Effective inpatient physical therapy care requires fluid understanding of pharmacology in correlation with functional movement. In this context, physical therapists working in any medical setting may enhance professional practice and patient outcomes by acquiring additional knowledge and comprehension of pharmaceuticals.
The scope of this course will prioritize essential components regarding pharmaceutical principles and will discuss common pharmaceutical categories relative to application in physical therapy clinical settings.
FEDERAL DRUG REGULATION
The 20th century is demarcated by U.S. federal law developments that have made drug developers responsible for the relative safety 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 benefits of individual pharmaceuticals; established the Drug Enforcement Agency (DEA) to regulate “controlled substances” under a legal foundation of preventing abuse; as well as economic support 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 medical 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 professionals, 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 protective equipment (PPE) to prevent exposure to blood and body fluids; and specialized disposal of sharp objects utilized for medical 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 uncommon 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-threatening 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 divided 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 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 pharmaceutical 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 provide 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 produce 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.
● - dine : Antiulcer agents. ● - done : Opioid analgesics. ● - ide : Oral hypoglycemic. ● - iam : Antianxiety agents. ● - micin : Antibiotics. ● - mide : Diuretics. ● - mycin : Antibiotics. ● - nium : Neuromuscular blocking agents.
● - olol : Beta blockers. ● - oxacin : Antibiotics. ● - pam : Antianxiety agents. ● - pril : ACE inhibitors. ● - sone : Steroids. ● - statin : Antilipemics.
● - vir : Antivirals. ● - zide : Diuretics.
Controlled substances include five categories, ranked in ascending 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 psychologically, and include LSD, marijuana and heroin. Schedule II drugs have a significant potential for addiction, are heavily restricted and dispensed via written prescription only, and include morphine, methadone and Ritalin. Schedule III drugs are considered moderately addictive due to composition with a small percentage 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. Substance abuse is the harmful or hazardous use of chemical agents, in which the individual adapts poorly under the influence of the substance. Consideration and examination must be included for patients who present with potential signs of substance abuse, which may mimic signs of a given pathology. Addiction is a compulsive urge to take a drug, while often rejecting all other activities. The confounding factor is that patients often begin taking an addictive drug for the purpose of managing pain after injury and develop tolerance over a given period of time (Watkins, 2013, p. 58). In addition, a person may experience habituation, which is psychological tolerance of a given drug, which leads to requiring increasing amounts to reach a desired effect. Substance abuse is more detectable in chronic
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