considers the reality of modern medicine, including chronic phar- maceutical application, multiple prescribers and transition of the care environment, depending on patient medical status. As well, Medicare regulations require that completing a full patient intake include a detailed inquiry of a patient’s medical records as well as communication with other members of the care team. Effective inpatient physical therapy care requires fluid under- standing of pharmacology in correlation with functional move- ment. In this context, physical therapists working in any medical setting may enhance professional practice and patient outcomes by acquiring additional knowledge and comprehension of phar- maceuticals. The scope of this course will prioritize essential components re- garding pharmaceutical principles and will discuss common phar- maceutical categories relative to application in physical therapy clinical settings.
cists have been formalized under the term “medication therapy management” (MTM), which has been adopted by 11 national pharmacy organizations. MTM is defined as “a distinct service or group of services that optimized drug therapy with the intent of improved therapeutic outcomes for individual patients.” MTM is collaborative between pharmacists, physicians and other health professionals. Although traditional points of physical therapy interest revolve around medication management in the home/ health setting and topical/transdermal pharmaceutical application in outpatient settings, the concept of medication management in physical therapy is essential for modern practice standards. Com - ponents of MTM include thorough medication review, examining safety and efficacy of medication therapy, applying education and enablement to enhance medication adherence, as well as docu- menting and communicating with prescribers for the purpose of comprehensive patient care (APTA, 2013). MTM is a product of the central role of pharmaceuticals in medical care. This approach
FEDERAL DRUG REGULATION
are primarily male, out of concern for female subjects who may become pregnant. This practice may be considerate for human life, as well as potential litigation, and can delay acquisition of information related to a drug’s effect on female subjects. Drugs have three names for consideration: Chemical name; brand or trade name; and generic name. The chemical name is basically the chemical compound, created for use by other pharmaceuti- cal entities to reproduce the drug. The brand name is designed for initial marketing by the developer and is intended to attract interest and describe the intended effects. The generic name is utilized for manufacture across multiple companies and may pro- vide common suffixes to indicate the drug class (Watkins, 2013, p. 55). The Patient Protection and Affordable Care Act of 2010 stipulates a 12-year patent protection period for newly approved pharmaceuticals, during which time the developing company has exclusive rights to production and sale (Katzung, 2018, p. 17). Afterward, any company may apply for federal approval to pro - duce and market said drug under a generic name without being required to pay licensing fees. A trademark is a branded name, which is often registered, and legally protected. The list below provides common suffixes of generic pharmaceutical names, with which to review and become familiar: • - caine : Local anesthetics. • - cillin : Antibiotics.
The 20th century is demarcated by U.S. federal law developments that have made drug developers responsible for the relative safe- ty of a drug; required prescription drugs to be administered under a physician’s supervision; created and empowered the Food and Drug Administration (FDA) to supervise secure development of new drugs; forced drug manufacturers to disclose risks and ben- efits of individual pharmaceuticals; established the Drug Enforce- ment Agency (DEA) to regulate “controlled substances” under a legal foundation of preventing abuse; as well as economic sup- port to speed up development of medications for relatively rare pathologies (Watkins 2013, pp. 44-45). The DEA enforces federal drug laws, including categorization of “controlled,” of which the majority requires formal prescription, versus “over the counter “(OTC) status for pharmaceuticals. Medications that require medi- cal prescriptions require the prescribing entity to be registered with the DEA. The Occupational Safety and Health Administration (OSHA) has expounded federal laws related to safety for healthcare profes- sionals, patients and the public. Primary OSHA regulations for healthcare workers include hand hygiene prior to and following direct patient contact; application of hand gloves prior to directly touching medications; utilization and education of personal pro- tective equipment (PPE) to prevent exposure to blood and body fluids; and specialized disposal of sharp objects utilized for medi- cal care. The FDA requires that pharmaceuticals are supported by scientific research and are proven safe and effective prior to marketing. This is defined as drugs performing specified actions without inducing unacceptable injury. Cost-benefit analysis is a significant practice in terms of developing pharmaceuticals. While it is not uncom- mon for U.S. drug approval to require a period of eight years or more, the FDA has the right to quicken sanctions to periods as low as six months for drugs that can treat patients in life-threaten- ing stages of illness. Drug development begins when researchers identify agents that demonstrate hopeful effects upon given pathologies. Agents must then undergo numerous stages of development and adhere to stern and precise regulatory requirements prior to application on human test subjects. Clinical trials provide information about a drug’s intended effects, side effects, toxicity, and interactions as compared to a placebo, i.e. an inactive substance, and are di- vided into four phases (Watkins, 2013). Generally, Phase I trials peak at 100 subjects, and are focused on drug safety. Phase II trials include several hundred subjects and examine drug efficacy. Phase III trials progress to thousands of subjects, and hone in on pharmaceutical dosage limitations, as well as establishment of therapeutic doses. Finally, Phase IV trials continue after the FDA approves a drug for marketing and distribution. Randomized control trials include control versus experimental groups, as well as double blinding of the subjects and clinicians with regards to drug administration. Clinical subjects for pharmaceutical testing
• - nium : Neuromuscular blocking agents. • - olol : Beta blockers. • - oxacin : Antibiotics. • - pam : Antianxiety agents. • - pril : ACE inhibitors. • - sone : Steroids. • - statin : Antilipemics.
• - dine : Antiulcer agents. • - done : Opioid analgesics. • - ide : Oral hypoglycemic. • - iam : Antianxiety agents. • - micin : Antibiotics. • - mide : Diuretics. • - mycin : Antibiotics.
• - vir : Antivirals. • - zide : Diuretics.
Controlled substances include five categories, ranked in ascend- ing order of potential of addiction and abuse. While drugs in the Schedule I category are deemed to have no medical value, the remaining categories are deemed medically beneficial. Schedule I drugs are regarded as highly addictive both physically and psy- chologically, and include LSD, marijuana and heroin. Schedule II drugs have a significant potential for addiction, are heavily restrict- ed and dispensed via written prescription only, and include mor - phine, methadone and Ritalin. Schedule III drugs are considered moderately addictive due to composition with a small percent - age of narcotic alongside a larger percentage of less-addictive pharmaceutical. Schedule III drugs have restricted refill limits and include codeine with Tylenol and hydrocodone (Watkins, 2013, p. 57). Allied health professionals, such as nurse practitioners and physician assistants, may write prescriptions for Schedule III substances, though a prescriber must sign each one. Schedule IV drugs include valium and Xanax; and Schedule V drugs include cough medicines with codeine.
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