In most states throughout the
In this NDA submission, the sponsor has proposed objectives and key elements of its CARESM (Convenient Access, Responsible Education) Program to be launched upon approval of Plan B as a non-prescription product. These programs are summarized as follows:
Subsection A - US Pharmacy Access Programs for Emergency Contraception
Subsection B - Barr’s Proposed Educational Program and Distribution for Plan B
Subsection A: US Pharmacy Access Programs for Emergency Contraception
As stated in the Plan B Safety Review section of the FDA
background document (Tab 5), emergency contraception can be provided directly
to a consumer by a qualified pharmacist in 5 States without an advance
prescription from a prescriber. Those
States and the year of initiation of the program in each State are
Represented below are copies of (1) the legislation
providing for such “pharmacy provision” in the State of
WAC 246-863-100 Pharmacist
prescriptive authority -- Prior board notification of written guideline or
protocol required. (1) A pharmacist planning to exercise prescriptive authority in his or
her practice (see RCW 18.64.011(11))
by initiating or modifying drug therapy in accordance with written guidelines
or protocols previously established and approved for his or her practice by a
practitioner authorized to prescribe drugs must have on file at his/her place
of practice a properly prepared written guideline or protocol indicating
approval has been granted by a practitioner authorized to prescribe. A copy of
the written guideline or protocol must also be on file with the board of
(2) For purposes of pharmacist prescriptive authority under RCW 18.64.011(11), a written guideline or protocol is defined as an agreement in which any practitioner authorized to prescribe legend drugs delegates to a pharmacist or group of pharmacists authority to conduct specified prescribing functions. Any modification of the written guideline or protocol shall be treated as a new protocol. It shall include:
(a) A statement identifying the practitioner authorized to prescribe and the pharmacist(s) who are party to the agreement. The practitioner authorized to prescribe must be in active practice, and the authority granted must be within the scope of the practitioners' current practice.
(b) A time period not to exceed 2 years during which the written guideline or protocol will be in effect.
(c) A statement of the type of prescriptive authority decisions which the pharmacist(s) is (are) authorized to make, which includes:
(i) A statement of the types of diseases, drugs, or drug categories involved, and the type of prescriptive authority activity (e.g., modification or initiation of drug therapy) authorized in each case.
(ii) A general statement of the procedures, decision criteria, or plan the pharmacist(s) is (are) to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
(d) A statement of the activities pharmacist(s) is (are) to follow in the course of exercising prescriptive authority, including documentation of decisions made, and a plan for communication or feedback to the authorizing practitioner concerning specific decisions made. Documentation may occur on the prescription record, patient drug profile, patient medical chart, or in a separate log book.
Authority: RCW 18.64.005
and chapter 18.64A
RCW. 91-18-057 (Order 191B), recodified as § 246-863-100, filed
2. Emergency Contraception Collaborative Agreement Protocol prototype
(posted on the
Emergency Contraception -
prototype ECP collaborative agreement protocol was developed using guidelines
ECP Collaborative Agreement Protocol
a licensed health care provider authorized to prescribe medications in the
Purpose: Provide access to emergency medication within required time frame and to ensure the patient receives adequate information to successfully complete therapy.
Procedure: When the patient requests ECPs, the pharmacist will assess the need for treatment and/or referral for contraceptive care. The pharmacist will determine the following:
· The date of the patient’s last menstrual period to rule out established pregnancy.
· That the elapsed time since unprotected intercourse is less than 72 hours.
· Whether the patient has been a victim of sexual assault.
· The age of the patient.
Referrals: If ECP services are not available at the pharmacy, the patient will be referred to another ECP provider. The pharmacist should refer the patient to see a physician or family planning clinic provider if established pregnancy cannot be ruled out or if the elapsed time since unprotected intercourse is greater than 72 hours (or as agreed upon by collaborators).
If there is a concern that the patient may have contracted a sexually transmitted disease through unprotected sex, and/or if the patient indicates that she has been sexually assaulted, the pharmacist will initiate appropriate referral while providing ECPs. When the patient is a minor and sexual assault or abuse is suspected, the pharmacist will report or cause a report to be made to Child Protective Services.
While ECPs can be used repeatedly without serious health risks, patients who request ECPs repeatedly will be referred to a physician or family planning clinic provider for use of a regular contraceptive method.
Prophylactic Provision: The pharmacist may also prescribe and dispense a course of ECPs to a patient in advance of the need for emergency contraception. In addition the pharmacist will counsel the patient on available options for regular contraceptive methods or offer to refer for additional contraceptive services.
ECP Product Selection: The pharmacist will only dispense medication from a list of products approved for emergency contraception and agreed upon as part of this agreement. The pharmacist should seek to provide the most effective ECP product to patients. The list will contain ECPs and adjunctive medications for nausea and vomiting associated with ECPs. The list will be maintained at the pharmacy and shared by all participants in the agreement. Along with the medication, patients will be provided with information concerning dosing, potential adverse effects, and follow-up contraceptive care
Documentation and quality assurance: Each prescription authorized by the pharmacist will be documented in a patient profile as required by law.
On a quarterly basis, the authorizing prescriber and the pharmacist will perform a quality assurance review of the prescribing decisions according to mutually acceptable criteria.
The pharmacist(s) who participate in the protocol must have completed training covering the procedures listed above, the management of the sensitive communications often encountered in emergency contraception, service to minors, and a crisis plan if the pharmacy operations are disrupted by individuals opposing emergency contraception. Further, the pharmacists agree to participate in the Emergency Contraception Hotline and provide data without patient identifiers to the Emergency Contraception Project.
The prescriptive authority is granted for a period of two years from the date of approval unless rescinded in writing earlier by either the authorizing prescriber or the pharmacist.
Authorizing Prescriber: _________________ License # _______________
Authorizing Pharmacist: ________________ License # _______________
SAMPLE List of Emergency Contraceptive Pill Formulations and Doses
Common Brand Names
Tablets per Dose
Timing of Administration
NG 0.50 mg + †EE 50 mcg
First dose within 72 hours of unprotected intercourse. Second dose 12 hours later.
(Anti-emetic taken 1 hour prior to each dose)
LNG 0.15 mg + EE 30 mcg
LNG 0.125 mg + EE 30 mcg
NG 0.30 mg + EE 30 mc
Nordette*(light orange tabs)
Levlen*(light orange tabs)
Levora (white tabs)
Tri-Levlen* (yellow tablets)
Dedicated Combination Product
LNG 0.25mg + EE 50mcg
Dedicated Levonorgestrel-only Product
LNG 0.75 mg
(No anti-emetic required)
• NG = norgestrel †EE = ethinyl estradiol §LNG = levonorgestrel
* Regimen recommended for ECP use by FDA Advisory Panel, 1996 November 1997 Revise: EC Protocol 3-01
TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 26 PHARMACIST PRESCRIPTIVE AUTHORITY
126.96.36.199 SCOPE: All pharmacists that intend to exercise the authority to prescribe dangerous drugs based on written protocols approved by the Board.
[188.8.131.52 NMAC - N, 12-15-02]
* * *
184.108.40.206 DURATION: Permanent.
[220.127.116.11 NMAC - N, 12-15-02]
18.104.22.168 EFFECTIVE DATE:
NMAC - N,
22.214.171.124 OBJECTIVE: The
objective of Part 26 of Chapter 19 is to protect the health and safety of
NMAC - N,
“Antigen” means a substance recognized by the body as being foreign; it
results in the production of specific antibodies directed against it.
B “Antibody” means a protein in the blood that is produced in response to stimulation by a specific antigen.
C “Immunization” means the act of inducing antibody formation, thus leading to immunity.
D “Vaccine” means a specially prepared antigen, which upon administration to a person, will result in immunity.
E “Vaccination” means the administration of any antigen in order to induce immunity; is not synonymous with immunization since vaccination does not imply success.(F “Written Protocol” means a physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the New Mexico Board of Pharmacy.
G. “Emergency Contraception Drug Therapy” means the use of a drug to prevent pregnancy after intercourse.
NMAC - N,
126.96.36.199 EMERGENCY CONTRACEPTION DRUG THERAPY:
Prescriptive authority for emergency contraception drug therapy shall be
exercised solely in accordance with the written protocol for emergency
contraception drug therapy approved by the Board;
(2) Any pharmacist exercising prescriptive authority for emergency contraception drug therapy must maintain a current copy of the written protocol for emergency contraception drug therapy approved by the Board.
B. EDUCATION AND TRAINING:
(1) The pharmacist must successfully complete a course of training in the subject area of emergency contraception drug therapy provided by: a) the Department of Health; or b) Planned Parenthood; or c) the American Council on Pharmaceutical Education (ACPE); or d) a similar health authority or professional body approved by the Board.
(2) Training must include study materials and instruction in the following content areas:
(a) Current standards for prescribing emergency contraception drug therapy;
(b) Identifying indications for the use of emergency contraception drug therapy;
(c) Interviewing patient to establish need for emergency contraception drug therapy;
(d) Counseling patient regarding the safety, efficacy and potential adverse effects of drug products for emergency contraception;
(e) Evaluating patient's medical profile for drug interaction;
(f) Referring patient follow-up care with primary healthcare provider;
(g) Informed consent;
(h) Record management;
(i) Management of adverse events, including identification, appropriate response, documentation and reporting.
Education: Any pharmacist exercising prescriptive
authority for emergency contraception drug therapy shall complete a minimum of
0.2 CEU of live ACPE approved emergency contraception drug therapy related
continuing education every two years. Such continuing education shall be
in addition to requirements in NMAC 188.8.131.52.
C. AUTHORIZED DRUGS:
(1) Prescriptive authority shall be limited to emergency contraception drug therapy and shall exclude any device intended to prevent pregnancy after intercourse.
(2) Prescriptive authority for emergency contraception drug therapy shall be limited to those drugs delineated in the written protocol for emergency contraception drug therapy approved by the Board.
(1) The prescribing pharmacist must generate a written or electronic prescription for any dangerous drug authorized;
(2) Informed consent must be documented in accordance with the approved protocol for emergency contraception drug therapy and a record of such consent maintained in the pharmacy for a period of at least three years.
Upon signed consent of the patient or guardian, the pharmacist shall notify the patient's designated physician or primary care provider of emergency contraception drug therapy prescribed and provided.
History of 16.19.26 NMAC: [RESERVED]
Subsection B: Barr’s Proposed Educational Program and Distribution for Plan B
Upon approval of Plan B as a non-prescription product, the sponsor proposes to launch the CARESM (Convenient Access, Responsible Education) Program that they have developed to ensure the product’s “appropriate and responsible use”. The program was designed to provide information to both consumers and health care professionals while providing “a framework for pharmacies to ensure consumer availability of Plan B”. The CARESM Program contains elements of professional education for health care providers and consumer education, in addition to distribution and monitoring programs. The sponsor has identified critical issues that at present limit a woman’s access to Plan B, and they believe that the CARESM Program’s educational and distribution features will address these:
· Prescription requirement results in delays in access to Plan B
· Pharmacies do not routinely stock Plan B
· Low awareness of Plan B exists among healthcare professionals as well as women of childbearing age
· There is limited access to accurate sources of information regarding Plan B
The CARESM Program has four core elements:
· Labeling - providing essential information to consumers and a toll-free informational phone number
· Education- intended for physicians, pharmacists and nurse practitioners, including educational materials for these practitioners to provide to women of childbearing potential
· Distribution- Plan B will be limited to retail operations with pharmacy services and clinics
· Monitoring- to evaluate the effectiveness of the program
The sponsor has listed a number of CARESM Program objectives in their background package. These objectives all target the promotion of “appropriate and responsible use” of their product and include:
1) That consumers and healthcare professionals understand what emergency contraception is and how to use it safely and effectively
2) That consumers and health care professionals understand how to obtain the product in a timely manner
3) That consumers understand that Plan B is for use only as an emergency contraceptive and is not for use as a routine contraceptive
4) That responsible use and ongoing dialogue between healthcare professionals and consumers regarding responsible behaviors relating to contraception is encouraged
5) That consumers are provided with information so that they can decide whether their use of Plan B would be appropriate
6) That additional resources are provided to assist populations with special needs, such as low literacy populations to make correct decisions regarding use of Plan B
7) That healthcare professionals are provided with information to guide their patients in purchasing and using Plan B
8) That retailers are provided with necessary information (for both pharmacies and consumers) to facilitate provision of information without impeding access.
The sponsor has highlighted some labeling refinements that include a larger outer package with increased font size that will contain a card to allow women to record the time of their first dose and the projected time of the second dose, and an additional patient package insert with information on contraceptive choices and sexually transmitted infections (STIs). The sponsor will also establish a 24-hour toll-free number staffed by healthcare professionals and a website.
Education is the second of the four core elements of the CARESM Program. This educational program will initially focus on healthcare professionals to ensure that they are prepared to support the needs of their patients. Physicians, physician assistants, nurse practitioners and pharmacists will be targeted in this first phase of education, which will include continuing education programs, materials prepared for distribution to patients, and ‘leveraging’ of State Boards of Pharmacy. They expect their sales force of 250 representatives to visit the offices of 30,000 physicians (primarily OB-Gyn’s) to support this element of the Program. Details of expected numbers of pharmacists that would receive education were not provided.
The sponsor will initiate a consumer education program once the professional audience has been introduced to the product (projected to be 6 months after product launch). The campaign will be designed to target women aged 17-44 years of age, and media placement that appeals to teens and adolescents will not be used. Details of this program were not provided, although it will focus on availability and appropriate use.
The sponsor states that Plan B will be available in retail outlets that typically sell a broad range of non-prescription medications and have pharmacy services staffed with pharmacists. The sponsor plans to sell directly to drug wholesalers, clinics, or retail chains and stores with valid pharmacy or drug wholesaler licenses. They will recommend that Plan B be sold only in retail pharmacies or stores with a pharmacy on-site but acknowledge that they cannot legally require that Plan B be limited to pharmacy only sales sites. The sponsor will also recommend that Plan B be placed on shelves near the pharmacy, in sight of the pharmacist or behind the counter.
The sponsor states that the monitoring element of the CARESM Program is complex due to difficulties in identifying women who have purchased the product. The sponsor proposes to use a variety of sources to obtain data to assess the Program’s effectiveness. These include surveys of healthcare professionals and collaboration with established professional groups that could gather information on Plan B use, e.g., college student health clinics, sex education teachers and reproductive health professionals. They also mention seeking inclusion of questions regarding Plan B use in standard survey systems, such as the CDC BRFSS (Behavior Risk Factor Surveillance System), YRBSS (Youth Risk Behavior Surveillance System) and NGO (Nongovernmental Organizations) surveys. From the NGO surveys, the sponsor would hope to obtain enough consumer data to be able to evaluate trends regarding the impact of non-prescription Plan B use on outcomes such as pregnancy rates, Plan B usage, abortion rates and STIs.
Reviewer Comments: The following comments were generated by DRUDP and DOTCDP reviewers.