Generic medicines are those which contain the same active ingredient (the ingredient which acts to cure

the condition the medicine is used to treat) in the same quantity as a brand-name medicine. Generic
medicines therefore have the same effect on the body in terms of curing disease as the brand-name
medicines which they copy.
However, generic medicines are sold using a different name and may contain different inactive
ingredients (ingredients that give the product its taste, shape texture, smell, et cetera, but which do not
affect the body to relieve health conditions) compared with their branded counterparts. They should not be
confused with counterfeit medicines, which are illegally manufactured copies that may or may not contain
the same active ingredient.
The number of generic medicines being distributed in Australia is increasing. This is a move supported by
the government, who have implemented a number of strategies to encourage the use of generic medicines
because they are often cheaper than brand-name medicines. Use of generic medicines may also have cost
benefits for the consumer and for pharmacies.
Although the use of generic medication is becoming more widely accepted by Australian doctors and
consumers, many consumers in Australia (and overseas) have a mistrust of generic medicines.
Furthermore, use of generic medication is still a controversial issue amongst doctors.
The generic pharmaceutical industry is growing, and these medicines are likely to become more common in
Australia in the future. Increased education about generic medicines and the similarities and differences
between generic and brand-name medicines is needed to allow consumers to make informed choices
about which medicines they use. There is also a need for education regarding the testing that is carried out
to ensure generic medicines are safe and have the same effect on the body as the brand they copy (known
as therapeutic bioequivalence). Consumers also need to be aware of the risks that can be associated with
switching from branded to generic medicines or vice versa.

What are branded medicines?

A branded medicine is the original product that has been developed by a pharmaceutical company. When
a company develops a new medicine, their product must undergo and pass rigorous tests and evaluations
to ensure that it is both effective in curing the condition it claims to treat and safe for human use. Because
pharmaceutical companies invest considerable amounts of money to develop a new medicine, they are
given the sole right to manufacture and distribute the medicine for a period of time.
When a pharmaceutical company is given sole rights of manufacture and distribution, the medicine is said
to have a patent on it. A patent is a technical description of what the drug is and what it is used for. For a
period of time after the patent is granted, no one else can produce a drug that is the same as the patented
drug; the medicine belongs exclusively to the original company. For this reason, branded medicines are the
most well known and most trusted type of that particular medicine.

What are generic medicines?

A generic medicine is a copy of the original branded product. Once the patent for the original product has
run out, the pharmaceutical company who developed the medicine no longer has the exclusive right to
produce and distribute the medicine. Other pharmaceutical companies are able to create their own version
of the medicine.
The type and quantity of the active ingredient in the generic product is the same as the branded version,
but the inactive ingredients are slightly different. The generic medicine is sold under a different brand
name and it may look different (e.g. in colour or shape) to the original.
Pseudo-generic medicines
A pseudo-generic product is not a remake of the original; it is an exact replica of the original. It is made
by the same company with exactly the same ingredients in the same way. The only difference is the name
and packaging.

These medicines are usually marketed by the same manufacturer at the same price as the original.
Pharmaceutical companies make pseudo-generic products to combat true generics and to discourage
competitor pharmaceutical companies from entering the market for that particular medicine.

Fillers, binders and lubricants

The inactive ingredients in a medicine can include substances such as lactose, dyes and gluten. For the
majority of people, making changes to these ingredients does not change the effectiveness or safety of the
medicine. The differences in formulation and production will, however, change the appearance of the
medicine, for example the shape, colour, taste or texture. Changing the appearance of a medicine does not
change the effect it has on the body, although it may affect the ease with which a person takes the
medicine (e.g. how easy it is to swallow).
Differences between generic and branded medicines are important for people who have allergies and
intolerances to some of the inactive ingredients used to make the medicine. Therefore it is very important to
discuss any allergies you may have with your doctor and pharmacist before you take any medication, and
before you switch from using a brand-name medicine to a generic medicine or vice versa.

Advantages of generic drugs

The major advantage of generic medicine use is the cost benefit. Generic medicine cannot be marketed at
a price higher than the branded medicine, so it is often a cheaper option, both for the consumer and the
government who pays for part of the cost of the medicine under the Pharmaceutical Benefits Scheme. This
may help people to take their medications as prescribed by the doctor.
More expensive medicines can sometimes affect peoples ability to strictly adhere to the dosage schedule
prescribed by the doctor, especially when there are many repeats and the medicine has to be purchased on
multiple occasions. In many cases, not finishing all repeats will have negative health effects: the medication
will not treat the intended condition as well as it should for example, a persons infection may not be
completely eliminated if they stop taking antibiotic medicines too early (although they will often feel fine
when they stop taking the medicine). Having cheaper medication available makes it financially easier to
continue with the medication for the whole duration of the prescription.
However, over two-thirds (68%) of generic medicines are the same price as the original. Despite this,
research shows that over half of people (55%) dont ask their pharmacist if the generic is any cheaper
before purchasing it. If cost is the same, most Australians (62%) would prefer the original medicine their
doctor prescribed over the generic their pharmacist is offering.

Disadvantages of generic medicines

Consumer confusion
Without properly understanding the similarities and differences between generic and branded medicines, it
is easy to become confused and anxious about taking a new medicine. This is particularly the case when
someone is used to taking a certain medicine and is introduced to a new medicine that has a different
name and appearance but is the same.There are two main points that you need to understand if you are
considering the switch to generic medication:
1. Even though a generic medicine may taste, look and be packaged differently, it has
the same active ingredient as the branded medicine you are used to taking. Therefore, the two
medicines cannot be taken together. This will lead to an overdose of that particular medicine.
Always remember that one replaces or is substituted for another.
2. The generic medicine has been thoroughly tested by the pharmaceutical company and the TGA.
The generic medicine is interchangeable with the branded medicine. This means that it will have
the same actions in the body as the original medicine. The only differences exist in the inactive
ingredients, which will not have any negative effect unless you have an allergy or intolerance.
However, when treating certain critical conditions such as epilepsy, the normally acceptable

equivalence range is too large. In these cases, your doctor will include instructions on the
prescription that substitutes should not be used and the pharmacist must not offer you a substitute.
Not understanding that the new medicine is substituting a medicine already being taken can lead to:

Decrease in medicine adherence due to confusion and anxiety about taking the new medicine; or

Overdose toxicity due to taking both the branded and generic forms.
If you are not comfortable with the concept of generic substitution, do not switch medicines.
How to minimise confusion
Doctors play a very important role in reducing confusion about generic medicines because their patients
take advice about medicine from them and trust their doctor to prescribe effective medicines. About 50% of
people involved in a study reported they would not switch to a generic medicine without first checking with
their doctor. This is indeed a good precaution to take. Your doctor can assess any potential risks and help
with any questions you may have about the new medication.
Make sure you have gathered all the information you need in order to understand and feel comfortable with
generic medicines by following some simple guidelines:

Education: Take the time to ask your doctor to explain the basic principles of generic medication.
Ensure you understand the concept of active and inactive ingredients. Become very familiar with
the active ingredient in the medication you are taking. The active ingredient is always printed on the
label of every medication. By knowing what active ingredient you need to take, you will not be confused
by different brand names.
Consistency: Being consistent with your brand decision is very important. If you have switched to
generic medication once, it is recommended that you continue with that brand. Multiple medicine
switches will increase confusion.
Medicine review: Make appointments to review your medications with your doctor. This will help
you feel in control of the medication requirements and give you the opportunity to ask any questions you
may have.
Instructions/labels: Basic labels and instructions can be attached to medicine packaging that
state clearly the dosing requirements. You can ask your pharmacist to add Label 15 to the new
medication: This medicine replaces [...]. Do not use both.

Why choose the branded medicine rather than the generic medicine?
For many people, substituting a brand name medicine for a generic copy is safe. However, you should not
substitute the brand of medication you are taking if any of the following situations apply to you:
1.
2.
3.

You do not understand the change and feel anxious;

Your doctor specifically tells you that substitution for your condition is associated with risks; or
You have dementia, a mental illness, or are taking multiple medications and are likely to get mixed
up if a new medicine replaces one of them.

Minimising patient confusion

Patient confusion caused by switching between brands of a medicine is a major concern for health professionals. 2-4 While the
extent of confusion is unknown, cases of double dosing, stopping medicines and reduced recognition of dispensing errors have
been attributed to brand switching, with some leading to patient harm. 5-9

Use the active ingredient name

Educating patients about the active ingredient name (that is, the drug or generic name) and using it consistently can
help reduce confusion over brand names.14,15 This is particularly important for patients discharged from hospital who

may receive unfamiliar brands.14 Encourage patients to use a Medicines List to record the active ingredient name of
their medicine, as well as other important information.15

Box 1: Discussing medicine brands at the time of prescribing

Use the active ingredient name instead of the brand name when discussing a medicine and what it is for.
Explain that the active ingredient is the chemical that makes the medicine work and is the name to look for on the prescription
label and the medicine container.
Explain that there may be more than one brand name for their medicine and that they all work just as well.

Ensuring safe switching

GPs, nurse practitioners and pharmacists can help prevent confusion about medicine brands by knowing when switching is
permitted and safe (see below) and by discussing medicine brands with patients and carers (see Boxes 1 and 3). 15-17

When is switching permitted?

Only offer an alternative brand if the medicines are listed as interchangeable on the PBS (see Box 2), the switch is
safe for the individual (see below) and the prescriber allows it. Only switch brands if the patient or carer consents to it
it is their choice.17

Are generic medicines as effective and safe as original brands?

While Australian GPs seldom disallow brand substitution24,25, doubts about generic medicines persist.2-4 A 2008
national survey of GPs found 21% agreed with the statement that generic medicines are not always as effective as
branded medicines, while a further 32% were undecided.3

Generic medicines meet the same standards

The Therapeutic Goods Administration (TGA) requires that generic medicines meet the same quality criteria and
manufacturing standards as original brands.26 The TGA also requires evidence of bioequivalence that is, a generic
medicine must have an equivalent drug plasma-concentration profile to the original brand or market leader.26
This means that while generic medicines may cost less than original brands, they are equivalent in dosage form,
safety, strength, route of administration, quality, bioavailability and intended use.8,27 If a medicine is listed on the PBS
as interchangeable, this means it is accepted as being bioequivalent by the TGA.
Generic medicines can have inactive ingredients that are different from those in the original product but these must
also meet the TGAs quality and safety criteria.18

Why do they cost less?

A common misconception is that generic medicines are less expensive than original brands because they have
inferior ingredients or are manufactured to lesser standards.11 However, the costs of ingredients and manufacturing
are typically similar.34
Generic medicines can be sold for less because suppliers do not need to recoup the large costs of research,
development and marketing of the original brand. Generic products are marketed by both innovator and generic
medicines companies.35 Increased use of generic medicines stimulates price competition among manufacturers and
lowers the price to the purchaser (that is, to the healthcare system and/or to the consumer).8

FACTS ABOUT GENERICS

Generic medicines contain the same active ingredients as brand medicines and
have the same effect.
Generic medicines or generics are medicines containing an active ingredient which is not protected by
patents. Generics are often marketed under the chemical name of the active ingredient. Generics come
onto the market once patents on brand medicines have expired.
Can I Be Sure That a Generic Medicine Is Just As Good As the Medicine I Received Previously?
YES. A generic medicine is approved by the authorities based on its quality, without taking price differences
into account.
Advantages of Generics
Generic medicines reduce the price of treatment, thus making treatment widely available. This is essential
to ensure the distribution of existing medicines and to create the necessary room in healthcare budgets to
put new types of medicines and new types of treatments into use. At the same time, the increased
competition provides a major incentive to develop new medicines, improving security of supply as several
identical medicines are produced by several different companies.
Facts About Generics
1.Generic medicines contain the same active ingredients as brand medicines and have the same effect.
The requirements on treatment effect, safety and side effects are similar to those of brand medicines.
2.Generic medicines are typically 20-80% cheaper than brand medicines due to the competition on prices
between products having the same treatment effect.
3.Generic medicines are subject to the exact same control of quality, safety and efficacy as all other
medicines. The National Board of Health has the overall control of all pharmaceutical companies in
Denmark, regardless of whether they produce brand or generic medicines.
4.A generic medicine might look different than the brand medicine, as colouring agents, flavourings and
other components of the medicine may be different. The effect, however, is the same.
Generic medicines are subject to the same EU procedures for approval and control of medicines as brand
medicines. The registration procedure takes from 1 to 3 years.
Same Requirements on Brand and Generic Medicines
The requirements on quality of the active ingredient and production are the same for brand and generic
medicines. To demonstrate that the effect is the same, the so-called bioequivalence is examined.
Bioequivalence is used not only for approval of generic medicines, but also for approval of brand
medicines. Whereas brand medicines must demonstrate bioequivalence to new experimental medicines,
generics must demonstrate bioequivalence to medicines already on the market. If a medicine changes form
e.g. from tablet to lozenge the new form must again demonstrate bioequivalence to the old.
The requirements of brand and generic medicines are thus the same. The requirements for approval and
documentation are the same throughout the Western world.
The only point where the content between different generic medicines or a generic and brand medicine
may differ is on excipients. Excipients are used to bind the medicine together, e.g. to produce a tablet.
Some patients are allergic to certain excipients, but it may as well be the excipients of a brand medicine as
of a generic medicine.
Also Known As
A medicine always contains an active ingredient with a therapeutic, or treatment, effect. Accordingly, all
medicines on the market have two names: a product name chosen by the pharmaceutical company and a
generic name corresponding to the chemical name of the active ingredient.
Some medicines are marketed under product names that differ widely from the generic name. These are
often medicines where the active ingredient of which is or has been patented. Contrary to this, generic

medicines are typically marketed under names very similar to the generic name of the active ingredient
(sometimes followed by the name of the pharmaceutical company).
Why the Talk of Copy Medicine?
Because generic medicines contain the same active ingredients as other medicines, generic medicines are
also known as copy medicines. Generic medicines are of the same quality, safety and efficacy as the
original medicines and are subject to the same regulatory control. Thus, the sobriquet copy does not have
the same negative connotations when applied to medicines as it has in other fields.
However, the term copy medicine should not be confused with counterfeit medicine sold illegally outside
the healthcare system. Authorities and pharmaceutical companies work together to prevent counterfeit
medicines from entering the market. So far, counterfeit medicines have never been found in the legitimate
distribution system in Denmark, i.e. at pharmacies and approved retailers.

MALPRACTICES
Abstract
Medical malpractice insurance policies customarily contain a cooperation clause requiring insured to
cooperate with the insurer's efforts to defend the insured against a claim. A common stipulation in this
clause forbids the insured from admitting liability to an injured or harmed party. Health professionals often
understand this clause to have a chilling effect on the truthful disclosure of medical error, which is morally
required of physicians when they know that a harm-causing error has occurred. This paper offers a two-part
response to the fear that medical error disclosure might result in a denial of malpractice insurance
coverage. Part one describes various legal precedents wherein insurers successfully invoked the
cooperation clause to deny coverage in instances of liability admission. This paper shows, however, that
the legally sanctioned reasons for denying coverage in these cases address factors other than an insured's
truthful and honest disclosure of what happened to a claimant. Consequently, these cases do not support
the belief that legal precedents discourage the truthful disclosure of harm-causing medical errors. Part two
of this paper proposes that the cooperation clause's prohibition of admission of liability in instances of
medical error disclosure might well be unenforceable, and that the clause might not even be actuarially
sound.
Introduction
The appearance of the Institute of Medicine's 2000 report, To Err Is Human, 1 marked a watershed in the
patient safety movement in the United States. Galvanizing the attentions of the lay public, health
professionals, and various regulatory and legislative groups, the report described the extent of the problem
of medical errors and laid out a fairly elaborate set of recommendations whereby patient safety measures
could be dramatically improved.
Other than remarking that a serious medical error if discussed at all, is discussed only behind closed
doors (p. ix), the report did not elaborate on the health professional's ethical duty to disclose harm-causing
errors, perhaps because the American Medical Association (AMA) had already done so nearly 20 years
before. Section 8.12 of the AMA's Code of Medical Ethics: Current Opinions clearly states,
It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with
patients. Patients have a right to know their past and present medical status and to be free of any mistaken

beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant
medical complications that may have resulted from the physician's mistake or judgment. In these situations,
the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of
what has occurred. Only through full disclosure is a patient able to make informed decisions regarding
future medical care.
Ethical responsibility includes informing patients of changes in their diagnoses resulting from retrospective
review of test results or any other information. This obligation holds even though the patient's medical
treatment or therapeutic options may not be altered by the new information.
Concern regarding legal liability which might result following truthful disclosure should not affect the
physician's honesty with a patient. 2
This statement nicely captures the moral rationale for error disclosure: Patients have a categorical right to a
reasonable disclosure of truthful information about their health conditions, to the extent that information is
available to and known by their treating professionals. 3 6 Historical anecdotes amply demonstrate,
however, that when a patient's adversity results from a medical error, the truth-telling and disclosure
obligations described in section 8.12 are frequently disappointed, and primarily for the very reason that the
section identifies: the professional's concern regarding legal liability. A 2002 study of disclosure practices
reported from more than 200 hospitals stated,
More than half of respondents reported that they would always disclose a death or serious injury, but when
presented with actual clinical scenarios, respondents were much less likely to disclose preventable harms
than to disclose nonpreventable harms of comparable severity. Reluctance to disclose preventable harms
was twice as likely to occur at hospitals having major concerns about the malpractice implications of
disclosure. 7
That finding ought not be surprising. A considerable body of literature attests to how the threat of a
malpractice action, along with feelings of inadequacy and incompetence, causes immense anxiety among
health professionals, and how they adopt a variety of defensive mechanismsincluding rationalization,
distortion, blame shifting, and omitting mention of the error to the harmed partywhen faced with the
commission of a harm-causing error. 8 11
In addition to the fear of inviting a lawsuit by truthfully disclosing error to the harmed party, another factor
that health lawyer Jack Schroder described as more subtle yet potentially more damaging is also
present. 12 It is that many malpractice insurance policies contain a clause that states, The insured shall not,
except at his own cost, make any payment, admit any liability, settle any claims, assume any obligations or
incur any expense without the written consent of the company. 13 This clause, which obligates the insured
to cooperate with his or her insurer and desist from cooperating or colluding with the injured party, has a
chilling effect on many error disclosures. The frank admission of a harm-causing errore.g., Mrs. Jones,
an error occurred in your care that was responsible for the harm you experienced, and we apologize for the
harm it causedis a slam-dunk admission of liability. Because it violates the cooperation clause, the
honest disclosure of harm-causing error risks the possibility that the insurer will refuse to cover whatever
associated costs, principally from a lawsuit, might occur to the insured from the error.
As an illustration that the cooperation clause is indeed taken seriously, consider the following: About 2
years after the Institute of Medicine's report, To Err Is Human, appeared, I posted an article on Emory
University's Center for Ethics Web log that not only urged the disclosure of error, but also recommended

that the professionals involved in the error request forgiveness from the harmed party. A colleague referred
my article to a senior medical administrator, who responded almost immediately with the following:
An admission of fault exposes the doctor and/or institution to damages per se. And the medical
malpractice...insurance policies usually provide that an admission of the insured of error voids coverage for
the related claims for damages. In today's world, that situation is simply not one that a doctor or hospital,
etc., can accept. In fact, a physician will not be admitted to the staff of most hospitals without evidence of
effective coverage under an adequate med mal policy. 14
The physician who wishes to act ethically and disclose a harm-causing error is therefore confronted by the
possibility of financial, and, perhaps professional, disaster. In what follows, however, I argue that (1)
reported cases where insurers successfully denied coverage to insureds who violated the cooperation
clause exhibit factual situations that bear no resemblance to a health professional's disclosure of harmcausing medical error, as morally required; (2) as applied to the truthful disclosure of medical error, the
cooperation clause might be unenforceable; and (3) as a strategy for conserving the insurer's loss
reserves, the practice of concealing error might be entirely counterproductive, i.e., concealing error might
cost the insurer more than would truthful disclosure of harm-causing error. I end this article by describing
how various States have enacted legislation that has removed certain fears connected with admitting error
and apologizing to the harmed party. Therefore, a more felicitous legal environment may be emerging that
encourages professionals to conduct harm-causing error conversations in a patient-centered way.

Conclusion
It remains possible that a health professional who discloses harm-causing error, despite a stipulation in his
or her malpractice policy that he or she refrain from doing so, will find the insurer refusing to provide
coverage. A review of the legal literature up until now, however, does not offer compelling evidence that
fuels fear of that likelihood. Furthermore, a growing body of research indicates that the truthful and honest
disclosure of harm-causing error may well prove a cost-effective rather than a cost-prohibitive strategy for
carriers. One hopes that these arguments and speculations will be further discussed and studied among
health professionals and their insurance carriers. Obviously, the eradication of needless fears that
compromise the truthful disclosure of harm-causing errors would serve to advance the development of
patient-centered sensibilities, which is a very good thing. It would, furthermore, be a heartening
development to find that the financial costs connected with error disclosure are significantly contained by
the implementation of patient-centered ethical practices.
Can physicians be sued for ethics violations? You bet they can! This blog entry will discuss some of the
issues around medical ethics.
Health care practitioners have a code of ethics to which they must adhere. Because of the Hippocratic
Oath, and the underlying power of their state and national licenses, they are held to a high ethical standard
in their medical practice. Patients place their trust in physicians, and thus physicians are bound by this
trust. Doctor-patient relationships by nature have open confidential communication as its foundation. In this
context ethical principles must be strictly adhered to.
Over the past several decades, medical technology and a growing impersonal aspect to patient care vis a
vis managed care (or what some would call, "mill care") has reduced the intimate nature of that doctorpatient relationship. While ethical requirements have not changed, the reduction in personal involvement,
and consequently the trust that grows from longstanding interpersonal relationships has resulted in a
situation where more and more patients are less reluctant to sue their physicians with whom they may have
not been able to establish committed relationships.
At the same time, within this growing impersonal context, doctors have sometimes forgotten their ethical
obligations. Also, as medical technology has advanced new ethical questions have been raised.

Introduction

Errare humanum est: to err is human is a well known saying that captures the fallibility of human beings.
Humans are fallible and as such they will make mistakes in their lives and work be they builders, bankers or
doctors.
The Institute of Medicine's report, To Err is Human: Building a Safer Health System bears witness to the
fact that medical errors are not uncommon. 1 According to this report, which defined an error as the failure
of a planned action to be completed as intended or the use of a wrong plan to achieve an aim, over one
million preventable adverse events occur each year in United States hospitals as a result of healthcare. Of
these events, an estimated 100 000 caused patients serious harm, while between 44 000 and 98 000 led to
death in hospitals in the United States. According to this report, more people die annually from preventable
adverse events related to healthcare than from motor vehicle accidents (43 458), breast cancer (42 297), or
AIDS (16 516) in the United States. This grim report indicates how common it is for medical practitioners to
make errors in their day to day clinical practice.
Although medical errors will likely continue as long as clinicians remain fallible humans, it does not mean
that it should be accepted as a matter of fact. Once they occur though, what should be the attitude of the
medical profession? Should it be to withhold such information from patients since what they don't know
can't hurt them or should such information be honestly disclosed to patients and the appropriate measures
taken to redress and prevent any such errors in future? The cultural change in acceptable medical
behaviour from a paternalistic stand of not wanting to upset the patient to that of open discussion makes it
imperative that doctors tell their patients the truth since deception in medical practice is no longer
acceptable. This change is supported by the fact that the codes of ethics of most medical associations
address disclosure of errors and incompetence.
For example, the Ghana Medical Association Guiding Principles states, Patients have a right to receive
relevant information about their own medical condition and its managementMedical and Dental
practitioners must always inform patients promptly of any significant errors that may be occurred in the
course of investigation or treatment. 2The American Medical Association Principles of Medical Ethics states,
A doctor shall be honest in all professional interactions. 3 In addition, when a patient suffers significant
medical complications that may have resulted from the doctor's mistake the doctor is ethically required to
inform the patient of the facts necessary to ensure understanding of what has occurred. 4 A doctor is thus
ethically bound to admit mistakes to the patient. Such ethical requirement is supported by both
deontological and consequentialist perspectives. 5 That is, by considering the ethical value of the action
alone and by considering the possible consequences of the action; it becomes obvious that the right thing
to do when errors occur is for doctors to tell patients about the errors.
Although most doctors do believe that errors should be disclosed to patients when they occur, in reality,
most doctors and institutions do not disclose such mishaps to patients and their families. Rather, they
engage in extensive cover ups under the guise of protecting the doctor-patient relationship and not causing
harm to patients. This is supported by evidence in the literature that doctors disclose errors to patients in
less than half of instances when a serious error occurs. 6
Since doctors are ethically bound to disclose errors that cause or may cause harm to patients, this paper
will show that non-disclosure of medical errors to patients and/or their families is an egregious violation of
ethical principles and cannot be justified .

Use of lead glazes

Lead glazes are most commonly used on earthenware, and on older bone china and porcelain. They are
reliable, easy to control, durable for most purposes and they produce attractive glazes.
When the glazes are properly formulated and fired at a high temperature, the lead is sealed. However, if
they are not properly prepared and fired, lead may leach (i.e. move from the glaze) into food stored in or on
the ceramic ware.
The degree of lead leaching from tableware can vary. It depends on how often the tableware is warmed
and used, and the amount of contact it has with food and drink. Cups and bowls are of greater concern
than dishes. Acidic foods will accelerate any leaching.
These days, raw or free lead is rarely used. The lead is compounded with silicate into a frit, which is less
dangerous. In catalogues, manufacturers label the glazes containing lead and use terms such as lead-free,
non-toxic and dinnerware-safe to identify lead-free glazes.
However, it is worth checking your kitchen to identify risky items and to ensure their use does not create
health hazards.

Risky ceramic ware

Ceramic ware with a corroded glaze is extremely dangerous and it should never be used to serve food or
drink. It is easy to see corroded glaze because it has a chalky-grey residue that is present after the item
has been washed.
Old tableware, especially imported items, homemade or handcrafted china should be treated cautiously.
Testing is recommended.
Highly decorated ceramic ware is of concern because of the high lead levels that are typically found in
brightly coloured glazes. Be wary of highly coloured glazes on inside surfaces that could have contact with
food or drink, as the potter might not have anticipated that the item would be used in this way when
applying the glaze.
Decorations on top of the glaze may present a health hazard. The decoration is on top of the glaze if you
can feel it when you rub your fingers across the ceramic ware or if you can see the brush strokes of the
decoration above the glazed surfaces.

What to do to reduce the risks

Ceramic ware and glazes that are risky should not be used to store food or drink. The longer the food is in
contact with such glazes, the more the lead will leach into it.
Highly acidic foods (for example citrus juices, apple or tomato juice, cola, salad dressings, vinegar, coffee,
tea and tomatoes) should not be served in questionable china.
Questionable china should not be used daily. Be wary of old coffee mugs, cheap, imported china and
ceramic containers. Heating or microwaving questionable china should be avoided. Heat can accelerate the
lead-leaching process. Reheating coffee in an old mug in the microwave is a particularly risky thing to do.

Testing for lead

Small test kits available from some paint wholesalers and hardware stores can test ceramic ware for lead.
The instructions are on the packet. The only drawback is that overseas experience with many of these test
kits suggests that false negative and false positive results may occur.
As an alternative, there is also an Australian Standard for testing the amount of leachable lead in ceramic
ware. This test is reliable, but it requires samples to be sent to a laboratory for analysis.
If you have any doubts about your ceramic ware, dont use it.

Other sources of lead in food

Lead from a number of sources can contaminate food. Some of these include soil, air-borne lead dust,
fertilisers, leaded crystal, pewter mugs and food cans.
Leaded crystal may contain anywhere between 14% and 36% lead oxide. Spirits kept in crystal decanters
for a long time can become heavily contaminated.
Lead solder was once widely used to seal canned foods. Now nearly all cans produced in Australia are
welded. Imported cans with lead solder are checked for lead contamination, but it is worth avoiding acidic
foods that are imported in soldered cans, particularly if the cans appear to be old.
Lead glazes are prohibited from use on commercial dinnerware in Australia. They are permitted on
decorative ceramic ware only.

Ceramics: Pretty, and Maybe Poisonous

Those brightly colored ceramic mugs you bought at the craft show certainly liven up your breakfast table. And that old
pitcher from the yard sale is just the perfect size for orange juice.
It's hard to imagine that such attractive pieces of pottery could be dangerous to your health.
In truth, they may cause lead poisoning and some may leach cadmium into food and drink. The glaze that gives
ceramics their shiny surfaces may release toxic levels of lead into your food. The FDA has strict limits on the amount
of lead that can leach from a ceramic piece. Cups, mugs, and pitchers have the most stringent limits. That's because
these pieces usually hold food longer, allowing more time for lead to leach.
As a part of the finishing process, clay objects are painted with glaze and fired at a high temperature in a kiln. The
result is a shiny, glassy finish.

Protective firing
Glazes that contain lead must be fired at high temperatures to make sure that the lead in the glaze won't leach into
food or beverages. When an improperly glazed object is used to store foods, a chemical reaction can release the
lead and cause problems.
Large manufacturers of pottery generally make products that are fired properly and are safe to use. The FDA requires
that any decorative ceramicware that reaches high levels of lead be permanently labeled that it's not to be used with
food.
The FDA says potential danger arises from products imported from Mexico, China, and several other countries.
These items may not be labeled, and there is no guarantee that these items have been fired correctly. The FDA tests
imported ceramics for lead, but has no control over objects ordered overseas or brought back by tourists.

Likewise, the agency can't monitor your local amateur pottery buff to make sure that he or she is selling safe
products. Small potters often can't control the firing of lead glazes as effectively as large commercial manufacturers
so their ceramics are more likely to leach illegal lead levels, although many do use lead-free glazes.
Antiques and collectibles may be suspect, as well.

Health risks
High levels of lead can harm the kidneys and liver, as well as the nervous, reproductive, cardiovascular, immune, and
gastrointestinal systems. Low levels of lead in children may cause learning, behavioral, and growth problems.
The FDA makes the following suggestions to avoid lead poisoning from ceramics:

Beware of products purchased in other countries. If you're unsure about safety standards, don't use them
with food.

Don't serve food or beverages in antiques or collectibles.

Be careful of ceramics made by amateurs or hobbyists.

Do not store food or beverages in vessels that are highly decorated on the inside.

Look for a warning label on the pottery such as "Not for Food Use--May Poison Food."

Be aware that no amount of washing, boiling, or other processing can remove lead from pottery.
If you want to be completely sure that a piece of pottery is safe, the only way to find out is to have it tested. You can
buy test kits at your local hardware store, or have the pottery tested by a lab. If you cannot test the pottery or
otherwise ensure it is from a reliable manufacturer, don't use it for cooking, serving, or storing food or beverages.

METATHIONE AND GLUTATHIONE

Metathione, also called Met Tathione, has the very peculiar aftereffect of actually lightening the
pigmentation of your skin over time. That astonished me that people would go for that purpose, since, being
from a beach area, everyone else needs a tan, maybe not the alternative. Therefore I was intrigued and did
some investigation into metathione and reading recommendations to find out precisely what they were
using it for and if it worked. I came across that not merely is metathione used generally for minimizing skin
pigmentation, but that it also has a wide selection of other health benefits. Metathione gets the active
ingredient glutathione, which can be technically a protein, being created from a series of 3 amino acids,
glutamic acid, cysteine, and glycine. This protein is really produced usually from the human anatomy and
among other items, has a very strong antioxidant property. But well go into more of the later.
Metathione has Glutathione in it, so that they are virtually identical in nature, although based on that which
you are using it for, metathione could be far better. Metathione comes in different forms including product
products, and dramas, products, and works by actually lightening the skins tones and returning a lighter
rosier appearance, which is considered to be more youthful and beautiful for many skin complexions. The
active component is L-Glutathione, and includes a few other compounds such as Alpha Lipoic Acid, LCysteine, and Vitamin D too. This is why that metathione is simply only an advanced version of glutathione.

Heat exhaustion definition and facts

Heat exhaustion is one part of the spectrum of heat-related illnessesthat begin with heat cramps,
progresses to heat exhaustion, and finally to heat stroke.

The body cools itself by sweating and allowing that sweat to evaporate. This requires enough fluid
in the body to make sweat, air circulating across the skin, and low enough air humidity to allow that
sweat to evaporate.

Activity in a hot environment can overwhelm the body's ability to cool itself, causing heat-related
symptoms.

Symptoms of heat exhaustion include profuse sweating, weakness, nausea, vomiting, headache,
lightheadedness, and muscle cramps.

Heat exhaustion can progress to heat stroke when the body's temperature regulation fails. The
affected individual develops a change in mental status, becomes confused, lethargic and may have a
seizure, the skin stops sweating, and the body temperature may exceed 106 F (41 C ). This is a lifethreatening condition and emergency medical attention is needed immediately.

Treatment for heat exhaustion includes recognizing the symptoms, stopping the activity, and
moving to a cooler environment. Rehydration with water or a sports drink is the cornerstone of
treatment for heat exhaustion. If nausea or vomiting prevents the affected individual from drinking
enough water, intravenous fluids may be required.

The Facts on Heat Stroke

Heat stroke is also known as sunstroke, thermic fever, or siriasis. It happens when the body's mechanisms for
controlling temperature fail. Heat stroke is a life-threatening emergency needing immediate treatment. While many
people feel sick and faint during heat waves, most of these people are suffering from heat exhaustion, a related
condition usually less serious than heat stroke.
There are two types of heat stroke: classic, non-exertional heat stroke (NEHS) and exertional heat stroke (EHS).
Classic heat stroke occurs most commonly in very young or older individuals, who have health risks and are in poor
environmental conditions. Exertional heat stroke occurs more often in younger, healthy individuals who participate in
strenuous physical activity.
Causes of Heat Stroke
Working or exercising in hot conditions or weather without drinking enough fluids is the main cause of heat
stroke. You can get heat stroke by not replacing lost fluids over days or weeks, or you can bring it on in a few hours
by exercising strenuously on a hot day without drinking plenty of liquids first.
Liquids help to cool us down by allowing the body to produce sweat. However, liquids are also necessary for bodily
functions, such as keeping up blood pressure. You can lose large amounts of body fluid in the form of sweat without
noticing any effects, but at a certain point the body will reserve the remaining fluid for vital functions and stop
sweating. The body's core temperature then shoots up, and cells start dying.
Sweat evaporates more rapidly in dry weather, cooling the body more efficiently than in humid weather. When
working in humid conditions, the core temperature rises more rapidly. This is why weather forecasts add a humidity
factor or heat index to represent how you will actually feel outdoors.
People with the following conditions are especially prone to heat stroke:

Alcoholism, chronic illnesses like heart disease, obesity, older age, Parkinson's disease, uncontrolled
diabetes, use of certain medications such as diuretics and antihistamines, use of some psychoactive drugs
such as alcohol and cocaine, Heavy clothing and some skin conditions can also contribute to the occurrence
of heat stroke.

Symptoms and Complications of Heat Stroke

The symptoms of heat stroke are quite different from those of heat exhaustion.
Symptoms of heat stroke:

extremely high core temperature of up to 41C (106F), hot, red, dry skin, rapid pulse, rapid, shallow
breathing, headache, confusion, strange behavior, possible loss of consciousness

Someone with heat stroke has stopped sweating, due to a failure in his or her heat control system.
High core temperatures damage the internal organs, especially the brain. The fluid loss can also produce
dangerously low blood pressure. Most people who are killed by heat stroke die when their heart stops pumping
effectively (circulatory failure). Even people who survive are likely to have permanent brain damage if their core
temperature has been over 40.6C (105F) for more than an hour or two.
Diagnosing Heat Stroke
Heat stroke is diagnosed by looking at signs and symptoms, such as body temperature, and finding out about the
person's recent activities.

Treating and Preventing Heat Stroke

Heat stroke is a medical emergency. Learn to recognize the symptoms listed above and take the appropriate
action. The heat stroke victim needs to see a doctor as soon as possible, but the first step is to get the core
temperature under control.
If you suspect someone has heat stroke, begin treating them immediately while someone else calls 9-1-1.
Everything must be done to cool the heat stroke victim immediately. The best solution is to remove them from the
sun, immerse the body in cold water, such as a river, stream, or bathtub. Otherwise, remove most of their clothes,
douse them with water, and fan them vigorously. Wrapping in wet sheets can help increase the rate of heat loss. If
the person is conscious and alert, offer him or her water or other fluids. Avoid caffeinated or alcoholic drinks because
they dehydrate you.
If the victim starts shivering, slow down the cooling treatment because shivering raises core temperature. Take the
person's temperature every 10 minutes if you have a thermometer handy. You should not let the core temperature fall
below 38C (100F), as this can result in an uncontrollable slide towards dangerously low temperatures
(hypothermia). All the while you should be making arrangements to get the victim to an emergency room. Watch for
signs of respiratory arrest (breathing failure) and be ready to give mouth-to-mouth resuscitation (rescue breathing).
The heat exhaustion victim should also be put in a cool place. Lay them down and give small gulps of liquid
every few minutes. "Sports" drinks are best but water is often more readily available. You should watch carefully for
signs of deterioration, but there's no need to rush to a hospital for a normal case of heat exhaustion.
The way to prevent these problems is to drink very large amounts of liquid during heat waves, especially if
you're planning on working or exercising outdoors. If exercising, approximately 500 mL to 1.8 L of water should
be consumed in the 3 hours before the activity with about 200 mL to 250 mL consumed every 20 minutes during the
activity. Fluid loss continues after the activity is over, so it is important to continue to consume water for several hours
after exercise. Some experts suggest continuing until urine is pale in colour.
You shouldn't take salt tablets unless you're also drinking a lot of water. When in very hot environments, drink every
hour whether you feel like it or not, since thirst is a late indicator of dehydration. To prevent heat stroke:

Avoid heavy outdoor activities in the summer during the hottest times of the day.

Wear loose-fitting, light-coloured clothes - light colours reflect more sunlight.

Try to relax in the shade during the hottest part of the day.

Avoid coffee and alcohol, especially beer, due to their fluid loss effect.

Learn the technique of mouth-to-mouth resuscitation.

Between 1999 and 2003, there were 3,442 reported deaths resulting from exposure to extreme
heat, according to the U.S. Centers for Disease Control and Prevention. During that time Arizona
had the highest number of deaths related to hyperthermia, which happens when the body
overheats (heatstroke is a form of it), followed by Nevada and Missouri.

Elderly people and young children, as well as people with chronic severe illnesses, are at highest
risk of heatstroke.

Heat hurts your insides too

There are a few different forms of heat-related illnesses.

Heat cramps are usually considered mild, and can be treated with liquids and going into a cool
environment. More severe is heat exhaustion, which involves elevation of body temperature,
headaches, nausea and vomiting.

And then there is heatstroke, which is the most life-threatening. Heatstroke resembles heat
exhaustion but may additionally involve neurological symptoms such as confusion and dizziness,
or even coma. The body can no longer sweat, and internal temperature skyrockets.

Geoff Stoker, 24, remembers sweating profusely at soccer camp in high school and then, after
three days, the sweating stopped altogether. He lost desire to eat, and vomited. His father, a
surgeon, treated him for heatstroke at home, and he had no long-term side effects.

In Musick's case, the heatstroke temporarily diminished his kidney function to about 50%.

Patients may also lose water weight through dehydration, said Dr. Sylvia Morris, hospitalist at
Emory University Hospital Midtown in Atlanta, Georgia. A hospitalist is a physician whose focus is
patients within a hospital.

Sanford's hospital typically sees one or two chronically ill elderly patients who live without air
conditioning and develop heatstroke in any given summer. But she believes the South sees fewer
cases because people in that region are more acclimated to high outdoor temperatures; they're
more used to having to deal with heat than in other parts of the United States.

Treatment

In severe cases, patients must be admitted to the intensive care unit, where medical staff watch
body temperature carefully. A 48-hour hospital stay would usually be necessary, Sanford said.

"If you can get them to treatment fairly quickly, they'll survive it," Sanford said. Chronic illnesses
can complicate recovery, however.

Treatment focuses on cooling the patient down to a normal body temperature. If the patient has a
clear airway, breathes normally and has normal circulation, medical staff will remove his or her
clothes and spray cool water while a fan is blowing, Sanford said. Cool intravenous fluids also bring
body temperature down.

Musick's wife Teresa, recognizing heatstroke symptoms, drove him to the hospital when she
noticed that his speech was slurred and his blood pressure was dropping. The emergency room
staff gave him an IV, and the next day he followed up with Melton, who gave him two more IV bags.

"His body is not able to cool itself effectively, and so for him, he needs to avoid prolonged working
in the heat. That's really his only option at this point, because I don't think his body will adapt,"
Melton said.

Avoiding heatstroke

To protect yourself, try to avoid strenuous physical activity outside during the hottest time of the day
-- between 10 a.m. and 6 p.m.

People who must work outside should make sure they drink plenty of water every half-hour or so
and take breaks in a cool environment if possible, Sanford said. Wearing lightweight, light-colored
clothing and a wide-brimmed hat can also help.

You can tell if you're dehydrated by looking at your urine, Melton said. If you've had adequate
amounts of water, your urine will probably look light in color; darker means you should drink more.

And make sure you check on the elderly, especially if they don't have air conditioning, Morris said.
They should spend time in cool places such as a library or a mall to get a break from the heat, she
said.

5 tips for surviving extreme heat

Kidney, liver and heart problems are all conditions that should make patients extra aware of the
heat, and they should talk with their doctors about heat exposure, said Morris.

"People tend to forget to drink. By the time you're thirsty, it's really too late," Morris said.

Musick said his problem is that he doesn't like to drink water so much, and his hydration concerns
his wife. But over the past three years he's made an effort to get at least 8 glasses a day in his
system.

Since his most recent heatstroke, he's been resting and hasn't been out on the farm.

"I am really pushing the hobby of farming to be retired," Teresa Musick said.