Pharmacy Law and Ethics: Evaluating the Safety of Prescription Drugs

This essay delves into the ethical and legal considerations surrounding prescription drugs, highlighting the risks associated with newly approved medications and adverse drug reactions. It discusses the concerns raised by physicians regarding the long-term effects of drugs and the significant number of hospitalizations and deaths linked to prescribed medications. The essay also critiques the pharmaceutical industry's focus on minor drug variations for profit rather than genuine therapeutic advancements, referencing research that questions the effectiveness of new drugs compared to older ones. Furthermore, it examines the influence of commercially funded clinical trials and biased reporting on drug efficacy, as well as the impact of expedited FDA approval processes on patient safety. The essay concludes by advocating for stricter FDA oversight and evidence-based drug approval to mitigate the risks associated with prescription drug use. Desklib provides access to similar solved assignments and study resources for students.

Running head: PHARMACY LAW ETHICS
Pharmacy law ethics
Name of the Student
Name of the university
Author Note

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There are a few new drugs that caused serious reaction after getting approval. So,
physicians recommended not to consume a drug at least after 5 years of patient trial. However,
almost 1.9 million hospitalization in a year occurred even after properly prescribed drug
consumption. 2.74 million of adverse drug reaction occurred in total in a year and 128000
people had died by prescribed drug reactions. This causes prescription drugs to be a major cause
of health risk and stoke had become 4th leading cause of death. According to report of European
commission, adverse drugs from prescription causes almost 328000 patients died in US and
Europe in a year. However, FDA acknowledges a few fractions of that cases. Almost 170 million
American patients take prescribed drugs and among them 80% is generic. However, patients,
who take new patented drugs are, only able to generate modest benefits over old drugs. A very
small number of drugs (11-15%) are capable of giving advantageous effect to the patient over the
pre-established drugs. Almost 4/5th of $70 billion was spend on slightly new variation of drugs.
In between 2002 to 2011, the researcher of France, the Netherlands and Canada had reported
that, 8% of new drugs were effective in nature (Light, 2014). Therapeutically similar drugs had
advantages like some patients may respond to a new drugs same class instead of old ones. The
main benefit of testing drugs is to identify specific patients who might get benefit from that drug.
Most of the significant discoveries resulted in clinical advancement. Silvio Garattini told “When
a major discovery actually helps patients, we feel very lucky.”
Introducing more number of minor variants of drug is not for the patient advancement and it is
just a marketing strategy. Jerry Avon told that laws for meaningful innovation are giving more
profit than medical advancement. Marc-Andre Gagnon has shown that net return on revenue has
enhanced 2.5 times to 3.2 times due to high price and more prescription by the physicians.

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The large companies have less risks as they only invest after the people have paid for the high
risks of research and they can divide the risks on various projects. In last 35 years, behind every
hospitalization there is almost 30 adverse events and 81 million adverse effects are experienced
by the Americans. Most of the medical error causes lack in productivity and road accidents.
Apart from the ‘R & D pipeline’, trial-journal pipeline is the randomized clinical trials and the
commercially funded clinical trials are less effective than non-commercially funded trials.
Pharmaceutical companies retain statistical data of the previous drugs and that were submitted to
FDA. Marc Rodwin reported that drug firm’s trial results are biased in nature. The twice biased
evidences are harming the science. Sergio Sismondo stated a new model that influence
physicians to prescribe new patented drugs. New FDA policies results faster response of drug
approval and this had enhanced the adverse events by 18%, death rate by 7.2%. The risk has
become 1 in 3 after this new policy. Vioxx drug disaster causes 40,000 deaths and a monitoring
system has been introduced. However, if FDA would approve drugs with adequate evidences, the
condition would improve and FDA can use its power to do so.

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Bibliography
Light, D. (2014). New Prescription Drugs: A Major Health Risk With Few Offsetting
Advantages. Ethics.harvard.edu. Available at: https://ethics.harvard.edu/blog/new-
prescription-drugs-major-health-risk-few-offsetting-advantages [Accessed 17 Dec. 2018].