AN ACT

 

<-1Amending the act of April 14, 1972 (P.L.233, No.64), entitled
2"An act relating to the manufacture, sale and possession of
3controlled substances, other drugs, devices and cosmetics;
4conferring powers on the courts and the secretary and
5Department of Health, and a newly created Pennsylvania Drug,
6Device and Cosmetic Board; establishing schedules of
7controlled substances; providing penalties; requiring
8registration of persons engaged in the drug trade and for the
9revocation or suspension of certain licenses and
10registrations; and repealing an act," further providing for
11schedules of controlled substances.

<-12Restricting access to the prescription painkiller Zohydro.

13The General Assembly of the Commonwealth of Pennsylvania
14hereby enacts as follows:

<-15Section 1. Section 4(1)(ii) of the act of April 14, 1972
16(P.L.233, No.64), known as The Controlled Substance, Drug,
17Device and Cosmetic Act, amended June 23, 2011 (P.L.36, No.7),
18is amended to read:

19Section 4. Schedules of Controlled Substances.--The
20following schedules include the controlled substances listed or
21to be listed by whatever official name, common or usual name,

1chemical name, or trade name designated.

2(1) Schedule I--In determining that a substance comes within
3this schedule, the secretary shall find: a high potential for
4abuse, no currently accepted medical use in the United States,
5and a lack of accepted safety for use under medical supervision.
6The following controlled substances are included in this
7schedule:

8* * *

9(ii) Any of the following opium derivatives, their salts,
10isomers and salts of isomers, unless specifically excepted,
11whenever the existence of such salts, isomers and salts of
12isomers is possible within the specific chemical designation:

131. Acetorphine.

142. Acetyldihydrocodeine.

153. Benzylmorphine.

164. Codeine methylbromide.

175. Codeine-N-Oxide.

186. Cyprenorphine.

197. Desomorphine.

208. Dihydromorphine.

219. Etorphine.

2210. Heroin.

2311. Hydromorphinol.

2412. Methyldesorphine.

2513. Methylhydromorphine.

2614. Morphine methylbromide.

2715. Morphine methylsulfonate.

2816. Morphine-N-Oxide.

2917. Myrophine.

3018. Nicocodeine.

119. Nicomorphine.

220. Normorphine.

321. Pholcodine.

422. Thebacon.

523. Zohydro.

6* * *

7Section 2. This act shall take effect in 60 days.

<-8Section 1. Definitions.

9The following words and phrases when used in this act shall
10have the meanings given to them in this section unless the
11context clearly indicates otherwise:

12"Prescriber." A physician, dentist, pharmacist, podiatrist,
13physician assistant, certified nurse practitioner, optometrist
14or other person licensed, registered or otherwise permitted to
15prescribe a controlled substance, other drug or device in the
16course of professional practice in this Commonwealth.

17Section 2. Requirements.

18As a condition of maintaining a professional license to
19practice medicine and to maintain prescribing authority, a
20prescriber must comply with the following requirements when
21prescribing Zohydro:

22(1) Conduct and document a thorough medical evaluation.

23(2) Conduct and document a risk assessment.

24(3) Document in the medical record that the prescription
25of hydrocodone without an abuse-deterrent formulation is
26required for the management of pain and that nothing else
27will effectively manage the severe pain.

28(4) Receive a signed informed consent form, including
29information from the drug insert.

30(5) Receive a chronic controlled substance treatment

1agreement that shall include conditions such as urine
2screening, pill counts, safe storage and disposal and other
3appropriate conditions as determined by the prescriber.

4(6) Query the Pennsylvania Prescription Accountability
5Monitoring System.

6(7) Determine a maximum daily dose, or a not-to-exceed
7value for the prescription to be transmitted to the pharmacy.

8(8) Schedule and undertake periodic follow-up visits and
9evaluations and referrals.

10Section 3. Effective date.

11This act shall take effect in 60 days.