Pharmacy Issues: 2004

1
Pharmacy Issues 2004

• Elizabeth Curry-Galvin, DVM
• Assistant Director, Scientific Activities
• AVMA-Schaumburg
• Egalvin_at_avma.org

2
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

3
Whats Compounding?

• Definition
• Simply, the preparation of custom medication for
  a particular patient (manipulation--gt 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

4
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)

5
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.

6
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!

7
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 patients best
  interest
• Little enforcement visible in recent
  history..changing

8
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

9
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

10
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

11
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 RD by drug companies
• Veterinarians will have fewer approved drugs
• Bulk ingredientsquality? bio-terrorism?
• Illegal

12
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

13
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

14
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.

15
New CPG on Compounding

• Replaced 1996 CPG (federal)
• Emphasizes FDAs 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

16
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?

17
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

18
In-Office Use

• In-Office Use generally recognized by state
  Pharmacy Boards
• Upon prescription, pharmacist prepares small
  quantity for veterinarians 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 knownwatch shelf life
• Not to be used as stock from which to dispense
• Makes pharmacist a wholesaler

19
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
• Dont buy pirated drugs wholesale for resale
• Dont receive a drug compounded by a pharmacist
  for a particular patient, change the label
  dispense

20
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 (?)

21
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

22
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 purchasers
  knowledge

23
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

24
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.

25
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.

26
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.

27
Ethical Product Diversion

• Distribution channel is manufacturers policy
• Not government restricted distribution, e.g. Rx
• Manufacturers responsibility to enforce its
  policycontact manufacturer with concerns
• Legally not appropriate for associations to seek
  to influence those policies
• Manufacturer may deny future purchases?
• Registered as distributor?
• Tax laws?

28
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

29
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 Cant police everything
• Offer clients value and convenience
• Speak factually
• Report complaints Complete documentation

30
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

31
AVMA Position on Internet Pharmacies

• Veterinarians 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

32
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.?

33
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

34
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
• Congressmans wifes experience (10 years), long
  overdue, important consumers 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

35
Environmental Scanning

• Readers Digest from Consumer Reports (a
  publication of Consumers Union)
• the veterinary care industry languishes in the
  Stone Age of consumer-protection law
• dispute a billFluffy may be held hostage under
  state lien laws
• vets dispense medicine, but few states require
  basic price disclosure and some dont even
  mandate written prescriptions for those keen on
  bargain hunting

36
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

37
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
• lt5 drop say 38 percent
• No change in revenue say 55
• Source The 2003 Well-Managed Practice Study
  according to Veterinary Economics, October 2003

38
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 halfretain most of cost
  base Source Peter
  Gripper, Anval, In Practice
  publication of British Veterinary Assoc.

39
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

40
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?
  

41
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