Pharmacy Law

1
Pharmacy Law

• Hints for answering
• law-related questions
• in a community pharmacy.

2
Why do I have to show an ID to buy certain kinds
of allergy medicine?

• If the allergy medicine contains Pseudoephedrine
  (Sudafed) there are limits on the amount that
  can be purchased
• An official ID must be presented to verify that a
  client is 18 years old or older
• The limit can be over-ridden with a prescription
  from a doctor
• If the medicine contains dextromethorphan,
• the pharmacy may require patients
• to be over 18.

3
Combat Methamphetamine Epidemic Act of 2005

• Title VII of the USA PATRIOT Improvement and
  Reauthorization Act of 2005, P.L. 109-177
• Restricts daily limit to 3.6 grams of
  pseudoephedrine per person
• Restricts daily limit to 2 packages per
  transaction

4
2005 WI Act 14- Regulation of Pseudoephedrine
Products

• Identifies pseudoephedrine products that fall
  under this law (tablets) and which do not
  (liquids and gel caps)
• May only be sold by a pharmacist or by someone
  under the direct supervision of the pharmacist
• Limits purchased amount to 7.5 grams in a 30-day
  period without physician, dentist, or
  veterinarian authorization

5
I dont have any questions, why do I have to wait
for a pharmacist?
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• WI law requires a pharmacist or intern to give
  consultation to every patient, every time, new
  prescription or refill
• This law can not be satisfied by a technician
  just asking whether the patient wants to speak
  with a pharmacist
• Most importantly, the pharmacist wants to check
  how the medication is working and whether the
  patient is experiencing any side effects

6
Phar 7.01 (1)(e)

• Wisconsin Blue Book
• Phar 7.01 Minimum procedures for compounding and
  dispensing.
• (e) Give the patient or agent appropriate
  consultation relative to the prescription except
  that prescriptions may be delivered by an agent
  of the pharmacist to a patients residence if the
  delivery is accompanied by appropriate directions
  and an indication that consultation is available
  by contacting the pharmacist. The consultation
  requirement applies to original and renewal
  prescription orders and, except when
  prescriptions are delivered to a patients
  residence, is not satisfied by only offering to
  provide consultation.

7
My dentist gave me a script for some pain meds
that I didnt need. Now I hurt my back and the
pharmacy wont let me fill the script. Why not?

• Many pain medications are controlled due to
  risks for dependence or misuse and the government
  has regulations for how they can be dispensed
• If the pain med is a Schedule II it can only be
  dispensed up to 60 days from the date on the
  prescription
• If the pain med is a Schedule III-V it can only
  be dispensed up to 6 months from the date on the
  prescription

8
Why does the pharmacy always have to contact my
sons doctor for his ADHD medicine?

• Most ADHD medications are classified Schedule
  II
• Federal Law does not allow Schedule II
  medications to have any refills
• Schedule II prescriptions can not be phoned in or
  faxed they must be brought into the pharmacy or
  mailed

9
I transferred my Valium to another pharmacy. Why
cant I transfer it back now?

• Valium is another controlled medication
• Federal law regulates that Schedule III-V
  medications may only be transferred once

10
Wisconsin Blue Book

• Phar 7.055 Transfer of prescription order
  information.
• (3) CONTROLLED SUBSTANCES. The transfer of
  prescription order information for controlled
  substances for the purposes of refill dispensing
  is permissible pursuant to the following
  requirements
• (a) The transfer of prescription order
  information is permissible only on a one time
  basis unless a computer system meeting the
  requirements of sub. (4) is used.

11
Wisconsin Blue Book

• Chapter Phar 8 Requirements for Controlled
  Substances
• Phar 8.05 Dispensing.
• (1) Prescription orders shall be written with
  ink or indelible pencil or be typewritten and
  shall be signed by the practitioner
• (2) If the person accepting the medication
  pursuant to any prescription order for a schedule
  II controlled substance, specified in s. 961.16,
  Stats., is not personally known to the
  pharmacist, there shall be written in ink, on the
  reverse side, the printed name, signature and
  address of the person.
• (4) A prescription containing a controlled
  substance listed in schedule II may be dispensed
  only pursuant to a written order signed by the
  prescribing individual practitioner, except in
  emergency situations. A prescription for a
  controlled substance listed in schedule II may
  not be dispensed more than 60 days after the date
  of issue on the prescription order.

12
Wisconsin Blue Book

• Phar 8.06 Renewing prescriptions.
• (1) No prescription containing a schedule II
  substance may be renewed.
• (3) No prescription containing a controlled
  substance listed in schedule III or IV may be
  dispensed or renewed more than 6 months after the
  date on which the prescription order was issued
  and no prescription authorized to be renewed may
  be renewed more than 5 times.

13
Wisconsin Blue Book

• Phar 8.07 Partial dispensing.
• (1) A pharmacist may partially dispense a
  prescription containing a controlled substance
  listed in schedule III, IV and V.
• (2) The partial dispensing of a prescription
  containing a controlled substance listed in
  schedule II is permissible, if the pharmacist is
  unable to supply the full quantity called for in
  a written or emergency electronic or oral
  prescription order, and the pharmacist makes a
  notation of the quantity supplied on the face of
  the written prescription order or written record
  of the emergency electronic or oral prescription
  order. The remaining portion of the prescription
  may be dispensed within 72 hours of the first
  partial dispensing. If the remaining portion is
  not dispensed within the 72 hour period, the
  pharmacist shall so notify the prescribing
  individual practitioner. No further quantity may
  be supplied beyond the 72 hours without a new
  prescription order.

14
Wisconsin Blue Book

• Phar 8.12 Prescription orders transmitted by
  facsimile machine.
• (1) PRESCRIPTION DRUGS OTHER THAN SCHEDULE II
  CONTROLLED SUBSTANCES A pharmacist may dispense
  a prescription drug, other than a schedule II
  controlled substance, pursuant to a prescription
  order transmitted by a facsimile machine from the
  practitioner or the practitioners agent to the
  dispensing pharmacy

15
Wisconsin Blue Book

• Phar 8.12 Prescription orders transmitted by
  facsimile machine.
• (2) SCHEDULE II CONTROLLED SUBSTANCES. A
  pharmacist may not dispense a schedule II
  controlled substance pursuant to a prescription
  order transmitted by a facsimile machine unless
  all of the conditions stated in sub. (1) are
  satisfied, and any of the following conditions
  are met
• (a) The prescription order is written for a
  schedule II controlled substance to be compounded
  for the direct administration to a patient by
  parenteral, intravenous, intramuscular,
  subcutaneous or intraspinal infusion, and is
  transmitted by the practitioner or the
  practitioners agent to the dispensing pharmacy
  by facsimile.
• (b) The prescription order is written for a
  schedule II controlled substance for a patient in
  a long term care facility, and is transmitted by
  the practitioner or the practitioners agent to
  the dispensing pharmacy by facsimile.
• (c) The prescription order is written for a
  schedule II controlled substance for a patient
  enrolled in a hospice certified by medicare under
  Title XVIII or licensed by this state, and is
  transmitted by the practitioner or the
  practitioners agent to the dispensing pharmacy
  by facsimile.

16
Why cant I bill Plan B to my insurance this time?

• Now that Plan B can be obtained over-the-counter
  for patients over 18, it is treated like other
  OTC products.
• We can only bill your insurance if you have a
  prescription from your physician.

17
Plan B OTC approval

• FDA Press Release August 24, 2006
• FDA Approves Over-the-Counter Access for Plan B
  for Women 18 and Older
• Plan B will remain available as a
  prescription-only product for women age 17 and
  under
• Plan B will be stocked by pharmacies behind the
  counter because it cannot be dispensed without a
  prescription or proof of age

18
Ive had this prescription for a year and still
have refills. What do you mean you have to
contact my doctor?

• Federal regulations mandate that non-scheduled
  prescriptions may only be filled for one year
  from the date they are written, regardless of the
  number of refills remaining
• Pharmacies can phone or fax doctors for refills
  of non-Scheduled and Schedule III-V medications

19
Wisconsin Blue Book

• Chapter Phar 7 Pharmacy Practice
• Phar 7.03 Prescription renewal limitations.
• A prescription order for any drug other than
  controlled substances, which bears renewal
  authorization permitting the pharmacist to renew
  the prescription as needed (PRN) by the patient,
  shall not be renewed beyond one year from the
  date originally prescribed. No prescription
  order containing either specific or PRN renewal
  authorization is valid after the
  patient-physician relationship has ceased.

20
References

• Combat Methamphetamine Epidemic Act
• http//www.deadiversion.usdoj.gov/meth/index.html
• Wisconsin Act 14
• http//drl.wi.gov/boards/phm/pap/ACT2014206-14-0
  5.pdf
• Wisconsin Blue Book
• http//www.legis.state.wi.us/rsb/code/phar/phar007
  .pdf
• http//www.legis.state.wi.us/rsb/code/phar/phar008
  .pdf
• Abood. Pharmacy Practice and the Law.
• 4th Edition. Chapter 4.
• FDA Plan B Press Release
• http//www.fda.gov/bbs/topics/NEWS/2006/NEW01436.h
  tml