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

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

State laws and rules vary-check Colorado

Pharmacy Issues: 2004


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

  • 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

  • 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” 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?

  • 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

  • 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 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

  • 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?

  • 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

  • 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 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 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

  • 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 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?

    • 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” 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

    • 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 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

    • 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


    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

    • 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 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

    • 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” 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

    • 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

    • 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 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

    • 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 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

    • 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

    • 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

    • 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

    • 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 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

    • 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 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 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

    • “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

    • 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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