Understanding US Food and Drug Administration Recalls

The Food and Drug Administration, the agency n charge of regulating the safety of drugs is the Food and Drug Administration, is empowered by the US government to review the application of a pharmaceutical company to manufacture and release to the market any new drug it develops. The FDA also can issue a recall for any drugs that it deems dangerous for consumers. It also issues valuable safety information so that the general public would know about which drug is unsafe to use.

Sometime, however, the important safety information which is being issued regularly by the Food and Drug Administration can be a little bit confusing. It is sometimes full of technical jargon that the consumer tends to get lost in the meaning of the words and paragraphs and some mistakes are made because of this.

To put it more clearly, the FDA can order a pharmaceutical company to recall what it deems as a dangerous drug that is being distributed in the market. The pharmaceutical company can also do it voluntarily if it finds out that the drugs in question are causing major side effects.

As soon as the recall is made by the FDA, the pharmaceutical companies must take full responsibility with regards to the pullout of these dangerous drugs and it also thoroughly checks that all the drugs in question are taken off the shelves. The pharmaceutical companies should also inform the FDA on the progress of the recalls until all the dangerous drugs are pulled out from the market.

During the drug recall, the FDA assumes the role of a monitoring agency and to ensure that the pharmaceutical company is following all the necessary procedures in pulling out all the drugs which have been found to cause serious side effects. After all the drugs have been pulled out, the FDA then would conduct an investigation on why the drug in question was defective and to supervise the destruction of all the recalled drugs or to make sure that the drugs are suitably reconditioned before they are reintroduced to the market.

There are three recall categories and these are Class I, Class II or Class III. In a Class I recall, the FDA finds that the drugs in question are causing serious side effects and a probable serious or fatal injury to the user exists and the drug has to be pulled out right away from the market. The Class II recall tells of a probability of injury to the user although not necessarily fatal but still one that can cause permanent damage to the user. The Class III injury meanwhile tells of a lesser, albeit, probable health risks which is why the drug is being recalled.

The United States Food and Drug Administration and NAFTA

The North American Free Trade Agreement (NAFTA) helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. NAFTA is an agreement between Canada, the US and Mexico that took effect on January 1, 1994, designed to increase the scope for the free flow trade and investment among these three countries. The US Food and Drug Administration (US FDA), which participated in the negotiation of NAFTA, has reviewed the US Food and Drug Administration standards for safety, purity and appropriate labeling of foods and has determined that these standards are consistent with the terms of the agreement. This is why no changes in US Food and Drug Administration standards are needed or proposed to implement NAFTA.

NAFTA does not change existing or future US Food and Drug Administration standards regarding pesticide use or pesticide and other chemical residue or contaminant standards for fresh or processed foods. NAFTA provisions safeguard the ability of the US Food Drug Administration to ensure food safety. In short, existing US Food and Drug Administration standards will continue to be applied to imported foods as well as domestically produced foods. This means that the U.S. will continue to prohibit any food shipments determined not to meet pesticide residue or other food safety requirements.

NAFTA has no effect on U.S. Food and Drug Administration laws and regulations in the area of safety, effectiveness, and appropriate labeling of human and animal drugs and medical devices. Any products coming into the U.S. must continue to meet all US FDA standards and requirements.

Additionally, NAFTA does not change or affect US Food Drug Administration laws and regulations with respect to US Food and Drug safety and appropriate labeling of dietary supplements imported in to the U.S.

U.S. FDA and TWG

Within the auspices of the NAFTA, the three countries have developed a technical working group on pesticides called TWG. It serves as a focal point for all issues related to pesticides for these countries. TWG's aim is to ensure that the countries can be assured of the legality and safety of foods produced in any of the NAFTA countries. US food and drug administration is providing trilateral cooperation between Mexico and Canada to enforce the TWG standards.

Article 723(6) makes explicit that any party challenging a U.S. Food and Drug Administration safety measure would have the burden of showing that the US Food and Drug measure is inconsistent with NAFTA. Whether any particular level of protection is "appropriate" is a social and political judgment that the agreement reserves for the government applying the measure (see Articles 712(2) and 724). As provided in Article 712, a sanitary measure is to be based on a risk assessment "as appropriate to the circumstances," and is not to be maintained where there is no longer a scientific basis for it. US Food and Drug Administration standards are already based on risk assessments and have a scientific basis. These NAFTA requirements help assure that measures applied by the other parties will not unfairly exclude U.S. food exports.

Routes of Drug Administration

Introduction: Route of administration is an important factor which influences the absorption of a drug. The interval between administration and onset of action is determined by the route of administration. Biological lag is the interval between administration of a drug and development of response.

Classification of routes: The routes of drug administration can be classifies as:

Oral or enteral route: It is most commonly used route for drug administration.

Advantages of oral route:

1. It is a safe, convenient and economical route.

2. Self medication is possible.

3. Withdrawal of the drug is possible.

Disadvantages of oral route:

1. Onset of drug action is slow.

2. Drugs which are bitter in taste cannot be administered.

3. Drugs producing nausea and vomiting cannot be administered.

4. The drug may be inactivated by gastric enzymes.

5. This route is not possible in an unconscious patient.

Enteric coated pills and tablets: These are oral preparations coated with cellulose acetate or gluten. These coatings cannot be destroyed by the acid juice of the stomach. Only the alkaline intestinal juice removes these coatings. So inactivation of the drug in the stomach is avoided. Thus a desired concentration of the drug is released in the intestine.

Sustained release or time release preparations (Spansules): These are oral preparations containing various coatings. Each coating dissolves at different time intervals releasing the active drug. So the drug is released slowed for prolonged periods.

Parenteral routes: Routes of administration other than oral (enteral) route are termed as parenteral.

Advantages of parenteral route:

1. Absorption is rapid and quick.

2. Accurate dose of the drug can be given.

3. The drug enters into circulation in an active form.

4. It is useful in emergency.

5. It is useful in case of an unconscious patient.

Disadvantages of parenteral route:

1. Pain may be produced by injection.

2. Abscess procedures are required for injection.

3. Sterile procedures are required for injection.

4. It is an expensive route.

5. Self medication is not possible.

a. Injection

1. Intradermal: The drug is injected in the layers of skin e.g. B.C.G vaccine.

2. Subcutaneous: Non-irritant substance alone can be injected by this route. The rate of absorption is even and slow and hence the effect is prolonged.

3. Intramuscular: The drug is injected deep into muscle tissue. The rate of absorption is uniform and onset of action is rapid.

4. Intravenous: A drug is directly injected into a vein.

Advantages:

(i) The drug enters into circulation in an active form.

(ii) Desired blood concentration can be obtained.

(iii) Quick and immediate effect is produced.

(iv) It is useful in case of emergency.

(v) It is useful in an unconscious patient.

Disadvantages:

(i) Drugs which precipitate blood constituents cannot be administered.

(ii) Untoward reactions, if occur are immediate.

(iii) Withdrawal of the drug is not possible.

5. Intra-arterial: In this route, a drug is injected into an artery. The effect of a drug can be localized in a particular organ or tissue by choosing the appropriate artery. Anticancer drugs are sometimes administered by this route.

6. Intraperitoneal: In this route, a drug is injected into the peritoneal cavity. By this, fluid like glucose and saline can be given to children.

7. Bone - marrow: Bone marrow injection is very similar to intravenous injection. This route is useful when veins are not available due to circulatory collapse or thrombosis. In adults, the sternum is chosen and in children, tibia or femur is chosen for injection.

b. Inhalation: Gases, volatile liquids, aerosols or vapours can be administered by this route.

Advantages:

1. Immediate absorption of the drug.

2. Localization of the effect in diseases of the respiratory tract.

Disadvantages:

1. Poor ability to regulate the dose.

2. Local irritation of the respiratory tract may increase its secretions.

3. Difficulty in the method of administration.

c. Transacutaneous route: It is further classified as

i) Iontophoresis

ii) Inunctions

iii) Jet injection

iv) Adhesive units.

i) Iontophoresis: In this method, a drug is driven deep into the skin by means of a galvanic current e.g. salicylates. Anode iontophoresis is used for positively charged drugs and cathode iontophoresis is use for negatively charged compounds.

ii) Inunction: It is rubbing the drug on the skin. The drug gets absorbed and produces systemic effect e.g. nitroglycerine ointment for angina.

iii) Jet injection: This method does not require a spring. So it is painless. Using a gun like instrument with a micro-fine orifice, the drug solution is projected as a high velocity jet (dermojet). The drug solution passes through superficial layers of skin and gets deposited in the subcutaneous tissue. This method is useful for mass inoculation.

iv) Adhesive units: It is a trans-dermal drug delivery system. It is available in the form of adhesive unit. It delivers the drug slowly. So it produces prolonged systemic effect. e.g. scopolamine for motion sickness.

d. Transmucosal route: It is further classified as

A) Sub-lingual

B) Trans-nasal

C) Trans-rectal.

A) Sub-lingual route: A tablet containing the drug is put under the tongue and allowed to dissolve in the mouth e.g. nitroglycerine and isoprenaline.

Advantages of sub-lingual route:

1. Rapid onset of action.

2. Termination of the effect by spitting the tablet.

3. Inactivation of the drug in the stomach is avoided.

4. The drug enters directly into systemic circulation without inactivation in the liver.

B) Trans-nasal route: It is useful for drugs in the form of snuff or nasal spray. The drug is readily absorbed through the mucous membrane of nose. e.g. posterior pituitary powder.

C) Trans-rectal route: Drugs can be absorbed through the rectum for producing systemic effects. e.g. aminophylline for broncho-spasm, diazepam for status epileptic-us. Advantages of rectal route are:

1. Gastric irritation is avoided.

2. It is useful in old and terminally ill patients.

e. New drug delivery systems:

i) Occusert: It is placed directly under the eyelid. It can release drugs like pilocarpine for prolonged periods.

ii) Progestasert: It is an intrauterine contraceptive device. It produces controlled release of progesterone within the uterus for a year.

iii) Pro-drug: It is an inactive drug which after administration is metabolized into an active drug. For example, I-dopa is an inactive compound. After administration, it is metabolized to the active drug dopamine which is effective in Parkinson.

Local application: Drugs in the form of powder, paste, lotion, drops and ointment can be applied locally for action at the site of application. Drugs can be applied on mucous membranes of nose, conjunctiva, vagina, urethra and rectum. The following are some preparations which are meant for local application:

1. Bougie for urethra.

2. Pessary for vagina.

3. Suppository for vagina and rectum.

4. Enemata for rectum.

Understanding US Food and Drug Administration Recalls

The Food and Drug Administration, the agency n charge of regulating the safety of drugs is the Food and Drug Administration, is empowered by the US government to review the application of a pharmaceutical company to manufacture and release to the market any new drug it develops. The FDA also can issue a recall for any drugs that it deems dangerous for consumers. It also issues valuable safety information so that the general public would know about which drug is unsafe to use.

Sometime, however, the important safety information which is being issued regularly by the Food and Drug Administration can be a little bit confusing. It is sometimes full of technical jargon that the consumer tends to get lost in the meaning of the words and paragraphs and some mistakes are made because of this.

To put it more clearly, the FDA can order a pharmaceutical company to recall what it deems as a dangerous drug that is being distributed in the market. The pharmaceutical company can also do it voluntarily if it finds out that the drugs in question are causing major side effects.

As soon as the recall is made by the FDA, the pharmaceutical companies must take full responsibility with regards to the pullout of these dangerous drugs and it also thoroughly checks that all the drugs in question are taken off the shelves. The pharmaceutical companies should also inform the FDA on the progress of the recalls until all the dangerous drugs are pulled out from the market.

During the drug recall, the FDA assumes the role of a monitoring agency and to ensure that the pharmaceutical company is following all the necessary procedures in pulling out all the drugs which have been found to cause serious side effects. After all the drugs have been pulled out, the FDA then would conduct an investigation on why the drug in question was defective and to supervise the destruction of all the recalled drugs or to make sure that the drugs are suitably reconditioned before they are reintroduced to the market.

There are three recall categories and these are Class I, Class II or Class III. In a Class I recall, the FDA finds that the drugs in question are causing serious side effects and a probable serious or fatal injury to the user exists and the drug has to be pulled out right away from the market. The Class II recall tells of a probability of injury to the user although not necessarily fatal but still one that can cause permanent damage to the user. The Class III injury meanwhile tells of a lesser, albeit, probable health risks which is why the drug is being recalled.

The United States Food and Drug Administration and NAFTA

The North American Free Trade Agreement (NAFTA) helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. NAFTA is an agreement between Canada, the US and Mexico that took effect on January 1, 1994, designed to increase the scope for the free flow trade and investment among these three countries. The US Food and Drug Administration (US FDA), which participated in the negotiation of NAFTA, has reviewed the US Food and Drug Administration standards for safety, purity and appropriate labeling of foods and has determined that these standards are consistent with the terms of the agreement. This is why no changes in US Food and Drug Administration standards are needed or proposed to implement NAFTA.

NAFTA does not change existing or future US Food and Drug Administration standards regarding pesticide use or pesticide and other chemical residue or contaminant standards for fresh or processed foods. NAFTA provisions safeguard the ability of the US Food Drug Administration to ensure food safety. In short, existing US Food and Drug Administration standards will continue to be applied to imported foods as well as domestically produced foods. This means that the U.S. will continue to prohibit any food shipments determined not to meet pesticide residue or other food safety requirements.

NAFTA has no effect on U.S. Food and Drug Administration laws and regulations in the area of safety, effectiveness, and appropriate labeling of human and animal drugs and medical devices. Any products coming into the U.S. must continue to meet all US FDA standards and requirements.

Additionally, NAFTA does not change or affect US Food Drug Administration laws and regulations with respect to US Food and Drug safety and appropriate labeling of dietary supplements imported in to the U.S.

U.S. FDA and TWG

Within the auspices of the NAFTA, the three countries have developed a technical working group on pesticides called TWG. It serves as a focal point for all issues related to pesticides for these countries. TWG's aim is to ensure that the countries can be assured of the legality and safety of foods produced in any of the NAFTA countries. US food and drug administration is providing trilateral cooperation between Mexico and Canada to enforce the TWG standards.

Article 723(6) makes explicit that any party challenging a U.S. Food and Drug Administration safety measure would have the burden of showing that the US Food and Drug measure is inconsistent with NAFTA. Whether any particular level of protection is "appropriate" is a social and political judgment that the agreement reserves for the government applying the measure (see Articles 712(2) and 724). As provided in Article 712, a sanitary measure is to be based on a risk assessment "as appropriate to the circumstances," and is not to be maintained where there is no longer a scientific basis for it. US Food and Drug Administration standards are already based on risk assessments and have a scientific basis. These NAFTA requirements help assure that measures applied by the other parties will not unfairly exclude U.S. food exports.

Routes of Drug Administration

Introduction: Route of administration is an important factor which influences the absorption of a drug. The interval between administration and onset of action is determined by the route of administration. Biological lag is the interval between administration of a drug and development of response.

Classification of routes: The routes of drug administration can be classifies as:

Oral or enteral route: It is most commonly used route for drug administration.

Advantages of oral route:

1. It is a safe, convenient and economical route.

2. Self medication is possible.

3. Withdrawal of the drug is possible.

Disadvantages of oral route:

1. Onset of drug action is slow.

2. Drugs which are bitter in taste cannot be administered.

3. Drugs producing nausea and vomiting cannot be administered.

4. The drug may be inactivated by gastric enzymes.

5. This route is not possible in an unconscious patient.

Enteric coated pills and tablets: These are oral preparations coated with cellulose acetate or gluten. These coatings cannot be destroyed by the acid juice of the stomach. Only the alkaline intestinal juice removes these coatings. So inactivation of the drug in the stomach is avoided. Thus a desired concentration of the drug is released in the intestine.

Sustained release or time release preparations (Spansules): These are oral preparations containing various coatings. Each coating dissolves at different time intervals releasing the active drug. So the drug is released slowed for prolonged periods.

Parenteral routes: Routes of administration other than oral (enteral) route are termed as parenteral.

Advantages of parenteral route:

1. Absorption is rapid and quick.

2. Accurate dose of the drug can be given.

3. The drug enters into circulation in an active form.

4. It is useful in emergency.

5. It is useful in case of an unconscious patient.

Disadvantages of parenteral route:

1. Pain may be produced by injection.

2. Abscess procedures are required for injection.

3. Sterile procedures are required for injection.

4. It is an expensive route.

5. Self medication is not possible.

a. Injection

1. Intradermal: The drug is injected in the layers of skin e.g. B.C.G vaccine.

2. Subcutaneous: Non-irritant substance alone can be injected by this route. The rate of absorption is even and slow and hence the effect is prolonged.

3. Intramuscular: The drug is injected deep into muscle tissue. The rate of absorption is uniform and onset of action is rapid.

4. Intravenous: A drug is directly injected into a vein.

Advantages:

(i) The drug enters into circulation in an active form.

(ii) Desired blood concentration can be obtained.

(iii) Quick and immediate effect is produced.

(iv) It is useful in case of emergency.

(v) It is useful in an unconscious patient.

Disadvantages:

(i) Drugs which precipitate blood constituents cannot be administered.

(ii) Untoward reactions, if occur are immediate.

(iii) Withdrawal of the drug is not possible.

5. Intra-arterial: In this route, a drug is injected into an artery. The effect of a drug can be localized in a particular organ or tissue by choosing the appropriate artery. Anticancer drugs are sometimes administered by this route.

6. Intraperitoneal: In this route, a drug is injected into the peritoneal cavity. By this, fluid like glucose and saline can be given to children.

7. Bone - marrow: Bone marrow injection is very similar to intravenous injection. This route is useful when veins are not available due to circulatory collapse or thrombosis. In adults, the sternum is chosen and in children, tibia or femur is chosen for injection.

b. Inhalation: Gases, volatile liquids, aerosols or vapours can be administered by this route.

Advantages:

1. Immediate absorption of the drug.

2. Localization of the effect in diseases of the respiratory tract.

Disadvantages:

1. Poor ability to regulate the dose.

2. Local irritation of the respiratory tract may increase its secretions.

3. Difficulty in the method of administration.

c. Transacutaneous route: It is further classified as

i) Iontophoresis

ii) Inunctions

iii) Jet injection

iv) Adhesive units.

i) Iontophoresis: In this method, a drug is driven deep into the skin by means of a galvanic current e.g. salicylates. Anode iontophoresis is used for positively charged drugs and cathode iontophoresis is use for negatively charged compounds.

ii) Inunction: It is rubbing the drug on the skin. The drug gets absorbed and produces systemic effect e.g. nitroglycerine ointment for angina.

iii) Jet injection: This method does not require a spring. So it is painless. Using a gun like instrument with a micro-fine orifice, the drug solution is projected as a high velocity jet (dermojet). The drug solution passes through superficial layers of skin and gets deposited in the subcutaneous tissue. This method is useful for mass inoculation.

iv) Adhesive units: It is a trans-dermal drug delivery system. It is available in the form of adhesive unit. It delivers the drug slowly. So it produces prolonged systemic effect. e.g. scopolamine for motion sickness.

d. Transmucosal route: It is further classified as

A) Sub-lingual

B) Trans-nasal

C) Trans-rectal.

A) Sub-lingual route: A tablet containing the drug is put under the tongue and allowed to dissolve in the mouth e.g. nitroglycerine and isoprenaline.

Advantages of sub-lingual route:

1. Rapid onset of action.

2. Termination of the effect by spitting the tablet.

3. Inactivation of the drug in the stomach is avoided.

4. The drug enters directly into systemic circulation without inactivation in the liver.

B) Trans-nasal route: It is useful for drugs in the form of snuff or nasal spray. The drug is readily absorbed through the mucous membrane of nose. e.g. posterior pituitary powder.

C) Trans-rectal route: Drugs can be absorbed through the rectum for producing systemic effects. e.g. aminophylline for broncho-spasm, diazepam for status epileptic-us. Advantages of rectal route are:

1. Gastric irritation is avoided.

2. It is useful in old and terminally ill patients.

e. New drug delivery systems:

i) Occusert: It is placed directly under the eyelid. It can release drugs like pilocarpine for prolonged periods.

ii) Progestasert: It is an intrauterine contraceptive device. It produces controlled release of progesterone within the uterus for a year.

iii) Pro-drug: It is an inactive drug which after administration is metabolized into an active drug. For example, I-dopa is an inactive compound. After administration, it is metabolized to the active drug dopamine which is effective in Parkinson.

Local application: Drugs in the form of powder, paste, lotion, drops and ointment can be applied locally for action at the site of application. Drugs can be applied on mucous membranes of nose, conjunctiva, vagina, urethra and rectum. The following are some preparations which are meant for local application:

1. Bougie for urethra.

2. Pessary for vagina.

3. Suppository for vagina and rectum.

4. Enemata for rectum.

Seek Help With Drug Rehabilitation Centers And Family

Hospitals are loaded with patients that have overdosed on addictive drugs; illegal and prescription. The trend has pointed upward at of the end of the last decade with no end in sight. Although the main culprit seems to be cocaine and heroin, legal drug abuse has taken on a new life. How can we hope to deal with all these kinds of drug abuse? There are many options available in this country thanks to the recognition of addictive personalities. Some people are in fact, born with inherent traits that make them easier targets for drug and alcohol abuse.

Knowing about addictive personalities is the first step toward resolving the various issues that come with this scenario. Over the years we have learned a few things about drug addiction and people prone to addiction, in fact, many of the top drug rehabilitation centers in this country are focused on exactly this type of situation. The staff members at these facilities are fully trained to help these personalities and help them cope with this undocumented disorder. There was a time when many people thought that people choose to be addicted to drugs and that stopping was just as easy as starting. We have matured since then and now we recognize different levels of addiction.

The fact remains that many of us are addicted to drugs whether we have addictive personalities or not. It just so happens that those born with certain traits are more prone to their addictions, thus; it is often much more difficult to break tough addictions. Daily treatment is necessary for extreme conditions and only a top notch drug rehabilitation clinic can provide this kind of attention.

We simply cannot ignore the cry for help addicts are shouting. Getting them help from drug rehabilitation clinics is only the beginning. The problem is only beginning to be looked at during this stage. Family and friends must take part in the recovery. If one of these elements is left out than it will be an extremely difficult battle for the user. Several support systems are needed to ensure any kind of success; it is up to you to do your part in helping your friends in need of drug rehabilitation. Many families dump their afflicted family member into these facilities and then let the magic happen; but full rehabilitation does not happen this way. Get involved by attending the center where they are being treated.