Section R9-6-409. Drug Prescription and Distribution Require- ments

A.      A primary care provider shall:

1.        Issue a prescription order:

a.        For each drug from the ADAP formulary prescribed for an applicant or enrolled individual by the pri- mary care provider;

b.        For dispensing up to a 30-day supply of the drug; and

c.        To authorize no more than a six-month supply of the drug, including the original prescription order and all refills;

2.        Submit:

a.        A written prescription order or copy of a written pre- scription order to the Department as specified in R9- 6-404(A)(3); and

b.        A written or oral prescription order to the vendor pharmacy when:

i.         Prescribing a drug for a newly enrolled individ- ual,

ii.        Prescribing a new drug for an enrolled individ- ual, or

iii.      Authorizing an additional six-month supply of a drug for an enrolled individual; and

3.        Notify the vendor pharmacy when discontinuing a drug for an enrolled individual.

B.       The Department shall forward a written prescription order sub- mitted to the Department as specified in subsection (A)(2)(a) to the vendor pharmacy within three business days of approv- ing an individual for initial enrollment.

C.      The vendor pharmacy shall:

1.        Maintain a supply of the drugs on the ADAP formulary available for dispensing;

2.        Receive prescription orders issued by an enrolled individ- ual’s primary care provider;

3.        Before dispensing drugs, verify:

a.        With an enrolled individual or the enrolled individ- ual’s representative the address to which the enrolled individual or the enrolled individual’s representative wants the drugs delivered, and

b.        An individual’s enrollment status;

4.        Dispense up to a 30-day supply of a drug to an enrolled individual:

a.        Upon receipt of a:

i.         Prescription order as specified in subsection (C)(2), or

ii.        Request from the enrolled individual or the enrolled individual’s representative for a refill of the drug;

b.        To the address identified, as specified in subsection (C)(3)(a); and

c.        So the drug is dispensed to the enrolled individual no later than three business days after the vendor pharmacy:

i.         Receives a prescription order or request for refill, as specified in subsection (C)(4)(a);

ii.        Has verified the address to which the drug is to be delivered, as specified in subsection (C)(3)(a); and

iii.      Has verified the individual’s enrollment status, as specified in subsection (C)(3)(b); and

5.        Notify the Department upon receiving a request for dis- pensing a drug for an individual who is neither enrolled nor provisionally enrolled in ADAP.

D.      The Department may authorize replacement of a drug when:

1.        The drug has been dispensed by the vendor pharmacy to an enrolled individual, and

2.        The enrolled individual or the enrolled individual’s repre- sentative claims the dispensed drug was lost, stolen, or damaged.

E.       The primary care provider of an enrolled individual may request approval of a restricted drug for the enrolled individual by:

1.        Completing a Department-provided form for each requested restricted drug that contains the following information:

a.        The name, business address, and telephone number of the primary care provider;

b.        The date of the request;

c.        The enrolled individual’s name and date of birth;

d.        The indications for the use of the restricted drug;

e.        The most recent results of laboratory analyses to support the request and the dates of the laboratory analyses;

f.         A justification for use of the restricted drug by the enrolled individual;

g.        An attestation by the primary care provider that:

i.         To the best of the primary care provider’s knowledge and belief, the information pre- sented in the request is accurate and complete; and

ii.        The primary care provider understands that the primary care provider is required to provide instructions to the enrolled individual regarding the use of the restricted drug and monitor the enrolled individual’s use of the restricted drug;

h.        The dated signature of the primary care provider;

i.         An attestation by the enrolled individual or the enrolled individual’s representative that the enrolled individual or the enrolled individual’s representative understands that the enrolled individual is required to:

i.         Follow the instructions of the enrolled individ- ual’s primary care provider regarding the use of the restricted drug; and

ii.        Have periodic laboratory analyses performed to support continuing use of the restricted drug; and

j.         The dated signature of the enrolled individual or the enrolled individual’s representative;

2.        Issuing  a  written   or  oral  prescription  order   for  the restricted drug to the vendor pharmacy; and

3.        Submitting to the Department:

a.        The completed drug-specific form specified in sub- section (E)(1), and

b.        Copies of the results of the most recent laboratory analyses to support the request for the restricted drug.

F.       If the restricted drug requested under subsection (E) is approved by the Department for an enrolled individual, the enrolled individual’s primary care provider shall:

1.        Provide instructions to the enrolled individual regarding the use of the restricted drug; and

2.        Monitor  the  enrolled  individual’s   use  of  and  clinical response to the restricted drug.

G.      When the Department receives a drug-specific form requesting a restricted drug for an enrolled individual, the Department shall:

1.        Review the documents submitted according to subsection (E)(3);

2.        Determine  whether  the  information   submitted  to  the Department:

a.        Is complete; and

b.        Substantiates that the enrolled individual’s use of the restricted drug is indicated; and

3.        Notify the following of the Department’s decision within five business days after receiving the request:

a.        The enrolled individual or the enrolled individual’s representative;

b.        The enrolled individual’s primary care provider; and

c.        The vendor pharmacy.

H.      If the Department denies a request for approval of a restricted drug for an enrolled individual, the Department shall send to the enrolled individual or the enrolled individual’s representa- tive a written notice of denial setting forth the information required under A.R.S. § 41-1092.03.

I.        The Department shall only authorize the distribution of drugs that are included on the ADAP formulary.

Historical Note

Adopted effective October 19, 1993 (Supp. 93-4).

Amended effective April 4, 1997 (Supp. 97-2). Former Section R9-6-409 renumbered to R9-6-902; new Section R9-6-409 renumbered from R9-6-408 and amended by final rulemaking at 8 A.A.R. 1953, effective April 3, 2002 (Supp. 02-2). Former R9-6-409 renumbered to R9- 6-410; new R9-6-409 renumbered from R9-6-407 and amended by final rulemaking at 13 A.A.R. 3329, effec- tive November 10, 2007 (Supp. 07-3).