Know about the switch of drug from otc to RX

What medications can give out with that medical prescription and to what extent could this benefit the health system and the patient?

Although this possibility exists, a series of potential risks that could worsen the patient's health (counting with factors such as self-medication) must be taken into account, and therefore the pharmacist's role is essential for the use of these medications. , thus guaranteeing the criteria of efficacy and safety.

Throughout history, we found great examples of medications that initially required a prescription and that suddenly changed their prescription and are now distributed freely in pharmacies and at the discretion of the patient and the pharmaceutical board. This is the case of the known ibuprofen for acute pain or Paracetamol for duration of fever. We also find antihistamines for the treatment of allergies (such as cetirizine or loratadine), proton pump inhibitors (omeprazole), antivirals for the treatment of cold sores (penciclovir or acyclovir) 2 or, more recently, hormonal contraceptive treatment with levonorgestrel, known as the morning after pill, with its non-prescription sale since 2009.

This type of change in legislation is known as a "switch", and is carried out not only in Europe, but also worldwide. This proposal originated in the United States, where Rx (medical prescription) and OTC drugs began to be differentiated for the first time in 1951 with the Durham-Humphrey Amendment. It defined the criteria according to which prescription medications could be used only under the supervision of a doctor, while all other medications could be sold as "over the counter", outside the counter. In 1962, the Kefauver-Harris Drug Amendments introduced more severe controls. At that time, manufacturers had to prove not only the safety of the products, but also their effectiveness in the indications that were planned for them.

Currently, the World-Self Medical Industry tells us for which conditions they could initially be considered non-prescription medications, due to their capacity for self-diagnosis and self-care

Regulatory criteria

Even so, what are the regulatory criteria that a medicine must meet to consider its otc to RX switch? The Agency for Medicines and Health Products postulates that a medicine not subject to medical prescription should consider processes or conditions that do not require an accurate diagnosis and whose toxicological evaluation, clinical data or its use and route of administration do not require a medical prescription  .

In addition, it should be noted that such medication:

• Cannot be financed with public funds.

• May not contain psychotropic or narcotic substances.

• Both its composition and its objective should be intended for use without the intervention of a doctor who makes the diagnosis, prescription or follow-up of treatment.

Of course, this option is not applicable to every otc drug development medication that requires a medical prescription, since all the safety and efficacy factors of its possible use without medical control must be taken into account, since there are drugs that can generate a dependency or whose levels of toxicity and adverse effects can be high, even with the administration of other medications due to the different interactions that could lead to.

In turn, also when assessing its availability we must take into account the route of administration and the consequences that may arise from its excessive use (maximum daily dose). The marketing time of the product registered over the years is also assessed, as well as the number of cases reported by pharma co vigilance, both of interactions and adverse effects, taking into account that, the greater the number of reported cases, the lower It will be acceptance as a future candidate for a switch .

In turn, also when assessing its availability we must take into account the route of administration and the consequences that may arise from its excessive use (maximum daily dose). The marketing time of the product registered over the years is also assessed, as well as the number of cases reported by pharma co vigilance, both of interactions and adverse effects, taking into account that, the greater the number of reported cases, the lower It will be acceptance as a future candidate for a switch . Also before lunch of medicine in market it must be approved by FDA.

 Source: 

https://pharmaceuticaldevelopmentgroup.home.blog/2019/11/14/know-about-the-switch-of-drug-from-otc-to-rx/

https://pharmdevgroup.hatenablog.com/entry/Know_about_the_switch_of_drug_from_otc_to_RX

https://medium.com/@kellyshelton602/know-about-the-switch-of-drug-from-otc-to-rx-87dddfd3ca28

http://pharmaceuticaldevelopmentservices.booklikes.com/post/1992136/know-about-the-switch-of-drug-from-otc-to-rx

https://www.evernote.com/shard/s366/sh/3706ad89-b65d-440e-90a3-b77cdf43ada6/a1e1d26f754f1181994c0644c98addf7

You should probably have heard of the word Nda consultants and you know that it is one of the new professions that have attracted the attention of several people, but do you really know who that professional is? Consultant is the professional who dominates a specific topic and uses his knowledge to help other people.

Today, there are several types of consultants in the market and the demand for these professionals is growing. In this text, we will explain in detail what that professional does and what skills a person needs to work in that area.

If you are interested in becoming an Nda consultant, these tips will help you discover if you have the profile and what you need to develop it.

If your idea is to hire a consultant for you or your company, we will show you exactly what you should look for when hiring.

What is the role of the consultant?

The objective of a consultancy, regardless of the area of action, is to assist the client in an issue that does not have enough knowledge to solve it for him. This client can be a company or a natural person, what defines it is the search for someone with authority in a niche of interest to respond to their needs.

The process can be done by a professional or a team composed of several consultants specialized in the field, which is common to find in large companies that provide advice or consulting.

The consultant's role is broad, but these are some of his main functions:

•             diagnose problems or aspects that can be optimized;

•             define the solutions and improvements that must be made;

•             set goals;

•             chart paths to achieve results.

The characteristics of a good consultant

A consultant must have some characteristics to carry out a good job. Without them, it is difficult to respond to the demands demanded by the work and become a professional reference in the area.

However, not everyone is born with all these skills, but most of them can be developed and perfected with much study, practice and experience.

Here are some features you need to have or develop to be a consultant:

1. be consistent

The consultant deals with people daily, so you need to have good communication to transmit your knowledge and guide customers in the best possible way.

If the work is intended for companies, you may have to face divergences between the objectives of the organization and the complaints of the employees, which demands even more articulation.

The consultant must have that ability to gain people's trust, transmit security, professionalism and understand exactly what he needs to do to deliver good results.

2. Have macro and systemic vision

Many times a consultant is hired to solve a specific problem. However, when you start the work you face several other issues that interfere with the final objective of the client. If you do not have a broad vision, you run the risk of working superficially, ignoring important aspects. The good consultant is one who sees his client or the company as a whole, considering all the ramifications of the problem identified and everyone involved in that situation.

3. Know your limits

It is important to remember that the consultant is someone with authority in his niche, but that does not mean he knows everything and cannot have doubts or difficulties.  Therefore, it is essential that you know how far you can go and when you have to ask for help or refuse a job. In addition, it is necessary that you also identify how far you can go during a consulting process without extrapolating what has been planned or what is consistent with the contracted service.

4. Involve everyone in a project

In the case of being 1 consultancy with more than one client, the consultant needs to have the necessary sensitivity to include everyone involved in the process. In a company, for example, it may be that hiring has occurred to implement a new project. Then, the consultant must carefully evaluate all organizational functioning, to understand which areas will be affected by the change.

After that diagnosis, you must have everyone participate in the process so that there are no failures when executing the defined actions. All people related to the area in question should feel valued and heard, because only then will they be motivated to contribute to business growth.

Source: 

https://pharmaceuticaldevelopmentgroup.home.blog/2019/11/11/know-about-quality-of-nda-consultants/

https://pharmdevgroup.hatenablog.com/entry/2019/11/11/160701

https://medium.com/@kellyshelton602/know-about-quality-of-nda-consultants-30dbf451da80?sk=60cf6e7c4ba6ab825973563ed1d749c3

http://pharmaceuticaldevelopmentservices.booklikes.com/post/1989821/know-about-quality-of-nda-consultants

https://www.evernote.com/shard/s366/sh/73da3bff-e032-4e8f-865b-1e59a6306e3e/ff9afd484e71ae299b55b4ccb8cda635

http://www.apsense.com/article/know-about-quality-of-nda-consultants.html

FDA proposes new guide for drug labeling

Founded in 1906, the Food and Drug Administration of the United States ( FDA ) is one of the oldest and most important regulatory agencies in the world regarding medicines and their proper functioning to protect people's health. However, the changes that are experienced daily have also forced it to be constantly updated.

In this way, the FDA update its proposal for a new guide on the characteristics of the labels of the medicines that are marketed in the United States. FDA drug labeling guidance that once approved will become the reference that all laboratories should adopt with their products.

Among the main changes proposed, the guide emphasizes that the indications on the label “must accurately reflect scientific evidence, as well as being written concisely to include the necessary information that clearly conveys the uses in which the drug has proven safe and effective. ”

Similarly, the terminology used must be "clinically relevant and scientifically valid and understandable to health professionals." In addition, the labeling must clearly specify the age groups indicated for the medication.

But in case you are interested in knowing the document in full with the proposed new FDA guide , you can do so at the following link.

Drug labeling

The Nutrition Information Label is found on packaged foods and beverages, and can serve as a daily guide for comparing foods and choosing healthy products.

The Food and Drug Administration of the United States (FDA) has launched a virtual tool that facilitates reading further facilitates the reading and interpretation of the information included in the food nutrition information label.

According to the written communication, the FDA's new online tool provides an overview of the nutrition label and an analysis of each nutrient and its role in their daily diet.

In addition, practical recommendations are constantly offered that simplify the FDA's advice on the use of the label to make informed decisions and control those nutrients that we could consume from " more " or " less ."

Information on the nutrition label

Know the various sections of the label and focus on those nutrients that interest you most. Each of them will include information on what it is, where it is located, what it is for and how it relates to your daily diet.

List of ingredients

Find tips for using the list of ingredients found in food and beverage packaging (almost always under the Nutrition Facts Label). The ingredient list helps identify whole grain ingredients, saturated fats and added sugars.

Nutritional glossary

Review common terms related to nutrition, organized in alphabetical order and with simple definitions.

Means

Browse with useful links to additional information from the FDA and other government agencies. This information will help you to continue researching nutrition issues.

Downloadable Information

Download nutritional information you can print to save and share. Download the package of materials or only those dedicated to the elements of the Nutritional Information Label that are of your particular interest.

The new Virtual Nutrition Information Label tool gives you a unique overview of the Nutritional Information Label and each of its elements. Discover and save this new interactive tool in your " favorites" for use in planning your meals and also use it as a reference on your mobile device when shopping.

By using new online tool you will become familiar with the Nutrition Information Label and be able to compare food and beverages, and be more informed to make better nutritional decisions for you and your family.

Why is the FDA approval process important?

FDA approval by FDA regulatory consultants is important because it validates the need for research studies on how drugs work in children, not just adults. It also allows us to determine the appropriate dose for children, determine the best way to administer them and evaluate any interaction between medications.

How does a medication or device achieve FDA approval?

For a medication or medical device to receive FDA approval, the manufacturer must prove to the FDA that the product is safe and effective. Although there is no risk-free medication or medical device, research studies and tests must show that the benefits of the medication or device for a certain condition outweigh the risks that the patient may take when using the product.

Source:


https://pharmaceuticaldevelopmentgroup.home.blog/2019/11/06/fda-proposes-new-guide-for-drug-labeling/

https://pharmdevgroup.hatenablog.com/entry/2019/11/05/151250

https://medium.com/@kellyshelton602/fda-proposes-new-guide-for-drug-labeling-920e891ade11

http://pharmaceuticaldevelopmentservices.booklikes.com/post/1985269/fda-proposes-new-guide-for-drug-labeling

https://www.evernote.com/shard/s366/sh/4775d2d1-f176-4dd8-bdc3-46061b9cb3a5/a0db078677ede8c9d7c0399655a14bc4

http://www.apsense.com/article/fda-proposes-new-guide-for-drug-labeling.html

Know how Food and Drug Administration of the United States work

The Food and Drug Administration of the United States ( FDA ) is one of the oldest and most important regulatory agencies in the world regarding medicines and their proper functioning to protect people's health. However, the changes that are experienced daily have also forced it to be constantly updated.

The FDA (Food and Drug Administration) has published a guide for the pharmaceutical industry with the aim of providing more clarity on the development of generic drugs . Specifically, it collects information on how companies should proceed to request the designation of competitive generic therapies (CGT)

In addition to taking appropriate measures to improve the competence of generics, the FDA is working to make the development of these drugs more efficient . Along these lines, the organization studies reducing approval times and providing greater transparency.

The following is a brief description of the steps necessary to achieve drug labeling FDA approval:

• Making a medicine: A company do generic drug product development  and requests FDA approval to sell it in the United States.

• Animal testing: Before assessing the medication in people, the company should test the new medication in animals to see if there is a likelihood of causing serious harm (for example, toxicity).

• IND request (for research of a new drug) The company submits a request for research of a new drug (IND) to the FDA based on the initial results of animal tests. These results should include the composition of the drug and the manufacturing and the proposed plan for the evaluation of the product in people.

• Clinical trials: After the FDA evaluates and approves the request for research of a new drug (IND), clinical trials with people can be initiated . There are 4 phases for clinical trials, beginning with small-scale trials and followed by large-scale trials. After clinical trials, the researchers present the study reports to the FDA.

• Request for a new drug (NDA) Once the drug manufacturer submits evidence that it is safe and effective, the company can submit the request for a new drug (NDA). The FDA reviews the request and makes the decision to approve or not approve the medication.

• Medication labeling : The FDA reviews the labeling or labeling to make sure that it communicates correct and appropriate information to health professionals and their consumers. 

• Facilities inspection : The FDA inspects the facilities where the medication will be manufactured.

• Medication approval: The FDA approves the NDA application (request for a new drug) and sends a response letter.

• Post-marketing monitoring: Once the FDA approves the medication, it requires companies to undergo FDA safety inspections regularly.

               

FDA proposes new guide for drug labeling

Among the main changes proposed, the guide emphasizes that the indications on the label “must accurately reflect scientific evidence, as well as being written concisely to include the necessary information that clearly conveys the uses in which the drug has proven safe and effective. ”

Similarly, the terminology used must be "clinically relevant and scientifically valid and understandable to health professionals." In addition, the labeling must clearly specify the age groups indicated for the medication.

FDA approval

When pharmaceutical companies develop a new medication, they conduct a series of studies to ensure that the medication is safe and effective before it can be sold and prescribed. Medications may be approved for:

•             A specific disease or group of diseases

•             People of a specific age

•             A specific problem (for example: pain)

•             A specific condition, such as obesity or pregnancy

Once the medication is approved by the FDA for a particular use, doctors can decide whether it is appropriate to use it in other patients. This is called prescribing medication for use “outside of what is indicated on the label” (“off-label” in English). It is called "outside the label" because the label of a medication indicates for which use it has been approved by the FDA.

Prescribing outside the label is quite common. There are many medications with uses outside the indicated that the doctors agree are effective and present no risks. Once a drug is approved for single  use , the company does not usually bother to be approved  again . The process costs a lot of money.

Source: 

https://pharmaceuticaldevelopmentgroup.home.blog/2019/11/05/know-how-food-and-drug-administration-of-the-united-states-work/

https://pharmdevgroup.hatenablog.com/entry/2019/11/05/151250

http://pharmaceuticaldevelopmentservices.booklikes.com/post/1984166/know-how-food-and-drug-administration-of-the-united-states-work

https://medium.com/@kellyshelton602/know-how-food-and-drug-administration-of-the-united-states-work-47fdd96ffa50

https://www.evernote.com/shard/s366/sh/a37676fd-705d-4437-a6af-1bfceafd852b/74d6b16b47d76aa16e70bd0a79a78d82