Clinical Pharmocology_Course 1_Sports Medics_Part1.pdf

4 | Clinical Pharmacology in Athletic Training Health Care Providers With Prescribing Authority A prescription drug or medication is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter (OTC) drugs can be obtained without a prescription....

4 | Clinical Pharmacology in Athletic Training Health Care Providers With Prescribing Authority A prescription drug or medication is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter (OTC) drugs can be obtained without a prescription. Substance control is important because of the TABLE 1.1 potential for misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug. Some states require prescribers (table 1.1) to register with a regulatory agency, such as a state board of pharmacy, in order to dispense controlled or noncontrolled prescription medications (or both). Due Summary of Health Care Providers With Prescribing Authority Prescriber Definition Prescriptive authority* Doctor of Medicine (MD) Doctor of Osteopathic Medicine (DO) Physicians who practice medicine or surgery Have the broadest prescriptive authority, including controlled or scheduled substances. Physician Assistant (PA) Practice medicine in collaboration with or under the indirect supervision of a physician Have limitations on prescription authority in some states and for controlled substances. Nurse Practitioner (NP) Doctor of Nursing Practice (DNP) Examine patients, diagnose illnesses, prescribe medication, and provide treatments Have prescription power with limitations for controlled substances (in some states); some states permit independent practice or require a written agreement with a physician in order to provide care. Doctor of Clinical Pharmacy (PharmD) Pharmacists who assess and manage patients’ medication therapy Some states allow prescriptive authority under protocol with a medical provider that includes prescriptive privileges and laboratory monitoring. Doctor of Podiatric Medicine (DPM) Podiatrists Diagnose and treat conditions affecting the foot, ankle, and structures of the leg Can prescribe or administer restricted medications; limited to scope of practice. Doctor of Optometry (OD) Optometrists who examine the eyes and visual systems and perform medical diagnosis and management of eye disease Can prescribe medications to treat certain eye diseases and issue glasses and contact lens prescriptions for corrective eyewear. Doctor of Dental Surgery (DDS) Doctor of Medicine in Dentistry (DMD) Dentists who treat various conditions that arise in the mouth, teeth, head, and neck Can prescribe medications such as antibiotics, fluorides, analgesics, local anesthetics, sedatives or hypnotics, and other medications related to dentistry. Clinical Psychologist (PhD or PsyD) Medical psychologists who have undergone specialized training May prescribe drugs to treat emotional and mental disorders, according to protocols, with an MD or DO. Doctor of Chiropractic (DC) Focus on manipulation of the musculoskeletal system, especially the spine May have the ability to write a prescription, depending on scope of practice laws in a specific jurisdiction. *Prescriptive authority regulates not only the HCP but also the type of medications that can be prescribed within their scope of practice. Only specifically authorized HCPs can prescribe controlled or scheduled drugs (MD, DO, and some PAs, DNPs, and pharmacists). Note. National or local (i.e., state or provincial) legislation governs who can write a prescription, and all prescribers must be appropriately licensed, certified, or registered. M.A. Cleary, T.E. Abdenour, and M. Pavolvich, Clinical Pharmacology in Athletic Training, Champaign, IL: Human Kinetics, 2022). For use only in Clinical Pharmacology Course 1-Sport Medics. Chapter 1 • Legal Aspects of Therapeutic Medication Management | 5 to the variability in state laws, it is imperative that all members of the sports medicine team be aware of the regulations in the states in which they practice.4 In addition to ATs, other HCPs must follow state and federal laws regarding administering and dispensing of medications, particularly in the youth sport setting. The secondary school setting is unique in that most patients are minors; in many states, this changes how the AT can practice. In most states, an AT is not permitted to furnish OTC medications to minors under any circumstance. In school systems, most states allow the school’s physician, school nurse, parent or guardian, and the affected student to administer medication. The Sports Medicine Team The care of an injured or ill patient may be the responsibility of one HCP or an interprofessional health care team of many providers. Depending on the location of patient care and the patient receiving it, the sports medicine team may include ATs, physicians (MD or DO), pharmacists (PharmD), physical therapists (DPT), nurses (various levels: RN or NP), physician assistants (PAs), chiropractors (DC), and athletic training students. Various members of the sports medicine team may manage different medications within their scope of practice, making it necessary to follow proper protocols for storing, packaging, transporting, tracking, administering, and dispensing both OTC and prescription medications. Even for nonprescription (i.e., OTC) drugs, it is essential that the sports medicine team understand and remain in compliance with all current federal and state laws and institutional regulations concerning medication management in the sports medicine setting. Role of the Directing Physician Within the sports medicine team, the team physician or directing physician takes a leadership role. Team physicians are usually primary care or family practice physicians or orthopedic surgeons who are hired by professional teams, colleges, and universities to provide medical care for their athletes.12 Medications may be prescribed by the team or institution’s physician or a patient’s personal physician. The directing physician is ultimately responsible for ensuring that records and medications, including sample medications, are distributed from or stored at the sports medicine facility or related location. The utility of dispensing sample medications is controversial, and their use has been prohibited in many hospital systems. Both the Accreditation Association for Ambulatory Health Care and the Joint Commission, organizations that accredit many collegiate student health centers and hospitals, have developed specific standards that must be followed for the use of sample medications. The physician must also supervise the disposal of expired medications and should review all protocols for the distribution of OTC medications. Although the athlete is ultimately responsible for avoiding prohibited medications and obtaining therapeutic-use exemption waivers (discussed in chapter 21), the physician should be familiar with medications that are banned or restricted by any relevant sports governing body.4 Role of the Athletic Trainer Unless explicitly authorized by individual state practice acts, ATs cannot legally dispense prescription medications, even under standing orders or with permission from a physician, because this places both parties at risk for legal liability.2 Although dispensing cannot be authorized, ATs may be permitted to administer OTC medications and certain emergency prescription drugs, such as epinephrine autoinjectors and naloxone, depending on their state practice acts. Athletic trainers should know how and when to use emergency medications (refer to Acute and Emergency Care in Athletic Training15) and must follow state and federal laws and regulations concerning the legal administration of medications.2,4 RED FLAG Administering and Dispensing Medication Drug administration refers to giving a single dose of medication for immediate use (or within 24 hours), whereas drug dispensing involves preparing, labeling, or providing multiple doses of a medication for future use. Once the physician administers the initial dose, the remainder of the prescription is likely to be referred to a local pharmacy with the expectation that it will be filled. These steps can cause time delays and added expense or increase the risk that the medication is not delivered to the patient. M.A. Cleary, T.E. Abdenour, and M. Pavolvich, Clinical Pharmacology in Athletic Training, Champaign, IL: Human Kinetics, 2022). For use only in Clinical Pharmacology Course 1-Sport Medics. 6 | Clinical Pharmacology in Athletic Training Current state and federal laws prohibit physicians from delegating the duty of prescription drug dispensing to providers not licensed to do so, including ATs.13 However, in some states, physicians can delegate the authority to dispense medications to other HCPs who are drug prescribers, including nurse practitioners and physician assistants. Certain states also permit ATs limited designation to administer medications under certain conditions, such as during an emergency.10 A formulary is a list of medications used by a health care entity. ATs must have the formulary when traveling with individual athletes and teams. Although there is widespread belief that ATs are not permitted to dispense OTC medication, it is challenging to find regulations prohibiting this practice. Ultimately, the decision to dispense OTC medication is dictated by existing state laws and practice acts and written policies and procedures established in consultation with the directing or collaborating physician. It is important to document all dispensed OTC medications in the proper format. Further, the AT must not administer any medication to minors or children (<18 years old). Adult athletes (>18 years) should sign an Assignment of Benefits and Athlete-to-AT Agency form (figure 1.1), which is important for providing legal authority for pharmacological (and other) treatments. Statements such as these create a chain of command for the transport of medications on the athlete’s behalf. To determine appropriate use in a particular institution or clinic, this form must always be discussed with the administration, including the athletic director, team physician, legal counsel, and risk management office. Athletic trainers work in a variety of clinical settings, each of which has unique circumstances concerning both OTC and prescription medications. For example, international, Olympic, and professional teams and most intercollegiate athletic conferences have requirements regarding the availability and use of both OTC and prescription medications. Athletic trainers working in emerging settings (e.g., dance companies, acrobatic troupes, orchestras, and live theaters) may also be confronted with unique considerations, such as having appropriate locations for the storage and dispensing of medications. When traveling within the United States or internationally with their patients, ATs must fully understand the local government laws and regulations (see additional details in Traveling With Prescription Medications).3,4 When administering medications, the AT must do the following:2,4,5 • Understand the federal and state laws regarding medication administration, dispensation, and storage. • Know and understand the regulations regarding medication and the athletic training practice acts in both the home state and the states she may visit with patients. • Act as a resource for questions or concerns about any medication the patient is given. • Develop policies and procedures for maintaining safe storage and inventory of medications. This includes appropriate documentation of any distributed medications. • Understand the role of an athletic training student, who is a student enrolled in classes while matriculating through a professional education program accredited by the Commission on Accreditation of Athletic Training Education. Best practices, therefore, prevent a noncertified or unlicensed student from administering or furnishing any medications. This guideline should be outlined in the clinic or facility’s policies and procedures. • Understand the role of volunteer student aides (those not currently enrolled in an accredited athletic training program). Student aides should not be involved in managing any medication. • Follow all requirements of standing orders with the directing physician. I authorize the athletic trainer listed below, under supervision and protocol of the team physician, to act as my caretaker and agent to receive, procure, store, transport, and issue any medications prescribed for me. While any medications are in my custody, I am responsible for their proper storage and will take necessary precautions to keep them out of the reach of children. FIGURE 1.1 A portion of an Assignment of Benefits and Athlete-to-AT Agency form. M.A. Cleary, T.E. Abdenour, and M. Pavolvich, Clinical Pharmacology in Athletic Training, Champaign, IL: Human Kinetics, 2022). For use only in Clinical Pharmacology Course 1-Sport Medics. Chapter 1 • Legal Aspects of Therapeutic Medication Management | 7 RED FLAG Athletic Training Students and OTC Medication Under no circumstances should athletic training students be involved in the conveyance of OTC medication to a patient. The temptation is to rationalize the availability of these medications, which are used regularly and do not require a physician prescription. Despite enthusiasm to assist a staff athletic trainer, the student must not be authorized to manage OTC medications for any purpose, such as restocking inventory or conveying medication to a patient. Conversely, a staff athletic trainer should not delegate this responsibility to a student due to liability and professional ethics concerns. Federal and State Laws The sports medicine team must be aware of federal and state regulations regarding the administration and dispensation of drugs or medications, as well as the regulations specific to each profession (e.g., AT, physician, pharmacist, school nurse). A drug is considered any substance (other than food and water) that is consumed, inhaled, injected, smoked, absorbed via a patch on the skin (transdermal), or dissolved under the tongue (sublingual) to create a physiological (and often psychological) change within the body. All members of the sports medicine team should be mindful of laws and regulations set forth by various state boards of medicine, state boards of athletic training, or related governing boards.4 Various U.S. federal agencies regulate how medication is dispensed and administered:4,11 • Food and Drug Administration (FDA)— Regulates the safety, efficacy, and security of drugs, including appropriate labeling. • Drug Enforcement Administration (DEA)— Enforces federal laws related to controlled substances. • Occupational Safety and Health Administration (OSHA)—Oversees concerns related to contamination of and exposure to hazardous drugs. U.S. Food and Drug Administration The FDA is the administrative body that oversees the drug research and development process in the United States and grants approval for marketing new drug products. It has no jurisdiction over supplements. To receive FDA approval for marketing, the originating institution or company must submit evidence of a drug’s safety and effectiveness. If a drug has not been shown through adequately controlled testing to be safe and effective for a specific use, it cannot be marketed in interstate commerce for this use.11 Unfortunately, “safe” can mean different things to the patient, the HCP, and society. Complete absence of risk is impossible to demonstrate, but this fact may not be understood by members of the public, who frequently assume that any medication sold with the approval of the FDA should be free of serious side effects. This confusion is a major factor in litigation and dissatisfaction with aspects of drugs and medical care.11 Drug Legislation Drug regulation in the United States reflects several health events that precipitated major shifts in public opinion. For example, the Federal Food, Drug, and Cosmetic Act (1938) was largely a reaction to deaths associated with the use of a preparation of sulfanilamide that was marketed before it and its vehicle had been adequately tested. Serious adverse effects were also attributed to thalidomide, an agent introduced in Europe in 1957 and marketed as a nontoxic hypnotic. It was promoted as being especially useful as a sleep aid during pregnancy. In 1961, reports were published suggesting that thalidomide was responsible for a dramatic increase in the incidence of a rare birth defect (phocomelia) involving shortening or complete absence of the arms and legs. Epidemiologic studies provided strong evidence for the association of this defect with thalidomide use by women during the first trimester of pregnancy, and the teratogenic drug was withdrawn from sale worldwide. An estimated 10,000 children were born with birth defects because of maternal exposure to this 1 agent. The tragedy led to the requirement for more extensive testing of new drugs for teratogenic effects and stimulated passage of the Kefauver-Harris Amendment of 1962 (see sidebar). Despite its disastrous fetal toxicity and effects in pregnancy, thalidomide is a relatively safe drug for people other than the fetus. Even the most serious risk of toxicities may be avoided or managed if understood. Despite its toxicity to the unborn fetus, thalidomide is now approved by the FDA for limited use as a potent immunoregulatory agent and to treat certain forms of leprosy.11 M.A. Cleary, T.E. Abdenour, and M. Pavolvich, Clinical Pharmacology in Athletic Training, Champaign, IL: Human Kinetics, 2022). For use only in Clinical Pharmacology Course 1-Sport Medics. 8 | Clinical Pharmacology in Athletic Training Relevant Legislation Regulating Drugs in the United States • Pure Food and Drug Act (1906)—Prohibited mislabeling and adulteration of foods and drugs (but • • • • • did not establish requirement for efficacy or safety). Harrison Narcotics Tax Act (1914)—Established regulations for the use of opium, opioids, and cocaine (marijuana added in 1937). Food, Drug, and Cosmetic Act (1938)—Required that new drugs be tested for safety as well as purity. Kefauver-Harris Amendment (1962)—Required proof of efficacy as well as safety for new drugs. Controlled Substances Act (1971)—Placed all substances that were in some manner regulated under existing federal law into 1 of 5 schedules. This placement is based on the substance’s medical use, potential for abuse, and safety or dependence liability. Dietary Supplement and Health Education Act (1994)—Amended the Food, Drug, and Cosmetics Act of 1938 to establish standards for dietary supplements but prohibited the FDA from applying drug efficacy and safety standards to supplements. Drug legislation in the United States underwent major revisions as of May 1, 1971, when the Controlled Substances Act (CSA) was enacted. This law requires that every person who manufactures, dispenses, prescribes, or administers any controlled substance be registered annually with the Attorney General; this registration function is the responsibility of the DEA.1 The Controlled Substances Act places all substances that were in some manner regulated under existing federal law into 1 of 5 schedules (see Drug Schedules later in this chapter) based on 3 factors:6 1. Potential for abuse—How likely is this drug to be abused? 2. Accepted medical use—Is this drug used as a treatment in the United States? 3. Safety and potential for addiction—Is this drug safe? How likely is this drug to cause addiction? What kinds of addiction? When prescribing medication to athletes or patients, prescribers must comply with all relevant laws regarding possessing and dispensing drugs, including controlled substances.12 Any HCP responsible for possessing, storing, and distributing controlled substances must be registered with the DEA to perform these functions. He must maintain accurate inventories, records, and security of the controlled substances.6 For these reasons, increasingly, athletic training clinics and facilities and many on-campus health care facilities do not allow controlled substances to be stored or distributed from the facility. Evidence in Pharmacology Heroin and Cocaine Heroin and cocaine are illicit drugs that are highly addictive. Abuse of either can be lethal; however, the federal government views them differently. The Controlled Substance Act classifies heroin as a Schedule I drug and cocaine as a Schedule II drug.14 The significant difference between the two is that heroin has no value or role as a prescription medication, whereas cocaine can be used as a local anesthetic for the oral, nasal, and laryngeal cavities.8 Drug Schedules Drugs, substances, and certain chemicals used to make drugs are classified into 5 schedules depending on the drug’s acceptable medical use and its potential for abuse or dependency (table 1.2). The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs have a high potential for abuse and the potential to create severe psychological or physical dependence and do not have an FDA-approved medical use (indication). Schedule II through V drugs do have an FDA-approved indication. The lower the number, the higher the potential for abuse and dependence. Schedule V drugs represent the least potential for abuse of the controlled substances. Noncontrolled substances are prescription medications with less risk of abuse or addiction that have the purpose of M.A. Cleary, T.E. Abdenour, and M. Pavolvich, Clinical Pharmacology in Athletic Training, Champaign, IL: Human Kinetics, 2022). For use only in Clinical Pharmacology Course 1-Sport Medics. Chapter 1 • Legal Aspects of Therapeutic Medication Management | 9 TABLE 1.2 Schedule Drug Schedules, Definitions, and Examples Based on the Controlled Substances Act Definition of drugs (substances or ­chemicals) Examples Schedule I Drugs with no currently accepted medical use and a high potential for abuse Heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), meth­ aqualone (Quaalude), and peyote Schedule II Drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence Cocaine, methamphetamine, meth­ adone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, hydrocodone (e.g., Vicodin), dextroamphetamine (Dexedrine), amphetamine and dextro­ amphetamine (Adderall), and methyl­ phenidate (Ritalin) Codeine (pure) and any drug for nonparenteral administration containing the equivalent of more than 90 mg of codeine per dosage unit Schedule III Drugs with a moderate to low potential for physical and psychological dependence Ketamine, anabolic steroids, and testos­ terone Products containing <90 mg of codeine per dosage unit (e.g., Tylenol with codeine) Schedule IV Drugs with a low potential for abuse and low risk of dependence Tramadol (Ultram), alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), zolpidem (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata) Schedule V Drugs with lower potential for abuse than Schedule IV; consist of preparations containing limited quantities of certain narcotics Lomotil, Motofen, Lyrica, gabapentin Cough preparations with <200 mg of codeine or per 100 mL (e.g., ­Robitussin-AC) Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Drugs listed are intended for general reference; this is not a comprehensive listing of all controlled substances. A substance need not be listed as a controlled substance to be treated as a Schedule I substance for criminal prosecution.6 Synthetic THC and THC analogs are FDA approved (see chapter 20 for a full discussion) and available as dronabinol (Marinol, Syndros) and nabilone (Cesamet). treating various medical conditions. A listing of drugs and their schedule can be found on the DEA website or CSA Scheduling by Alphabetical Order.7 Traveling With Prescription Medications Physicians, ATs, and other HCPs who travel outside of their state of licensure must be careful to ensure that they are properly handling and dispensing medications according to legislation for the state they are visiting. Moreover, physicians should not delegate to ATs the responsibility to dispense controlled substances.12 The sports medicine team (whether they travel or not) should be aware of the following:3,10 • To dispense or administer a drug, the prescriber (e.g., physician assistant or nurse practitioner) must be licensed or otherwise M.A. Cleary, T.E. Abdenour, and M. Pavolvich, Clinical Pharmacology in Athletic Training, Champaign, IL: Human Kinetics, 2022). For use only in Clinical Pharmacology Course 1-Sport Medics.