pharmacy issues: 2004
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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Pharmacy Issues: 2004
Elizabeth Curry-Galvin, DVMAssistant Director, Scientific Activities
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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