Various healthcare facilities’ operations are guided by rules and regulations, including drug use and medical devices. Apart from the Federal laws that regulate the drug administration, state laws also regulate the use of drugs, especially drug commercials via intrastate without the Federal laws’ regulation (Steiner, 2013). Other bodies that regulate and address the use of drugs are the Joint Commission standards (TJC), Food and Drugs Administration (FDA), and Medicare conditions. All these bodies are established to ensure safety measures and enforcement of laws related to the marketing and use of drugs, formulary systems, and the controlled substance act.
Part of the comprehensive drug abuse prevention and control act of 1970 was used to formulate the Controlled Substances Act (CSA). The establishment of this act was to regulate the distribution system, research, and treatment of drug abuse, including the importation and exportation of controlled substances (Steiner, 2013). This act has a huge impact on drug use to protect patients’/prescriber’s safety and requires every institutional practitioner to follow the standard chain of manufacturing, distributing, and dispensing (Pisano, 1996). CSA is a subsector under the Drug Enforcement Administration (DEA) authority which exercises its controls through Federal regulation. Although different states now have laws and regulations similar to the Controlled Substances Act, they complement that of the federal administrative agency to control the manufacturing, distribution, and sale of drugs within their states.
The formulary system is a major focus in a healthcare organization (pharmaceutical), known for promoting high-quality medical care, rational prescription, effective utilization, and cost-effective usage of drugs (Steiner, 2013; Goldberg, 1997). This system weighs the options and regulates the selection of drugs for patient care. It involves a group of medical staff committees that decides, controls, coordinates, and form the formulary of the system. The primary goal of this system is to assist decision-makers in choosing the safest and most cost-effective agents for treating medical problems (Helmons, Kosterink & Daniels, 2014). However, establishing an accurate and well-detailed formulary system that includes all clinical scenarios, especially that of drug usage, is impossible. It’s quite impossible to establish an accurate formulary system that covers every clinical scenario, especially the use of drugs. Therefore, United States hospitals can obtain a nonformulary system that plays the formulary system role when needed.
The formulary system operates in different forms, such as the closed and open formulary, and they experience implementation challenges (Goldberg, 1997). For example, some article reviews emphasized that the use of a closed formulary system will lead to increased use of a nonformulary due to a limited list of drugs chosen by a committee that will be covered by a prescription drug plan. As a result, prescribers may decide to dispense or administer unfamiliar drugs with nonformulary medications, which could compromise patients’ safety (Helmons et al., 2014). In contrast, an open formulary would help counter closed formulary due to having a comprehensive list of drugs and few restrictions for providers. However, adopting this type of system will affect the Managed Care Organization (MCO) goals of controlling utilization and minimizing drug inventory expenses that might lead to waste of expired, infrequently used medications (Goldberg, 1997; Helmons et al., 2014).
Adopting an open formulary system can create problems for patients and even prescribers. A good example is the case study of a physician caring for patients with hemophilia. A patient suffering from hemophilia with developed antibodies of a clotting factor is required to have enormous amounts of externally administered factors when they bleed. However, in a case where this administration is not included in the formulary list for this category of patients, the other alternative would be to administer a large amount of factor episode by episode. In this case, it is likely that either the patient or the physician would prefer the medication for hemophilia that is excluded in the formulary because it is a one-time cure rather than a gradual process (Avorn, 2012). Another factor to consider in this case study is the high cost of a one-time treatment, which is one of the focuses of the formulary system.
Moreover, the food and drug administration (FDA) is effortlessly trying to make the use of drugs more healthy and helpful to both users and prescribers. The approval of new drugs was included as part of the FDA’s strategic effort to support and contribute to public safety. However, the approval of new drugs can be complicated with a controversial process due to errors that US Food and Drug Administration (FDA) sometimes makes. One of the errors is related to ‘fast-track’ options to quickly approve new drugs for serious illnesses (Martin & Shenfield, 2016). When the approval of drugs with limited information is about to be fast-tracked, there is a high chance of identifying the adverse drug reaction before prescribing or marketing the drug.
The FDA has received a series of criticism due to the good and bad consequences of new drug use. Even though the goal of the FDA’s new drug approval is to strike an effective balance between cost, safety, and access among drug users, competing with the public interest is unsatisfiable (Steiner, 2013). A good example of the positive and negative effects of FDA approval of new drug use can be seen in the approval of thalidomide. Thalidomide was approved by the FDA in the United States as the effective cure for leprosy, although the risk of causing a defect during childbirth is high.
Nevertheless, the use of thalidomide was approved, though with the restriction that requires patients’ registration and giving special training to prescribers. Many also argue that the FDA should go beyond the approval of a new drug and put more effort into training about the safety and proper use of drugs (Kesselheim, Avorn & Sarpatwari, 2016). Information regarding the use of drugs and their adverse effects should be provided to patients. The information should include the side effects because any evolving knowledge on an approved or prescribed drug can lead to additional information on a drug’s label.
Drug labeling is another crucial aspect of drug use. It is within the control FDA to approve drugs and devices, which includes labeling. Drug labelings are information that accompanies or explains a drug to prescribers or users, which must be approved by the FDA. However, a drug approved for a specific condition could be used for another purpose even without the FDA’s approval. The drugs used for a purpose that is not approved by the FDA are called off-label drugs (Steiner, 2013; Meadows & Hollowell, 2008). The prescription of off-label drugs for an unapproved condition would not necessarily violate federal law except for its causes of injury to patients.
The mission of the FDA is not to prohibit the use of off-label drugs but to regulate and promote public safety by ensuring the proper and general safety of a drug before it is sent to the market. Healthcare organization is faced with different challenges when the use of off-label drugs cause injuries to the patient. Off-label drugs could promote high-cost medicines, which could lead to wasteful use of scarce health care resources. It may also lead to label creep whereby the prescribers are not concerned about expanding the clinical usage of medicine through evidence of efficacy in clinical trials. Similarly, the use of off-label drugs affects drug regulations and clinical research. As a result, there is a reduction in the incentive for pharmaceutical companies to conduct clinical trials (Ghinea, Kerridge, & Lipworth, 2017).
Another challenge facing healthcare organizations aside the off-labeled drugs is the high cost of drugs. Healthcare organizations are not only faced with the issues of being off-labeled but also the high cost of drugs is also another challenge of the HCOs. The effect of high-priced drugs goes beyond the HCOs, affecting patients and insurers. The clinical implication of high-cost drugs cannot be overemphasized, while patients who require an expensive drug for treatments are expected to pay a higher copayment for their medications. This could put more strain on patients, especially those who are low-income earners, and might lead to negative health outcomes (Kesselheim et al., 2016).
An example of a high-cost drug is Sovaldi used for the treatment of hepatitis C infection. The prescription of this drug to a patient with hepatitis C will require upfront payment from the patient’s payer. This is the major reason why most health insurance plan rations healthcare to keep high drug costs from affecting their operations. Some government-owned plans are also affected by these high drug costs. For example, the staff of the Oregon Health Plan (OHP), a state’s health insurance plan for low-income residents, recently recommended that the plan should deny routine coverage for Sovaldi (Barlas, 2014). This is due to their inability to put up with the cost of covering more hepatitis C patients due to the high cost of medication.
In conclusion, several pieces of literature reviews have attested to the inability to fully comply with the system of formulary, which would increase the adoption of the non-formulary system. Also, a restriction was placed on FDA concerning the use of off-label drugs to allow all drug users to benefit from the effective use of medication. Lastly, the increasing cost and complexity of drug development have resulted in the high cost of drugs, which makes the United States consider a government-protected monopoly to drug manufacturers combined with restriction of price negotiation (Kesselheim et al., 2016).
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