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Pharmacy Issues: 2004

Elizabeth Curry-Galvin, DVMAssistant Director, Scientific Activities

AVMA-SchaumburgEgalvin@avma.org

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Pharmacy Issues: 2004

Topics Compounding Ethical Products Internet Pharmacies

Context Business Legal Ethical

Reminder Allegations, No Names Policy vs. Not State laws and rules

vary-check Colorado

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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

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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)

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2 Compounding Issues

Address Piracy Compounding from bulk drugs is not legal

Need regulatory discretion 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.

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“Piracy” (manufacturing

unapproved drugs) “Piracy” as distinct from traditional compounding

Essentially wholesaling unapproved drugsMade from bulk ingredients Circumvents FDA drug approval & monitoring processMass markets products with little quality controlMimic approved drug (knock-off)

Omeprazole, enrofloxacin, praziquantal, ivermectin formulationsBeware these are not generics!

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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

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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

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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

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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

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Why is Piracy Bad?

Denies patient treatment with approved drugSafe, effective, pure, potent, stable, GMPs

Exposes patient to unapproved drugContaminated, 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

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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

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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

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2 Compounding Issues

Address Piracy Compounding from bulk drugs is not legal

Need regulatory discretion 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.

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New CPG on Compounding

Replaced 1996 CPG (federal) Emphasizes FDA’s concern with compounding

that approximates manufacturingWritten 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

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New CPG on Compounding

Less text on regulatory discretion for medically necessary bulk drugs

Includes an AppendixBulk drugs for which the FDA would not ordinarily

object if compoundedCertain 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?

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Should CPG be withdrawn?

IACP (pharmacists) lobbying veterinarians COBTA says “no”

Pro-enforcement against mfg. of unapproved drugsSeeking 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

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In-Office Use “In-Office Use” generally recognized by state

Pharmacy BoardsUpon prescription, pharmacist prepares small quantity

for veterinarian’s “in-office” use (administration)Facilitates timely administration of medication since

compounded drug often mailedProduct labeled “In-Office Use” in place of patient nameStability not definitively known…watch shelf lifeNot to be used as stock from which to dispense

Makes pharmacist a “wholesaler”

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“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

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“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 (?)

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Reminders

A drug is a formulation, not just an active ingredient

Changes in formulation affect bioavailabilityAdsorption, Distribution, Metabolism, Excretion

transdermals

Alterations in bioavailability affect treatment outcome

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Reminders

Compounded drugs are NOT genericsGenerics have been approved by FDA to ensure

safety, efficacy, quality, stability, package, label Flavored preparations can be legally

compounded when APPROVED drugs are flavoredFlavoring can be an non-legal profit center for

those who flavor bulk drugs without purchaser’s knowledge

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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

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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.”

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“Ethical” Products

AVMA defines ethical product:Mfg. voluntarily limits sale to veterinariansOften different name/packaging than direct to

consumer productsSold only to veterinarians as a condition of sale

that is specified in a sales agreement or on the product label.

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“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.”

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“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?

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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

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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

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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

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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

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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….?

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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

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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

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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…”

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Environmental Scanning

VIPPS program for “veterinary pharmacies” To my knowledge, there are no animal-related:

Pharmacy school classes required for graduationLicensure requirementsCE requirements

American College of Veterinary PharmacistsOffering certification to pharmacists who complete

educational program on animal drugs and their regulation

Society of Veterinary Hospital Pharmacists

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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 respondents6-10% drop say 6 percent<5% drop say 38 percentNo change in revenue say 55%

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

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Environmental Scanning

Prepare for change-United KingdomAddress current medicine margins Identify contribution to practice income & profitsAssess true costs of supplying medicines

Premises, heating, lightingStaff 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.

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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

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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?

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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