Drug Shortages Continue To Effect Patient Care - Research Paper Example

Drug Shortages Continue to Affect Patient Care Introduction Drug shortage in the United States has grown in prevalence and magnitude over the recent decade due to numerous factors. One of the most important factors is the quality control problems confronted by generic drug manufacturers. Drug shortages may lead to substandard patient care. There are numerous disappointments related to drug shortages like identifying the root of a drug shortage and the likely duration, finding a generic replacement or another source, determining medicinal alternatives, and dealing with elevated costs. In addition, alternative sources could heighten the possibility of prescription errors resulting in harmful results (ASHP 2011, para 3-4). Several of the underlying factors are incorrect product use classification, quality control issues, manufacturer problems, the regulatory authority of Food and Drug Administration (FDA), etc. Thus, this essay argues that even though there are many companies willing to produce the drugs that are in short supply, drug shortages will continue to increase and endanger patients. Overview of the Problem In a perfect setting, health care providers would be capable of constantly projecting and ordering the correct volume of drugs in a prompt way so that drug companies could manufacture adequate volumes and distributors could distribute the products in a timely way. The purpose of just-in-time (JIT) inventory method is to lessen binding substantial amount of cash for long durations and, furthermore, to minimize the cost related to inventory management. There have been numerous aspects that affect drug manufacturing (ASHP 2006, 22). Several of these aspects involve debt to shareholders, profitability, FDA approval issues, insufficient availability of raw materials, complicated manufacturing procedures, and industry merging. At times production deficiencies arise when drug companies miscalculate the demand for products due to newly implemented treatment policies, new symptoms, changes in medical procedure, and low-quality planning. Stopping production, changes in agreement, sudden withdrawals, and marketing policies can also bring about drug shortages (ASHP 2006. 22-23). Hence, the effect that drug shortages have on pharmacies can be overwhelming and could involve a rise in drug costs as an outcome of buying non-contracted drugs which could unfavorably impact packaged product agreements (Quick et al. 1997, 13). At times, manufacturers will be incapable of supplying a pharmaceutical due to a variety of supply and demand circumstances. This might include the failure of the manufacturer to acquire raw materials, production problems associated with equipment malfunction, or plainly the failure to manufacture adequate quantities to cope with the demand. Even though adverse, drug shortages are a fact that should be addressed to prevent endangering patient care. According to the professional practice associate for the American Society of Health-System Pharmacists (ASHP), Joe Deffenbaugh, “It’s [drug shortage] a multi-faceted problem with many different owners and many different vested interests. It’s an international issue. All it takes is one glitch in taking a product from raw material to patient to create mass problems” (Gebhart 2000, 50). Out of the blue, the mass media has found out about the issue of drug shortages. *graph taken from Koh (2011, 1) The above figure illustrates the pattern in the general prevalence of drug shortages over the recent years as revealed by the FDA, and the comparative prevalence of shortages caused by sterile injectables (Koh 2011, 1). As stated in a current report, the prevalence and effect of drug shortages have increased in severity, and shortages impact every part of the health care sector. Roughly 240 drugs were either out of stock or insufficient in 2010 and roughly 400 generic counterparts were ordered several days ahead (n.a. 2011, B03). Generally, these situations did not advance to severe scarcities, but they reveal weaknesses and insecurities in the supply chain that raise concerns nationwide. A large number of the drugs pinpointed in 2010 are still out of stock or lacking in 2011. Sterile injectable products, which are very important in the acute care sector, comprise 77% of drugs running low in 2010 (Cherici et al. 2011, 1). Current media reports draw attention to the dilemmas of physicians and patients confronted with shortages for critical care prescriptions, anesthetic drugs, and cancer medications that have resulted in disruptions in surgical procedures and treatment or adjustments in care policies. Back orders led to patients receiving replacement treatments that raise costs in patient care (Cherici et al. 2011, 1-2). However, the major problem is the absence of effective dissemination of information. Nobody is certain just how severe and pervasive drug shortages have turned out to be. As reported by the American Society for Parenteral & Enteral Nutrition (ASPEN), the multivitamins Pediatric IV has been scarce for several years now. The Infectious Diseases Society of America (IDSA) revealed that its people have been confronting short supplies of oral typhoid vaccine, urokinase, and antimicrobial for almost a year now (Gebhart 2000, 50). As stated by the president of IDSA, Catherine Wilfert, “I’m surprised at how widespread the problem appears to be. It’s not just a single drug, such as penicillin G, which initially called attention to this issue. It’s a much broader and more serious problem than we thought” (Gebhart 2000, 50). Numerous scholars and ASHP are putting emphasis on three factors: (1) intensified implementation of appropriate manufacturing processes by the FDA; (2) just-in-time distribution strategy; and (3) availability of basic goods. Drug Shortages will Increase and Endanger Patient Care Continuing drug shortages have turned out to be a threat. It is restricting patient-care options, impacting clinical results, and using up already insufficient pharmacy funds. As stated by Sylvia Bartel, vice president of DanaFarber Cancer Institute’s pharmacy services (Gebhart 2011, para 2): The shortage has changed how we handle these products and these patients. We are doing more advance planning for individual patients to ensure that product is available when needed. We are sequestering product for specific patients. We are making multiple calls daily to FDA, to manufacturers, wholesalers to move in parallel with shortages instead of being surprised by them. It is a matter of putting additional resources and staff behind the effort. And every time we have to substitute a drug or a formulation, safety becomes a huge issue. Issues of safety are major for generic drugs. The Institute for Safe Medication Practices has associated drug shortages with unfavorable clinical results and inaccuracies. According to the executive vice president of Institute for Safe Medicine Practices (ISMP), Allen Vaida, “Drug shortages put patients at risk of not receiving the most appropriate therapy or not receiving any therapy at all. One of the respondents in a survey asked what to tell breast cancer and lymphoma patients—that you had a curable disease but you’re going to die because the right drug isn’t available?” (Gebhart 2011, para 4). A number of antiviral and antibiotic deficiencies increase the rate of patient mortality as certain viruses and bacteria were not responsive to alternative prescriptions (Cherici et al. 2011, 2). Continuing drug shortages are severely affecting patient care and raising expenditures of the health care sector of the United States, as recently reported by ASHP. As stated by the CEO and executive vice president of ASHP, Henri Manasse (ASHP 2011, para 4): Drug shortages are a national health crisis. Particularly troubling are reports that pharmacists are being pulled away from clinical duties to manage shortages. This means that patients don’t have access to the medication expertise that pharmacists provide making patients even more vulnerable to harm. The impact on our health care system is enormous. It’s urgent that stakeholders work together to find solutions to this serious public health threat. The safety of patients is constantly a problem with drug shortages. Major prescription inaccuracies can take place when the only available drug does not have the usual strength used. Mistakes can take place in measuring, compounding, and administration (Saine 2009, 69). Serious prescription mistakes can also take place when the only available drug is in an unusual packaging. A quite unforgettable shortage wherein particular packaging was out of stock was the short supply of Abboject and Lifeshield emergency drug syringes in 2003 (Saine 2009, 70). Largely, the drugs remain in sufficient supply in other types during the shortage; nevertheless, it continued to be a possible safety concern, especially in emergency circumstances when physicians were accustomed to searching for a particular product. In 2008, sodium bicarbonate and sodium chloride shortages took place bringing about possible safety concerns because of a complete absence of the tablet dosage casing (Saine 2009, 70). Although salt and baking soda, or sodium bicarbonate powder, were largely obtainable, the user-friendly tablet dosage casing was out of stock (Saine 2009, 70). Health care providers and patients were left no other choice but to estimate the same quantities of salt and baking soda to continue treatment. Numerous patients found such options unpleasant, making them vulnerable to more difficult situations because of noncompliance (Saine 2009, 70-71). Furthermore, a number of patients needed particular quantities which were difficult to measure. Packaging shortages in specific forms can also result in errors. A large number of hospitals make use of Add-Vantage vials for measurements of antibiotics to prevent excess when constancy could be a concern and to enhance availability (Fred 2005, 54). The unavailability of this packaging form necessitates adjustments to usual nursing and pharmacy practices, putting in additional process that may result in error, and could possibly impede treatment for a number of patients. A widely recognized source of prescription inaccuracies is when products sound or look the same. The unavailability of drugs resulted in a product blunder between dextrose 5% and bicarbonate 5% plainly due to the fact that the products had the same appearance. A hospital mistakenly used sodium bicarbonate 5% for pediatric patients instead of dextrose 5% (Saine 2009, 70-71). The hospital, before the shortage, was buying sodium bicarbonate 5% to lessen the possibility of error, but a shortage forced the hospital to buy the products from another provider (p. 71). Before, circumstances wherein a drug is only obtainable from another company might not have been regarded a shortage by a number of physicians. Yet, computerization is altering this belief. A shortage of one particular drug can bring about unfavorable outcomes when computerized systems are attuned to a particular product (ASHP 2006, 22). A product from another company could affect pre-packaging device cylinders, computerized dispensing storages, and order entry processes. Safety is definitely an issue when a substitute product is needed. Physicians may doubt the effectiveness of a substitute product, especially when they have knowledge of and actual experience with the favored substitute (ASHP 2006, 22-23). Lack of knowledge about substitute products poses another possible safety hazard. Physicians should be completely knowledgeable of the effectiveness features of an alternative product to guarantee the safety of patients. More often than not, no single substitute product can be sufficient, just like what happened when succinylcholine became out of stock (ASHP 2006, 23). Because of the shortage several clinics and hospitals were forced to stop treatments. Generic Drug Companies Suffering from Quality Control Issues Among the main contributing factors to drug shortages are quality control problems faced by generic drug manufacturers. The quality of generic drugs is at times very low. Quality control issues are adversely affecting the availability of a huge number of drugs. Moreover, manufacturers are choosing to halt production of several drugs on the whole. As stated by the Government Accountability Office (GAO), “manufacturing problems were the primary cause of most shortages” (Burton 2011, para 4). According to the report of the GAO researchers, almost all drug shortages they examined thoroughly were due to production issues, as well as those that led to manufacturing failures. Other failures arose from interruptions in supply of the raw materials needed to produce drugs. And those, as well, according to GAO, were due to quality control issues and unnamed manufacturing disruptions (Burton 2011, para 4-5). No less than 42% of the shortages of sterile injectables in 2010 were caused by quality issues like the detection of newly discovered contaminations, microbial impurities, and changes in strength (Cherici et al. 2011, 1). Interruptions in the manufacturing processes raise the expenditures of manufacturers to guarantee the safety and quality of their products. Demands are growing to counteract profit declines arising from healthcare reorganization, termination or expiration of patents, and ventures associated with FDA regulatory policies for long existing goods. Manufacturers are postponing or withdrawing investments, thus affecting availability of products (n.a. 2012, para 8-12). Manufacturers are not obliged to release a statement of product withdrawal to the FDA except if they are the exclusive producer of a life-prolonging drug administered to stop or delay the progress of an incapacitating illness. Timely notification, in spite of such narrow conditions, thwarted several drug shortages in 2010 (Gupta 2011, 79). However, most drugs in short supply are sterile injectables, which are produced with a complicated, thorough procedure to guarantee their quality and safety. This makes manufacturing blunders more likely (Gupta 2011, 79). Due to its complicated nature, sterile injectables are more costly to manufacture, which could force a manufacturer to concentrate on producing more cost-effective prescription drugs. Numerous factors can create quality control problems for drug manufacturers, such as reduction in the number of personnel, an adjustment of a manufacturer’s resources from production to research and development, obsolete facilities, etc. Modifications in a product’s preparation and inadequate production capacities can also contribute to drug shortages. Moreover, the FDA endorses a particular production line to manufacture a particular drug at a particular site. As a result, drug companies cannot easily embark on manufacturing a scarce drug elsewhere in a site. Furthermore, producers usually utilize the same manufacturing tools for numerous drugs; hence it is not easy to boost production of a particular product without resulting in production interruptions and shortages for another (Gu et al. 2011, 2). As a result, at times it is feasible to boost drug production simply by purchasing more tools or having an agreement with other manufacturers to generate the product. Nonetheless, this is not a simple solution, for there is frequently a major delay between a production expansion and a shortage at another site. On the other hand, the FDA has responded to an accusation that it is responsible for severe shortages of major drugs. Valerie Jensen of the FDA answered that quality issues are the major root of the drug shortages. According to Jensen, a large percentage of the shortages in 2010 were brought about by quality problems, such as contamination and sterility issues. She further claimed that, “In 2011, we’re seeing the same trend, a very large number of quality product issues leading to shortages” (Gardner 2011, para 6). It has been widely known in the United States that numerous injectables manufacturers have been overwhelmed by various types of contamination, such as ‘floating particles’. Glass chips have also been seen continually in injectables vials (Staton 2011, para 3). American Regent, for example, has withdrawn several products contaminated by glass specks and silicon bits. The company has injectables that are now in short supply (Staton 2011, para 3). The FDA currently made public guidelines for industry concerning the releasing of information about drug shortages to the bureau. A current commentary from the Wall Street Journal made clear that, “The shortages occurred when Benvenue, one of only four domestic suppliers, closed its plant because it could no longer guarantee product safety” (Federgruen 2012, para 1). Primarily, the number of generic drug manufacturers has declined. Supply delays are widespread, as well as the risk that a facility totally ceases operation for a long time due to quality issues. Additionally, dissimilar from many consumer-products companies, numerous drug companies were not able to spend for quality-control and technological expansions that would lessen the possibilities of incomplete or total facility closures, and this in spite of the FDA’s repeatedly publicized present policies for good manufacturing practices (GMPs) (Federgruen 2012, para 1-3). Underlying quality control issues are the government’s rigid price regulations for generic drug products, particularly when bought by Medicaid and Medicare. These strictly reduced prices tempt drug companies to leave different markets, or to shift their production capability into more lucrative, patented drug products (Federgruen 2012, para 5). In addition, low prices have a tendency to weaken the justification for expenditures in more advanced production systems and technologies. Government price regulations on generic pharmaceuticals narrow the profitability of producers in numerous instances. Also, the government’s supervision of production quality and safety is worsening drug shortages. Drug companies generate numerous requests for new production facilities and production systems in current facilities. The government was not able to apportion resources to employ a sufficient number of assessors to review the requests or overseers to evaluate the facilities (Federgruen 2012, para 7). As a result, several analysts claimed that one solution to quality control problems, and consequently, to drug shortages is to loosen up or abolish government price regulations, and to improve the FDA’s assessment capabilities. Drug Shortages in the United States are Likely to Increase due to its High Prevalence Drug shortages are not a new problem for the United States, and its likely continuance will depend on its prevalence. Health care practitioners believe that drug manufacturers have a thinning commitment in guaranteeing a quality and steady supply. However, an association representing pharmaceutical firms holds the FDA responsible for implementing unreasonably rigid inspections and putting a stop to production operations for trivial problems. The absence of a solution and incessant blaming negatively affects patients and the health care sector. In a current investigation by the American Hospital Association, a sizeable number of the 820 hospitals they surveyed revealed that they had to postpone treatment and were not able to give patients the needed medication for their illness (Yukhananov 2011, para 14). Many patients had to take a less effectual substitute drugs. Safe Medication Practices (ISMP) discloses that a number of patients died due to drug shortages. According to Fight Colorectal Cancer’s Nancy Roach, “of the 140,000 patients diagnosed with colorectal cancer each year, about 80,000 are expected to rely on typical treatments like fluorouracil or leucovorin, both currently in short supply” (Yukhananov 2011, para 16). Different recommendations to solve the chronic issue of drug shortages have stopped, not least due to the uncertainty of the source. The process of distributing prescription drugs to patients is far more complicated and challenging than most people think, particularly patients. Drug shortages are multifaceted, and seldom is it feasible to identify a single or precise cause. Several of the aspects affecting drug availability are expected and identifiable, whereas others are not. For the purposes of the discussion, it is important to enumerate and reiterate some of the unpredictable and predictable aspects that may lead to drug shortages (Gu et al. 2011, 1-5): (1) Natural disasters could bring about a shortage by destroying or altering the materials (e.g. plants) used in the exclusive manufacturing of a product and causing sudden impairment to production facilities; (2) Scarcity of raw materials could have a serious effect on drug availability. Difficulties may surface when the raw materials are hard to extract; (3) Shortages can take place when the main or only producer of a good has its manufacturing operations stopped by the FDA due to, for instance, noncompliance to good manufacturing practices; (4) At times, drug companies will permanently or momentarily trim down production while they transfer facilities, investments, or production; (5) A drug company may cease production of a drug due to possible safety issues, low demand, or low profitability; (6) Company mergers could lead to the withdrawal of products and limiting the emphasis of the product line. A consequent decrease in suppliers can put a particular marketplace at risk for shortages; (7) At times, the entrance of another generic product may cause a reduction in the production of the pioneer product and generate a momentary decrease in the availability of a specific drug; (8) At times, demand for a product can go beyond the current production capability as can take place when modifications in a product preparation or packaging, new clinical procedures, epidemics, or other unforeseen boosts in demand take place. This kind of changes in demand could be more challenging when the production system for the product is complex or resources required are scarce; (9) The success of pharmaceuticals draws the attention of sellers who produce unnatural shortages by discriminatingly buying volumes of products and thus exhausting supplies. These sellers afterward sell the goods to people at exaggerated prices; and (10) The heightened use of major sellers may have worsened drug shortages by trimming down the quantity of product existing in the supply chain. It is now difficult to simply solve shortages by depending on stored inventories due to the fact that both the health care sector and merchants keep the least amount of stockpile. Consequently, supply problems of manufacturers are passed on instantly to the consumers without the help of an inventory cushion, thus building up the prevalence of temporary shortages that could affect organizations. Thus, in summary, causes of shortages generally identified are supply and demand issues, manufacturing difficulties, raw material scarcity, product withdrawal, and regulatory problems. Astonishingly, some experts claimed that roughly 27 percent of shortages are unaccounted for (Gu et al. 2011, 1). Drug manufacturers could at times be hesitant to disclose information about a shortage due to problem-solving, legal, and public relation concerns. Some experts claim that although the factual causes of shortages may still be unidentified, it is essential to look into the common factors underlying a shortage as component of the planning and evaluation procedure. For instance, according to Quick and colleagues (1997), identifying that an adjustment in the supply is less important to a shortage in raw material is an indication that the shortage will probably be extensive and prolonged. Identifying which medicinal groups of drugs have been scarce can present accurate idea to those divisions within the organization that should have an invested commitment to collaborate with the pharmacy to resolve a certain shortage. It is not easy to estimate the duration of extensive shortages. Shortages that affect patient and hospital care are usually lengthy. Sadly, institutions do not receive much assistance from external organizations in dealing with shortages. The FDA has restricted power as regards to shortages and merely participates if a drug is verified to be clinically important. Since there is no updated or sophisticated warning mechanism and developing a useful organizational plan requires substantial amount of time, pharmacists have had to put into practice their own plans to accurately recognize drug shortages (Gu et al. 2011, 4-5). Valuable results can be attained when the shortage is recognized in a timely manner, there is opportunity to inform other providers or professionals and collect data/information about the shortage problem, and alternatives for putting off harmful impacts on patient care can be studied. Conclusions The quality, cost, and supply of drug products in the United States are now becoming one of the most important issues the government and private sectors have to confront. Safe, high-quality, affordable, and effectual prescription drugs are in short supply or out of stock. But very few studies on the development of these drugs are in progress because formulation of new drugs is costly and encouragements apparently are not sufficient to motivate substantial research and development. Therefore, in conclusion, although there are many drug companies willing to produce the drugs needed, drug shortages will continue to increase and endanger patient care. Drug companies are continuously suffering from serious manufacturing problems and quality control issues, and strict government requirements contribute further to the problem of drug shortages in the United States. Works Cited n.a. “Dangers of Worsening Drug Shortages; Remedy Unavailability Could Start Costing American Lives.” The Washington Times, 2011. Print. n.a. “Senate Easily Passes FDA User Fee Bill, Reconciliation with House Version Looms.” McDermott Will & Emery. 29 May 2012. Web. 4 June 2012. 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