The Food and Drug Administration of the United States (FDA) has the authority to require a drug safety program known as a Risk Evaluation and Mitigation Strategy (REMS) for certain medications that raise serious safety concerns. The goal of this program is to ensure that the benefits of the medication outweigh the risks of the medication.
What REMS means?
The importance of risk reduction stands out as one of the most noticeable and differentiating elements of speciality drugs in comparison to other types of pharmaceuticals. Now, before you pounce all on me, let me a moment to set the record straight. Yes, there is always an inherent requirement for a pharmacist to limit the dangers connected with any medicine.
Having said that, the necessity of providing this service has taken on a new significance in light of the availability of speciality pharmaceuticals. These kinds of pharmaceuticals have a well-established track record of being able to provide miraculous results in the patients for whom they were designed.
Having the potential for a large payoff does not come without the chance of great hazards. As a consequence of this, specialized pharmaceuticals call on the clinical skills of pharmacists to an extent that has never been seen before. There are, however, some specialized drugs for which it is necessary to go above and beyond in order to guarantee the best possible results.
- This practice is now often referred to as the risk evaluation and mitigation strategy (REMS);
- REMS programs are safety measures that have been advocated by the FDA;
- These strategies are predicated on the management of risks that are either known to be considerable or that may have the potential to be severe;
The concept of reducing one’s exposure to danger, at least to some extent, is not a novel one. In point of fact, REMS came into existence in the 1960s as a direct response to the catastrophe that was caused by thalidomide. In the late 1950s, pregnant women in Europe, Australia, and Japan were given thalidomide to cure their nausea as a form of treatment for leprosy.
Thalidomide is an immunomodulatory drug that is also used to treat other diseases. Although it was successful in lowering feelings of sickness, beneath the surface, it was having a far more significant effect.
When these women gave birth to their children, it was discovered that their usage of thalidomide during pregnancy caused a serious birth condition known as phocomelia. Phocomelia is characterized by a shortening or disappearance of limbs. Because of this, the medicine was quickly rendered illegal in a number of different nations.
This catastrophe was prevented from occurring in the United States of America before there was even a chance that it might have started. The Food and Drug Administration stopped the approval of the medicine before the disaster that was caused by thalidomide could occur in the United States.
Concerns regarding peripheral neuropathy, which in some cases could not be reversed, were raised in conjunction with the usage of the medicine. The judgment made by the FDA in this case had the unintended consequence of preventing thousands of infants from being born with comparable birth abnormalities.
The tragic events that unfolded as a result of the use of thalidomide served as the impetus for the passing of the Drug Amendments of 1962. This law instantly expanded supervision, and it applies to all pharmaceuticals now available on the market as well as those that are in the process of being developed.
In this first iteration of REMS, it was necessary for pharmaceuticals to demonstrate that they met criteria relating to both their safety and their efficacy before being authorized for use. The concept of a safety plan for pharmaceuticals with potentially substantial dangers developed as a result of these observations.
- In the 1970s, the Controlled Substance Act was passed into law and began imposing controls on prescription drugs that had a high potential for misuse;
- In addition, the Food, Drug, and Cosmetic Act was passed into law, which paved the way for the introduction of package inserts in retail products;
Beginning in the late 1980s and continuing into the 1990s, patients taking specific drugs were required to participate in accompanying safety programs. The most noteworthy instance of this happened in 1988, when individuals who used Accutane were had to complete a pregnancy prevention program prior to having their prescriptions refilled.
- The most significant advancement for the concept of REMS came in 2004, when the FDA mandated the development of risk minimization action plans for specific medications that had an abnormally high risk and benefit profile associated with their use;
Among the first pharmaceuticals to be subjected to enhanced scrutiny were prescription drugs like Accutane and Tracleer prescribed under the iPledge and TAP programs, respectively. The Food and Drug Administration Amendments Act was passed in 2007, giving birth to the modern iteration of the Risk Evaluation and Mitigation Strategy (REMS) program.
As a consequence of this, the Food and Drug Administration (FDA) was given the authority to improve drug safety measures across the industry, and they did just that. In the event that post-marketing safety concerns surface, medications that were already available for purchase might be made to comply with the REMS requirement.
If significant safety issues were found during clinical testing, then pharmaceuticals that are now going through the approval process would also be subject to the requirement. In either scenario, the Food and Drug Administration (FDA) was intent on making some treatments be subject to an ongoing requirement to weigh the potential downsides against the potential upsides.
What does REMS mean to you, either as a specialist pharmacy or a speciality pharmacist, and why is it important? I have two thoughts that I hope immediately come to mind. To begin, pharmacies and pharmacists have the responsibility to provide patients with care that is in their absolute best interest.
If you are counseling a patient about a REMS medicine and you fail to advise the patient adequately for whatever reason, then you have failed to satisfy your main commitment. This is the case regardless of why you failed to counsel effectively. We are aware of the positives, negatives, and undesirable side effects that come along with using a REMS medicine.
- It is of the utmost importance that we educate these patients, monitor them, continue to educate them, and continue to monitor them;
- It would be foolish to not do this task in an efficient manner;
- The road of engaging in dangerous business might result in unpleasant repercussions not just for you as an individual, but also for the company that you work for;
Although the producers and the FDA are watching, it is unlikely that they are doing so in real time; nonetheless, you see the concept. As a result, there is always the chance of an unanticipated audit taking place. In the event that either you or the pharmacy are found to be in violation of the compliance standards, please make sure that your checkbook is easily accessible.
- I’m not sure about you, but I don’t want to put myself in such a precarious situation;
- About the Author Joe Thomas received his Doctor of Pharmacy degree from Duquesne University;
- He is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh;
The MSPBA program is a 12-month, executive-style graduate education program designed for working professionals who are striving to be tomorrow’s leaders in the business of medicines. Over the course of the last several years, he has spent his time working in a variety of specialized pharmacies, where he has been involved in both staff and corporate experiences.
When is a REMS required?
- What exactly is the function of something called a Risk Evaluation and Mitigation Strategy (REMS)? The purpose of risk evaluation and mitigation strategies, or REMS, is to assist lower the likelihood of a certain major adverse event or its severity. They assist support the safe use of a medicine as indicated in the product’s prescription information that has been authorized by the FDA. As soon as the FDA decides that a REMS is required for a medicine, the pharmaceutical makers of that drug are obligated to create, implement, and evaluate a REMS that is particular to their drug product. REMS can provide safe access for patients to certain drugs with serious risks.
- Which drugs are eligible for a REMS? If the FDA finds that requiring a REMS for prescription medications and biologics is required to guarantee that the benefits of the medication exceed the dangers, the agency has the authority to make this requirement. The FDA has the authority to demand a REMS for generic versions of prescription drugs as well, but these drugs must comply with a distinct set of regulations. REMS are not applicable to pharmaceuticals that can be purchased over the counter (OTC). Because of the known or anticipated severe hazards that are linked with medicine, these drugs would not be licensed or they would be removed from the market if a REMS were not in place to monitor them.
- How does the FDA decide whether or not a particular medicine need a REMS? The following factors are taken into account by FDA employees (such as clinical reviewers, safety reviewers, and so on)
- Whether there is a specific danger or hazards connected with the medicine that, when weighed against its advantages, cause the medication to be less desirable overall
- whether or not further interventions over and above the labeling that has been authorized by the FDA are required to guarantee that the benefits of the medicine exceed its hazards.
- The possible hardship that the REMS standards might impose is another factor that is taken into consideration. Please refer to the FDA’s Application of Statutory Factors in Determining When a REMS is Necessary: Guidance for Industry for any further information you may require. The Food and Treatment Administration (FDA) may also gather information from patients and caregivers who are currently coping with the condition that the drug is intended to treat, as well as from outside experts who serve on advisory committees that offer guidance to the agency.
- How exactly can a REMS reduce the dangers posed by a medication? Interventions that support and promote the safe use of the medicine may be included in REMS. One such illustration of this would be a medication that, if taken, very instantly precipitates a life-threatening allergic reaction. It is vital to have a REMS in place to ensure that the medicine is only given out in medical facilities that have staff members who are trained to handle severe allergic reactions, as well as fast access to the requisite therapies and equipment for handling such occurrences.
REMS can provide safe access for patients to certain drugs with serious risks that otherwise may not be approved and available on the market. It is important for health care professionals, patients, and all others who are affected by REMS to be aware of this fact.
Another illustration of this would be making sure that certain laboratory testing has been finished and the findings have been examined before a prescription for medicine is renewed. The education of health care professionals about which individuals may be at the greatest risk of having an adverse event and who, as a result, should not be supplied a prescription is one potential risk mitigation strategy that can be implemented by other REMS.
- Does the FDA create each of the REMS individually? While the Food and Drug Administration (FDA) is the entity that decides whether or not a REMS is required, it is the maker of the pharmaceutical that is responsible for designing and carrying out the program after it has been approved by the FDA. Some manufacturers create these programs on their own, while others contract third-party suppliers or other businesses to create and carry out the programs on their own.
- Whom should I speak with if I want more information on a certain REMS? You can contact the FDA by calling (855) 543-3784 or (301) 796-3400, or by sending an email to [email protected] to receive information on the currently authorized REMS. Alternatively, you can find this information on the REMS@FDA website. You may also go to the medication’s REMS website, which has details on the individual programs as well as information on how to get in touch with the REMS administrator or the manufacturer.
- How can we tell whether the REMS is effectively reducing the risk? It is up to the maker of the particular drug to devise an evaluation strategy in order to figure out whether or not the REMS is successfully achieving its risk reduction objective. Following REMS approval, manufacturers are required to provide the FDA with a REMS assessment report at regular intervals. This report must include an analysis, findings, and conclusions concerning whether or not the REMS is successfully meeting its goals, as well as what, if any, modifications may be required. The Food and Drug Administration (FDA) examines the REMS assessment reports in order to ascertain whether or not the REMS assessment report is comprehensive, whether or not the REMS is successfully achieving its objectives, and whether or not the REMS objectives, elements, tools, or assessment plan ought to be altered.
- I have been told that if a medicine has a REMS, it signifies that there won’t be a generic version of the drug
- is this true? No. In order to comply with the regulation, all generic versions of a medicine that already has a REMS in place must also have their own REMS. Sometimes the maker of the brand name product and the manufacturer of the generic equivalent will work together to create and execute a REMS (i. At other times, the brand name drug and the generic version of the drug will each have their own unique REMS, but they will still have the same overall goal(s), objectives, and equivalent mechanisms in place to accomplish those goals and criteria.
- Are REMS permanent? Will FDA ever sunset a REMS? If the FDA determines, after reviewing REMS assessments or other information, that the additional precautions included in a REMS are no longer required to guarantee that a medication’s benefits are greater than its risks, then the FDA may deactivate the REMS entirely or remove certain components of the REMS.
- Are there any pharmaceuticals that have REMS that have been authorized but the drug itself has been taken off the market, either because of new major safety problems or because of dangers that REMS were unable to mitigate? If so, what are those medications? To this day, the Food and Medicine Administration (FDA) has not taken a drug off the market that was given a REMS because of new or significant problems that the REMS was unable to resolve.
How many drugs are in REMS?
Belief in the importance of safety As of October 2020, there are 59 items that have REMS programs that have been authorized by the FDA.
What is included in REMS?
REMS are comprised of information that is communicated to and/or required activities that are carried out by one or more participants (for example, health care providers, pharmacists, and patients) who prescribe, dispense, or take the medication. REMS also include a risk mitigation goal as part of their structure.
What drugs are REMS drugs?
In what opioid analgesics are this REMS’s participants interested? All of the following are examples of branded and generic medication items that fall under the purview of this REMS:
- Oral dose formulations containing: codeine and codeine analogs
- tapentadol or tramadol
- or tramadol
- Intranasal butorphanol
- There are indications for the use of fentanyl transdermal delivery systems, buprenorphine buccal film, and buprenorphine transdermal delivery systems as pain medications.
- Tablets and liquid formulations of methadone are available for use as pain medications.
How do REMS work?
Photograph published on Unsplash by Alexander Andrews. As soon as I began delving into CSS, I discovered a wide variety of units for font-size. It wasn’t entirely clear to me which one to use when, where, or why, so that was a source of some confusion. After devoting some time to the task, I discovered three different units that I ultimately opted to include in my work: px, em, and rem.
Pixels are the most straightforward unit of measurement to work with. However, there is a catch to this. Let’s imagine that we succeeded to keep the media queries under control while also using pixels across our website.
What should you do in the event that a user modifies the default font size of their browser (or device)? The font size of your header will not change from its current setting (let’s say 20px). As a result, the user’s preferred fonts will not be reflected.
Which does not provide for a positive experience for the user. Therefore, while pixels may be useful for spacing and layout, they are not useful for determining font size. The ems and rems are on their way to the rescue.
The font size of an element’s parent is used to determine what size an em should be set to. For instance, if there is a div element that is specified with the font-size: 16px attribute, then for that div as well as for its descendants, 1em equals 16px. The element’s font size will be inherited from the parent element if it does not have an explicit font-size definition.
- The inheritance is passed down through the generations of ancestors in this manner all the way until it reaches the root element;
- The browser will supply the default size of the font for the root element;
Here is a model for them to follow. You can see that we set the font size of the parent to 20 pixels and the font size of the child to 1.5 em here. There is a difference between the computed font sizes of both children (#outerChild and #innerChild). The font-size of #outerChild is inherited from its parent.
parent. Therefore, the computed font size of #outerChild will be 1.5 times 20 pixels, which is equal to 30 pixels. Additionally, the font size of a #innerChild is determined by the size of its parent #outerChild (which already has computed font-size of 30px).
Therefore, the estimated font size of nested child will be 1.5 times 30 pixels, which is equal to 45 pixels. It is imperative that you give great consideration to your plan if you intend to employ them for your units. When working on a project that uses em, it is recommended that you do not declare the font size directly, with the exception of the root element.
Em works really well with layouts like sidebar menus, in which you want the font size of the submenu items to progressively go smaller. This is an illustration of what I mean. It is possible that you should also use em with media queries.
Here is an excellent article that I discovered to be of tremendous assistance. rem values are not relative to the parent element but rather are relative to the root HTML element. In other words, if the font size of the root element is 16 pixels, then 1 rem is equivalent to 16 pixels for all of the child components.
In the event that font-size is not specifically set in the root element, 1rem will be equivalent to the standard font-size that is supplied by the browser (usually 16px). When it comes to space and font size, rem is the unit of measurement that I find most useful.
Because rem use the font-size of the root element rather than the font-size of its parent. Let’s say that the font size for the root element is set to 10 pixels, which means that 1 rem is equal to 10 pixels everywhere else on our homepage. Calculations are made much simpler by the fact that 1 px is equal to 0.1 rem.
However, if you choose to specify the root font size in pixels, you will run into the identical issue that I discussed in the px section. The % represents one answer to this predicament. The font size of the browser is often set to 16 points by default.
If you set the font size to 100%, 1 rem will be equal to 16 pixels. However, this will make it more difficult to perform computations. Setting the font size to 62.5% is a more effective method. mostly due to the fact that 62.5% of 16px equals 10px. Therefore, 1 rem is equal to 10 pixels.
The following is an example of code written in SCSS: Altering the font size of your browser and experimenting with zooming in and out are also effective ways to view the results. ems and rems helped me find solutions to difficulties I was having with pixels.
I make use of rem when it comes to spacing (margin, padding, etc.) and scaling fonts. And I utilize em for layouts like menu. Please let me know on twitter if you are aware of any further applications for ems and rems.
What is a REMS assessment?
One method for determining the degree to which patients, caregivers, or health care professionals understand the risks associated with a medicine and/or how to utilize it is to conduct REMS assessment questionnaires.
How do I enroll in REMS?
Fill out the Rosiglitazone REMS Prescriber Enrollment Form in its entirety, including your signature, and send it in to the Rosiglitazone REMS Program. Confirm that you are willing to fill out and sign a Rosiglitazone REMS Patient Enrollment Form for every patient that is enrolled in the program.
Why does clozapine have a REMS requirement?
The Food and Treatment Administration (FDA) gave its approval for revisions to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) on July 29, 2021. These improvements were made to guarantee that the benefits of the drug exceed the risk of severe neutropenia.
The Clozapine Risk Evaluation and Mitigation Strategy (REMS) is a common system REMS for all authorized medicines containing clozapine. The Clozapine Risk Evaluation and Mitigation Strategy (REMS) provides a centralized system for prescribers and pharmacists to manage patient risk, regardless of which clozapine product is being used by the patient.
This ensures that appropriate patient monitoring for and management of clozapine-induced severe neutropenia occurs. Before the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program was approved, various clozapine manufacturers ran their own patient registries independently.
The new standards will become mandatory on November 15, 2021, when they are scheduled to take effect. Some of the more important ones are as follows:
It will no longer be possible for pharmacies to verify safe use circumstances for clozapine by the use of telecommunication verification, which is also known as the switch system.
You can get the authorization to distribute clozapine by calling the contact center or going online to the REMS website. Both of these options are available.
To verify information and get a REMS dispense permission, pharmacists will need to go to the website www.
clozapinerems. com or call the Clozapine Contact Center. In order to distribute clozapine, pharmacists are required to do so.
Complete the New Patient Status Form to capture all outpatients’ medical monitoring.
This form has to be turned in on a monthly basis.
According to the Prescribing Information, continued patient monitoring is required at all times.
The safe administration of clozapine will not be affected in any way by these modifications.
What is a REMS communication plan?
Communication Plan The REMS might demand that the manufacturer develop a communication plan. This plan might involve sending letters to health care providers; disseminating information to providers about REMS elements to encourage implementation or explain safety protocols; or disseminating information through professional organizations.
What is opioid analgesic REMS program?
Opioid Analgesic REMS is one approach among numerous national and state attempts to minimize the risk of abuse, misuse, addiction, overdose, and mortality caused by prescription opioid analgesics. The Opioid Analgesic REMS was authorized on September 18, 2018, and is one of the strategies.
What is REMS Etasu?
Elements to Assure Safe Use (ETASU) ETASU refers to any necessary medical procedures or other steps that must be carried out by a medical expert before prescribing or distributing the medication. In order for the patient to continue receiving therapy, it is possible that some steps may be necessary.