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It is a very useful move to warm up such leg muscles as the triceps erectile dysfunction in young order viagra sublingual master card, the flexors erectile dysfunction treatment melbourne generic viagra sublingual 100 mg with mastercard, and extensors during cold weather erectile dysfunction medicine names generic viagra sublingual 100mg on line. Picking Up Picking up is a movement done with the palms of both hands erectile dysfunction treatment germany viagra sublingual 100 mg with visa, fin gers extended impotence stress purchase viagra sublingual 100mg online. Grasp the body part between both hands erectile dysfunction drugs used cheap viagra sublingual line, start to squeeze it gently, and simultaneously lift the muscle away from the bone struc ture at right angles. Pressure should be adjusted to the size of the muscle and its level of tension-tenderness (10 to 15 and eventually up to 20 pounds with each hand). This manipu lation will contribute mostly to toning the muscle as well as increasing circulation. Picking up is used mostly on the upper forelegs and hind legs; it is good on the stifle and 3. But nor mally it is used in sports massage, in short therapeutic treatments, or in a warm-up routine prior to exercise. If the muscles treated show acute signs of inflammation, do not use this movement. This movement efficiently increases circula tion and also is very useful in fighting inflammation over the muscles of the back. It can be used before saddling your horse, but mostly should be used after removing the saddle. Wringing is done with the palmar surface of the hand, thumbs extended at a 45-degree angle from the hand. Apply both hands flat on the body part; then start wringing the muscle side to side, almost in the same way you would wring a wet cloth. Wringing is a very efficient way to stimulate circulation and warm up muscles in a short time. Use an average pressure, starting at about 2 pounds and building to 15 pounds, depending on the 70 Equine Massage 3. Remain light when going over bony areas such as the spine, scapula, or point of the hip. A faster rhythm (2 strokes per second) will be very stimulating and may be irritating to the horse. Skin Rolling Skin rolling is a very soothing manipulation that is used mostly to: Maintain a healthy and shining coat Prevent the formation of excess adhesions Maintain elasticity of the skin With thumbs on one side and fingers on the other, grasp and lift the skin. Using either one or both hands (preferably both), push the thumbs forward, rolling the skin toward the fingers. The fingers draw the skin toward the thumbs, lifting, stretching, and squeezing the tissues effectively. Skin rolling is a gliding movement that should be performed in a slow, soothing manner to avoid irritating the skin, especially over areas where the underlying tissues are close to the bone. Progressively increase your pressure by a few pounds to the point of stretching the structure you are treating. Done gently, with 1 or 2 pounds of pressure vibra tions have a mechanical, soothing effect with a strong nervous reflex effect. When employed more heavily, with 2 to 5 pounds of pressure and at a faster, more aggressive rhythm, vibrations are a mechani cally stimulating move and less of a nervous reflex. Use the flat-hand vibration move in a gentle manner (light pres sure) over the sacrum for a couple of minutes when starting the relaxation routine. It is very efficient in eliciting the parasympa thetic nervous response, reaching the central nervous system (brain) quickly. This will soothe swollen joints, whether caused by acute trauma or chronic injury. Vibrations are also good for inflamed rheumatism or arthritis where regular massage is contraindicated. Intersperse effleurage and stroking frequently with this move to drain the tissues and relax the animal. A full treatment using this movement alone should not exceed 3 minutes over a small area or 5 minutes over a larger one. Shaking Shaking is a very strong mechanical movement used frequently in sports massage to increase circulation. Shaking is performed with either the fingertips or the whole hand in full contact with the body part. When applied briskly (2 or 3 strokes per second), it is one of the most stimulating massage moves. Take care not to irritate the nerve endings of the skin, espe cially if an inflammation is present. Always ease off a little when going over bony processes such as the point of the hip or the scapular spine. Principles and Concepts of Massage 75 Friction this movement is mostly used in sports therapy to break down adhesions and scar tissue (fibrosis) over muscular fibers, tendons, ligaments, fascia, joint capsules, and bones. Always warm up the area thoroughly with effleurages, wringings, and kneadings before proceeding to frictions. Frictions consist of small, deep, circular movements applied across the length of the muscle or up and down over a patch of fibrous tissue. Use the tip of your thumb or fingers when using this movement on small, local areas. Both styles are mechanically stimulating to the body, causing increased blood circulation. Keep in mind the degree of tissue inflammation, the dimension of the adhesions, and their location in relation to other structures (bones, joints, or veins). To break down fibrous adhesions you need to use a fair amount of pressure, starting at around 10 to 15 pounds of pressure, pro gressively building up to 30 pounds; adjust accordingly depending on your aim. Always warm up the area thoroughly before starting, and drain the area well when finished. It is better to reduce scar formation over the course of several massages than to take the risk of worsening the area and creating more inflammation. It is very important to intersperse your work with copious effleurage drainage every 20 or 30 seconds, and some wringing to keep the tissues warm. When working a patch of scar tissue, start from the periphery and work toward the center of the scar with moderate pressure (8 to 12 pounds) to loosen the fibers. Then use friction across the whole fibrous patch, going sideways or up and down (depending on the nature of the scar formation) in a circular fashion, using a much heavier pressure (15 to 25 pounds). As you use friction to relieve new adhesions or to break down old fibrous masses, it is good to ice before and after treatment. Simply apply a cold pack or use the ice massage tech nique described in chapter 4. Owing to the nature of the nerve tissues and their function, be very gentle and careful in your work. All are mechanically stimulating to the nerves except for the nerve stroking manipulation, which is a pure nerv ous reflex movement. Your initial contact over the course of the nerve should be very light; use almost no pressure until you feel that the horse has accepted your work. Even during the course of the treatment, however, too heavy a pressure or movements that are performed too quickly can trigger a very abrupt, almost panicky reaction from the animal. Here, these massage moves are pre sented in the order that they should be used to treat a nerve con dition such as neuralgia, which is the aching of a nerve after a strain. Because it would be irritating to the nerve, do not apply nerve stroking too long. Since this is the first movement you will use in this treatment, be extremely cautious during the initial contact. This would be very irritating, especially over the areas where the skin is very thin and the nerve is right underneath (the inside of the legs, for example). At the end of a nerve treatment, you can apply nerve stroking as a finishing touch to soothe and relax. If the nerve course shows some inflammation, it would be beneficial to cool the area first (see cold hydrotherapy application, chapter 4). Use only very light pressure points afterwards (1 to 2 pounds), progressively increasing as the structure improves. And be alert when using this massage move because the horse might abruptly move his leg in response to the pressure. Nerve Friction To perform nerve friction, use the friction massage move described earlier. Only apply nerve friction once the area is well warmed up through your massage treatment so your horse is well aware of your working that area. When a nerve has been elongated (overstretched during a bad fall, for example), apply a light friction along the whole course of the nerve. When a nerve has been totally severed (as with a bad cut, for example), you only need to work the few inches above the sec tion that was injured. Nerve Stretching Nerve stretching is basically a regular stretch of the limb that will affect the course of the injured nerve (see chapter 8). This stretch is done much more cautiously than others, starting with a very small stretch and progressively getting deeper over the course of several sessions. Never use the nerve stretch during the acute stage (first 24 hours) of an injury; stretching should only be used in the chronic stage (past 72 hours) of recovery. Principles and Concepts of Massage 81 Tapotements Tapotement massage consists of a series of soft blows to the body, done rhythmically. Light clapping, cupping, and hacking are done at approx imately 2 to 3 beats per second for starters, then up to 6 beats per second when the horse is warmed up. Heavier beating and pounding are performed more slowly, at 2 to 3 beats per second. The moves are mostly used to increase circulation and to energize the body; they are used frequently in therapeutic massage treat ments, sports massage sessions, and in warm-up routines. Done on their own, tapotements are very effective for warm ing up muscle groups just prior to exercise. Your horse might take some time to adapt to tapotements, but he will soon learn to like them. The application of tapotements should last a few minutes: 1 or 2 minutes over small areas and up to 3 minutes when working large parts. Clapping Clapping is done with the palm of the hand, the hand flat and the fingers stretched as though applauding. Use only 2 or 3 pounds of pressure to start, building to 5 or 10 pounds of pressure. This is a softer version of clap ping that is used over the rib cage and around bony structures (scapula, withers, hip, stifle, etc. Hacking Hacking is done in a springing manner with the flat side of the hand, the fingers spread out in a flexible, non-rigid manner. Use 5 to 10 pounds of pressure, and up to 15 pounds when working over big, bulky muscles. It is a favorite move to treat the back muscles or the thicker muscle of the hindquarters. Beating Beating is done with a relaxed closed fist, hitting the muscle groups with the flat side of the hand. Only use this move after you have already done several clapping, cupping, and hacking moves, and only over fleshy parts. A strong stimulation of fluid circulation will immediately follow this application. This move is rarely used except for deep stimulation of big muscle groups like those of the hindquarters. The Laying on of Hands the laying on of hands has great therapeutic value in soothing acute wounds, inflammation, nerve irritation, and stress of a mechanical or nervous origin even though it is not technically a classical massage movement. The technique is used where regular massage cannot be used; it is a great addition to regular treatment routines that furthers the soothing effect. Put your hands gently over the area of concern and mindfully feel the energy, the vibration of that part. The feeling of closeness that will quickly develop between you and the animal is a sure sign of the effectiveness of this procedure. As the nervous stress con nected to that particular problem releases, you will feel a heat wave coming out of the part treated. That heat wave will be pro portional to the stress recorded and the pain involved. When massage is contraindicated, the laying on of hands will often bring soothing energy to an irritated area, relieving pain. Basic Massage Movements Massage is classified into three basic groups: Soothing, stimulating, and producing a pure nervous reflex. Soothing Massage Movements A soothing massage can inhibit nerve impulses to the muscles, which results in relaxation. This reflex stimulates muscle tone (light contraction, causing an increase in blood and lymph circulation with resultant increased oxygenation, etc. Rhythm and pressure play important roles in the degree of stimulation you want to induce.

If on warfarin (Coumadin) erectile dysfunction meds viagra sublingual 100mg generic, the attending physician must confirm stability without complications erectile dysfunction treatment with exercise purchase 100mg viagra sublingual mastercard. Current 24-hour Holter monitor evaluation to include select representative tracings erectile dysfunction due to diabetes buy viagra sublingual cheap. Current M-mode impotence is the order viagra sublingual australia, 2-dimensional erectile dysfunction causes tiredness discount viagra sublingual 100 mg with visa, and M-Mode Doppler echocardiogram erectile dysfunction aids cheap viagra sublingual uk, specifically including chamber dimensions and valvular gradients. Examples include epinephrine injection, cardiac trauma, complications of catheterization, Factor V Leiden, etc. Recovery time before consideration and required tests will vary by the airman medical certificate applied for and the categories above. Copies of all medical records (inpatient and outpatient) pertaining to the event, including all labs, tests, or study results and reports. Required documentation for all pilots with any of the remaining conditions above: a. Additional required documentation for first and unlimited* second class airmen a. The applicant should indicate if a lower class medical certificate is acceptable (if they are found ineligible for the class sought) E. Additional required documentation for percutaneous coronary intervention: the applicant must provide the operative or post procedure report. Note: If cardiac catheterization and/or coronary angiography have been performed, all reports and actual films (if films are requested) must be submitted for review. Neuropsychological evaluations should be conducted by a qualified neuropsychologist with additional training in aviation specific topics. To promote test security, itemized lists of tests comprising psychological/neuropsychological test batteries have been moved to a secure site. When an applicant with a history of diabetes is examined for the first time, the Examiner should explain the procedures involved and assist in obtaining prior records and current special testing. Applicants with a diagnosis of diabetes mellitus controlled by diet alone are considered eligible for all classes of medical certificates under the medical standards, provided they have no evidence of associated disqualifying cardiovascular, neurological, renal, or ophthalmological disease. Specialized examinations need not be performed unless indicated by history or clinical findings. For medications currently allowed, see chart of Acceptable Combinations of Diabetes Medications. An Examiner may re-issue a subsequent airman medical certificate under the provisions of the Authorization. The report must contain a statement regarding the medication used, dosage, the absence or presence of side effects and clinically significant hypoglycemic episodes, and an indication of satisfactory control of the diabetes. The results of an A1C hemoglobin determination within the past 30 days must be included. Note must also be made of the presence of cardiovascular, neurological, renal, and/or ophthalmological disease. The presence of one or more of these associated diseases will not be, per se, disqualifying but the disease(s) must be carefully evaluated to determine any added risk to aviation safety. Hemoglobin A1C lab value and date (A1C lab value must be taken more than 30 days after medication change and within 90 days of re/certification) 5. Any evidence of progressive diabetes induced end organ disease Cardiac. Yes No Treating Provider Signature Date Note: Acceptable Combinations of Diabetes Medications and copies of this form for future follow-ups can be found at Airmen with a current 3rd class certificate will have the limitation removed with their next certificate. See the links below (or the following pages in this document) for details of what specific information must be included for each requirement/report for third-class certification. For details of what specific information must be included for each requirement/report (Items #1-7), see the following pages. Submit the following performed within the past 90 days: Item # 1 Initial Comprehensive report from your treating board-certified endocrinologist. It should be marked with times/dates of flights and any actions taken for glucose correction during flight activities. Thyroid palpation and skin exam (acanthosis nigricans, insulin injection or insertion sites, lipodystrophy); and 4. Readings from (at a minimum) the preceding 6 months for initial certification and thereafter 3 months. Have automatic alarms for notification for high or low glucose readings with at least two of the following: audio, visual, or tactile; 4. Visual field defects: type of test, method used (confrontation fields are acceptable). Evaluation from a board-certified cardiologist assessing cardiac risk factors; and 2. Maximal exercise treadmill stress testing (Bruce), beginning at age 40, and every 5 years thereafter and as clinically indicated. Customize low glucose to 70 mg/dL and high glucose to 250 mg/dL before printing report. Various flight safety considerations for this serious health condition could not be safely mitigated for commercial operations until recently. Testing ensures both good control and demonstrates the absence of end-organ damage. If the latter is present, the potential risk of cognitive impairment is increased, which could be magnified in a hypoxic or high-stress environment, affecting safety. While your physician understands how to keep your blood sugar stable while on the ground, he/she may not understand the additional challenges of the demanding aviation environment and may not consider them when determining clinical limitations. Be sure to discuss with your physician the fact that you operate in an environment that can be both hypoxic and place high demands on your ability to think clearly and rapidly. It is in your best interest to inform them to ensure that you receive the appropriate evaluations and care. Low blood sugar can be present at levels below 70 mg/dL and high blood sugar 267 Guide for Aviation Medical Examiners can cause cognitive impairment at levels just above 250 mg/dl. Accordingly, values between 100 and 200 are highly recommended, but the blood sugar is mandated at 70-250. Additionally, the acceptable range for the blood sugar is narrow because workload demands may render blood sugar testing and insulin injection difficult or even impossible. In addition, the more time spent in a low blood sugar or hypoglycemic condition, the more likely that one is unaware of it. The best way to ensure good control in flight is to require blood sugar maintenance in a tight range in the days and hours prior to the flight. Turbulence can make it impossible for pilots to perform finger sticks, even with an autopilot and/or second pilot. You should have a backup correction pen and basal insulin available if using an insulin pump. In this case, go to a back-up plan for the remainder of the flight and measure your finger stick blood sugar every 30 minutes. If you are unable to correct your blood sugar, treat this as any in flight emergency and land as soon as practicable. This risk is present each time there is a change in pressure altitude, however, airmen can mitigate the risk by limiting the amount of insulin available for injection and by clearing bubbles at the top of ascent. These pumps are relatively resistant to the effects of pressure changes and provide obvious advantages to pilots who operate aircraft in the flight levels. The ability to suspend insulin delivery for a low reading is a good safety feature. In addition, as previously noted, a pump in which the insulin reservoir is not in direct line for delivery is preferred. Talk with your board-certified endocrinologist about whether or not adjustments should be made on days when you are flying. If neither the primary nor the backup system is functional, you must terminate flight activity. Individuals certificated under this policy will be required to provide medical documentation regarding their history of treatment, accidents, and current medical status. There are no restrictions regarding flight outside of the United States air space. The applicant must have had no recurrent (two or more) episodes of hypoglycemia in the past 5 years and none in the preceding 1 year which resulted in loss of consciousness, seizure, impaired cognitive function or requiring intervention by another party, or occurring without warning (hypoglycemia unawareness). The applicant will be required to provide copies of all medical records as well as accident and incident records pertinent to their history of diabetes. A report of a complete medical examination preferably by a physician who specializes in the treatment of diabetes will be required. Two measurements of glycosylated hemoglobin (total A1 or A1c concentration and the laboratory reference range), separated by at least 90 days. Specific reference to the presence or absence of cerebrovascular, cardiovascular, or peripheral vascular disease or neuropathy. Confirmation by an eye specialist of the absence of clinically significant eye disease. Verification that the applicant has been educated in diabetes and its control and understands the actions that should be taken if complications, especially hypoglycemia, should arise. The examining physician must also verify that the applicant has the ability and willingness to properly monitor and manage his or her diabetes. In order to serve as a pilot in command, you must have a valid medical certificate for the type of operation performed. This evaluation must include a general physical examination, review of the interval medical history, and the results of a test for glycosylated hemoglobin concentration. The results of these quarterly evaluations must be accumulated and submitted annually unless there has been a change. On an annual basis, the reports from the examining physician must include confirmation by an eye specialist of the absence of significant eye disease. Monitoring and Actions Required During Flight Operations To ensure safe flight, the insulin using diabetic airman must carry during flight a recording glucometer; adequate supplies to obtain blood samples; and an amount of rapidly absorbable glucose, in 10 gm portions, appropriate to the planned duration of the flight. One-half hour prior to flight, the airman must measure the blood glucose concentration. If it is less than 100 mg/dl the individual must ingest an appropriate (not less than 10 gm) glucose snack and measure the glucose concentration one-half hour later. If the concentration is within 100 300 mg/dl, flight operations may be undertaken. If less than 100, the process must be repeated; if over 300, the flight must be canceled. One hour into the flight, at each successive hour of flight, and within one half hour prior to landing, the airman must measure their blood glucose concentration. If the 272 Guide for Aviation Medical Examiners concentration is less than 100 mg/dl, a 20 gm glucose snack shall be ingested. If the concentration is greater than 300 mg/dl, the airman must land at the nearest suitable airport and may not resume flight until the glucose concentration can be maintained in the 100 300 mg/dl range. In respect to determining blood glucose concentrations during flight, the airman must use judgment in deciding whether measuring concentrations or operational demands of the environment. In cases where it is decided that operational demands take priority, the airman must ingest a10 gm glucose snack and measure his or her blood glucose level 1 hour later. If measurement is not practical at that time, the airman must ingest a 20 gm glucose snack and land at the nearest suitable airport so that a determination of the blood glucose concentration may be made. Those individuals who have a negative work-up may be issued the appropriate class of medical certificate. If areas of ischemia are noted, a coronary angiogram may be indicated for definitive diagnosis. An assessment of cognitive function (preferably by Cogscreen or other test battery acceptable to the Federal Air Surgeon) must be submitted. Additional cognitive function tests may be required as indicated by results of the cognitive tests. At the time of initial application, viral load must not exceed 1,000 copies per milliliter of plasma, and cognitive testing must show no significant deficit(s) that would preclude the safe performance of airman duties. If granted Authorization for Special Issuance, follow-up requirements will be specified in the Authorization letter. Persons on an antiretroviral medication will be considered only if the medication is approved by the U. Food and Drug Administration and is used in accordance with an acceptable drug therapy protocol. In order to be considered for a medical certificate the following data must be provided: 1. Follow-up neurological psychological evaluations are required annually for first and second-class pilots and every other year for third-class. Formal cognitive function testing if due; and Any other tests advised by the treating physician. This report should include the information outlined below, along with any separate additional testing.

Most regulations for expedited reporting of clinical trial and spontaneous reports stipulate that the regulatory clock begins with the first awareness of a valid case by anyone in a company anywhere in the world erectile dysfunction vacuum pumps pros cons order viagra sublingual with visa. Special considerations might apply under some circumstances erectile dysfunction treatment bay area generic 100mg viagra sublingual with amex, such as in the following not unusual scenario: initial awareness comes from a printout by a literature search service or from an abstract that does not provide sufficient individual patient and other details to satisfy the minimum criteria for a case; a copy of the full paper or abstract is ordered; the original paper is in a language unfamiliar to the company erectile dysfunction treatment austin tx discount 100 mg viagra sublingual otc. For reports uncovered by foreign affiliates of a multinational company in a journal published in their local language impotence vasectomy buy viagra sublingual, the situation is a bit more straightforward; that affiliate will still have to provide impotence urology buy line viagra sublingual, say herbal erectile dysfunction pills review viagra sublingual 100 mg amex, an appropriate translation, typically in English, to the central safety department of the corporation. Journals may be circulated to staff in a number of different departments and in a number of different countries. A published report may thus become known to individuals within a company soon after a journal is received. However, individual members of a safety department with responsibility for managing such a report may or may not be the first to become aware of an article on safety or an individual case. Journals are often read for many 46 reasons and identification of a case report may depend on the skills of the reader. In many companies, there is a formal process for screening the literature for safety information, which may be under the responsibility of someone within the company library, within the safety department, or through an outside contractor, for example. Although others outside the safety department may come upon a relevant article, they may not bring it to the attention of the safety people, knowing that such an automatic search process is in effect. The drug safety unit of a company also requires adequate time to process the case(s) and conduct appropriate evaluation. Recognizing the difficulties involved, the general recommendations on reporting timelines are as follows: o Companies should establish processes for timely access to and review of the literature to permit expedited reporting of relevant cases within the 13 usual timeframe (15 calendar days from recognition of a valid case). It is recognized that cases described in the literature may have occurred long before publication, and that a sense of urgency for reporting might be perceived as inappropriate. However, especially when the case(s) represent new information, attempts to obtain any needed follow-up should still be made promptly and the case(s) dutifully reported to regulators as necessary. When is translation required, to what extent, and into what language(s) should it be done In general, for most countries other than those whose language is that of the journal, the internationally accepted standard is that translations can be in English; however, as noted, several regulators might require translation into the local language for some or all literature reports. Because experience suggests that literature reports are often sufficiently complete and detailed enough to permit evaluation, the need for follow-up may not be as important. However, caution is always appropriate to be aware of fraudulent or fictitious reports. Additionally, the lag time between the event and publication has often resulted in the original medical records having been archived and less available than for more recent cases, making it less likely that an author will respond to requests for information; authors may be much less likely than other reporters to cooperate since they believe and often reply that all the pertinent and important information is in the publication; and, there appears to be less urgency in follow-up, since, by the time a case appears in the published literature, considerable time is likely to have elapsed since its occurrence. In either case, the publication details should be added to the case record along with any additional important medical details relevant to the case; the new information should be handled as for any other follow-up report for regulatory reporting purposes, including on an expedited basis if appropriate. It would be highly unusual for such publications to provide information beyond what was already reported. Thus, the fact that the study results have been published should not, per se, be the subject of a follow-up report to the original case submission or study-report regulatory filings. In addition to the regulatory standards against which companies and regulators manage literature safety information, there have been attempts to set publication standards for authors and editors on content guidelines for adverse experiences and on informing companies or regulators of cases on a 14 timely basis (the Morges recommendations). Editors of journals often do not require that adverse reaction reports be submitted to the manufacturer or regulator at or before the time of submission of a manuscript for publication. Similarly, authors all too frequently fail to report cases in a timely way, either because they are not accustomed to spontaneous reporting or prefer to wait and only publish the case or case series. Changes to these unfortunate practices would help both companies and regulators fulfill their obligations and responsibilities and would ultimately help to improve the quality of case reports as a result of interactions between the authors and knowledgeable company representatives. Minimum information requirements for single and multiple case reports were defined, i. The guidelines developed in Morges are accessible on the Drug Information Association web site: <dia@diahome. Additionally, when the report is sent to companies prior to publication, they can provide comments and information that the author will often find very useful in his/ her interpretation of individual cases as well as in placing such cases in perspective relative to the overall safety experience. Furthermore, advanced notice to a company or regulator of a proposed publication can prepare these parties for disseminating any necessary information to the public or 15 professionals. While exchange of information and opinions between authors and those who receive advanced draft copies can enhance the process, clearly no parties should exercise pressure or influence against publication. It represents a network of millions of computers throughout the world that have the ability to interconnect on a full-time or part-time basis. It is expected to transform the healthcare landscape by offering unprecedented access to information, and it will empower 15 See Appendix 1. The Internet represents an opportunity in pharmacovigilance but careful thought must be given to whether and how this tool should be used for drug safety monitoring 17 or to share objective drug safety information. Transmission and retrieval of information with the Internet is relatively fast and simple. However, the ability to search for and obtain comprehensive information on a particular subject may be difficult depending on the choice of search engine(s), data classification and selection of search-term(s). Many websites have prescribing information for healthcare professionals and an area for posing and answering questions. From a pharmacovigilance perspective it is important to distinguish between (1) the collection (receipt) of safety data or correspondence over the Internet by companies or regulators from healthcare professionals or consumers. These two different uses of the medium do not necessarily carry the same responsibilities and processes. Some Practical Issues Several considerations bear on the possible use of the Internet for pharmacovigilance and drug safety applications. The Internet is also playing an ever increasing role in drug development, marketing and sales of 16 Poste, G. The Internet, Adverse Events and Safety, International Journal of Pharmaceutical Medicine, 12:83-86, 1998. Information Privacy and Security the need for personal data protection is particularly important with a medium such as the Internet over which potentially sensitive health information is readily exchanged. There is also the risk that information may by accessed by unintended parties and that the information may be deliberately altered. While these actions are not unique to the Internet, they are facilitated with such a medium and precautionary measures are advisable. Benghiat, Security in Web Clinical Trials, Applied Clinical Trials, 8:40-45, 1999. Currently, there does not appear to be any clear regulatory guidance for companies on how to approach information on the Internet. There is considerable variation between companies on what their homepages say about adverse reaction reporting. Many companies receive reports, mostly from consumers, via e-mail or message fields on their website, even though companies may not encourage direct Internet reporting. The typical debate on whether scanty, possibly incorrect information is better than no information at all also applies to the Internet as a source; as usual, judgment will be needed on a case-by-case basis. This temptation may well increase if the fictitious case reports were intended to be seen by persons other than the usual regulatory or company recipient. It is therefore particularly important to check the credentials of the reporter; this is sometimes difficult if not impossible without direct contact. It should be recognized that any abuse that can occur on the Internet also occurs now via more traditional media. Source of Literature and Medicinal Product Information the Internet provides access to a wealth of published literature from peer reviewed and other journals, but it also generates an enormous amount of anecdotal exchanges. Chat rooms, bulletin boards, and websites produce volumes of information that must be cautiously evaluated before acceptance. Experience to date generally indicates that spontaneous reports from chat rooms provide very scanty information. The onus is clearly on the reader to try to determine the validity and reliability of the information. Although this could be achieved at relatively low cost, given the borderless nature of the Internet there is a potential for confusion, even misinformation, given the different content and requirements for labeling in different countries and in different languages, even for the same product. Retrieving Information from the Internet When attempting to search for relevant safety data, for example, care must be taken in accessing or retrieving information on the Internet. Terminology standards and classification protocols will influence the ability to search for and retrieve the desired information. It is also important to select the appropriate search engine(s), in order to optimize data retrieval. However, it must be acknowledged that even using multiple search engines will only reach a fraction of available web sites. Access to Web Site Information Information posted on web sites primarily intended for persons in one country may be accessible to people in many other countries. For example, direct-to consumer advertising of prescription medicines may be accessed in countries where it is not allowed. Companies frequently post on the Internet the approved patient information for their products. At present, this information often differs from country to country, but it would not be unreasonable to post multiple versions of the approved patient leaflet, each in the language or languages of the country in which it is approved. It has always been a goal of pharmacovigilance to encourage and facilitate spontaneous reporting. It will be necessary to identify the reporter and to establish that there is an identifiable patient as part of the minimum criteria for a report. There are confidentiality and authentication issues, but the form with defined minimum criteria could be downloaded and sent by e-mail. What is the responsibility for screening a company or regulatory website for safety reports A procedure should be in place to ensure daily screening by a designated person(s) of the website(s) in order to identify potential safety case reports. It is also recommended that such sites be visited selectively for discussions on a significant drug safety issue in order to determine whether potentially useful safety information has been overlooked or whether information has been adequately communicated. Should product safety information be disseminated by companies and regulators via the Internet The Internet could have an important role in the transmission to healthcare professionals and, as appropriate, to consumers of consistent, up to date messages concerning safety and other aspects of labeling (for example, new warnings and contraindications). Use of the Internet in this way could also accelerate the availability of key information, subsequent to approval by regulators (if needed). Official data sheets and patient leaflets are already available through the Internet. The Working Group has specific recommendations in this area: In principle, the message should be consistent around the world since the Internet generally does not respect geographic boundaries. However, due to local labeling and language differences, this may not be possible to accomplish for all product details. In spite of the widespread availability of the Internet, many people do not have access to it or use it as a major source of information. Therefore, it is important that Internet and traditional sources convey the same message, including promotional material. In addition, due to the generally passive nature of Internet communication, traditional sources should be continually made available. Important safety information, such as that conveyed in Dear Doctor Letters, should be disseminated via the Internet as well as through more traditional mechanisms. Appropriate hyperlinks to sources of detailed information on such changes can also be provided. There is, however, an increase in types of reports that do not fall neatly into either of these categories. Many of these newer reports are generated by marketing programs used by pharmaceutical companies and through the increasing use of methods to encourage contact between consumers and the pharmaceu tical company. Pharmaceutical companies continue to struggle with determining how to handle such reports. The underlying assumption of a spontaneous reporting system is that health care providers and others make an effort to report. Letter or prominent notification in the lay or professional press about a suspect serious adverse reaction); new reports are thus stimulated, although they should still be considered spontaneous reports.

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Abdominal pain associated with Irritable Bowel Syndrome Linaclotide, a minimally absorbed peptide guanylate cyclase-C agonist at a dose of 290 g once daily significantly improved abdominal pain (48. Diarrhoea was the most common adverse event in patients treated with linaclotide (4. Chronic Pelvic Pain is well defined and involves multiple mechanisms as described in previous sections of chapters. The management requires a holistic approach with biological, psychological and social components. Unfortunately, the failure of one agent does not exclude potential benefit of an alternative. If the benefit is limited by side-effects, then the lowest effective dose should be found (by dose titration). Sometimes, patients will prefer a higher level of pain and have fewer side-effects. A review questions its routine use as a first line analgesic based on inadequate evidence of efficacy in many pain conditions including dysmenorrhoea [456]. It will not be effective for all patients and individual responses should be reviewed when deciding on longer term use. They have a peripheral effect, hence their use in conditions involving peripheral or inflammatory mechanisms. They are commonly used for pelvic pain; many are available over the counter and are usually well tolerated. They have more side-effects than paracetamol, including indigestion, headaches and drowsiness. If this is not achieved, or side-effects are limiting, then they should be withdrawn. Neuromodulators these are agents that are not simple analgesics but used to modulate neuropathic or centrally mediated pain. There are several classes commonly used with recognised benefits in pain medicine. They are taken on a regular basis and all have side-effects that may limit use in some patients. Not all the agents are licensed for use in pain management but there is a history and evidence to demonstrate their benefit. The general method for using these agents is by titrating the dose against benefit and side-effects. The aim is for patients to have an improvement in their QoL, which is often best assessed by alterations in their function. It is common to use these agents in combination but studies comparing different agents against each other, or in combination, are lacking. Early identification of neuropathic pain with a simple questionnaire could facilitate targeted therapy with neuromodulators [63]. They also have anxiolytic affects [460] and are frequently limited by their side-effects. Tricyclic antidepressants have a long history of use in pain medicine and have been subjected to a Cochrane review [461], suggesting that they are effective for neuropathic pain. Amitriptyline is the most commonly used member at doses from 10 to 75 mg/day (sometimes rising to 150 mg/day). There is moderately strong evidence of benefit in diabetic neuropathy and fibromyalgia at a dose of 60 mg/day [462]. Selective serotonin re-uptake inhibitors are antidepressants with fewer side-effects. They are effective for depression, but there have been insufficient studies to demonstrate their benefit in pelvic or neuropathic pain [461-463]. Anticonvulsants Anticonvulsants are commonly used in the management of neuropathic pain. Gabapentin is commonly used for neuropathic pain and has been systematically reviewed [465]. For higher dose levels, reference should be made to local formularies, and many clinicians do not routinely exceed 2. A more recent pilot study suggests that gabapentin is beneficial and tolerable; a larger study is required to provide a definitive result [467]. The same systematic review found that doses less than 150 mg/day are unlikely to provide benefit. A review for chronic pelvic pain syndrome (prostate) only found a single reviewable study that does not show overall symptom improvement but suggests individual symptoms may improve. A formal assessment of efficacy against side-effects is required with the patient in order to determine longer-term treatment. Other agents can be used in the management of neuropathic pain but they are best administered only by specialists in the management of pain and familiar with their use. As with all good pain management, they are used as part of a comprehensive multi-dimensional management plan. Opioids Opioids are used for chronic non-malignant pain and may be beneficial for a small number of patients. Often patients will stop taking oral opioids due to side-effects or insufficient analgesic effect [469]. They should only be used in conjunction with a management plan with consultation between clinicians experienced in their use. It is suggested that a pain management unit should be involved along with the patient and their primary care physician. There are well established guidelines for the use of opioids in pain management as well as considering the potential risks [470]. Opioids Aware is a web based resource for patients and healthcare professionals, jointly produced by the Faculty of Pain Medicine of Royal College of Anaesthetists and Public Health England, to support prescribing of opioid medicines for pain. Oral administration is preferable, but if poorly tolerated, a percutaneous (patch) route may have advantages. More invasive approaches are less commonly used and within the realms of specialist units. Side-effects are common, including constipation, nausea, reduced QoL, opioid tolerance, hormonal and immunological effects along with psychological changes and require active management. This is another reason for these drugs to be used in a controlled way for long-term management of non-malignant pain. The aim is to use a slow or sustained release preparation starting with a low-dose and titrating the dose every three days to one week against improvement in both function and pain. There are a variety of other agents available and some are mentioned below: Transdermal fentanyl may be considered when oral preparations are restricted. It may also be beneficial when there are intolerable side-effects from other opioids. Oxycodone may have greater efficacy than morphine in some situations, such as hyperalgesic states including visceral pain [472]. Tramadol is an established analgesic with dual effects on opioid receptors and serotonin release. More recently, tapentadol, has been released with opioid action and noradrenaline re-uptake inhibition. It is too early to assess its real value in the armamentarium for pain management. Hydrodistension and Botulinum toxin type A Botulinum toxin type A may have an antinociceptive effect on bladder afferent pathways, producing symptomatic and urodynamic improvements [124]. Botulinum toxin type A trigonal-only injection seems effective and long-lasting as 87% of patients reported improvement after three months follow-up [474]. Since the 1970s resection and fulguration have been reported to achieve symptom relief, often for more than three years [481, 482]. Prolonged amelioration of pain and urgency has been described for transurethral laser ablation as well [483]. Major surgery should be preceded by thorough pre-operative evaluation, with an emphasis on determining the relevant disease location and subtype. As early as 1967, it was reported that bladder augmentation without removal of the diseased tissue was not appropriate [484]. Supratrigonal cystectomy with subsequent bladder augmentation represents the most favoured continence-preserving surgical technique. Various intestinal segments have been used for supratrigonal augmentation [486-488]. Subtrigonal resection has the potential of removing the trigone as a possible disease site, but at the cost of requiring ureteral re-implantation. Trigonal disease is reported in 50% of patients and surgical failure has been blamed on the trigone being left in place [489]. In contrast, another study [490] reported six out of seventeen patients being completely cured by supratrigonal resection [489]. A recent study on female sexuality after cystectomy and orthotopic ileal neobladder showed pain relief in all patients, but only one regained normal sexual activity [491]. For cosmetic reasons, continent diversion is preferred, particularly in younger patients. After orthotopic bladder augmentation, particularly when removing the trigone, voiding may be incomplete and require intermittent self-catheterisation. Patients considering these procedures must be capable of performing, accepting and tolerating self-catheterisation. It is important to note that pregnancies with subsequent lower-segment Caesarean section have been reported after ileocystoplasty [493, 494]. Recently, a large Chinese randomised-controlled trial of circumcision combined with a triple oral therapy (ciprofloxacin, ibuprofen, tamsulosin) vs. However, despite a large cohort, the study results are questionable because of the weak theoretical background, and a potential large placebo effect lacking a sham control. Before having an impact on recommendations, the results of this study have to be independently confirmed and the treatment effect must persist. Testicular Pain Syndrome Microsurgical denervation of the spermatic can be offered to patients with testicular pain. In a long term follow up study, patients who had a positive result on blocking the spermatic cord were found to have a good result following denervation [496]. An early scar excision before three to six months after pain onset was associated with better pain relief. Adhesiolysis is still in discussion in the pain management after laparotomy/laparascopy for different surgical indications in the pelvis and entire abdomen. A recent study has shown, that adhesiolysis is associated with an increased risk of operative complications, and additional operations and increased health care costs as compared to laparoscopy alone [498]. One trial comparing two forms of laser reported good results, but did not compare with sham treatment [500]. The majority of publications on treatment of urethral pain syndrome have come from psychologists [189]. In patients with adenomyosis, the only curative surgery is hysterectomy but patients can benefit from hormonal therapy and analgesics (see 5. Pudendal Neuralgia and surgery Decompression of an entrapped or injured nerve is a routine approach and probably should apply to the pudendal nerve as it applies to all other nerves. There are several approaches and the approach of choice probably depends upon the nature of the pathology. The most traditional approach is transgluteal; however, a transperineal approach may be an alternative, particularly if the nerve damage is thought to be related to previous pelvic surgery [196, 263, 505-509]. This study suggests that, if the patient has had the pain for less than six years, 66% of patients will see some improvement with surgery (compared to 40% if the pain has been present for more than six years). On talking to patients that have undergone surgery, providing the diagnosis was clear-cut; most patients are grateful to have undergone surgery but many still have symptoms that need management. These techniques are only used as part of a broader management plan and require regular follow-up. These are expensive interventional techniques for patients refractory to other therapies. There has been growing evidence in small case series or pilot studies, but more detailed research is required [511]. Its role in overactive bladder and faecal incontinence is more robust but is limited for pain. Over 90% of patients treated with neuromodulation stated that they would undergo implantation again [512]. Long-term results were verified in a retrospective study of patients from 1994 to 2008 [513]. The most frequent reason for explantation was poor outcome (54% of the failed patients). In a study of women who underwent permanent device implantation from 2002 to 2004 [465], mean pre /post operative pelvic pain and urgency/frequency scores were 21. Pudendal Neuralgia Pudendal neuralgia represents a peripheral nerve injury and as such should respond to neuromodulation by implanted pulse generators. However, it is important that the stimulation is perceived in the same site as the perceived pain. There is limited experience with sacral root stimulation and as a result stimulation for pudendal neuralgia should only be undertaken in specialised centres and in centres that can provide multi-disciplinary care [514-517]. Chronic Anal Pain Syndrome In a large cohort of 170 patients with functional anorectal pain from the St. Sacral neuromodulation has been reported to be somewhat beneficial in two uncontrolled studies, showing improvement in about half the patients [518, 519].

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