Virginia Board of Pharmacy Law Update

1
Virginia Board of PharmacyLaw Update

• VPhA Annual Meeting
• August 7, 2007
• Elizabeth Scott (Scotti) Russell,
• Executive Director
• J. Samuel (Sammy) Johnson,
• Deputy Director of Enforcement

2
Overview of Program

• Review recent changes to laws, regulations, and
  guidance documents.
• Review how to participate in the regulatory
  change process and some identified potentially
  problematic regulations.

3
Overview of Program (cont.)

• Describe new initiatives
• Inspection program ticketing
• Inspecting for patient safety
• Increased efficiencies in disciplinary processes
• Mandatory reporting legislative proposal
• CQI regulations
• Specific CE requirements legislative proposal
• Expiration dates for licenses

4
Overview of Program (cont.)

• Highlight resources available on the Boards
  website.
• Explain appropriate responses to real life
  questionable scenarios.
• Review outsourcing regulations.

5
Overview of Program (cont.)

• Miscellaneous
• Storage requirements of certain specialty drugs
• Electronic prescribing
• Internet prescriptions and solicitations
• Requirements for drug losses
• CII multiple prescriptions on same day
• Update on PMP

6
2007 General Assembly

• from Board of Pharmacy perspective, active
  session, but
• pretty quiet outcome

7
New Laws Effective July 1, 2007

• PA with prescriptive authority may now prescribe
  Schedules II-VI, Schedule II added
• Limited, prescriptive authority, 54.1-2952.1
• Written prescriptions must contain
• name of the supervising practitioner
• PAs DEA license number for Schedules II through
  V.
• Summary of all prescriptive authorities, refer to
  Guidance Document 110-8.
• Summary of all prescription requirements, refer
  to Guidance Document 110-35.

8
New Laws (cont.)

• Changes to grounds for disciplinary action
• 54.1-3316 amended to consolidate, clarify, and
  adds grounds for the discipline of persons and
  entities regulated by the Board of Pharmacy
• Cleanly defines that theft or diversion of a
  controlled substance is now a violation
• Federal agency suspension or revocation (DEA,
  FDA, other)

9
1. changes to 3316 cont.

• Any felony or misdemeanor involving moral
  turpitude
• Has conducted practice so as to be a danger
• Allows for the Board to define unprofessional
  conduct in rule

10
almost new laws

• Senate Bills 879 978
• would have required electronic tracking of
  methamphetamine precursors
• would have required BOP to establish and
  administer system
• significant expense, raised fees
• left in Courts of Justice
• stakeholder workgroup

11
almost new laws (cont)

• SB1391 Board Composition, the bill required for
  the 8 pharmacists members
• at least one pharmacy benefits manager
• and one member of the managed care community
• passed the Senate and was tabled in HWI

12
Periodic Review of Regulations-Overview

• Identify potentially problematic regulations
  (cannot address statutes) via public comment and
  Board committee (done).
• Create Notice of Intended Regulatory Action
  (NOIRA)- list of all identified regulations
  (done).
• NOIRA will be published 8/6/2007, public comment
  accepted until 9/5/2007.

13
Periodic Review of Regulations-Overview

• Proposed regulation amendments developed and
  Board adopts
• Administrative review, and once published 60 day
  public comment period.
• Board summarizes and responds to public comment
  and if no substantive changes are made can adopt
  final regulations
• Administrative review, and once published become
  effective within 30 days

14
Examples of Identified Regulations

• 18VAC110-20-102 Criteria for approval for
  training programs.
• Currently, no expiration date.
• No process for reviewing programs for law
  updates, etc.
• No process or requirement for submitting changes
  to a program.

15
Examples of Identified Regulations

• 18VAC110-20-80 and 18VAC110-20-104
• One rule requires pharmacist to notify Board
  immediately of change of address.
• One rule requires pharmacy technicians to notify
  Board within 30 days of change of address.
• Considering changing both to notifying Board
  within 14 days of change of address.

16
Examples of Identified Regulations

• 18VAC110-20-110 Pharmacy permits generally.
• Consider adding guidance document 110-40 which
  states pharmacy permit may not be issued prior to
  3 weeks of opening date.
• Add prohibition of operating from private
  residence or dwelling.
• Consider prohibition of 2 permits being issued
  for same physical space.

17
Examples of Identified Regulations

• 18VAC110-20-110 Pharmacy permits generally.
• Consider requiring PIC to write Void on
  pharmacy permit and effective date of termination
  when permit is returned to Board.
• Consider making outgoing inventory voluntary,
  unless good cause shown as to why pharmacy will
  not allow it.

18
Examples of Identified Regulations

• 18VAC110-20-111 Pharmacy technicians.
• Add requirement for pharmacies to maintain start
  date and completion date for each pharmacy
  technician in training program.
• Consider requiring pharmacy technicians to post
  registrations.
• Consider maximum time pharmacy technician may
  remain in training program to prevent person from
  going from program to program without
  registering.

19
Examples of Identified Regulations

• 18VAC110-20-130 Pharmacy closings going out of
  business change of ownership.
• Add requirement for pharmacy to transfer
  prescription files somewhere where a patient can
  access.

20
Examples of Identified Regulations

• 18VAC110-20-180 Security System.
• May require alarm to be hard wired or use new
  wireless technology utilizing a monitored
  battery.
• Clarify need that all alarms must be monitored.
• Consider eliminating exemption from having an
  alarm system, or change it from requiring
  installation of alarm within 72 hours of pharmacy
  closing to prior to closing.

21
Examples of Identified Regulations

• 18VAC110-20-200 Storage of drugs, devices, and
  controlled paraphernalia expired drugs.
• May add rules allowing for automated will call
  devices which is now approved in a pilot.
• Clarify where will call may be stored
• Clarify whether Rx medical devices must be stored
  similar to drug paraphernalia or may be displayed
  outside prescription department.

22
Examples of Identified Regulations

• 18VAC110-20-240 Manner of maintaining records,
  prescriptions, inventory records.
• Consider requiring perpetual inventory for CII
  drugs and possibly hydrocodone products, to
  include monthly count-back to reconcile count at
  least every 30 days.
• May need to clarify that records may be stored
  within building where drugs are stored.
• May require maintaining CVI invoices

23
Examples of Identified Regulations

• 18VAC110-20-270 Dispensing of prescriptions
  supervision of pharmacy technicians.
• Consider modifying ratios of pharmacist to
  pharmacy technician in training and pharmacy
  technicians.
• Consider requirement to retain knowingly forged
  prescription possibly after verifying with
  prescriber.

24
Examples of Identified Regulations

• 18VAC110-20-280 Transmission of a prescription
  order by facsimile machine.
• Clarify that hospice may be home hospice.
• Change nursing home to long term care facility.
• Clarify that a nurse may fax a verbal order even
  though order is not being faxed from prescribers
  practice location.
• Considering allow faxing of CIII-VI from a LTC
  facility to pharmacy and establish time
  requirements for following up with hard copy.

25
Examples of Identified Regulations

• 18VAC110-20-320 Refilling of Schedule III through
  VI prescriptions.
• D. Authorized refills of all prescription drugs
  may only be dispensed in reasonable conformity
  with the directions for use as indicated by the
  practitioner if directions have not been
  provided, then any authorized refills may only be
  dispensed in reasonable conformity with the
  recommended dosage and with the exercise of sound
  professional judgment.
• May amend to allow for early refill due to good
  cause or absence (vacation).
• Clarify that intent is referring to time of
  refills and not the ability to change the
  prescription based on strength of drug in stock.

26
New or Amended Guidance Documents

• 110-12 Compliance Packaging Labeling
• 110-15 Albuterol Inhalers
• 110-35 Rx blank requirements (chart orders)
• 110-40 Issuing a new pharmacy permit
• Full list of guidance documents attached

27
Question

• May a long term care facility separate compliance
  packaging containers from a full package for a
  patient going out on temporary leave, weekend
  pass, etc?

28
Answer-see Guidance doc 110-12

• yes, provided the packaging complies with USP
  patient med pack requirements and provided each
  container is labeled appropriately with contents
  and a copy of the main labeling or other document
  containing substantially the same information is
  provided with it.

29
Question

• If a pharmacy has a prescription with valid
  refills for an albuterol MDI that has been
  previously filled with a CFC product, may a
  pharmacist substitute an HFA product for refills?

30
Answer see Guidance doc 110-15

• Yes, provided the prescriber did not specify CFC
  on the prescription, and provided the pharmacist
  specifically counsels the patient about the
  change to include the reason for the change and
  differences that the patient may experience.

31
Question

• May a community pharmacy dispense pursuant to a
  chart order?

32
Answer see Guidance doc 110-35

• Yes provided
• The chart order was written for a patient while
  in a hospital or long term care facility.
• The pharmacist has all information necessary to
  constitute a valid outpatient prescription.
• The pharmacist in an outpatient setting must have
  direction, either written or obtained verbally,
  that the chart order is actually intended to be
  outpatient or discharge prescription orders, and
  not merely a listing drugs the patient was taking
  while an inpatient.
• The orders include some direction related to
  quantity to be dispensed or authorized duration
  of the order by which the pharmacist can
  calculate the authorized quantity using
  directions for use and duration

33
Question

• May an applicant apply and obtain a pharmacy
  permit 3 months prior to the anticipated opening
  date?

34
Answer see Guidance doc 110-40

• No, because once a permit is issued, drugs may be
  purchased and stocked and without the pharmacy
  being open, the drugs may not have appropriate
  oversight, and may be more prone to diversion or
  improper storage conditions.

35
Guidance doc 110-40 (cont)

• The Board of Pharmacy will not issue a pharmacy
  permit more than three weeks prior to the
  designated opening date on the application. Once
  the permit is issued, prescription drugs may not
  be stocked earlier than two weeks prior to the
  designated opening date. Once prescription drugs
  have been placed in the pharmacy, a pharmacist
  must be present during the expected normal hours
  of operation. The pharmacist in charge must be
  present on a regular basis. If there is a change
  in the designated opening date, the pharmacy will
  notify the Board office and the pharmacist will
  continue to be on-site during the expected normal
  hours of operation.

36
New Initiatives Under Consideration 1.
Inspection program ticketing

• Consider allowing inspectors to immediately issue
  a streamlined consent order for a pharmacy upon
  identifying certain infractions.
• Inspector would leave a ticket requiring a
  monetary penalty to be mailed to the Board.
• Violation would be against the pharmacy permit,
  not PIC.
• Payment responsibility left to the business.

37
New Initiatives Under Consideration (cont)
Inspection program ticketing

• Examples of deficiencies which may lead to
  ticket
• No documentation of biennial inventory
• No documentation of PIC change of inventory
• No functional monitoring thermometer in
  refrigerator
• Expired drugs not separated from dispensing stock

38
New Initiatives Under Consideration (cont)
Inspection program ticketing

• Pharmacy may appeal ticket within given
  time-frame.
• could provide missing documentation if
  appropriate without hearing
• could request an informal conference
• Fines and affected deficiencies have not been
  established as of yet.
• Plan to have in place sometime in 2008.

39
New Initiatives Under Consideration (cont)
Inspecting for Patient Safety

• Board desires to be more proactive in continuous
  quality care for patient safety.
• Through collaborative efforts with ISMP, plans to
  develop a guidance document starting with 3-10
  factors which may result in dispensing errors.

40
New Initiatives Under Consideration (cont)
Inspecting for Patient Safety

• Inspectors will survey pharmacy for these factors
  and present it in the form of risk management.
• Inspectors will look for ongoing efforts in
  quality control.
• Educational in nature to begin, not punitive

41
New Initiatives Under Consideration (cont)
Disciplinary Processes

• Impetus for change
• Virginia Performs measures state agency
  performances and is intended to provide
  transparency in government.
• Accessed via the Board website, you can view the
  scorecard for Department of Health Professions.
• Governor initiated essentially 3 measures
• One key measure To investigate and process
  cases related to patient care within 250 days.

42
New Initiatives Under Consideration (cont)
Disciplinary Processes

• Methods for improving efficiency in handling
  cases
• Implement ticketing program for routine
  inspections.
• Use of agency subordinate (current or former
  Board member, staff, or other qualified person
  who hears cases at informal level and recommends
  decision to Board)

43
New Initiatives Under Consideration (cont)
Mandatory Reporting (for 2009 GA)

• BOP is considering a legislative proposal to
  require reporting to the Board certain known,
  serious grounds for suspension/revocation of a
  license of another licensee e.g.
• Intentional or negligent conduct likely to cause
  harm
• Professional incompetence
• Unprofessional conduct
• Mental or physical impairment
• Substance abuse or diversion
• similar to current requirements for health care
  institutions
• knowledge by virtue of reporters professional
  responsibilities
• would provide immunity to reporting persons

44
New Initiatives Under Consideration (cont)
Mandatory Reporting (for 2009 GA)

• Consider mandatory reporting of dispensing errors
  without patient/pharmacy/pharmacist identifiers
  for use in prevention
• Needs considerable research and collaboration
  with other organizations
• Needs definition of dispensing errors
• Would be used by third parties to make changes to
  systems, drug names, etc.

45
New Initiatives Under Consideration (cont) Drug
Disposal Collection

• Exploring ability to allow the public to return
  unwanted dispensed drugs to a designated location
  for the purpose of destruction.
• Current laws prohibit public from transferring
  drugs to anyone for destruction.
• Accumulation of unwanted drugs potentially leads
  to drug diversion, negative environmental impacts
  and accidental overdoses.

46
New Initiatives Under Consideration (cont) Drug
Disposal Collection

• Will require collaboration between law
  enforcement officials, pharmacists, and pharmacy
  technicians.
• Several states have existing pilot programs
• Washington
• Maine
• Florida
• Wisconsin

47
New Initiatives Under Consideration (cont)
Specific CE Requirements

• Plan to submit a legislative proposal to provide
  authority to mandate pharmacists and pharmacy
  technicians complete CE on a particular topic.
• Ex patient safety curriculum, state laws update,
  or any current core competency.

48
New Initiatives Under Consideration (cont)
Specific CE Requirements

• Requirement would not be in regulation but the
  Board would provide notice a year in advance of
  the requirement.
• Notification could be included on the renewal
  statement prior to the year in question.
• Flexible have ability to choose the type of CE,
  or not to mandate a particular topic in a given
  year.

49
New Initiatives Under Consideration (cont)
License Renewal Process Review

• Board planning to submit a legislative proposal
  to remove all renewal dates from statute, and
  allow the Board to set renewal dates in
  regulation.
• Will continue requiring annual renewal, but may
  move away from 12/31 for some types of licensees.
• Pharmacists and pharmacy technicians will
  continue to renew as of 12/31 annually--easier
  for CE requirements
• Will not go to biennial renewal.

50
Board of Pharmacy Website

• www.dhp.virginia.gov/pharmacy
• FAQs
• Guidance Documents
• Current Laws and Regulations
• E-newsletters and Recent Presentations
• Forms and Applications
• License Look-up

51
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52
Question

• As PIC, you learn that a new pharmacist and a new
  pharmacy technician will be transferred to work
  in your pharmacy. You wish to confirm that they
  are licensed properly with the Board. How would
  you verify this information?

53
Answer

• Access License Look-up feature on the Boards
  website.

54
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56
Question

• You learn that the pharmacist is licensed, but
  there is no record for the pharmacy technician
  indicating a current active registration. You
  inform the pharmacy technician, but she is unsure
  of the registration process. How can you obtain
  information regarding the registration process?

57
Answer

• Access Information for technicians or click on
  FAQs.

58
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60
Question

• You have a pharmacy intern working at your
  pharmacy who is on a school rotation. You
  question whether 4 pharmacy technicians and 1
  pharmacy intern on rotation may work at the same
  time under the supervision of 1 pharmacist.
• Is this allowed and where could you find the
  answer?

61
Answer

• Yes. Refer to guidance document 110-33.

62
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63
Question

• Where can I read about the latest Board
  information?

64
Answer

• Click on Newsletters and Presentations.
• Be sure that we have your current email address
  so that you receive notifications of posting of
  new e-newsletters.
• To provide this information
• write or email the information to the board
• change it yourself via the website under update
  your information by logging in using your user
  ID and password you created during renewal
  process

65
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68
Real Life Scenarios
69
Dispensing Scenario 1

• You are working in a pharmacy in Virginia and a
  receive a faxed prescription for Lortab 5mg/500mg
  30.
• It contains all the necessary elements for a
  prescription, but you notice that the doctors
  address is Georgia and the patients address is
  Virginia.

70
Dispensing Scenario 1

• What should you consider when determining whether
  to dispense the prescription?

71
Dispensing Scenario 1

• Can you legally dispense a prescription from an
  out of state prescriber?

72
Dispensing Scenario 1

• YES.

73
Dispensing Scenario 1

• 54.1-3303 Drug Control Act
• C. A pharmacist may dispense a controlled
  substance pursuant to a prescription of an
  out-of-state practitioner of medicine,
  osteopathy, podiatry, dentistry or veterinary
  medicine authorized to issue such prescription if
  the prescription complies with the requirements
  of this chapter and Chapter 34 ( 54.1-3400 et
  seq.) of this title, known as the "Drug Control
  Act."

74
Dispensing Scenario 1

• Is there a bona fide practitioner-patient
  relationship?

75
Dispensing Scenario 1

• Maybe- you may need to obtain more information
  from the patient or the prescriber to determine
  this.

76
Dispensing Scenario 1

• When were you actually seen by this prescriber or
  one of his colleagues?

77
Dispensing Scenario 1

• When were you actually seen by this prescriber or
  one of his colleagues?
• The patient states he has never seen this
  prescriber. He completed a medical survey online
  and was told that prescription would be faxed to
  this pharmacy.

78
Dispensing Scenario 1

• Prescription lacks a bona fide practitioner-patien
  t relationship. Decline to fill the
  prescription.
• It is not acceptable for a patient to complete an
  online questionnaire or to simply provide medical
  records to the prescriber.
• The prescriber must have a record on file of the
  patient and must have performed a physical
  evaluation at some point.

79
Dispensing Scenario 2

• You receive solicitation via fax from a PBM to
  act as a fulfillment partner. They claim to
  use telemedicine and will fax you valid
  prescriptions from Virginia prescribers. They
  offer an enticing reimbursement rate especially
  for dispensing Schedules III-V drugs. You are
  instructed to log on to a secure site to print
  out mailing labels as the drugs must be mailed
  that day.

80
Dispensing Scenario 2

• Do you sign the contract?

81
Dispensing Scenario 2

• No!
• These arrangements usually involve the patient
  communicating health problems on-line to
  contracted physicians located in multiple states.
  They will then have a physician using a Virginia
  address to fax a prescription to the pharmacy.

82
Dispensing Scenario 2

• Ask yourself the common-sense questions
• Why must I mail these prescriptions?
• Why cant the patients pick them up?
• Why is the reimbursement rate unbelievably high?
• Why is the reimbursement rate higher if I
  dispense Schedules III-V?

83
Dispensing Scenario 2

• Pharmacies that have been targeted by the DEA for
  illegal dispensing are trying this new strategy.
• This ractice can puts legitimate pharmacies in
  jeopardy of possible criminal activity.

84
Dispensing Scenario 3

• A prescription is presented to the pharmacist for
  Ortho Tri-Cyclen.
• You notice that the prescriber is a dentist.
• After asking the female patient a few questions,
  you learn that her husband is the dentist
  prescribing this drug.

85
Dispensing Scenario 3

• What should you consider when evaluating the
  prescription?

86
Dispensing Scenario 3

• Is this prescription within the dentists scope
  of practice?

87
Dispensing Scenario 3

• No. The practice of dentistry is limited to the
  oral cavity and the maxillofacial, adjacent and
  associated structures. Therefore, this is not a
  valid prescription

88
Dispensing Scenario 4

• An OB/GYN calls a verbal prescription in for her
  husband for Lomotil 10, 1 tab po q6h prn
  diarrhea, no refills.
• Is this compliant with Board of Medicine
  regulations?

89
Dispensing Scenario 4

• Perhaps.
• It is written for one prescribed course of
  medication for a single episode of an acute
  illness.
• She may prescribe for her husband as long as she
  maintains a patient record.

90
Dispensing Scenario 4

• Is it problematic for an OB/GYN to treat a man?

91
Dispensing Scenario 4

• No.
• Practitioners of medicine or osteopathic medicine
  have the broadest scope of practice.
• Practice of medicine involves the prevention,
  diagnosis and treatment of human physical or
  mental ailments, conditions, diseases, pain or
  infirmities that affect patients of all ages and
  both sexes.

92
Dispensing Scenario 4

• Board of Medicine issues all practitioners of
  medicine and osteopathic medicine the same type
  of license. It does not license practitioners by
  their specialized field of expertise.
• Drug Control Act permits practitioners of
  medicine and osteopathic medicine to prescribe
  Schedules II-VI.

93
Dispensing Scenario 4

• Dentists, podiatrists, TPA-certified optometrists
  and veterinarians have a more limited scope of
  practice, because their professional license
  authorizes the treatment of a specific area of
  the body or a specific population group.
• Nurse practitioners and physician assistants have
  limited, dependent prescriptive authorities, and
  therefore, the scope of practice is determined by
  the scope of practice of the supervising
  practitioner and what is authorized in the
  practice agreement.

94
Dispensing Scenario 4

• 18VAC85-20-25. Treating and prescribing for self
  or family
• A. Treating or prescribing shall be based on a
  bona fide practitioner-patient relationship, and
  prescribing shall meet the criteria set forth in
  54.1-3303 of the Code of Virginia.
• B. A practitioner shall not prescribe a
  controlled substance to himself or a family
  member, other than Schedule VI as defined in
  54.1-3455 of the Code of Virginia, unless the
  prescribing occurs in an emergency situation or
  in isolated settings where there is no other
  qualified practitioner available to the patient,
  or it is for a single episode of an acute illness
  through one prescribed course of medication.
• C. When treating or prescribing for self or
  family, the practitioner shall maintain a patient
  record documenting compliance with statutory
  criteria for a bona fide practitioner-patient
  relationship.

95
Dispensing Scenario 5

• A psychiatrist routinely prescribes himself
  Atenolol 50mg 1 po qd for blood pressure.
• Is this compliant with Board of Medicines
  regulations?

96
Dispensing Scenario 5

• Probably.
• It is a schedule VI drug and therefore, refills
  are allowed. He is a practitioner of medicine
  and therefore, if he feels that he may adequately
  treat blood pressure then he may do so based on
  his medical training.
• He may prescribe for himself as long as he
  maintains a patient record.

97
Possible action when presented a
questionable/invalid prescription

• Use professional judgment.
• Consider notifying the prescriber.
• Consider making a request from the Prescription
  Monitoring Program.
• Decline to fill the prescription.
• If a known forgery, keep the prescription.

98
Dispensing Scenario 6

• You receive a call from a pharmacist in Canada
  who is requesting a prescription transfer.
  Additionally, you learn that the patient has been
  communicating with the Canadian pharmacist and
  prompted him to call you for the transfer.
• Should you transfer the prescription to
  accommodate the patients request?

99
Dispensing Scenario 6

• No.
• It is illegal for a pharmacy located in Canada to
  ship prescription drugs into the United States,
  therefore, this prescription cannot be legally
  filled or refilled in this instance.
• Recall that 18VAC110-20-360 stated a copy may be
  given provided the drug can be filled or refilled.

100
Dispensing Scenario 7

• You are presented one prescription for Adderall
  with an issuance date of 8/1/07 and it contains
  the phrase Do not fill until 8/15/07.
• Is this a problem?

101
Dispensing Scenario 7

• No. It would be a problem, according to the DEA,
  if the prescriber wrote multiple prescriptions
  for the same Schedule II drug with instructions
  indicating to dispense the prescriptions on
  sequential days.
• DEA viewed this as tantamount to indicating
  refills for a Schedule II drug.

102
Dispensing Scenario 7

• It is not a problem to simply write a phrase on a
  single prescription requesting that it not be
  dispensed until a later date.

103
Multiple Schedule II Prescriptions

• This will be changing this Fall when DEAs
  proposed regulations become final regulations.
• Changes will allow practitioners to provide
  individual patients with multiple prescriptions,
  to be filled sequentially, for the same schedule
  II controlled substance, with such multiple
  prescriptions having the combined effect of
  allowing a patient to receive over time up to a
  90-day supply of that controlled substance.

104
Dispensing Scenario 8

• A patient presents a prescription for
• Percocet 5mg/325mg, 1 tab po q6h prn pain,
• 150. His insurance will only cover 120
• tablets.He states that he would like the
• remaining 30 tablets and that he will pay
• cash for them.
• Is this acceptable?

105
Dispensing Scenario 8

• Maybe.
• The pharmacys official dispensing records must
  show only one transaction which accurately
  indicates the total number of tablets dispensed
  pursuant to this prescription.
• The dispensing record may not appear as two
  transactions since a Schedule II may not be
  refilled and this does not comply with the
  provisions for allowable partial dispensing of
  Schedule II drugs.

106
Dispensing Scenario 9

• You have requested information from the
  Prescription Monitoring Program as the result of
  receiving a suspicious prescription.
• The PMP report confirmed your suspicion that this
  patient is doctor shopping.
• What can you now legally do with this information
  from the report?

107
Dispensing Scenario 9

• The PMP report belongs to the pharmacist
  requesting the information.
• Not to be filed in the prescription file.
• Cannot share report with other pharmacists,
  prescribers, patients.

108
Dispensing Scenario 9

• Could decide to decline the prescription, but may
  not reveal on the back of the prescription why it
  is being declined. 18VAC110-20-270
• Could notify the prescriber that the prescription
  is being declined and encourage him to request
  information from the PMP on this patient.

109
Dispensing Scenario 9

• You may not breach the patients confidentiality
  by revealing the specific details from the PMP
  report.
• This report is your personal property and should
  not be attached to the prescription or kept in
  the prescription files.
• You should either shred the report or maintain it
  in a secure location within the pharmacy.

110
Dispensing Scenario 9

• Should you be contacted by a pharmacist working
  in another pharmacy who has just received the
  prescription that you declined, you may not
  reveal the information from the report.
• You may only encourage him to make a request to
  PMP on this individual.

111
Dispensing Scenario 10

• You receive a prescription which you confirm to
• be a forgery.
• Do you call the Board of Pharmacy?

112
Dispensing Scenario 10

• No
• Unless the patient is also a licensee of DHP,
• you should call local law enforcement or the
• Virginia State Police?

113
Dispensing Scenario 11

• You discover that a pharmacist has diverted a
• Significant quantity of Schedule III drugs.
• To whom do you report the loss of drugs?

114
Dispensing Scenario 11

• To the DEA and the Board of Pharmacy
• While not currently required, the loss can be
  more completely investigated if you provide the
  name of the licensee involved to the Enforcement
  Division of the Department of Health Professions.
• 1-800-533-1560

115
Dispensing Scenario 11

• 54.1-3404. Inventories of controlled substances
  required of certain persons contents and form of
  record. E. Whenever any registrant or
  licensee discovers a theft or any other unusual
  loss of any controlled substance, he shall
  immediately report such theft or loss to the
  Board. If the registrant or licensee is unable to
  determine the exact kind and quantity of the drug
  loss, he shall immediately make a complete
  inventory of all Schedule I through V drugs.
  Within 30 days after the discovery of a loss of
  drugs, the registrant or licensee shall furnish
  the Board with a listing of the kind, quantity
  and strength of such drugs lost.

116
Outsourcing

117
Outsourcing Question 1

• Pharmacy A receives a prescription and enters it
  into the computer.
• Pharmacist at pharmacy B checks the data entry.
• Pharmacist at pharmacy C performs a drug review.
• Finally the pharmacist at pharmacy A counts the
  drug and dispenses it to the patient.

118
Outsourcing Question 1

• Is this process compliant with current pharmacy
  laws and regulations?

119
Outsourcing Question 1

• Yes
• If it complies with 18VAC110-20-276.

120
Outsourcing

• 18VAC110-20-276 does not allow dispensing of the
  drug, but does allow for other pharmacies to
  participate in entering the prescription,
  performing a prospective drug review, performing
  therapeutic interventions, communicating with
  the prescriber, and performing counseling.

121
Outsourcing

• A pharmacy may outsource these functions to
  another pharmacy located in Virginia or another
  non-resident pharmacy, or to an employee licensed
  in Virginia and working from a remote location.
• Pharmacies must share ownership or have a written
  contract describing the scope, responsibilities
  and accountabilities of each pharmacy.

122
Outsourcing

• All pharmacies must comply with Virginias
  standards for supervision of pharmacy
  technicians.
• A pharmacist licensed in Virginia must perform a
  check for accuracy of any processing done by the
  remote pharmacy.

123
Outsourcing

• Must have a common electronic file or technology
  which allows sufficient information to be shared.
• A one-time written notice or posted sign must
  notify patients of the names of the pharmacies
  participating in outsourcing.

124
Outsourcing

• Each pharmacy must maintain a manual containing
• Responsibilities of each pharmacy
• Names, address, telephone and permit numbers of
  all pharmacies involved
• Procedures for protecting the confidentiality
  and integrity of patient information

125
Outsourcing

• Procedures for ensuring that pharmacists
  performing prospective drug reviews have access
  to appropriate drug information resources
• Procedures for maintaining required records
• Procedures for complying with all applicable laws
  and regulations to include counseling

126
Outsourcing

• Procedures for objectively and systematically
  monitoring and evaluating the quality of the
  program to resolve problems and improve services
  and
• Procedures for annually reviewing the written
  policies and procedures for needed modifications
  and documenting such review.

127
Outsourcing

• Additionally, pharmacies shall maintain
  retrievable records which show, for each
  prescription processed, each individual
  processing function and identity of the
  pharmacist or pharmacy technician who performs a
  processing function and the pharmacist who
  checked the processing function, if applicable.

128
Miscellaneous Points

129
Storage requirement- Question

• What is the appropriate temperature range for
  storing drugs in the freezer?

130
Answer

• -4 and 14F

131
Storage requirements for specialty drugs

• New drugs requiring storage in a freezer.
• Ex Zostavax
• Freezer temp -4 and 14F
• During shipping -4F or colder
• Store at an average temperature of 5F or colder
  until it is reconstituted for injection

132
Storage requirements for specialty drugs

• May use any freezer, including frost-free, that
  has a separate sealed freezer door.
• Small refrigerators with an inside freezer
  compartment are often noncompliant with the
  freezer standards.
• Refer to August E-newsletter for more info.

133
Question 1Electronic prescribing

• Patient presents prescription for Ambien 5mg.
• It appears to have been electronically generated
  and contains an electronic signature. Can you
  legally dispense this prescription?

134
Question 1

• No.
• If the prescription is printed out and handed to
  the patient then it must bear a manual signature.

135
Question 2
True or False- A biennial inventory may appear
as one large alphabetical list of all drugs in
Schedules II-V?
136
Question 2

• FALSE- Schedule II drugs must be listed
  separately from Schedules III-V.
• 54.1-3404 18 VAC 110-20-240

137
Question 2

• 54.1-3404 18 VAC 110-20-240 Records
• Inventory must be signed, dated, and indicate
  if taken at opening or closing of business.
• If 24 hour pharmacy, note whether the receipt or
  distribution of drugs on the inventory date
  occurred before or after the inventory was taken.
• Entire inventory must be completed at one time.

138
Question 3

• True or False- You are compliant if you sign the
  record of receipt (invoices) of Schedule III-V
  drugs?

139
Question 3

• FALSE- You must record the actual date of receipt
  on the record.
• There is no requirement that the record be signed.

140
Question 4
True or False-You may store prescription
records and inventories in an off-site storage
area if approved by the DEA.
141
Question 4
False.
142
Question 4
54.1-3404 18 VAC 110-20-240 Records All
executed order forms, prescriptions, and
inventories of Schedule II through V drugs shall
be maintained at the same location as the stock
of drugs. If authorized by DEA, other records
pertaining to Schedule II through V drugs, such
as invoices, may be maintained in an off-site
data base or in secured storage. All records in
offsite storage shall be retrieved and made
available for inspection or audit within 48 hours
of a request by the board or an authorized agent.
143
Question 4
54.1-3404 18 VAC 110-20-240 Records Retain
copy of letter sent to DEA requesting off-site
storage for Board inspector to review.
144
Question 5

• True or False- If all of the pharmacy technicians
  are registered, the pharmacy does not need a
  site-specific pharmacy technician training
  manual.

145
Question 5

• FALSE- Every pharmacy must maintain a
  site-specific training manual.
• 18VAC110-20-111

146
Question 5

• 18VAC110-20-111 Pharmacy Technicians
• Documentation of successful completion of the
  site specific training program must be maintained
  for each pharmacy technician for the duration of
  employment and for a period of two years from
  date of termination of employment.

147
Question 5

• 18VAC110-20-111 Pharmacy Technicians
• Documentation for currently employed pharmacy
  technicians shall be maintained on site or at
  another location where the records are readily
  retrievable upon request for inspection. After
  employment is terminated, such documentation may
  be maintained at an off-site location where it is
  retrievable upon request.

148
Prescription Monitoring Program

• Program Statistics
• And
• Update

149
Records in Database
150
REPORTING OF DATA

• Please do not switch to reporting with NPI
  numbers. The NCPDP number is the number to use.
  You will be notified if there is a change to the
  reporting requirements.
• Remember For the 1-15 of each month the
  reporting deadline is the 25th of that month, for
  the 16-31 of each month the reporting deadline is
  the 10th of the following month.

151
Program Requests Fulfilled
152
Website Registrations
Note 6333 Total requests for all of 2006.
153
DHP IS MOVING!!!! (again)

• The offices of DHP will be moving mid-August.
• Offices will have to close Thursday, August 16 at
  noon, and will re-open at the new location
  Monday, August 20 at 815 AM.
• Limited interruption of website functions
• Interruption of phone, email, and faxing the
  entire move time

154
Address until 8/16/07

• Virginia Board of Pharmacy
• 6603 West Broad Street
• 5th Floor
• Richmond, VA 23230
• Phone [phone]
• www.dhp.virginia.gov/pharmacy
• pharmbd_at_dhp.virginia.gov

155
New Address as of 8/20/07

• Virginia Board of Pharmacy
• 9960 Mayland Drive
• Suite 300
• Richmond, VA 23233-1463
• new phone number 804-367-4456
• new fax number 804-527-4472
• www.dhp.virginia.gov/pharmacy
• pharmbd_at_dhp.virginia.gov

156
PMP New Contact information

• New address effective August 20, 2007
• Prescription Monitoring Program
• 9960 Mayland Drive, Suite 300
• Richmond, VA 23233-1463
• New Main Number 804-367-4566
• Secondary Number 804-367-4409
• Fax [phone]

157
QUESTIONS??