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18 Mich. St. U. J. Med. & L. 1 Michigan State University Journal of Medicine & Law Spring, 2014 GAUGING THE HEARTBEAT OF E-PRESCRIPTIONS? - A RETROSPECTIVE ANALYSIS Samuel D. Hodge, Jr. 1 Allison Kilcourse 2 Copyright © 2014 Michigan State University Journal of Medicine & Law; Samuel D. Hodge, Jr. and Allison Kilcourse The desire to take medicine is perhaps the greatest feature which distinguishes man from animals. ---Sir William Osler (1849 -1919) I. Statistical Overview 3 II. Medication Errors 4 III. Pharmacist Liability 5 IV. Physician Liability 6 V. The E-Prescription Process 7 VI. E-Prescriptions and the Government 9 VII. Electronic Prescriptions and the Private Sector 11 VIII. The Disadvantages of E-Prescriptions 12 A. State Responses to Electronic Prescriptions 16 1. General E-Prescription Laws 16 2. Controlled Substances 20 IX. Cases Involving E-Prescriptions 22 A. Administrative Rulings 22 B. Criminal Cases 23 C. Malpractice 25 X. Conclusion 26 Medicine has undergone a major transformation in the way routine business is transacted. This metamorphous is primarily the result of converting paper charts into electronic medical records. 3 The government has invested *2 heavily in this digital conversion by providing financial incentives and imposing penalties to encourage its implementation. 4 This incentive program included the conversion to digital prescriptions. 5 “[A] record 788 million prescriptions were routed electronically in 2012,” and this number will only increase with time. 6 E-prescription 7 is a computer generated system that allows physicians to electronically transmit medication orders “directly to a pharmacy from the point-of-care.” 8 The inclusion of electronic prescribing 9 in the Medicare Modernization Act of 2003 provided the impetus for this change, and the Institute of Medicine's report in 2006 on the role of e-prescribing in reducing medication mistakes received much publicity, helping to promote awareness of e-prescribing's role in improving patient safety. 10 *3 Compared to paper or fax prescriptions, e-prescribing improves medication safety, improve[s] prescribing accuracy and efficiency, increase[s] practice effectiveness while improving health care quality and reducing health care costs. 11 This article will explore the issues involving e-prescriptions and will examine whether the touted benefits of the system have come to fruition. I. Statistical Overview There has been a significant increase in the issuance of medication recently because of the development of new drugs and the need to care for the elderly. 12 One merely has to look at the growth of pharmacies in local neighborhoods to appreciate this fact. Whether these businesses are stand-alone stores or branches in supermarkets, pharmacies are dominate fixtures in the landscape. This development is not surprising because the vast majority of individuals take at least one pill on a daily basis, and more than one quarter of the population ingests five pills or more. 13 Those over 65 are the biggest consumers of drugs, and the use of multiple medications has risen during the past

Gauging the Heartbeat of E-Prescriptions

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18 Mich. St. U. J. Med. & L. 1

Michigan State University Journal of Medicine & Law

Spring, 2014

GAUGING THE HEARTBEAT OF E-PRESCRIPTIONS? - A RETROSPECTIVE ANALYSIS

Samuel D. Hodge, Jr.1 Allison Kilcourse2

Copyright © 2014 Michigan State University Journal of Medicine & Law; Samuel D. Hodge, Jr. and Allison Kilcourse

The desire to take medicine is perhaps the greatest feature which distinguishes man from animals.

---Sir William Osler

(1849 -1919) I. Statistical Overview 3

II. Medication Errors 4

III. Pharmacist Liability 5

IV. Physician Liability 6

V. The E-Prescription Process 7

VI. E-Prescriptions and the Government 9

VII. Electronic Prescriptions and the Private Sector 11

VIII. The Disadvantages of E-Prescriptions 12

A. State Responses to Electronic Prescriptions 16

1. General E-Prescription Laws 16

2. Controlled Substances 20

IX. Cases Involving E-Prescriptions 22

A. Administrative Rulings 22

B. Criminal Cases 23

C. Malpractice 25

X. Conclusion 26

Medicine has undergone a major transformation in the way routine business is transacted. This metamorphous is primarily the result of

converting paper charts into electronic medical records.3 The government has invested *2 heavily in this digital conversion by providing

financial incentives and imposing penalties to encourage its implementation.4 This incentive program included the conversion to digital

prescriptions.5 “[A] record 788 million prescriptions were routed electronically in 2012,” and this number will only increase with time.6

E-prescription7 is a computer generated system that allows physicians to electronically transmit medication orders “directly to a pharmacy

from the point-of-care.”8 The inclusion of electronic prescribing9 in the Medicare Modernization Act of 2003 provided the impetus for this

change, and the Institute of Medicine's report in 2006 on the role of e-prescribing in reducing medication mistakes received much publicity,

helping to promote awareness of e-prescribing's role in improving patient safety.10

*3 Compared to paper or fax prescriptions, e-prescribing improves medication safety, improve[s] prescribing accuracy and efficiency,

increase[s] practice effectiveness while improving health care quality and reducing health care costs.11

This article will explore the issues involving e-prescriptions and will examine whether the touted benefits of the system have come to fruition.

I. Statistical Overview

There has been a significant increase in the issuance of medication recently because of the development of new drugs and the need to care

for the elderly.12 One merely has to look at the growth of pharmacies in local neighborhoods to appreciate this fact. Whether these

businesses are stand-alone stores or branches in supermarkets, pharmacies are dominate fixtures in the landscape. This development is not

surprising because the vast majority of individuals take at least one pill on a daily basis, and more than one quarter of the population ingests

five pills or more.13 Those over 65 are the biggest consumers of drugs, and the use of multiple medications has risen during the past

decade.14 “In any given week 56% of children are taking at least one medication and 27% take two or more; 21% use at least one

prescription drug.”15 Therefore, it is not surprising that there are a number of problems associated with the issuance and consumption of

drugs.

According to the Department of Heath and Human Services, a study commissioned by the National Association of Chain Drug Stores

concluded that employees of drug stores place over 150 million calls to physicians each year to discuss perceived medication mistakes or to

obtain an explanation of prescription orders.16

Handwriting medication orders can be unproductive because of the frequent need to contact heath care providers over poor penmanship,

and having to re-enter the information required to satisfy federal and state reporting requirements. *4 17 An ancillary problem is that the sick

are inconvenienced by wasting time while their prescriptions are filled.18

II. Medication Errors

Medication is an amazing supplement for improving health. It can be utilized to “cure infectious diseases, prevent problems from chronic

diseases, and ease pain. But medicines can also cause harmful reactions if not used properly. Errors can happen in the hospital, at the

doctor's office, at the pharmacy, or at home.”19

A medication error is defined as follows:

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the

health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and

systems, including prescribing order communication, product labeling, packaging, and nomenclature; compounding; dispensing; distribution;

administration; education; monitoring; and use.20

It is not surprising, therefore, that medication errors injure “at least 1.5 million people every year.”21 In fact, it is estimated that “at least one

medication error per hospital patient, per day occurs,” and “400,000 preventable drug-related injuries happen each year.”22 Further, “800,000

medication errors also occur in long-term care settings and about 530,000 occur among Medicare patients.”23

The National Academy of Sciences has enumerated several ways to decrease mistakes. The first recommendation calls for improving

patient-provider partnerships while encouraging consumers to become active partners in their own care.24 New and improved drug

information resources are called for as well, with improved web sites to “serve as a centralized source of comprehensive, objective, and

easy-to-understand information about drugs for consumers” and improved “drug naming, labeling, and packaging.”25

The most prominent of these recommendations, however, is the implementation of e-prescriptions. “Studies indicate that paper-based

prescribing is *5 associated with high rates of error.”26 “Electronic prescribing is safer because it eliminates problems with handwriting

legibility and, when combined with decision-support tools, automatically alerts prescribers to possible drug interactions, allergies, and other

potential problems.”27

III. Pharmacist Liability

Pharmacists are not immune from lawsuits over medication errors even though a health care provider issues the prescription. “Generally, a

pharmacist does not generally have a duty to question a judgment made by a physician as to the propriety of a prescription,” but “a

pharmacist does have a duty to be alert for clear errors28 and mistakes with a prescription.”29 Clear errors include, “obvious lethal doses;

inadequacies in the instructions; known contraindications; or incompatible prescriptions.”30 The extent to which particular jurisdictions hold a

pharmacist liable varies.31 For instance, “[s]ome courts have recognized the duty of a pharmacy to read prescriptions and be aware of patent

inadequacies in the instructions as to the maximum safe dosage of known toxic drugs and medicines”; however, other courts have noted that

“a pharmacist has no common law or statutory duty to refuse a prescription simply because it is for a quantity beyond that normally

prescribed or to warn the patient's physician of that fact.”32Additionally, “[t]he Omnibus Budget Reconciliation Act (OBRA) of 1990 expanded

the pharmacist's role in reducing the risks of prescribed drugs by requiring that they counsel Medicaid recipients.”33

*6 If a claim is brought against a pharmacist, three approaches can be used by the plaintiff:

first, they can request the claim to assert that a reasonable pharmacist concerned about the safety and efficacy of the prescribed drug has a

duty to communicate with the prescribing doctor Second, if the state has passed a statute or regulation specifically imposing a duty on

pharmacists to warn or counsel, plaintiffs can invoke that law as defining a new standard of care for pharmacists Third, plaintiffs can argue

that these earlier decisions present[[[] a standard-of-care question for the jury, one that turns on the facts of particular cases.34

Regardless of specific case law, it is widely accepted that a pharmacist has a duty to accurately fill a prescription.35 While this requirement

has been upheld in a number of cases,36 other courts have held that “the pharmacist has no duty to caution the patient of the possible

undesirable effects of the drug, absent special circumstances or neglect.”37

IV. Physician Liability

Medication errors by physicians can occur in a variety of ways, ranging from the writing of the initial prescription to the administration of the

drug. Obviously, a person may be injured if the physician prescribes the wrong medication or the doctor misdiagnosis the medical issue and

prescribes the wrong medicine.

The list of possible mistakes and errors seems endless; however, the most common error involves the dosage - the patient is provided with

either too little or too much of a drug.38Prescriptions mistakes can be fatal and are *7 traditionally caused by a doctor's inadequate

understanding of a drug's use, prescriptions that are hard to read, or medication errors attributable to drugs that have similar sounding

names.39

V. The E-Prescription Process

The high incidence of an adverse drug event is not surprising considering the complexity of medical care.40 Because of the claimed ability to

reduce medication orders that are hard to read, e-prescriptions are advocated as a method to eliminate this problem. After all, this new

electronic system is able to provide the doctor with an automated warning system at the time the prescription is issued while the doctor is

able to view the medical records of the patient.41 The pharmacy is aided by the smaller number of medication errors that require clarification

and the elimination of paper prescriptions. These benefits allow the druggist to spend more time with the customer.42

The e-prescription system relies upon computers and their data entry abilities.43 A basic system will include the necessary e-prescribing

software and internet connection between the heath care provider and pharmacy.44 The American College of Rheumatology notes that the

system has the advantage of allowing a doctor to electronically review the patient's health insurance coverage and medication history and

sending the prescription over the internet directly to the patient's pharmacy.45 It also allows the pharmacy to electronically notify the physician

when the medication has to be renewed.46

The digital transmission process starts when the patient and doctor discuss the current problems and treatment options. As the electronic

prescription *8 is typed, the e-prescribing system links electronically to a hub to ascertain whether the person is eligible for payment of the

medication.47 The patient's up-to-date medication history is then displayed to the doctor at the point-of-care.48 This is reviewed along with

clinical alerts, prescription history, eligibility, and prior authorization information, followed by the physician choosing the therapy and verifying

the patient's pharmacy of choice.49 Once the prescription is completed, the e-script is sent to the pharmacy. The druggist then fills the

prescription and sends a fill acknowledgment to the physician.50

Converting to an electronic prescription system, however, is not without its financial costs.51 The first step requires a choice between a stand-

alone or e-prescribing within an electronic medical records system or EMR.52 A stand-alone system is cheaper and easier to install. However,

it may not have the full performance abilities of an electronic medical records system.53 Additional factors that go into the selection process

include the cost of a wireless network, the price of the hardware, licensing fees for the software and the conversion cost of transferring the

existing records to the electronic system. Other considerations include networking costs, such as Internet connectivity, wireless network,

practice management system integration into the new system; hardware costs such as desktops, laptops, servers, and printers; software

licensing costs and future upgrades; yearly fees, such as subscription or licensing costs; training and support; transferring records from the

existing system to the new one; and creating communication procedures between the current office equipment and the e-prescribing

system.54

A survey conducted by the Texas Medical Association determined that the median cost for implementing an EMR system was about $25,000

per doctor.55 The following table depicts the usual costs for lower, mid-range, and *9 higher cost EMRs systems for an average size practice

in Texas, which consists of 3.5 full time employed physicians.56 Sample Costs (Based on an Average, 3.5-physician practice)

Item Product A Product B Product C

Software Licenses $ 31,980 $ 61,020 $ 71,000

Data Conversion $ 2,995 $ 2,900 $ 5,000 Other Licenses - $ 6,691 $ 8,000

Training $ 6,205 $ 26,449 $ 50,635

Installation $ 4,480 $ 12,345 $ 4,940

Discounts - ($ 23,215) ($ 19,402)

Annual Recurring Costs $ 12,871 $ 26,834 $ 21,537

Hardware/Network $ 30,000 $ 30,000 $ 30,000

Project Total $ 88,531 $ 143,024 $ 171,710

These costs seem expensive but the government provided substantial incentives to hospitals and physicians under Medicare and Medicaid

for those who complied with the mandates of “meaningful use” by 2011.57 The financial inducements offered by the government under

Medicare can reach $44,000 and $63,750 under Medicaid.58

VI. E-Prescriptions and the Government

The federal government has actively encouraged and heavily invested in the adoption of e-prescriptions.59 The Electronic Prescribing (eRx)

Incentive Program utilizes a mixture of incentive payments and compensation adjustments to boost electronic prescribing by eligible health

care providers.60 Health care providers of Medicare patients who use an e-prescribing system for patients covered by the “Physician Fee

Schedule” will receive a financial incentive *10 by the government.61 Conversely, physicians who do not utilize this new electronic

prescription system for Medicare Part B services will be fined starting in 2012.62 Those who have not become electronic prescribers63 will be

subject to a 2.0% payment adjustment on their Medicare Part B fees for services provided in 2014.64 As the Secretary of Health and Human

Services Secretary noted, the e-prescribing incentives and penalties set forth in the Medicare law will “have a profound effect on the adoption

and use of e-prescribing.”65

The following table represents the carrot and stick approach offered by the federal government:66

INCENTIVE/PENALTY SCHEDULE

YEAR INCENTIVE PENALTY

2009 2% 0%

2010 2% 0%

2011 1% 0% 2012 1% -1%

2013 0.5% -1.5%

2014 0% -2%

Beyond 0% -2%

Any health care professional who orders medications is bound by the requirements of the eRx program.67 Generally, those who do not

actively participate in a Medicare program are exempt.68

*11 Federal law judiciously monitors the issuance of controlled substances and traditionally required that a prescription for a controlled

substance be in writing, and that prerequisite may only be satisfied through the issuance of a paper prescription. Because of the

advancements in technology and security proficiencies for electronic uses, the Drug Enforcement Administration recently amended its

regulations to afford doctors with the option of using electronic prescriptions for controlled substances instead of paper prescriptions.69 Some

states now allow controlled substances to be prescribed electronically while others exclude Schedule II controlled drugs because of their high

risk for abuse.70

VII. Electronic Prescriptions and the Private Sector

“The private sector has spurred the growth of e-prescribing as well. Several private initiatives, by insurers and other payors, have increased

the frequency of e-prescribing. Most notably, the National ePrescribing Patient Safety Initiative (“NEPSI”) coalition is dedicated to the

increased use of e-prescribing software.”71 “NEPSI has offered free software to physicians that encounter financial barriers in their

practices.”72 Some private health insurance carriers have also actively encouraged the implementation of digital prescriptions. For example,

“Horizon Blue Cross Blue Shield of New Jersey serves as the conduit for organizations in New Jersey interested in adopting NEPSI's free

eRx solution, eRx NOW from Allscripts.”73 This software enables Rx powered technology to help physicians write electronic

prescriptions.74 “Network physicians who have implemented an approved electronic prescribing (e-prescribing) tool may also be eligible for

discounts on their medical malpractice insurance premiums.”75 Blue Cross and Blue Shield of Illinois is an advocate of this new system

because it believes that e-prescriptions will increase patient safety by affording heath care providers the ability to transmit medication orders

directly *12 from their offices to the pharmacy.76 Humana Insurance Company notifies its subscribers that doctors benefit from electronic

prescriptions because it gives them access to medication, health, and personal information to ensure that physicians are able to prescribe

the correct medicines.77 This electronic system allows the doctor to “pull up [patient] prescription benefit information, access specific drug

information, and electronically track any problems [the patient] may have with certain medicines.”78

VIII. The Disadvantages of E-Prescriptions

The use of E-prescriptions by physicians continues to grow. It has been reported that in 2012, 47% of visits to physicians generated an

electronically delivered medication history and 44% of drug orders were sent electronically.79 Small practices were the leaders in the

adoption of e-prescribing, with 65% of practices with six to ten doctors being e-subscribers.80 E-Prescriptions, however, are not without their

problems and some of the claimed benefits for adoption have not come to fruition.

Some of the major barriers to EMR use that have consistently emerged are high startup costs, slow and uncertain financial payoffs, and large

initial physician expenditures of time.81 The Center for Health Systems Change also notes that physicians have emphasized “two barriers to

use: 1) tools to view and import the data into patient records [are] cumbersome to use in some systems; and 2) the data [is] not always

perceived as useful enough to warrant the additional time to access and review them, particularly during time-pressed patient visits.”82

While these are understandable issues and most likely represent short term problems, prescription errors persist with the digital systems.

Surprisingly, e-prescriptions are not error free with a mistake rate that is comparable to the traditional handwritten order.83 For instance, an

error rate of more than sixty *13 percent was found in electronic medication orders for failing to provide such things as drug usage or

dose.84 Error rates also varied by computerized prescribing system, from 5.1% to 37.5%;85 one-third of those mistakes had the potential for

harm.86 “A breakdown of the errors by category showed that the four most common classes of drugs containing medication errors were anti-

infectives (40.3%), nervous-system drugs (13.9%), and respiratory-system drugs (8.6%). The most common drug classes associated with

potential [adverse drug events] were nervous-system drugs (27.0%), cardiovascular drugs (13.5%), and anti-infectives (12.3%).”87 One

expert explained that many of the errors or miscommunications that happen with digitally sent prescriptions occur because physicians are not

providing all of the necessary information concerning the medication that needs to be issued such as the complete product name, strength

and dosage.88 The e-prescription may also be transmitted to the pharmacy with the correct drug name, but not the correct strength and/or

dosage.89 Common abbreviations used on handwritten prescriptions may also “get lost in translation” if they are entered into the e-

prescription platform.90 There have even been cases where physicians have added notes concerning a patient's use of the medication, but

this practice has resulted in additional confusion on occasion because there may be a discrepancy between the pharmacy records and the

instructions by the physician.91

The error rates and their severity also varied by computerized prescribing system, implying that some systems may be better suited for

preventing mistakes than others.92 Therefore, merely implementing a computer system for dispensing medication is not the answer.93Instead,

the prescribing system must have comprehensive functionality and processes in place to guarantee meaningful system use in order to

decrease medication errors.94 A different study supported these findings and noted that “[b]asic computerized prescribing systems may not

be adequate to reduce errors. More advanced systems with *14 dose and frequency checking are likely needed to prevent potentially harmful

errors.”95

Another analysis of users of electronic transmission of new prescriptions reported that about one-third of patients arrived to pick up their

medication before the pharmacy had received the orders.96 Some doctors blame this development on the failure of pharmacy workers to be

adequately trained to appreciate new e-prescriptions.97 This problem, however, should disappear once workers gain more familiarity with this

new system.98Pharmacist counter by blaming the doctor for the failure to promptly send the prescription or by transmitting the medication

orders to the wrong drug store.99

All parties noted that the electronic renewal process was not as successful on a consistent basis.100 New prescription routing and renewals

proved to be more challenging to assimilate into organization workflows.101 Physicians who received e-renewal requests identified several

ways in which this process broke down causing inefficiencies.102 They complained that pharmacy did not also request electronic renewals of

medication orders or make duplicative requests for a particular medication by different means even though the physician had responded to

the initial request electronically.103 Nevertheless, those who answered the survey emphasized the time-saving benefits of the electronic

renewal procedure when working correctly.104

A number of physicians also use e-prescriptions just enough to avoid the financial penalties imposed by the federal government, but “‘they

don't make e-prescribing part of their routine”’ practices.105 Part of this resistance is because their staffs are not doing their part in the

process.106 For example, “[t]he nurses or medical assistants may not have entered the medication lists for patients who haven't [been] seen

since the doctor started e-prescribing. In some cases, they haven't asked patients about their preferred pharmacies and put those in the

system.”107

*15 Even with the benefits of e-prescriptions some physician are simply reticent to convert to this digital system.108 Reasons vary and include

not wanting to use a computer, not wanting to incur the cost of the program, and being afraid that their employees won't use the

system.109 Some physicians have experienced problems with the drop down menu screens where the doctor is requested to enter the correct

dosage.110 Some systems don't confirm the dosage, and in other cases, the doctor incorrectly selects the value above or below the proper

dosage. Another criticism is “alert fatigue” where so many cautions appear that physicians start to ignore them.111 In fact, it was found that

few physicians alter their prescriptions in response to a drug allergy or interaction notice, and there are a few systems that the threshold for

alerting was fixed too low.112 The recommendation was that “[c]omputerized physician order entry systems should suppress alerts for

renewals of medication combinations that patients currently tolerate” without harm.113

The Health Insurance and Accountability and Portability Act of 1996 (HIPAA) also plays a role in the adoption of digital system with the

enactment of regulations on security and privacy.114 Several mandates must be followed, including: “secure point-to-point electronic

transmission of the prescription at each [connection] in the chain, entity authentication, audit trails and data authentication to ensure that data

have not been changed or altered during transmission.”115 Each doctor who is allowed to use the e-Rx software is provided with a name and

unique password that must be protected and learned.116 This has raised the concern that the busy doctor must remember yet a different

password.117Nevertheless, use of a password to enter the electronic prescription system is necessary for security purposes.118 Perhaps in

the future, entry may be obtained by using iris patterns, fingerprints or proximity badges.119

*16 E-prescriptions may subject physicians to special malpractice concerns.120 Doctors now have the ability to review the medication history

of a patient through this new electronic system, so they may be held accountable for an adverse drug reaction with medication ordered by

another doctor.121 For example, the e-prescribing system has the ability to notify a doctor of an adverse drug reaction with another pill that

the patient is taking.122 Even though the physician did not order that other medication, a duty may be imposed on the doctor to investigate

that possible drug interaction.123

A. State Responses to Electronic Prescriptions

States have enacted legislation or adopted regulations to address e-prescribing of non-controlled substances but these laws are of recent

vintage which is a reflection of digital medication orders being in their infancy stage.124 As a general rule, these directives regulate the

prescribing and filling of e-prescriptions by healthcare professions and pharmacies.125

An analysis demonstrates that these laws are not uniform. Some states set up detailed requirements for the use of e-prescriptions and others

impose privacy of information safeguards. Several states require pharmacists to exercise professional judgment regarding the accuracy,

validity, and authenticity of these digital prescriptions. The difficulty is that some of the state laws meant to implement electronic prescriptions

may actually complicate its use. Some of the problems include: contradictory prescription mandates among varying sets of statutes and

regulations; requiring pharmacies to keep e-prescription records in hard copy; and patient consent mandates for the digital transmission of

their prescription orders.126

1. General E-Prescription Laws

The following are sample statutes to provide a flavor of the different approaches taken by the states. Oregon was an earlier adopter of a law

on electronic *17 prescription when it enacted legislation in 2003.127 That state provides that prescription drug orders may be sent

electronically from a practitioner authorized to prescribe drugs directly to the dispensing pharmacist of the patient's choice with no intervening

person having access to the drug order.128 The form must contain the doctor's telephone number for verbal confirmation, the time and date of

transmission, the identity of the pharmacy intended to obtain the order and all other information required for a prescription by federal or state

law; and the transmission must be traceable to the prescribing practitioner by a digital signature or other secure method of validation.129 A

duty is imposed upon the dispensing pharmacist to exercise professional judgment regarding the accuracy, validity and authenticity of drug

order.130 Finally, no additional charge may be made to the patient because the drug order was transmitted electronically.131

Michigan amended its law in 2012 to provide that a prescription may be transmitted electronically as long as the order form is transmitted in

compliance with the Health Insurance Portability and Accountability Act of 1996.132 The electronically transmitted prescription must include

the name, address and telephone of the ordering doctor, the name of the patient, an electronic signature or other identifier that identifies and

authenticates the prescriber, the time and date of the transmission, the identity of the pharmacy intended to obtain the order and any other

information required by federal or state law.133 Michigan also imposes a duty on the pharmacist to “exercise professional judgment regarding

the accuracy, validity, and authenticity of the transmitted prescription.”134

South Carolina provides that a practitioner “may electronically transmit a prescription to a pharmacy” under very rigorous conditions.135 South

Carolina further requires that a doctor/patient relationship exist; “the prescription must identify the [doctor's] phone number, the time and date

of transmission, and the pharmacy intended to receive the transmission.”136 Additionally,

[t]he prescription must be transmitted by the authorized practitioner or the practitioner's designated agent to the pharmacy of the patient's

choice, and the prescription must be received only by a pharmacy, with no intervening person or entity having access to view, read,

manipulate, alter, store, or delete the electronic prescription prior to its receipt at the pharmacy.137

*18 The prescription must also contain the doctor's electronic or digital signature or key code.138 Nothing, however, may be construed to

prohibit a physician from utilizing a routing firm to transmit a prescription, except that a routing company shall provide its tax identification

number to the Board of Pharmacy before offering its services.139

Washington provides that a prescription may be sent electronically to a pharmacy of the patient's choice if the electronic transmission

“compl[ies] with all applicable statutes and rules regarding the form, content, recordkeeping, and processing of a prescription for a legend

drug;” the systems sending and receiving the electronic drug request must be approved by the board, but these requirements do “not apply

to facsimile equipment transmitting an exact visual image of the prescription.”140 Medication orders are to be treated as “confidential health

information, and may be released only to the patient or the patient's authorized representative, the prescriber or other authorized practitioner

then caring for the patient, or other persons specifically authorized by law to receive such information.”141 Like a number of other jurisdictions,

a duty is imposed upon the pharmacist to “exercise professional judgment regarding the accuracy, validity, and authenticity of the

prescription drug order received [electronically], consistent with federal and state laws.”142

Alabama has a regulation that is directed to electronic prescriptions for non-controlled legend drugs and mandates that “the prescription must

include the patient's name and address, the drug prescribed, strength per dosage unit, directions for use, and the name of the prescriber or

authorized agent.”143 Prescriptions

transmitted over an e-prescription network approved by the Board [and] all transmissions must ensure appropriate security and authenticity

to include the following: An electronic signature process enabling the pharmacy to ensure the identity of the prescriber; [the] [d]ate and time

stamp; [a] transmitting system identifier; [a] prescriber internal sender identification; and a pharmacy internal receiver identification.144

California's law is contained in its Administrative Code and provides that “prescriptions may be transmitted by electronic means from the

prescriber to the pharmacy.”145 “An electronically transmitted prescription order shall include the name and address of the prescriber, a

telephone number for oral confirmation, date of transmission and the identity of the recipient, as well as any other information required by

federal or state law or regulations.”146 “A *19 pharmacy receiving an electronic image transmission prescription shall either receive the

prescription in hard copy form or have the capacity to retrieve a hard copy facsimile of the prescription from the pharmacy's computer

memory.”147 Also, its law provides that “[a]n electronically transmitted prescription shall be transmitted only to the pharmacy of the patient's

choice.”148 “This requirement shall not apply to orders for medications to be administered in an acute care hospital.”149

Minnesota's law, which became effective on January 1, 2011, is very detailed and requires that “all providers, group purchasers, prescribers,

and dispensers must establish, maintain, and use an electronic prescription drug program.”150 All transactions “must use either HL7

messages or the NCPDP SCRIPT Standard to transmit prescriptions or prescription-related information internally when the sender and the

recipient are part of the same legal entity.”151 “If an entity sends prescriptions outside the entity, it must use the NCPDP SCRIPT Standard or

other applicable standards required by this section.”152 “[A]ny clinic with two or fewer practicing physicians, [however,] is exempt if the clinic is

making a good-faith effort to meet the electronic health records system requirement that includes an electronic prescribing

component.”153 The statute then enumerates twelve transactions that must use the NCPDP SCRIPT Standard including transactions such as

new prescription transactions, prescription change request transactions and prescription change response transactions.154

Pennsylvania law defines an electronically transmitted prescription as an original prescription or refill authorization sent by electronic means,

and includes computer-to-computer, computer-to-facsimile machine or e-mail transmission.155 That prescription must be sent directly to a

pharmacy of the patient's choice and include the prescriber's telephone number, the date of the transmission, the name of the pharmacy

intended to receive the transmission and the prescription must be electronically encrypted or transmitted by technological means designed to

protect and prevent access, alteration, manipulation or use by any unauthorized person.156 A hard copy or a readily retrievable image of the

prescription information must be stored for at least two years.157

*20 2. Controlled Substances

Since the federal government only recently granted physicians the right to electronically dispense controlled substances, a number of states

have not yet addressed this issue. Pennsylvania, however, has considered the issue and noted that “a prescription for a Schedule II, III, IV or

V controlled substance is considered a written prescription order on a prescription blank and may be accepted by a pharmacist provided that

the transmission complies with this chapter and other requirements....”158 Minnesota provides that Schedule II controlled substances may

only be issued through a written prescription or, in an emergency situation, may be dispensed at the oral prescription of a practitioner so long

as it is reduced promptly to writing and filed by the pharmacist.159 West Virginia also restricts the issuances of Schedule II substances to an

emergency but the statute does not include Minnesota's rule that the prescription must then be reduced to writing.160 Kentucky law

specifically notes a Schedule II substance may only be issued through a written prescription while Schedules III, IV, and V drugs may be

dispensed following a written, electronic, or oral prescription.161

Kansas provides that, in emergency situations, a controlled substance in Schedule II “may be dispensed upon oral prescription of a

prescriber [as long as the order is] reduced promptly to writing or transmitted electronically and filed by the pharmacy.”162 However, no refills

are allowed for a Schedule II substance.163 California allows physicians to only prescribe Schedule II, III, or IV drugs pursuant to § 4170 of

California's Business and Professions Code, which requires that prior to dispensing, the prescriber must offer to provide a written prescription

to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.164 Electronic prescriptions for Schedule II drugs

in Alabama and Montana cannot be issued without an accompanying hard-copy prescription while e-prescriptions for controlled substances

classified as III-V are prohibited.165

New York's law is very specific when it comes to issuing controlled substances.166 That state's law provides that “[n]o controlled substance

may be [issued] except on an official New York state prescription or on an electronic prescription, and in good faith and in the course of [the

doctor's] professional *21 practice only.”167 The prescription must contain the name, address, and age of the ultimate user; the name,

address, Federal registration number, telephone number, and digital signature of the prescribing practitioner; and it must contain specific

directions for use, including but not limited to the dosage and frequency of amount and the maximum daily dosage.168 “No such prescription

shall be made for a quantity of controlled substances which would exceed a thirty day supply....”169 New York, however, permits a physician

to order as much as three months of a controlled substance as long as it is given to treat a medical condition that has been specifically

identified by the commissioner as allowing the issuance of more than a thirty day supply.170

Texas law was amended in 2012 and appears to be one of the most detailed in the United States involving controlled substances.171 Texas

allows a doctor to e-prescribe a controlled substance listed in Schedule II as long as it sequentially numbered.172Prescriptions dealing with

controlled substances must contain the date the prescription is issued; the controlled substance prescribed; the quantity of controlled

substance prescribed, shown numerically if the prescription is electronic; the intended use of the controlled substance or the diagnosis for

which it is prescribed with the instructions for use of the substance; the practitioner's name, address, and Federal Drug Enforcement

Administration number issued for prescribing a controlled substance in Texas; the name, address, and date of birth or age of the person for

whom the controlled substance is prescribed; and, the earliest date on which a pharmacy may fill the prescription.173 Each dispensing

pharmacist is also mandated to fill in on the official prescription form in the electronic prescription record, each item of information given

orally to the dispensing pharmacy and the date the order is filled.174 Electronic prescription shall appropriately note the identity of the

dispensing pharmacist; retain with the records of the pharmacy for at least two years the electronic prescription, the name of the patient and

send all information required by the director, including any information required to complete an electronic prescription record, to the director

by electronic transfer not later than the seventh day after the date the prescription is filled.175

*22 IX. Cases Involving E-Prescriptions

There have not been many reported cases concerning e-prescriptions, presumably because the technology and its widespread use are fairly

new. Most of the published litigation involves criminal prosecutions.

A. Administrative Rulings

One of the earliest cases dealing with the electronic transmission of a prescription occurred in 1998.176 Walgreen Company was charged with

violating “various regulatory statutes and administrative rules relating to pharmacies when, as part of a test program, it [received]

prescriptions orders from [doctors] through [e-mail], and provided used computers for some of the physicians participating in the test.”177 In

Walgreen Co. v. Wisconsin Pharmacy Examining Bd., the Wisconsin Pharmacy Examining Board “concluded that the use of computer-

transmitted prescriptions violated [the law] which require[d] written prescription orders to be signed by the prescribing physician.”178Although

this was a case of first impression “involving computer transmission of prescriptions from physician to pharmacy,” the court found in favor of

Walgreens.179 It used as precedent a case in which a facsimile prescription transmission was equivalent to telephone orders.180

Logan v. St. Charles Health Council, Inc. involved a claim for a violation of a state privacy statute.181 The plaintiff, a physician, filed suit as the

result “of her employment by a federally-assisted health care center.”182 She “became credentialed to provide certain medical services to

veterans at [a clinic] [and] was provided an identification code that allowed her to electronically [send] prescriptions to the VA hospital

pharmacy, and access VA patient files.”183 The plaintiff claimed that while on vacation, others “began using [her] name and identification

code to write prescriptions to be filled at the VA pharmacy” without her knowledge.184 Additionally, the physician-plaintiff asserted that upon

her return, the defendants refused to take remedial action to correct the records related to those medication orders.185 The defense argued

that “[t]he Federal Tort Claims Act provides the exclusive remedy for damages resulting *23 from ‘the performance of medical, surgical,

dental, or related functions' by Public Health Service employees acting within the scope of their employment.”186 The plaintiff, however,

maintained that this federal law should not extend to her claim because her suit did not sound in medical malpractice.187 The court agreed

and remanded the matter to state court to proceed on the privacy statute violation.188

In Brighton Pharmacy, Inc. v. Colorado State Pharmacy Bd., a pharmacy and pharmacist appealed a challenge to the Colorado State

Pharmacy Board ruling that:

A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a

legitimate medical purpose by an authorized practitioner. A pharmacist shall not dispense a prescription drug if the pharmacist knows or

should have known that the order for such drug was issued on the basis of an internet-based questionnaire, an internet-based consultation,

or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.189

“[A] typical scenario addressed by this Rule involves websites to which a consumer can go and request a prescription for a particular

pharmaceutical.”190 “Requests for Viagra and hydrocodone constitute a significant portion of the business.”191 The purchaser then responds

to a variety of set questions exclusive to the requested drug.192 The person's responses are sent to a doctor who then issues the electronic

prescription through a participating pharmacy.193 Often, the parties are from varying states and have never met.194 Although the court

acknowledged that there are many legitimate scenarios in which this type of transaction could occur, it was in the bounds of the Board to

create and uphold the rule prohibiting prescriptions based on internet questionnaires.195

B. Criminal Cases

United States v. Hanny involved the sale of prescription drugs over the Internet.196 The defendant was a retired surgeon who received an

offer to work for “a company that sold prescription drugs over the Internet.”197 The company *24 wanted the physician “to authorize

prescriptions to its Internet customers.”198 Even though he “questioned the legality [[[of the business] and consulted an attorney,” the

defendant went to work for the company.199 “To authorize the sale, the physician would [affix] his electronic signature to the order.”200 The

doctor was not required to see the patient, and the electronic order was sent to a participating pharmacy to fill.201 The defendant authorized

over 2,400 medication orders and kept a portion of each sale.202 Eventually, the Missouri Board of Medicine informed the physician that his

actions were illegal, but he continued to prescribe medication.203 He was then charged with conspiring to distribute a controlled substance

outside the normal medical practice.204 The defendant pleaded guilty, and on sentencing, the judge determined that the physician was

involved in selling drugs through mass-marketing by means of an interactive computer service and received an enhancement penalty. This

decision was upheld on appeal.205

United States ex rel. Ciaschini v. Ahold USA Inc. involved a qui tam realtor claim by a whistle blower against a pharmacy alleging it had

submitted false claims to the government in order to obtain Medicare and Medicaid payments for prescription drugs provided to customers in

violation of the False Claims Act.206 The plaintiff was a licensed pharmacist at The Stop & Shop Supermarket Company in

Massachusetts.207 It was practice for the pharmacists employed by the business “‘to electronically submit prescriptions of a Beneficiary of a

Federal Health Care Program to Corporate Headquarters, which, in turn, electronically submitted the claim for payment to the Federal Health

Care Program through the [firm's] electronic billing system.”’208 The plaintiff alleged that these submissions were false for a number of

reasons.209 The court dismissed the suit because the plaintiff failed to provide sufficient details connecting the entry of the information in the

computer system to planned claims filed with the government.210

United States v. Ghassan Haj-Hamed, involved a physician who was “indicted on twenty-two counts of distributing prescription drugs without

a legitimate medical purpose.”211

*25 An investigation revealed that Dr. Haj-Hamed routinely spoke to patients for a minute or so without conducting any meaningful physical

examination. He then prescribed frequently abused controlled substances to the patients in exchange for cash payments. A confidential

source told agents that Dr. Haj-Hamed referred to himself as ‘Dr. Feel Good.’ Others considered him an easy source for obtaining Oxycontin

and other controlled substances. It was noteworthy is that he told patients to ‘fill their prescriptions in Ohio or Indiana to avoid Kentucky's

electronic prescription-tracking system.212

The government eventually dismissed twenty-one counts in exchange for the defendant pleading guilty to one count.213

Thacker v. Kentucky dealt with a person arrested for driving under the influence.214 During the traffic stop, a police officer found prescription

drug containers for controlled medications and learned that defendant had been charged with prescription forgery.215 A detective then

requested a KASPER report, which described the defendant's prescription activity in Kentucky and showed that suspect had been issued

overlapping prescriptions.216 The detective then questioned defendant's pharmacies about the prescriptions.217 The appellate court held that

the detective's use of the KASPER-derived information system was not an unreasonable search and seizure.218 Instead, the search

exception to an arrest warrant applied because the State had a substantial interest in tracing drug distributions, and the KASPER system

reasonably advanced that interest.219

C. Malpractice

In Washington v. United States, a claim was filed under the Federal Tort Claims Act as the result of an amputation of a leg and subsequent

patient death.220 The facts show that the decedent was an insulin dependent diabetic. He “stepped on a nail, causing a puncture wound to

his left foot[[[,]” developed an abscess, and was given a prescription which was ordered electronically by the doctor at the VA.221 To obtain

the medication after the doctor's visit, the patient presented himself “at the pharmacy located in the VA.”222Following his visit, the patient went

to the nurse whose notes show that he was sent to *26the pharmacy for medication and instructions.223 The decedent's wife, however, said

that the nurse told them that the medicine would be mailed, so they went home.224 The patient's name appeared on a list of those who failed

to pick up ordered prescriptions.225Two days later, he returned to the VA and his foot was much worse.226 He was finally given the medication

and the pharmacist noted that it was about to be mailed to him.227Two days later, the patient was seen at the VA Emergency Room with an

abscess and cellulitis.228 He was admitted to the hospital and his blood sugar count was highly elevated.229 Eventually, his leg was

amputated because the infection was not controlled.230 After a prolonged hospitalization, he died.231 Multiple counts of negligence were

advanced including that he was initially sent home with conflicting instructions relating to his medication so he was delayed in starting his

antibiotics.232 The court agreed and found in the decedent's favor.233

X. Conclusion

The issuance and consumption of medication has a number of problems. Historically, the staffs of pharmacies make millions of calls to

physicians in an effort to clarify prescriptions or to inquire about possible medication errors. Doctors and their staff also spend valuable time

each day answering these inquires. Electronic prescribing of medication has been heavily promoted as the solution to these problems, and

the federal government has spent millions of dollars to encourage physicians to adopt these digital systems. Unfortunately, errors persist with

electronic prescribing and healthcare providers question whether the time needed to view and import the information into patient records

merits the extra time needed to access and review them.

Regardless of the existing issues, so much time and money has been expended with this conversion process that digital prescriptions are not

about to disappear. Most of the experienced difficulties relate to the growing pains of new technology and the reluctance of people to adopt

and learn a new system. It is anticipated that these problems will be resolved in the coming years so the prognosis of electronic prescriptions

is robust. More and more healthcare providers will adopt this electronic method of prescribing medication especially in *27 view of the

financial penalties being imposed by the federal government for those who do not use this technology.

Footnotes

1

Samuel D. Hodge, Jr. is a professor and chair of the Legal Studies Department at Temple University where he teaches both law and

anatomy. He lectures nationally on anatomy and trauma and is considered one of the most popular speakers of continuing legal education

courses in the country. Professor Hodge is a graduate of Temple University Beasley School of Law and is a member of the American College

of Legal Medicine.

2

Allison Kilcourse currently works for the law firm of Galerman and Tabakin, LLP in Jenkintown, Pennsylvania. She is a graduate of Temple

University Beasley School of Law and completed her undergraduate studies at Saint Joseph's University, receiving a B.A. in International

Affairs and Political Science.

3

The American Recovery and Reinvestment Act deals with the conversion of paper charts into electronic medical records. It is believed that

there are many benefits for this conversion including streamlining patient care and providing long-term savings in the health field. The

electronic medical records stimulus also offers financial incentives and penalties to entice physicians to convert to the paperless electronic

medical record systems. See generally What are the Benefits of Electronic Medical Records?, MEDICALRECORDS.COM, http://

www.medicalrecords.com/physicians/what-are-the-benefits-of-working-with-emr (last updated May 21, 2013).

4

Charles S. Hartig, Regulatory Barriers When Implementing E-Prescribing of Controlled Substances: Could Model Language Be The

Solution?, 5 ST. LOUIS U. J. HEALTH L. & POL'Y 213, 217 (2011). As President George Bush noted in his State of the Union Address on

January 20, 2004: “By computerizing health records, we can avoid dangerous medical mistakes, reduce costs, and improve care.” He also

believes that innovations in electronic health records and the secure exchange of medical data will assist in transforming health care by

improving health care quality, reducing paperwork, preventing medical errors, reducing health care costs, improving administrative

efficiencies, and increasing access to affordable health care. See generally Transforming Health Care: The President's Health Information

Technology Plan, THE WHITE HOUSE, http://georgewbush-whitehouse.archives.gov/infocus/technology/economic_

policy200404/chap3.html (last visited June 21, 2013).

5

VIST-A was the first major initiative into the world of electronic health records and e-prescribing, with the Veteran Affairs' computerization of

health records. Douglas Goldstein et al., Case Studies of VistA Implementation — United States and International, in MEDICAL

INFORMATICS 20/20, 223, 226, 263 (2007), available at http:// www.jblearning.com/samples/0763739251/39251_ CH09&uscore;

223_284.pdf; see also Charles S. Hartig, Regulatory Barriers When Implementing E-Prescribing of Controlled Substances: Could Model

Language Be The Solution?, 5 ST. LOUIS U. J. HEALTH L. & POL'Y 213, 213-214 (2011).

6

The National Progress Report on E Prescribing and Safe Rx Rankings, SURESRCIPTS, http://www.surescripts.com/about-e-

prescribing/progress-reports/national-progress-reports (last visited June 26, 2013).

7

The court in Brody v. Zix Corp., No. 3:04-CV1931-K, 2006 WL 2739352, at *1 (N.D. Tex., 2006) noted that electronic prescriptions were

“intended to alleviate problems with illegible physician handwriting on prescriptions and help doctors streamline the process of dealing with

insurance companies and pharmacies.”

8

E-Prescribing, CENTERS FOR MEDICARE AND MEDICAID SERVICES, http:// www.cms.gov/Medicare/E-

Health/Eprescribing/index.html?redirect=/eprescribing/ (last visited June 21, 2013).

9

The use and benefits of e-prescriptions was noted as early as 1986. John Donald noted in the British Medical Journal that “[a] computer is

used to produce all prescriptions for patients.... This method of prescribing improves safety, saves time, decrease prescribing cost, and

provides an instant audit of all important prescribing parameters.”). John B. Donald, On Line Prescribing by Computer, 292 BR. MED. J. 937,

937 (1986).

10

See id.

11

What Are Some of The Benefits of E-Prescribing?, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, http://

www.hrsa.gov/healthit/toolbox/HealthITAdoptiontoolbox/ElectronicPrescribing/benefitsepres.html (last visited June 21, 2013).

12

Bo Hovstadius, Bengt Astrand, and Goran Petersson, Dispensed Drugs and Multiple Medications in the Swedish Population: An Individual-

Based Register Study, BMC CLINICAL PHARMACOLOGY (2009), http:// www.biomedcentral.com/1472-6904/9/11 (last visited February 16,

2012).

13

Medication Safety Basics, CENTER FOR DISEASES CONTROL AND PREVENTION, http://www.cdc.gov/medicationsafety/basics.html (last

visited February 16, 2012).

14

Patterns of Medication Use in the United States, SLONE EPIDEMIOLOGY CENTER AT BOSTON UNIVERSITY at *1 (2006), available at

http:// www.bu.edu/slone/research/studies/slone-survey/.

15

Id. at 14.

16

What Are Some of The Benefits of E-Prescribing?, supra note 11.

17

Jeff Todd, E-Prescribing In A Changing Legal Environment, 12 RICH. J.L. & TECH. 12, 5 (2006).

18

Id.

19

Medication Errors, FDA, http:// www.fda.gov/drugs/drugsafety/medicationerrors/default.htm (last updated Aug. 08, 2013).

20

Id.

21

Christine Stencel & Chris Dobbins, Medication Errors Injure 1.5 Million People and Cost Billions of Dollars Annually, NEWS FROM THE

NATIONAL ACADEMIES, (July 20, 2006), http:// www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11623.

22

Id.

23

Id.

24

Id.

25

Id.

26

Stencel & Dobbins, supra note 21, at 1.

27

Id.

28

In Springhill Hospitals, Inc. v. Larrimore, the court noted that a hospital's policy to its druggist is that “the prescribing physician shall be called

for consultation whenever the pharmacist deems it necessary upon reviewing a medication order to prevent any unwanted outcome,” did not

impose liability separate and apart from doctor if the druggist contacted the physician as required. Springhill Hospitals, Inc. v. Larrimore, 5

So.3d 513, 521 (Ala. 2008).

29

LAURA DIETZ ET AL., 25 AM. JUR. 2D DRUGS AND CONTROLLED SUBSTANCES § 249 (2013).

30

Id.

31

“When the condition worsens after a prescription error, pharmacies often are quick to claim that this would have happened anyway and that

the plaintiff cannot prove that the error made a difference. For example, pharmacies have claimed that a person's infection would not have

improved even if an antibiotic—instead of a decongestant—had been dispensed; that ulcerative colitis would have necessitated removal of

the large intestine even if an incorrect and ineffective steroid dose had been filed; that no studies show that getting diabetes medication

instead of a muscle relaxant causes kidney damage.” Trent B. Speckhals, Not What The Doctor Ordered: prescription errors—when a patient

gets the wrong drug, at the wrong strength, or with the wrong directions—can be serious and even deadly. With thorough preparation, you

can show that the pharmacy committed malpractice, TRIAL Dec. 1, 2010, at 34.

32

DEITZ, supra note 29.

33

Frank M. McCLellan, Reading the RX Right is not Enough: millions of Americans rely on prescribed drugs to stay healthy—and on their

pharmacists to protect them from medication errors. Some courts are beginning to recognize that pharmacists must do more than fill

prescriptions accurately, TRIAL, May 1, 2002, at 26. “Alabama codified Omnibus Budget Reconciliation Act in 1991” and noted:

“Pharmacists, because of their strategic position in the health care system, have traditionally provided drug information to their patients and

to other health care professionals.” “Pharmacists are also required to review prescriptions for contraindications, drug interactions, and

incorrect dosages. Pharmacists may also discuss side effects, adverse interactions, and contraindications. Pharmacies are required to keep

patient medication profiles that incorporate the patient's name, age, sex, patient history, and a list of prescription medications.” Julie L.

Doughty,Walls v. Alpharma: Is the Learned Intermediary Doctrine the Right Cure for Pharmacists in Alabama?, 9 JONES L. REV. 37, 45

(2005).

34

Id. at 28.

35

Thomas William Arbon & S. Craig Smith, Prescription for Error, TRIAL, Oct. 1999, at 66. In Simmons v. Apex Drug Stores, Inc., plaintiff sued

defendant-pharmacist after receiving an antidepressant, for which he suffered an adverse reaction, instead of a prescription for an appetite

suppressant. While the claim was dismissed under a statute of limitations defense, the court held the pharmacist's actions to be a breach of

duty and the proximate cause.Simmons v. Apex Drug Stores, Inc., 506 N.W.2d 562, 564-65 (Mich. App. 1993), modified by Patterson v.

Kleiman, 526 N.W. 2d 879 (Mich. 1994).

36

Walter v. Wal-Mart Stores, Inc., 748 A.2d 961, 968 (Me. 2000), see alsoHarco Drugs, Inc. v. Holloway, 669 So. 2d 878, 880-81 (Ala. 1995).

37

Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 466-67 (Tex. App. 2000).

38

Kathleen Michon, Medical Malpractice: Common Errors by Doctors and Hospitals, NOLO, http://www.nolo.com/legal-encyclopedia/medical-

malpractice-common-errors-doctors-hospitals-32289.html (last visited June 20, 2013).

39

Mary A. Fischer, When Bad Medicine Happens to Good People, OPRAH MAG. (May 2005), http://www.oprah.com/health/What-Happens-

When-Doctors-Make-Medical-Mistakes-Misdiagnosis.

40

What Are Some of The Benefits of E-Prescribing?, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, http://

www.hrsa.gov/healthit/toolbox/HealthITAdoptiontoolbox/ElectronicPrescribing/benefitsepres.html (last visited June 21, 2013).

41

Id.

42

Benefits of E-Prescribing for Pharmacists, SURESCRIPTS, http:// www.surescripts.com/about-e-prescribing/benefits-of-e-prescribing_for-

pharmacies (last visited June 20, 2013). Unlike faxes or paper prescriptions, e-prescriptions go directly into the pharmacist's computer.

Authorizations for medication renewals can be serviced with just a few keystrokes. When compared with the paper form of prescriptions,

electronic prescriptions decrease the amount of employee time needed to finish dispensing activities by 27% for new prescriptions and 10%

for renewals (valued at $1.07 and $0.41 per prescription respectively). Id

43

Shawn Riley, The Benefits of E-prescribing for Today's Physician, HEALTHTECHNICA.COM, (Nov. 12, 2010), http://

www.healthtechnica.com/blogsphere/2010/11/12/the-benefits-of-e-prescribing-for-todays-physician/#sthash.botCbGFd.dpuf.

44

Id.

45

What is E-Prescribing?, AM. COLL. OF RHEUMATOLOGY, http:// www.rheumatology.org/Practice/Office/Hit/E-Prescribing/ (last visited June

20, 2013).

46

Id.

47

Id.

48

Id.

49

Id.

50

Id.

51

The power of the government to influence the practice of medicine is demonstrated by the fact that the number of prescriptions that were

sent to drug stores electronically increased by 181% in 2009 compared with 2008. Robert Lowes, Use of Electronic Prescribing Nearly

Tripled in 2009, MEDSCAPE (Mar. 5, 2010), http://www.medscape.com/viewarticle/718039. Despite these statistics, only about 36% of all

prescriptions were sent electronically in the United States in 2011. Randall Stross, Chicken Scratches vs. Electronic Prescriptions, N.Y.

TIMES (Apr. 28, 2012), http://www.nytimes.com/2012/04/29/business/e-prescriptions-reduce-errors-but-their-adoption-is-slow.html?_r=0.

52

How Much Does An E-Prescribing System Cost?, HEALTH RES. AND SERVS. ADMIN., http://

www.hrsa.gov/healthit/toolbox/HealthITAdoptiontoolbox/ElectronicPrescribing/costofepres.html (last visited June 20, 2013).

53

Considerations in Choosing an E-Prescribing System, AM. COLL. OF PHYSICIANS, http://www.acponline.org/running_

practice/technology/eprescribing/medicare_program_choosing.pdf (last visited June 20, 2013).

54

HEALTH RES. AND SERVS. ADMIN., supra note 52.

55

Id. See also Crystal Conde, RECs to the Rescue: Regional Centers Help Physicians Use HIT, Tex Med. 2010; 106(4):61-67, http://

www.texmed.org/Template.aspx?id =16095#sthash.ITC09mUI.dpuf (last visited February 10, 2014).

56

Id.

57

Id.

58

Clinician's Guide to E-Prescriptions, CTR. FOR IMPROVING MEDICATION MGMT.,

http://www.surescripts.com/media/800052/cliniciansguidee-prescribing_ 2011.pdf (last visited June 20, 2013).

59

Electronic Prescribing (eRx) Incentive Program, Centers for Medicare and Medicaid Services, CMS.GOV,

http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ERxIncentive/index.html?redirect=/ erxincentive (last

modified July, 17, 2013).

60

Id.

61

Id.

62

Id.

63

It is anticipated that this incentive program will increase those using electronic prescribing from 15% to 95% in just a decade. Amanda

Baltazar, Electronic Prescribing, ABOUT.COM PHARMACY, http:// pharmacy.about.com/od/Technology/a/Electronic-Prescribing.htm (last

visited June 20, 2013).

64

Centers for Medicare and Medicaid Services, CMS.gov, supra note 59.

65

Law Will Boost E-Prescribing, HHS Secretary Says, GOVERNMENT HEALTH IT (July 21, 2008), http://www.govhealthit.com/news/law-will-

boost-e-prescribing-hhs-secretary-says.

66

Electronic Prescribing (eRx) Incentive Program, AM. OSTEOPATH ASS'N, http://www.osteopathic.org/inside-aoa/development/practice-

mgt/Pages/erx-incentive-program.aspx (last visited June 20, 2013).

67

As of Spring 2013, “more than 291,000 providers and 3,800 hospitals have received incentive payments.” Kelly Kennedy, Incentives Push

Doctors To Electronic Medical Records, USA Today (May 22, 2013), http:// www.usatoday.com/story/news/health/2013/05/22/more-doctors-

hospitals-using-electronic-medical-records/2350811/.

68

Electronic Prescribing (eRx) Incentive Program, supra note 66, at 1.

69

Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process, FED. REGISTER (Mar. 26, 2013), https://

www.federalregister.gov/articles/2013/03/26/2013-06918/electronic-prescriptions-for-controlled-substances-notice-of-approved-certification-

process.

70

Electronic Prescriptions for Controlled Substances Clarification, FED. REGISTER (Oct. 11, 2011), http://www.deadiversion.usdoj.gov/fed_

regs/notices/2011/fr1019.htm.

71

Charles Hartig, Regulatory Barriers When Implementing E-Prescribing of Controlled Substances: Could Model Language Be The Solution? 5

ST. LOUIS UNIV. J. HEALTH LAW & POLICY 213, 218 (2011).

72

Id. at 218-19.

73

E-Prescribing & Incentives, HORIZON BLUE CROSS AND BLUE SHIELD OF N.J., http://www.horizonblue.com/providers/services-

programs/pharmacy-programs/e-prescribing-incentives (last visited Jan. 8, 2014).

74

Id.

75

Id.

76

E-Prescribing Collaborative Program, BLUECROSS BLUESHIELD OF ILLINOIS, http://www.bcbsil.com/provider/pharmacy/eprescribing.html

(last visited Jan. 8, 2014).

77

Electronic Prescribing, HUMANA, https://www.humana.com/insurance-through-employer/pharmacy/rx-tools/eprescribe.

78

Id.

79

The National Progress Report on E-Prescribing and Safe-Rx Rankings for 2012, SURESCRIPTS,

http://www.surescripts.com/downloads/npr/National%20Progress%CC20Report%CC20on%CC20E%CC20Prescribing%CC20Year%C̈̈̈̈ 12.pdf

.

80

Id.

81

Robert H. Miller & Ida Sim, Physicians' Use of Electronic Medical Records: Barriers and Solutions, 23 HEALTH AFFAIRS 116, 119 (2004),

available at http://www.mariaskachko.com/healthcare/articles/physician_use_EMR.pdf.

82

Joy M. Grossman et al., Physician Practices, E-Prescribing and Accessing Information to Improve Prescribing Decisions, 20 CENTER FOR

STUDYING HEALTH SYSTEM CHANGE 1, 1 (2011), http://www.hschange.com/CONTENT/1202/.

83

Ed Silverman, E-Prescribing & Handwritten Error Rates Are Similar, PHARMOLAT, (July 5, 2011), http://www.pharmalive.com/e-prescribing-

handwritten-error-rates-are-similar.

84

Id.

85

Id.

86

Karen Nanji et al., Errors Associated With Outpatient Computerized Prescribing Systems, 18 J. AM. MED. INFORM. ASSOC. 767, 767

(2011), http:// jamia.bmj.com/content/early/2011/06/09/amiajnl-2011-000205.abstract.

87

Id.

88

Melissa Krause and Fred Hamlin, E-Prescribing: Expectations and Limitations, Computer Talk, November/December 2010 at 41,

http://phsirx.com/wp-content/uploads/2011/12/ViewPoints_Nov-Dec2010.pdf (last visited June 26, 2013).

89

Id.

90

Id.

91

Id.

92

Nanji et al., supra note 86, at 772.

93

Id.

94

Id.

95

Tejal K. Gandhi et al., Outpatient Prescribing Errors and The Impact of Computerized Prescribing, 9 J. GEN. INTERN. MED. 837, 837

(2005), http:// www.ncbi.nlm.nih.gov/pmc/articles/PMC1490201/pdf/jgi_05414.pdf.

96

Joy M. Grossman et al., Transmitting and Processing Electronic Prescriptions: Experiences of Physician Practices and Pharmacies, 19 J.

AM. MED. INFORM. ASSOC. 353, 356 (2011), http:// www.ncbi.nlm.nih.gov/pubmed/22101907.

97

Id.

98

Id.

99

Id.

100

Id.

101

Id.

102

Id.

103

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Kenneth Terry, Be Warned: e-Prescribing's 6 Big Challenges for Doctors, MEDSCAPE TODAY,

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Id.

107

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108

Marrisa Torrieri, Safe E-Prescribing: A Primer for Practices, PHYSICIAN PRACTICE, http://

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109

Id.

110

Id. at 2.

111

Id.

112

Saul N. Weingart et al., Physicians' Decisions to Override Computerized Drug Alerts in Primary Care, ARCH INTERN MED. 2625, 2625

(2003).

113

Id.

114

Richard H. Schwartz & Michael Martin, Electronic Prescribing Holds Both Promises and Problems, HEALIO PEDIATRICS: INFECTIOUS

DISEASES IN CHILDREN, http://www.healio.com/pediatrics/practice-management/news/print/infectious-diseases-in-children/#b16e5b4d-

c817-4b13-a14c-79e155d4a5e9'/electronic-prescribing-holds-both-promises-and-problems (last visited June 21, 2013).

115

Id.

116

Id.

117

Id.

118

Id.

119

Id.

120

See generally David B. Towel, E-prescribing Malpractice Risks, THE DOCTORS COMPANY, http://

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121

Id.

122

Id.

123

Id.

124

Id.

125

Jon White, Report on State Prescribing Laws - Implications for E-Prescribing, PRIVACY AND SECURITY SOLUTIONS FOR

INTEROPERABLE HEALER INFORMATION EXCHANGE, ES-1, August 2009, http:// www.healthit.gov/sites/default/files/290-05-0015-state-

rx-law-report-2.pdf (last visited June 25, 2013).

126

Id. at 3-1. According to an article published by the American Academy of Orthopedic Surgeons, all 50 states and the District of Columbia

have rules or statutes dealing with e-prescriptions. See Jackie Ryan, Nuts and Bolts of E-Prescribing, AAOS NOW, Vol. 7, No. 6, June 2013,

http:// www.aaos.org/news/aaosnow/oct08/managing6.asp (last visited June 25, 2013).

127

OR. REV. STATE. ANN. § 475.188(2)(a)-(b) (West 2013).

128

Id.

129

§ 475.188(2)(c)-(d).

130

§ 475.188(4).

131

§ 475.188(8).

132

See generally MICH. COMP. LAWS ANN. § 333.17754 (West 2013).

133

§ 333.17754(1)(a)-(f).

134

§ 333.17754(3).

135

S.C. CODE ANN. § 44-117-320(A) (2013).

136

§ 44-117-320(A)(1)-(2).

137

§ 44-117-320(A)(3).

138

§ 44-117-320(A)(5).

139

§ 44-117-320(C)(1).

140

WASH. REV. CODE ANN. § 69.50.312(1)(a)-(b) (West 2013).

141

§ 69.50.312(1)(d).

142

§ 69.50.312(1)(f).

143

ALA. ADMIN CODE r. § 680-X-2-32(a) (2013).

144

§ 680-X-2-32(b).

145

CAL. CODE REGS. TIT. 16, § 1717.4(a) (2013).

146

§ 1717.4(c).

147

§ 1717.4(e).

148

§ 1717.4(f).

149

Id.

150

MINN. STAT. ANN. § 62J.497(Subd. 2.)(a) (West 2013).

151

§ 62J.497(Subd. 2.)(c).

152

Id.

153

§ 62J.497(Subd. 2.)(d).

154

§ 62J.497(Subd. 3.)(4)-(6).

155

49 PA. CODE § 27.201(a) (2013).

156

§ 27.201(b)-(b)(iv).

157

§ 27.201(b)(4).

158

§ 27.201(b)(5).

159

MINN. STAT. ANN. § 152.11 (West 2013).

160

W. VA. CODE § 60A-3-308 (2013).

161

KY. REV. STAT. § 218A.110 (West 2013).

162

KAN. STAT. ANN. § 65-4123(b) (West 2013).

163

Id.

164

CAL. BUS. & PROF. CODE § 4170(a)(6) (West 2013).

165

Jeff Byers, POCP: States' E-Prescribing Rules For Controlled Substances Vary, Health Imaging,

http://www.healthimaging.com/topics/oncology-imaging/pocp-states-e-prescribing-rules-controlled-substances-vary (last visted February 13,

2014).

166

See generally N.Y. PUB. HEALTH LAW § 33321 (McKinney 2013).

167

§ 3332(1).

168

§ 3332(2)(a)-(c).

169

§ 3332(3).

170

Id.

171

See generally TEX. HEALTH & SAFETY CODE ANN. § 481.075 (West 2013).

172

§ 481.075(a)-(b).

173

§ 481.075(e)-(g).

174

§ 481.075(g)(1).

175

White, supra note 125, at A-1.

176

See generally Walgreen Co. v. Wis. Pharmacy Examining Bd., No. 97-1513, 217 WL 65551 at *1 (Wis. App., Feb. 19, 1998).

177

Id.

178

Id.

179

Id. at 3.

180

Id.

181

Logan v. St. Charles Health Council, No. 1:06CV00039, 2006 WL 1149214 at *1 (W.D. Va., May 1, 2006).

182

Id.

183

Id.

184

Id.

185

Id.

186

Id.

187

Id.

188

Id.

189

Brighton Pharmacy Inc. v. Colo. State Pharmacy Examining Bd., 160 P.3d 412, 415 (2007).

190

Id.

191

Id.

192

Id.

193

Id. at 415.

194

Id.

195

Id. at 414.

196

United States v. Hanny, 509 F.3d 916, 917 (2007).

197

Id.

198

Id.

199

Id.

200

Id. at 917.

201

Id.

202

Id.

203

Id.

204

Id. at 918.

205

Id. at 920.

206

See generally United States ex rel. Ciaschini v. Ahold USA Inc., 282 F.R.D. 27 (2012).

207

Id. at 29.

208

Id. at n. 40.

209

Id. at n. 41.

210

Id. at 35-36.

211

United States v. Haj-Hamad, 549 F.3d 1020, 1022 (2008).

212

Id.

213

Id.

214

Thacker v. Kentucky, 80 S.W.3d 451, 453 (2002).

215

Id.

216

Id.

217

Id.

218

Id. at 456.

219

Id. at 455.

220

Washington v. United States, No. 1:04 CV 007 TCM, 2005 WL 1799737 at *1 (E.D. Mo., July 27, 2005).

221

Id.

222

Id. at 3.

223

Id.

224

Id.

225

Id.

226

Id. at 4.

227

Id.

228

Id.

229

Id.

230

Id. at 5.

231

Id. at 6.

232

Id. at 8.

233

Id. at 12.

18 MSUJMEDL 1

End of Document © 2016 Thomson Reuters. No claim to original U.S.

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