The Office of Prescription Drug Promotion (OPDP) of the U.S Food and Drug Administration (FDA) has reviewed a print advertisement for the approved product LATISSE® (Bimatoprost Opthalmic Solution 0.03%) in various pharmaceutical journals and magazines. This print advertisement was found to have inadequate balance of benefit and risk information. As a result, LATISSE® print advertisement was found to violate PhRMA Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines. It specifically violates the guideline principle # 2, 10,11, 13, 14, 16. This print advertisement is concerning from a public health perspective because it creates a misleading and misinformed impression about the safety and approved indication for LATISSE® .
Background
Below are the indication and summary of the most serious and most common risks associated with the use of LATISSE®.
According to its FDA-approved product labeling :
LATISSE® is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
Important limitations of Use:
Use in pediatric patients below the age of 16 years is
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LATISSE® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated is required to be mentioned in the print advertisement. Also, the direction that it is important to apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators should have been mentioned to inform the patients about the proper usage of the product. Such statements raise considerable public health concerns and are particularly alarming when not informed in the
This report is Part 1 of assignment for Marketing MBA 565-MBOL1 to Dr. Stephen Baglione
This advanced lash treatment offers an array of advantages: It helps to lengthen the lifespan of lashes, so you lose lashes less frequently. It also improves the texture and condition of your lashes; lashes
There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment.
Many patients are finding it more difficult to afford their prescription medications. Comparing health care expenditures in the United States, prescription drug costs rank third compared to hospital expenses and physician services (Omojasola, Hernandez, Sansgiry, & Jones, 2012, p. 479). The rising cost of prescription drugs is concerning to many patients. “The high out-of-pocket prescription drug cost is associated with medication non-adherence and adverse health outcomes” Omojasola, et al., 2012, p. 480).
Prescription drug abuse and overdose-related deaths have reached an epidemic level in the United States and are an urgent public health concern. To combat this opioid crisis, in 2016 Comprehensive Addiction and Recovery Act (CARA) was signed into law. CARA authorizes grants to increase access to treatment services and opioid reversal drugs such as Naloxone, strengthen the Prescription Drug Monitoring Program (PDMP), expand prevention and educational efforts. In spite of the extensive range of activities authorized by CARA to control this epidemic, the US has experienced an increase in the number of the opioid overdose-related emergency visit from 2016 to September 2017. Therefore, after considering the policy options to reform this act, the most apropos solution would be the universal mandate of PDMP use. Mandating PDMPs can reduce prescription overdose and misuse of opioids. In order to ensure the impact of this program, PDMPs will have to be implemented on a Federal level. This will essentially make sure that all states taking part in the program are responsible for keeping track of registered physicians and dispensers under the Prescription
The intended use of medications is meant to improve a person’ health, it is very important the individual administering medication or self-medicating use the drugs correctly, by following the doctors’ instruction for the medication prescribed. Medication is given to diagnose, treat, and prevent illness. Medication can be very dangerous, which can potentially cause harm or even deaf if it’s not used properly.
Perming lotion is then applied evenly over the lashes and cover by a cotton pad or lint pad to generate heat for the lotion to work. Once the perming lotion time is up, it is then gently removed and a fixing lotion is applied along with clean lint pads or cotton pads for around 10-15mins, then the fixing lotion is gentle removed and the rods slowly rolled back releasing the lashes and a cooling moisturising lotion is applied to the eye area. For more detailed information see appendix A and appendix B.
Today prescription medication is taken for reasons or in ways or amounts not intended by a doctor, or taken by someone other than the person for whom they are prescribed. The estimated deaths from prescription medications are increasing each year. Narcotics are the most common abuse substance by Americans, after alcohol and marijuana. By keeping track of prescriptions could cut down the deaths and prevent the escalation of addiction.
Greg a 14-year-old boy living with his parents in the basement. He has to take these off label prescription drug. An off label prescription drug is a drug that isn’t prescription by a doctor or pro. Greg could find these drugs on the streets or even with his family members. Be sure to take your drugs to a doctor and get them copied and your drugs. Greg is taking these drugs to feel better but he doesn’t know if they should be off labeled by a pro or just somebody else. When off label drugs were in the 1980’s it is different than today. It’s different because the drugs used back then were, just for pain. But today we use drugs to get better with an illness or disease. Off label drugs has been used since the 1980’s, supporters and no supporters argue if off label drugs are a good thing or not.
With access to prescription drugs, people are able to treat a multitude of diseases and illnesses. These drugs help deal with pain, inability to sleep, depression, and much more. Every day we are increasingly living in a world where there is better living through chemicals. However, what most do not seem to see is the rising tide of pain, illness, and ultimately death being caused by the pills people take every day. Most keep drugs in a special place in their minds, where they see them as harmless. Sadly, this is not the case, and in some cases our prescription drugs can be just as harmful as illegal drugs (King 68).
Even though people need their prescriptions, the abuse of them is getting out of control and we need to find a way to regulate it better,because it can destroy a family, cause some to become addicted, or even kill them. Prescription drugs are no joke, they can be worse than illegal drugs like marijuana, cocaine, and even heroin. The only difference is a doctor can prescribe these types of drugs. The problem we run into with prescription drugs is there is not enough being done to keep the person from becoming addicted or them selling to others. In 2007 2.5 million Americans abused just painkillers (Drug free world). That is not even including the other two types. Now it is starting to affect teens, one out of every ten teenagers admit to abusing a prescribed drug(Drug-free world).
The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability. With eyes only on profitability this can create a hazard for patients because there
In the United States of America, there is prescription drug abuse epidemic that continues to be a growing concern. Prescription drugs cause a large amount of overdoses and result in an abundant amount of deaths each year. A government study conducted shows this epidemic is scarily on the rise, “A recent government study found a 400% increase in prescription drug abuse between 1998 and 2008” (Schreiner 531). The excessive use of prescription drug abuse is leading to nonmedical use of the drugs, and creating addiction. Furthermore society is paying an extreme amount of money in this battle. With this drug abuse on the rise, legislators must create a law preventing doctors and pharmacists from over prescribing prescription medications as well a law to require they both participate in drug monitoring programs to prevent drug abuse. Now is the time that doctors and the pharmaceutical industry must be held accountable for their role in causing one of America’s worst addictions. The over medication of prescription drugs in the United States must be brought to an end by legislators creating laws to stop
In our experience with Pharmasim we learned that Marketing decision making must be very sensitive and responsive to everything going on in the industry which is very complex. Consumer responses to marketing tactics can be volatile and unpredictable and no idea is guaranteed to work well. Marketing is a matter of meticulous research, assumptions, planning, and volatility at times. Overall we took away two major points: 1) that it is important to consider the product lifecycle in evaluating how to promote businesses and, 2) that the “Sweet Spot” as a competitive advantage should be the greatest point of consideration when evaluating how to best gain leverage to beat the competition in the minds of
Years ago, the common image of an adolescent drug abuser was a teen trying to escape from reality on illegal substances like cocaine, heroin, or marijuana. Today, there is a great discrepancy between that perception and the reality of who is likely to abuse drugs. A teenage drug abuser might not have to look any further than his or her parent’s medicine chest to ‘score.’ Prescription drug abuse by teens is on the rise. Also, teens are looking to prescription drugs to fulfill different needs other than to feel good or escape the pressures of adulthood. Teens may be just as likely to resort to drugs with ‘speedy’ side effects, like Ritalin to help them study longer, as they are to use prescription