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Top Adding - Can The Over-Prescription of Antibiotics Lead To The Revocation Of A Medical License
Doctors have been prescribing antibiotics for years now when patients come into their office complaining of the common cold (even though antibiotics are ineffectual
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
to treat a cold's viral basis) in large part because of patient demands. This has led to great concern in the medical and scientific communities that such overuse o
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
antibiotics has caused an increase in antibiotic-resistant strains of certain bacteria. Can such over prescription of antibiotics lead to the revocation of a medica
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
license? This intriguing possibility is raised by the Third Department's decision today in Matter of Ostad v New York State Dept. of Health, 2007 NY Slip Op 04020.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
he facts were as follows. In support of its allegations of negligence, gross incompetence and failure to maintain accurate medical records, the Bureau of Professiona
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Medical Conduct (BPMC) presented evidence that the doctor at issue had repeatedly prescribed antibiotics to four pediatric patients with complaints of sore, red thr
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ats without recording adequate medical histories or doing throat cultures, and despite his having made a diagnosis for which antibiotics would be ineffective. BPMC's
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
expert established the standard of care for diagnosing such ailments in children and explained the adverse consequences of the improper prescription of antibiotics.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
In his defense, the doctor presented no expert witness at the hearing and admitted that his notes did not reflect the patients' medical histories. However, he expla
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ned that he dispensed with throat cultures and routinely prescribed antibiotics because he served a low-income community whose members could not be depended upon to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
eturn if the cultures revealed the need for medication and, in any event, red throats always meant strep throat (which would justify antibiotics). The doctor further
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
testified that the nature of his patients' community justified giving lower-cost, but less appropriate, medications, and that he often prescribed antibiotics simply
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ecause the parents demanded them. A Hearing Committee found the testimony of BPMC's expert to be highly credible while rejecting the doctor's attempts to justify his
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
actions. It also found that the doctor believed that a lower standard of medical care was justified by his patients' economic status.
Based on this evidence, the Th
Based on this evidence, the Th
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ird Department found in the doctor's article 78 challenge to his revocation that there was substantial evidence before the Hearing Committee that the doctor repeated
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
y failed to "exercise the care that a reasonably prudent physician would exercise under the circumstances" and that his conduct was sufficiently egregious to constit
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
te gross incompetence. It thus denied his challenge to his revocation.
It should be noted that there were additional factors which led to the revocation of the doct
It should be noted that there were additional factors which led to the revocation of the doct
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r's license (making a false statement on an application for reappointment to the staff of a local hospital, a prior history of prior professional misconduct, and a c
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
iminal conviction). Nevertheless, it appears that the doctor's inappropriate prescription of antibiotics constituted a major basis for his revocation. So, doctors wi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
l clearly want to take note of this decision. But will this decision be enough to put fear into doctors to overcome their patients' continued demands for antibiotics
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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