Massachusetts Board of
Registration in Pharmacy
239 Causeway St, Suite 216
Boston, MA 02114
1. Policy 2005-01 c. supporting Collaborative Drug Therapy Management
Continuation of Drug Therapy Upon concepts; and
Discontinuance of a Practitioner’s d. ongoing education to consumers and pharmacists regarding
new laws for dispensing emergency contraception (EC).
Practice – A Joint Policy of the Department of
Public Health, Drug Control Program and Board I ask all Massachusetts pharmacists to closely examine
their evolving responsibilities in the health care system.
of Registration in Pharmacy
The role of pharmacists continues to expand and we
When a pharmacist becomes aware that a practitioner, should all embrace the changes and be aware of these
or other person authorized to prescribe in accordance with new responsibilities. In the coming year, I ask all of you
M.G.L. c. 94C, has ceased to practice for any reason and to identify one major issue of importance to your practice
that the practitioner-patient relationship has ended, existing and become more personally involved with it. Together,
drug therapy may still need to be continued. Therefore, a we can make the practice of pharmacy all that it is meant
pharmacist may, pursuant to a prescription previously issued to be and improve our professional image in the communi-
by that practitioner or other authorized prescriber and in the ties we serve.
exercise of good professional judgment, dispense remaining
reﬁlls of a prescription up to a maximum 90-day supply, to 3. Clariﬁcation of Technician Registration
enable the patient to establish a relationship with another Requirements Since registration issues involving
practitioner. Reﬁlls authorized pursuant to this policy may certain individuals em- ployed as pharmacy technicians in
not be dispensed in quantities greater than a 30-day supply Massachusetts pharma- cies continue, the Board believes it
in a single ﬁlling, except where patient insurance coverage is necessary to reiterate the message that appeared in the
requires dispensing of a 60- or 90-day supply. April 2005 Newsletter. All individuals employed as
2. Letter from the President pharmacy technicians in the Commonwealth must (after
By George A. Cayer, RPh completing required training and examination) file an
It is truly an honor to serve as president of the Massa- application for registra- tion as a pharmacy technician with
chusetts Board of Registration in Pharmacy for 2006. The the Board. Every two years after the initial registration
practice of pharmacy is always changing and 2006 will be period, all pharmacy technicians are required to file a
no different. Some of the opportunities and challenges facing renewal application with the Board. Please be reminded
the Board under my presidency this year are: that Pharmacy Tech- nician Certification Board (PTCB)
a. Ongoing education of pharmacists regarding the imple- certification is not the equivalent of the state-mandated
mentation of continuous quality improvement (CQI) requirement of current registration with the Board for
program requirements of 247 Code of Massachusetts employment as a pharma- cy technician in the
Regulation 15.00. Quality must be the focal point of all Commonwealth. The Board is aware of individuals who
licensed pharmacies in Massachusetts; have achieved PTCB certification and began employment
b. Ongoing education of the important role pharmacy as technicians without applying for registration by the
technicians have in supporting pharmacists in every Board, as required by M.G.L. c. 112,
patient setting; §24C-24E. Other individuals who have achieved PTCB
Continued on page 2
MA Vol. 12, No. 2 Page 1
Continued from page 1 a. the pharmacist is currently licensed by the Pharmacy
certification after registering as pharmacy technicians Board;
with the Board have then failed to renew their technician b. the pharmacist has completed training accredited by
registration with the Board after the initial registration the Accreditation Council [for] Pharmacy Education
period. Since current registration by the Board is statuto- (ACPE) or offered by an “Approved College or School
rily mandated for employment as a pharmacy technician in of Pharmacy” (247 CMR 2.00), which training shall
the Commonwealth, any individual employed as a include instruction on:
pharmacy technician who is not in compliance with state 1. referring patient for additional service and follow-up;
laws and Board regulations (247 CMR 8.02-8.07), as well as
2. quality assurance; and
any pharmacist and pharmacy employing such person, risks
adverse action by the Board and law enforcement 3. proper documentation.
authorities for unlicensed practice. c. the Standing Order is maintained on ﬁle (readily retriev-
able) at the pharmacy; and
4. Joint Guideline for Pharmacist Dispensing d. a copy of the Standing Order has been ﬁled with the
of Emergency Contraception The Department of Pharmacy Board.
Public Health (Department), specifically the Board of Training
Registration in Pharmacy (Pharmacy Board), the Board of
Proof of training must be on ﬁle (readily retrievable) at
Registration in Medicine and the Drug Control Program the pharmacy.
under authority of M.G.L. c. 94C, have adopted Guidelines
(Pharmacy Board Policy No.
2006-1) that describe the requirements for pharmacists to A copy of the Standing Order must be maintained on ﬁle
dispense Emergency Contraception (EC) pursuant to (readily retrievable) at each participating pharmacy site.
M.G.L. c. 94C, § 19A in accordance with a written One copy of the Standing Order must be ﬁled with the
standardized procedure or protocol (i.e., Standing Order) Board. Where a Standing Order provided to the participating
developed by an actively practicing physician registered pharmacy includes a certiﬁcation that the Order has been
with the Commissioner to distribute or dispense a con- ﬁled with the Board, it is not necessary to make duplicate
trolled substance in the course of professional practice ﬁlings with the Board.
pursuant to M.G.L. c. 94C, §7. Pursuant to the statute, Offer to Provide Medication Counseling
the Standing Order must be maintained on file at the As currently required by M.G.L. c. 94C and Pharmacy
participating pharmacy and a copy filed with the Phar- Board regulations 247 CMR.
macy Board. In addition to requirements for dispensing, Required Reporting
these Guidelines set forth requirements for training and In accordance with M.G.L. c. 94C, § 19A(d), annual re-
reporting. Physician Orders Are Required to Dispense porting of dispensings is required. Where possible, reports
EC Prior to the enactment of Chapter 91 of the Acts of shall aggregate the total number of units of use dispensed
2005, a prescription from an authorized prescriber in pursuant to a Standing Order (not including units of use
compliance with Department regulations was required to dispensed pursuant to a prescription). Reports are not
dispense EC public records and shall not include any patient names or
(e.g., Plan B). identiﬁers.
In accordance with M.G.L. c. 94C, § 19A, a pharmacist Annual reports must be electronically submitted to the
may now alternatively dispense EC pursuant to a Standing Department not later than August 1st for the period from
Order developed by an actively practicing registered phy- July 1 through June 30 of the prior year. An authorized
sician (see the Guidelines below). Standing Orders must representative for a group of pharmacies under common
include written, standardized procedures and protocols; ownership or control of one entity may report on behalf
the printed name and signature of the physician; and the of all pharmacies, provided subtotals are submitted for
entity(ies) authorized by the Physician. A physician may each location by permit number (and zip code). A
issue a Standing Order for a pharmacist, pharmacy or group reporting format will be available on the Department’s
of pharmacies under common ownership or control of one website.
entity. Reports shall be submitted electronically to the Depart-
Guidelines for Dispensing EC Pursuant to ment. Instructions will be provided on the Department’s
Standing Order website.
A pharmacist may dispense EC pursuant to a Standing
Order of an actively practicing physician who is registered
with the Commissioner provided that:
5. Massachusetts Professional on its letterhead that clariﬁes that the training offered on a
Recovery Program speciﬁc date covering the topics required by Board Policy
No. 2006-1. If the pharmacist does not have requisite proof
Program for Chemically Dependent of training from ACPE or the approved college or school
Pharmacists and Allied Health Professionals of pharmacy where he or she received training or the
“Licensed professionals reaching out to help other licensed training curriculum did not cover requisite topics, the
professionals cope with alcohol and drug problems.” For pharmacist is advised to seek further training to document
conﬁdential information please contact the Massachu- setts that he or she possesses requisite qualiﬁcations.
Professional Recovery Program (MPRS) Coordinator Tim 3. Question: If a pharmacist works in multiple locations,
McCarthy at 617/973-0910 or visit the MPRS Web site at as a “ﬂoater,” does the pharmacist need proof of training
www.mass.gov/dpl/services/mprs.htm. to be readily retrievable in each location (or just in his
6. Frequently Asked Questions About or her home location)?
Implementation of Chapter 91 of the Answer: Yes. A pharmacist must have proof of training
readily retrievable at each location in which the phar-
Acts of 2005 ‘Timely Access to macist dispenses EC pursuant to a standing order.
Emergency Contraception’ (March 2006) The best practice is for the pharmacist to file a hard
Pharmacy Training, Filing, and Practice copy of the training certificate with each work site so
1. Question: Is a pharmacist required to provide EC to a that the pharmacy may make such proof available to
pharmacy customer who does not have a prescription? Massachusetts Department of Public Health (MDPH)
Answer: No. Dispensing under a standing order is inspectors upon request. Alternatively, if the pharmacy
voluntary. In accor- dance with M.G.L. c. 94C, §19A, a where the pharmacist works can readily retrieve or
trained pharmacist may now alternatively dispense EC download a copy of training certificate(s) of completion
pursuant to a standing order developed by an actively via the Internet (using a unique identifier assigned by an
practicing registered physician. See Board Policy No. approved college of pharmacy), or any other electronic
2006-1. Prior to the enactment of Chapter 91 of the Acts of means of transmitting proof of training, such as by fax
2005, a prescription from an authorized prescriber in or e-mail attachment, maintenance of a hard copy at each
compliance with Department regulations was required to work site is not necessary.
dispense EC. 4. Question: How will a pharmacist know that a particular
2. Question: Can a pharmacist dispense Plan B pursuant to a standing order signed by a particular physician has been
standing order if he or she completed training required by ﬁled with the Board of Registration in Pharmacy and is
M.G.L. c. 94C §19(A)(c) prior to implementation of the law ready for use? Answer: See best practice suggestion(s)
on December 14, 2005? (Or, does the pharmacist need further for physicians
training?) Answer: Generally, yes if the pharmacist has (Question No. 9 below).
completed the substantive training prerequisites. The new 5. Question: If a pharmacy has a standing order on ﬁle
law speciﬁes training content areas that must be mastered at the pharmacy and at the Board of Registration in
prior to a pharmacist dispensing EC per a standing order. Pharmacy that authorizes the dispensing of Plan B per
the standing order by any qualiﬁed pharmacist practic-
Board Policy No. 2006-1 requires that proof of training must
ing at that location, must all pharmacists who practice
be on ﬁle (readily retrievable) at the pharmacy.
at that pharmacy location dispense Plan B under the
Those pharmacists who received training prior to De- standing order?
cember 14, 2005, are advised to consult with ACPE or the
approved college or school of pharmacy where the pharma-
cist received training to make sure that such institution has The new state law on timely access to EC does not re-
provided the pharmacist with requisite proof of training on quire all pharmacists employed at a particular location to
the following topics: dispense under a standing order. Conditions of employment
and scheduling of shifts of pharmacists who opt to partici-
Referring patient for additional service and follow-up;
pate are matters left to the management prerogative of the
Quality assurance; and employer.
Proper documentation. 6. Question: Is it necessary for minors (persons under age
If the certiﬁcate of completion issued by ACPE or the 18) to obtain parental consent to obtain EC medication
approved college or school of pharmacy is dated before from a pharmacist or pharmacy that is authorized to
December 14, 2005, ACPE or the approved college or dispense under a standing order?
school of pharmacy that issued the certiﬁcate of completion
may provide the pharmacist with additional documentation Continued on page 6
(Applicability of the contents of articles in the National Pharmacy Compliance
and can only be ascertained by examining t
An extemporaneous solution was to be prepared at this pharmacy
FDA Cautions Consumers About Filling US that specialized in compounded prescriptions since a liquid for-
Prescriptions Abroad mulation was not commercially available. A pharmacy technician
Food and Drug Administration (FDA) issued a warning to incorrectly entered the concentration of the prescribed solution
health care professionals and consumers that filling their prescrip- into the computer as 50 mg/mL instead of 50 mg/5 mL, along
tions abroad may have adverse health consequences due to the with the prescribed directions to give 2 tsp at bedtime. He then
confusion with drug brand names that could inadvertently lead proceeded to prepare the solution using the incorrect concentra-
consumers to take the wrong medication for their condition. In tion on the label rather than the concentration indicated on the
an investigation, FDA has found that many foreign medications,
although marketed under the same or similar-sounding brand prescription. When the compound was completed, the technician
names as those in the United States, contain different active placed it in a holding area to await a pharmacist’s verification.
ingredients than in the US. Taking a different active ingredient At this time, one of the two pharmacists on duty was at lunch
could potentially harm the user. and the high workload of the pharmacy made it difficult for the
FDA found 105 US brand names that have foreign counterparts pharmacist to check the prescription right away. When the child’s
that look or sound so similar that consumers who fill such prescrip- mother returned to pick up the prescription, the cash register clerk
tions abroad may receive a drug with the wrong active ingredient. retrieved the prescription from the holding area without telling a
For example, in the United Kingdom, Amyben®, a brand name pharmacist, and gave it to the mother, unaware that it had not yet
for a drug product containing amiodarone, used to treat abnormal been checked. At bedtime, the mother administered 2 tsp of the
heart rhythms, could be mistaken for Ambien®, a US brand name drug (500 mg instead of the intended 100 mg) to the child. When
for a sedative. Using Amyben instead of Ambien could have a she went to wake him the next morning, the child was dead. An
serious adverse outcome. For more information on this topic visit autopsy confirmed imipramine poisoning.
www.fda.gov/oc/opacom/reports/confusingnames.html. There are many factors that contributed to this error includ-
Safety Can Not be Sacrificed ing inaccurate order entry and issues related to high workload.
For Speed However, a critical breakdown in safety processes occurred when
This column was prepared by the Institute the cash register clerk took the prescription from the pharmacy
for Safe Medication Practices (ISMP). ISMP holding area (to prevent the mother from waiting any longer for
is an independent nonprofit agency that works the prescription), thereby circumventing the usual pharmacist
closely with United States Pharmacopeia (USP) verification process.
and FDA in analyzing medication errors, near While this error underscores a growing problem in health care,
misses, and potentially hazardous conditions as the problem was clearly evident to this pharmacy owner – even
reported by pharmacists and other practitioners. ISMP then makes a year before the error occurred. When interviewed for an article
appropriate contacts with companies and regulators, gathers ex- that appeared in a national publication, he vented his frustrations
pert opinion about prevention measures, then publishes its recom- about the scant attention paid in our society to pharmacist work-
mendations. If you would like to report a problem confidentially load difficulties faced in today’s health care environment. On
to these organizations, go to the ISMP Web site (www.ismp.org) the day of the interview, 49 prescriptions were in the process of
for links with USP, ISMP, and FDA. Or call 1-800/23-ERROR to being prepared and about a dozen patients were standing in line
report directly to the USP-ISMP Medication Errors Reporting or wandering around the store waiting for prescriptions. Yet this
Program. ISMP address: 1800 Byberry Rd, Huntingdon Valley, was a slow day. The owner also said that, while managed care
PA 19006. Phone: 215/947-7797. E-mail: email@example.com. had reduced profits considerably over the past several years, pre-
Problem: Typically, pharmacies have developed well-estab- scription volume had increased 50% (at the time of the error, the
lished methods for monitoring the accuracy of the dispensing pro- pharmacy was dispensing about 10,000 prescriptions per month
cess. But today, pharmacy work is increasingly stressful and these versus 7,000 per month during the prior year, without an increase
checks and balances can easily be strained beyond capacity. With in staff) and medication regimens and drug interactions were more
an increasing number of prescriptions and a shortage of qualified complex. To overcome these barriers, the owner added private
pharmacists, conditions are ripe for potentially unsafe working consultation areas for patient counseling; installed a $175,000
conditions – long hours without breaks; multitasking between robot that accurately dispenses the 200 most common drugs;
answering phones, overseeing other pharmacy staff, dispensing and diversified sales to offset full-time pharmacists’ salaries. But
prescriptions, and counseling patients; and ever-increasing time these efforts could not have prevented this tragic fatal error that
spent attending to insurance issues. Inevitably, these conditions circumvented the normal safety processes.
can increase the chance for dispensing errors. Safe Practice Recommendations: The environment and
One pharmacy knows this all too well after a five-year-old boy demands placed on health professionals significantly affect their
died as a result of an order entry and medication compounding ability to provide safe health care services. While technology such
error that was not caught by the usual verification process. In this as robots can help, overstressed professionals cannot consistently
case, imipramine was dispensed in a concentration five times perform at the maximum level of safety. Therefore, it is impor-
greater than prescribed. Imipramine is a tricyclic antidepressant tant that the public and health care leadership understand this
used to treat adults, but it is also used to treat childhood enuresis. problem so they can be more open to tradeoffs, such as working
with one patient at a time and incurring longer turnaround times, According to the House Report, the purpose of the Act is
which are necessary to enhance patient safety. With a shortage of “to prevent the abuse of steroids by professional athletes. It
qualified professionals, we need to demand more rapid adoption will also address the widespread use of steroids and steroid
of computerized prescribing to reduce time spent with prescription precursors by college, high school, and even middle school
transcription. We should identify the biggest distractions that occur in students.”
The changes to the definition include the following:
our workplaces and eliminate or reduce the source by batching
common interruptions and reorganizing work areas. Staff members Correction of the listing of steroid names resulting from the
need to be properly trained to understand safety procedures that passage of the Anabolic Steroid Control Act of 1990.
are in place and know the limits of their specific duties. Fail-safe Replacement of the list of 23 steroids with a list of 59 steroids,
including both intrinsically active steroids as well as steroid
processes to ensure an independent double check before dispensing
medications and performing other critical processes are a must. The
Automatic scheduling of the salts, esters, and ethers of Schedule
pharmacy where this error occurred now requires two pharmacists III anabolic steroids without the need to prove that these salts,
to check every prescription. Unfortunately, this level of vigilance is esters, or ethers promote muscle growth.
typical after a patient has been harmed from an error. In other Removal of the automatic scheduling of isomers of steroids
pharmacies, especially where there is only one pharmacist on duty, listed as Schedule III anabolic steroids.
technicians may be involved in the double-check process. Addition of dehydroepiandrosterone to the list of excluded
A few other strategies can be used to prevent similar errors: substances.
Have one person perform order entry and a different person FDA Unveils New Package Insert Format
prepare the prescription, if possible, to add an independent
validation of the order entry process. On January 18, 2006, FDA unveiled a major revision to the
format of prescription drug information, commonly called the
Do not prepare prescriptions using only the computer-generated
package insert, which will give health care professionals clear
label, as order entry may have been incorrect.
and concise prescribing information. This new format was
Ensure that the original prescription, computer-generated la- developed in order to manage the risks of medication use and
bel, prepared product, and manufacturer’s product(s) remain reduce medical errors; the new package insert will provide
together throughout the preparation process. the most up-to-date information in an easy-to-read format.
Verify dispensing accuracy by comparing the original prescrip- This new format will also make prescription information more
tion with the labeled patient product and the manufacturer’s accessible for use with electronic prescribing tools and other
product(s) used. electronic information resources.
NIH Develops Community Drug Alert Bulletin Revised for the first time in more than 25 years, the new format
The National Institute on Drug Abuse, as part of the Na- requires that the prescription information for new and recently
tional Institutes of Health (NIH), has developed a new Com- approved products meet specific graphical requirements and
munity Drug Alert Bulletin that addresses the latest scientific includes the reorganization of critical information so physicians
research on the non-medical use of prescription drugs of abuse can find the information they need quickly. Some of the more
important changes include:
This bulletin is geared toward parents, teachers, counselors,
A new section called Highlights to provide immediate access
school nurses, and health professionals who are associated with
to the most important prescribing information about benefits
those at risk from prescription drug abuse for non-medical pur-
poses. It summarizes the growing problem in the US and the trend
A table of contents for easy reference to detailed safety and
of non-medical use of prescription drugs. For more information on efficacy information.
this bulletin visit www.nida.nih.gov/PrescripAlert/index.html.
The date of initial product approval, making it easier to deter-
Implementation of the Anabolic Steroid mine how long a product has been on the market.
Control Act of 2004 A toll-free number and Internet reporting information for sus-
According to the December 16, 2005 Federal Register, effec- pected adverse events to encourage more widespread reporting
tive January 20, 2005, the Anabolic Steroid Control Act of 2004 of suspected side effects.
amended the Controlled Substances Act (CSA) and replaced the This new format will be integrated into FDA’s other e-
existing definition of “anabolic steroid” with a new definition. Health initiatives and standards-settings through a variety of
This new definition changed the basis for all future administrative ongoing initiatives at FDA. For more information please visit
scheduling actions relating to the control of the anabolic steroids as www.fda.gov/cder/regulatory/physLabel/default.htm.
Schedule III controlled substances (CS) by eliminating the require-
ment to prove muscle growth. Also, the Act lists 59 substances as
being anabolic steroids; these substances and their salts, esters, and
ethers are Schedule III CS. The Act also revised the language of
the CSA requiring exclusion of certain over-the-counter products
from regulation as CS.
Continued from page 3 Standing Order and Physician Practice
Answer: No. Chapter 91 of the Acts of 2005 does not 9. Question: How will a physician know that a particular
mandate parental consent for teens to obtain EC from standing order has been ﬁled with the Board of Registra-
a pharmacist or pharmacy. The law does not prevent a tion in Pharmacy and is ready for use?
teen from involving her parent. Answ e r: Obs er ve th e fo ll o wi n g b e st pr act ic e
7. Question: What should a pharmacist do if a pharmacy suggestion(s).
customer discloses that the need for EC results from Best practice(s):
Send the standing order via certified mail with return
An sw e r: Ob se r ve t he fo ll o wi n g b es t pr ac ti ce receipt requested in order to track delivery and receipt
suggestion(s). of the order. (The Board will not provide alternative
Provide standard medication screening and offer phar- written or oral confirmation of receipt of the standing
maceutical counseling consistent with M.G.L.§ 94C § 21A order on file.)
and 247 CMR 9.07. If a patient reports no contraindications, On each standardized order transmitted to the Board,
dispense medication per a standing order or, if customer include (1) the effective date and (2) the date that the
presents a prescription, per the prescription. order is transmitted to the Board for ﬁling.
Provide appropriate referrals: 10. Question: Does a physician need to verify that a phar-
For medical treatment and care, refer the pharmacy macist has been trained before signing a standing order
customer to a local rape crisis center and/or hospital with that pharmacist?
emergency department. Answer: Generally, no but a physician may wish to
For nearest Rape Crisis Center, visit www.mass.gov/dph/ verify training before signing a standing order. Under
fch/sapss/sites.htm. M.G.L. c. 94C §19(A), pharmacists must complete requisite
For nearest MDPH-designated hospital emergency room training before dispensing EC per a standing order. Board
that uses MDPH-certiﬁed sexual assault nurse examiners Policy No. 2006-1 requires that proof of training must be on
to collect forensic evidence, visit www.mass.gov/dph/fch/ ﬁle (readily retrievable) at the pharmacy.
State law does not require or prohibit a physician from
For conﬁdential rape crisis counseling, refer pharmacy seeking to verify that an individual pharmacist has completed
customer to the state’s conﬁdential rape crisis hotline: training before signing a standing order. Nothing prohibits
For hotline numbers, see: www.mass.gov/dph/fch/sapss/ a licensed physician from providing a licensed pharmacy
sites.htm. with a standing order that is signed and dated in advance
For the statewide Spanish Language Helpline, call Llá- of the date that an individual phar- macist working at
manos: 1/800-223-5001. Note: Under Massachusetts law, such pharmacy completes requisite training, so long as
information transmitted in conﬁdence by and between a there are adequate personnel and management systems
victim of sexual assault and a sexual assault counselor in place at the pharmacy for use of the standing order. A
including all information received by the sexual assault pharmacist commencing employ- ment at a pharmacy
counselor that arises out of and in the course of such that has a standing order on file for use by trained
counseling shall not be subject to discovery and shall be pharmacists may dispense EC pursuant to the standing
inadmissible in any criminal or civil proceeding without the order provided that such pharmacist has completed
prior written consent of the victim to whom the report, requisite training.
record, working paper or memorandum relates. See M.G.L. 11. Question: If a physician signs an order authorizing all
c. 233 §20J. The statutory deﬁnition for qualiﬁed pharmacists practicing at a pharmacy located
“sexual assault counselor” does not include a pharmacist at one particular location to dispense per the physician’s
and the statutory privilege codiﬁed in §20J does not apply standing order and one of the pharmacists who works
to pharmacy conversations or records maintained by the at that pharmacy also works at another pharmacy loca-
pharmacist. tion that does not have a standing order on ﬁle, can the
8. Question: Are additional MDPH materials available to pharmacist “carry” the standing order from location to
pharmacists and health care providers? location so as to “transfer” the physician’s standing order
Answer: Not at this time. to different location(s) that do not have a standing order
Some materials are posted on the MDPH and the Board on ﬁle?
of Registration in Pharmacy Web sites. MDPH is preparing a Answer: No.
pharmacist toolkit that is anticipated to contain other See Frequently Asked Questions for pharmacists
information for participating pharmacists. Check the MDPH (Question No. 3 on page 5).
and the Board of Registration in Pharmacy Web sites for
forthcoming materials. Continued on page 7
Continued from page 6 porate entity to dispense EC per his or her standing order. Or,
Board Policy No. 2006-1 speciﬁes that a copy of the stand- a physician may choose to sign a standing order authorizing
ing order must be maintained on ﬁle (readily retrievable) at one particular pharmacist.
each participating pharmacy site. If the physician’s standing 14. Question: Does a physician who authorizes dispensing
order is written to authorize a speciﬁc individual per a standing order increase his or her risk of liability?
pharmacist to dispense per the standing order at any Answer: Participating physicians (and participating
pharmacy where he or she practices, copies of the standing pharmacists) are advised to consult their legal counsel
order must be on ﬁle at each pharmacy location where such and/or insurance agent regarding risk management
pharmacist practices. issues and adequacy of professional malpractice
12. Question: Will it still be necessary for physicians to insurance.
write prescriptions for EC now that Plan B may be 15. Question: Is there increased liability for the physi-
available at some pharmacies via a standing order? cian if his or her standing order is written so as to
Answer: Yes. authorize a participating pharmacist to dispense to
Nothing in the new law limits or otherwise changes a pharmacy patients who report having sexual inter-
physician’s authority to write a prescription for Plan B or course within the preceding 120-hour period of time if
other prescription medication. the physician and the pharmacist know that, for
It is not certain that an individual patient in need of EC maximum effectiveness, EC should be administered
will be able to obtain EC medication from a pharmacy as soon as possible and, if possible, within 72 hours
without a prescription. Access under the new state law of sexual intercourse?
is contingent on a number of factors including, but not Answer: Participating physicians (and participating
limited to: (1) pharmacies “opting in” to dispense under pharmacists) are advised to consult their legal counsel
a standing order, and (2) a pharmacist with the requisite and/or insurance agent regarding risk management issues
qualiﬁcations and training being available and ready to and liability issues.
serve a pharmacy customer who arrives without a written 16. Question: Do new MDPH regulations found at 105
prescription. CMR 130.1040 to 130.1043 regarding timely access to
In cases where a treating physician (or pharmacist acting EC for rape survivors only apply to emergency depart-
under a standing order) determines in his or her profes- ments of hospitals?
sional judgment that Plan B is contraindicated but another Answer: Yes. Amendments to the MDPH hospital
prescription medication is necessary, a prescription is licensure regulations only apply to emergency departments
required. of hospitals.
In cases where a patient under the physician’s care seeks 17. Question: If a woman calls her doctor’s ofﬁce in need
a prescription that can be ﬁlled and reﬁlled in the future of EC, does the new law (Chapter 91 of the Acts of
(eg, while traveling if contraceptive method fails), the 2005) require her doctor or other licensed professionals
best practice for ensuring access to EC is to give the in that medical practice to give the caller a prescrip-
patient a prescription. tion or provide her with information on where she can
13. Question: The MDPH model standing order asks the obtain it?
physician to “List Pharmacy or Corporate Entity.” A. Answer: No.
Does this mean that a physician can authorize The legislature did not change the physician’s authority to
all pharmacists who work at a particular location prescribe Plan B or other prescription medications for EC.
(eg, pharmacy ABC located at 123 Washington The new statutory and regulatory requirements regarding
Street,Town T, MA)? provision of EC for female rape victims only applies to
B. Can a physician use a standing order to authorize a hospital emergency departments.
corporate entity that operates a chain of pharmacies Other
(eg, to the ABC Corporation that owns and operates
18. Question: If I obtain EC from a pharmacist
20 licensed pharmacies in one or more geographic
pursuant to a standing order, will MassHealth
locations in the Commonwealth)?
(Medicaid) or private insurance pay for it? Will
Answers to 13A and 13B: Yes. insurance also pay if I request EC for the future,
The scope of the standing order is a matter that is left to before I need to take it?
the discretion of the physician signing the standing order. A
Answer: The new law does not address matters
physician may sign a standing order that authorizes qualiﬁed
related to insurance coverage and beneﬁts.
pharmacists practicing at a particular pharmacy location or
qualiﬁed pharmacists who are employed by a particular cor- Currently, MassHealth (Medicaid) provides coverage
for EC. For questions regarding MassHealth coverage and
beneﬁts and applicable co-payment for physician visits and
Continued on page 8
Continued from page 7 William A. Gouveia, RPh, MS.......................... Member
for prescription medication, call the MassHealth Customer Sophia Pasedis. RPh, PharmD .......................... Member
Service Center: 1-800/841-2900 (TTY: 1-800/497-4648 for Harold B. Sparr, RPh, MS............................... Secretary
people with partial or total hearing loss). Staff
Questions regarding private insurance products, cover- Chuck Young, RPh ........................... Executive Director
age, and beneﬁts should be addressed to your health J.D. Coffey, RPh ...............................Associate Director
Susan Manning, Esq................. Administrative Counsel
19. Question: Who in MDPH handles questions regarding
Leo A. McKenna III, RPh, PharmD ........ CQI Surveyor
Pharmacy and Emergency Department access to EC?
Lau Kwan ................................ Administrative Assistant
Carolyn Reid ........................... Administrative Assistant
Karen L. Fishman.............................Complaint Monitor
Family Planning Program, Karen Edlund:
Ofﬁce of Public Protection Agents
Samuel J. Penta, RPh, Supervisor .............617/973-0861
Sexual Assault Prevention and Survivor Services
Program, Marci Diamond: 617/624-5457 James C. Emery, CPhT .............................617/973-0862
Division of Health Care Quality, 617/753-8000
Pharmacists/Pharmacies: Board of Registration in
Pharmacy, Chuck Young or J.D. Coffey: 1-800/414-0168
Drug Control Program, 617/983-6700
Board of Registration in Medicine, Assistant General
Counsel Robert Harvey: 617/654-9800
Board Member List Page 8 – April 2006
George A. Cayer, RPh ..................................... President The Massachusetts Board of Registration in Pharmacy News is published
Donald D. Accetta, MD, MPH ......... Physician Member by the Iowa Board of Pharmacy Examiners and the National Association
of Boards of Pharmacy Foundation, Inc, to promote voluntary compli-
Marilyn M. Barron, MSW...................... Public Member ance of pharmacy and drug law. The opinions and views expressed in
Joel R. Berman, RPh ......................................... Member this publication do not necessarily reﬂect the ofﬁcial views, opinions, or
Steven Budish ........................................ Public Member policies of the Foundation or the Board unless expressly so stated.
Karen M. Ryle, RPh, MS ......................... Past President Charles R. Young, RPh, CFE - State News Editor
James T. DeVita, RPh............................. President-Elect Carmen A. Catizone, MS, RPh, DPh - National News Editor
& Executive Editor
Kathy J. Fabiszewski, PhD, RN ............. Nurse Member Larissa Doucette - Editorial Manager