The Reforming of Health Care as it Pertains to Prescription Drugs in the United States

HCS/440
08/05/2013
Professor Michele Burka, MBA

The Reforming of Health Care as it Pertains to Prescription Drugs in the United States
The Problem
America stands on the precipice of a new health epidemic; prescription drugs are the new face of concern for the average American citizen.; cost, shortages, and abuse can often be found on any given day in print, online, or more commonly, social networking sites. As technology continues to advance, so too does the ability to procure medications for 90% of what the body needs to maintain optimal health. In addition to this, agenda pushing doctors, contractual obligations to pharmaceutical manufacturers, and drug reps have created a health care atmosphere where it is almost impossible to walk into a physician’s office for an annual health screening without leaving with a handful of questionable ‘needed’ prescriptions. Doctors are prescribing more medications than ever before seen. This is in fact creating more prescription related abuse.
With this new availability comes the responsibility of ensuring those receiving are adequately informed of consequences, and potential addiction issues. All too often, a consumer seeks advice from a healthcare provider and does not self-educate on the medication received. Yes, medical staff, especially the prescribing individual has a personal and professional responsibility to the consumer to inform of potential risks associated with the medication. However, in the end, personal responsibility takes precedence to any other person’s social responsibility. Medication comes with a price, and it is unfortunate that the price is at times not a monetary value, but an emotional and physical price instead.
With the current health care reform policies coming into effect as early as 2014, Americans also face the cost of using formulary prescription drug manifests. The uses of these lists are intended to cut down on consumer spending, and lower participant’s drug costs. However, these formulary lists can be short sighted and exclude viable medications consumers need for health. This is a potentially compromising situation to the benefit of both the consumer and the insuring entity. As no two insurance entities have the same formulary, list consumers will be hard pressed to decide which is best for a family or for an individual. Additionally, with formulary lists changing almost monthly, what is a viable option to the consumer today, may in fact not be cost effective in the future.
Furthermore, American pharmaceutical companies struggle to keep abreast of the increase in need of specific prescription medications. Whether by choice, or by honest error, drug shortages cost consumers, and health care provider’s alike considerable amounts of cold hard cash annually. Cost and demand is a simple principle to understand when it comes to drug shortages; when the demand is high, the price is higher. Prescription drug shortages not only hurt the pocketbook, but also the health of every American involved that is in dire need and require those medications. People will pay almost anything for the ‘medicine’ called life.
Potential Solutions for Prescription Abuses
Prescription drug abuse in the United States (U.S.) has become an ever-growing and wide-ranging issue. No longer is it the ‘junkie’ that suffers this horrible plight, it is also the soccer mom, the teacher, the youth minister, and the champion equestrian rider that addiction has found. Abuse of medication can be classified as any use other than the purpose for which it was ordered. It is possible that medication once used for physical and mental need is now used for physical and mental maintenance. Meaning, a physical or mental chemical dependency can develop in association to some prescription medications. Those prescribed may find that though they no longer are in need of said medication medically, it is physically and mentally a challenge to abstain from the medication due the body and minds desire for the it.
Prescription drug abuse may also include taking medication not order to the one consuming it, selling prescribed medications to those it is not prescribed to, buying prescription medication not prescribed to the person, or consuming the medication in contradiction to the written order for the prescription medication. The prescription drugs most often abused include painkillers, sedatives, anti-anxiety medications, and stimulants.
Once again, as technology advances, the ways in which to acquire medication advances as well. Online pharmacies advertise controlled substances for a fraction of the American consumer’s price, and anyone with desperation, ingenuity, and the ability to type can order online. Online pharmacies make getting prescription drugs easy, much easier than buying medication from the streets.
According to Smith (2012), potential policies advocating for the prevention of prescription drug abuse include; adopting the “oxy-free” emergency room approach pioneered in Seattle. This also includes promoting education about effective pain management and alternatives to consumers in the emergency room. Smith also advocates for new legislation that; 1) Increases the criminal and civil penalties for robbing pharmacies to equal that of robbing federally insured entities. 2) Address shortages in treatment facilities/programs. 3) Create legislation requiring prescription manufacturer’s financial responsibility for the proper disposal and destruction of unused pharmaceuticals. 4) Create legislation requiring insuring entities to promote non-medicated pain management options. 5) Create and negotiate a countywide data-sharing manifest to attempt to cut down on interstate/intrastate drug trafficking of prescription medications. 6) Create legislation for a countrywide prescription-monitoring program in accordance with all the previously mentioned applicable solutions and require adequate funding throughout (Smith, 2012). American consumers are not the only ones abusing prescription medications; those licensed to prescribe medications have at times been guilty of questionable actions pertaining to the prescribing and distributing of prescription medications. ‘Pill Mills’ can be found throughout the United States, and there is currently legislation in place providing for the disciplinary action to those found at fault for manipulating and abusing the right to prescribe. Doctors abusing the ability to write prescriptions can suffer the loss of their medical license, lose insurability, and face severe civil and criminal charges. In addition to this, the social stigma that follows this type of health care scandal can make the physician a pariah in his or her community.
Licensed prescribers may only write a specified (and monitored) amount of prescriptions at any given time to any given consumer. It is unlawful for a physician to self-prescribe, or prescribe to immediate family, or to use a pseudo-name. If caught, loss of licensing ability, and criminal charges may apply; most certainly a review by a medical review board. Though harsh and strict penalties are in place, abusers still manage to acquire what they need, and dubious physicians continue to abuse the authority to prescribe (Smith, 2012).
Transforming Prescription Drug Deficiency’s; Possible Prevention
The U.S. suffers as many countries do throughout the world from the shortage of prescription medication required to maintain the health and well-being of its citizens. Having the FDA perform audits is just one of the ways that the U.S. government can help reduce prescription drug shortages (Kweder, 2011). In order to safeguard patients receive adequate care, the FDA should be cautious to probable scarcities of certain forms of prescription medications, and have a keen eye on all prospective and current errors (Kweder, 2011). The FDA must likewise take into the consideration (but they will use this option very lightly) of provisionally importing non-FDA-approved versions of critical drugs, if the shortage of the product cannot be resolved immediately (Kweder, 2011), or the shortage has immeasurable consequences to potential loss of life. Though a dangerous decision, in large part because non-FDA sanctioned products may carry high safety concerns, these ‘imports’ that are not FDA-approved would require scrutiny first, before being circulated to the general consumer to ensure its safety; this can in fact cause an associated delay in consumer acquisition (Kweder, 2011). Since 2011, the FDA has been working diligently facilitating the prevention of drug shortages by amplifying its numbers of staff in the appropriate departments to help with inspections that assistance in alleviating drug shortages (Kweder, 2011). In addition to this, the FDA recurrently conducts annual assemblies with stakeholders to discuss inhibition and mitigate drug deficiencies (Wosinska, 2012).
Added latent resolution to the existing concern of prescription shortages in the U.S. is the forecasting of data through the induction of an analyzing database requiring all historical data, and present prescription drug shortages (Wosinska, 2012). Government official’s base assumptions on trends analysis as to when, where, and how often drug shortages occur. Though specific outcomes are uncertain, the FDA in practice of this system, the possibility to determine specific times of the year shortages occur exist; therefore, the FDA can alert the manufacturers on when to prepare them to make more of the product(Wosinska, 2012).. However, in the end it is up to the manufacturer whether this drug is manufactured to prevent shortages.
Alternatively, another way that the government could possibly alleviate prospective drug shortages is to begin stockpiling the most critically forecasted drugs with the potential for shortage (Wosinska, 2012).. This option could conceivably help address future drug shortages and could feasibly keep the prices of drugs from skyrocketing. However, this option cannot be fulfilled unless the production capacity of the drug industries across the country are increased (Wosinska, 2012).
Formulary Prescription Drugs; Archaic or Futuristic?
In the interim, the U.S. health care market incorporates additional measure to promote cost effective pricing for its consumers in addition to adequate supplying of prescription medications, and attempting to control prescription drug abuse. The use of formulary prescription lists by insuring entities necessitates a purpose for an individual’s benefits. Formulary lists is to direct patients/consumers to the costs savings medications that are fittingly effective for treating health conditions or concerns. Should the patient or his or her physician decide to choose a medication not covered under the formulary list the result is the patient/consumer paying out-of-pocket for the medication (Bihari, 2013)?
Albeit formulary lists do attempt to control prescription drug costs, there are restrictions that apply. An insuring entity’s unambiguous restrictions such as the limit or restriction of unapproved medication(s) standing as the largest of many (Bihari, 2013). These restrictions are put in place to encourage the patient’s health care provider to use medications properly and to save costs by preventing medications that are overly used (Bihari, 2013). These restrictions include: 1) Prior Authorization- a method by which a consumer’s health care provider must obtain/request approval from the patient’s health plan to grant approval/coverage for the medication listed on the formulary. 2) Quality Care Dosing-, a method in which a consumer’s health plan checks prescription medications before they are filled. These quantities are based on recognized standards of care, as well as the approved dosing guidelines mandated and recommended by the FDA. 3) Step Therapy- a method where a consumer’s health plan requires a patient to try a cheaper medication first to treat the current health condition, before using/prescribing a different medication for the condition (Bihari, 2013)
Often, individuals run into the problem with formulary lists when prescribers write orders for non-formulary medications. Specific exceptions exist to the mandates set forth by the health insurance’s formulary list. At the discretion of the health plan, consideration may be made for the consumer and the insuring entity may; 1) Cover a medication that is not on the formulary that is being prescribed. 2) Waive coverage restrictions/limits on the medication being prescribed. 3) Give the medication prescribed a more affordable co-payment. A.) The physician will have to send in a request form to the insurance company including information that supports why the drug is medically necessary for the patient. B.) If the prescription is approved it will then be subject to a Tier 3 copayment. C.) If it is rejected then you have the right to appeal (Bihari, 2013).
Does the use of a formulary manifest solve the issue of affordable prescription drug costs? Perhaps, at times. Potential solutions to this issue are requiring legislation to review current standards and set the tone for changing formulary lists. Often consumers on a long-standing medication find out too late that the medication has changed to require a prior authorization, or is no longer covered. Consumers should be given an acceptable notice by insurers that medication currently taken is changing in requirement (Bihari, 2013). This affords the consumers time to find alternative forms of medication without stress, and possible withdrawal side effects with authorizations become time excessive.
Additionally, consumers should be given opportunity to decide what should and should not be covered by the formulary (Bihari, 2013). Surveys, informational evaluations can be acquired by the insuring entity as to the desire of the majority for whom they insure, from there the insuring entity can negotiate a contract with manufacturers (Bihari, 2013). Insuring entities have the understanding that a happy consumer is a happy bottom line.
In Conclusion
America stands on the precipice of a new health epidemic; prescription drugs are the new face of concern for the average American citizen; cost, shortages, and abuse. These are the major concerns associated with American pharmaceuticals. New health care reform has Americans even more concerned with where they stand in accordance to the rules, regulations, and costs in prescriptions for the future. It is unknown.
What is known however that legislation is and mandates are required to monitor and control drug procurement. Harsher penalties for abusers, and more affordable options for the innocent consumer. Currently, there appears to be no true middle ground. Both the manufacturer, and the consumer need protection from high costs, and high unobtainable demand. Another known certainty is that the American health care system is imperfect but improving; just as the American consumers are. This will continue to be a work in progress.

Reference
Bihari, M. (2013). Understanding Your Health Plan Drug Formulary. Retrieved from http://healthinsurance.about.com/od/prescriptiondrugs/a/understanding_formulary.htm
Kweder, S. (2011, December 15). Prescription Drug Shortages: Examining a Public Health Concern and Potential Solutions. Retrieved August 4, 2013, from U.S. Food and Drug Administration: http://www.fda.gov/NewsEvents/Testimony/ucm282956.htm
Smith, C. (2012). Investigate West. Retrieved from http://www.invw.org/post/some-solutions-for-ending-1250
Wosinska, M. (2012, May 2). Healhcare Shortage: Why a Government Stockpile Falls Short As A Solution. Retrieved August 4, 2013, from Health Affairs Blog: http://healthaffairs.org/blog/2012/05/02/drug-shortages-why-a-government-stockpile-falls-short-as-a-solution/