Overview of
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
1. 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
pharmacy.
(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.
[Statutory
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 -
Protocol
|
This
prototype ECP collaborative agreement protocol was developed using guidelines
from the |
ECP
Collaborative Agreement Protocol
As
a licensed health care provider authorized to prescribe medications in the
State of
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.
Date____________________
Signed:
Authorizing
Prescriber: _________________ License # _______________
Authorizing
Pharmacist: ________________ License # _______________
SAMPLE
List of Emergency Contraceptive Pill Formulations and Doses
|
Formulation |
Common Brand Names |
Tablets per Dose |
Doses Required |
Timing of Administration |
|
NG 0.50 mg + †EE 50 mcg |
Ovral*(white tabs) |
2 |
2 |
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) Triphasil*(yellow
tablets) Lo/Ovral*(white tabs) |
4 4 4 |
2 2 2 |
Same |
|
Dedicated
Combination Product |
||||
|
LNG
0.25mg + EE 50mcg |
Preven® |
2 |
2 |
Same |
|
Dedicated
Levonorgestrel-only Product |
||||
|
LNG
0.75 mg |
Plan B® |
1 |
2 |
Same (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
3. State
of
TITLE
16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER
19 PHARMACISTS
PART 26 PHARMACIST
PRESCRIPTIVE AUTHORITY
16.19.26.2 SCOPE: All
pharmacists that intend to exercise the authority to prescribe dangerous drugs
based on written protocols approved by the Board.
[16.19.26.2 NMAC - N, 12-15-02]
* * *
16.19.26.4
DURATION: Permanent.
[16.19.26.4 NMAC - N, 12-15-02]
16.19.26.5 EFFECTIVE DATE:
[16.19.26.5
NMAC - N,
16.19.26.6 OBJECTIVE: The
objective of Part 26 of Chapter 19 is to protect the health and safety of
[16.19.26.6
NMAC - N,
16.19.26.7 DEFINITIONS:
A
“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.
[16.19.26.7
NMAC - N,
16.19.26.9 EMERGENCY
CONTRACEPTION DRUG THERAPY:
A. PROTOCOL:
(1)
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.
(3) Continuing
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 16.19.4.10.
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.
D. RECORDS:
(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.
E. NOTIFICATION:
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.
Labeling
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.
Distribution
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.