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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEIn 2004, Assemblyman Anthony Chiappone introduced a bill, A 2714, to permit pharmacists who work under a protocol to provide emergency contraception directly to women. The bill says that pharmacists must work under a protocol, put the pharmacist and the physician name on the prescription, and must send the file to the physician for review right away. The bill has been referred to the Assembly Health and Human Services Committee, but has not been heard and the session has adjourned. In January 2006, Assemblywoman Linda Stender (D) introduced a similar bill AB 2137. In June 2003, both houses of the New Jersey legislature passed a passed a new Pharmacy Practice Act, but authority was not granted to pharmacists to initiate EC. Planned Parenthood Affiliates of New Jersey sees EC as a priority but formal outreach to pharmacists or surveys has not been conducted at this time. Planned Parenthood’s top EC priority is assuring that victims of sexual assault can obtain EC in hospital emergency rooms. Planned Parenthood has partnered with the New Jersey Coalition Against Sexual Assault to conduct a survey about EC information provided to patients in emergency rooms. EC access is also a priority of the Choice New Jersey coalition.
CONTACTSJoseph V. Roney, R.Ph., FASCP Michele Jaker
USEFUL LINKSNew Jersey Board of Pharmacy New Jersey Pharmacists Association New Jersey Legislature Planned Parenthood Affiliates of New Jersey Planned Parenthood of Central New Jersey Planned Parenthood of Metro New Jersey Planned Parenthood of Southern New Jersey Planned Parenthood of Greater Northern New Jersey Planned Parenthood Association of the Mercer Area
PROTOCOL ENVIRONMENTPossible Environment: Revision to Existing Authority Required This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community. Pharmacist initiation of EC would require:
PHARMACY PRACTICE ACTPharmacy Practice Act Regulatory and Statutory Authority Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003. NEW JERSEY On June 30, 2003, both houses of the New Jersey legislature passed and sent to the Governor for his signature the “New Jersey Pharmacy Practice Act.” The bill repeals the current law, reenacts most of its provisions with some changes, and includes several new provisions. Most notable among the new provisions, the bill authorizes pharmacists to monitor, modify, continue, and discontinue a patient's drug, biological and device-related therapy pursuant to a patient-specific and disease-specific written protocol by a collaborating physician. The protocol must define the pharmacist’s functions, provide for physician notification of the pharmacist’s activities, and be consented to by the patient. Such an agreement may not last for more than two years. A provision in the bill (as originally introduced) to also allow pharmacists to “prescribe and initiate drug therapy” was dropped during deliberations, though pharmacists retained the ability to make a therapeutic interchange for the originally prescribed drug. The pharmacist may also dispense a prescription in a different dosage form than originally prescribed if the ingredients are of the same chemical composition as those specified by the prescriber, and he or she notifies the prescriber of this change within 48 hours. These collaborative drug therapy management provisions will not apply to hospital pharmacists, provided that prescribing within those institutions takes place under the guidance of a Pharmacy and Therapeutics Committee in accordance with regulations issued by the Board of Pharmacy. Pharmacists may also administer, by ingestion, inhalation or injection, any prescription drug appropriately prescribed or indicated under collaborative drug therapy management to a specific patient if:
This would presumably include emergency contraceptives. The legislation tasks the Board of Pharmacy with issuing regulations establishing the specific requirements, as delineated in the bill, to be included in any written protocol between a physician and pharmacist. Statutory authority: A. 570 (passed by the legislature June 26, 2003) Regulatory authority: To be promulgated after the above legislation is signed by the Governor.
NEW JERSEY STATUTE Editor’s Note: Because the full bill is over 10 pages long, only those portions of the newly proposed Pharmacy Practice Act pertaining to collaborative drug therapy management, drug administration and the general practice of pharmacy are included here to conserve space. Additions to current law are underlined. Deletions are in [brackets.] ASSEMBLY Bill No. 570 An Act regulating and licensing pharmacists and repealing various parts of the statutory law. Be It Enacted by the Senate and General Assembly of the State of New Jersey: 1. a. This act shall be known and may be cited as the “New Jersey Pharmacy Practice Act.” b. The practice of pharmacy in this State is declared a health care professional practice affecting the public health, safety and welfare and is subject to regulation and control in the public interest. It is further declared to be a matter of public interest and concern that the practice of pharmacy merits and receives the confidence of the public and that only qualified persons be permitted to engage in the practice of pharmacy in this State. This act shall be liberally construed to carry out these objectives and purposes. c. It is the purpose of this act to promote, preserve and protect the public health, safety and welfare by and through the effective control and regulation of the practice of pharmacy, the licensure of pharmacists and the permitting, control and regulation of all pharmacy practice sites 4[,]4 in 4[or out of]4 this State 4[,]4 that engage in the practice of pharmacy. 2. As used in this act: “Administer” means the direct application of a drug to the body of a patient or research subject by subcutaneous, intramuscular or intradermal injection, inhalation 4[,] or4 ingestion 4[or any other means]4 by a pharmacist engaged in collaborative practice or in accordance with regulations 4[of] jointly promulgated by4 the board 4and the State Board of Medical Examiners4. * * * “Collaborative drug therapy management” means a written protocol 1directed on a voluntary basis by a patient's physician 4, with the patient's consent,4 that is1 between a patient's physician who is treating the patient for a specific disease and a pharmacist for cooperative management of a patient's drug, biological and device-related health care needs, which 2[may include, but not be limited to] 4[includes2:] shall be conducted in accordance with regulations jointly promulgated by the board and the State Board of Medical Examiners and shall only include the4 collecting, analyzing and monitoring of patient data; ordering 4or performing4 of laboratory tests 2based on the standing orders of a physician as set forth in the written protocol2; ordering 4[or performing]4 of clinical tests 2based on the standing orders of a physician as set forth in the written protocol, 4[which] provided those laboratory4 tests are2 1granted waived status in accordance with the provisions of the “New Jersey Clinical Laboratory Improvement Act,” P.L.1975, c.166 (C.45:9-42.26 et seq.)1 2and are for the treatment of a disease state identified 4jointly4 by the board 4and the State Board of Medical Examiners4 as subject to collaborative drug therapy management2 ; 1[prescribing,]1 2[initiating,]2 modifying, continuing or discontinuing drug or device therapy; and therapeutic drug monitoring with appropriate modification to dose, dosage regimen, dosage forms or route of administration. 1The interpretation of clinical or laboratory tests under a written protocol may 3only3 be performed by a pharmacist 3[if so agreed to by the physician in the protocol] in direct consultation with a physician3 .1 * * * “Deliver” or “delivery” means the actual 2,2 constructive or attempted transfer of a drug or device from one person to another, whether or not for consideration. “Device” means an instrument, apparatus, implement, machine, contrivance, implant or other similar or related article, including any component part or accessory, which is required under federal law to bear the label “RX Only.” “Dispense” or “dispensing” means the procedure entailing the interpretation of a practitioner's prescription order for a drug, biological or device, and pursuant to that order the proper selection, measuring, compounding, labeling and packaging in a proper container for subsequent administration to, or use by, a patient. “Dosage form” means the physical formulation or medium in which the product is intended, manufactured and made available for use, including, but not limited to: tablets, capsules, oral solutions 4[and suspensions] , aerosols, inhalers, gels, lotions, creams, ointments, transdermals and suppositories, and the particular form of the above which utilizes a specific technology or mechanism to control, enhance or direct the release, targeting, systemic absorption or other delivery of a dosage regimen in the body4 .1 * * * “Electronic means” means any electronic or digital transmission format, including facsimile or computer generated messaging.4 “Immediate supervision” means a level of control which assures that the pharmacist is physically present at the pharmacy practice site and has the responsibility for 4[the]4 accuracy and safety with respect to the actions of pharmacy technicians, interns and externs. * * * [“Licensed or permitted non-resident pharmacy” means a pharmacy located outside this State that solicits, advertises, ships, mails or delivers drugs pursuant to a valid prescription into this State.]1 * * * “Medication order” means a prescription for a specific patient in an institutional setting. “Modifying” means to change a specific drug, the dosage, or route of delivery of a drug currently being administered for an existing diagnosis pursuant to a collaborative drug therapy management.2 * * * “Pharmaceutical care” means the provision by a pharmacist of drug therapy review and other related patient care services intended to achieve positive outcomes related to the treatment, cure or prevention of a disease; control, elimination or reduction of a patient's symptoms; or arresting or slowing of a disease process as defined by the rules and regulations of the board. * * * “Pharmacist in collaborative practice” means a pharmacist engaged in the collaborative drug therapy management of a patient's drug, biological and device-related health care needs pursuant to a written protocol, in collaboration with a licensed physician and in accordance with the 4[board's]4 regulations 4jointly promulgated by the board and the State Board of Medical Examiners4. “Pharmacy practice site” means any place in 2[or outside of]2 this State 4[2or another state2]4 where drugs are dispensed or pharmaceutical care is provided by a licensed pharmacist 4, but shall not include a medical office under the control of a licensed physician4. “Pharmacy technician” means an individual working in a pharmacy practice site who, under the immediate supervision of a pharmacist, assists in pharmacy activities 1as1 permitted by 1section 41 of this act and1 the rules and regulations of the board that do not require the professional judgment of a pharmacist. “Practice of pharmacy” means a health care service by a pharmacist that includes 1[, but is not limited to]1: compounding, dispensing and labeling of drugs, biologicals, radio pharmaceuticals or devices; overseeing automated medication systems; interpreting and evaluating prescriptions; administering and distributing drugs, biologicals and devices; maintaining prescription drug records; advising and consulting on the therapeutic values, content, hazards and uses of drugs, biologicals and devices; managing and monitoring drug therapy; collecting, analyzing and monitoring patient data; performing drug utilization reviews; storing prescription drugs and devices; supervising technicians, interns and externs; and such other acts, services, operations or transactions necessary, or incidental to, providing pharmaceutical care and education. In accordance with written guidelines or protocols established with a licensed physician, the “practice of pharmacy” also includes 1[:] collaborative drug therapy management including1 2[initiating,]2 1[prescribing,]1 modifying, continuing or discontinuing drug or device therapy; 1[collaborative drug therapy management;]1 ordering 4or performing4 of laboratory tests 4under collaborative drug therapy management4; and ordering 4[and performance of]4 clinical tests 4, excluding laboratory tests, unless those tests are part of collaborative drug therapy management4. * * * “Therapeutic interchange” means the substitution and dispensing of a 4drug4 chemically dissimilar 2[but clinically equivalent]2 4[drug than] from4 the prescription drug originally prescribed.1 * * * 8. The board shall make, adopt, amend and repeal those rules and regulations necessary for the proper administration and enforcement of this act. Those rules and regulations shall be promulgated in accordance with the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.). 4Rules pertaining to collaborative drug therapy management and administration of drugs by pharmacists shall be jointly promulgated by the board and the State Board of Medical Examiners.4 * * * 21. A pharmacist may dispense a prescription in a different dosage form than originally prescribed if the pharmacist notifies the prescriber no later than 48 hours following the dispensing of the prescription 2, provided the dosage form dispensed has the 4[same approximate] appropriate4 drug release rate2. 1 22. In establishing requirements for pharmacists to engage in collaborative practice as provided in paragraph (4) of subsection a. of section 9 of this act, the board shall include in these requirements, but not be limited to, provisions that any written protocol between a physician and pharmacist: a. is agreed to by both the physician and the pharmacist 4with the consent of the patient4; b. identifies, by name and title, each physician and each pharmacist who is permitted to participate in a patient's collaborative drug therapy management; c. specifies the functions and responsibilities the pharmacist will be performing; d. is available at the practice sites of the pharmacist and physician and made available at each site to the patient; e. is initiated and utilized at the sole discretion of the physician for a specific patient; f. may be terminated at any time by either party by written documentation; g. establishes when physician notification is required, the physician chart update interval, and an appropriate time frame within which the pharmacist must notify the physician of any change in dose, duration or frequency of medication prescribed; 4[and]4 h. remains in effect for a period not to exceed two years upon the conclusion of which, or sooner, the parties shall review the protocol and make a determination as to its renewal, modification or termination 4; and i. establish the means by which the patient will be advised of the right to elect to participate in and withdraw from the collaborative drug therapy management4.1 23. a. Each collaborative drug therapy management shall be between a single patient's specific physician and the patient's pharmacist or 4[pharmacists] pharmacy4 and address that patient's specific condition, disease or diseases. b. 2[A] No2 collaborative drug therapy management 2[may] shall2 include, 2[with] without2 the prior consent of 4the patient and4 the patient's physician who has signed the protocol, therapeutic interchange 2[for the prescription drug originally prescribed for the patient's specific condition, disease or diseases] at the time of dispensing2 , provided that written confirmation of this prior consent, which may be by electronic means, shall be obtained pursuant to record keeping guidelines to be established by 4regulation jointly promulgated by4 the board 4and the State Board of Medical Examiners4.1 24. a. No pharmacist shall administer a prescription medication directly to a patient without appropriate education or certification, as determined by the board 4in accordance with the requirements set forth in the rules jointly promulgated by the board and the State Board of Medical Examiners4. Such medication shall only be for the treatment of a disease for which a nationally certified program is in effect, or as determined by the board, and only if utilized for the treatment of that disease for which the medication is prescribed or indicated or for which the collaborative drug therapy management permits. b. Notwithstanding any law, rule or regulation to the contrary, other than for pediatric immunizations, a pharmacist may administer drugs in immunization programs and programs sponsored by governmental agencies that are not patient specific 2provided the pharmacist is appropriately educated and qualified, as determined by the board2 4in accordance with the requirements set forth in the rules jointly promulgated by the board and the State Board of Medical Examiners4 .1 25. The provisions of this act regulating collaborative drug therapy management shall not apply to any pharmacist practicing in a hospital, provided that prescribing within these institutions takes place under the guidance of a pharmacy and therapeutics committee in accordance with procedures as determined by regulations 4[of] jointly promulgated by4 the board 4and the State Board of Medical Examiners4.1 26. In addition to the provisions of section 8 of P.L.1978, c.73 (C.45:1-21), the board may refuse an application for examination or may suspend or revoke the certificate of a licensed pharmacist upon proof satisfactory to the board that such licensed pharmacist is guilty of grossly unprofessional conduct and the following acts are hereby declared to constitute grossly unprofessional conduct for the purpose of this act: * * * g. Engaging in activities beyond the scope of a collaborative drug therapy management agreement.4 Before a certificate shall be refused, suspended or revoked, the accused person shall be furnished with a copy of the complaint and given a hearing before the board. Any person whose certificate is so suspended or revoked shall be deemed an unlicensed person during the period of such suspension or revocation, and as those shall be subject to the penalties prescribed in this act, but that person may, at the discretion of the board, have his certificate reinstated at any time without an examination, upon application to the board. Any person to whom a certificate shall be denied by the board or whose certificate shall be suspended or revoked by the board shall have the right to review that action by appeal to the Appellate Division of the Superior Court in lieu of prerogative writ.1 * * * [35.] 42.1 R.S.45:14-1 et seq.; section 6 of P.L.1970, c.331 (C.45:14-3.1); section 4 of P.L.1991, c.304 (C.45:14-3.2) P.L.1946, c.177 (C.45:14-7.2); P.L.1948, c.50 (C45:14-7.3); P.L.1969, c.164 (C.45:14-8.1); P.L.1944, c.132 (C.45:14-11.1); P.L.1995, c.79 (C.45:14-11.11 through 45:14-11.16), section 3 of P.L.1965, c.120 (C.45:14-12.1); P.L.1996, c.154 (C.45:14-14.1 through 45:14-14.6); P.L.1993, c.120 (C.45:14-15.1 through 45:14-15.4); section 2 of P.L.1953, c.329 (C.45:14-16.1); sections 1 and 2 of P.L.1949, c.93 (C.45:14-26.1 and 45:14-26.2); and P.L.1948, c.105 (C.45:14-36.1 through 45:14-36.4) are repealed. [36.] 43.1 This act shall take effect 1[on the 180th day following enactment, except that section 4 shall take effect]1 4on the 180th day following enactment, except that section 4 shall take effect4 immediately.
NEW JERSEY REGULATIONS Not yet promulgated
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