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1 Pharmacy Technicians: Roles, Responsibilities and Contributions to the Provision of Pharmacy Services in Health-System Settings White paper drafted by the Organizational Affairs Committee of the Michigan Society of Health- System Pharmacists

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1

Pharmacy Technicians: Roles, Responsibilities and Contributions to the Provision of Pharmacy

Services in Health-System Settings

White paper drafted by the Organizational Affairs Committee of the Michigan Society of Health-

System Pharmacists

2

AUTHOR INFORMATION:

Stephen M. Stout, Pharm.D., MS (corresponding author)

Pharmacotherapy Specialist, Wolters Kluwer Clinical Drug Information

2242 Georgetown Blvd, Ann Arbor, MI 48105

Ph: (517) 449-9286; [email protected]

Ryan Bickel, Pharm.D., MHA, BCPS

Pharmacy Manager, Borgess Pipp Hospital

411 Naomi St., Plainwell, MI 49080

Ph: (269) 685-0754; [email protected]

Ryan Foster, Pharm.D., MBA

Director, Pharmacy Services, Spectrum Health Hospital Group

100 Michigan Street NE, Grand Rapids, MI 49503

Ph: 616.391.3028; [email protected]

3

Mark Isopi, Pharm.D., MBA, FASHP

Senior Regional Medical Liaison, Amgen Inc.

34922 Pembroke Ave, Livonia, MI 48152

Ph: 248-893-7509; [email protected]

All authors: Nothing to disclose.

4

ABSTRACT

Pharmacy technician roles, responsibilities and contributions to care were not formally

established in the state of Michigan until Public Act 285 (formerly Senate Bill 92) was signed

into law in September 2014. This Act, which is scheduled to go into effect on Oct. 1, 2015,

establishes licensure requirements for technicians and defines practice in a way that allows for

expanded technician contributions. While pharmacy leaders in the state generally view

expansion of technician roles favorably, the lack of any formal definition and regulation of

technician practice was previously seen as a primary barrier to progress in this area.

Accordingly, Michigan pharmacy technicians have been under-utilized in some roles relative to

national trends. The Organizational Affairs Committee urges continued advancement and

specialization of the pharmacy technician workforce, with the expectation that this will: 1) save

pharmacist hours and/or free pharmacists for other activities, without compromising patient

care; 2) increase diversity, specialization and job satisfaction among pharmacy technicians; and

3) advance the standing and image of the field as a long-term career option for prospective

candidates.

5

INTRODUCTION

In early 2003, the Council on Credentialing in Pharmacy (CCP) published its “White Paper on

Pharmacy Technicians 2002: Needed Changes Can No Longer Wait,” a declaration endorsed by

12 member organizations of CCP, including the American Pharmacists Association, American

Society of Health-System Pharmacists (ASHP) and the American College of Clinical Pharmacy.1

The white paper’s stated purpose was “To set forth the issues that must be resolved to

promote the development of a strong and competent pharmacy technician work force.” The

CCP recommended that action be pursued in five areas with respect to pharmacy technicians

and/or other support personnel, with the aim of formalizing roles and expectations for these

individuals and maximizing their contributions to pharmacy services:

1) Defining and communicating a vision, with specific goals and plans for pursuit of that

vision;

2) Defining roles, responsibilities and competencies;

3) Establishing education and training standards, and maintenance requirements for these;

4) Establishing credentialing and accreditation standards; and

5) Establishing and promoting adoption of regulatory standards consistent with the above.

In Michigan, a milestone in progress toward this vision was reached in September 2014 when

Public Act 285 (PA 285, formerly Senate Bill 92) was signed into law by Gov. Rick Snyder.

Previously, Michigan was one of only six states that did not regulate pharmacy technicians.2 PA

285 amends the Michigan Public Health Code to establish education, licensure and

maintenance requirements for pharmacy technicians, as a subfield of pharmacy, and is

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scheduled to be enacted on Oct. 1, 2015.3 The Act broadly defines pharmacy technician

practice as including the following activities:

Assisting in the dispensing process

Handling transfer of prescriptions, except controlled substances prescriptions

Compounding drugs

Preparing or mixing intravenous drugs for injection into a human or veterinary patient

Contacting prescribers concerning prescription drug order clarification, which does not

include drug regimen review or clinical or therapeutic interpretation

Receiving verbal orders for prescription drugs, except orders for controlled substances

Any other specifically authorized functions

The Organizational Affairs Committee (OAC) of the Michigan Society of Health-System

Pharmacists (MSHP) created this document to attempt to more specifically define pharmacy

technician roles, responsibilities and contributions to the provision of pharmacy services in

health-system settings in Michigan, as a contribution to the ongoing professional dialogue

concerning regulation and advancement of this field.

LITERATURE REVIEW

Scope of Practice

Based on searches of recent scientific and trade literature, three major national publications

have attempted to characterize the scope of pharmacy technician practice in the United States:

ASHP’s 2007 “ASHP Long-Range Vision for the Pharmacy Work Force in Hospitals and Health

7

Systems: Ensuring the Best Use of Medicines in Hospitals and Health Systems;”4 CCP’s 2009

“Scope of Contemporary Pharmacy Practice: Roles, Responsibilities, and Functions of

Pharmacists and Pharmacy Technicians;”5 and the National Association of Boards of Pharmacy

(NABP)’s 2012 “Model State Pharmacy Act and Model Rules of the National Association of

Boards of Pharmacy.”6 Pharmacy technician practice as outlined in all of these documents

occurs under the supervision of a pharmacist, and the practice roles are a sub-set of pharmacy

practice roles (i.e., there are no functions unique to pharmacy technicians).

The vision outlined by ASHP in 2007 describes a scope of pharmacy technician practice in

health-system settings as including the following:4

Drug product:

o Acquisition

o Preparation

o Dispensing

o Distribution

Management and supervision of:

o Drug acquisition and supply logistics

o Use of technology and aspects of informatics

o Quality assurance activities

o Other pharmacy technicians

Assisting in data collection and screening for therapeutic drug monitoring

The CCP publication borrows its definition of pharmacy technician practice from NABP, defining

technician practice as including the following:5

8

Assisting in dispensing

Medical claims processing

Medication stocking

Cashiering

Not including:

o Drug utilization review

o Clinical conflict resolution

o Prescriber contact for order clarification or therapy modification

o Patient counseling

o Dispensing process validation

o Prescription transfer

o Receipt of new prescription drug orders

In addition to the above, NABP also includes a section describing somewhat expanded practice

roles of certified pharmacy technicians (certification as determined by the state board of

pharmacy) as including:6

Receiving new medication orders

Prescription transfer

Compounding

Assisting in dispensing

Performing all functions allowed to be performed by technicians, but specifically

excluding:

o Drug utilization review

9

o Clinical conflict resolution

o Prescriber contact for order clarification or therapy modification

o Patient counseling

o Dispensing process validation

The definition of technician practice in PA 285 (see INTRODUCTION), while not identical to any

of the above, is most consistent with the final and broadest definition put forward by NABP and

with a trend toward advancement of practice roles for qualified technicians as described below.

Trends and Emerging Practice Roles

Beyond the basic definition of pharmacy technician practice, the CCP publication goes on to

describe a pharmacy technician practice analysis, completed in 2005, evaluating the

professional activities of certified pharmacy technicians (CPhTs, in this sense reflecting

certification specifically by the Pharmacy Technician Certification Board [PTCB]).5,7 In this

analysis, a survey of pharmacists, CPhTs, technician educators, regulators and state pharmacy

board representatives indicated that, while health-system CPhTs were primarily responsible for

assisting inpatient dispensing, preparing intravenous admixtures and pre/repackaging

medications, compared to previous surveys they were increasingly involved in activities such

as:7

Compounding

Communicating changes in product availability

Coordinating different forms of communication throughout the practice setting

10

Performing and documenting equipment sanitation, maintenance and calibration

Quality assurance activities (pharmacy technicians in general; not specific to health

systems):

o Multiple-point checking

o Assisting monitoring of patient outcomes

o Inventory control

o Coordinating medication error communication

o Education, training and certification

o Reviewing billing discrepancies / fraud issues

“Tech-check-tech” (TCT), a practice model in which pharmacy technicians rather than

pharmacists check the accuracy of order filling by other technicians, was the subject of a recent

literature review.8 Across 11 published studies describing the practice in different institutions,

the accuracy of TCT protocols was comparable to pharmacist checking for prescription order

accuracy.

Other literature in the past 10 years has described pharmacy technician involvement in other

novel or advanced practice roles in the U.S., including:

Taking medication histories9-11

Medication reconciliation12,13

Maintaining patient records14

Screening patient profiles to identify candidates for clinical interventions14

Requesting prescription refill authorizations from prescribers11

Counseling on nonprescription medications11

11

Scripted patient education14

CURRENT STATE OF PRACTICE IN MICHIGAN

In 2011, MSHP initiated the Pharmacy Practice Model Initiative of Michigan (PPMI2) as a means

to refine and implement recommendations from ASHP’s Pharmacy Practice Model Initiative.

One of the first actions taken by MSHP was to survey the directors of pharmacy at Michigan

hospitals. MSHP utilized an early version of ASHP’s Hospital Self-assessment Tool,15 which

contained 15 questions relating to pharmacy technician practice. Most of the questions

focused on specific tasks or activities performed by technicians; however, a couple addressed

technician certification status and opportunities for advancement. Approximately one-third

(n=35) of the hospital pharmacy directors in the state completed the survey by the end of June

2011. In June 2013, the MSHP Organizational Affairs Committee contacted ASHP and requested

the current results of the Hospital Self-assessment Tool for Michigan hospitals. Fifty-two

hospitals had completed the assessment. A review of the survey responses (Table 1) shows

that pharmacy technician practice in Michigan has made little advancement since the original

survey.

12 Table 1. ASHP Hospital Self-Assessment Tool: Michigan Hospital Responses Relating to Pharmacy

Technician Practice

Question Answer Choice MI 2011 (N=35)

MI 2013 (N=52)

US 2013 (N=1,079)

1. Are medication distribution tasks assigned to pharmacy technicians to allow redeployment of pharmacists’ time to drug therapy management activities at your hospital/health system?

Tasks fully assigned throughout all areas

Tasks fully assigned for some areas

Tasks partially assigned in some or all areas

Tasks not assigned

Not applicable

31.4%

11.4%

57.1%

0.0%

0.0%

26.9%

21.2%

50.0%

1.9%

0.0%

38.9%

25.0%

31.0%

4.2%

0.0%

2. Is initiation of medication reconciliation, including obtaining and documenting patient medication information for pharmacist review, assigned to pharmacy technicians who have appropriate education and training at your hospital/health system?

Tasks fully assigned throughout all areas

Tasks fully assigned for some areas

Tasks partially assigned in some or all areas

Tasks not assigned

Not permitted by law

0.0%

5.7%

8.6%

85.7%

0.0%

0.0%

5.8%

5.8%

88.5%

0.0%

3.0%

6.9%

7.2%

77.5%

5.7%

3. Is review of patient charts to identify medication allergies that require pharmacist follow up assigned to pharmacy technicians who have appropriate education and training at your hospital/health system (e.g., identify allergies not documented in the pharmacy information system)?

Exists in all areas/situations (100%)

Exists in most areas/situations (50–99%)

Exists only in some areas/situations (1-49%)

Does not exist (0%)

0.0%

5.7%

8.6%

85.7%

1.9%

3.9%

5.8%

88.5%

2.5%

2.7%

6.5%

88.3%

4. If permitted by law, is the accuracy of medication dispensing by pharmacy technicians checked by other technicians (i.e., "tech-check-tech") who have appropriate education and training at your hospital/health system?

Exists in all areas/situations (100%)

Exists in most areas/situations (50–99%)

Exists only in some areas/situations (1-49%)

Does not exist (0%)

Not permitted by law

0.0%

11.4%

20.0%

42.9%

25.7%

0.0%

3.9%

15.4%

44.2%

36.5%

5.2%

6.9%

9.9%

43.8%

34.2%

5. Is the compounding of routine sterile preparations in conformance with well-documented procedures performed by pharmacy technicians who have appropriate education and training at your hospital/health system?

Exists in all areas/situations (100%)

Exists in most areas/situations (50–99%)

Exists only in some areas/situations (1-49%)

Does not exist (0%)

Not applicable

57.1%

25.7%

2.9%

14.3%

0.0%

57.7%

25.0%

3.9%

13.5%

0.0%

64.6%

22.6%

4.1%

5.8%

2.9%

13

6. Is the compilation of clinical monitoring information (e.g., International Normalized Ratios) for pharmacist review assigned to pharmacy technicians who have appropriate education and training at your hospital/health system?

Tasks fully assigned throughout all areas

Tasks fully assigned for some areas

Tasks partially assigned in some or all areas

Tasks not assigned

Tasks performed by hospital information system

0.0%

2.9%

0.0%

82.9%

14.3%

0.0%

3.9%

0.0%

82.7%

13.5%

1.3%

1.8%

3.0%

78.9%

15.1%

7. Is the inspection and replenishment of medication storage devices assigned to pharmacy technicians who have appropriate education and training at your hospital/health system?

Yes

No

97.1%

2.9%

98.1%

1.9%

96.7%

3.3%

8. Is the management of controlled substance systems assigned to pharmacy technicians who have appropriate education and training at your hospital/health system?

Yes

No

74.3%

25.7%

76.9%

23.1%

72.3%

27.7%

9. Is the management of medication assistance programs assigned to pharmacy technicians who have appropriate education and training at your hospital/health systems?

Yes

No

Not applicable

8.6%

48.6%

42.9%

5.8%

46.2%

48.1%

18.8%

30.6%

50.6%

10. Are components of quality improvement programs conducted by pharmacy technicians who have appropriate education and training at your hospital/health system?

Exists in all areas/situations (100%)

Exists in most areas/situations (50–99%)

Exists only in some areas/situations (1-49%)

Does not exist (0%)

Not applicable

2.9%

14.3%

60.0%

22.9%

0.0%

1.9%

13.5%

55.8%

28.9%

0.0%

7.5%

14.4%

42.8%

31.8%

3.5%

11. Is the management of pharmacy department information technology systems, including routine database management and billing systems, assigned to pharmacy technicians who have appropriate education and training at your hospital/health system?

Exists in all areas/situations (100%)

Exists in most areas/situations (50–99%)

Exists only in some areas/situations (1-49%)

Does not exist (0%)

Not applicable

22.9%

28.6%

37.1%

11.4%

0.0%

17.3%

30.8%

36.5%

13.5%

1.9%

17.0%

25.1%

32.3%

20.6%

5.0%

12. Is the supervision of other pharmacy technicians assigned to technicians who have appropriate education and training at your hospital/health system?

Exists in all areas/situations (100%)

Exists in most areas/situations (50–99%)

Exists only in some areas/situations (1-49%)

Does not exist (0%)

Not applicable

8.6%

17.1%

8.6%

60.0%

5.7%

7.7%

17.3%

17.3%

50.0%

7.7%

17.8%

13.9%

13.6%

46.2%

8.4%

14

13. Are pharmacy technicians at your hospital/health system certified by the Pharmacy Technician Certification Board (PTCB)?

All pharmacy technicians are PTCB-certified (100%)

Most pharmacy technicians are PTCB-certified (50%-99%)

Some pharmacy technicians are PTCB-certified (1%-49%)

No pharmacy technicians are PTCB-certified (0%)

57.1%

25.7%

11.4%

5.7%

48.1%

28.9%

19.2%

3.9%

42.7%

32.4%

19.4%

5.6%

14. Are all distributive functions that do not require a pharmacist's clinical judgment assigned to pharmacy technicians at your hospital/health system?

Yes

No

60.0%

40.0%

55.8%

44.2%

65.8%

34.2%

15. Are opportunities for advanced, specialized pharmacy technician roles available at your hospital/health system (examples of advanced pharmacy technician roles include: dispensing medications with remote video supervision, managing medication assistance programs, initiation of medication reconciliation [obtaining list], order entry for pharmacist's verification, and technician supervising other technicians)?

Yes

No

40.0%

60.0%

38.5%

61.5%

40.4%

59.7%

When compared to the national results, it appears that Michigan hospitals lag behind other

states in optimizing the use of pharmacy technicians. In general, Michigan hospitals are less

comfortable delegating distributive functions, which do not require pharmacist judgment, to

technicians. Fewer Michigan hospitals use technicians to manage medication assistance

programs or assist with quality improvement programs.

The ASHP assessment tool provided a glimpse of pharmacy technician practice in Michigan, but

MSHP desired to know more. In 2011, MSHP created a second survey, which was distributed to

the 50 participants of the PPMI2 Conference. The participants consisted of pharmacy leaders

from across the state representing various aspects of health-system pharmacy practice,

15

including acute care, ambulatory care and academia. This survey assessed the participants’

vision of technician practice and barriers to achieving this vision. Forty-two pharmacists (84

percent) completed the PPMI2 survey. Approximately two-thirds of participants strongly agreed

that pharmacy technicians, with appropriate education and training, should be used much more

extensively in Michigan hospitals to free up pharmacists to perform clinical activities. The

respondents generally agreed that the future vision of pharmacy practice in Michigan has

pharmacy technicians taking increased ownership of drug preparation and distribution. A level

of uncertainty existed about liberalizing the practice of tech-check-tech. Table 2 summarizes

the survey results regarding the preferred future for pharmacy technicians.

The PPMI2 survey also attempted to identify barriers that must be addressed before pharmacy

technicians can achieve an optimal practice in Michigan. The top five barriers included:

1. Lack of recognition and legal accountability by the state of Michigan.

2. Lack of standardized education and training.

3. Large variability in the roles of pharmacy technicians among various hospitals.

4. Lack of career ladders for technicians.

5. Too few technicians are interested in pursuing the occupation as a long-term career.

16

Table 2. PPMI2 Conference Participants’ Level of Agreement Regarding the Preferred Future

for Pharmacy Technicians.

Agree Neutral Disagree

All distributive tasks that do not require clinical judgment are assigned to technicians.

90% 7% 3%

Technicians are responsible for drug product preparation and distribution work within a well-documented, quality assurance environment designed to ensure patient safety.

92% 2% 5%

Each technician has documented competency for the tasks within his job description.

91% 2% 7%

Tech-check-tech when appropriate information technology and other safeguards are in place to ensure accuracy and safety.

71% 26% 3%

WHY TO PURSUE ADVANCED ROLES, TRAINING AND FURTHER DEVELOPMENT

Health care organizations are facing a veritable health care tsunami: ICD 10, value-based

purchasing, Medicaid expansion, and the unknown potential impact of the Affordable Care Act,

just to name a few. These initiatives are placing a renewed focus on improving clinical

outcomes, improving safety and quality, and controlling costs. With an effective pharmacy

practice model, pharmacists and pharmacy technicians will be able to effectively support each

of these initiatives. The effectiveness of a pharmacy practice model will, in large part, be

determined by the ability of pharmacies to leverage the unique skills and expertise of certified

pharmacy technicians. Historically, pharmacists have been reluctant to delegate many routine

responsibilities to pharmacy technicians. However, as pharmacist roles evolve and the scope of

pharmacy practice changes, the delegation of basic dispensing functions and other technical

17

tasks becomes imperative. Pharmacists are shifting focus to spend more time on medication

therapy management and utilization and less time on dispensing functions.

Advancing the roles of pharmacy technicians should be an important focus for all pharmacy

departments. However, before technicians can begin to practice in these advanced roles, an

effective training program and evaluation methodology is needed. In many organizations,

technician training is inconsistent and not well defined. This often leads to high turnover and

staff dissatisfaction. Effective training programs have been shown to reduce turnover and

improve employee satisfaction.16,17 With standardized, reproducible training programs,

pharmacy technicians can begin to operate at higher levels within the health care system.

Advanced roles for pharmacy technicians extend pharmacy services and allow pharmacists to

focus on the aspects of the medication use system that require clinical decision making.

Pharmacy technicians fill drug orders, compound complex sterile products and maintain

medication stocks. In addition, they may: interact with patients to obtain accurate medication

histories for medication reconciliation; review medication profiles and lab results with defined

guidelines to support pharmacists; and evaluate, implement and maintain pharmacy

automation. Utilizing unit-based pharmacy technicians to coordinate and communicate

medication needs has been shown to reduce calls to pharmacy and reduce the number of late

or missed medication administration events.18 Pharmacy technicians have also been shown to

positively impact the accuracy of medication histories taken for medication reconciliation.13,19

Although the need to advance pharmacy technician roles is clear, the environment to foster this

advancement is lacking. Barriers to broader, systematic advancement include inconsistent

state requirements for pharmacy technicians and the lack of advanced or specialty technician

18

certification. According to Everett McAllister, chief executive officer and executive director of

PTCB, the next step in advancing the role of the pharmacy technician is to “develop an

enhanced credentialing system.”20 Many organizations have transformed their pharmacy

practice models to be more nimble and more responsive to the changing needs of the health

care landscape. Doing so has allowed pharmacists to move beyond traditional dispensing roles

and assume more responsibility for clinical outcomes. In order to sustain the gains and further

develop the role of pharmacists and pharmacy technicians, organizations must develop new

ways of thinking around the deployment of pharmacy resources. Providing challenging,

rewarding opportunities promises to improve retention, satisfaction and, ultimately, patient

outcomes.

The Michigan Society of Health-System Pharmacists Board of Directors approved the content of

this white paper on Jan. 15, 2015. Ed.

19

REFERENCES

1 Council on Credentialing in Pharmacy. 2002 white paper on pharmacy technicians:

Needed changes can no longer wait. J Manag Care Pharm. 2003; 9: 72-83.

2 National Association of Boards of Pharmacy. Survey of pharmacy law.

http://www.nabp.net/publications/survey-of-pharmacy-law/.

3 Michigan Senate Bill 0092.

http://www.legislature.mi.gov/(S(h2exwtfy51k2umnjgycipo45))/mileg.aspx?page=GetO

bject&objectname=2013-SB-0092.

4 American Society of Health-System Pharmacists. ASHP long-range vision for the

pharmacy work force in hospitals and health systems: Ensuring the best use of

medicines in hospitals and health systems. Am J Health Syst Pharm. 2007; 64: 1320-30.

5 Council on Credentialing in Pharmacy, Albanese NP, Rouse MJ. Scope of contemporary

pharmacy practice: Roles, responsibilities, and functions of pharmacists and pharmacy

technicians. J Am Pharm Assoc (2003). 2010; 50: e35-69.

6 National Association of Boards of Pharmacy. Model state pharmacy act and model rules

of the National Association of Boards of Pharmacy.

http://www.nabp.net/publications/model-act.

7 Muenzen PM, Corrigan MM, Smith MA et al. Updating the pharmacy technician

certification examination: A practice analysis study. Am J Health Syst Pharm. 2005; 62:

2542-6.

8 Adams AJ, Martin SJ, Stolpe SF. "Tech-check-tech": A review of the evidence on its safety

and benefits. Am J Health Syst Pharm. 2011; 68: 1824-33.

20

9 Michels RD, Meisel SB. Program using pharmacy technicians to obtain medication

histories. Am J Health Syst Pharm. 2003; 60: 1982-6.

10 Knight H, Edgerton L, Foster R. Pharmacy technicians obtaining medication histories

within the emergency department. Am J Health Syst Pharm. 2010; 67: 512-4.

11 Friesner DL, Scott DM. Identifying characteristics that allow pharmacy technicians to

assume unconventional roles in the pharmacy. J Am Pharm Assoc (2003). 2010; 50: 686-

97.

12 Thompson CA. Legality of technicians' involvement in medication reconciliation not

clear. Am J Health Syst Pharm. 2009; 66: 433-4.

13 Siemianowski LA, Sen S, George JM. Impact of pharmacy technician-centered

medication reconciliation on optimization of antiretroviral therapy and opportunistic

infection prophylaxis in hospitalized patients with HIV/AIDS. J Pharm Pract. 2013; 26:

428-33.

14 Weber E, Hepfinger C, Koontz R et al. Pharmacy technicians supporting clinical functions.

Am J Health Syst Pharm. 2005; 62: 2466-72.

15 American Society of Health-System Pharmacists. PPMI hospital self-assessment.

http://www.ppmiassessment.org/.

16 Fox KC. Mentor program boosts new nurses' satisfaction and lowers turnover rate. J

Contin Educ Nurs. 2010; 41: 311-6.

17 Gebhart F. Trained technicians cut pharmacist turnover at CVS. Drug Topics 2001; 145:

58.

21

18 Conroy C, Cattell R, Nicholls M. Contribution of a ward-based technician service to

delivering effective patient health care and reducing dispensary workload. International

Journal of Pharmacy Practice 2011; 10: 171-75.

19 van den Bemt PM, van den Broek S, van Nunen AK et al. Medication reconciliation

performed by pharmacy technicians at the time of preoperative screening. Ann

Pharmacother. 2009; 43: 868-74.

20 Traynor K. New PTCB chief seeks to advance technician practice. Am J Health Syst

Pharm. 2012; 69: 820, 22.