FD

1
Unit 3

2
Wyoming Pharmacy Act

• The fundamental basis for pharmacy practice is
  the Wyoming Pharmacy Act.
  
• A complete copy of the Act and the associated
  Rules and Regulations available at
  
• www.pharmacyboard.state.wy.us
• The WPA creates and empowers the Board of
  Pharmacy to
  
• grant licenses,
• regulate the profession, and
• write regulations designed to fulfill the
  legislative intent in writing the law.

3
The WPA is part of what may be thought of as a
pyramid.

• At the top of the pyramid is the Constitution.
• Extremely general
• At the bottom of the pyramid are regulatory
  agencies - the Board of Pharmacy
  
• It actually carries on the business of
  regulation.
  
• Pyramid metaphor useful
• from the point of view of the regulated public,
  content is added proceeding from the top to the
  bottom.

4
No WY case law stemming from WPA

• perhaps, a tribute to the profession as practiced
  in Wyoming, or to
  
• the esteem for Wyoming pharmacists held by their
  patients and the public.
  
• no cases to explain the statute and the
  regulations.

5
The Enabling Statute

• Pharmacy Board
• consists of 3 voting members, pharmacists, and 3
  advisory (ex officio) members a physician, a
  dentist, and a veterinarian.
  
• The Governor appoints the members for a term of 6
  years.
  
• the Board has a mandate to exercise the public
  interest, not the interests of the profession.

6
Rules and Regulations

• In 33-24-102(c), the Wyoming legislature gives
  the Board the power to
  
• promulgate reasonable rules and regulations as
  necessary to carry out the purposes and
  
• enforce the provisions of this act.
• Without the rulemaking procedure, the Board would
  not be able to provide direction to pharmacies
  
• which utensils and references must be present in
  every pharmacy, how licensing exams are to be
  carried out, or what the Code of Ethics shall
  consist of.
• The Wyoming Pharmacy Act Rules and Regulations
  consists of 13 Chapters of both procedural and
  substantive material.
  
• www.Upharmacyboard.state.wy.us

7
Power of the Rules

• Rules and Regulations have the same force and
  effect as the Pharmacy Practice Act when
  
• they are authorized by the legislature and passed
  according to proper procedure.
  
• The Board could not promulgate regulations
  relating to the practicing of accountants.
  
• Substantial changes must first provide
• notice to interested parties and
• the opportunity to for comment and a public
  hearing.

8
Recent Rulemaking Actions

• The Board of Pharmacy has exercised its
  rulemaking machinery many times in recent years,
  making some significant changes.
  
• changes to Chapter 2,
• the addition of Chapter 12 Institutional
  Pharmacy,
  
• the addition of Chapter 13 concerning
  compounding, and
  
• the a significant change to the requirements on
  the prescription label.
  
• Chapters 4, 9, and 10 have been significantly
  changed.
  
• changes to the Controlled Substances Regulations

9
Pharmacists

• 33-24-124. Persons deemed practicing pharmacy.
• Any person shall be deemed to be practicing
  pharmacy within the meaning of this act who
  provides collaborative pharmaceutical care or
  prepares, or compounds, or processes, or
  packages, or repackages, or labels, or dispenses,
  or sells, or offers for sale, at retail or in
  connection with operation of a health-care
  facility, any dangerous drugs, medicines,
  poisons, chemicals, narcotics, or prescriptions,
  which are identified as such in accordance with
  this act.
• This section was enacted for the purpose of
  identifying and prosecuting persons engaged in
  practice without a license and was intended to be
  used in prosecution.
• An unintended consequence is that it serves as a
  definition of the scope of pharmacy practice.

10
Licensure.

• The Board is empowered to grant a license for the
  practice of pharmacy and a
  
• license for the operation of a pharmacy.
• Pharmacist Examination
• a minimum of 75 on the NAPLEX exam, and
• a minimum of 75 on the MPJE.
• Retakes are permitted, up to a total of 3 times
  for the NAPLEX and an unspecified number of times
  for the law exam.

11
Licensure 2

• Applicants must complete an internship prior to
  licensing.
  
• 2000 hours must be served
• This may include up to 1600 hours obtained
  through UWs clinical clerkship program.

12
Reciprocity

• The WPA recognizes a transfer procedure for
  pharmacists licensed in other
  
• jurisdictions.
• Renewals
• On or before December 31 each year each licensee
  must renew the license application
  
• transmitting the license number, address, proof
  of completed continuing education, and the
  required fee to the office of the Board.

13
Continuing Education

• proof of not less than 6 hours (3/5 of one
  continuing education unit) nor more than 15 hours
  (or 1.5 ceu) as prescribed by the Board.
  
• Currently pharmacists must obtain 12 hours (1.2
  ceu).
  
• up to 12 hours may be carried forward to the next
  year.

14
Discipline of Pharmacists

• The third prong of the quality assurance process
  is the Boards power to maintain standards of
  practice through the power to discipline
  licensees (Revocation or suspension
  33-24-122).
• using the valuable license as leverage to obtain
  compliance
  
• reprimand,
• censure,
• fines,
• probation,
• suspension, and
• revocation of the license.

15
There are a number of basic grounds for
discipline

• conviction of a crime involving moral turpitude,
  
  
• renting or loaning a license,
• submitting false information to the Board, and
• willful violations of any part of the law, rules
  or regulations.
  
• behavioral problems that impede professional
  abilities including
  
• substance abuse,
• senility, and
• mental or physical impairment
• Unprofessional conduct

16
Unprofessional Conduct

• Fraud,
• improper substitution,
• betraying patient confidencesT,
• false advertising,
• filling a prescription without confidence in its
  validity,
  
• filling a prescription that is too old (2
  years),
  
• using outdated or improperly stored drugs, and
• other actions relevant to professional character,

17
Code of Ethics

• The current Wyoming Code of Ethics is located in
  Chapter IV of the Rules and Regulations, as
  follows
  
• A pharmacist shall hold the health and safety of
  patients to be of first consideration and shall
  render to each patient the full measure of
  ability as an essential health practitioner.
• A pharmacist shall not condone the dispensing,
  promoting or distributing of drugs or medical
  devices which are not of good quality, do not
  meet standards required by law or which lack
  therapeutic value for the patient.
• A pharmacist shall strive to perfect and enlarge
  professional knowledge and shall utilize and make
  available that knowledge as required in
  accordance with professional judgment.
• A pharmacist has the duty to observe the law,
  uphold the dignity and honor of the profession
  and to accept its ethical principles.

18
Ethics 2

• A pharmacist shall seek at all times only fair
  and reasonable remuneration for services. This
  shall include neither exorbitant pricing of
  prescription drugs nor selling below the cost of
  prescription drugs to the pharmacist in order to
  gain an unfair competitive advantage.
• Pharmacists shall not agree to participate in
  transactions with health professionals or any
  other person under which fees are divided or
  which may cause financial or other exploitation
  in connection with the rendering of professional
  services.
• A pharmacist shall respect the confidential and
  personal nature of patient records and shall not
  disclose the information without proper patient
  authorization except when required by law.
  However, when the best interest of the patient
  requires it or in an emergency medical situation,
  the patient's records may be released to another
  pharmacist or other medical personnel involved in
  treating the patient.
• A pharmacist shall not agree to practice under
  terms or conditions which may interfere with or
  impair the proper exercise of professional
  judgment or skill.

19
Ethics - 3

• A pharmacist shall provide information to
  patients regarding professional services
  truthfully, accurately and fully and shall avoid
  misleading patients regarding the nature, cost or
  value of the pharmacist's professional services.
• A pharmacist shall not provide untruthful
  information to the patient or insurance company
  regarding cost of medication to the patient.
  
• A pharmacist shall not provide practitioners with
  pre-printed prescription blanks bearing the
  pharmacy or pharmacist name or address.
  
• A pharmacist shall not advertise in an untruthful
  or misleading manner, including any form of "bait
  and switch".

20
Interns

• students may obtain a registration to function as
  an intern after the first professional year has
  been completed.

21
Technicians

• Note that the regulations relating to technicians
  (Chapter 10) have been revised as of March 1,
  2002.
  
• The changes are substantial.
• Highlights include changes in permissible
  activities defined as pharmacy functions
  including community pharmacy, hospital pharmacy,
  and compounding practice.

22
Pharmacies

• Pharmacies are required to obtain a license from
  the Board prior to doing business (33-24-113).
  
• this applies to institutional and community
  pharmacies.
  
• Each pharmacy must list the names of its
  pharmacists and interns with the Board.
  
• A Pharmacist-in-charge must be named and the
  Board notified any time a new PIC is named.

23
PIC

• The PIC must be on site at least 32 hours per
  week or 80 of the time the pharmacy is open,
  whichever is greater.
  
• The Board requires the PIC to
• Establish policies and procedures for
• Procurement, storage, preparation and
  dispensing,
  
• Drug recall,
• Delivery of prescriptions after hours discussing
  how it will occur, guarantees the offer to
  counsel, security and confidentiality, is used
  only when required.

24
PIC - 2

• Supervise all employees,
• Ensure all licenses are up to date and staff
  adequately trained,
  
• Report any loss or theft.
• The Board is specifically given the authority to
  prescribe the minimum facilities,
  
• apparatus, utensils and stock of drugs and
  medicines (33-24-114) required to operate a
  
• pharmacy.

25
Other Businesses

• Wholesalers
• Chapter 8 of the Rules and Regulations is devoted
  entirely to the regulation of drug wholesalers.
  
• As with pharmacy practice, the Boards fulcrum to
  assure quality is the license.
  
• Wholesalers must be granted a license to do
  business in Wyoming
  
• The Wyoming regulations would characterize a
  retail pharmacy as a wholesaler if it transfers
  excessive amounts of medication to other
  pharmacies.
• the gross dollar value of a pharmacys transfers
  exceeds 5 of the total prescription drug sales
  in a 12-month period

26
Non-resident dispensers

• mail-order dispensers
• A non-resident pharmacy license must be obtained
  from the Board as well as a controlled substance
  registration if they want to dispense these.
  
• Nursing Home Emergency Stock
• Vendor pharmacies are permitted to maintain a
  stock of emergency medications in
  
• client nursing home pursuant to a permit issued
  by the Board
  
• The emergency stock may consist of up to 48
  different medications.
  
• The emergency drug supply may only be stocked and
  restocked by a licensed pharmacist

27
Prescriptions

• Prescription means an order for medication by a
  person licensed and authorized by the state board
  of medicine, the state board of dental examiners,
  the state board of nursing, the state board of
  registration in podiatry, the state board of
  examiners in optometry or the state board of
  veterinary medicine which is dispensed to or for
  an ultimate user.
• Each prescription memorandum shall Ube maintained
  and open for inspection by agents of the board
  for a period of two (2) yearsU from the date it
  is filed.

28
Prescriptions - 2

• A valid prescription shall contain the following
  information
  
• Name of patient
• Name and strength of drug
• Quantity to be dispensed
• Directions for using the drug
• Date of issuance by practitioner
• Prescriptions for controlled substances shall
  include the DEA number and address of prescribing
  practitioner and address of the patient,
  
• Recognizable signature of the practitioner,
• In the case of an oral order the name of the
  authorized agent if conveyed by other than the
  prescribing practitioner.

29
Faxed prescriptions

• Prescriptions may be transmitted to the
  pharmacist in written form orally, including by
  telephone, by telephonic facsimile (FAX), and
  electronically.
• Schedule II controlled substances may be
  transmitted by FAX if they meet certian
  conditions.

30
Other FAX requirements include

• A notation that this is a FAX prescription.
• Telephone number and FAX number of the
  practitioner.
  
• Name, address, telephone number and FAX number of
  pharmacy to which the prescription is being
  FAXed.
  
• Date and time of FAX, if not otherwise programmed
  into transmission.
  
• Name of individual acting as practitioners
  agent, if other than practitioner.

31
FAX - 3

• Prescriptions for Schedule III, IV, and V
  controlled substances may be transmitted by FAX.
  
  
• Schedule II controlled substance prescriptions
  may be transmitted by FAX, if
  
• A prescription for a schedule II narcotic
  substance to be compounded for the direct
  administration to a patient by parenteral,
  intravenous, intra-muscular, subcutaneous or
  intra-spinal infusion or
• A prescription written for a schedule II
  substance for a resident of a Long Term Care
  Facility or
  
• A prescription written for a schedule II
  substance for a terminally ill patient. The
  pharmacist shall so annotate a FAXED schedule II
  prescription as being for a terminally ill
  patient.

32
Electronic Prescriptions

• Section 31 of the Rules provide for the validity
  of electronic prescriptions when the following
  are satisfied
  
• Transmitted directly from prescriber to
  pharmacy,
  
• Contain the phone number of the prescriber, time
  and date, name of the intended pharmacy, and
  anything else required by law,
  
• Contain digital signature of prescriber, (Note
  this must be approved and on file with the
  Board),
  
• Deemed an original drug order provided it is kept
  on file and readily retrievable for a period of 2
  years, and
  
• Contain all legally required information.

33
Oral orders for prescriptions and refills

• oral orders for prescriptions are permitted in
  Wyoming
  
• except Schedule II (C-II) controlled substances
  which require an emergency situation pharmacist
  is required to immediately reduce to writing all
  relevant information,
• the date of the oral order and
• the pharmacists initials and
• the name of the practitioner or agent
  transmitting the information.

34
Transfer of prescriptions

• The procedure (Ch.2, 10, a-j) is very detailed.
• transfer is only valid when there is legal life
  to the prescription
  
• there are refills remaining and
• it is less than 1 year old.
• C-IIs may never be transferred and
• C-III through V may be transferred once recording
  the DEA numbers of the prescriber and transferor.

35
The transferring pharmacist shall

• i) Write the word void across the face of the
  original prescription order to make the order
  invalid or electronically document that the
  prescription has been voided
• ii) Record on the reverse side of the invalidated
  prescription order or electronically document
  
• His/her name
• The name of the receiving pharmacist
• The name of the receiving pharmacy
• The address of the receiving pharmacy and
• The date of the transfer.
• In the case of a controlled substance in schedule
  III through V, the Drug Enforcement
  Administration registration number of the
  receiving pharmacy.

36
The receiving pharmacist receiving shall

• reduce the transferred information to writing
• write the word transfer or a word of similar
  import on the face of the transferred
  prescription order or
  
• electronically document that the prescription has
  been transferred, and
  
• provide all information required by law or
  regulation to be on the prescription order,
  including
  
• The date of issue of the original prescription
  order
  
• The date of initial compounding and dispensing of
  the original prescription order
  
• The number of refills authorized
• The number of valid refills remaining
• The date of the last refill of the original
  prescription order
  
• The prescription order number from which the
  prescription order information was transferred
  
• The name and license number of the transferring
  pharmacist
  
• The name and address of the transferring pharmacy.

37
Generic Substitution

• Wyomings Generic Substitution Act was made law
  in 1979.
  
• Wyoming gives a measure of protection for
  pharmacists.
  
• When generic substitution occurs in a fashion
  that is procedurally correct, pharmacists are
  protected from liability.
  
• The procedure may be summarized as follows.
• Unless the practitioner clearly prohibits
  substitution a generic substitute may be
  provided if it is rated as bioequivalent
  (A-rated) by the FDAs publication Approved
  Drug Products (affectionately known as the
  orange book) or the equivalent. When the
  substitution is orally prohibited, the pharmacist
  is directed to make reasonable efforts to obtain
  a written prescription with the words brand
  medically necessary written on the face by the
  prescriber.

38
Generics - 2

• a pharmacist may substitute a lower retail-priced
  generic, unless the patient objects
  
• When a generic product is ordered the lowest
  retail cost generic equivalent in stock shall be
  dispensed.
  
• "Generically equivalent drug" means a drug that
  contains identical active ingredients in the
  identical dosage forms. Essentially this is an
  A-rated bioequivalent drug as identified by the
  FDA in the Orange Book. The orange book is
  published annually with monthly updates. Also it
  is available on the FDAs website at
  www.fda.gov/cder/ob/default.htm

39
Generic Ratings

• The rating system generally consists of two
  letters.
  
• If the first letter is an A as compared to the
  reference product, then it is considered
  bioequivalent by the FDA,
  
• if the first letter is B it is not
  bioequivalent and may not be used as a generic
  substitute. A third character (a number) may be
  added if there are two or more reference products
  that may not be equivalent to each other.
• In such a case, all three characters must be the
  same to permit substitution.

40
Example

• Code Ingredient Form Strength Name Manufacturer
• AB2 nifedipine ER tab 30mg Procardia XL Pfizer
• AB2 nifedipine ER tab 30mg Nifedipine Biovail
• AB1 nifedipine ER tab 30mg Nifedipine Elan
• A pharmacist may substitute Biovails product but
  not Elans for Procardia XL.

41
Generics (cont.)

• Finally, the label shall contain the name and
  strength of the medication (unless prohibited by
  the prescriber) and the NDC number noted on the
  prescription.

42
33-24-203. Code imprint required for the
manufacture and distribution of dangerous

• substances listing of substances with board of
  pharmacy exceptions exemptions.
  
• No dangerous substance in solid dosage form shall
  be manufactured or
  
• distributed in this state unless it is clearly
  marked or imprinted with a code imprint
  
• identifying the drug and the manufacturer or
  distributor of the drug.
  
• This article shall not apply to non-narcotic,
  nonprescription, prepackaged
  
• medicinal preparations contained in distinctive
  and original unbroken containers,
  
• when the medicinal preparations are identified by
  and sold under a trade name of
  
• the manufacturer or primary distributor and are
  sold or offered for sale to the
  
• general public, if the articles meet the
  requirements of state and federal food, drug
  
• and cosmetic laws.

43
Profiles, Prospective DUR, and Patient Counseling

• In 1990, a budget reconciliation provision
  threatened to withdraw federal support for state
  Medicaid programs if state governments did not
  demand more from pharmacists. The result
• all 50 states passed some form of mandate
  directing pharmacists to have a full database of
  information, make prospective reviews of
  medication regimens, and offer to counsel
  patients about their medication.
• Wyomings law is contained in 33-24-136(c), (d)
  and Chapter 9 of the Rules and Regulations.
  
• Chapter 9 has the important details.
• Note that previously counseling was limited under
  this part to Medicaid patients.
  
• The Board recognized that all patients were
  entitled to counseling and encouraged the
  legislature to extend to all patients on new
  prescriptions.

44
Collaborative Pharmaceutical Care

• In 2000, Wyoming joined a majority of states that
  allow pharmacists to provide a high level of
  clinical service.
  
• The WPA definition is a pharmacist working in
  collaboration with physicians and other medical
  providers authorized to prescribe medications.
  
• Chapter 2, 30 provides much more detail.
• In addition, there must be a means for the
  physician to monitor compliance and written
  consent by each patient. The physician may
  override at any time and either party may
  terminate by written notice.

45
Compounding

• The Board has recently written comprehensive
  rules relating to compounding
  
• Chapter 13 of the Rules.
• Compounding is defined as the preparation,
  mixing or assembling of a drug as the result of
  a prescription drug order or in anticipation of
  orders based on routine regularly observed
  prescribing patterns. This does not include
  reconstituting non-sterile products (e.g., oral
  antibiotics).
• The Board took care to distinguish compounding
  from manufacturing

46
Compounding 2

• The Rule, is about maintaining the integrity and
  quality of compounding activities.
  
• personnel engaged in the process must be properly
  trained,
  
• the environment must be clean and orderly,
• the pharmacy must have proper equipment, and
• quality control measures must be in place.
• The PIC is required to document proficiency in
  the art before allowing an individual to engage
  in the process.
  
• The facility shall have adequate space,
• be maintained in a good working order to
  accommodate materials and equipment.

47
Compounding 3

• Bulk chemicals must be stored in a clean, dry,
  temperature-controlled environment. Refrigeration
  must be adequate.
  
• There must be adequate lighting, ventilation and
  potable water for drinking and washing.
  
• Hot and cold water must be available.
• Equipment must be of appropriate design and
  capacity.
  
• Measuring devices must be accurate and properly
  calibrated.
  
• Recorded procedures must be established to guide
  production and ensure quality.
  
• For those products produced in quantities that
  exceed the need for a single prescription
  additional documentation is required.

48
Compounding 4

• A log is required containing the following
  information
  
• The name of the product,
• List of ingredients, quantities, manufacturer of
  precursors with the lot number and expiration
  dates,
  
• Product lot number,
• Beyond use date (based on the pharmacists
  professional judgment, published data, and/or
  testing),
  
• Date of preparation, initials of the pharmacist
  (or supervising RPh if produced by a
  technician),
  
• Quantity.
• Finally, a policy and procedure manual must be
  developed by the Pharmacist-in-charge and
  reviewed annually.

49
Dangerous Substances and Poisons

• The dangerous substances provisions are still
  present in the law but are something of an
  anachronism. They are supplanted by legend drugs
  (i.e., FDA legend), which are adopted in whole as
  dangerous drugs.
• Note however, that the Board has used this
  provision in regard to C-V codeine-containing
  cough syrups to make these prescription-only in
  the state.

50
33-24-125. Dangerous substances generally.

• Dangerous drugs, medicines, poisons, chemicals,
  and narcotics include only those drugs,
  chemicals, poisons, medicines and other
  substances which are intended for use by man()

51
33-24-126. Dangerous substances compilation of
list.

• In compiling such list of dangerous substances
  ... the board shall consider all information
  which shall come to its attention from reasonably
  reliable sources... .
• Wyoming is consistent with the federal statutes
  and regulations.
  
• The Board has also included all C-V codeine
  containing anti-tussives and all single-entity
  ephedrine products.

52
33-24-137. Sale of poison.

• It shall be unlawful
• For any person, either on his own behalf or while
  in the employ of another, to sell or give away
  any poison, as designated by the board of
  pharmacy without first recording in a book to be
  kept for that purpose, with an indelible pencil
  or ink, the date, the name and address of the
  person to whom, and the amount and kind of poison
  delivered, except when such poison is sold on the
  written prescription of an osteopath,
  physician, dentist or veterinarian
• To give a false name and address to be recorded
• For any person having custody of such record book
  to refuse to produce it on demand for the
  inspection of any authorized representative of
  the board of pharmacy or other duly authorized
  officer.

53
33-24-138. Poison" labels.

• It shall be unlawful for any person to sell at
  retail, any poison without affixing to the
  package or receptacle containing the same, a
  label conspicuously bearing the word "poison,"
  and the name and the business address of the
  seller. Any person selling poison shall satisfy
  himself that such poison is to be legitimately
  used. The provisions of this section shall not
  apply to the sale of poison on a physician's
  written prescription or in the original package
  of the manufacturer.

54
33-24-204. Violations seizure by the board of
pharmacy.

• All dangerous substances in solid dosage form
  that are possessed, distributed, sold or offered
  for sale in violation of the provisions of this
  article are deemed contraband and shall be seized
  by the Wyoming board of pharmacy and summarily
  forfeited to the state.