FOIA allows release of documents from the government

Description: This Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute

What is FOIA?

The Freedom of Information Act (FOIA) represents the implementation of freedom of information legislation in the United States.It was signed into law by President Lyndon B. Johnson on July 4, 1966 and subsequently has been amended in 1996, 2002, 2007. This act allows for the full or partial disclosure of previously unreleased information and documents controlled by the United States Government. This Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute

Background

With the stress on constitutional rights for information, it was considered important to make government information available to the public.  However since some of the information was sensitive and need not necessarily be known by the general public, this law was enacted. The belief was that the people have the ‘right to know’ about government information and could place a request for such information.

Applicability

The act explicitly applies only to executive branch government agencies. These agencies are supposed to declare the process for requesting the information or documents pertaining to the information.  This act also specifies the legal recourse in case the executive agency does not comply with the requirements of the act.

Exemptions

There are nine exemptions to the act and there are several areas of discrepancy in these exemptions. These exemptions were brought about to address the issues of sensitivity and personal rights.

Here are the exemptions

1. Executive orders kept secret in the interest of national defense or foreign policy

2.Records that are solely related to the internal personnel rules and practices of agovernment agency

3. Information that is specifically exempted from disclosure by the legislative statutes

4. Privileged or confidential commercial or financial information and trade secrets

5. Anyinter-agency or intra-agency communication in the form of memoranda or lettersthat is otherwise not available by law to any party other than the ones that are a party to litigation.

6.Files containing personnel information or medical information the disclosure of which can constitute invasion of privacy.

7. Information records compiled for the purpose of law enforcement the disclosure of which

  1. could interfere with enforcement proceedings,
  2. could constitute invasion of privacy,
  3. could disclose identity of a person, state, nation or other entities that disclose information on a confidential basis,
  4. is related to criminal law enforcement,
  5. intelligence information,
  6. information about the techniques of law enforcement the disclosure of which could support or assist in circumvention of the law and
  7. information that can endanger the life or physical safety of an individual.

8. Information related to the regulation or supervision of a financial institution.

9.Certain confidential geological and geophysical information and data including maps.

API is the biologically activesubstance in a drug

A pharmaceutical drug consists of the API and the excipient, the inert substance

 

Introduction: Active Pharmaceutical Ingredient

An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that is biologically active. Some medications may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon which originally denoted a magical substance or drug.

Drug Ingredients

A drug in the dosage form consists of two ingredients: One is the API, which is the drug itself, this is the ingredient that treats or relieves the symptoms of the specific medical conditions; the second ingredient is a substance that acts as filler in order to give volume and substance to the tablet or drug. It is called as an excipient, which is the liquid the API is suspended in or is the substance of the tablet. The excipient is a pharmaceutically inert substance.

Every drug is defined based on its active pharmaceutical ingredient. It is important to understand the compatibility of API of one drug with that of the other, because when patients are on multiple medications, these API can interfere with each other. This could have effects ranging from minor side effects to serious repercussions such as life threatening complications.

Pharmaceutical Drugs vs. Herbal Medicines

The APIs are what differentiate a pharmaceutical drug from herbal medicines. In case of herbal medicines, the API are not identified, or there are more than one APIs and in most cases, these APIs although identified cannot be recreated through chemical or laboratory methods. This prevents standardization of herbal medicines; in many cases clinical trials do not provide substantial evidence of positive, or for that matter, any negative effect of a suspected API in herbal medicines.Thus further leads to complications in labeling. Due to non-existence of a standard dosage or identified API, the drug effects are interpreted haphazardly and lose objectivity.

Importance of API

APIs are the essence of pharmaceutical market and, for that matter, global healthcare. While there are several challenges faced by API manufacturing companies in terms of standardization and compliance requirements, there is equally good number of opportunities such as improved credibility and ability to penetrate global markets.

API Awareness

Due to the increased awareness of APIs, and their importance, potential effects and side effects, several online services have come up with information identifying the APIs in pharmaceutical medication. An example is the following website.  The authenticity of information on this website is not guaranteed.

 

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Nutraceuticals are foods that provide medical or health benefits

Description: Since nutraceuticals are preventives, FDA is less stringent in enforcing regulations on nutraceuticals than on drugs

What are Nutraceuticals?

 Definition

Nutraceuticals are defined as food or parts of food that provide medical or health benefits, including the prevention and treatment of disease.  The term ‘nutraceuticals’ combines nutrition and pharmaceutical.

isolated nutrients, herbal products, and processed foods such as cereals, dietary supplements and specific diets,  genetically engineered foods, soups, probiotics, antioxidants, phytochemicals,fortified food products and beverages all fall in the category of nutraceuticals. The term nutraceuticals was originally defined by Dr. Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine (FIM), Crawford, New Jersey

The medicinal components of food are simple or complex chemical components which are derived from plant, food, and microbial sources. These are known to provide medicinal benefits as part of the food and are valuable to long-term health.

Categories of Nutraceuticals

Some of the important categories of nutraceuticals are

  1. Dietary supplements including botanicals such as vitamins,carotene, minerals, and co-enzyme Q, Ginseng, Gingko Balboa and Saint John’s Wort.
  2. Functional foods such as oats, bran, Probiotics like oligo-fructose used for control of intestinal problems, Omega-3 used in prevention of heart disease, Canola oil for cholesterol reductionand Stanolshelp in the reduction of cholesterol absorption.
  3. Medicinal foods:lacto-ferine for immunityenhancement,transgenic plants for oral vaccination against infectious diseases.
  4.  Some of the other food that is being used for its medicinal value since ancient history areantioxidants such as grapes, flavonoids in citrus fruits, wine, dark chocolate and tea as well asanthocyanin found in berries.

Regulations and the FDA

Unlike pharmaceutical drugs, there are no standard regulations that guide the nutraceuticals industry and nutraceutical products. These are considered under the bracket of dietary supplements for all regulatory purposes.

Nutraceuticals foods are not subject to the stringent testing and regulations as pharmaceutical drugs. The American Nutraceuticals Association works with the Food & Drug Administration in developing industry and scientific standards for products and manufacturers,consumer education, and other related consumer protection roles. The FDA alerts the public as well as the providers about the dietary supplement companies receiving warning letters about their products.

Nutraceuticals – Future

In 2005, the National Academies Institute of Medicine and National Research Council created a blue-ribbon committee to create an improved framework for the Federal Food & Drug Administration to evaluate dietary supplements. Even the improved framework fails to distinguish between “nutraceuticals” and “dietary supplements”. Regulations in this direction are yet to be formulated.

Nutraceuticals are foods that provide medical or health benefits

Description: Since nutraceuticals are preventives, FDA is less stringent in enforcing regulations on nutraceuticals than on drugs

What are Nutraceuticals?

 Definition

Nutraceuticals are defined as food or parts of food that provide medical or health benefits, including the prevention and treatment of disease.  The term ‘nutraceuticals’ combines nutrition and pharmaceutical.

isolated nutrients, herbal products, and processed foods such as cereals, dietary supplements and specific diets,  genetically engineered foods, soups, probiotics, antioxidants, phytochemicals,fortified food products and beverages all fall in the category of nutraceuticals. The term nutraceuticals was originally defined by Dr. Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine (FIM), Crawford, New Jersey

The medicinal components of food are simple or complex chemical components which are derived from plant, food, and microbial sources. These are known to provide medicinal benefits as part of the food and are valuable to long-term health.

Categories of Nutraceuticals

Some of the important categories of nutraceuticals are

  1. Dietary supplements including botanicals such as vitamins,carotene, minerals, and co-enzyme Q, Ginseng, Gingko Balboa and Saint John’s Wort.
  2. Functional foods such as oats, bran, Probiotics like oligo-fructose used for control of intestinal problems, Omega-3 used in prevention of heart disease, Canola oil for cholesterol reductionand Stanolshelp in the reduction of cholesterol absorption.
  3. Medicinal foods:lacto-ferine for immunityenhancement,transgenic plants for oral vaccination against infectious diseases.
  4.  Some of the other food that is being used for its medicinal value since ancient history areantioxidants such as grapes, flavonoids in citrus fruits, wine, dark chocolate and tea as well asanthocyanin found in berries.

Regulations and the FDA

Unlike pharmaceutical drugs, there are no standard regulations that guide the nutraceuticals industry and nutraceutical products. These are considered under the bracket of dietary supplements for all regulatory purposes.

Nutraceuticals foods are not subject to the stringent testing and regulations as pharmaceutical drugs. The American Nutraceuticals Association works with the Food & Drug Administration in developing industry and scientific standards for products and manufacturers,consumer education, and other related consumer protection roles. The FDA alerts the public as well as the providers about the dietary supplement companies receiving warning letters about their products.

Nutraceuticals – Future

In 2005, the National Academies Institute of Medicine and National Research Council created a blue-ribbon committee to create an improved framework for the Federal Food & Drug Administration to evaluate dietary supplements. Even the improved framework fails to distinguish between “nutraceuticals” and “dietary supplements”. Regulations in this direction are yet to be formulated. 

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Glucose Testing Devices are used to measure the blood sugar level

Description: Good glucose control using home monitors lead to fewer complications

Introduction

Glucose Testing Devices are the devices used to measure the blood sugar (glucose) level.  Blood sugar is glucose that is a source of energy to the body. Generally the body regulates the amount of glucose in the blood with the help of insulin, however if the body is unable to regulate the glucose level, the person’s condition can be hypoglycemic, hyperglycemic or diabetic.

Glucose Testing Devices

Most store-bought glucose testing devices are home-use test kits. These devices use a quantitative method to find out the amount of glucose present in a blood sample. The results help in determining the periodic adjustments in treatment. With these tests one can know if the level of glucose is dangerously high or low and monitor the effect of dietary control on the blood glucose level.

In recent years more and more diabetics use the glucose testing devices and The Diabetes Control and Complications Trial of 1993 (http://diabetes.niddk.nih.gov/dm/pubs/control/) also has shown that good glucose control using home monitors led to fewer complications.

Usage

In general, most devices require the patient to prick the fingertip with a lancet to get a drop of blood. This blood is then placed on a disposable “test strip” which is coated with chemicals that react with glucose in the blood. Then the test strip is placed into the device meter and the meters report results in milligrams of glucose per deciliter of blood or mg/dl.

The treating physicians specify how often one should test ones glucose level. The standard levels for fasting blood glucose level (fasting for 8-10 hours) should be lower than 126 mg/dL and the blood glucose level immediately after eating food should be lower than 200 mg/dL.

Accuracy

The accuracy of these devices varies based on the quality of the device, the test strips, and also on ones RBC count.

Interfering substances

Some substances, such as Vitamin C and uric acid, or certain medication for co-morbidities, certain ingredients of the food, may interfere with the glucose testing and thus alter the results. Altitude, temperature, and humidity are some of the environmental factors that affect the glucose test results are

Glucose testing devices available in the market differ basically in the ease of use, accuracy, testing speed, overall size, ability to store test results in memory, cost of the device and variety of test strips.

Home Test Results vs. Laboratory Test Results

Most home blood glucose meters measure glucose in whole blood whereas most lab tests measure glucose in plasma.  The lab test results may be 10-15% higher than the home test results. Some home test devices these days give values that are plasma equivalent.

Compliance means conforming to set standards

Description: Compliance is monitored by the bodies that enact different compliance standards and laws.

Understanding the Idea of Compliance

 

What is compliance?

Compliance means conforming to set standards, or rules and regulations or abiding by the laws of the land. While some compliance standards like the ISO focus on adhering to standard procedures, some others require adheringto quality or safety standards, and a host of others like HIPAA and banking standards may require all the above.

Compliance can be a ‘state of being’ or the ‘the process of’ adhering to compliance standards’.For example: A ‘Standards body’ like the Institute of Electrical and Electronics Engineers (IEEE) may specify software development standards, this is the ‘process’ of adhering to rules. Now, if the software is distributed in compliance with the vendors licensing agreement, this is ‘being’ in accordance with rules.

Need for compliance

Formulation of compliance standards is rooted in several factors and events in the past and has evolved over time. Some standards are set keeping future possibilities in view. The factors and purposes that have influenced the need for compliance standards are:

  1. Ethical, safety, accountability, transparency and traceability reasons
  2. To ensure quality of products and services
  3. For documentation and review purposes
  4. To prevent possible legal hassles
  5. For performance analysis or other statistical analysis
  6. To incorporate Best Practices and for the common good

Types of compliance

There are several types of compliance standards for specific fields like corporate, healthcare, banking, patient, clinical, Human Resources, food safety, trade and logistics, regulatory and quality compliance and more.

Monitoring compliance

Compliance is monitored by the bodies that enact different compliance standards and laws. While some are government bodies like the HIPAA regulatory body and FDA for drug administration and compliance, there are several independent bodies that monitor other compliance standards, such as the ISO, IEEE and others.

Advantages of compliance

  1. Compliance standards help in inculcating ethical, fair and best practices
  2. By adhering to compliance standards in manufacturing and servicing, one can bring about consistency in products and performance
  3. Avoids redundancy, misunderstanding, misinterpretation and litigation
  4. Protects the rights of all stakeholders
  5. Checks wastage, misuse or misappropriation of funds or material or power
  6. Prevents scams, scandals, and data theft, and ensures safety, security and privacy of data  and builds reputation
  7. Helps in easy supervision due to a standardized system being in place.

Non-compliance

Non- compliance is failure or refusal to comply with the set standards. This may lead to

  1. Fines or penalties by the governing bodies
  2. Compliance certificate getting cancelled
  3. Litigation and bad reputation
  4. Financial loss or loss of business
  5. Inspections and checks from other governing bodies
  6. Getting Business license cancelled or privileges scrapped off

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

: In vitro diagnostics are performed outside the living organism in a controlled environment

Description: These are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms

Understanding In-Vitro Diagnostics

In vitro diagnostics: Introduction

The word ‘invitro’ means ‘in glass’ in Latin. In vitro diagnostics are performed outside the living organism in a controlled environment, generally in a test tube.  The diagnostic tests can include simple blood cell count to sophisticated DNA technology applications. These tests are generally conducted in pathology laboratories of hospitals, drug development facilities and other research facilities.

In Vitro Diagnostic Device

In Vitro Diagnostic Devices are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms. These samples could be blood, tissue, urine, or other pus cells that are taken from the living organism, generally human beings. A detailed observation of these samples for the content and the quantity or count of different contents helps in identifying a medical condition, or in identifying the severity of the medical condition. These diagnostics devices can also be used to check the effects of medication or other treatments on a medical condition.  IVD devices include reagents, calibrators, specimen receptacles, meters, control materials, software, kits and many other related instruments.

IVD Disciplines

There are several IVD disciplines such as clinical chemistry, haemostasis, haematology, molecular diagnostics, immunochemistry, and microbiology. The focus area of each of these disciplines is different although all of them aim at infection detection, diagnosis or prevention of medical conditions as well as drug therapy monitoring. IVD diagnostic techniques are extensively used in research and drug formulation.

Specimen Receptacle

Specimen receptacles are the devices that contain and preserve the specimens or samples derived from the human body. These are specifically designed and manufactured with the intention of being put to use for in vitro diagnostic examination. 

Common InVitro Tests

Common tests include liver enzymes, blood tests for glucose, levels of electrolytes such as calcium, sodium, and potassium, thyroid tests, blood composition tests, lipid profile, and tests for drugs.

In Vitro Diagnostic Directive (IVDD)

The Directive 98/79/EC by the European Parliament and the Council has brought about In Vitro Diagnostics Directive which specifies regulatory requirements  for compliance following which the product can be allowed for CE marking. This is important for manufacturers to gain access to the markets in the European Economic Area (EEA). This is done in order to safeguard patient’s health and safety and to ensure that the product meets the required quality standards and performs as intended.

Indispensible IVD

IVD diagnostics has become an essential and indispensible part of global health care. Rapid technological advancement , increased awareness about healthcare as well as improved drug development techniques have all contributed to make in vitro diagnostics an important part of healthcare industry.

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884