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INTRODUCTION

This educational module addresses amendments to the Texas State Board of Pharmacy (TSBP) Rules, which are part of the Texas Administrative Code (TAC), that were adopted from 2016 to 2019. Recent amendments modify definitions related to pharmacy practice, clarify operational standards for pharmacies, and update pharmacy record-keeping requirements, as well as expand the role of pharmacists in patient care and patient access to life-saving medications. Pharmacy Rules and Laws are found in the Texas Pharmacy Act, which is Chapters 551 through 569 of the Texas Occupations Code, and the Texas Pharmacy Rules, which are found in Chapters 281 through 315 of the TAC.¹

As of the time of publication, this module supplies the most current information regarding pharmacy laws and regulations in Texas. Check the Pharmacy Rules and Laws for updates concerning specific practice areas. All proposed and adopted changes to pharmacy law in Texas are published in the Texas Register—the weekly bulletin for rule-making within the state. Current copies of the Texas Register can be accessed at the website of the Office of the Secretary of State of Texas: http://www.sos.state.tx.us/texreg/index.shtml.²

Continuing education requirements

Every 2 years, pharmacists licensed in the state of Texas must complete at least 30 contact hours (3.0 continuing education units [CEUs]) of continuing education in order to apply for license renewal. As of January 1, 2015, at least 1 of the hours (0.1 CEUs) must be related to Texas pharmacy laws or rules. As of January 1, 2019, at least 1 of the hours (0.1 CEUs) must be related to opioid abuse.^1,3 The purpose of these requirements, as stated in Board Rule 295.8, is to enhance the professional competency of licensed pharmacists and protect the health and welfare of the citizens of Texas.¹

Similarly, pharmacy technicians registered in the state of Texas must also complete continuing education requirements. Every 2 years, registered technicians must obtain 20 hours of education, and 1 of these hours must be related to Texas pharmacy law.⁴

OPIOID USE AND ABUSE IN THE UNITED STATES

The term “opioid” refers to any compound that binds to an opiate receptor in the body; such receptors are widely distributed throughout the central and peripheral nervous systems and are involved in pain modulation, among other activities. The related term, “opiate,” refers to a naturally derived alkaloid from the opium poppy, such as morphine or codeine.^5,6 Opioids are semi-synthetic opiates and include methadone, fentanyl, and propoxyphene. The term “narcotic” is a legal, not medical, term that designates a group of illegal drugs.⁵

In the United States (U.S.), opioids have been used for decades in oral, intravenous, and transdermal forms to treat both acute and chronic pain.⁵ Most often, opioids are used to treat moderate to severe pain, but some opioids are used to treat cough and diarrhea.⁶ While the analgesia achieved with opioids is effective, the pain control can be accompanied by a host of undesirable effects, including constipation, itching, pupillary constriction, somnolence, mental cloudiness, and respiratory depression. Mood effects such as dysphoria and euphoria also occur with opioid use.⁵

Opioids can trigger powerful reward pathways and the reinforcing outcomes (especially the pleasurable effects) achieved with opioid use lead to cravings, even in the absence of pain.⁵ These cravings can lead to drug-seeking behaviors and, ultimately, to drug use disorder: people may try to take the drug in a way or at a dose that was not prescribed; they may attempt to take someone else’s medication; or they may take it only with the intent to get “high,” not to relieve pain.⁶

Previously, opioids were used primarily for severe acute pain, post-surgical pain, and end-of-life care, but, by the end of the 20th century, opioids had gained popularity for many types of pain, including chronic non-cancer pain. In fact, the number of opioids prescribed quadrupled from 1999 to 2010 and continued to increase, and an estimated 20% of patients who seek care for pain-related complaints are prescribed an opioid.⁷ The increased use, increased dosages, and increased lengths of treatments led to over-prescribing of opioids and increased rates of opioid misuse and abuse,⁸ as well as opioid use disorder and overdoses.^7,9

Morbidity and mortality related to prescription opioid use rose in tandem with the increased over-reliance on opioids.⁷ In 2017, 47,600 deaths in the U.S. were attributed to an opioid. The figure represents a more than 2.5-fold increase in deaths in only 1 decade. Approximately one-third of the deaths involved prescription opioids.¹⁰ More than 2 million people in the U.S. likely have opioid use disorder (i.e., addiction) associated with prescription opioids, which means that many people are still at risk for negative outcomes related to this class of medications.⁷

Opioid prescribing rates and habits vary among states and there is no consensus among practitioners regarding how to safely and effectively use opioids for pain control. The Centers for Disease Control and Prevention (CDC) published guidelines for the prescribing of opioids that include complete assessment of patients who complain of pain, initiation of nonpharmacological treatments, evaluation of patient goals and expectations regarding pain management, and consideration of the risks and benefits of all treatment options. Proper dosage form selection, dose initiation and titration, and tapering and discontinuation of therapy are also paramount to safe and effective opioid use (Table 1).^9,11 Slowly, states are implementing their own methods of controlling and recording the use of opioids in an effort to curb the misuse of such drugs and mitigate the risks associated with prevalent opioid use.

Opioid prescribing in Texas

In 2017, prescribers in Texas wrote 53.1 opioid prescriptions for every 100 people. (The national average was 58.7 prescriptions.) The same year, the rate of deaths in Texas involving opioid overdose was 5.1 deaths per 100,000 persons. This represents one of the lowest rates of overdose deaths and is nearly one-third of the national average of 14.6 deaths per 100,000 people.¹²

Synthetic opioids (e.g., fentanyl, heroin) are increasingly involved in opioid-related deaths in Texas, and overdoses related to prescription opioids remain the leading cause of opioid-related deaths. In 2017, 348 deaths were attributed to synthetic opioids, 569 were attributed to heroin, and 646 were attributed to prescription opioids. Still, despite the lower number of deaths in Texas than in other states, any death related to opioids is unacceptable and the goal for opioid-related deaths should be zero.¹²

Prescription monitoring program

While Texas has rates that are lower than the national averages when it comes to opioid prescriptions and related deaths, there is still more than can be done to improve public health and minimize misuse and diversion of opioids. The Texas Prescription Program (TPP) was created in 1981 by the Texas Department of Public Safety, becoming law on January 1, 1982. It was originally intended to monitor prescriptions for Schedule II controlled substances. As of September 1, 2008, the TPP was expanded to monitor Schedule III, IV, and V prescriptions. In 2016, TPP authority was transferred from the Department of Public Safety to the TSBP.¹³

In its current form, the TSBP’s Prescription Monitoring Program (PMP) collects information about all Schedule II through V controlled substances dispensed by an outpatient pharmacy in Texas or to a Texas resident by an out-of-state pharmacy. (While many states do allow some level of communication among PMP databases, not all PMPs are fully integrated yet. Therefore, prescriptions filled outside the state of Texas may not be accessible by Texas’s PMP.) The aim of the PMP is to control the misuse and abuse of controlled substances by following them from manufacturer to ultimate user. The PMP can be used by prescribers and pharmacists to verify records and assess patient prescription histories. Additionally, the PMP can generate data regarding trends in prescribing and dispensing of controlled substances, which can inform prescribing practices.¹³

As of September 1, 2017, all pharmacies that are licensed in Texas and dispense controlled substances are required to report information about dispensed prescriptions to the PMP database. Reporting is required within 1 business day of the complete filling of the prescription. Pharmacies that do not comply with reporting requirements can face administrative, civil, or criminal penalties.^13,14

In an effort to eliminate duplicate prescribing or overprescribing of controlled substances, a new mandate has been added to prescribing and dispensing requirements. Beginning March 1, 2020, prescribers (other than veterinarians) and pharmacists must check a patient’s PMP history before prescribing or dispensing opioids, benzodiazepines, barbiturates, or carisoprodol.¹⁴ In order to comply with this requirement, all prescribers and pharmacies will need to establish an online account with AWARxE, the portal for accessing the PMP database. The database shares information among 30 states and organizations to allow for easy tracking of prescriptions and flagging of information that may indicate illicit activity, drug abuse, drug diversion, or “doctor shopping.” Technicians may participate in the PMP by serving as pharmacists’ designees or delegates for accessing and logging prescription information into the PMP.^15,16

Opioid prescription forms. As part of the PMP, official prescription forms for some controlled substances are changing. As of June 1, 2019, all prescription forms for Schedule II drugs must meet new requirements; any forms ordered before September 1, 2018 are not valid.^17,18 The changes are in response to reports of pharmacies dispensing Schedule II prescriptions that were issued on fraudulent forms. All new forms must contain the following features: a unique control number, a pantograph (security feature that produces the word “VOID” on the face of the form when it is copied or scanned), thermochromic ink, and a watermark of the seal of the State of Texas.¹⁹

Some physicians in Texas are pushing back against the new PMP requirements for fear of pharmacist overreach. Some prescribers feel that pharmacists will be overstepping professional boundaries and second-guessing the appropriateness and legitimacy of prescriptions. Some concerns are based on cases of delayed patient care because pharmacists have sought more information from prescribers or corporate policies have prevented pharmacists from dispensing above quantity or dosage limits placed on certain drugs.²⁰ However, the intention of the PMP is to make patients safer and curb abuse and misuse of potentially dangerous, addictive drugs.

Electronic prescribing

The state of Texas has taken another step to decrease inappropriate use of opioids, as well as other controlled substances. In May of 2019, the Texas Senate passed House Bill 2174, which requires electronic prescribing (e-prescribing) of all controlled substances starting January 1, 2021. This legislation is designed to improve patient care and increase safety and security in the prescribing process. E-prescribing eliminates handwriting errors, and the Drug Enforcement Administration (DEA) requires 2-factor authentication for e-prescribing, which reduces the likelihood of fraudulent prescriptions. Self-reports by drug abusers suggest that more than 900,000 diverted opioid prescriptions are tied to forged paper prescriptions in Texas. Currently, only 14% of prescriptions for controlled substance are issued electronically, so the new requirements are designed to add another layer of safety to opioid prescribing.²¹

Continued use of opioids

Despite the risks associated with opioids, they remain a cornerstone for treatment of cancer-related pain and end-of-life care. The American Society of Clinical Oncology (ASCO) maintains that opioid therapy is necessary for the unique pain management needs of patients with cancer. However, ASCO understands that balance between patient needs and public safety must be achieved. ASCO has worked with public health organizations and professional societies to advocate against arbitrary limits on opioid prescribing that could limit patient access to needed care and provoke prescriber discipline. They have published recommendations and developed educational tools to help prescribers understand evidence-based care guidelines, as well as statutory and regulatory requirements, related to opioid use.¹⁰

Additionally, the escalation of opioid use and subsequent epidemic proportions of abuse also have mental health components and implications, which cannot be completely separated from the overall issue of abuse and dependence. A one-size-fits-all approach to curbing opioid misuse—mainly by changing prescribing habits and regulating access to opioids—will likely not cure the entire problem related to opioid misuse,¹⁰ and it will likely be some time before the full impact of regulatory and prescribing changes are seen on a large scale.

PHARMACIST INVOLVEMENT IN PATIENT CARE

Recently, the role of the pharmacist has been expanding (and advancing) to include direct patient care. Scope-of-practice laws for pharmacists are determined on a state-by-state basis, but there is a coordinated effort among advocacy and professional organizations to cement pharmacists’ roles as healthcare providers and establish pharmacists as leaders in patient-centered care.²² To that end, Texas has recently amended Pharmacy Rules to allow pharmacists to have more decision-making capabilities, especially in potentially life-threatening situations.

Epinephrine administration

Anaphylaxis is a serious, generalized or systemic allergic reaction. It is unpredictable and has a rapid onset. Anaphylaxis can result from exposure to numerous allergic triggers, including food, insect venom, and medications. The incidence of anaphylaxis is on the rise, in part due to the increased number of food allergies in children.^23-26 Recent data suggest that the incidence of anaphylaxis is 60 to 950 cases per 100,000 people, and the lifetime prevalence of anaphylaxis is estimated to be between 0.05% and 2%.²⁵

Anaphylaxis is potentially fatal and immediate recognition and treatment of symptoms is required. The American Academy of Pediatrics; the American Academy of Allergy, Asthma and Immunology; the American College of Allergy, Asthma and Immunology; the Joint Council of Allergy, Asthma and Immunology; and the National Institute of Allergy and Infectious Diseases all recommend epinephrine as the treatment of choice for anaphylaxis.^27-29 Epinephrine is a vasocontrictor and, therefore, prevents or decreases upper airway mucosal edema, hypotension, and shock. It also acts as a bronchodilator and has cardiac inotropic and chronotropic effects.²⁹

Epinephrine is indicated in the emergency treatment of allergic reactions, and there are no absolute contraindications to epinephrine during life-threatening situations. Epinephrine may cause adverse reactions including anxiety, apprehension, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea, vomiting, headache, and respiratory problems. ³⁰

Epinephrine can be life-saving if it is administered as soon as anaphylaxis is recognized.²⁹ Unfortunately, the overall use of epinephrine as first-line treatment of anaphylaxis is low and underscores the needs for the establishment of standardized protocols for anaphylaxis management.²⁵ The development of safe, user-friendly auto-injector devices has led to increased availability of epinephrine for emergency use in community settings, such as homes, schools, and sports activities, which will allow increased access to prompt anaphylaxis treatment.^26,31 In 2016, a new rule (TAC 295.16) was enacted in Texas that gave pharmacists the authority to administer epinephrine through an auto-injector device to a patient in an emergency situation.³² No prescription is needed to administer the epinephrine. Epinephrine auto-injectors should only be used to administer epinephrine intramuscularly into the anterolateral aspect of the thigh. It should not be injected into the buttocks or into the hands or feet, nor should epinephrine auto-injectors be used for intravenous administration.³⁰

According to the TAC, an anaphylactic emergency is defined as: “a sudden, severe, and potentially life-threatening allergic reaction that occurs when a person is exposed to an allergen. Symptoms may include shortness of breath, wheezing, difficulty breathing, difficulty talking or swallowing, hives, itching, swelling, shock, or asthma. Causes may include, but are not limited to, an insect sting, food allergy, drug reaction, or exercise.”³²

The pharmacist’s authority to administer epinephrine may not be delegated to another individual, and the epinephrine administered must be in the legal possession of the pharmacist or pharmacy that is responsible for accountability and record-keeping. The pharmacist may not be paid for this service but may seek reimbursement for the costs of the epinephrine auto-injector. Pharmacists who administer epinephrine in good faith cannot be held liable for damages incurred related to epinephrine administration.³²

A pharmacist who administers epinephrine to a patient must ensure that 911 is called immediately after administration and that the patient is evaluated by emergency services. The pharmacist must also notify the individual’s primary care physician as soon as is practical but not more than 72 hours from the time of epinephrine administration. A record must be maintained at the pharmacy for at least 2 years that contains the name of the patient, the age of the patient (if younger than 8 years old), the name and manufacturer of the epinephrine auto-injector, the date of administration, the name and title of pharmacist administering the epinephrine, and the name and contact information for the pharmacy.³² Technicians may be involved in the delivery of epinephrine by ensuring that supplies related to epinephrine injection are available and accessible in the case of an emergency, and they may assist with the record-keeping requirements.^33,34

Prior to this rule change, pharmacists were only allowed to call 911 if patients presented to a pharmacy showing symptoms of anaphylaxis. Now, pharmacists are allowed to administer potentially life-saving medication to patients most in need. This allows pharmacists to meet the needs of patients and play an important role in the healthcare system. Patients are now able to appear at a community pharmacy—which may be closer and easier to access than a traditional emergency department—when facing a life-threatening allergic reaction. While there are limited examples so far of pharmacists administering epinephrine, having such a law on the books in Texas heightens the awareness of pharmacists as healthcare providers and shows patients that pharmacists are well-positioned to play an increasing role in healthcare delivery.³⁵

All patients who have a known allergy or have had a previous allergic reaction or anaphylaxis should be counseled to avoid allergens and to know the symptoms of an allergic reaction.²⁷ Further, patients at risk for allergen exposure and possible anaphylaxis should carry epinephrine with them at all times.²⁸

Dispensing of opioid antagonists

Naloxone is an opioid antagonist and it has long been the definitive treatment for opioid overdose. Parenteral administration was previously the only option, but new, less invasive and easier-to-use products have been developed to increase access to this potentially life-saving antidote. Specifically, an intranasal formulation is now available that offers a cost-effective and simple means of administration that can be used outside of healthcare settings.³⁶

With the growing misuse of opioids and the increasing number of opioid overdose-related deaths, many states have increased access to naloxone, an opioid antagonist. It is a safe, cost-effective treatment for overdose that can be easily administered by patients themselves, family members, caregivers, or bystanders in the case of an emergency.³⁷

As of 2016, after the passage of House Bill 1462, pharmacists in Texas are allowed to dispense an opioid antagonist to persons at risk of opioid-related drug overdose or to a family member, friend, or other person able to assist a person at risk for an opioid-related overdose.³⁸ According to the TAC, an opioid-related drug overdose is a “condition, evidenced by symptoms such as extreme physical illness, decreased level of consciousness, constriction of the pupils, respiratory depression, or coma, that a layperson would reasonably believe to be the result of the consumption or use of an opioid.”³⁸ The purpose of the new rule is to combat the effects of opioid overdose.

Prescribers in Texas can prescribe life-saving antidotes, such as naloxone, to people (or friends and family) who are at risk for opioid overdose, and—now—they can also issue standing orders for opioid antagonists so pharmacists can dispense an antidote for an at-risk person. The medication can be dispensed under either of these prescription types and is considered to be dispensed for a legitimate medical purpose.³⁸ To facilitate pharmacists being able to participate in standing order programs, the Texas Pharmacy Association has obtained a standing order that authorizes a pharmacist to dispense an opioid antagonist.³⁹

The opioid antagonist can be dispensed in any of the following formulations: intramuscular naloxone aqueous solution multidose vial or pre-filled syringe (excluding auto-injector devices), intranasal naloxone for administration by mucosal atomization device, or naloxone nasal spray.^38,39 A pharmacist who chooses to fill or not to fill a prescription for an opioid antagonist is not liable for any outcomes resulting from the refusal to dispense or eventual administration of the opioid antagonist.³⁸

In order to dispense an opioid antagonist, pharmacists in Texas must have completed a 1-hour course accredited by the Accreditation Council for Pharmacy Education and coordinated by the Texas Pharmacy Association. The CE course can be found on the website of the Texas Pharmacy Association and is available to both member and non-member pharmacists. Any pharmacist working under a standing order must maintain an active license to practice in the state of Texas and must remain in good standing with the TSBP.⁴⁰

The American Medical Association Task Force to Reduce Opioid Abuse provides resources for prescribing opioid antagonists, and the CDC, as well as other advocacy organizations such as Prescribe to Prevent, offer resources for clinicians and consumers about safe opioid use, overdose prevention, and administration of opioid antagonists. Also, more than half of the states in the U.S. have “standing order” programs for naloxone dispensing, similar to that in Texas, which allow pharmacists to dispense opioid antagonists to patients at risk for overdose.⁴¹ However, adoption and implementation of naloxone access laws have been slow, with an inadequate number of pharmacies stocking and dispensing the opioid antidote, even after the state laws were enacted. In a survey of Texas pharmacies, nearly all stock naloxone and most allow a customer to purchase naloxone for another person. Still, barriers remain to naloxone access, including the inability or unwillingness to bill insurance for the naloxone. Also, some pharmacists reported that they thought the dispensing requirements only applied during acute overdose situations, when, in fact, naloxone may be dispensed before an overdose occurs in order for patients and caregivers to be prepared in the case of an accidental or intentional overdose.⁴²

Pharmacists play an important role in counseling and educating patients, caregivers, and the community about the safe use of opioids, as well as how to recognize signs and symptoms of an overdose.³⁷ And now, thanks to new laws around the country and in Texas, pharmacists can help ensure access to life-saving antidotes for opioid overdoses.

OPERATIONAL CHANGES

Several recent updates to the TSBP Rules do not affect direct patient care or medication access but do impact operational standards or licensure requirements.

Licensure and registration requirements

Requirements for pharmacy technician registration were amended, effective March 19, 2017. The changes removed the requirement that a technician pass a certification exam given by the Pharmacy Technician Certification Board (PTCB). Now, a technician may apply for registration after passing any examination approved by the TSBP. Currently, the PTCB exam or the Exam for the Certification of Pharmacy Technicians (ExCPT) are approved and accepted by the TSBP.^4,43

Effective March 2018, the Texas Pharmacy Act was amended to remove the requirement that a person must be of “good moral character” to obtain a pharmacist license. The requirements for age (minimum of 18 years old) and education (graduation from a domestic or foreign college of pharmacy, completion of the specified numbered of internship hours, and eligibility to obtain a license) remain unchanged.⁴⁴

“Moral character” is formed from the habits, actions, and emotional responses of a person. To be of “good” moral character implies that a person knows what is good and ethical and act in a way to uphold such virtues. In healthcare, to be of “good character” has been equated to following a “good conscience” in the treatment of patients.⁴⁵

In most states, an applicant for pharmacist licensure needs to report prosecutions, convictions, illegal drug use, and, sometimes, arrests. State boards of pharmacy evaluate applications and use these self-reports to determine if a pharmacist is of “good moral character.” A criminal record (or even an accusation and exoneration) does not automatically preclude an applicant from obtaining a license, but this information can be used by a pharmacy board as evidence of lack of good moral character. Such reviews of records are in place in order to maintain public health, safety, and welfare.⁴⁶ Language requiring “good moral character” remains in most other states’ laws governing pharmacist licensure and it is unclear why this rule was changed in Texas.

Another change to the licensing requirements in Texas was adopted in 2019. The change allows military service members, military veterans, or military spouses to place a pharmacist license on inactive status while not practicing in Texas without paying a fee.⁴⁷ Normally, the fee for maintaining a pharmacist license in Texas (either active or inactive status) is $281 every 2 years.⁴⁸ Pharmacists with an inactive license are not required to report continuing education hours during their inactive status.³

Library references

Library requirements for Texas pharmacies were amended in 2017. Class A (community) pharmacies are required to maintain a library of reference materials that includes hard copies or electronic versions of the following materials⁴⁹:

• Texas Pharmacy Act and rules
• Texas Dangerous Drug Act and rules
• Texas Controlled Substances Act and rules
• Federal Controlled Substances Act and rules
• Patient prescription drug information reference text or leaflets that are designed for and available to patients
• Drug interaction information including information to determine the severity or significance of an interaction, as well as to provide appropriate recommendations
• Basic antidote information and the number to the closest local poison control center

As of 2017, the list now includes a general reference text on veterinary drugs, if a pharmacy dispenses veterinary prescriptions.⁴⁹

Prescription pickup and delivery

An amendment to Board Rule 291.9 clarified the definitions of prescription pickup and delivery locations. A pharmacy may use an employee, a courier, or the U.S. Mail (at the request of the patient) to pick up prescriptions at the office or home of a prescriber, the residence or place of employment of the person for whom the prescription was issued, or a hospital or medical care facility in which the patient is receiving treatment. A pharmacy may deliver prescription medications to the office of the prescriber if the prescription is for a dangerous drug or for a single dose of a controlled substance that is for administration to the patient in the prescriber’s office; the residence of the person for whom the prescription was issued; the place of employment of the person for whom the prescription was issued, if the person is present to accept delivery; or a hospital or medical care facility in which the patient is receiving treatment.⁴⁹ These definitions are now consistent with the prescription pickup and delivery requirements of the DEA.

Automated prescription storage and delivery

An updated Board Rule 291.33 amended requirements for the use of automated storage devices in Class A pharmacies. The changes allow for the storage, management, purchase, and delivery of prescriptions during and after pharmacy hours from an automated device. The amendments also clarify that the prescription may only be dispensed if it is authorized by the prescriber. An automated storage and distribution device can be used for pick-up of a previously verified prescription by a patient or patient's agent, if a notice is posted that includes the following information⁵⁰:

• The pharmacist is off-site and not present in the pharmacy
• No new prescriptions may be prepared at the pharmacy but previously verified prescriptions may be delivered to the patient or the patient's agent; and
• The date/time when the pharmacist will return

The prescription department must remain locked and secured to prohibit unauthorized entry.⁵⁰

An automated storage and distribution device can only be used to deliver a previously verified prescription refill to a patient or patient’s agent. It cannot be used to deliver a new prescription. It also cannot be used to deliver a controlled substance. The drugs stored in the automated storage and distribution device must be stored at proper temperatures.⁵⁰

The patient or patient's agent must be given the option to use the system and must also be given a means by which to access a pharmacist for questions regarding the prescription either at the pharmacy where the automated storage and distribution device is located or by a telephone available at the pharmacy that connects directly to another pharmacy.⁵⁰ All pharmacists and pharmacy technicians, as well as any other licensed healthcare personnel, involved in the use of automated delivery systems must be well trained in the use of the system and demonstrate comprehensive knowledge of the policies and procedures for its use.³³

Automated prescription delivery systems have the potential to increase patient access to medications.⁵¹ Patients are generally accepting of automated technology, and it offers few barriers to pharmacist access.⁵²

Telepharmacy

Changes were made to Rule 291.121 to clarify requirements for delivery of drugs at a remote site through telepharmacy services. As of 2018, a pharmacy is allowed to provide telepharmacy services at no more than 2 remote sites. A pharmacist must visit each dispensing site at least monthly and the inventory of controlled substances must be reconciled monthly by a pharmacist from the provider pharmacy. A pharmacist must be on site when services are provided that require the physical presence of a pharmacist, including immunizations.⁵³

Any technicians operating at a remote site must be continuously supervised by a pharmacist. These technicians must be counted when establishing the technician/pharmacist ratio of the provider pharmacy. This ratio may not exceed 3 technicians per pharmacist.⁵³

A telepharmacy system may not dispense Schedule II controlled substances, nor may it operate within 22 miles, by road, of a Class A pharmacy. Drugs dispensed at the remote site through a telepharmacy system can only be delivered to the patient or patient’s agent at the remote site.⁵³

Telepharmacy is an important innovation in healthcare. Approximately one-fifth of the population in the U.S. lives in rural areas, but independently owned rural pharmacies are closing their doors and ceasing to operate, limiting pharmaceutical services for these communities.^54,55 Additionally, even rural hospitals have limited on-site pharmacist coverage.⁵⁶ Through telecommunication platforms, pharmaceutical services, such as drug review and monitoring, medication dispensing, medication therapy management, and patient counseling, can be accessed by patients living in remote areas without physical access to a pharmacist. Texas was one of the earliest states to enact laws and regulations specific to telepharmacy,⁵⁴ and the continued safe expansion of telepharmacy services has the potential to advance quality care and improve patient outcomes in rural communities.

CONCLUSION

Laws and regulations governing the practice of pharmacy in the state of Texas are continually reviewed by the TSBP and amended as needed or warranted according to changes in education requirements, practice site conditions, or patient care needs. Some changes are significant and impact the daily operations of pharmacists in many settings, while others are little more than vocabulary clarifications or grammatical changes to existing laws and rules. However, the purpose of the changes is to provide for the safest and best care possible for patients in Texas. Staying up to date with changes—both big and small—is a necessary part of pharmacy practice and guarantees that pharmacists and pharmacy technicians are operating within contemporary knowledge and practice standards. The current version of the Texas Pharmacy Act is available at https://www.pharmacy.texas.gov/Rules_Pharmacy_Act.asp and the Texas Pharmacy Rules are available at https://www.pharmacy.texas.gov/Rules_Pharmacy_Rules.asp.

REFERENCES

1. Texas Administrative Code: Section 295.8. Continuing education requirements. http://txrules.elaws.us/rule/title22_chapter295_sec.295.8. Updated June 9, 2019. Accessed July 1, 2019.
2. Texas State Board of Pharmacy. Rule changes. https://www.pharmacy.texas.gov/Rules_Changes.asp. Accessed July 1, 2019.
3. Texas State Board of Pharmacy. Continuing education: reporting requirements. https://www.pharmacy.texas.gov/infocist/continue.asp. Accessed July 1, 2019.
4. Texas Administrative Code: Section 297.8: Continuing education requirements. http://txrules.elaws.us/rule/title22_chapter297_sec.297.8. Updated June 9, 2019. Accessed July 31, 2019.
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6. National Institute on Drug Abuse. Prescription opioids. https://www.drugabuse.gov/publications/drugfacts/prescription-opioids. Revised June 2019. Accessed July 1, 2019.
7. Guy GP, Zhang K, Bohm MK, et al. Vital signs: changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66(26):697-704.
8. Ballantyne JC. Opioids for the treatment of chronic pain: mistakes made, lessons learned, and future directions. Anesth Analg. 2017;125(5):1769-78.
9. Dowell A, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain – United States, 2016. MMWR Recom Rep. 2016;65(No. RR-1):1-49.
10. Page R, Blanchard E. Opioids and cancer pain: patients’ needs and access challenges. J Oncol Pract. 2019;15(5):229-32.
11. Kroenke K, Alford DP, Argoff C, et al. Challenges with implementing the centers for disease control and prevention opioid guideline: a consensus panel report. Pain Med. 2019;20(4):724-35.
12. National Institute on Drug Abuse. Texas opioid summary. https://www.drugabuse.gov/opioid-summaries-by-state/texas-opioid-summary. Revised March 2019. Accessed July 1, 2019.
13. Texas State Board of Pharmacy. Texas Prescription Monitoring Program. https://www.pharmacy.texas.gov/files_pdf/3Texas_Prescription_Monitoring_Program_info.pdf. Published September 2017. Accessed July 1, 2019.
14. Texas State Board of Pharmacy. Texas Prescription Monitoring Program. https://www.pharmacy.texas.gov/PMP/. Accessed July 1, 2019.
15. Texas State Board of Pharmacy. Texas Prescription Monitoring Program: AWARxE. https://www.pharmacy.texas.gov/PMP/aware.asp. Accessed July 1, 2019.
16. Doolittle D. Are you ready for changes to opioid prescribing in Texas? Texas Medical Association. https://www.texmed.org/TexasMedicineDetail.aspx?id=48385. Updated June 19, 2019. Accessed July 1, 2019.
17. Texas State Board of Pharmacy. Official prescription form for schedule II drugs. https://www.pharmacy.texas.gov/PMP/OfficialCIIForms.asp. Accessed July 1, 2019.
18. Texas State Board of Pharmacy. Texas prescription monitoring program frequently asked questions regarding prescription pad orders. https://www.pharmacy.texas.gov/files_pdf/5CII_PrescriptionFormFAQ.pdf. Published September 2018. Accessed July 1, 2019.
19. Texas State Board of Pharmacy. Fraudulent official prescription forms. https://www.pharmacy.texas.gov/files_pdf/7FRAUDULENT_OFFICIAL_PRESCRIPTION_FORMS.pdf. Published July 16, 2018. Accessed July 1, 2019.
20. Physicians warn of overreach in new pharmacy prescription rules. Texas Medical Association. https://www.texmed.org/Template.aspx?id=49236. Published December 5, 2018. Accessed July 1, 2019.
21. Sparks B. Legislature advances bill mandating e-prescribing of controlled substances. Texas Pharmacy Association. https://www.texaspharmacy.org/news/452938/Legislature-Advances-Bill-Mandating-e-Prescribing-of-Controlled-Substances.htm. Published May 21, 2019. Accessed July 1, 2019.
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32. Texas Administrative Code. Section 295.16: Administration of epinephrine by a pharmacist. http://txrules.elaws.us/rule/title22_chapter295_sec.295.16. Updated June 9, 2019. Accessed July 1, 2019.
33. Texas Administrative Code. Section 291.32: Personnel. http://txrules.elaws.us/rule/title22_chapter291_sec.291.32. Updated June 9, 2019. Accessed July 31, 2019.
34. Duties of pharmacy technicians and pharmacy technician trainees in Class A (community) pharmacy under the supervision of a pharmacist. https://www.pharmacy.texas.gov/files_pdf/tech_duty_chart_2012.pdf. Published February 2012. Accessed July 31, 2019.
35. Dereyan A. Pharmacists allowed to administer epinephrine in Texas. Pharmacy Times. https://www.pharmacytimes.com/resource-centers/allergy/pharmacists-allowed-to-administer-epinephrine-in-texas. Published January 11, 2016. Accessed July 1, 2019.
36. Gufford BT, Ainslie GR, White JR Jr, et al. Comparison of a new intranasal naloxone formulation to intramuscular naloxone: results from hypothesis-generating small clinical studies. Clin Transl Sci. 2017;10(5):380-6.
37. Toderika Y, Williams S. Naloxone for opioid overdose and the role of the pharmacist. Consult Pharm. 2018;33(2):98-104.
38. Texas Administrative Code. Section 295.14: Dispensing of opioid antagonist by pharmacist. http://txrules.elaws.us/rule/title22_chapter295_sec.295.14. Updated June 9, 2019. Accessed July 1, 2019.
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47. Texas Administrative Code. Section 283.12: Licensing for military service members, military veterans, and military spouses. http://txrules.elaws.us/rule/title22_chapter283_sec.283.12. Updated June 9, 2019. Accessed July 1, 2019.
48. Texas Administrative Code. Section 295.5: Pharmacist license or renewal fees. http://txrules.elaws.us/rule/title22_chapter295_sec.295.5. Updated June 9, 2019. Accessed July 1, 2019.
49. Texas Administrative Code. Section 291.33.: Operational standards. http://txrules.elaws.us/rule/title22_chapter291_sec.291.33. Updated June 9, 2019. Accessed July 1, 2019.
50. Texas Administrative Code. Section 291.9: Prescription pick up locations. http://txrules.elaws.us/rule/title22_chapter291_sec.291.9. Updated June 9, 2019. Accessed July 1, 2019
51. Palacio A, Keller VF, Chen J, et al. Can physicians deliver chronic medications at the point of care? Am J Med Qual. 2015;31(3):256-64.
52. Hirsch JD, Oen A, Robertson S, et al. Patient request for pharmacist counseling and satisfaction: automated prescription delivery system versus regular pick-up counter. J Am Pharm Assoc (2003). 2009;49(1):73-7.
53. Texas Administrative Code. Section 291.121: Remote pharmacy services. http://txrules.elaws.us/rule/title22_chapter291_sec.291.121. Updated June 9, 2019. Accessed July 1, 2019.
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56. Casey M, Elias W, Knudson A, Gregg W. Implementation of telepharmacy in rural hospitals: potential for improving medication safety. Upper Midwest Rural Health Research Center. http://rhrc.umn.edu/wp-content/files_mf/telepharmacy.pdf. Published December 2008. Accessed July 1, 2019.

 

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