk ingredients for individual, non-food animals, within a VCPR because no drug is approved and available to adequately treat the patient.


Piracy manufacturing unapproved drugs

“Piracy” (manufacturing unapproved drugs)

  • “Piracy” as distinct from traditional compounding

    • Essentially wholesaling unapproved drugs

    • Made from bulk ingredients

    • Circumvents FDA drug approval & monitoring process

    • Mass markets products with little quality control

    • Mimic approved drug (knock-off)

      • Omeprazole, enrofloxacin, praziquantal, ivermectin formulations

    • Beware these are not generics!


Why piracy

Why Piracy?

  • Financial Drivers $$$$$

    • Pirating firms

      • Mass production with no FDA costs

    • Veterinarians

      • Purchase drug at lower price than approved product, pass along or keep savings

  • Unfamiliarity

    • Lack of appreciation of differences between FDA approved and compounded drug

    • Lack knowledge of laws and rules

    • Mistaking compounded drugs for generic drugs

    • Assuming provider is working in patient’s best interest

  • Little enforcement visible in recent history..changing


Approved drug assurances

Approved Drug Assurances

  • Safe

    • Studied under label conditions of use in target species

    • No contaminants (chemical, biological, toxins)

  • Effective

    • Studied under label conditions of use

    • Not sub- or super-potent (active ingredient)

    • Formulation proven successful

  • Batch to batch consistency

    • No surprises

    • You get what you paid for


Approved drug assurances1

Approved Drug Assurances

  • Scientifically proven expiration dates

  • Scientifically proven withdrawal times

  • Proper packaging assures stability

  • Label information derived from studies

    • Dose, indications, precautions, contraindications

  • Post-marketing surveillance / Label updates

    • Adverse event tracking


Laws rules

Laws & Rules

  • Federal Oversight

    • Different “rules” for humans vs. animals!

    • FFDCA does not permit veterinarians to compound unapproved finished drug products from bulk drug substances (affirmed by two Federal Appeals Court decisions)

    • AMDUCA-permits compounding from approved drugs

    • FDA Compliance Policy Guide on Compounding

      • “when the scope and nature of compounding raise the kinds of concerns normally associated with a drug manufacturer”

  • State Oversight

    • Board of Pharmacy

      • Laws, regulations, policies, standards


Why is piracy bad

Why is Piracy Bad?

  • Denies patient treatment with approved drug

    • Safe, effective, pure, potent, stable, GMPs

  • Exposes patient to unapproved drug

    • Contaminated, sub- or super-potent, unstable

  • Exposes parties to unnecessary liability

  • Undermines R&D by drug companies

  • Veterinarians will have fewer approved drugs

  • Bulk ingredients…quality? bio-terrorism?

  • Illegal


Avma position on compounding

AVMA Position on Compounding

  • Decision to use compounded drug driven by veterinarian within VCPR

  • Comply with AMDUCA and FDA Compliance Policy Guide on Compounding for Animals

  • Food safety concerns preclude use unless information exists to assure avoidance of illegal tissue residues


Avma position on compounding1

AVMA Position on Compounding

  • Limited to:

    • Safety and efficacy of compounded drug demonstrated in target species,

    • Response to therapy or drug concentrations can be monitored, or

    • Individual patients where no other drug delivery is practical.

  • Precautions, counsel client, adverse reactions, unintended exposure


2 compounding issues1

2 Compounding Issues

  • Address Piracy

  • Compounding from bulk drugs is not legal

    • Need regulatorydiscretion from states and FDA when veterinarians compound medically necessary drugs from bulk ingredients for individual, non-food animals, within a VCPR because no drug is approved and available to adequately treat the patient.


New cpg on compounding

New CPG on Compounding

  • Replaced 1996 CPG (federal)

  • Emphasizes FDA’s concern with compounding that approximates manufacturing

    • Written to facilitate enforcement

  • Did it make use of bulk drugs in compounding illegal?

    • No, compounding from bulk drugs has been not legal for years

  • However, less text on regulatory discretion..bulk


New cpg on compounding1

New CPG on Compounding

  • Less text on regulatory discretion for medically necessary bulk drugs

  • Includes an Appendix

    • Bulk drugs for which the FDA would not ordinarily object if compounded

      • Certain large animal antidotes

  • No listing of bulk drugs that are important

    companion animal therapeutics, e.g. potassium bromide

    • Makes one worried if needed drug is “not on the list”

  • Renewed visibility of thorny issue

  • Business as usual?


  • Should cpg be withdrawn

    Should CPG be withdrawn?

    • IACP (pharmacists) lobbying veterinarians

    • COBTA says “no”

      • Pro-enforcement against mfg. of unapproved drugs

      • Seeking ways to specify regulatory discretion

        • Medically necessary drugs compounded from bulk ingredients for individual non-food animals when no such approved drug exists

    • COBTA meets March 26-27


    In office use

    In-Office Use

    • “In-Office Use” generally recognized by state Pharmacy Boards

      • Upon prescription, pharmacist prepares small quantity for veterinarian’s “in-office” use (administration)

      • Facilitates timely administration of medication since compounded drug often mailed

      • Product labeled “In-Office Use” in place of patient name

      • Stability not definitively known…watch shelf life

      • Not to be used as stock from which to dispense

        • Makes pharmacist a “wholesaler”


    Resale of compounded products

    “Resale” of Compounded Products

    • FDA Compliance Policy Guide

      • Concern with “compounding drugs for third parties who resell to individual patients, or offering compounded drugs at wholesale to other state licensed persons or commercial entities for resale.”

    • Possible state Board of Pharmacy rules

      • Makes pharmacist a wholesaler

    • Don’t buy pirated drugs wholesale for resale

    • Don’t receive a drug compounded by a pharmacist for a particular patient, change the label & dispense


    Resale of compounded products1

    “Resale” of Compounded Products

    • Question whether you can dispense “In-Office Use” compounded drug to provide timely treatment and bridge the time needed for the mail order drug to arrive (needed regulatory discretion)

    • Question whether you can prescribe, pay for, and receive a drug compounded by a pharmacist for a particular patient, then sell it (unaltered) to the client with a mark-up (?)


    Reminders

    Reminders

    • A drug is a formulation, not just an active ingredient

    • Changes in formulation affect bioavailability

      • Adsorption, Distribution, Metabolism, Excretion

        • transdermals

    • Alterations in bioavailability affect treatment outcome


    Reminders1

    Reminders

    • Compounded drugs are NOT generics

      • Generics have been approved by FDA to ensure safety, efficacy, quality, stability, package, label

    • Flavored preparations can be legally compounded when APPROVED drugs are flavored

      • Flavoring can be an non-legal profit center for those who flavor bulk drugs without purchaser’s knowledge


    State compounding issues

    State Compounding Issues

    • Arkansas Board of Pharmacy Regulation 07-02-0002 Section (m)(5)

      • “Compounding for office stock for veterinarians is prohibited, except for compounds to be used in life-threatening situations where lack of immediate availability of the product could result in patient harm and no FDA-approved product is commercially available.”

    • ArVMA opposes, under discussion


    State compounding issues1

    State Compounding Issues

    • Texas Board of Pharmacy Proposal

      • “The quantity of all compounded pharmaceuticals distributed to all practitioners during the previous 12 months pursuant to this exception does not exceed 5% of all prescriptions compounded and dispensed during the previous 12 months. For the purposes of the exception, distributions to practitioners shall not be included in the 5% if the pharmacy receives and documents within 30 days of distribution, the name of the patient to whom the compounded pharmaceutical was administered.”


    Ethical products

    “Ethical” Products

    • AVMA defines ethical product:

      • Mfg. voluntarily limits sale to veterinarians

      • Often different name/packaging than direct to consumer products

      • Sold only to veterinarians as a condition of sale that is specified in a sales agreement or on the product label.


    Ethical products1

    “Ethical” Products

    • AVMA Principles of Vet. Med. Ethics state

      • “it is unethical for veterinarians to use or permit the use of their names, signatures, or professional status in connection with the resale of ethical products in a manner which violates those directions or conditions specified by the manufacturer to ensure the safe and efficacious use of the product.”


    Ethical product diversion

    “Ethical” Product Diversion

    • Distribution channel is manufacturer’s policy

    • Not government restricted distribution, e.g. Rx

    • Manufacturer’s responsibility to enforce its policy—contact manufacturer with concerns

    • Legally not appropriate for associations to seek to influence those policies

    • Manufacturer may deny future purchases?

    • Registered as distributor?

    • Tax laws?


    Flea and tick

    Flea and Tick

    • 40% of practices only sell flea and tick products to clients who have visited with the pet in the last year.

    • 43% practices sell to anyone

    • Source: VetMedTeam.com in Veterinary Economics, October 2003


    Internet pharmacies

    Internet Pharmacies

    • Internet pharmacies are here to stay!

    • Honor client requests for prescriptions

    • Know your rights

    • Know your responsibilities

    • Answers & enforcement frequently found at state level

    • Do your part right; Can’t police everything

    • Offer clients value and convenience

    • Speak factually

    • Report complaints; Complete documentation


    Avma position on internet pharmacies

    AVMA Position on Internet Pharmacies

    • Drug therapy initiated by DVM within VCPR

    • Veterinarians should honor client requests to prescribe rather than dispense a drug

    • Client has option of filling at any pharmacy

    • Might advise clients of VIPPS pharmacies

    • Veterinarians asked by pharmacies to approve prescriptions they have not initiated should do so only if the prescription is appropriate and VCPR exists


    Avma position on internet pharmacies1

    AVMA Position on Internet Pharmacies

    • Veterinarian’s purview to determine medical criteria whereby drug is indicated, not pharmacist

    • Maintain written record of prescription

    • Communicate proper use, risks regardless of drug source

    • Use of drugs of foreign origin that lack FDA approval generally is not permitted


    Current commonly asked dvm questions

    Current Commonly Asked DVM Questions

    • Can I charge for a prescription?

    • Do I have to provide a prescription?

    • Can I write a prescription to be used at a Canadian pharmacy?

    • Generic substitution?

    • Can I ignore the fax, but work with client, and offer a written Rx? Hospital policy?

    • What can I say about the pharmacy?

    • Can I insist the client come in for a written Rx?

    • Where do I report….?


    Other contacts

    Other Contacts

    • Consumer calls

      • Is it legal for my vet to…

    • Agency Calls: MO, MI, TN, DE responding to consumers allegations

    • (Per FTC: It would be within its jurisdiction to create a regulation if consumer complaints indicate consumers need greater protection)

    • Jurisdictional Challenges: agencies may not see total picture

    • Internet (human) pharmacy is exploring animal drugs


    Environmental scanning ftc

    Environmental Scanning-FTC

    • 1978 FTC regulations require prescribers to provide eyeglass prescriptions; upheld by courts

    • Dec. 6, 2003 President Bush signed Fairness to Contact Lens Consumers Act; FTC jurisdiction

      • Congressman’s wife’s experience (10 years), “long overdue, important consumer’s rights issue”

      • Requires prescriber to provide copy of prescription

      • Prescriber may not charge for prescription

      • Requires prescriber to verify electronic prescription requests w/in 8 business hours or request is considered authorized

      • Consumers Union an early supporter


    Environmental scanning

    Environmental Scanning

    • Reader’s Digest from Consumer Reports (a publication of Consumer’s Union)

      • “…the veterinary care industry languishes in the Stone Age of consumer-protection law…”

      • “…dispute a bill…Fluffy may be held hostage under state lien laws…”

      • “…vets dispense medicine, but few states require basic price disclosure and some don’t even mandate written prescriptions for those keen on bargain hunting…”


    Environmental scanning1

    Environmental Scanning

    • VIPPS program for “veterinary pharmacies”

    • To my knowledge, there are no animal-related:

      • Pharmacy school classes required for graduation

      • Licensure requirements

      • CE requirements

    • American College of Veterinary Pharmacists

      • Offering certification to pharmacists who complete educational program on animal drugs and their regulation

    • Society of Veterinary Hospital Pharmacists


    Revenue impact of i p in well managed practices

    Revenue Impact of I.P. in Well-Managed Practices

    • Medicine dispensed: 15% total revenue

    • 50% say volume of meds dispensed declining

    • Drop in pharmacy revenue?

      • 11% drop say 1 percent of respondents

      • 6-10% drop say 6 percent

      • <5% drop say 38 percent

      • No change in revenue say 55%

        • Source: The 2003 Well-Managed Practice Study according to Veterinary Economics, October 2003


    Environmental scanning2

    Environmental Scanning

    • Prepare for change-United Kingdom

      • Address current medicine margins

      • Identify contribution to practice income & profits

      • Assess true costs of supplying medicines

        • Premises, heating, lighting

        • Staff time for ordering, unpacking orders, stock control, auditing stock and labeling, dispensing.

      • Consider difference between all medicine sales being lost vs.losing half…retain most of cost base Source: Peter Gripper, Anval, “In Practice” publication of British Veterinary Assoc.


    Environmental scanning3

    Environmental Scanning

    • Pharmacy and flea and tick products provide an average of just 3-4% of gross profit and

    • Pharmaceuticals have even less of an impact on the bottom line after accounting for operating expenses

      • Source: Cynthia Wutchiett, Wutchiett, Tumblin and Assoc. in Veterinary Economics, September 2003

  • “By overcharging for medications or refusing to volunteer written prescriptions, the profession invites both regulation and loss of respect.”

    • Source: Linda Walker, Amboy Assoc., Veterinary Economics, Sept 2003


  • Enviromental scanning

    Enviromental Scanning

    • “Charge for your time both on the farm and in the exam room” and

    • “Those fighting the Internet are modern day Don Quixotes.” Source: David M. Lane, DVM Newsmagazine, Jan 2004

    • Wake up call: “Change emphasis from selling products to providing services-and charging appropriately for services” and

    • Sell at competitive prices to avoid client perception that everything else is overpriced Source: Ronald Whitford, Veterinary Forum, Sept 2003

    • Impact of pet insurance?Taxation of Internet?


    Need for information exchange

    Need for Information Exchange

    • Know your state rules and tell others!

    • Understand application of jurisdiction

      • Recycling

      • Label of dispensed products

    • Groom relationships between Bd. Of Vet Med and Bd of Pharm

    • Groom relationships between state VMA and state Boards

      • Boards know the rules

      • VMAs have constant interaction with profession

    • Report trouble! And document! Are laws/rules adequate?

    • Envision a preferred future


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