President`s Message

“In Unity There is Strength”
President
Andrew Stein
Birds Hill Pharmacy, Needham
(781) 449-0550
1st Vice-President
Oleg Urim
Flag Pharmacy, Lynn
(781) 599-5900
2nd Vice-President
Delilah Barnes
Sullivan’s Pharmacy, Roslindale
(617) 323-6544
Legal Counsel
Paul Garbarini
PO Box 1551
Northampton, MA 01061
(413) 727-8191
www.paulgarbarinilaw.com
Chairman of the Board
Derrick Anderson
J.E. Pierce Apothecary, Brookline
Executive Director
Todd Brown, Stoughton
Treasurer
Mark Yorra, Brookline
Trustees of the Permanent Fund
Saad Dinno, Acton
Tim Fensky, Roslindale
Newton Trevens, Brighton
Board of Directors
Delilah Barnes, Mansfield
Richard Brisson, New Bedford
Raied Dinno, Newton
Phillip Falzarano , N. Dartmouth
Thomas Libby, Quincy
Kelly Nippins, Quincy
Lisa Rogers, Waltham
Legislative Chairman
Tom Cory
Standard Pharmacy, Fall River
Massachusetts Independent
Pharmacists Association
20 Paul David Way
Stoughton, MA 02072
Phone (781) 297-0965
Fax (866) 475-6284
Volume XXXII, Issue 9 October 2013
President’s Message
Dear Colleagues,
Thank you to all who participated in last month’s meeting. It was nice to see
a few new faces there. One of the items discussed was the issue of pharmacy
safety. It appears that there is a resurgence of pharmacy robberies. In light of
this, MIPA will be looking to host Rx Patrol and a DEA representative at our
November meeting. Rx Patrol was established by Purdue Pharma and their
goal is to collect and analyze information about robberies and distribute this
information to law enforcement across the country. They have a presentation
which will focus on different policies and protocols we can implement to
better protect our staff and patients.
October is a big month for open enrollment with insurance companies. For
those of us engaged in compounding, now is a good time to inform our
Harvard Pilgrim patients that they can have easier coverage of their
medication by switching plans. It is surprising how many patients don’t
realize they have a choice when it comes to changing insurers. The rumor has
it that Harvard Pilgrim, while being rated the top insurer, is struggling.
Losing plan sponsors and clients would show other insurers that their policy
towards compounded medication is callous and not effective. Continue to
encourage patients to voice displeasure through Facebook and Twitter. Also,
any patient willing to speak with the media about how the lack of coverage
has been a hardship should contact me or Todd Brown. We are trying to
continue having stories published in local media outlets, and the best way to
convey the message is to have a person with a compelling situation.
(Continued on page 3)
In this Issue
Page
President’s Message
1
Legal Counsel Message
2
And Much More!
For more information visit www.mipanet.org
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Legal Counsel’s Message
“Honesty is the best policy- when there is money in it”.
Mark Twain, American author/humorist/misanthrope (1835-1910)
Mr. Twain once again provides both insight and humor into a place that rarely receives or perceives itAmerican health care and privacy laws. The above-quoted adage could have the following line added to it
- “honesty is the best policy- and it may save you money and heartache”. Many MIPA members have
contacted my office over the years with questions regarding privacy laws, HIPAA, the HITECH Act, the
MA Data Security Act and other rules and regulations controlling the use of protected health information.
Most pharmacists realize that they, or more appropriately the business entity they own or represent,
should rightfully be considered a repository of protected health information for each and every patient we
care for. Numerous instances happen throughout the daily lives of independent pharmacists regarding the
permitted use of protected health information, and for most intents and purposes, pharmacists do a
tremendous job in safeguarding this vital information.
In the past few years, however, pharmacists have been required (not asked) to play a bigger role in
tracking the dispensing and use of controlled substances. No longer are pharmacists merely required to
maintain records of the disposition of controlled substances received and dispensed (by the usual
means- prescription files, records of transfer between practitioners, 222 Forms, CSOS forms, Schedule III
-IV invoices, records of reverse distribution, etc.). The role of the pharmacist is now under much greater
scrutiny since pharmacists in nearly every state (Missouri is the sole remaining holdout) must report, in
one timely fashion or another, records of the dispensing of controlled substances to their patients to their
respective state by means of a Prescription Monitoring Program (hereinafter PMP).
So big deal Paul, we've been doing this for years- why write a newsletter about the PMP now, so long
after the fact? My concern is for the pharmacist who may not entirely understand the role he or she plays
in obtaining, reporting and safeguarding access to the information reported and indeed compiled by the
PMP. Once a pharmacist is presented with a prescription for a controlled substance, and he or she
determines that said prescription appears to be legitimately issued and in turn dispenses the controlled
substance in question, they must, pursuant to 247 CMR 5.04(1)(2) and 105 CMR 700.012(A)(5), transmit
said dispensing data to the PMP at least once every seven days and no later than 10 days after dispensing
as mandated by the PMP. Some pharmacists view their obligations to the PMP as nothing more than
that- once the information is obtained and transmitted to the PMP there no longer is any continuous duty.
But what about the continuing obligations of a pharmacist licensed in Massachusetts to the safeguard the
information transmitted to the PMP and to prevent unauthorized access to the information contained in the
PMP? I daresay that there is no greater concentrated combined source of both controlled substance
dispensing information and protected health information. What must a pharmacist do to prevent
themselves from incurring legal liability for use or disclosure of information to and from the PMP? To
paraphrase Mark Twain- Is honesty the best policy and the least expensive for a dispensing pharmacist?
Let's take a look.
To participate in the PMP, a pharmacist must agree to basic terms- that you are a duly registered
practitioner, that you are duly enrolled in the PMP, that you will only use your credentials to access the
system, and that you will not allow anyone else to use your credentials to access the system.
(Continued on page 5)
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Technician Competency Exam Available
MIPA has available to any “Store or “Owner Manager” member a new series of Board of Pharmacy
approved technician competency exams. The exams are designed to be utilized as a minimum
competency exam requirement for technician registration. Individuals who order the exams receive goals
and objectives covered by the exam, three versions of the exam, and answer keys and exam maps to
interpret exam results. The Association invested a great deal of time in preparing these exams for the
benefit of our members. These exams may be photocopied and used as many times as needed. The exams
are valid until December 31, 2014. The Association is making this exam available to members for $30.
This covers the cost of preparing the exam as well as postage and handling.
Exam Order Form
Pharmacist Name:________________________________Pharmacist’s Lic#________________
Pharmacy Name___________________________________ Tel#(Daytime)_________________
Street Address:_________________________________________________________________
City:______________________________State:_____________Zip_____________________
Credit Card (circle one)
Mastercard
Visa
American Express
Name on Credit Card:___________________________________________________________
Credit Card#____________________________________Exp Date_______________________
Street Address______________________________________Security Code________________
Make check payable to: Massachusetts Independent Pharmacists Association (MIPA), or include credit
card information above and send to: MIPA 20 Paul David Way Stoughton, MA 02072 or fax
to (866) 475-6284. The cost for MIPA Members is $30, For nonmembers $60.
President’s Message (Continued)
Also, be advised that the audit bill and compounding bills are moving through the State legislature. Any
pharmacy that has had difficulty with an audit should inform Todd of the scenario. State legislators want
to know about PBM abuses and how these audits have affected local businesses. We are small
businesses in someone’s district and we need to leverage this to our advantage. We are vote wielding
citizens who make significant contributions to the local economy. Alone we are not great in number; but,
as whole we are a strong voice.
Sincerely,
Andrew Stein
President
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MIPA Meeting
The next MIPA meeting will be held on Tuesday October 8th at the Chateau Restaurant in Natick.
Meetings are also scheduled for November 13th, December 10th, and January 8th. All members are
invited. The meetings will start at 7:15pm and includes dinner (attendees are charged $20 toward the
dinner). To reserve space for the next meeting please call, fax, or email the Association by October 7th.
Chateau Restaurant
404 Providence Highway (Route #1)
Norwood, MA 02062 (781) 762-5335
From I-95 (north or south) take the US-1 SOUTH (exit 15B), towards Norwood. Proceed on Route #1
through one set of traffic lights. Take a right on the ramp approximately ½ mile after the light (toward
Norwood Center). Proceed completely around the rotary so that you are traveling on Route 1 in the
opposite direction. The Chateau is approximately 200 yards on the right side.
A Thought For the Day
“Autumn is a second spring where every leaf is a flower”
Albert Camus
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Legal Counsel’s Message (Continued)
The use of the Online PMP by a pharmacist is multi-purposed- to prevent the dispensing of controlled
substances to the same individual from multiple sources, to prevent the unlawful, illicit diversion of
controlled substances and to safeguard the information contained in the PMP from being used in any
way other than the legally authorized manner permitted by the PMP.
Assume you receive a prescription for a controlled substance from a patient. You determine, based on
the totality of the circumstances that the prescription appears legitimate and you then check the online
PMP to ascertain whether the patient has obtained similar medications from other prescribers for this or
a similar controlled substance. Assume that your query of the online PMP reveals nothing unusual and
that the patient has not received controlled substance medication from any other prescriber in a fairly
long time. You decide to fill the prescription, it is dispensed and you then submit the required data for
this (and other controlled substance prescriptions) to the PMP in the time frame required.
Imagine, if you would, that a fellow pharmacist working at another site tells his chief certified
technician to contact your pharmacy and she asks if you have any suspicions about a patient you have
dispensed controlled substances to in the past. Assume that you do not have a prescription presented to
you for this specific patient at this time. To satisfy your own curiosity you decide to access the online
PMP to review the aforementioned patient's controlled substance history. You do and the patient appears
to have visited every independent pharmacy in eastern Massachusetts in the last 3 months and obtained a
slew of medications, all from different prescribers. Upon learning this you tell the certified technician
what you have discovered, you become enraged and contact my office asking what you can do to “shut
this guy off”. (Continued on page 7)
Compounding Legislation Set to Pass in the Massachusetts House
of Representatives
The Massachusetts House of Representatives is expected to pass legislation that would provide
additional oversight and safeguards for compounding pharmacies. Included in this legislation is training
for Board of Pharmacy Inspectors, regular inspections, the ability of the Board to fine pharmacies for
violations (commensurate with the violation), and new license category for sterile compounders.
The legislation maintains the Board of Pharmacy would be comprised of a majority of pharmacists (this
was changed from Governor Patrick’s original proposal) and would also increase the continuing
education requirement for all pharmacists from 15 hours to 20 hours annually.
Overall the Association is extremely pleased with the legislation as most of it is reasonable and will
enable community pharmacy to deal with the compounding tragedy and move onto other issues.
Once the legislation passes the House of Representatives it will go to the Senate. There we expect
additional modifications. The Association has and will continue to work with the senate to ensure future
changes continue to provide access to compounded prescriptions in a safe manner. We hope the
legislation will be passed and enacted later this year.
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Legal Counsel’s Message (Continued)
My first question for you is- did you have a prescription presented by the patient or his agent at the time
you queried the database? And you reply no, I did it only after another pharmacist “tipped” me off. I then
tell you some bad news- that your query of the database is a violation of the terms of the PMP as you
essentially went on a “fishing expedition” to see if you could uncover any unsavory data about the
patient. Under the terms on the Online PMP a pharmacist may not query the database unless he or she has
been presented with a prescription. Each and every log-in, or access, to the online PMP is monitored. If
this unauthorized access becomes known to Health and Human Services (and it probably will, in all
likelihood), your right to use the system may be revoked, your controlled substance registration may be
suspended or terminated (pursuant to 105 CMR 700.004(L)(1)), possibly saying goodbye to your
facilities license, and a referral for criminal prosecution or disciplinary action by the Board of Pharmacy
(or a combination of the two) may be made. All because you decided it was worthwhile to go on a fishing
expedition. Please remember that you can only access the online PMP when you have a prescription in
hand and need to review that patient's controlled substance history. Use outside of this narrow exception
may be hazardous to your livelihood- again honesty is best policy, especially when it saves you money!
To illustrate what I have attempted to describe above I give to you the recent case law decision, Brumley
v. City of Cleveland, Tenn. Ct. App., No. E2012-00002-COA-R3-CV (2013). In this matter a narcotics
unit detective for the Cleveland (TN) Police Department conducted an investigation to determine if a
director of a drug task force was abusing prescription medications. His actions, to say the least, appear
unorthodox and the detective was terminated from his position. The case really involves matters of
employment law, but the matter which caused his termination has everything to do with how an online
PMP should be treated- with a great deal of deference and respect for the information it contains and why
this information should not be accessed for “fishing expeditions”.
The detective in question was an officer for 14 years. One day he was approached by two members of a
drug task force unit who suspected that the task force director was abusing prescription medications. In
fact a criminal court judge later told the detective that the task force director seemed to be “under the
influence” while obtaining warrants in the judge’s chambers.
The detective obtained the task force directors social security number and date of birth illicitly and then
approached a friend, who happened to be a pharmacist and asked for his assistance in accessing the
online PMP to continue his investigation. The friend did not personally have access to the online PMP
but he contacted two other pharmacists who checked the task force director's prescription history and
both concluded that their review did not raise any suspicion of illegal activity. The actions of the
pharmacists in accessing the database without subsequently processing a prescription raised a red flag for
the individuals entrusted with monitoring the online PMP. The Tennessee Bureau of Investigation
investigated the breach of the online PMP and determined that the detective had “illegally instigated a
search of the PMP”. The Attorney General contacted the police unit the detective was employed at and
the Internal Affairs unit conducted an investigation of the detective's conduct. The police department
concluded that the detective had, in part, violated the state law regarding confidentiality of the database.
The detective was terminated and sued to get his job back. The City manager denied his request, and on
appeal, the appellate court agreed that his termination was proper, considering the acts that he stood
accused of.
(Continued on page 9)
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House of Representatives Approves Compounding, Track-and-Trace Bill,
Senate Poised to Vote
This legislation is significantly better than previous versions and is achieves a balance between federal
and state oversight of compounding. The balance was struck in the new legislation, H.R. 3204, by:
Requiring FDA to engage in two-way communications with state pharmacy boards, an element that
was lacking in FDA's response to NECC's activities.
 Preserving and protecting the practice of traditional pharmacy compounding that occurs in
community pharmacies.
 Permitting entities engaged in sterile compounding to voluntarily register as "outsourcing
facilities" subject to good manufacturing practices, risked-based inspections, and other new
standards.

Here is what the compromise does not do (as previous versions did):
Exempt entire classes of trade (such as hospital pharmacies), while subjecting community
pharmacies to broad federal oversight, even though they had no role in the tragic meningitis
outbreak.
 Allow the FDA to create a "do not compound" list of specific types of drugs it deemed too difficult
to compound.
 Require pharmacies to report to the FDA every time they compound a drug because of shortages.

At this moment it is not clear when the Senate will vote (due to the federal shutdown)
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Legal Counsel’s Message (Continued)
At appeal the detective pressed for the appellate court to recognize that his actions were proper. The
appellate court quoted the attorney employed by the Tennessee Board of Pharmacy who stated “you
cannot ask a pharmacist or initiate conversation with a pharmacist to indulge or look at the database. It
must be done by a court order signed by the district Attorney and the judge”.
Here the court clearly viewed the detective's actions as unlawful and upheld his termination. What about
the three pharmacists who so willfully entertained the detective's request? I am not in possession of what
the Board of Pharmacy in Tennessee has or may do to these pharmacists, but I am fairly certain that it
will be a severe sanction against their livelihood. All because they did something that they knew, or
should have known, that they could not do- give access to law enforcement to the online PMP. The
police are well aware that if they do wish to obtain information from the online PMP that they can only
obtain it from the system itself, once a warrant/subpoena has been issued by a court of competent
jurisdiction. To avoid liability, what pharmacists should always do is act reasonably under the
circumstances. Was it reasonable for the pharmacists to supply this information- no it was not. The
agreement to provide confidential online PMP information to law enforcement acting under the color of
authority alone would support an indictment for conspiracy to violate the privacy laws and possibly the
Controlled Substance Act.
Your ability to utilize the online PMP is based, in large part, upon your conduct. If you observe the rules
surrounding the online PMP you can utilize it as a tool to reduce the risk of diversion of controlled
substances. To willfully violate the terms of the online PMP is to invite tremendous legal, political,
administrative and regulatory pressure upon your license to practice. As noted above, honesty is best
policy- it will save you money and heartache in the long run. Ask yourself if you would want just anybody out there who has access to the PMP to obtain your information, or that of your loved ones without
an officially sanctioned reason for doing so. And always remember that Big Brother is watching-- if this
case does not underscore that notion, I don't know what does.
Do you have a question regarding pharmacy practice that you would like answered? MIPA members can
call anytime and the first 15 minutes of any consultation are free. If you've got a question call me and I
will (hopefully) have an answer. This month's newsletter is intended for purposes of informing MIPA
members of a recent pharmacy case law decision that may be important to them. While I do
endeavor to address the concerns of MIPA members, this newsletter is not intended to replace legal
advice already received or to serve as legal advice to any specific reader. No attorney-client relationship
is created by publication of this message. For specific legal advice regarding this or any other matter,
please contact my office at 413.727.8191 or my new website at www.paulgarbarinilaw.com
Sincerely,
Paul M. Garbarini, R. Ph., Esq.
Legal Counsel
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The Customer Satisfaction Gap Continues to Widen between
Brick and Mortar and Mail-Order Pharmacies
Mail-order pharmacies once held a customer satisfaction advantage over brick and mortar pharmacies
mainly due to perceived cost competitiveness, satisfaction with brick and mortar pharmacies continues
to increase at a faster pace, according to the J.D. Power 2013 U.S. Pharmacy Studies' released recently.
KEY FINDINGS

Although customer satisfaction with mail-order pharmacies improves to 797 index points on a 1,000point scale in 2013, up from 792 in 2012, satisfaction with brick and mortar pharmacies increases by
23 points during the same time period, now averaging 837 points.

While mail order had a seven-point advantage in perceived cost competitiveness over brick and
mortar in 2011, in 2013 it is at a 20-point disadvantage in the cost factor.

The percentage of customers who indicate refilling prescriptions at a brick and mortar pharmacy has
increased to 61 percent in 2013--up from 58 percent three years ago.

In the brick and mortar segment, Good Neighbor Pharmacy ranks highest among chain drug store
pharmacies; Target ranks highest among mass merchandiser pharmacies; and Publix ranks highest
among supermarket pharmacies.
The 2013 U.S. Pharmacy Study is based on responses from more than 13,500 pharmacy customers who
filled a new prescription or refilled a prescription during the three months prior to the survey period.
Customer satisfaction with brick and mortar pharmacies is measured across five key factors: prescription
ordering; store; cost; non-pharmacist staff; and pharmacist. Four factors are examined in the mail-order
segment: cost; prescription delivery; prescription ordering process; and customer service experience.
The study, now in its seventh year, was fielded between July and August 2013.
Pharmacy coalition endorses PBM reform legislation
A coalition that includes pharmacy-advocacy groups has endorsed legislation it says will bring fairness
and integrity to the Medicare Part D pharmacy program.
The PBM Reform Coalition sent a letter of support to backers of U.S. Senate legislation that addresses
standards for basic pharmacy audits, further transparency of payment methodology to pharmacies, and
recoupment of funds to Medicare by pharmacy benefit managers (PBMs). Members of the coalition
include the National Association of Chain Drug Stores (NACDS), the National Community
Pharmacists Association (NCPA), the Food Marketing Institute, GeriMed, H-E-B, MHA, Omnicare,
PCAN, PharMerica, and Walgreens.
For more information visit www.rxchoiceandaccess.com/
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Classified Advertisements
Classified Advertisements are free to members. Members are encouraged to take advantage of this
benefit. Individuals interested in placing classified advertisements should contact the Association.

MIPA is updating its fax and distribution list. Store members and owner/manager members can
receive timely information and updates by fax and are eligible for this service at no extra charge.
Members must have a dedicated fax line. To be added to this list send your name and fax number to
the Association.

MIPA is updating its email distribution list. All members can receive timely information from the
Association. To be added to this list send your email address to Todd Brown at [email protected]
Two Positive Changes for Medicare D Plans
Two Medicare Part D policy changes that will promote meaningful adherence and reduce medication
waste will take effect in the 2014 plan year. The new edition of the Medicare & You handbook mailed to
all Medicare beneficiaries last month addresses both automatic mail order refills and prorated copays.
The key sections state:

"...some automatic delivery services were creating waste and unnecessary costs for people with
Medicare and the Part D program. By January 2014, to make sure you still need a prescription before
they send you a refill, prescription drug plans should get your approval to deliver a prescription, new
or refill, before each delivery, except when you ask for the refill or request a new prescription… The
plan won't automatically ship your refills unless you confirm you still want to get the order. This
new policy won't affect refill reminder programs where you go in person to pick-up the prescription
and it won't apply to long-term care pharmacies that give out and deliver drugs."

"Usually, the amount you pay for a covered prescription is for a one-month supply of a drug.
However, starting in 2014, you can request less than a one-month supply for most types of drugs.
You might do this if you're trying a new medication that's known to have significant side effects or
you want to synchronize the refills for all your medications. If you do this, the amount you pay is
reduced based on the quantity you actually get. Talk with your prescriber to get a prescription for
less than a one-month supply."
Purdue Hands California List of Risky OxyContin Prescribers
Purdue Pharma spokesman Jim Heins said that his company has recently complied with a request from
the Medical Board of California to turn over the names of 49 doctors in the state who are suspected of
prescribing OxyContin in a reckless fashion. Heins added that since Purdue provided the names of the
doctors, the Medical Board has made a new request that covers a longer period of time.
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