Drug Shortage in Pharmaceutical Industry - Term Paper Example

?Running Head: DRUG SHORTAGE IN PHARMACEUTICAL INDUSTRY Inserts His/Her Inserts Grade Inserts : Table of Contents Drug Shortage In the developed and advanced world of the present century, the pharmaceutical industry has grown just like the other manufacturing and service industry. The healthcare sector in any region is directly linked with the pharmaceutical industry of the region thus, elaborating that a progress in the pharmaceutical industry helps the healthcare sector in prospering. The current era is witnessing serious threats to this health-related industry. This paper will discuss upon one of the major challenges, .i.e. Drug Shortage that the pharmaceutical industry is encountering these days. The issue will be illustrated with the help of evidences, tables, and graphs. Introduction to Pharmaceutical Industry One of the major sectors of development in any country’s economy is its pharmaceutical industry upon which the healthcare of the region is based. The concept of a pharmaceutical industry refers to the development, production, and marketing of the drugs which are licensed for the utilization as medicines (John, Horst, Gerd, 2007). The companies in this industry deal with the brand medication, generic medicines and in the medical services. However, they are required to comply by various laws and adhere to regulations concerning with the testing, patenting, and guaranteeing the efficacy and safety of the dug marketing. The industry researches, discovers and develops the drugs which are utilized by the humanity for the purpose of curing certain diseases and illnesses. Drug Shortage The prolonged shortage of the growing number of drugs is largely impacting the patients and the healthcare sector in United States and all across the world. The shortage of drugs has gained greater heights in the past two years, and has taken its roots largely from the disruptions in supply chain manufacturing failures that are involved in the treatments through the clinical methods. It is becoming difficult for the oncologists to gain access to the widely used chemotherapies for the treatment of seriously ill patients. The operations are being postponed by surgeons for the reason that they do not have access to pain medications and aesthetics. Even doctors are struggling to get their hands on the important parenterals for the patients needing infusions and for premature babies. To add to this, there are over dozens of clinical trials which have been stopped due to the shortage of sufficient supplies of cancer drugs that are used as controls or major segments of treatment arms (Jill, 2011). According to the records of FDA, the drug shortages in the United States have raised from the 157 shortages in 2009 to 178 drug shortages in the year 2010. The University of Utah Drug Information Service is observed to have identified 210 drug shortages until September 2010 and is looking for some 260 dynamic shortages around the nation. FDA reported last year that three-fourths of the shortages included sterile injectables and most of them were needed for the drugs which are ‘medically necessary’ (Ali, 2011). The chart given below depicts the recently reported drug shortages in the United States: Figure 1: Newly reported drug shortages The chart exhibited above indicates that the shortage of drugs has been occurring on an inclining trend since last few years. Beginning from the year 2005, the drug shortage was only 74, which rose to 129 shortages in 2007, 166 in 2009, and 211 in 2010 (Howard, 2011). We can easily anticipate and assume that the condition may worsen in next few years if the solutions are not adopted and shortage of drugs remain in the similar condition as now. Drugs in Short Supply According to an ASHP list, the drugs which are short in quantity include the sterile injectable, which constitute of inexpensive and widely used chemotherapeutic agents. Adding to this, the list includes an increasing quantity of the antibiotics, anesthetics, sedatives, analgesics, and the electrolyte additives and vitamin essential for the intravenous feedings. Moreover, the fact that the generally administered medications for the critical care is either scant or are in no supply is striking. They include amiodarone, diazepam, diltiazem, atropine, digoxin, epinephrine, dopamine, heparin, furosemide, lidocaine, labetalol, norepinephrine and morphine (ASHP, 2012). The figure given below shows just an incidence of the annual shortages of drugs as observed by the Food and Drugs Administration (FDA) and University of Utah Drug Information Service (DIS): Figure: Incidence of Drug Shortages According to the figure, there is an acute prevalence of the drug shortage. The other statistics may be old but the projected estimate shown for the year 2011 indicates a sharply inclining rate of the shortage of drugs. The estimated incidence of the drug shortage has been reported to reach till a total of 360 as examined by both FDA and DIS (JoAnn, 2012). The United States in particular lack some important chemotherapy drugs which include methotrexate, cytarabine, vincristine, doxorubicin, bleomycin, leucovorin, and paclitaxel. Moreover, using the substitutes in order to recover the shortage has created further problems. Many of the medication errors were credited to lack of practitioner’s experience with the alternative products. For example, levoleucovorin administered incorrectly, when utilized as a replacement for leucovorin or for a 1000-mg vial of cytarabine instead of the usual 500-mg one, resulted in a medication overdose. Currently, various drugs necessary for the chemotherapy regimens regarding the treatment and healing of different forms of cancer have countered scarcity in the last one year. This includes leucovorin, vinblastine, asparaginase, and fluorouracil. For instance, Thyrogen®, which is a thyroid-stimulating synthetic hormone injected to the patient suffering from thyroid cancer, has faced short supply in the mid 2011 and earlier parts of the year 2012. Consequently, more than 30,000 patients suffering from the thyroid cancer are compelled to make a bleak selection: either proceed with the cancer treatment despite the knowledge of side effects or delay the treatment. The FDA has been taking steps to address the crucial scantiness of the cancer treatment drugs, such as methotrexate, which is used to treat the multiple myeloma, acute lymphoblastic leukemia, ovarian cancer and other conditions. Effects of the Drug Shortage The effects from the shortage of very important drugs are resulting into the occurrence of various consequences. A brief description of the stakeholders being affected from the drug scantiness is given below: Patients The far-reaching detrimental consequences of the drug shortages on patients result into cancellation or delays of surgery or treatment. An analysis of 228 hospital and pharmacy professionals in the year 2011 indicated that, 80% of them had gone through the context of drug shortages which either resulted in cancellation or delays of patient interventions. Besides this, substandard care was provided to the patients, which was either in the form of no drugs or their alternatives and proven ineffective. The patients’ safety was compromised as a result of medication errors and overdose. Complications increase and even resulted into death. The following graph summarizes the consequences of the shortage of drugs that patients had to face: Figure 4: Impacts of Drug Shortage on Patient Care The American Hospitals Association reported 82% of the patients to have experienced delayed treatment. As of June 2011 statistics, 69% patients rcieved less effective drug, 63% patients were unable to receive the recommended treatment, while 35% of the total patients had to undergo negative results of the shortage of actual drug (Marie, 2011). Providers The pharmacy professionals are required to spend more time and effort in negotiating and searching for the deteriorating drug supplies. The physicians and nurses need to spend additional hours selecting the best replacement of the drugs. The care providers in the pharmaceutical industry apply the optimum therapy to reschedule and postpone surgeries. Hospitals According to the AHA survey of 820 hospitals, it was discovered that more than 99.5% of the hospitals underwent through the shortage of one or more drugs. 92% reported that they had to counter rising drug costs in the form of replacements, and over 50% of the hospitals were unable to provide their patients with the prescribed treatments and medications. The following figure depicts the extent of rising average cost of the alternative drugs: Figure 3: The average price of actual and alternative drugs The chart exhibits the comparison between the costs to the physicians in case of using actual and alternative drugs. For instance, the actual drug, Paclitaxel used to cure ovarian, breast and lung cancer costs $312 AWP per dose; however, in case of shortage, the alternative drug, Paclitaxel protein abound would alone cost the pharmacologists $ 5,824 AWP per dose. Similarly, doxorubicin costs $ 120 AWP per dose, while its replacement drug, Liposomal doxorubicin, would cost $ 5,789 AWP per dose (Gatesman; Smith, 2011). This suggests the extent of rising costs that the pharmaceutical industry has to cope up with in case of the drug shortages. Research The most affected scanty drugs include the chemotherapy medications which are a necessary element in the various research trials and are either used in combination with newer products or alone. According to the reports of Coalition of Cancer Cooperative Groups, more than half of the total cancer trials need chemotherapeutic agents as the foundation drugs which are vanishing these days. Causes of Drug Shortage Various multifactor and interrelated trends have accumulated as the contributors to the current shortage of drugs in the pharmaceutical industry. Regulatory The primary reason for the drug shortage, as given by the FDA, includes the shutdown of production due to the disruptions in manufacturing processes. This might include the impurities or foreign particulates and ingredient microbial contamination which are present in medicines and prevent the quality of the drugs from meeting the regulations and standards of FDA. In case of the delays in production, the procedures and rules of FDA result into disincentives which discourage the producers of drugs to increase the drug supply in times of shortages. Economic The production and supplies of generic drugs bear slim profit margins. Many of the drugs in the current supply are older and have lower margins of profits. Therefore, instead of entering the old markets, the manufacturers may be ready to leave and try for some new and more revenue generating brand-name product. Health Care The persistent changes in clinical practices, newer guideline for the performance of therapies, unexpected spread of disease and stockpiling by the end-users create exacerbate shortages in the drugs market. Seeking Solutions In accordance with the identification of the systematic nature of the shortage of drugs, ASHP, ISMP, ASGO, and ASA have conducted various meetings to suggest the solutions to overcoming this shortage in the pharmaceutical industry. Amongst various solutions, the most important ones are as follows: In order to recover from production shutdowns, the product contamination has to be eliminated. The facilities must pass the FDA inspection and conduct comprehensive tests to ensure product safety. The raw materials for the manufacturing of drugs must be given a strong oversight. The communication across the supply chain of the drugs should be improved and the regulatory definitions of the ‘medically necessary’ drugs should be clarified by the FDA in order to respond to the impending drug shortages. New production facilities need to be built in order to meet the competitive demand of the generic drugs. The additional production capacities would be sufficient to meet the current demand supply gap. Conclusion The shortage of drugs, or prescribed medicines, is the major dilemma of the pharmaceutical industry in the present times. This results into various consequences which the stakeholders in the industry might face in the form of delayed or cancelled treatments, medical errors, rising costs, and demand supply gap. It is high time that the need to create surplus production and regulate the policies of the industry has arisen. REFERENCES Ali Afnan, 2011, ‘Drug Shortages and Accountability’, Web, Retrieved on April 13, 2012 ASHP, 2012, ‘Drug Shortages: Current Drugs’, Web, Retrieved on April 13, 2012 Gatesman ML; Smith TJ, 2011, ‘The shortage of essential chemotherapy drugs in the United States’, The New England Journal Of Medicine, Volume 365, No. 18, Print. Howard Larkin, 2011, ‘Drug Shortage May Be Worst in 30 Years: Hospitals have trouble getting common, critical meacauons for surgery, cancer care, and other areas’, Hospitals & Health Networks Report, Print. Jill Wechesler, 2011, ‘Struggling with Shortages: Clamor for critical therapies prompts probes of prices, production practices’, Washington Report, Print. JoAnn Grif Alspach, 2012, ‘Is the Drug shortage affecting Patient care in your critical care unit?’ Critical Care Nurse, Volume 32, No. 1, Print. Marie Watteau, 2011, ‘Patient Treatment Delayed Due to Drug Shortages, New Survey Finds’, Web, Retrieved on April 13, 2012 Read More