Unusual Dispensing Scenarios

1
Unusual Dispensing Scenarios

• Caroline Juran
• Deputy Executive Director
• Board of Pharmacy
• www.dhp.virginia.gov

2
Objectives

• Determining the validity of a prescription in
  various scenarios.
• Does a bona fide practitioner-patient
  relationship exist?
• Is it within the prescribers scope of
  practice?
• Is the prescription compliant with regulations or
  guidance when prescribed for the practitioner or
  his family?

3
Objectives, cont.

• Possible action when presented a
  questionable/invalid prescription.
• Proper procedure for transferring Schedule III-VI
  prescriptions and the pharmacists obligation.
• Dispensing Schedule II prescriptions.
• Review the current status of issuing multiple
  prescriptions for the same CII drug.
• Review when a CII prescription may be partially
  dispensed and the proper procedures.

4
Objectives, cont.

• Miscellaneous topics.
• Electronic prescriptions.
• Periodic Regulatory Review.
• Prescription Monitoring Program.

5
Validity of Prescription

• Bona fide practitioner-patient relationship

6
Validity of Prescription, cont.

• 54.1-3303 (A) from the Code of Virginia
• For purposes of this section, a bona fide
  practitioner-patient-pharmacist relationship is
  one in which a practitioner prescribes, and a
  pharmacist dispenses, controlled substances in
  good faith to his patient for a medicinal or
  therapeutic purpose within the course of his
  professional practice.
• (i) ensure that a medical or drug history is
  obtained
• (ii) provide information to the patient about
  the benefits and risks of the drug being
  prescribed
• (iii) perform or have performed an appropriate
  examination of the patient, either physically or
  by the use of instrumentation and diagnostic
  equipment through which images and medical
  records may be transmitted electronically except
  for medical emergencies, the examination of the
  patient shall have been performed by the
  practitioner himself, within the group in which
  he practices, or by a consulting practitioner
  prior to issuing a prescription
• (iv) initiate additional interventions and
  follow-up care, if necessary, especially if a
  prescribed drug may have serious side effects.

7
Dispensing Scenario 1

• You are working in a pharmacy in Virginia and a
  patient presents a prescription for Lortab
  5mg/500mg 30. It contains all the necessary
  elements for a prescription, but you notice that
  the doctors address is Florida and the patients
  address is Virginia. What should you consider
  when determining whether to dispense the
  prescription?

8
Dispensing Scenario 1

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

9
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."

10
Dispensing Scenario 1

• Is there a bona fide practitioner-patient
  relationship?
• Maybe- may need to obtain more information from
  the patient or the prescriber to determine this.

11
Dispensing Scenario 1

• Was this prescription given to you in the
  doctors office in Florida?
• If not, how did you obtain this prescription?
• Have you ever been seen by this prescriber or one
  of his colleagues?

12
Dispensing Scenario 1

• Was this prescription given to you in the
  doctors office in Florida? No.
• If not, how did you obtain this prescription?
  Patient completed medical survey online and Rx
  was mailed to patients home.
• Have you ever been seen by this prescriber or one
  of his colleagues? No.

13
Dispensing Scenario 1

• Result Prescription lacks a bona fide
  practitioner-patient 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.

14
Dispensing Scenario 2

• You receive solicitation from a mail order
  pharmacy to act as a fulfillment partner. They
  promise a fulfillment fee of 3.50 per script
  that your pharmacy ships out and will provide you
  with a computer, printer, labels, etc. They will
  also reimburse you for the cost of your drugs.
  Do you sign the contract?

15
Dispensing Scenario 2

• NO!!!
• These arrangements involve the patient
  communicating health problems on-line to
  contracted physicians located in multiple states.
  The physician will then transmit a prescription
  to the pharmacy for dispensing.
• At no time does a bona fide practitioner-patient
  relationship exist, therefore this is not a valid
  prescription.

16
Dispensing Scenario 2

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

17
Validity of Prescription, cont.

• Prescribers scope of practice

18
Validity of Prescription, cont.

• 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.
• 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.

19
Validity of Prescription, cont.

• 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.

20
Dispensing Scenario 3

• A prescription is presented to you, the
  pharmacist, for the dispensing of Bactrim DS for
  the treatment of a UTI. However, you notice that
  the prescriber is a dentist. After asking the
  female patient a few questions, you learn that
  she is a friend of the dentist, and that she had
  called him requesting that he prescribe something
  to treat her UTI. What should you consider when
  evaluating the prescription?

21
Dispensing Scenario 3

• Is this prescription within the dentists scope
  of practice? 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.

22
Validity of Prescription, cont.

• Prescribing for self or family

23
Validity of Prescription, cont.

• 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.

24
Dispensing Scenario 4

• A physician 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?

25
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.

26
Dispensing Scenario 5

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

27
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.

28
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.

29
Declining a Prescription

• 18VAC110-20-270
• Pharmacist shall record on the back of the
  prescription
• the word declined
• the name, address, and telephone number of the
  pharmacy
• the date filling of the prescription was declined
  
• the signature of the pharmacist.

30
Declining a Prescription

• The reason for declining the prescription is not
  legally required and should not be included on
  the back of the prescription.

31
Transferring a Prescription

• 18VAC110-20-360
• A copy of a prescription for a Schedule III- VI
  drug shall be given upon request by one pharmacy
  to another pharmacy provided the drug can be
  filled or refilled
• Provided the patient has given permission for the
  transfer.

32
Transferring a Prescription

• The transferring pharmacy records
• On the face of the prescription
• the word "VOID"
• On the reverse of the prescription
• the name, address and, except for Schedule VI,
  DEA number of the pharmacy, to which it was
  transferred
• for an oral transfer, the name of the pharmacist
  receiving the prescription information
• The date of the transfer and, in the case of an
  oral transfer, the name of the pharmacist
  transferring the information.

33
Transferring a Prescription

• The receiving pharmacy
• Records the word "TRANSFER" on the face of the
  prescription
• Collects all information required to be on a
  prescription to include
• Date of issuance of original prescription
• Original number of refills authorized on the
  original prescription
• Date of original dispensing, if applicable
• Number of valid refills remaining and date of
  last dispensing
• Pharmacy name, address, DEA registry number
  except for Schedule VI prescriptions, and
  original prescription number from which the
  prescription information was transferred and
• Name of transferring pharmacist, if transferred
  orally.

34
Transferring a Prescription

• The transfer may occur between two pharmacies
  either orally by direct communication between the
  transferring pharmacist and the receiving
  pharmacist, or by facsimile machine or by
  electronic transmission.
• All required information may be captured on the
  hard copy or in an automated data processing
  system used for storage and retrieval of
  dispensing information.

35
Transferring a Prescription

• For prescriptions transferred between pharmacies
  using a common database, the pharmacy receiving
  the prescription shall not be required to
  maintain a hard copy pursuant to 18VAC110-20-240
  B provided that the system used is capable of
  generating a hard copy of the transferred
  prescription upon request or except as required
  by federal law.

36
Transferring a Prescription

• The transfer of a Schedule III-V prescription for
  the purpose of refill dispensing is permissible
  only one time (DEA rule), however, pharmacies
  electronically sharing a real-time, on-line
  database may transfer up to the maximum refills
  permitted by law and the prescriber's
  authorization.

37
Transferring a Prescription

• The required information for an electronic
  transfer using a shared real-time, on-line
  database is the same as is required for a manual
  transfer plus the date(s) and locations of
  previous refill(s).
• Title 21 Code of Federal Regulations Section
  1306.25

38
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?

39
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.

40
Multiple Schedule II Prescriptions

• In 2004, the DEA interpreted that a prescriber
  writing multiple prescriptions for the same
  Schedule II drug with instructions indicating to
  dispense the prescriptions on sequential days was
  tantamount to indicating refills for a Schedule
  II drug and therefore not allowed.

41
Multiple Schedule II Prescriptions

• In the Fall of 2006, the DEA published proposed
  regulations which would amend its current
  regulations to 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.

42
Multiple Schedule II Prescriptions

• Proposed requirements for multiple prescriptions
  Sec. 1306.12 of the CFR
• Must be for legitimate medical purpose and within
  the prescribers usual course of practice.
• The individual practitioner indicates the
  earliest date on which a pharmacy may fill the
  prescription, except on the first prescription if
  intended to be filled immediately.
• That it does not create an undue risk of
  diversion or abuse.

43
Proposed requirements for multiple prescriptions
Sec. 1306.12 of the CFR, cont.

• Nothing shall be construed as mandating or
  encouraging individual practitioners to issue
  multiple prescriptions or to see their patients
  only once every 90 days when prescribing Schedule
  II controlled substances. Rather, individual
  practitioners must determine on their own, based
  on sound medical judgment, and in accordance with
  established medical standards, whether it is
  appropriate to issue multiple prescriptions and
  how often to see their patients when doing so.

44
Proposed requirements for Sec. 1306.14 CFR

• (e) Where a prescription that has been prepared
  in accordance with Sec. 1306.12(b) contains
  instructions from the prescribing practitioner
  indicating that the prescription shall not be
  filled until a certain date, no pharmacist may
  fill the prescription before that date.

45
Multiple Schedule II Prescriptions

• To date, these proposed changes to the Code of
  Federal Regulations have not been finalized and
  remain in a proposed status. Therefore, the
  practice of issuing multiple prescriptions for a
  Schedule II drug with instructions to dispense on
  sequential days is not currently recognized as an
  acceptable practice by the DEA.
• Please note that the date of issuance of all
  prescriptions must be the date that the
  prescriber issued the prescription, and should
  not bear a date in the future.

46
Partial Dispensing of Schedule II Drugs

• 18VAC110-20-310
• When a partial dispensing is allowed
• If pharmacist is unable to supply full quantity,
  however, remaining quantity must be dispensed
  within 72 hours.
• For a patient in a long term care facility.
• For a patient with a terminally ill diagnosis.

47
Partial Dispensing of Schedule II Drugs

• If pharmacist is unable to supply full quantity
• The remaining quantity must be dispensed within
  72 hours and notation of the quantity supplied
  must be recorded on the face of the written
  prescription.
• If unable to dispense remaining within 72 hours,
  pharmacist must notify prescriber.
• New prescription required for further dispensing.

48
Partial Dispensing of Schedule II Drugs

• For a patient in a long term care facility
• May be partially filled for a period not to
  exceed 60 days from the date of issuance.
• Shall record on the back of the prescription (or
  on another appropriate record, uniformly
  maintained and readily retrievable) the date of
  the partial dispensing, quantity dispensed,
  remaining quantity authorized to be dispensed,
  and the identification of the dispensing
  pharmacist.
• Total quantity in all partial dispensing shall
  not exceed the total quantity prescribed.

49
Partial Dispensing of Schedule II Drugs

• For a patient in a long term care facility, cont.
• Information may be maintained in a computerized
  system if this system has the capability to
  permit
• 1. Output (display or printout) of the original
  prescription number, date of issue,
  identification of prescribing practitioner,
  identification of patient, identification of the
  long-term care facility, identification of drug
  authorized (to include dosage form, strength, and
  quantity), listing of partial dispensing under
  each prescription and the information required on
  the previous slide.
• 2. Immediate (real time) updating of the
  prescription record each time a partial
  dispensing of the prescription is conducted.

50
Partial Dispensing of Schedule II Drugs

• For a patient with a medical diagnosis
  documenting a terminal illness
• Same procedure and allowances for documentation
  as for a long term care patient plus the
  following requirements
• Pharmacist shall verify the patient as terminally
  ill and record such notation on the prescription.
  
• Prior to the subsequent partial filling, the
  pharmacist shall determine that it is necessary.

51
Dispensing Scenario 7

• 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?

52
Dispensing Scenario 7

• 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.

53
Miscellaneous Topics

• Electronic prescriptions are initiated in the
  prescribers computer, electronically signed and
  are either sent directly to the pharmacys
  computer or to the fax machine.
• Only Schedule VI drugs may be electronically
  transmitted.

54
Miscellaneous Topics

• Electronic signatures may appear as a digital
  signature or may simply contain a phrase
  indicating that it was electronically signed the
  prescriber. This information generally appears
  typed.
• An electronic signature belongs to the
  individual. It is secure and often password
  protected. Therefore, only this individual may
  cause the computer to electronically sign the
  prescription.

55
Miscellaneous Topics

• When a prescription is received via the fax
  machine, the pharmacist will need to know if this
  was electronically transmitted from the
  prescribers computer, or if it was placed in the
  prescribers fax machine and simply faxed to the
  pharmacy.

56
Miscellaneous Topics

• If electronically transmitted it must comply with
  18VAC110-20-285 and is only valid for Schedule
  VI.
• If faxed it must comply with 18VAC110-20-280 and
  must bear a manual signature. Schedules III-VI
  may be faxed along with a few provisions for
  faxing a Schedule II.

57
Miscellaneous Topics

• May need to verify the method of transmission
  with the prescriber if unclear.

58
Periodic Regulatory Review Period

• Board currently accepting public comment
  regarding needed changes or suggestions for
  regulations.
• Cannot directly address statutes, only
  regulations.
• Comments must be in writing and identify the
  specific regulation in question.

59
Periodic Regulatory Review Period

• Virginia Board of Pharmacy
• 6603 West Broad Street
• 5th Floor
• Richmond, VA 23230
• pharmbd_at_dhp.virginia.gov

60
Prescription Monitoring ProgramWhat Must Be
Reported

• Dispensing data for all Schedule II, III, and IV
  drugs to include
• Patients name, DOB
• Drug name, quantity
• Date of dispensing
• Prescribers and Dispensers identifier number

61
Prescription Monitoring Program When To Report

• At least Bi-monthly
• By the 10th of each month, drugs dispensed from
  the 16th through the 31st of the previous month
• By the 25th of each month, drugs dispensed from
  the 1st through the 15th of that month

62
Prescription Monitoring ProgramNon-Reporting List

• Sent to PMP program director within 2 business
  days of deadlines for each reporting period.
• Letter will be sent to all non-reporting
  dispensers requesting data.
• Inadequate response will lead to certified letter
  being sent.

63
Prescription Monitoring ProgramNon-Reporting List

• Inadequate response will result in referral for
  possible disciplinary action.
• Possible pre-hearing consent order requiring
  immediate submission of data and 1,000 fine for
  each unreported period.

64
MAKING REQUESTS ONLINE

• www.dhp.virginia.gov/pmpdatacenter
• Must register first
• Fill out registration form click on Submit
• Print out form and fax to [phone]
• Username and password will be mailed to address
  of record

65
Notice In response to a problem with prescription
drug abuse in Virginia, the General Assembly
passed a law establishing a statewide
Prescription Monitoring Program. This program
collects prescription data for specified drug
schedules into a central database, which can then
be used by limited authorized users to assist in
deterring the illegitimate use of prescription
drugs. As authorized users of the program,
pharmacists may request information from Program
files on all Schedule II-IV prescriptions
dispensed to a patient to assist them in
determining the validity of a prescription. The
information collected in this program is
maintained by the Department of Health
Professions, and strict security and
confidentiality measures are enforced. Only those
persons authorized by law can be provided
information from the database.
66
DISCLOSURE OF PMP INFORMATION

• 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

67
Dispensing Scenario 8

• A patient presents a prescription for Vicodin
  5mg/500mg, 30. Your pharmacy technician notices
  in the computer that this patient just had Lortab
  7.5mg/500mg, 40 filled two days ago and it was
  prescribed by a different physician.
  Additionally, you notice that he has filled other
  controlled substances written by a third
  physician in the recent past. What may be
  appropriate action for you, the pharmacist, to
  take?

68
Dispensing Scenario 8

• Since your pharmacy displays a public notice
  alerting the public to the pharmacists ability
  to access PMP, you may request information on
  this patient from the program to help determine
  the validity of the prescription and whether this
  patient is doctor shopping.

69
Dispensing Scenario 8

• The report from the PMP reveals that this patient
  has had 7 prescriptions for Schedules II, III,
  and IV filled at 4 different pharmacies over the
  last 3 months. Additionally, the 7 prescriptions
  were prescribed by 6 different physicians. You
  decide that this patient may truly be doctor
  shopping. What now?

70
Dispensing Scenario 8

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

71
Dispensing Scenario 8

• 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.

72
Dispensing Scenario 8

• 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.

73
Prescription Monitoring Program

• Currently, approximately 200 pharmacists and 400
  physicians have registered to access the PMP.
• PMP processes approximately 300-400 requests per
  week.
• The database has over 9 million prescription
  records.

74
Miscellaneous Topics

• Newsletter
• Most recent publication posted to the Boards
  website on February 1, 2007.
• Quarterly.
• Sign-up to receive alert emails by providing the
  Board your email address.

75
QUESTIONS??