July 01, 2019

States Are Looking to Pharmacists to Increase Access to Tobacco Cessation Therapy

Krystalyn K. Weaver, Pharm D, JD Candidate, Class of 2021, George Mason University Antonin Scalia Law School, Arlington, VA and Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Endowed Professor of Leadership, University of Kentucky College of Pharmacy, Lexington, KY

Though the United States’ adult cigarette-smoking rate is at an all-time low,1 the health effects of smoking remain prevalent and devastating. Helping current smokers quit should remain a focus for healthcare professionals and policy makers. Some states are recognizing the capabilities and accessibility of pharmacists and are looking to them to help by authorizing pharmacists to autonomously prescribe tobacco cessation therapy.

Mission Not Yet Accomplished

While public health officials and advocates have reason to celebrate a lower U.S. smoking rate, it falls short of a “mission accomplished” declaration. Although the overall adult smoking rate has decreased to 14 percent, certain subgroups of Americans still use tobacco at much higher rates, including people with less education, people with no insurance or who are covered by Medicaid, and certain racial groups.2 An estimated 480,000 people die each year from smoking-related illness.3 That is the equivalent of about 22 Boeing 747 airplanes full of people crashing – every week.4 In contrast, in 2017 70,237 people in the United States died from a drug overdose.5 While the attention on the opioid crisis is justified and necessary, the comparison demonstrates that preventing tobacco-related death and illness should remain on the nation’s list of priorities.

In 2009, then-President Obama signed into law the Family Smoking Prevention and Tobacco Control Act.6 The law authorized the U.S Food and Drug Administration (FDA) to regulate tobacco products, which was aimed, in part, to decrease youth cigarette use.7 Indeed, the most recent tobacco use statistics suggest that youth cigarette smoking has continued to decline – down from 13 percent in 2016 to 10 percent in 2017.8 Nineteen percent of twelfth graders, however, reported nicotine vaping in 2017 with devices such as e-cigarettes or Juuls.9 Teen e-cigarette users are 23 percent more likely to start smoking tobacco products in the next six months than non-users.10 With so many teens using e-cigarettes converting to smoked tobacco products, it is unlikely that smoking is a generational problem that will go away with time. Policies aimed at preventing tobacco use must be paired with tobacco cessation support.

Pharmacists, Accessible and Capable, Can Help People Quit

 While quitting smoking is often a long and challenging process, there are evidence-based treatments available, including counseling and medications, that can help — if they are accessible and used.11 Most smokers report that they want to quit but fewer than 10 percent report success in doing so within the past year.12

The Centers for Disease Control and Prevention (CDC), the Tobacco Control Network, and Centers for Medicare & Medicaid Services have identified pharmacists as a solution for increasing patient access to tobacco cessation treatments.13 Not only are pharmacists highly accessible14 and highly trained,15 research shows that pharmacists can effectively help people quit smoking by providing cessation counseling and prescribing tobacco cessation medications.16

New Mexico Takes the Lead

In 2004, New Mexico was the first state to expand pharmacists’ scope of practice to include autonomous tobacco cessation aid prescribing.17 The authorizing statute, passed by the legislature in 2001,18 says the New Mexico board of pharmacy “shall . . . adopt, after approval by the New Mexico board of medical examiners and the board of nursing, rules and protocols for the prescribing of dangerous drug therapy . . ..”19 The statute also requires that the adopted rules and protocols must include “the appropriate notification of the primary or appropriate physician of the person receiving the dangerous drug therapy.”20 The approved protocol allows pharmacists to prescribe any “FDA approved products for tobacco cessation.”21

In the 15 years since pharmacists were first able to prescribe tobacco cessation medications, there have been no reported problems.22 Research has demonstrated that pharmacist-provided tobacco cessation services are just as effective as those services provided by other healthcare providers.23 In one New Mexico-based study of 1,437 smokers who received pharmacist-provided tobacco cessation services, quit rates were similar to those achieved by other healthcare professionals.24 Of note, study participants were recruited by the participating pharmacists at local community pharmacies, and 64 percent of the patients in the study did not have health insurance.25 That many patients in the study did not have health insurance indicates that pharmacists can serve as an access point for patients who otherwise would not receive preventive health services.26

Another sign of success is that since the time that the tobacco cessation prescribing protocol was approved, the New Mexico boards of pharmacy, medical examiners, and nursing have approved several other pharmacist-prescribing protocols. Those protocols authorize pharmacists to autonomously prescribe tuberculosis testing,27 naloxone,28 and hormonal contraceptives.29

Autonomous Prescribing vs. Collaborative Prescribing

While New Mexico’s authority relates to autonomous pharmacist prescribing, pharmacists can also prescribe in many states under a collaborative practice agreement (CPA). In 1979, Washington State was the first state to allow pharmacists to prescribe under a CPA between a pharmacist and a “practitioner authorized to prescribe drugs,” most often a physician.30 CPAs allow a physician (or another prescriber, in many states) to delegate certain patient care functions — including prescribing — to pharmacists under certain parameters delineated in the CPA.31 Prescribing under a CPA is considered “dependent” prescriptive authority because it depends on another prescriber’s approval. In contrast, “independent” or autonomous prescriptive authority comes directly from a state authority, such as the board of pharmacy.32

Independent prescriptive authority may come in one of two forms: a statewide protocol or category specific authority.33 A statewide protocol, like in New Mexico, requires certain procedures the pharmacist must follow while prescribing.34 With category specific authority, the state simply identifies the category of medications the pharmacist may prescribe and leaves the details to the pharmacist to determine based on the standard of care.35

Autonomous vs. Collaborative Prescribing for Tobacco Cessation

While tobacco cessation medications can be prescribed pursuant to a CPA, certain barriers (such as requirements that the patient first see the physician before the pharmacist can prescribe) make the implementation of such a service challenging, or even infeasible, in many states.

For example, compare Washington State’s CPA provisions to those of Kansas. In Washington State, a pharmacist can care for patients the authorizing physician has not yet seen, so long as that authority is in the CPA.36 This flexibility allows pharmacists to provide acute and preventive care, such as tobacco cessation services, for patients who may not have a primary care provider – and then connect them with one for future care.

By contrast, prescribing for acute conditions and preventive care services is largely infeasible under Kansas’s authority. In Kansas, CPAs must be limited to a specific patient who is being treated by the authorizing physician.37 While a physician and a pharmacist could develop a CPA that allows the pharmacist to prescribe for the physician’s patients, the paperwork burden is much greater than in Washington’s model. Additionally, patients without a primary care provider, who most need increased access to care, are excluded altogether.

In both models, for a community to have access to pharmacist-provided services that include prescribing authority, the pharmacist must find a physician willing to authorize the CPA.38 This can present an insurmountable barrier for some, leaving patients without access to this additional resource.

Other States Authorize Autonomous Prescribing, Often with Added Restrictions

Recognizing both the barriers of CPAs and the opportunity to more fully utilize pharmacists’ skills, the prevalence of autonomous prescribing authority has grown, especially in the last five years.  Eight states (Arizona,39 California,40 Colorado,41 Idaho,42 Indiana,43 Iowa,44 Maine,45 and Oregon46) have followed New Mexico’s lead and authorized pharmacist prescribing of tobacco cessation products.47 Although the concept has broad support,48 objections have been raised, often from state medical societies. These objections primarily relate to pharmacists’ qualifications,49 fragmentation of care,50 and the safety of the medications themselves.51 This has caused some of these new laws to be less expansive and/or impose additional obligations on the pharmacist.

Pharmacist Qualifications

Opponents of autonomous pharmacist prescribing of tobacco cessation medications will claim that pharmacists lack the qualifications necessary to assess patients and prescribe medications. The rationale for this argument is that since pharmacists go through less training than physicians, they cannot safely act as prescribers. However, that is not necessarily so. Pharmacists, who earn a Doctor of Pharmacy degree before sitting for the national licensing exam, receive six to eight years of clinical training that includes tobacco cessation training.52 Pharmacist training focuses on pharmacotherapy and the provision of patient-centered care.53 Even if it were true that pharmacists need further training to prescribe tobacco cessation medications, policymakers need not reject the concept of pharmacists prescribing these drugs altogether. States can accommodate this concern with required education as a prerequisite to pharmacist prescriptive authority. California’s statute, for example, calls for initial training and continuing education every other year.54 Other states’ education provisions are included in Table 1.

Table 1

State

Training Requirements

Arizona55

“[A] course of training accredited by the accreditation council for pharmacy education in the subject area of tobacco cessation and successfully complete two hours of accreditation council for pharmacy education accredited tobacco cessation continuing education programs on license renewal.”

California56

“[A] minimum of two hours of an approved continuing education program specific to smoking cessation therapy and nicotine replacement therapy, or an equivalent curriculum-based training program completed within the last two years in an accredited California school of pharmacy.

Additionally, pharmacists who participate in this protocol must complete ongoing continuing education focused on smoking cessation therapy from an approved provider once every two years.”

Colorado57

“Accreditation Council for Pharmacy Education (ACPE) accredited program in tobacco cessation.”

Idaho58

“[A] course on tobacco cessation therapy taught by a provider accredited by the accreditation council for pharmacy education or by a comparable provider recognized by the board.”

Indiana

No specific requirement

Iowa59

Statute: “[C]ontinuing pharmacy education related to statewide protocols recognized and approved by the board.”

Proposed rule: “ACPE-approved continuing education program of at least one-hour duration related to nicotine replacement tobacco cessation product utilization.”

Maine

No specific requirement

New Mexico60

“[A] course of training, accredited by the accreditation council for pharmacy education (ACPE), in the subject area of tobacco cessation drug therapy provided by: a) the department of health; or b) health and human services or c) a similar health authority or professional body approved by the board.”

“[A] minimum of 0.2 CEU of ACPE approved tobacco cessation drug therapy related continuing education every two years.”

Oregon61

Recommended (not yet adopted): “1 time course minimum 2 hours of CPE.”

Fragmentation of Care

Opponents also allege that pharmacists should not prescribe tobacco cessation medications because it will lead to fragmentation of care, The idea behind this contention is that with more providers writing prescriptions, it is less likely that all providers will know the patient’s full medication regimen. Healthcare fragmentation is, indeed, a serious problem in the United States – regardless of pharmacists’ ability to prescribe.62

Still, concerns about care fragmentation need not derail policy proposals that allow pharmacists to prescribe tobacco cessation medications. Many patients do not have a primary care provider, so pharmacists can serve as a new entry point to the healthcare system generally and provide referrals, as needed.63 For those patients who do have a regular primary care provider, care fragmentation can be addressed with increased communication between the pharmacist and primary care provider.

As with education/qualification concerns, states can include communication requirements in laws authorizing pharmacist prescribing to reduce the fragmentation of care. Most states that authorize pharmacists to prescribe tobacco cessation therapy require the pharmacist to send a notification to the patients’ primary care physician, if they have one, after prescribing a medication.64 See Table 2 for each states’ notification requirements. Even in states without an explicit requirement, communication is a foundational component of all pharmacist-provided patient care services.65

Table 2

State

Notification Requirements

Arizona66

“Notify the qualified patient’s designated primary care provider within seventy-two hours after the medication is prescribed.”

California67

“The pharmacist notifies the patient’s primary care provider of any drugs or devices furnished to the patient, or enters the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist provides the patient with a written record of the drugs or devices furnished and advises the patient to consult a physician of the patient’s choice.”

Colorado68

“[A] process shall be in place for the pharmacist to communicate with the patient’s primary care provider and document changes to the patient’s medical record. If the patient does not have a primary care provider, or is unable to provide contact information for his or her primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished and advise the patient to consult an appropriate health care professional of the patient’s choice.”

Idaho69

“When a pharmacist prescribes a tobacco cessation product [. . .] Notification of the patient screening, the prescription record and the follow-up care plan shall be provided to the patient's primary care provider, as applicable, within five (5) business days following the prescribing of a tobacco cessation product.”

Indiana

No specific requirement

Iowa70

Statute: “Notify the patient’s primary health care provider of any prescription drugs, products, tests, or treatments administered to the patient, or enter such information in a patient record system also used by the primary health care provider, as permitted by the primary health care provider. If the patient does not have a primary health care provider, the pharmacist shall provide the patient with a written record of the prescription drugs, products, tests, or treatment provided to the patient and shall advise the patient to consult a physician.”

Regulation: “As soon as reasonably possible, the authorized pharmacist shall notify the patient's primary health care provider of the nicotine replacement tobacco cessation product provided to the patient. If the patient does not have a primary health care provider, the authorized pharmacist shall provide the patient with a written record of the nicotine replacement tobacco cessation product provided to the patient and shall advise the patient to consult a physician.”

Maine

No specific requirement

New Mexico71

Regulation: “Upon signed consent of the patient, the pharmacist shall notify the patient's designated physician or primary care provider of tobacco cessation drug therapy prescribed.”

Protocol: “Provide notice to the patient's primary practitioner within 15 days of writing the prescription.”

Oregon72

Recommended (not yet adopted): “Pharmacist prescribing requirements: [. . .] notification of providers upon prescribing.”

Medication Safety

Opponents to this autonomous prescribing authority frequently attack the safety of tobacco cessation products themselves as reason to prohibit such prescribing.73 Criticism is typically aimed more specifically at varenicline (Chantix) and bupropion (Zyban), which work differently than nicotine replacement therapies (NRTs) like nicotine gum or the patch.

How the Medicines Work

NRTs aid in tobacco cessation by replacing the active ingredient in tobacco, nicotine, so patients can avoid withdrawal symptoms that result from quitting tobacco abruptly and focus on habit changes.

Varenicline is a partial nicotine agonist.74 This means that the drug will bind with the receptor where nicotine usually binds. When varenicline binds to this receptor, it gives the patient a similar effect that nicotine does but at a much lower level, which helps stave off nicotine cravings.75 Varenicline also blocks nicotine from binding the receptor. By blocking nicotine, patients can continue to smoke after starting varenicline but will not feel the “positive” effects that makes smoking addictive. Without the positive effects, smokers tend to take more notice of the negatives of smoking (e.g., the bad taste and smell), which makes quitting easier.

Bupropion’s mechanism of action is not well understood. In addition to its indication as a smoking cessation aid, it is indicated for the treatment of major depressive disorder.76

Varenicline and Bupropion Boxed Warning Removed with EAGLES Data

In 2009, FDA required both that varenicline and bupropion labels contain a Boxed Warning (commonly referred to as a “black box warning”) based on case reports of serious changes in mood and behavior.77 FDA, however, removed these warnings in 2016 based on the results of a large clinical trial studying the safety and efficacy of the medications, the EAGLES study.78

The EAGLES study included over 8,000 participants and was double-blind, randomized, and placebo-controlled — the gold standard in medical research.79 This research showed that side effects from varenicline and bupropion were similar to that of the over-the-counter nicotine patch, both for patients with and without a history of psychiatric conditions.80 The study also demonstrated that varenicline and bupropion are more effective at helping people quit smoking than are NRTs, with varenicline having the highest overall quit rate.81 Considering this information, FDA concluded that the benefits of varenicline and bupropion outweigh their risks and thus removed the Boxed Warning from their labels.82

The EAGLES study’s safety and efficacy conclusions are consistent with other research.83 Clinical guidelines from the American College of Cardiology recommend varenicline as first-line therapy.84 There have even been calls for varenicline to be available over the counter,85 and research funded by the National Institutes of Health is underway to examine the safety and efficacy of over-the-counter varenicline.86

Opponents Continue to Raise Safety Concerns

Despite the evidence supporting tobacco cessation medications’ safety and effectiveness and the extensive harms tobacco use causes, opponents — usually physician associations — continue to argue that the medications are too dangerous for pharmacists to prescribe.87 Even if varenicline and bupropion carried higher risks of side effects, as the director of the Idaho Board of Pharmacy put it, “side effects are a fixed characteristic of the drug. [. . .] The risk of side effects doesn’t change if a physician prescribes it, a pharmacist prescribes it, or Mickey Mouse prescribes it.”88

Considering similar arguments are raised in opposition to pharmacist prescribing of immunizations,89 hormonal contraceptives,90 and even mild acne treatments,91 the opposition may be more related to scope of practice “turf wars” than evidence-based medicine. Similar contention is often seen in efforts to expand the scope of practice of nurse practitioners,92 physician assistants,93 and other non-physician providers.94

Several states, as a result of opponents’ lobbying, have limited pharmacist prescriptive authority to nicotine replacement products — most of which are available over the counter and are less effective than varenicline and bupropion.95 See Table 3 for a breakdown of which states allow pharmacists to prescribe which tobacco cessation aids.

Table 3

State

Varenicline

Bupropion

OTC NRTs96

Rx-Only NRTs97

Arizona98

 

 

x

x

California99

 

 

 

x

Colorado100

x

x

x

x

Idaho101

x

x

x

x

Indiana

Not specified in statute

Iowa102

 

 

x

x

Maine103

 

 

x

 

New Mexico104

x

x

x

x

Oregon105

x

x

x

x

Legislative Activity in 2019

As of June 2019, state lawmakers in nine states introduced legislation that would allow pharmacists to prescribe tobacco cessation products. In two states (Arkansas106 and West Virginia107) the governor has signed the legislation. In one (Missouri108) both chambers passed the legislation, and it is currently awaiting the governor’s signature. Legislation is still pending in Massachusetts,109 Minnesota,110 and Rhode Island,111 and has died in Connecticut,112 Maryland,113 and Texas.114

Conclusion

Even as adult smoking rates decline, the health and economic effects of tobacco use in the United States are significant. Helping people quit smoking continues to be an important public health goal. Evidence shows that pharmacists are capable of providing effective tobacco cessation therapy services and that FDA-approved tobacco cessation aids are safe and effective. Thus, states are likely to continue to consider policies that utilize pharmacists to help people quit smoking, including pharmacist authority to prescribe tobacco cessation aids. Policy makers should consider the breadth of evidence available when safety concerns are raised and weigh the small risks of tobacco cessation medications with the large benefits of being smoke-free.

Mission Not Yet Accomplished

While public health officials and advocates have reason to celebrate a lower U.S. smoking rate, it falls short of a “mission accomplished” declaration. Although the overall adult smoking rate has decreased to 14 percent, certain subgroups of Americans still use tobacco at much higher rates, including people with less education, people with no insurance or who are covered by Medicaid, and certain racial groups.2 An estimated 480,000 people die each year from smoking-related illness.3 That is the equivalent of about 22 Boeing 747 airplanes full of people crashing – every week.4 In contrast, in 2017 70,237 people in the United States died from a drug overdose.5 While the attention on the opioid crisis is justified and necessary, the comparison demonstrates that preventing tobacco-related death and illness should remain on the nation’s list of priorities.

In 2009, then-President Obama signed into law the Family Smoking Prevention and Tobacco Control Act.6 The law authorized the U.S Food and Drug Administration (FDA) to regulate tobacco products, which was aimed, in part, to decrease youth cigarette use.7 Indeed, the most recent tobacco use statistics suggest that youth cigarette smoking has continued to decline – down from 13 percent in 2016 to 10 percent in 2017.8 Nineteen percent of twelfth graders, however, reported nicotine vaping in 2017 with devices such as e-cigarettes or Juuls.9 Teen e-cigarette users are 23 percent more likely to start smoking tobacco products in the next six months than non-users.10 With so many teens using e-cigarettes converting to smoked tobacco products, it is unlikely that smoking is a generational problem that will go away with time. Policies aimed at preventing tobacco use must be paired with tobacco cessation support.

Pharmacists, Accessible and Capable, Can Help People Quit

While quitting smoking is often a long and challenging process, there are evidence-based treatments available, including counseling and medications, that can help — if they are accessible and used.11 Most smokers report that they want to quit but fewer than 10 percent report success in doing so within the past year.12

The Centers for Disease Control and Prevention (CDC), the Tobacco Control Network, and Centers for Medicare & Medicaid Services have identified pharmacists as a solution for increasing patient access to tobacco cessation treatments.13 Not only are pharmacists highly accessible14 and highly trained,15 research shows that pharmacists can effectively help people quit smoking by providing cessation counseling and prescribing tobacco cessation medications.16

New Mexico Takes the Lead

In 2004, New Mexico was the first state to expand pharmacists’ scope of practice to include autonomous tobacco cessation aid prescribing.17 The authorizing statute, passed by the legislature in 2001,18 says the New Mexico board of pharmacy “shall . . . adopt, after approval by the New Mexico board of medical examiners and the board of nursing, rules and protocols for the prescribing of dangerous drug therapy . . ..”19 The statute also requires that the adopted rules and protocols must include “the appropriate notification of the primary or appropriate physician of the person receiving the dangerous drug therapy.”20 The approved protocol allows pharmacists to prescribe any “FDA approved products for tobacco cessation.”21

In the 15 years since pharmacists were first able to prescribe tobacco cessation medications, there have been no reported problems.22 Research has demonstrated that pharmacist-provided tobacco cessation services are just as effective as those services provided by other healthcare providers.23 In one New Mexico-based study of 1,437 smokers who received pharmacist-provided tobacco cessation services, quit rates were similar to those achieved by other healthcare professionals.24 Of note, study participants were recruited by the participating pharmacists at local community pharmacies, and 64 percent of the patients in the study did not have health insurance.25 That many patients in the study did not have health insurance indicates that pharmacists can serve as an access point for patients who otherwise would not receive preventive health services.26

Another sign of success is that since the time that the tobacco cessation prescribing protocol was approved, the New Mexico boards of pharmacy, medical examiners, and nursing have approved several other pharmacist-prescribing protocols. Those protocols authorize pharmacists to autonomously prescribe tuberculosis testing,27 naloxone,28 and hormonal contraceptives.29

Autonomous Prescribing vs. Collaborative Prescribing

While New Mexico’s authority relates to autonomous pharmacist prescribing, pharmacists can also prescribe in many states under a collaborative practice agreement (CPA). In 1979, Washington State was the first state to allow pharmacists to prescribe under a CPA between a pharmacist and a “practitioner authorized to prescribe drugs,” most often a physician.30 CPAs allow a physician (or another prescriber, in many states) to delegate certain patient care functions — including prescribing — to pharmacists under certain parameters delineated in the CPA.31 Prescribing under a CPA is considered “dependent” prescriptive authority because it depends on another prescriber’s approval. In contrast, “independent” or autonomous prescriptive authority comes directly from a state authority, such as the board of pharmacy.32

Independent prescriptive authority may come in one of two forms: a statewide protocol or category specific authority.33 A statewide protocol, like in New Mexico, requires certain procedures the pharmacist must follow while prescribing.34 With category specific authority, the state simply identifies the category of medications the pharmacist may prescribe and leaves the details to the pharmacist to determine based on the standard of care.35

Autonomous vs. Collaborative Prescribing for Tobacco Cessation

While tobacco cessation medications can be prescribed pursuant to a CPA, certain barriers (such as requirements that the patient first see the physician before the pharmacist can prescribe) make the implementation of such a service challenging, or even infeasible, in many states.

For example, compare Washington State’s CPA provisions to those of Kansas. In Washington State, a pharmacist can care for patients the authorizing physician has not yet seen, so long as that authority is in the CPA.36 This flexibility allows pharmacists to provide acute and preventive care, such as tobacco cessation services, for patients who may not have a primary care provider – and then connect them with one for future care.

By contrast, prescribing for acute conditions and preventive care services is largely infeasible under Kansas’s authority. In Kansas, CPAs must be limited to a specific patient who is being treated by the authorizing physician.37 While a physician and a pharmacist could develop a CPA that allows the pharmacist to prescribe for the physician’s patients, the paperwork burden is much greater than in Washington’s model. Additionally, patients without a primary care provider, who most need increased access to care, are excluded altogether.

In both models, for a community to have access to pharmacist-provided services that include prescribing authority, the pharmacist must find a physician willing to authorize the CPA.38 This can present an insurmountable barrier for some, leaving patients without access to this additional resource.

Other States Authorize Autonomous Prescribing, Often with Added Restrictions

Recognizing both the barriers of CPAs and the opportunity to more fully utilize pharmacists’ skills, the prevalence of autonomous prescribing authority has grown, especially in the last five years.  Eight states (Arizona,39 California,40 Colorado,41 Idaho,42 Indiana,43 Iowa,44 Maine,45 and Oregon46) have followed New Mexico’s lead and authorized pharmacist prescribing of tobacco cessation products.47 Although the concept has broad support,48 objections have been raised, often from state medical societies. These objections primarily relate to pharmacists’ qualifications,49 fragmentation of care,50 and the safety of the medications themselves.51 This has caused some of these new laws to be less expansive and/or impose additional obligations on the pharmacist.

Pharmacist Qualifications

Opponents of autonomous pharmacist prescribing of tobacco cessation medications will claim that pharmacists lack the qualifications necessary to assess patients and prescribe medications. The rationale for this argument is that since pharmacists go through less training than physicians, they cannot safely act as prescribers. However, that is not necessarily so. Pharmacists, who earn a Doctor of Pharmacy degree before sitting for the national licensing exam, receive six to eight years of clinical training that includes tobacco cessation training.52 Pharmacist training focuses on pharmacotherapy and the provision of patient-centered care.53 Even if it were true that pharmacists need further training to prescribe tobacco cessation medications, policymakers need not reject the concept of pharmacists prescribing these drugs altogether. States can accommodate this concern with required education as a prerequisite to pharmacist prescriptive authority. California’s statute, for example, calls for initial training and continuing education every other year.54 Other states’ education provisions are included in Table 1.

Table 1

State

Training Requirements

Arizona55

“[A] course of training accredited by the accreditation council for pharmacy education in the subject area of tobacco cessation and successfully complete two hours of accreditation council for pharmacy education accredited tobacco cessation continuing education programs on license renewal.”

California56

“[A] minimum of two hours of an approved continuing education program specific to smoking cessation therapy and nicotine replacement therapy, or an equivalent curriculum-based training program completed within the last two years in an accredited California school of pharmacy.

Additionally, pharmacists who participate in this protocol must complete ongoing continuing education focused on smoking cessation therapy from an approved provider once every two years.”

Colorado57

“Accreditation Council for Pharmacy Education (ACPE) accredited program in tobacco cessation.”

Idaho58

“[A] course on tobacco cessation therapy taught by a provider accredited by the accreditation council for pharmacy education or by a comparable provider recognized by the board.”

Indiana

No specific requirement

Iowa59

Statute: “[C]ontinuing pharmacy education related to statewide protocols recognized and approved by the board.”

Proposed rule: “ACPE-approved continuing education program of at least one-hour duration related to nicotine replacement tobacco cessation product utilization.”

Maine

No specific requirement

New Mexico60

“[A] course of training, accredited by the accreditation council for pharmacy education (ACPE), in the subject area of tobacco cessation drug therapy provided by: a) the department of health; or b) health and human services or c) a similar health authority or professional body approved by the board.”

“[A] minimum of 0.2 CEU of ACPE approved tobacco cessation drug therapy related continuing education every two years.”

Oregon61

Recommended (not yet adopted): “1 time course minimum 2 hours of CPE.”

 

Fragmentation of Care

Opponents also allege that pharmacists should not prescribe tobacco cessation medications because it will lead to fragmentation of care, The idea behind this contention is that with more providers writing prescriptions, it is less likely that all providers will know the patient’s full medication regimen. Healthcare fragmentation is, indeed, a serious problem in the United States – regardless of pharmacists’ ability to prescribe.62

Still, concerns about care fragmentation need not derail policy proposals that allow pharmacists to prescribe tobacco cessation medications. Many patients do not have a primary care provider, so pharmacists can serve as a new entry point to the healthcare system generally and provide referrals, as needed.63 For those patients who do have a regular primary care provider, care fragmentation can be addressed with increased communication between the pharmacist and primary care provider.

As with education/qualification concerns, states can include communication requirements in laws authorizing pharmacist prescribing to reduce the fragmentation of care. Most states that authorize pharmacists to prescribe tobacco cessation therapy require the pharmacist to send a notification to the patients’ primary care physician, if they have one, after prescribing a medication.64 See Table 2 for each states’ notification requirements. Even in states without an explicit requirement, communication is a foundational component of all pharmacist-provided patient care services.65

Table 2

State

Notification Requirements

Arizona66

“Notify the qualified patient’s designated primary care provider within seventy-two hours after the medication is prescribed.”

California67

“The pharmacist notifies the patient’s primary care provider of any drugs or devices furnished to the patient, or enters the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist provides the patient with a written record of the drugs or devices furnished and advises the patient to consult a physician of the patient’s choice.”

Colorado68

“[A] process shall be in place for the pharmacist to communicate with the patient’s primary care provider and document changes to the patient’s medical record. If the patient does not have a primary care provider, or is unable to provide contact information for his or her primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished and advise the patient to consult an appropriate health care professional of the patient’s choice.”

Idaho69

“When a pharmacist prescribes a tobacco cessation product [. . .] Notification of the patient screening, the prescription record and the follow-up care plan shall be provided to the patient's primary care provider, as applicable, within five (5) business days following the prescribing of a tobacco cessation product.”

Indiana

No specific requirement

Iowa70

Statute: “Notify the patient’s primary health care provider of any prescription drugs, products, tests, or treatments administered to the patient, or enter such information in a patient record system also used by the primary health care provider, as permitted by the primary health care provider. If the patient does not have a primary health care provider, the pharmacist shall provide the patient with a written record of the prescription drugs, products, tests, or treatment provided to the patient and shall advise the patient to consult a physician.”

Regulation: “As soon as reasonably possible, the authorized pharmacist shall notify the patient's primary health care provider of the nicotine replacement tobacco cessation product provided to the patient. If the patient does not have a primary health care provider, the authorized pharmacist shall provide the patient with a written record of the nicotine replacement tobacco cessation product provided to the patient and shall advise the patient to consult a physician.”

Maine

No specific requirement

New Mexico71

Regulation: “Upon signed consent of the patient, the pharmacist shall notify the patient's designated physician or primary care provider of tobacco cessation drug therapy prescribed.”

Protocol: “Provide notice to the patient's primary practitioner within 15 days of writing the prescription.”

Oregon72

Recommended (not yet adopted): “Pharmacist prescribing requirements: [. . .] notification of providers upon prescribing.”

 

Medication Safety

Opponents to this autonomous prescribing authority frequently attack the safety of tobacco cessation products themselves as reason to prohibit such prescribing.73 Criticism is typically aimed more specifically at varenicline (Chantix) and bupropion (Zyban), which work differently than nicotine replacement therapies (NRTs) like nicotine gum or the patch.

How the Medicines Work

NRTs aid in tobacco cessation by replacing the active ingredient in tobacco, nicotine, so patients can avoid withdrawal symptoms that result from quitting tobacco abruptly and focus on habit changes.

Varenicline is a partial nicotine agonist.74 This means that the drug will bind with the receptor where nicotine usually binds. When varenicline binds to this receptor, it gives the patient a similar effect that nicotine does but at a much lower level, which helps stave off nicotine cravings.75 Varenicline also blocks nicotine from binding the receptor. By blocking nicotine, patients can continue to smoke after starting varenicline but will not feel the “positive” effects that makes smoking addictive. Without the positive effects, smokers tend to take more notice of the negatives of smoking (e.g., the bad taste and smell), which makes quitting easier.

Bupropion’s mechanism of action is not well understood. In addition to its indication as a smoking cessation aid, it is indicated for the treatment of major depressive disorder.76

Varenicline and Bupropion Boxed Warning Removed with EAGLES Data

In 2009, FDA required both that varenicline and bupropion labels contain a Boxed Warning (commonly referred to as a “black box warning”) based on case reports of serious changes in mood and behavior.77 FDA, however, removed these warnings in 2016 based on the results of a large clinical trial studying the safety and efficacy of the medications, the EAGLES study.78

The EAGLES study included over 8,000 participants and was double-blind, randomized, and placebo-controlled — the gold standard in medical research.79 This research showed that side effects from varenicline and bupropion were similar to that of the over-the-counter nicotine patch, both for patients with and without a history of psychiatric conditions.80 The study also demonstrated that varenicline and bupropion are more effective at helping people quit smoking than are NRTs, with varenicline having the highest overall quit rate.81 Considering this information, FDA concluded that the benefits of varenicline and bupropion outweigh their risks and thus removed the Boxed Warning from their labels.82

The EAGLES study’s safety and efficacy conclusions are consistent with other research.83 Clinical guidelines from the American College of Cardiology recommend varenicline as first-line therapy.84 There have even been calls for varenicline to be available over the counter,85 and research funded by the National Institutes of Health is underway to examine the safety and efficacy of over-the-counter varenicline.86

Opponents Continue to Raise Safety Concerns

Despite the evidence supporting tobacco cessation medications’ safety and effectiveness and the extensive harms tobacco use causes, opponents — usually physician associations — continue to argue that the medications are too dangerous for pharmacists to prescribe.87 Even if varenicline and bupropion carried higher risks of side effects, as the director of the Idaho Board of Pharmacy put it, “side effects are a fixed characteristic of the drug. [. . .] The risk of side effects doesn’t change if a physician prescribes it, a pharmacist prescribes it, or Mickey Mouse prescribes it.”88

Considering similar arguments are raised in opposition to pharmacist prescribing of immunizations,89 hormonal contraceptives,90 and even mild acne treatments,91 the opposition may be more related to scope of practice “turf wars” than evidence-based medicine. Similar contention is often seen in efforts to expand the scope of practice of nurse practitioners,92 physician assistants,93 and other non-physician providers.94

Several states, as a result of opponents’ lobbying, have limited pharmacist prescriptive authority to nicotine replacement products — most of which are available over the counter and are less effective than varenicline and bupropion.95 See Table 3 for a breakdown of which states allow pharmacists to prescribe which tobacco cessation aids.

Table 3

State

Varenicline

Bupropion

OTC NRTs96

Rx-Only NRTs97

Arizona98

 

 

x

x

California99

 

 

 

x

Colorado100

x

x

x

x

Idaho101

x

x

x

x

Indiana

Not specified in statute

Iowa102

 

 

x

x

Maine103

 

 

x

 

New Mexico104

x

x

x

x

Oregon105

x

x

x

x

 

Legislative Activity in 2019

As of June 2019, state lawmakers in nine states introduced legislation that would allow pharmacists to prescribe tobacco cessation products. In two states (Arkansas106 and West Virginia107) the governor has signed the legislation. In one (Missouri108) both chambers passed the legislation, and it is currently awaiting the governor’s signature. Legislation is still pending in Massachusetts,109 Minnesota,110 and Rhode Island,111 and has died in Connecticut,112 Maryland,113 and Texas.114

Conclusion

Even as adult smoking rates decline, the health and economic effects of tobacco use in the United States are significant. Helping people quit smoking continues to be an important public health goal. Evidence shows that pharmacists are capable of providing effective tobacco cessation therapy services and that FDA-approved tobacco cessation aids are safe and effective. Thus, states are likely to continue to consider policies that utilize pharmacists to help people quit smoking, including pharmacist authority to prescribe tobacco cessation aids. Policy makers should consider the breadth of evidence available when safety concerns are raised and weigh the small risks of tobacco cessation medications with the large benefits of being smoke-free.

  1. Cigarette Smoking Among U.S. Adults Lowest Ever Recorded: 14% in 2017, Nov. 8, 2018, available at https://www.cdc.gov/media/releases/2018/p1108-cigarette-smoking-adults.html (last accessed June 26, 2019).
  2.  See id. According to the CDC, tobacco use rates in 2017 were at 42% for people with a General Education Development (GED) certificate, 31% for people who were uninsured, 28% for people insured by Medicaid, and 30% for Non-Hispanic American Indian/Alaska Native Americans.
  3.  See U.S. Department of Health and Human Services, The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. Printed with corrections, January 2014; Centers for Disease Control and Prevention, QuickStats: Number of Deaths from 10 Leading Causes—National Vital Statistics System, United States, 2010, Morbidity and Mortality Weekly Report 2013:62(08);155, available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6208a8.htm?s_cid=mm6208a8_w (last accessed June 26, 2019).
  4.  A typical 747 plane holds 410 passengers. See Boeing, Boeing 747-8, available at https://www.boeing.com/commercial/747/ (last accessed June 26, 2019).
  5.  See National Institute on Drug Abuse, National Institutes of Health, Overdose Death Rates, Jan. 2019, available at https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates (last accessed June 26, 2019).
  6.  See 21 C.F.R. §§ 1100, 1140, 1143 (2016).
  7.  See Tilburg W, et al, FDA Regulation of Electronic Nicotine Delivery Systems and the "Deeming" Rule: What's Left for States? 20 J. Health Care L. & Pol'y 27, 54-56 (2017).
  8.  See supra note 3 (CDC QuickStats).
  9.  See Miech, RA, et al., Monitoring the Future national survey results on drug use, 1975–2017: Volume I, Secondary school students. Ann Arbor: Institute for Social Research, The University of Michigan (2018) at page 14, available at http://monitoringthefuture.org/pubs/monographs/mtf-vol1_2017.pdf (last accessed June 26, 2019).
  10.  See National Institute on Drug Abuse, National Institutes of Health, Teens and E-cigarettes, Feb. 2016, available at https://www.drugabuse.gov/related-topics/trends-statistics/infographics/teens-e-cigarettes (last accessed June 26, 2019).
  11.  See Centers for Disease Control and Prevention, Quitting Smoking Among Adults—United States, 2000–2015, Morbidity and Mortality Weekly Report 2017;65(52):1457-64, available at https://www.cdc.gov/mmwr/volumes/65/wr/mm6552a1.htm?s_cid=mm6552a1_w%20 (last accessed June 26, 2019).
  12.  See id.
  13.  See Centers for Disease Control and Prevention, Pharmacists: Help Your Patients Quit Smoking, April 22, 2019, available at https://www.cdc.gov/tobacco/campaign/tips/partners/health/pharmacist/index.html (last accessed June 26, 2019); Department of Health and Human Services, Centers for Medicare & Medicaid Services; CMCS Informational Bulletin, State Flexibility to Facilitate Timely Access to Drug Therapy by Expanding the Scope of Pharmacy Practice using Collaborative Practice Agreements, Standing Orders or Other Predetermined Protocols, Jan. 17, 2017, available at https://www.medicaid.gov/federal-policy-guidance/downloads/cib011717.pdf (last accessed June 26, 2019);  Tobacco Control Network, Access to Tobacco Cessation Medication Through Pharmacists, Feb 8, 2017, available at http://www.astho.org/Prevention/Tobacco/Tobacco-Cessation-Via-Pharmacists/ (last accessed June 26, 2019).
  14.  Ninety-one percent of Americans live within five miles of a community pharmacy. See National Association of Chain Drug Stores, Face-to-face with Community Pharmacies, available at http://www.nacds.org/pdfs/about/rximpact-leavebehind.pdf (last accessed June 26, 2019).
  15.  Pharmacists receive at least six years of higher education and are required to earn a Doctor of Pharmacy degree before sitting for the licensure exam. See Pharmacists for Healthier Lives, Your Closest Doctor is Usually a Pharmacist, available at https://pharmacistsforhealthierlives.org (last accessed June 26, 2019).
  16.  See Chen T, et al., Comparison of an Intensive Pharmacist-Managed Telephone Clinic with Standard of Care for Tobacco Cessation in a Veteran Population, Health Promot Pract, 2013; 15(4):512-520; see also Shen X, et al., Quitting Patterns and Predictors of Success Among Participants in a Tobacco Cessation Program Provided by Pharmacists in New Mexico, J Manag Care Pharm, 2014;20(6):579-87.
  17.  N.M. Code R. § 16.19.26.11.
  18.  2001 N.M. SB 353.
  19.  N.M. Stat. Ann. § 61-11-6.
  20.  Id.
  21.  See New Mexico Regulation & Licensing Department, Pharmacy: Links; Pharmacist Prescriptive Authority, Protocol for Pharmacist Prescribing of Tobacco Cessation Products, available at http://www.rld.state.nm.us/boards/Pharmacy_Links.aspx (last accessed June 26, 2019). “FDA” in the New Mexico regulation stands for the Food and Drug Administration.
  22.  Telephone Interview with R. Dale Tinker, Executive Director, New Mexico Pharmacists Association (Jan. 11, 2019).
  23.  Shen X, et al., Quitting Patterns and Predictors of Success Among Participants in a Tobacco Cessation Program Provided by Pharmacists in New Mexico, J Manag Care Pharm, 2014;20(6):579-87.
  24.  Id.
  25.  Id.
  26.  See DeVoe JE, et al., Receipt of Preventive Care Among Adults: Insurance Status and Usual Source of Care, AJPH, 2003;93(5):786-91.
  27.  N.M. Code R. § 16.19.26.12.
  28.  N.M. Code R. § 16.19.26.13.
  29.  Pharmacist authority to prescribe vaccines, N.M. Code R. § 16.19.26.9, and emergency contraceptives  N.M. Code R. § 16.19.26.10, was approved around the same time as tobacco cessation. N.M. Code R. § 16.19.26.14. 
  30.  Wash. Rev. Code Ann. § 18.64.011(28).
  31.  See Adams AJ and Weaver KK, The continuum of pharmacist prescriptive authority, Ann. Pharmacother., 2016;50:778–784.
  32.  See id.
  33.  See id.
  34.  See id.
  35.  See id.
  36.  WAC 246-863-100; see Washington State Pharmacy Quality Assurance Commission, Interim Guidance on Collaborative Drug Therapy, December 2018, available at https://www.doh.wa.gov/Portals/1/Documents/Pubs/690327.pdf (last accessed June 26, 2019).
  37.  Kan. Admin. Regs. § 68-7-22.
  38.  See Centers for Disease Control and Prevention, Advancing Team-Based Care Through Collaborative Practice Agreements: A Resource and Implementation Guide for Adding Pharmacists to the Care Team, 2017, available at https://www.cdc.gov/dhdsp/pubs/docs/CPA-Team-Based-Care.pdf (last accessed June 26, 2019).
  39.  Ariz. Rev. Stat. § 32-1979.03.
  40.  Cal. Bus. & Prof. Code § 4052.9.
  41.  3 Colo. Code Regs. § 719-1, Rule 17.00.50; State of Colorado Department of Regulatory Agencies, Colorado State Board of Pharmacy Approved Statewide Protocol for Dispensing Tobacco Cessation Products, available at https://drive.google.com/file/d/0B-K5DhxXxJZbZTcwZ1FTZ1c2Mzg/view (last accessed June 26, 2019).
  42.  Idaho Code § 54-1733E.
  43.  Indiana’s statute provides “the state health commissioner or the commissioner’s designated public health authority who is a licensed prescriber” with discretionary authority to issue a statewide standing order. At the time this article was published, the discretionary authority had not yet been exercised. Ind. Code Ann. § 16-19-4-11.
  44.  Iowa Code § 155A.46.
  45.  32 M.R.S. § 13702-A(28).
  46.  Discretionary authority provided in statute, currently under review in the regulatory process. Or. Rev. Stat. Ann. § 689.645; see Oregon Board of Pharmacy, Board Meeting Agenda Feb. 6-7, 2019, page 79-80, available at https://www.oregon.gov/pharmacy/Imports/Agendas/AgendaFeb2019.pdf (last accessed June 26, 2019).
  47.  See Adams AJ and Hudmon KS, Pharmacist prescriptive authority for smoking cessation medications in the United States, JAPhA, 2018;58:253-57.
  48.  Supra note 13.
  49.  See Brown R, Committee approves bill to give pharmacists ability to prescribe smoking cessation drugs, Idaho Press, (Jan. 25, 2017), available at https://www.idahopress.com/news/local/committee-approves-bill-to-give-pharmacists-ability-to-prescribe-smoking/article_33320f9f-fcb6-52af-876c-3077987d460f.html (last accessed June 26, 2019).
  50.  Supra note 47.
  51.  Id.
  52.  See Corelli RL, et al., Evaluation of a train-the-trainer program for tobacco cessation, Am J Pharm Educ. 2007;71(5):109.
  53.  See Accreditation Council for Pharmacy Education, Accreditation standards and key elements for the professional program in pharmacy leading to the Doctor of Pharmacy degree, 2015, available at https://www.acpe-accredit.org/pdf/Standards2016FINAL.pdf (last accessed June 26, 2019).
  54.  Cal. Bus. & Prof. Code § 4052.9.
  55.  Ariz. Rev. Stat. § 32-1979.03(B).
  56.  Cal. Code Regs. tit. 16, § 1746.2(8).
  57.  Supra note 43 at page 1.
  58.  Idaho Code § 54-1733E(1).
  59.  Iowa Code § 155A.46(2)(c); 2018 IA Regulation Text 4096.
  60.  N.M. Code R. § 16.19.26.11(B)
  61.  Supra note 46 at page 79.
  62.  See, e.g., Stange KC, The Problem of Fragmentation and the Need for Integrative Solutions, Ann. Fam. Med. 2009;7(2):100–103.
  63.  Supra note 47.
  64.  Supra note 47.
  65.  See Joint Commission of Pharmacy Practitioners, Pharmacists’ Patient Care Process, May 29, 2014, available at https://jcpp.net/wp-content/uploads/2016/03/PatientCareProcess-with-supporting-organizations.pdf (last accessed June 26, 2019).
  66.  Ariz. Rev. Stat. § 32-1979.03(C)(1).
  67.  Cal. Bus. & Prof. Code § 4052.9(a)(2); Cal. Code Regs. tit. 16, § 1746.2(6).
  68.  Supra note 41 at page 5.
  69.  Idaho Code § 54-1733E(3).
  70.  Iowa Code § 155A.46(2)(b); 2018 IA Regulation Text 4096.
  71.  N.M. Code R. § 16.19.26.11(E); supra note 21.
  72.  Supra note 46 at page 80.
  73.  Supra note 47. See Idaho Senate, Health and Welfare Committee Minutes, Feb. 1, 2017, available at https://legislature.idaho.gov/wp-content/uploads/sessioninfo/2017/standingcommittees/170201_sh&w_0300AM-Minutes.pdf (last accessed June 26, 2019).
  74.  See, e.g., Chantix® (varenicline) Full Prescribing Information, available at http://labeling.pfizer.com/ShowLabeling.aspx?id=557 (last accessed June 26, 2019).
  75.  See, e.g., American Cancer Society, Prescription Drugs to Help You Quit Tobacco, Jan. 12, 2019, available at https://www.cancer.org/healthy/stay-away-from-tobacco/guide-quitting-smoking/prescription-drugs-to-help-you-quit-smoking.html (last accessed June 26, 2019).
  76.  See, e.g., Zyban® (bupropion) Full Prescribing Information, available at https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Zyban/pdf/ZYBAN-PI-MG.PDF (last accessed June 26, 2019).
  77.  See U.S. Food and Drug Administration, FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings, Dec. 16, 2016, available at https://www.fda.gov/Drugs/DrugSafety/ucm532221.htm (last accessed June 26, 2019). Though “Boxed Warning” is the official term, these FDA-established warnings are included on a prescription drug’s label to warn of serious or life-threatening risks. They are also commonly referred to as a “black box warning.” See U.S. Food and Drug Administration, A Guide to Drug Safety Terms at FDA, available at https://www.fda.gov/media/74382/download (last accessed June 26, 2019).
  78.  See id. See also, Anthenelli RM, et al., Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial, Lancet, 2016;387(10037):2507e2520.
  79.  See id. (Anthenelli).
  80.  See id.
  81.  See id.
  82.  Supra note 77.
  83.  Cahill K, et. al., Pharmacological interventions for smoking cessation: an overview and network meta-analysis, Cochrane Database Syst Rev. 2013;(5).
  84.  See Barua RS, et. al., 2018 ACC expert consensus decision pathway on tobacco cessation treatment. J Am Coll Cardiol 2018;72:3332–65.
  85.  See Leischow SJ, Increasing Smoking Cessation in the United States: Expanding the Availability of Over-the-Counter Medications, JAMA 2019;321(6): 541-42.
  86.  See U.S. National Library of Medicine, Varenicline OTC Trial on Efficacy and Safety (VOTC), ClinicalTrials.gov Identifier: NCT03557294, available at https://clinicaltrials.gov/ct2/show/NCT03557294 (last accessed June 26, 2019).
  87.  During testimony in the Idaho State Senate, one physician incorrectly asserted that bupropion still carried an FDA-mandated Black Box warning, more than a year after FDA announced its removal. See supra note 73 (Idaho Senate, Health and Welfare Committee Minutes).
  88.  See supra note 49.
  89.  See Iowa Chapter of the American Academy of Pediatrics, Iowa-AAP Position on Pharmacy Administration of Childhood Vaccines, available at http://www.scottadvconsult.com/wp-content/uploads/2018/03/AAP-position-on-pharmacy-immunization.pdf (last accessed June 26, 2019) (opposing 2018 Iowa Senate File 2322); North Carolina Academy of Family Physicians, Academy Continues to Push Against Pharmacy Immunization Expansion, May 20, 2011, available at https://www.ncafp.com/publications/NCAFPNotes/archives/2011/V10N20.htm (last accessed June 26, 2019); American Academy of Family Physicians Academy Chapters Use AAFP Resource to Fight Pharmacist-administered Inoculations Legislation, June 22, 2011, available at https://www.aafp.org/news/government-medicine/20110622pharmbrief.html (last accessed June 26, 2019). But see American Medical Association Policy, Role of Pharmacists in Improving Immunization Rates H-440.836, 2014, available at https://policysearch.ama-assn.org/policyfinder/detail/pharmacist?uri=%2FAMADoc%2FHOD.xml-0-3852.xml (last accessed June 26, 2019).
  90.  See Curtis T, Md. pharmacists now birth control providers, The Daily Record, June 30, 2017, available at https://thedailyrecord.com/maryland-medical-law/2017/06/30/md-pharmacists-now-birth-control-providers/ (last accessed June 26, 2019).
  91.  Minutes of the Idaho State Board of Pharmacy, Aug. 2, 2018, at page 6, available at https://bop.idaho.gov/board_meeting/2018-08-30_Minutes_August-2-2018_APPROVED.pdf (last accessed June 26, 2019). “Suzanne Olbricht, MD, President, American Academy of Dermatology Association submitted written public comment opposing pharmacist prescribing for mild acne, indicating her organization’s belief that a board-certified dermatologist is needed to make a proper diagnosis of mild acne.”
  92.  See Japsen B, Nurses Say AMA Launching 'Turf War' Over Direct Patient Access, Forbes, Nov. 20, 2017, available at https://www.forbes.com/sites/brucejapsen/2017/11/20/nurses-say-ama-launching-turf-war-over-direct-patient-access/#15be465d1168 (last accessed June 26, 2019); Timmons E, Healthcare License Turf Wars: The Effects of Expanded Nurse Practitioner and Physician Assistant Scope of Practice on Medicaid Patient Access, Mercatus Center, George Mason University, Jan. 26, 2016, available at https://www.mercatus.org/publication/healthcare-license-expanded-nurse-practitioner-physician-assistant-scope-of-practice (last accessed June 26, 2019).
  93.  See id. (Timmons E).
  94.  See Coalition for Patients’ Rights, Coalition for Patients Right’s Response to the American Medical Association (AMA) Resolution 214, Dec. 9, 2017, available at https://nebula.wsimg.com/e409cae637e0ac0114530d6d11668e14?AccessKeyId=7C7F0F1D91567704475F&disposition=0&alloworigin=1 (last accessed June 26, 2019).
  95.  See supra note 47.
  96.  Over-the-Counter Nicotine Replacement Therapy.
  97.  Prescription-Only Nicotine Replacement Therapy.
  98.  Ariz. Rev. Stat. § 32-1979.03(A).
  99.  Cal. Bus. & Prof. Code § 4052.9(a); Cal. Code Regs. tit. 16, § 1746.2(5).
  100.  Supra note 41 at page 3.
  101.  Idaho Code § 54-1733E.
  102.  Iowa Code § 155A.46(1)(a)(2); 2018 IA Regulation Text 4096.
  103.  Me. Rev. Stat. tit. 32, § 13702-A(28).
  104.  Supra note 21 at paragraph G.
  105.  Recommended, not yet adopted by the board of pharmacy. Supra note 46 at page 76-77, 79.
  106.  2019 Bill Text AR H.B. 1263.
  107.  2019 Bill Text WV H.B. 2525.
  108.  2019 Bill Text MO S.B. 514.
  109.  2019 Bill Text MA S.B. 1310.
  110.  2019 Bill Text MN S.B. 1960.
  111.  2019 Bill Text RI H.B. 5558.
  112.  2019 Bill Text CT H.B. 6543.
  113.  2019 Bill Text MD H.B. 497.
  114.  2019 Bill Text TX S.B. 835.

Krystalyn Weaver

National Alliance of State Pharmacy Associations (NASPA)

Krystalyn Weaver is Vice President of Policy for the National Alliance of State Pharmacy Associations (NASPA) and entering her third year as a part-time law student at the George Mason University Antonin Scalia Law School. In her role at NASPA, Ms. Weaver focuses on pharmacist scope of practice and other state policies affecting the practice of pharmacy. She earned her Bachelor and Doctor of Pharmacy degrees from the University of Toledo College of Pharmacy. Ms. Weaver can be reached at kweave2@gmu.edu.  . 

Joseph L. Fink III

University of Kentucky College of Pharmacy

Joseph L. Fink III is Professor of Pharmacy Law and Policy as well as Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington. He is also a professor of Health Management and Policy in the UK College of Public Health, Professor of Clinical Leadership and Management in the UK College of Health Sciences, and Professor in the Martin School of Public Policy and Administration at UK. He holds a pharmacy degree from the Philadelphia College of Pharmacy and Science and earned a J.D. at Georgetown University Law Center. His scholarly works have focused on exploring and explaining legal and regulatory developments related to pharmacists, pharmacies, and pharmaceuticals. He was the founder and first president of the American Society for Pharmacy Law. He may be reached at jfink@uky.edu.