Drug Shortages affecting Patient-Care in the US and the FDAs Role in it - Research Paper Example

Module Drug Shortages affecting Patient-Care in the U.S. and the FDA’s Role in it Introduction Most Americans sincerely believe that if they were to suddenly fall ill, they would be able to have access to the necessary medicine to treat their condition. The shortage of drugs is something that they usually associate with third world nations that do not have efficient healthcare sectors to deal with the needs of the population. However, they could not be more wrong. There have been many recent reports of a drug shortage crisis in the United States. Moreover, it has not been discussed comprehensively by the press; causing many citizens to presume that only a small section of medical facilities in low income areas are experiencing this situation. Drug shortages are caused by different factors that are based on the different stages of the life-cycle of a drug. Reasons for Drug Shortages Different trends can result in drug shortages. Some of these include: 1. The Unavailability of Raw Materials Shortages can be caused by the suboptimal quality of the substances needed to manufacture drugs. Ineffective alternatives tend to flood the market when the original manufacturer of a drug, particularly when it is a single pharmaceutical company, shuts down. In such cases, the suboptimal drugs that flood the market may have chemical instabilities, and other impurities. In has been established that in America, more than 70% of the raw materials for drugs are imported from foreign nations by pharmaceutical companies. Drug shortages will therefore occur if the raw materials are affected by any type of infection while still in their nation as the orders for them then have to be cancelled and the exporting nation given an extended period to get more raw materials. Such shortages can be particularly difficult to tackle when the manufacturing company that processes the raw materials stops all operations as this will affect all its partner companies in different nations. In America, the healthcare sector deals with such challenges by assigning personnel to track and solve such problems before they have the chance to adversely affect it. Most American pharmacy managers go to great lengths to know the cost of alternative forms of therapy and treatment, and how they can use these different types of treatment on their patients. In the past, drug manufacturers have been particularly reluctant to provide such information. This is not just because they see this as being a method of sabotaging their own success. The fact is that there is a lot of uncertainty about the production process as well as distribution process drugs. The supply chain in the production and distribution of pharmaceutical drugs has many participants, any of who can cause delays or shortages if their role is somehow affected. There are the raw material suppliers, the wholesalers, the regulators, the buying groups, the prime vendors, and lastly, the end-user organizations affiliated with the healthcare sector. Most of these groups will acquire the needed goods just in time to avoid a lapse that can result in a shortage. This negatively affects the capacity of the supply chain to sustain the availability of drug products when the health care sector experiences interruptions in one or ore of the drug making processes. Most end-user organizations affiliated with the healthcare sector do not even make use of their own inventories any more. They have to rely on their suppliers for daily replacements. With the non-existence of such inventories which can act as a buffer, even a momentary back order will turn into a serious drug product deficiency for the end-user organization. Another cause of the shortage of raw materials used to manufacture drugs is hostilities in the country with the raw products. When the raw materials of drugs grow naturally in developing countries where there are wars or periodic tropical diseases that affect the plants that produce the raw materials, the prime raw materials will be hard to acquire, resulting in shortages of the drug. In addition, the raw material can also be affected by environmental changes that adversely affect natural plants, or contamination at some stage in the process of harvesting or when in storage. Sometimes the Food and Drug Administration organization, which has the responsibility of approving drug substances for public use in America, can halt the production of drug substances that do not comply with the rules of the (CGMPs) ‘Current Good Manufacturing Practices’. The FDA has the responsibility of ensuring that unsafe drugs are not released into the market. Sometimes what is presumed to be a safety related issue may actually just be a technical mistake in the drug’s labeling (Tone and Watkins, 39). In such a case, effecting the recall of the drug is more of an ethical quandary as the recall might result in a shortage which could result in the death of patients. Manufacturers of drugs can also bring about shortages when they reduce the quantity of drugs they are generating or transfer resources to different products (Hawthorne, 122). Most drug manufacturers, for example, will shift raw materials to form other goods once they have realized their annual quotas in drug production. Drug manufacturers also reallocate raw materials in this way when the proceeds they get for making the drug do not cover or far exceed the production costs. For them, this is a cost effective practice; but it can result in shortages when there is more demand for the drug than what is available. Sometimes, in such cases, organizations like the FDA might step in to try and persuade the drug manufacturer to keep producing the drug. For instance, the FDA sometimes offers incentives for pharmaceutical companies so that they can make drugs for uncommon disorders that only affect a small percentage of the population. There are also drugs that have controlled distribution methods. This also results in shortages. In many cases, for instance, pharmaceutical companies will restrict the availability of products that have adverse side effects so that only selected end-users who meet the requirements demanded by the drug’s manufacturers have access to them (McKenna, 14A). Pharmaceutical corporations will also put such restrictions on obtaining drugs that are in demand but have been produced in small quantity. Another cause for shortages is the introduction of generic drugs into the market. Generic drugs can lead to the decreased production of the original drug; thus causing an overall shortage of the drug product. 2. Mergers and Manufacturer’s Decisions Mergers between drug manufacturers often cause the discontinuation of the production of drugs that do not have great demand. Also, the merged producers of competing drugs may choose to consolidate production, which results in more vulnerable product supply when problems emerge (Thompson, 10). From a business standpoint, the mergers of pharmaceutical companies are usually perceived as being good business decisions as they result in reduced costs, stop all attempts of duplication of drugs, and create synergies. Such mergers, in many quarters, are perceived to be a normal part of the development of an industry that needs to keep realizing profits in order to remain relevant. Many times, when merged pharmaceutical companies make the decision to discontinue the production of a specific drug, they do not have to inform organizations such as the FDA about their decision unless they are the sole supplier of the drug to be discontinued (Garnier, 72). Also, there are no laws that compel drug companies to manufacture drugs that can save lives. When drug companies that have merged make the decision to discontinue the manufacture of a particular drug, their competitors have to scramble their operations quickly in order to meet the deficiency. This is because the merged companies, as a result of the anti-trust regulation, may be unable to inform their business rivals of the decision to discontinue the production of a particular drug, thus hinting that they should increase the production of that drug. This usually results in serious shortages being experienced before the FDA can work with other pharmaceutical companies to start producing the needed drug again. This is why the existence of multiple drug manufacturers is always a good thing because shortages become a rare thing even with mergers and discontinuations taking place on a regular basis. Certain incentives like tax credits could convince other drug manufacturers to start producing a drug product that was manufactured by a company that is now part of a merger. Drug shortages can also be caused by low profit margins (Jenks, 914). For instance, generic drug manufacturers can have a low profit margin since their line of business is subject to the commodity business system. Pricing, in such cases, is reliant on the number of existing manufacturers, and so competition results in reduced prices. This causes some generic manufacturers to cease operations even when their drugs have market. Poor drug-ordering function can also result in drug shortages. Sometimes there are sudden needs for particular drug products that were not anticipated. For instance, when epidemics occur, the government may require a large volume of drugs to be furnished to medical facilities according to specific government stipulations. In such cases, pharmaceutical corporations have no other choice but to do the government’s bidding. This can result in sudden shortages due to the transference of huge stocks of drugs. Sometimes the shortages continue even when the drug products go unused if the epidemic is quickly eradicated because there is a lot of red-tape involved in the process of returning them to healthcare facilities. Sometimes manufacturers of drugs also intentionally cause shortages by amassing huge quantities of drugs in warehouses so that the demand in the market for them exceeds the supply. This then allows he manufacturers to sell the drugs at hiked prices when they finally release them for distribution. 3. Regulatory Concerns, and the Noncompliance with Current Good Manufacturing Practices (cGMPs) Another important reason for drug shortages is the regulatory obstacles that exist between manufacturers and organizations such as the FDA, and the lack of communications between them. The FDA may take long to approve of a newly formed drug; thus resulting in a shortage. Many drug manufacturers feel that the procedure used in order for the FDA to approve of new drugs is too long and costly. Most companies are discouraged by this fact from starting the production of new drugs. Even though the requirements of the Good Manufacturing Practices (cGMP) Act were created established to allow every drug producing company to be able to use individualized approaches in the manufacture of drugs, the regulars have slowly been altered over time. It is not uncommon today for drug shortages to result from the failure of a pharmaceutical company to meet the regulations in the Good Manufacturing Practices (cGMP) Act. The manufacturers who are in agreement with all the regulations of the cGMP Act usually manufacture only according to their given quotients; and are thus unable to provide more drugs when there is a greater demand. They only plan for the production of the quantity of drugs that they are certain they will be able to sell. Persistent regulatory lapses at drug production plants also worsen drug shortages. These lapses may include the need for repairs in old and decrepit production facilities, or the lack of funding for the upgrading of production facilities. Other plants have to make do with a reduced workforce due to implementing lay-offs in order to save on costs. Sometimes regulatory lapses comprise of more serious problems such as the existence of pest problems within production facilities, which causes all production to cease until the problem has been efficiently dealt with. The FDA has been particularly strict in seeking to ensure that the production facilities of all pharmaceutical companies meet the stipulated standards before they can be allowed to engage in drug production (Munos, 961). For some companies, this causes them to momentarily shut down as they may not have the necessary capital to implement all the changes required by the FDA. Other pharmaceutical companies may have the needed capital to do so, but will require extended periods of time in order to implement all the recommendations of the FDA. 4. Unexpected Demand for Drug Products When there is an unexpected demand for a drug, a shortage will result due to the unexpected disruption in the drug supply chain. Unexpected demand in the market may be caused by the incidence of the outbreak of an epidemic or rare disease. For instance, the H1N1 pandemic in 2009 resulted in a shortage of Tamiflu in America because the FDA had changed the use of the Emergency Use Authorizations (EUAs) act to accommodate the federal government's requirements n dealing with the disease. 5. How Low-Quality Contributes to Shortages Most consumers do not make a distinction between the quality of the different drugs that they purchase. Even why they buy generic drugs, they will automatically presume that the generic drug is as good as its original version simply because it is in the market. This also means that any deficiency in the reliability of drug supply that is the result of quality failures will not be perceived to be a matter for concern. This lack of awareness is not also characteristic in end-users but also in the providers of the drugs. Providers might to be able to tell if the drug is of poor quality if it is tested on a healthy population. However, the users of drugs are usually ill people whose immune systems are already compromised. These patients present many characteristics even before drugs are administered; and so it can be difficult to tell if the drug is the cause of other symptoms in their bodies, or if it is just their illness manifesting in other ways. This means that hardly any medical practitioners take time to determine if substandard drugs may be causing adverse symptoms in any group of patients. In addition, it is presumed that drugs produced in America are of the highest quality-particularly when compared with those produced in less developed nations. Also, even though most consumers will not spend more money in purchasing high-quality drugs if there is a generic substitute of the same drug in the market, most pharmaceutical corporations try to manufacture drugs in the best available conditions. Still, economic realities compel the companies to try to save on costs wherever possible. This means that the companies are faced with ethical dilemmas as to whether to keep realizing profits or make decisions that will ensure the safety of patients. Even quality, itself, is a concept that is fully transparent. There are daily operations that go into ensuring that a drug is of the highest quality. There may be issues to do with employees, available materials, sterility assurance, and staff control; all of which need to be adequately solved in order to ensure that drug production is not adversely affected by any of these factors. For instance, employees have to be fully attentive in order to produce high quality drugs. This means that they have to have good working schedules, competitive salaries, and compensation packages. If they are worried about any one of these options, they may not see the need of putting their best effort into ensuring that the pharmaceutical organization they work for realizes its own objectives. 6. Natural Disasters Natural disasters experienced in nations that produce raw materials for drugs can result in drug shortages as they may cause contamination of the raw materials, or damage the equipment used in the processing of the raw materials. This causes disruptions in the drug products supply chain as manufacturing operations have to be stopped until the equipment can be repaired. 7. Labor Disruptions Labor disruptions such as strikes in the production plants or among the processors of raw materials for drugs can affect the manufacturer’s productivity thus resulting in shortages. 8. Other causes of drug shortages are voluntary recalls due to contaminants found in drugs or adverse reactions experienced by patients. It is important for health sector workers to be able to foresee drug shortages or come up with ways of treating patients in case of shortages because shortages can result in the death of patients. This is especially important in the matter of life saving drugs. This is because, if medical practitioners wait until there is a drug shortage before seeking alternative treatments, they may not have adequate time to get the alternative treatments and save the patient’s life. In addition, they need to become more familiar with how to administer the correct doses of the alternative treatments before they can use them on their patients. How the FDA contributes to the Drug-Shortage Problem. Sometimes the FDA exacerbates drug shortage situations because of some of its outdated regulations. For instance, the FDA may compel drug processing companies to carry out renovations without understanding what is necessary and what is not (Hilts, 85). The FDA officials may not be in a position to understand the processes of drug production or how to solve problems that crop up in the various stages of production. For instance, when some drug processing plants in the past experienced reduced profits, the FDA required them to upgrade their production facilities. This was not necessary- what might have worked while also saving on costs is the implementation of targeted fixes. Most pharmaceutical corporations aim to generate drugs in the best conditions. They are ware that they will lose their market or even face litigation if they generate drugs that are substandard (Johnson, 15). Many times, they implement rules for production that ensure that they produce the highest quality of drugs with the available resources. This means that, for them, some actions or requirements on the part of the FDA are viewed as being over-regulations. The reality is that FDA officials will always find some type of flaw in any production facility if they are determined to find something wrong. What is important is finding if the flaws they find pose any real danger to patients as well as the rest of the public. An existing lack of regulatory balance on the part of the FDA can affect the public in worse ways than in causing mere drug shortages. The cost of stopping the operations of drug processing plants far exceeds the expected benefits of such an action. Drug companies require a lot of capital to start. In addition, many investors are wary of the regulations of bodies such as the FDA and their ability to shape the profits of pharmaceutical plants. The shutting down of drug producing companies can result in infections the shortage of a wide selection of drugs- and the consequent illness or death of sections of the population. In spite of their busy operations that usually take place during the day as well as at night, most drug production companies in America today have to choose to produce particular drugs as a result of the FDA’s efforts. Some have even temporarily halted all operations pending further consultation with FDA representatives as they may not be able to make profits if they are forced to function at half their capacity. The reasons why FDA representatives do not appear to understand the full effect of their actions is because there is a type of disconnect between the FDA officers who carry out inspections on drug production facilities and their colleagues in the FDA headquarters, most of whom are scientists, who are responsible for determining the compliance rules and regulations. The FDA field force tends to hold the view that the closing down of manufacturing plants that do not meet the requirements of the FDA is something that will hurt the pharmaceutical company’s management while benefiting the public (Fox, Birt, James, Soflin, Kaye, Sakai, Tribble, Robinson, Johnson, and Eckel, 1340). They also carry out the necessary inspections without first having read about how pharmaceutical companies positively benefit the society and why they are so important to the public. Ideally, the shutdown of a drug processing plant should be the last resort after all other attempts to compel its management to make suitable corrections have failed. Another way in which the FDA contributes to drug shortages is by forcing pharmaceutical companies that do not have the latest technological gadgets to purchase them or shut down until they can be acquired. The FDA is aware that new technology will result in less mistakes during the processing of drugs and also facilitate easier inspection of a company’s records. Many times, FDA officials implement compliance programs that then result in inspections being carried out in various drug production facilities. The reality is that, as businesses that have to make a profit, pharmaceutical companies cannot procure every new technological gadget if they do not have to in order to produce drugs that can still be safely used by the public. The companies also have to make profits in order to remain in the market, and costly and unnecessary technological equipment may just be an extra expense that could be done without. When pharmaceutical companies are penalized for this decision, it is the society that suffers as a result of the consequent drug shortages (Ansel, 71). In order to enforce its new rules while also ensuring that the public is not left without the necessary drugs, it would be better for the FDA to inform the pharmaceutical company of the new rules on acquiring technological equipment and educate them about what the benefits of such a purchase would be. If the pharmaceutical company has reservations about using extra capital to purchase what it might deem to be unnecessary equipment, FDA officials might consider meeting with the corporation’s executives to discuss the best way for both parties to help each other in realizing each others’ objectives. The pharmaceutical company could also be allowed extra time to save, purchase, install and use the equipment in order to ascertain if it will be of good use to the company. Sometimes, new technologically advanced equipment is unnecessary; particularly when the old system is still fully operational. Decisions concerning the implementation of new technology are never easy for any business to make. This is because they are not only about the capital used to purchase them. New technologically advanced production implements usually come in a limited capacity. For most pharmaceutical corporations, there is also the decision on whether to keep the existing labor force while reintroducing or purchasing other models of the marginal and older gadgets, or choosing the new gadgets, which are also the ones being recommended by the FDA. Choosing to use the new gadgets is a proposition that may mean laying off some workers whose functions are taken over by machinery. Either way, the pharmaceutical company has to make a decision that will result in profits. CONCLUSION The rising increase of drug shortage incidences in the U.S. has resulted in a compromised health care sector. While both the government and different health based organizations are seeking for ways to adequately deal with this problem, it should be assumed that this issue requires solutions that will put into effect long term plans as it is by no means a short term problem. This requires the joint efforts of the public, pharmaceutical corporations, as well as the government. The main issues that need to be understood include the reasons why shortages occur, and how to deal with them effectively, and establishing an understanding with the nations that have the raw materials that are used in drug production. The latter is a particularly important point to be considered as it may involve providing security for firms in foreign lands that are responsible for the processing of the raw materials used in drug production. It is also important for the FDA to be able to discuss with pharmaceutical companies ways of implementing new regulations without having to shut down drug production facilities. Works Cited Ansel, Howard. Pharmaceutical Calculations. Philadelphia: Lippincott Williams & Wilkins, 2009. Fox, Erin, Anette Birt, Ken James, Donna Soflin, Tom Kaye, Richrd Sakai, Dennis Tribble, Daniel Robinson, Phil Johnson, and Stephen Eckel. “ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems.” Am J Health-Syst Pharm 66 (2009):1399- 406 Garnier, Jean-Pierre. “Rebuilding the R&D engine in Big Pharma.” Harvard Bus. Rev. 86 (2008): 68–76 Hawthorne, Fran. Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat. Hoboken: Wiley, 2005. Hilts, Phillip. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. North Carolina: The University of North Carolina Press, 2004. Jenks, Susan. “Efforts underway to curb drug shortages.” J Natl Cancer Inst. 103.12 (2011): 914–915 Johnson, Thomas. “Drug shortages: An increasing problem for patients and clinicians.” S D Med. 64.1 (2011): 14–15 McKenna, Maryn. “Hospital pharmacists scrambling amid vast drug shortages: Emergency physicians between rock and hard place.” Ann Emerg Med. 57.2 (2011): 13A–15A Munos, Bernard. “Lessons from 60 years of pharmaceutical innovation. Nature Rev.” Drug Discov. 8 (2009): 959–968. Thompson, Cheryl. “Stakeholders in supply chain discuss shortages.” Am J Health Syst Pharm. 68 (2011): 9–10 Tone, Andrea, and Elizabeth Watkins. Medicating Modern America: Prescription Drugs in History. New York: NYU Press, 2007. Read More