S3114

An Act concerning tamper-resistant opioid drugs and supplementing P.L.1977, c.240 (C.24:6E-1 et seq.).

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. The Legislature finds and declares that:

a. Prescription drug abuse is the fastest-growing drug problem in this nation, and data from the National Survey on Drug Use and Health show that nearly one-third of people aged 12 and over who used drugs for the first time in 2009 began with nonmedical use of a prescription drug;

b. The incidence of opioid abuse, in particular, has increased greatly in the United States in recent years and continues to rise;

c. Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers;

d. Studies show that addicts tend to crush or otherwise break down time-released products into a form that can be snorted or injected for a more intense high, and so formulations that make it more difficult to crush or otherwise manipulate those products may mitigate the potential for abuse;

e. Drug manufacturers have created novel technologies that may help deter the inappropriate use of opioid medications, and the federal Food and Drug Administration has afforded priority review to new drug applications for opioids incorporating such tamper resistance technologies; and

f. Given the critically important public health and law enforcement goals of preventing the abuse and misuse of opioids, it is manifestly in the public interest for the public policy of this State to encourage drug manufacturers to develop opioid products with tamper resistance technologies and thereby promote the efficient use of scarce health care resources.

2. a. (1) The New Jersey State Board of Pharmacy shall compile and publish a list of opioid analgesic drugs that incorporate tamper resistance technology approved by the federal Food and Drug Administration pursuant to an application that includes at least one human tampering or abuse-potential study, or a laboratory study comparing the tamper- or abuse-resistant properties of the drug to one or more opioid analgesic drugs that have been approved by the federal Food and Drug Administration and that serve as a positive control. The list shall include a determination by the board as to which of the listed opioid analgesic drugs incorporating tamper resistance technologies provide substantially similar tamper-resistant properties, based solely upon one or more studies submitted by the drug manufacturer pursuant to paragraph (2) of this subsection.

(2) It shall be the responsibility of the drug manufacturer to submit to the board such studies as are necessary to meet the requirements for listing by the board pursuant to paragraph (1) of

this subsection; and the board, no later than the 60th day following receipt thereof, shall notify the manufacturer of its determination as to whether the submitted study meets the requirements for listing. If the board determines that the study meets the requirements for listing, the board shall immediately update its list to include the drug.

(3) For the purposes of this section, “opioid analgesic drug” means a drug in the opioid analgesic drug class that is prescribed to treat moderate to severe pain or other conditions, whether in immediate release or extended release form, and whether or not combined with other drug substances to form a single dosage form.

b. Inclusion of a drug on the list pursuant to subsection a. of this section shall not require that a drug bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time it is listed pursuant to subsection a. of this section.

3. Notwithstanding the provisions of any law to the contrary, a pharmacist shall not substitute an opioid analgesic drug that is otherwise eligible for such substitution for an opioid analgesic drug, whether it is a brand name or generic drug product, that incorporates a tamper resistance technology and is included on the list published by the New Jersey State Board of Pharmacy pursuant to section 2 of this act, unless the pharmacist first verifies that the substitute drug has been listed by the board as providing substantially similar tamper resistance technology. If the substitute drug is not included on the published list, the pharmacist shall obtain: written, signed consent from the prescribing practitioner for such substitution; or verbal consent from the prescribing practitioner for such substitution that is documented by the pharmacist in the pharmacy records for that patient by a consent form. The consent form shall include: the name of the person who obtained verbal consent from the prescribing practitioner; the date that the verbal consent was obtained; the name of the prescribing practitioner who provided verbal consent; and any special instructions pertaining to the patient that were provided by the prescribing practitioner to the person who obtained the verbal consent.

4. This act shall take effect on the first day of the fourth month next following the date of enactment.

STATEMENT

The purpose of this bill is to reduce opioid abuse by ensuring that when a practitioner prescribes an opioid analgesic drug that incorporates tamper resistance technology, the pharmacy will not routinely substitute a drug lacking that technology.

The bill provides specifically as follows:

· The New Jersey State Board of Pharmacy (NJSBP) is to compile and publish a list of opioid analgesic drugs that incorporate tamper resistance technology approved by the federal Food and Drug Administration, and a pharmacist is prohibited from substituting an opioid analgesic drug that is otherwise eligible for such substitution for an opioid analgesic drug, whether it is a brand name or generic drug product, that incorporates a tamper resistance technology and is included on the NJSBP list unless the pharmacist first verifies that the substitute drug has been listed by NJSBP as providing substantially similar tamper resistance technology.

· If the substitute drug is not on the list, the pharmacist is to obtain: written, signed consent from the prescribing practitioner for the substitution; or verbal consent from the prescribing practitioner for such substitution that is documented by the pharmacist in the pharmacy records for that patient by a consent form that includes: the name of the person who obtained verbal consent from the prescribing practitioner; the date that the verbal consent was obtained; the name of the prescribing practitioner who provided verbal consent; and any special instructions pertaining to the patient that were provided by the prescribing practitioner to the person who obtained the verbal consent.

· NJSBP is to include on the list a determination as to which of the listed opioid analgesic drugs incorporating tamper resistance technologies provide substantially similar tamper-resistant properties, based solely upon one or more studies submitted by the drug manufacturer pursuant to the bill.

· It is the responsibility of the drug manufacturer to submit to NJSBP such studies as are necessary to meet the requirements for listing by it pursuant to the bill; and NJSBP, no later than the 60th day following receipt thereof, is to notify the manufacturer of its determination as to whether the submitted study meets the requirements for listing. If NJSBP determines that the study meets the requirements for listing, it will immediately update its list to include the drug.

· Drugs included on the list would not be required to bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time they are listed.

· The bill defines “opioid analgesic drug” to mean a drug in the opioid analgesic drug class that is prescribed to treat moderate to severe pain or other conditions, whether in immediate release or extended release form, and whether or not combined with other drug substances to form a single dosage form.

· The bill takes effect on the first day of the fourth month following its enactment.