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Dr. Julia Wilson, Executive Director MVMA Lunch N’ Learn March 8, 2016
Dr. Julia Wilson, Executive Director
MVMA Lunch N’ Learn
March 8, 2016
Objectives:1. Explain current laws and rules related to pharmacy FAQ’s:
a) legal compounding and enforcement discretion guidelines for office use
b) labels on dispensed medications
c) veterinarian-client-patient relationship (VCPR) and medical records
d) drug storage, returned and expired medications
e) gifts from pharmaceutical companies
f) mandatory reporting of diversion by licensed employee
g) Tramadol shopping
h) Outline what to do when a pharmacy asks for an NPI number
2. Provide information re: anticipated rollout of criminal background checks mandated by the legislature
3. What if your new hire doesn’t pass the NAVLE?
4. What care can an owner provide to their animal?
5. Discuss any other regulatory questions
License to practice is a binding legal contract
Statutes§ are written by the legislature
Rules are written by the Board of Veterinary Medicine -> year long approval processwith opportunity for public comment
Define the expected MINIMUM standard of practice
Failure to abide by them can jeopardize both the veterinary license and DEA registration
Legal language needs to be read very closely
“may” = optional “shall” or “must” = no choice
Punctuation matters in long sentences.
.
Go to Minnesota State Legislature website
http://www.leg.state.mn.us/
Start with the Veterinary Practice Act: §156◦ For more details, go to Rule 9100
.
Click on Statute of interest or simply do key word search
Two ways to search for key word(s):
or use “Control” and letter “f”
If you might want to print or save, open the law or rule as a “pdf”
Example: With §156 open, if search for ”equine”
.
Legal definition means most regulations of the MN Board of Pharmacy apply to DVM’s
§ 151.01 DEFINITIONS
Subdivision 23: “Practitioner” means a person licensed as
a physician, osteopath, dentist, optometrist, podiatrist, veterinarian or advanced practice registered nurse.
§ 151.37 LEGEND DRUGSSubdivision 3: A licensed DVM, in the course of professional practice only, and not for use by a human being, may personally prescribe, administer,
and dispense a legend drug…
.
Practice in which a licensed health professional, or a person under their supervision, combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient
Veterinary Practice Act Statute 156.18
If valid VCPR, DVM can:
- add flavoring or a vehicle to an FDA-approvedmedication
- dilute an approved medication
- make a combination of 2or more approvedmedications, and/or over the counter medications
- dispense to a client but must follow ALL labeling rules*that apply to medications
* More on labels later
Minimize risk of health endangerment, yet allow health professionals to provide medication unavailable in other forms
Accountability – quality control, safety,
accurate labeling
Traceability if product recall is needed
Public protection – Eg. residues in food, sport
drug testing, multidrug resistant bacteria
2009 Franck’s Pharmacy : 21 polo ponies died
in Florida after given mix with 100x amount of Na selenite.
2012 New England Compounding Center in Massachusetts:
3 fungus-contaminated lots of preservative-free
methylprednisolone acetate – a total of nearly 17,000
doses used for epidural injections ->
More than 730 cases fungal meningitis, spinal/paraspinal
infections, and/or peripheral joint infections,
55 deaths.
All pharmacies selling compounded
medications for use in animals in
Minnesota must be licensed as a
compounding pharmacy by the
Minnesota Board of Pharmacy ->
check Board’s website for license
status and past discipline before
ordering
http://mn.gov/boards/pharmacy/
-> “Public” Heading, then “License
Verification”
Pharmacy Rule 6800.3100 Compounding & Dispensing
Uses surveyors to inspect pharmacies for regulatory
compliance
Duties, Certification, Accountability, Notice Required,
Exception (inpatients)
FDA Regulations on Compounding – most currently exclude
veterinarians and non-food animals
Federal Guidance for Industry (GFI) Compounding Animal
Drugs from Bulk Drug Substances
Federal Update: Draft Guidance on Animal Drug
Compounding from Bulk Drug Substances
Boards frequently receive questions about the sale of drug products to health practitioners and clinics for office use.
Most common question:
Can a pharmacy fill a prescription that is not written for a specific patient but is instead written out for “office use”?
Short answer = “No”
MN Rules 6800.0100, Subp. 11:
“Prescription drug order” - a lawful written, oral, or electronic order of a practitioner for a drug for a specific patient. A prescription drug order must contain the information specified in this chapter and in Minnesota Statutes, section 151.01, subdivision 16.
MN Stat. 151.01, subd 16: . . ."prescription" means a signed written order, or an oral order reduced to writing . . . issued for an individual patient and containing the following: . . . name and address of the patient . . .
Pharmacy allowed to sell drugs to health practitioner or clinic at wholesale only if licensed by the Board of Pharmacy as a wholesaler
See MN Stat. 151.44 (a) – definition of “wholesale drug distribution”; (b) definition of “wholesale drug distributor” and MN Stat. 151.47 requiring wholesalers to be licensed.
Note definition of wholesale drug distributor includes option for registration of pharmacies
Don’t!
MN Stat. 151.46 - unlawful . . . to knowingly purchase or receive a prescription drug from a source other than person or entity licensed under the laws of the state . . .
* A person violating the provisions
of this section is guilty of a misdemeanor.
Can a practitioner or hospital buy compounded drugs from a pharmacy?
Can a practitioner or hospital buy compounded drugs from a pharmacy that that is also licensed as a wholesaler?
Short answer to both questions = “No”
WHY NOT?
Extemporaneous compounding - the preparation of a drug product upon receipt
of a prescription for a specific patient.
Bulk compounding - preparation by a pharmacy of a supply of a compounded drug product that is sufficient to meet its short-term anticipated need for the filling of prescriptions. Also called “anticipatory compounding”
Minnesota Statute §151.01, subd. 14:
“Manufacturing”, except in the case of bulk compounding, prepackaging or extemporaneous compounding within a pharmacy, means and includes the production, quality control and standardization by mechanical, physical, chemical, or pharmaceutical means, packing, repacking, tableting, encapsulating, labeling, relabeling, filling or by any other process, of all drugs, medicines, chemicals, or poisons, without exception, for medicinal purposes”.
Minnesota Rules 6800.3300 requires compounding to be done pursuant to United States Pharmacopeia(USP) Chapters 795 or 797 standards.
USP Chapter 795: compounding differs from manufacturing by the existence of a“practitioner-patient-compounder relationship”.
A drug product prepared for office-use without a specific patient = no such relationship exists.
Why? The pharmacist has no idea who the drug will be administered to at the time he or she is preparing it.
Preparing a drug for office use is not actually compounding - it is manufacturing
MN Stat. 151.25 requires registration of anyone engaged in manufacturing.
A pharmacy that prepares a compounded drug and sells it to a practitioner or hospital for “office use” needs to be licensed not only as a wholesaler – but also as a manufacturer.
Drug Quality & Security Act (DQSA) 11/27/13
Rewrite of Section 503a of Food, Drug, & Cosmetic Act
FDA given clear authority to register and regulate facilities that:• Prepare sterile products
• Ship them across state lines
• Sell at wholesale - or even do anticipatory compounding
• Called “Outsourcing Facilities”
Drug Quality & Security Act (DQSA)Prohibits compounding of certain products
• Drugs removed from the market for safety and effectiveness reasons
• Copies or combinations of marketed FDA-approved drugs
Unless there is a drug shortage
• Drugs that that show demonstrable difficulty for safe compounding
• Extended release oral products
• Transdermal patches
What about buprenorphine or fentanyl for cats?
How am I supposed to practice
when the animal needs a medication
only available through compounding?
Result of urgent request from MVMA and concerned veterinarians
Board of Pharmacy will exercise enforcement discretion for a pharmacy providing a compounded drug to a DVM at wholesale without first receiving a patient-specific prescription ONLY when:
Drug is needed in urgent or emergency situation No timely access to compounding pharmacy (weekend) No FDA-approved, commercially manufactured drug, or
documented shortage of such drug(cont)
Enforcement discretion ONLY when Compounded drug is to be administered by DVM, bona fide employee, or dispensed to client for a maximum of 5 days
• Pharmacy is licensed as a MN drug wholesaler
• Pharmacy has selected sterile or non-sterile compounding licensing category
• Pharmacy is appropriately registered with DEA if compounding products with controlled substances
• Check license types:
http://mn.gov/boards/pharmacy/public/
Board of Veterinary Medicine Expectations:• Inform client that the medication is compounded,
and has a slight increase in risk of adverse events
• Inform client that only a five day supply is allowed
• Note client conversation in medical record or have client sign a statement
• State that the medication is compounded on the label and note details of prescription in record.
• If longer treatment is needed, send prescription ASAP to pharmacy, direct ship to client
Requirements outlined in §156.18 Veterinary Prescription Drugs
Subdivision 2 • Name and address of veterinarian• Date of filling• Species of patient• Name or names of drug• Strength of drug or drugs• Directions for use• Withdrawal time for food animals• Cautionary statements if warranted
Eg. Estrumate, Hydrocodone
Patient and client name Trade name and generic Amount dispensed Childproof packaging Drug expiration date DVM’s business phone #
Pharmacy Rules
6800.3400 Subp. 4 Veterinary Label
6800.9950-4 Dispensing by Practitioners• Patient or client name• Food animal only:
• Name & address of facility where will be used
• Name & address of DVM for Rx
• Quantity of drug(s)• Manufacturer• Name, address & phone # of pharmacy• Prescription #• Label on each individual bottle or package if in
manufacturer’s original packaging
1. DVM assumes responsibility for medical judgments of health, need for treatment AND client agrees to follow DVM’s instructions
- Has DVM examined the animal or herd?
- When was the animal or herd examined?
- Who is the true client?
Owner?
Owner employee?
Trainer?
Stable owner?
Dog sitter?
Owner’s son or daughter?
2. DVM has sufficient knowledge of animal to make at least a tentative diagnosis
AND DVM must be acquainted with keeping and care of the animal by examination or medically appropriate and timely visits to animal’s premise
- Is a diagnosis written in the medical record?
- What is timely? BVM opinion = within 1 year
- Can you make a diagnosis over the phone?
- What if it is a contagious disease you just diagnosed in a herd or house mate?
3. DVM is available for consultation in case of adverse reactions or treatment failure
- What does “available” mean?
Phone?
Email?
Video camera?
Turf to Emergency Clinic?
If group practice, can partner access medical record?
- What if sent medication to owner now in another state?
4. DVM maintains records documenting:
patient visits
diagnosis
treatments
drugs prescribed, dispensed or administered
“other relevant information”
Ideally would want to access records remotely
Additional medical record requirements: Rule 9100.0800 Minimum Standards
Storage: Prevent contamination & deterioration per USP Formulary
Expired Drugs = Adulterated Drugs
Returned Drugs = Adulterated Drugs
§151.34 and 151.35
Prohibited Acts1) Unlawful to manufacture, sell or deliver, hold or
offer for sale any drug that is adulterated or misbranded
2) Adulterate of misbrand any drug
3) Receive in commerce any drug that is adulterated or misbranded, and to deliver or proffer delivery thereof for pay or otherwise
§151.461 Gifts to Practitioners Prohibited
Pharmaceutical Industry must report to Board of Pharmacy annually
Includes meals at CE presentations
Does not include:- professional samples for FREE distribution to patients
- items with a total combined retail value < $50
- payment to the sponsor of a medical conference, professional meeting or other educational program, provided the payment is not made directly to a practitioner, AND is used
solely for bona fide
educational purposes
§151.461 Gifts to Practitioners Prohibited
Does not include (continued)- reasonable honoraria and payment of
reasonable expenses of a practitioner who serves on the faculty at a professional or educational conference or meeting
- compensation for substantial professional or consulting services in connection with a genuine research project
- publications and educational materials
- salaries or other benefits paid to employees
New law took effect August 1, 2014 §214.33
Applies to anyone employing a licensed health professional -> must report to corresponding health-licensing board unless individual is already enrolled in HPSP*
Options for non-employers to report DVM’s that are endangering self, others, or patients:
- report to Board of Veterinary Medicine
- 3rd party report to HPSP*
- report to law enforcement
- persuade individual to self-reportto HPSP
* Health Professionals Services Program
http://mn.gov/health-licensing-boards/hpsp/
NPI = National Provider Identifier
Required for prescriptions for humans
Used for tracking insurance reimbursement
Not applicable to veterinarians
Pharmacy should know NPI not required for DVM prescription
May be a software issue with chain pharmacies
Educational effort by Board of Pharmacy not entirely effective to date.
Contact Board of Pharmacy if pharmacy declines to fill a veterinary prescription for lack of #.
Illegal if veterinarian is not first consulted and agrees to the change
Cannot change medication, directions, or quantity
Cannot change DVM’s address from what is on the prescription
Contact Board of Pharmacy if pharmacy does not contact DVM before making any change
Tramadol became a controlled substance on August 18, 2014.
Index of suspicion: New client asking for tramadol, obvious chronic lameness
Regular client asking for tramadol before NSAID’s
Requests for frequent refills or prescriptions
Ask client if animal was seen by another veterinarian
Limit amount and write note in record
If DEA license holder, look up PET (not owner)in Prescription Monitoring Program
Report individual to law enforcement for investigation
§214.075 Law passed in 2013
Purpose – protect the public All licensed health professionals will
be required to have a CBC
Beginning Spring, 2016, all applicants for a Minnesota veterinary license must have a criminal background check.
By January 1, 2017, all health-licensing boards must submit a plan for how to complete CBC’s on all current licensees
One time requirement
Simple process which compares fingerprints with FBI and Minnesota’s Bureau of Criminal Apprehension (BCA) databases
Veterinarian pays one time fee (~$34.75) at the time of application
Packet of forms sent to DVM
Veterinarian has fingerprints taken at any law enforcement agency (possible cost) or at the Board’s building (free)
-> forms & fingerprints to CBC Program Office
-> sent to BCA -> FBI -> BCA
-> results back to CBC Office -> results to Board
Expected time for confidential report = 2-3 weeks, possibly longer
What if something shows up?
- court documents may be requested
- report will be reviewed by a Board Committee
- Committee may determine that a conference with the individual is needed for more information
Examples of potential outcomes:
- no action taken, license granted
- referral to HPSP if chemical impairment offense
- license issued but conditional
- license denied
Planning for CBC’s for current licensees:
- common plan for all health-licensing boards
- likely tied to renewals
- expect staggered roll out for professions
- must be presented to & approved by the legislature, likely statute change
= opportunity for public comment
Still to be determined: Will “rat back” be part of the requirement?
Means that FBI and BCA would let licensing board know if licensee was convicted of a crime after the CBC
It doesn’t work that way, Doc.
You’re supposed to confess your sins.
Practice of Veterinary Medicine – defined in 156.12
Exemptions in Subd. 2
(a) Emergencies when a veterinarian cannot be procured
(b) Regular veterinary student under the direct supervision of a licensed veterinarian
(c) Veterinarian regularly licensed in another jurisdiction who is only consulting with a veterinarian licensed in Minnesota
(d) Owner of an animal or owner’s employee
(e) & (i) UMN Veterinarians in some circumstances (h) Employee of a licensed veterinarian
(j) Licensed chiropractor registered to work on animals with the Chiropractic board
Practice of Veterinary Medicine – defined in 156.12
Exemptions in Subd. 2 (b)
Warning: Veterinarians that are no longer regular students
CANNOT perform surgery, diagnose, prognose, or prescribe, even with supervision
Must be an employee, only “tech”-like work
Examples: Have not passed the NAVLE
Foreign graduate that is not licensed elsewhere in the US
Practice of Veterinary Medicine – defined in 156.12
Exemptions in Subd. 2 (d)
Not prohibited (i.e. allowed)“the owner of an animal and the owner’s regular employee from caring for and administering to the animal belonging to the owner, except where the ownership of the animal was transferred for the purposes of circumventing this chapter.”
Surgery is NOT “caring for” or “administering to”Could be animal cruelty.
If done with anesthetics, the veterinarian that provided them is complicit and subjectto discipline by the Board.
Cody Wiberg, Pharm.D., M.S., R.Ph.Executive Director
Minnesota Board of Pharmacy
2829 University Avenue SE, #530
Minneapolis, MN 55414
(651)201-2825 (651)201-2837 (fax)
Julia Wilson, DVM, DACVIMExecutive Director
Minnesota Board of Veterinary Medicine
2829 University Avenue SE, #401
Minneapolis, MN 55414
(651)201-2844 (651)201-2842 (fax)
