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By: Jennifer Lynn Garst, MD

  • Professor of Medicine
  • Member of the Duke Cancer Institute

https://medicine.duke.edu/faculty/jennifer-lynn-garst-md

It is made more obvious by alternate stimulation of one eye then the other ensuring that the intensity and duration of stimulation of each eye are the same (swinging penlight test) juniper allergy treatment 400 mg quibron-t otc. It will be present also if there is a large retinal or severe macular lesion allergy medicine comparison chart discount quibron-t 400 mg line, but even dense cataract does not impair the pupillary light response allergy treatment time cheap 400 mg quibron-t with mastercard. Absolute afferent pupillary defect is the absence of pupillary response to allergy bronchitis purchase quibron-t 400mg online light stimulation of a completely blind (amaurotic) eye. Light shone into the normal eye would still induce a consensual response in the blind eye (Figure 14–34). An afferent pupillary defect can still be identified if one pupil is either not visible, due to corneal disease, or is unable to respond due to structural damage or damage to its innervation, for example, third nerve palsy, by examination of the normal pupil as light is shone into the normal and then into the abnormal eye. This is most commonly due to an afferent pupillary defect (such as in optic nerve disease) because the pupillary light reflex to stimulation of the affected eye is reduced but the near response is normal. It occurs also in lesions of the ciliary ganglion or of the midbrain, in which the light reflex pathway is relatively dorsal and the near response pathway relatively ventral. Causes include tonic pupil (see later in the chapter), midbrain tumors and infarcts, diabetes, chronic alcoholism, encephalitis, and central nervous system degenerative disease. Argyll Robertson pupils, which are usually bilateral, are typically small (less than 3 mm in diameter), commonly irregular and eccentric, do not respond to light stimulation but do respond to a near stimulus, and dilate poorly with mydriatics as a consequence of concomitant iris atrophy. The pattern of recovery is influenced by fibers in the short ciliary nerves subserving the near response outnumbering those subserving the light reflex by 30:1. Accommodation usually recovers fully, but incomplete reinnervation of the iris results in segmental iris constriction and pupillary light 669 near dissociation. Subsequent involvement of the other eye over a period of 10 years occurs in 50% of individuals, but bilateral tonic pupils may be due to autonomic neuropathy. The sympathetic fibers then follow the nasociliary branch of the ophthalmic division of the fifth nerve and the long ciliary nerves to the iris and innervate Müller muscle and the iris dilator. Melanocyte maturation in the iris depends on sympathetic innervation; thus, a less pigmented (bluer) iris occurs in congenital or longstanding acquired Horner’s syndrome. Sweating on the ipsilateral face and neck is reduced in central and preganglionic lesions, whereas it is normal in postganglionic lesions because the relevant nerve fibers follow the external rather than the internal carotid artery. Central Horner’s syndrome may be due to brainstem infarction, particularly lateral medullary infarction (Wallenberg’s syndrome), syringomyelia, or cervical cord tumor. Preganglionic Horner’s syndrome may be due to cervical rib, cervical vertebral fractures, apical pulmonary lesions—particularly bronchogenic carcinoma (Pancoast’s syndrome)—or brachial plexus injuries. Postganglionic Horner’s syndrome may be due to carotid artery dissection, skull base tumors, or cluster headache. The localization of central and preganglionic Horner’s syndrome is often apparent from the associated clinical features. Sudden-onset isolated painful Horner’s syndrome, particularly with a recent history of neck trauma or associated with pain in the neck or jaw, necessitates urgent 670 investigation for carotid dissection, which may lead to thrombotic or embolic stroke. Horner’s syndrome associated with chronic facial pain, particularly if associated with fifth, sixth, third, fourth, or second cranial nerve palsy, requires investigation for skull-base tumor. In most cases of isolated congenital Horner’s syndrome, no etiology is identified. Birth trauma is a commonly identified cause, and neuroblastoma is occasionally responsible. Unexplained acquired Horner’s syndrome in infants requires imaging for neuroblastoma. Pharmacologic testing with apraclonidine drops confirms Horner’s syndrome by reversal of the anisocoria, with the affected pupil becoming larger than the normal pupil. Hydroxyamphetamine drops differentiate central and preganglionic from postganglionic lesions, but they are difficult to obtain. Coordination of eye movements requires connections between these ocular motor nuclei, the internuclear pathways. The supranuclear pathways are responsible for generation of the commands necessary for the execution of the appropriate movement, whether it be voluntary or involuntary. Classification & Generation of Eye Movements Eye movements are classified as fast or slow (Table 14–2). The generation of a fast eye movement involves a pulse of increased innervation to move the eye in the required direction and a step increase in tonic innervation to maintain the new position in the orbit by counteracting the viscoelastic forces working to return the eye to the primary position. The step change in tonic innervation is produced by the tonic cells of the neural integrator, so called because it effectively integrates the pulse to produce the step. There is a close relationship between the amplitude of movement and its peak velocity, with larger movements having greater peak velocities. The generation of a slow eye movement involves a maintained increase of tonic innervation of magnitude correlating with the required velocity of movement. Thus, the clinical clues to a supranuclear lesion are a differential effect on horizontal and vertical eye movements or upon saccadic, pursuit, and vestibular eye movements. In diffuse brainstem disease, such features may not be apparent, and differentiation from disease at the neuromuscular junction or within the extraocular muscles on clinical grounds can be difficult. Disease of the internuclear pathways results in a disruption of the conjugacy of eye movements. In infranuclear disease, the pattern of eye movement disturbance reflects the involvement of one or more cranial nerves or their nuclei. There may also be insufficiency or spasm of convergence and/or accommodation and loss of downward fast eye movements. The syndrome results from damage to the dorsal midbrain usually involving the posterior commissure. Pineal tumor, hydrocephalus, midbrain infarct or arteriovenous malformation, and trauma may be responsible. Spasm of the Near Response Spasm of the near response, also known as convergence or accommodative spasm, is usually caused by functional disease, but it may be caused by a midbrain lesion. It is characterized by convergent strabismus with diplopia, miotic pupils, and spasm of accommodation (induced myopia). In functional disease, the features are usually intermittent and provoked by eye movement examination. Cyclopentolate 1%, one drop in each eye twice daily, with reading glasses to compensate for loss of accommodation may be helpful. Convergence Insufficiency Convergence insufficiency is characterized by diplopia for near vision in the absence of any impairment of adduction on monocular testing, with refractive error, particularly presbyopia, also having been excluded. It is caused by functional disease or dysfunction of the supranuclear pathway for convergence in the midbrain. In organic lesions, pupillary miosis may still occur when convergence is attempted, whereas in functional disease, it does not. It contains many pathways connecting nuclei within the brainstem, particularly those concerned with eye movements. The typical manifestation of damage to the medial longitudinal fasciculus is an internuclear ophthalmoplegia, in which conjugate horizontal eye movements are disrupted due to failure of coordination between the sixth nerve nucleus in the pons and the third nerve nucleus in the midbrain. On horizontal eye movements, abduction of each eye is normal, whereas adduction of the eye ipsilateral to the lesion of the brainstem is impaired (ie, there is incoordination of gaze to the contralateral side). In the most severe form, there is complete loss of adduction on horizontal gaze, producing constant diplopia on lateral gaze (Figure 14–12). Convergence is characteristically preserved in internuclear ophthalmoplegia except when the lesion is in the midbrain, when the convergence mechanisms may also be affected. Another feature of internuclear ophthalmoplegia is nystagmus in the abducting eye on attempted horizontal gaze, which is at least in part a result of compensation for the failure of adduction in the other eye. Internuclear ophthalmoplegia may be due to multiple sclerosis (usually in young adults), brainstem infarction (usually in older adults), tumor, arteriovenous malformation, Wernicke’s encephalopathy, and encephalitis. Bilateral internuclear ophthalmoplegia is most commonly due to multiple sclerosis. A horizontal gaze palsy combined with an internuclear ophthalmoplegia, due to a lesion of the sixth nerve nucleus or paramedian pontine reticular formation extending into the ipsilateral medial longitudinal fasciculus, affects all horizontal eye movements in the ipsilateral eye and adduction in the contralateral eye. Misalignment of the visual axes results in diplopia, unless there is suppression that more commonly develops in children than adults. There may be an abnormal head posture (head turn to the same side in sixth nerve palsy or head tilt to the opposite side in fourth nerve palsy).

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Licorice is sometimes called an adrenal-hormonal that is said to allergy girl quibron-t 400mg free shipping stimulate the production of interferon allergy testing no needles 400 mg quibron-t with amex, the agent thought to allergy greenville sc purchase quibron-t 400mg mastercard be key in preventing and treating immune-response deficiency diseases allergy testing erie pa buy 400 mg quibron-t. The herb contains a natural hormone that induces the adrenal cortex to produce larger amounts of cortisone and aldosterone and assists the body to handle stress and relieve exhaustion. Licorice produces mild estrogenic effects and is said to normalize ovulation in women experiencing infrequent menstruation and ease menopausal symptoms. The active ingredient, glycyrrhizic acid, is known to be fifty-times sweeter than sugar cane, but it does not promote thirst; it actually will alleviate thirst. The glycyrrhizin content has a chemical structure similar that of human steroid hormones, which appear to help raise blood sugar levels to normal. Precautions: Pregnant women, diabetics and those with high blood pressure should avoid this herb. People with high blood pressure, kidney disease, gallbladder disease and cirrhosis should avoid this herb. Large doses of Licorice may induce sodium retention and potassium depletion and can lead to hypertension and edema. Use of Licorice should be done under the supervision of a health care provider or qualified practitioner. Linseed helps lower cholesterol and blood sugar levels, improve circulation and immune function, and treat inflammatory disorders. Flax is a hardy annual that grows from one to four feet with narrow, hairy leaves and red, white, or blue flowers that are followed by spherical capsules (bols), which contain the Linseeds (or Flaxseeds) that are high in oils with linoleic acid. The Bible tells us that Rahab in Jericho hid two spies under stems of Flax she had been drying, and Solomon praised his wife, who separated the fibers of the plant for fine linen. The Egyptians made fine linen clothing and used it for wrapping mummies in the embalming process. The medicinal properties of Linseeds were known to the Greeks, as Hippocrates recommended them for inflammations of the mucous membranes and digestive disorders; and in eighth-century France, Charlemagne passed laws requiring that the seeds be consumed to keep his subjects healthy. Hebert, the first farmer in Canada, brought it to New France, where today the crop grows widely on the prairies of Canada for its oil-rich seeds. The majority of fat in Linseed (more than seventy percent) includes polyunsaturated fatty acids, namely alpha-linolenic acid (parent of Omega-3) and linoleic acid (parent of Omega-6), the "good fats. However, the body cannot manufacture them; their presence depends totally on dietary consumption. Linseed contains the linoleic and linolenic acids needed for production of hormone-like prostaglandins, which are vital for many bodily functions. Linseeds are not only rich in Omega-3 and Omega-6 polyunsaturated fatty acids, but they are also a wealth of nutrients, such as calcium, iron, magnesium, manganese, phosphorus, potassium, sulfur, vanadium, zinc, protein, mucilage, digestive enzymes, saponin, beta carotene, B-vitamins and vitamin E. Most of the soluble fiber in Flax is mucilage gum, which is a thick, sticky substance that blocks cholesterol absorption and helps balance blood-glucose levels. With regard to strokes, the Omega-3 fatty acids in Linseed also appear to protect against stroke by regulating blood clotting and platelet aggregation. A high-fiber diet including Linseed has been linked to a reduced risk of many chronic diseases, including diverticulosis and certain malignant diseases, i. Through these mechanisms, Linseed may play an important role in the clinical management of autoimmune diseases and certain hormone-dependent malignancies (breast, endometrial and prostate). Linseeds have been used as a relaxing expectorant, easing sore throats and hacking coughs. The mucilage in Linseed has been effective for inflammations of the mucous membranes, which is soothing for many conditions including pharyngitis and gastritis. Linseed is an old remedy when used topically as a poultice for inflammations and ulcers and as a drawing poultice for boils and abscesses. Precautions: Currently, there are no known warnings or contraindications with the use of Linseed. Recent experiments have claimed that the herb may be helpful to smokers who wish to "quit the habit" and have tried all other remedies without success. At the same time, Lobelia is also supposed to calm the nerves and relax the muscles of the body. Plant Description: Lobelia is a very common weed that is indigenous to North America and grows wild throughout the United States in pastures, meadows, and cultivated fields. It is a short-lived annual or biennial that has erect, angular, hairy stems with a milky sap and bears light serrate leaves with numerous small, blue-violet flowers that grow in a spike-like fashion. Lobelia thrives in rich, moist, slightly acid soil in full sun or partial shade and reaches a height of three feet. Although very pretty when growing in the wild, it is highly controversial and should be handled only by qualified health care practitioners, as it can be very harmful if eaten. The plant has a disagreeable odor and a burning taste (somewhat like an acrid tobacco) and will cause a flow of saliva. History: Lobelia was named after the botanist, Matthias de Lobel, a native of Lille, who died in London in 1616. However, the discovery of Lobelia is credited to Samuel Thomson (1769-1843), a pioneer herbalist and founder of Physiomedicalism, and the herb was the mainstay of his Botanic Family Physician in 1831. It was reported to treat bronchitis, laryngitis, asthma and convulsive and inflammatory disorders, such as epilepsy, tetanus, diphtheria and tonsillitis. The Penobscot Indians of New England also used it for bronchial complaints, and the Meskwaki tribe secretly included its finely ground roots in the food eaten by quarreling couples to make the pair fall in love again. It was theorized that the plant failed to affect a cure, possibly because the Native Americans used it in combination with other herbs, or because the vitality of the plant was lost after, it was dried. Today, Lobelia is an ingredient in some cough medicines (supporting its historical use as an expectorant in folk medicine) and is found in some over-the-counter preparations marketed to break the smoking habit. Some of the constituents included in Lobelia are the piperidine alkaloids, lobeline, (first isolated by Proctor in 1838) and isolobeline, lobelic acid, gum, resin, chlorophyll, essential oil, lignin, salts of lime and potassium, ferric oxide, manganese and vitamins A and C. Medical Uses: Lobelia has been used for centuries as an expectorant that promotes the expulsion of phlegm from the lungs and is believed to be helpful in cases of asthma, bronchitis, whooping cough and pleurisy. As a relaxant and antispasmodic, Lobelia is said to relax smooth muscle and has thus been useful in easing muscle tension and convulsions, and calming the nerves. It has also been thought to relieve mild depression, hyperactivity and possibly even induce a state of euphoria. In times past, the herb was commonly employed in midwifery to alleviate rigidity of the pelvic musculature and as a sedative to relax women preparing for childbirth. Lobelia is considered a diaphoretic that promotes perspiration and helps to lower fever and cool the body (also ridding the body of toxins through the skin). Used externally, Lobelia is believed to reduce inflammation and pain and is often used in poultices for bruises, sprains, ringworm, poison ivy irritation, skin diseases, poisonous stings, insect bites, whiplash, rheumatism, tennis elbow, boils and ulcers. Lobelia is a highly controversial herb, but current evidence suggests that it may aid smokers to "quit the habit," as it produces similar effects as the nicotine in tobacco and is thought to make the taste of tobacco repulsive. This acrid herb is also said to stimulate respiration and was once used to stimulate the respiration of newborn infants. When overused, however, it will cause vomiting, drowsiness, weakened pulse, and respiratory failure, and great care should be exercised with its use. It is recommended that Lobelia always be used in consultation with a health care provider. Used externally (and best with slippery elm and soap), Lobelia will bring abscesses and boils to a head. Precautions: Great care should be exercised with the use of Lobelia, since it has poisonous potential and is controversial. Pregnant and nursing women and people with high blood pressure should not use Lobelia. Overdoses of the herb (many times the recommended amounts) produce vomiting, sweating, pain, paralysis, depressed temperatures, rapid (but feeble) pulse, collapse, and possibly coma and death. Also, a bittersweet aromatic is used to relieve colic, indigestion and flatulence. Plant Description: Lovage is a native of the Mediterranean region of southern Europe and Asia Minor and grows both wild and cultivated throughout Europe. In the summer, the plant bears pale yellow flowers, followed by small, yellowish brown, extremely aromatic fruits. The odor of the whole plant is very strong, and its taste is warm and aromatic and abounds with a yellowish, gummy, resinous juice. The plant thrives best in rich, moist, well-drained soil in a sunny situation, and the entire plant is used for medicinal purposes.

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This is a melanocytic – Stasis dermatitis lesion because there are aggregated brown globules – Psoriasis (circles) allergy medicine before bed buy quibron-t 400mg online. Pinpoint and larger glomerular vessels represent a pattern with foci of streaks at the periphery (boxes) allergy medicine during ivf generic quibron-t 400 mg with visa. Seen only on the face allergy shots pregnant discount quibron-t 400 mg online, nose allergy treatment and high blood pressure buy quibron-t 400 mg free shipping, and ears white and gray blotches (yellow arrows) make up the. This Remnants of a fingerprint pattern (yellow boxes) with case demonstrates variations of the classic criteria. The pattern (black boxes) around follicular openings dermoscopic criteria for a seborrheic keratosis are not (arrows) are are also seen. There is asymmetry of color and structure, melanophages and free melanin in the papillary asymmetrical pigmentation (black arrows) around dermis, not atypical melanocytes. A subset of lichen follicular openings (red arrows), annular-granular planus–like keratosis are thought to represent an structures (circles), and irregular dark blotches (boxes). Rhomboid is a parallelogram with 2 pairs of parallel scopic features associated with solar lentigo, actinic lines in which the opposite sides have equal length and keratosis, and melanoma. Use the area and/or areas there are obtuse angles with atypical features to make an incisional biopsy. Black, brown, or gray thickening completely surround pigmentation or circle within a circle. The pigmented bands are not uniform in color and thickness (black arrows) with loss of parallelism (broken up line segments). Loss of B parallelism is created by the atypical melanocytes that produce pigment irregularly. Medications (chemotherapeutic agents, multiple nails) arrows) and purple blotches (white arrows) result from. This small papule was only found after Terminal hairs with perifollicular hypopigmentation a complete skin examination. There are different (boxes), pigment network (circles), and brown dots shades of pink color, pinpoint (boxes), and comma (arrows) characterize this small congenital melanocytic shaped vessels (yellow arrows) plus a milky red area nevus. Amelanotic melanoma and Merkel cell carcinoma are in the clinical and dermoscopic differential diagnosis. Asymmetry of color – Pink and structure (+), the multicomponent global pattern – Black pigment network (1, 2, 3) irregular brown globules (boxes), irregular – Atypical dark blotches (yellow arrows), and scar tissue (stars). Spitzoid is the term used when any of the different with arborizing vessels (black arrows) characterize 6 patterns is seen this recurrent nevus. Review the original – Streaks and/or dots and globules at the periphery pathology report to confirm the benign nature of this – Light/dark brown, black, or blue color centrally lesion. There are a few streaks (red arrows) at all points of the periphery foci of irregular brown dots and globules (boxes), characterize this classic symmetrical starburst/Spitzoid irregular dark blotches (black arrows), and multifocal pattern. The – this can have any combination of melanoma hypopigmentation (black stars) should not be confused specific criteria similar to superficial spreading with regression. Following these, lesions with digital der criteria found on the trunk and extremities (Figs. Dermoscopy might not be as helpful to make the diag has aggregated brown globules (boxes). There is an nosis as the history of a melanoma being previously absence of melanoma-specific criteria found on the excised face with different shades of pink and brown color plus. Pigmented and/or nonpigmented macules, papules, arrows) should not be confused with the milia-like and ulcerated or nonulcerated nodules can be seen in cysts of a seborrheic keratosis. However, this with dermoscopy set of clinical and dermoscopic features should raise a red flag for concern. Dermoscopy should not only be used on clinically suspicious lesions if one wants to diagnose melanoma incognito. Both can have pigmented and nonpig meet this criterion and can be found anywhere in the mented variants lesion. Dermoscopic features of solar lentigo, actinic kerato sis, and melanoma can be found in the same lesion Pearl. Multiple biopsies might be needed to make the correct the globules are the main dermoscopic feature used to diagnosis differentiate sebaceous gland hyperplasia from basal cell. Lesion with the dermoscopic criteria for 2 different nodule, patch, plaque pathologies. With or without homogeneous brown color and/or seen within the other dark dots and globules (pigmented Bowen disease). Examples include – Seborrheic keratosis, basal cell carcinoma Pearls – Seborrheic keratosis, in situ or invasive squamous. Clinically and dermoscopically a pink scaly lesion with cell carcinoma pinpoint and/or glomerular vessels is not diagnostic of – Seborrheic keratosis, amelanotic, or pigmented Bowen disease. It is possible to see if the nits are full (vital nits) or empty growing nodule (arrow) representing a squamous cell which helps determine the success or failure of treatment carcinoma and the mountain and valley pattern of a seborrheic keratosis (box) characterize this lesion. The Pediculosis Pubis cobblestone pattern of a nevus is in the dermoscopic It is possible to easily see the parasite attached to adjacent differential diagnosis. Pigment network, brown globules, homogeneous blue fibrosing alopecia, discoid lupus, folliculitis decalvans) color, or parallel patterns. There are criteria for a seborrheic keratosis or basal Congenital Hair Shaft Abnormalities cell carcinoma associated with pigment network and Monilethrix brown globules. Elliptical nodes (normal shaft diameter) cytic lesion, seborrheic keratosis, dermatofibroma. Narrow internodes (dystrophic hairs) pyogenic granuloma, or ink spot lentigo; therefore. Elliptical nodes regularly separated by narrow internodes the lesion should be considered melanocytic. Hair shafts bend regularly at multiple locations in different nocytic lesion, seborrheic keratosis, basal cell carci directions noma, dermatofibroma, or hemangioma; therefore. Trichorrhexis invaginata (“bamboo hair”) the lesion should be considered melanocytic. Alternating light and dark bands are seen clinically cysts, pseudofollicular openings, fat fingers, and hair-. Which criteria can be used to diagnose a basal cell Pili trianGuli anD CanaliCuli carcinoma? Flattened hairs with longitudinal groves hypopigmentation Pili bifurCati anD MultiGeMini C. The absence of a pigment network, arborizing vessels, pigmentation, ulceration, spoke-wheel structures. A variable number of red, sharply demarcated vascu lar spaces called lacunae and fibrous septae 1. Pigment network, arborizing vessels, and central specific criteria such as symmetry of color and white patch structure and one prominent color. Usually they have several well-developed melanoma periphery specific criteria such as asymmetry of color and C. A central white patch and peripheral pigment structure, multicomponent global pattern, regular network network, regular globules, and regular streaks. They contain a variable number of melanoma like cysts specific criteria such as asymmetry of color and struc E. Multifocal hypopigmentation, arborizing vessels, and ture, multicomponent global pattern, irregular local a central bluish white veil criteria, 5 or 6 colors, and polymorphous vessels. Melanoma-specific criteria on the trunk and extremities Answers can contain this combination of criteria: 1. Asymmetry of color and structure, a cobblestone variation of pigment network (regular and/or irregular), global pattern, and regular globules or blotches multiple brown dots and/or globules, homogeneous B. A multicomponent global pattern, symmetry of color blue color of a blue nevus, and parallel patterns seen on and structure, regular network, regular globules, and acral skin. The default category is the last way to diag regression nose a melanocytic lesion. Polymorphous vessels, arborizing vessels, 2 colors, openings can be seen in melanocytic lesions but are not and regular streaks primary criteria to make the diagnosis. Irregular network, irregular globules, irregular and C diagnose a basal cell carcinoma, dermatofbroma, blotches, and regression and hemangioma. Diagnosing a melanocytic lesion by default means that one does not see criteria for a melanocytic lesion, 8.

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In the United States allergy treatment 10 purchase quibron-t 400 mg without a prescription, this obligation generally falls to allergy treatment pregnancy buy quibron-t 400 mg on-line the original brand name manufacturer of the drug allergy forecast zyrtec generic quibron-t 400mg fast delivery. Even with a single company statement allergy symptoms vs flu symptoms buy 400 mg quibron-t visa, however, there is often debate and sometimes discrepant views between personnel within the organization. Such a nonstandardized company view can lead to the same adverse event case report being reported to some authorities and not reported to others elsewhere, even when judged against the same source reference document. Regulators, partly due to their position, seem to be more pragmatic in their views (previously cited example regarding spontaneous abortion). Often the problem is within the company itself where sometimes (particularly in the United States) there is a need to adhere to a legalistic interpretation of the regulations. When one examines the diverse responses received to the examples presented in this informal survey (Tables 1, 2, and 3), it is quite apparent that there is indeed a need to develop standardized approaches in determining ‘‘expectedness’’ or ‘‘labeledness’’ and seriousness. If one accepts the last guideline, that if in doubt report, and bears in mind that the core safety data sheet contains the central elements pertinent to safe use of the drug, wherever in the world the drug is marketed, it should be easy to determine the company stance for labeledness equivalence, and the company can then generate a universal list of adverse events which would always be viewed as medically, and consequently regulatory, serious by that organization. If this information is stored in the company’s computerized database, an automated regulatory reporting algorithm can indicate those cases to be reported to the regulatory authorities worldwide, thus saving debate, and possible company embarrassment. Whether or not the reader agrees with each guideline presented above, and recognizing that there will always be medical ‘‘gray’’ areas, the authors recommend a unified within-company position now for standardizing ‘‘expectedness’’ and ‘‘seriousness’’ for adverse event case reporting, and hopefully, a unified between-company position in the future. Difficulties often emerge in the case evaluation process, particularly in the absence of clear criteria such as hospitalization, life-threatening, death; in such cases, medical judgement is called for. It is suggested that a list of terms that would always be considered ‘‘serious‘‘ could be developed to provide some guidance and to reduce uncertainty in what should be reportable to regulators. Such a list is not meant to be a substitute for case-by-case review and decisionmaking; however, it can provide a mechanism for assigning medical seriousness in the absence of detailed and confirming information. As a result, the sample list presented should not be regarded as thorough or definitive, but rather a starting point. Different users may wish to develop their own custom-designed list to serve their special needs related to the medical aspects of their products and the diseases they treat. The terms given do not necessarily refer to a serious condition per se, but may be indicative of a serious syndrome. Paragraph numbering is also used for demonstration purposes to highlight the order proposed for the template. Case reference number 16041938 is a spontaneous case report sent by a hospital pharmacist which refers to a male aged 84 years. The patient’s past medical history included gastric ulcer, asthma, and hypertension. The following drugs are known to have been taken by the patient prior to the event (start date in parentheses): cimetidine (1996), steroids (1990) and tetracycline (September 9, 1999). Some 12 hours later, and 10 minutes following the latest dose, the patient developed rash, dyspnea and queasiness. Over the period of the next two days, the patient also developed chest pain and later unconsciousness. The patient was treated for the event with a beta-blocker; qweasytrol was discontinued on 8 January 2000. The patient died on 12 January 2000 from myocardial infarction; no autopsy was done. Death occurred approximately 12 days after the treatment with qweasytrol began and 4 days after it was discontinued. In his opinion, 297 other possible etiological factors include hypertension and the patient’s age. The company believes the following facts are also relevant in this case: as a highly selective epsilon — G2 receptor antagonist, there is no known plausible mechanism by which the drug would cause a myocardial infarction. However, if there were a rechallenge, a typical paragraph might read: Qweasytrol was subsequently reintroduced and the event did/did not recur. When qweasytrol was again discontinued, the event abated/did not abate/had an unknown outcome. Examples of Acceptable Company Clinical Evaluation Comments for Possible use in Paragraph 8 of a Standard Narrative 1. The available pre-clinical data did not suggest a possibility that the subject drug would induce —. As only limited information has been obtained so far, it is difficult to assess a cause and effect relationship. The temporal relationship (6 weeks) between the onset of the event and administration of drug x, which has a one-hour half-life, makes any causal relationship unlikely. It is of interest to note that the patient was subsequently rechallenged at the same dose without recurrence of the adverse effect. The following important information is lacking —, thus the causal relationship to drug x is not assessable. The event resolved while drug x was continued at the same dose which makes any relationship to the drug unlikely. The co-medications y and z should also be considered causative; the reported event is labeled for both drugs. The company’s view is that the event is not due to the drug for the following reasons —. This adverse event is not reflected in the prescribing information, but will be monitored closely in the future. The medication was not administered according to the dosage recommendation for the drug. The investigator on follow-up has changed his assessment from ‘‘probably’’ to ‘‘probably not’’ for the following reasons —. This case has also been forwarded to (name of the other manufacturer) as — (drug name) is the primary suspect drug. The patient’s medical history provides an alternative explanation for the reported event. Examples of Unacceptable Company Clinical Evaluation Comments for Paragraph 8 of a Standard Narrative 1. The investigator changed his assessment from ‘‘probably’’ to ‘‘probably not’’ on follow-up. Furthermore, for products with subsequent additional regulatory approvals (new indications, new dosage forms, etc. This has significant implications with regard to database cut-off dates (data lock-points), analysis and presentation of data, as well as for preparation and submission of reports (which is required no more than 60 days beyond the data lock-point date. However, this schedule will mean that for older products not approved through the centralized or mutual recognition procedures, reports on a single drug covering different time periods (6 months, one year or 5 years of data) may be required, possibly at different times, in different countries, depending on the approval dates in those countries. A few regulatory authorities are not prepared to accept reports which are perceived to be out of date with reference to the product’s local birthdate. For example, the Finnish and Belgian agencies demand that the cut-off date (data lock-point) for a five year report be within 6 months prior to the renewal date. Theoretically, if an international birthdate acceptable in all countries could be established for all formulations of a drug, the five-year report could be compiled only once every 5 years when the product had reached maturity in all relevant countries; regulators would have to agree to permit flexibility in earlier submissions relative to the local birthdates to allow synchroniza tion of reports for all regulators. At present, companies are dealing with this situation in a number of different ways. Some companies supplement their already prepared five-year updates with line listings of reports covering the time between the cut-off for the five-year report and the later submission. Others produce a series of five-year reports that cover overlapping 5 year periods. Neither approach is ideal — they are very time consuming and defeat the objective of having harmonized, integrated and consistent analyses for all regulators at the same time. The situation becomes even more complicated if the reporting clock is set back to six-monthly when a new formulation or new indication is approved for a drug already on or near a 5 year reporting schedule. Similarly, six-monthly reports may be required by a country when its first 302 approval is obtained several years beyond the original international birthdate, even for a drug with a well established safety profile. These requirements are often specific to different formulations of the same active ingredient, based on their different approval dates not only in the same country but in different countries. On the other hand, the first license renewal application must be submitted at least three months before the expiration date of the marketing license (60 months after approval); in practice, because it takes about three months to prepare a renewal report, the first license renewal submission will cover only 4.

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References:

  • http://meak.org/science/Jennifer-Lynn-Gars/purchase-online-terramycin-no-rx/
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