Venous Disorders and Graduated Compression Therapy: Ensuring the Proper Fit for Patient Compliance

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  • Discussion Points: Welcome Introduction of Speaker, including background of Speaker Explain the format for the day: Morning - a knowledge-based continuing education program designed to increase medical knowledge, comfort in consulting patients about compression stockings and venous disorders. Afternoon - opportunity to practice measuring and fitting for compression stockings and have some hands on time donning and doffing stockings to ensure your comfort and ability in servicing your patients.
  • Read slide.
  • Incidence of venous disorders increases with age and is more common in women with 40% of women in their 50s suffering some sort of venous disorder. Across all ages and genders, 60% of Americans suffer from venous disease and it sequlae. It is estimated that 60-75% of the blood in the body is to be found in the veins (Bergan, p.40) Discussion Points: Mention that 1-in-2 people in the room today have a venous disorder, majority are likely in the early stages of chronic venous insufficiency.
  • Read slide. These risk factors are supported in several clinical studies, let’s look at a couple. Obesity (BMI>30)
  • The optimal treatment of VTE during pregnancy has not been studied via randomized controlled trials, and clinical recommendations are based on expert opinion. Therapeutic anticoagulation is indicated when DVT orPE is diagnosed. Anticoagulation options include lowmolecular-weight heparins (LMWHs), unfractionated heparin (UFH), and warfarin (Coumadin; postpartum only). Not well researched and reported is also leg edema attributed to early stages of venous insufficiency.
  • Women who are pregnant are at risk of developing varicose veins. Approximately 30 % of women pregnant for the first time, and 55 % of women who have had two or more pregnancies, may develop varicose veins. During pregnancy, blood volume increases by 40 to 50%. The effects of progesterone cause the vein walls to become less elastic and dilate. The pressure of the fetal head in the pelvis can compress pelvic veins and obstruct venous outflow from the leg. While varicose veins may subside postpartum, with each subsequent pregnancy, they are far less likely to completely disappear. Wearing compression hosiery during pregnancy will aid in the prevention of varicose veins. 1. Swiss Medical Weekly 2001: 131: 659-662 2. Physiology: Issue 9, (1998) 1-3 Physiological Changes Associated with Pregnancy 3. Br J. Obstec Gynecol. 1999 Jun; 106; 106(6): 563-9: The effect of compression therapy in venous haemodymanics in pregnant women
  • Discuss the differences and importance of the 3 vein systems with more emphasis on the 1 st two and the volumes of blood that the 1 st two systems handle. Lastly, point out the various veins that are categorized within each system (i.e., the popliteal vein in the deep system and the saphenous vein in the superficial system and those being the common points of a dvt.)
  • To summarize…think of the three systems of veins as you would a road map… The interstate handles a larger volume of traffic, just like the deep vein system handles more blood volume. It is also a more direct route (point “a” to point “b”) DENOTED AS THE BLUE ANIMATION The side roads, like the superficial roads, feed into the interstate. They are smaller roads and have handle a low volume. DENOTED AS THE YELLOW ANIMATION The perforating veins are the on-ramps which take blood from one system to the other. DENOTED AS THE RED ANIMATION What happens to the traffic flow when there is an accident (1) on the exit ramp and/or (2) on the interstate? Discuss the flow and reversing of flow, increasing pressure. Introduce the concept of DVT in the deep vein (interstate)
  • The primary function of the venous system is to return blood to the heart. In the closed circulatory system, venous return is equal to cardiac output.
  • The major peripheral pump consists of calf muscle surrounding the soleal sinuses and tibial veins. Think of the calf muscles as the peripheral heart. Calf pump activity lowers the venous pressure and reduces capillary hydrostatic pressure. The prevents edema from developing in the dependent limb. Every time the calf muscle contracts the pressure in the deep veins rises as the contained blood is compressed and moved upwards against the force of gravity. When the calf muscle relaxes, the emptied segment of vein relaxes and blood is sucked in from the capillary bed and surface veins. Calf pump malfuction is central to the development of chronic venous insufficency.
  • Other ‘pumps’ that help to push venous blood toward the heart include: Ankle and foot pumps contract to force blood upwards. The ankle pump works in close relation to the calf muscle pump that is of primary source for the venous return from the lower extremities. It assists the calf muscle with flexion and extension of the foot causing contraction. Any movement of the ankle joint causes tension, and as a result, the diameter of the short saphenous vein diminishes causing an emptying of the vein. The foot pump lies between the sole and the bones of the foot. Venous valves are absent in the sole of the foot, so blood is squeezed out of the veins by body weight when standing or walking. This effect can also be achieved with Medical Graduated Compression.” The diaphragm , the membrane that separates the abdominal cavity from the chest cavity, can help pump blood through the veins. (Ask the audience to take a deep breath) When you take a deep breath, this causes the diaphragm to pull down- pulling air into our lungs—but it also creates a pushing down pressure on the veins in the legs. (Ask the audience to exhale—hard!!) This action pulls the diaphragm up, which pushes the air out of our lungs and pulls the blood upward through our veins toward our heart. Fitters, this can be a useful piece of information when you go into long term care facilities and are working with more sedentary people. A few deep breaths every few minutes can make a difference for good leg health.
  • The valves function to ensure uni-directional blood flow. Venous valves are tissue paper thin structures, bicuspid structures that resemble upside down parachutes and are found every 2 to 7 cm depending on the size of the vein. The valves provide a one-way flow of venous blood, against gravity, and back to the heart . When venous valves are competent and working properly, the blood can oppose to forces of gravity and flow upwards to the heart. Distal flow and flow through the communicating veins is normally prevented by the venous valves. In order for valvular closure to occur, there must be a reversal of normal transvalvular pressure gradient. Venous flow is not in a steady state but is normally pulsatile. Hydrostatic pressure is reduced by the action of competent valves in conjunction with action of the peripheral pumps. In the resting position, with the foot flat on the floor, there is no venous flow. In the heel strike position, the venous plexus under the heel; and plantar surface of the foot is emptied. This is why you may commonly hear that one should flex their feet while on an airplane to maintain blood flow to the heart.
  • Research suggests that there are several attributing factors to valve dysfunction: Vein wall injury allows the vein to elongate and dilate thus producing the visual manifestations of varicose veins. An increase in the vein diameter is one cause of valve dysfunction that results in reflux. The effect of persistent reflux causes a chronic increase in distal venous blood pressure. Prolonged increase venous blood pressure or venous hypertension initiates a cascade of pathologic events which cause vein valves to become perforated, torn, and ever scarred to the point of near total absence. Venous hypertension commonly manifest itself as edema, pain, itching, skin discoloration, and in worst case scenarios ulceration. The earliest signs of this process is elongated and dilated veins in the epidermis and dermis known as spider veins (telangiectasias) seen as the blue-green or purplish veins beneath the skin and slightly deeper are the torturous and inflamed varicose veins (Bergan, p. 42-43). Address specific patient demographics and lifestyles which can be attributed to damaged valves, and the pathophysiology behind each specific occurrence. For example, address age (elasticity of vein walls), illness, smoking, obesity, pregnancy (hormone changes, increased blood flow, fetal head resting on left iliac vein). Address how damaged valves and lack of contraction create an incompetent vein system. When valves are incompetent blood refluxes and influx is sluggish; blood may leak through the opening in the valve causing blood “pooling”. Mention how incompetent valves contribute to pooling of blood in the legs, ankles, and feet which manifests as edema. As this occurs, pressures increase in the veins due to the need to re-direct the blood, and this leads to veins distending to accommodate increased blood volume, this further pulls the valves apart, and this cascade continues and most patients ultimately start to notice and/or address their venous condition as they notice the unsightly veins – varicose veins. Varicose Veins Frequently associated with heredity, jobs involving prolonged standing or pregnancy. Great saphenous vein and its branches are most commonly affected. May begin at the thigh and extend to the foot Can be caused by a DVT or secondary varicosities (a clot in the deep vein system).
  • Dynamic pressure represents the energy imparted by the pumping action of the heart; the majority is dissipated in the arterial circulation. The remaining venous portion is the pressure gradient between the capillary bed and the atrium. When supine, gravitational pressures are neutralized and blood flows along a dynamic pressure gradient. Hydrostatic pressure is generated by gravity. When standing still, extremity venous pressure is primarily determined by the distance (height) to the right atrium. The density and weight of blood contribute a constant proportion in addition to height of the column. Pressures in structures above the atrium (upper extremity, cervical) do not fall below zero when upright due to coaptation of the venous walls. An additional 6mm Hg is added to UE pressures (height of the first rib).
  • Note from standing still to walking it takes 7 steps to cause blood pressure to fall. Incompetent Valves Image Failure of the calf pump to function properly causes the venous pressure to remain elevated when subjects are erect (which was evident on the chart showed on previous slides). As mentioned in discussion of muscle pumps, specifically the calf muscle pump, every time the calf muscle contracts the pressure in the deep veins rises as the contained blood is compressed and moved upwards against the force of gravity. When the calf muscle relaxes, the emptied segment of vein relaxes and blood is sucked in from the capillary bed and surface veins. This causes the pressure to fall to approximately a third of the resting level, i.e. 100mmHg to 30mmHg. Repeated movement of the leg to cause calf muscle movement causes an incremental fall in pressure and returns venous blood towards the heart. Compression stockings improve the drainage of superficial venous blood, thereby reducing the risk of over-distension.
  • Read slide.
  • First review Vichow’s Triad as it relates to any patient getting a DVT. Give examples of situations of stasis (sitting for long periods of time either on a job or airplane or even being immobile in a hospital bed), hypercoagulable states (caused by familial history or hormones), and endothelial injury (surgery, bumping the leg, car accident). Bring awareness to the role that pharmacist can play in discharge counseling to hospital discharges and anticoagulant patients. The media is now attempting to do a better job in brining awareness with the recent Serena Williams PE incident.
  • The point of the slide and study is to emphasize that there are protocols in place for DVT prophylaxis and management within the hospital setting, including the placement of patients on anti-embolisms stockings during hospital admission; however after hospital discharge the risk does not dissipate. There is not a continuity of care in the transition from the hospital to the community setting. That a large majority of patients that present to your pharmacy counter with hospital discharge prescriptions are prime targets for your recommendation of graduated compression garments to prophylaxis against a DVT, PE, or both.
  • Peripheral artery disease: pain that worsens with activity because further depriving oxygen supply Peripheral vein disease: pain that improves with activity Also can identify arterial vs. vein disease by taking the ankle brachial index. This test is done by taking the blood pressure at the brachial artery in the arm and at the ankle. Then taking the index of the systolic blood pressure of the ankle over the arm. A ratio of 1 is normal and if <0.8 this indicates some arterial insufficiency.
  • Telangiectasia (or spider veins or reticular veins) are the small red, blue, and purplish veins that appear on the skin surface. They are more of cosmetic concern versus painful. Varicose Veins can be characterized are primary or secondary in nature. PRIMARY Varicose Veins have no apparent cause, are frequently associated with heredity, jobs involving prolonged standing or pregnancy. Varicose veins are typically seen within the great saphenous vein and its branches, and may begin at the thigh and extend to the foot. SECONDARY Varicose Veins are a direct result of deep vein occlusions. If an occlusion occurs there is increased pressure within the deep vein system. Once the deep veins have been occluded by a thrombus, the resulting ambulatory venous hypertension continues to dilate the veins rendering more and more of the venous valves incompetent. The larger and longer the clot the greater the potential for multiple valve damage. The venous reflux results in higher venous pressure in the deep system which is transmitted to the superficial veins via the perforating veins and this can result in varicose dilatation of the superficial veins.
  • C linical E tilolgy or cause A natomy P athophysiology
  • As the drug information specialist, we should be reading the labels, package inserts/prescribing information specifically noting the Important Safety Information. Put your clinical skills into practice.
  • Venous insufficiency is a manageable condition. Once damage is done to the vein system, treatment goals are to restore the patients functionality and make them comfortable which can be achieved by [Read Next Slide].
  • Read slide. The treatment modalities mentioned in the literature for prevention, treatment, or management of any venous disease are listed here. You will notice as we address each of the treatment modalities that some are more specific to one disorder over the other. For example, the pharmacologics and herbal alternatives are specific to DVT, PE, VTEs whereas vein procedures are specific to spider veins and varicose veins and the mechanical compression can be utilized in any vein disease. Non-Pharmacologics/Mechanical Compression Restores venous blood return to heart Reduces or prevents edema Slows progression of venous disorders
  • Pharmacologics are limited to anticoagulant therapy and have been shown in the literature to reduce symptomatic and asymptomatic VTE (combination of DVT and PE) by 50-65%. This statistic is derived from studies done in a controlled hospital setting, very little to no clinical studies have been conducted in the ambulatory setting. This is why we will see that clinical guidelines addressing use of these medications listed below are specific to hospitalized patients and do not carry over to community recommendations.
  • Clinical evidence as provided through the Natural Medicine Comprehensive Database supports that the following herbal alternatives Taking horse chestnut seed extract orally can reduce some symptoms of chronic venous insufficiency, such as varicose veins, pain, tiredness, tension, swelling in the legs, itching, and edema. Taking butcher's broom orally alone, or in combination with vitamin C and hesperidin, seems to relieve chronic venous insufficiency symptoms including pain, heaviness, leg cramps, itching, and swelling. Taking grape seed extract or its proanthocyanidin constituents orally seems to reduce subjective symptoms of chronic venous insufficiency and improve venous tone. Additionally, in one clinical trial, a specific grape leaf extract, known as red vine leaf extract (AS 195, Antistax, Boehringer Ingelheim), was given orally to patients with stage I and stage II chronic venous insufficiency. Leg edema significantly decreased after 6 weeks of treatment compared to placebo. Doses of 360 mg and 720 mg daily were both effective, but the higher dose produced a slightly greater effect. Patients also reported significant decreases in subjective complaints such as tired or heavy legs, tension, and tingling and pain after 12 weeks of treatment. Taking pycnogenol orally seems to significantly reduce symptoms of leg pain and heaviness, and edema in people with chronic venous insufficiency (CVI) when used for 3-12 weeks. The dose of pycnogenol used most often is 100-120 mg three times daily, but lower doses of 50 mg three times daily or 45 mg to 90 mg once daily also seem to be effective. Some people also use horse chestnut seed extract to treat chronic venous insufficiency, but pycnogenol alone appears to be more effective. Taking sweet clover orally seems to be effective for problems associated with chronic venous insufficiency such as varicose veins
  • Read Slide. The notes below are FYI in case questions are asked; however, on average these procedures are performed by a vasuclar physician and he/she will provide a full consult for the patient. This is a rare area seen by pharmacists or technicians. Sclerotherapy consists of injecting a sclerosing agent into a vein, causing an inflammatory reaction in the endothelium of the vein wall. The vein walls swell from the inflammation and adhere together under compression and form a scar (fibrotic cords) that is absorbed by the body. Sclerotherapy can treat both small superficial varicose veins and spider veins. This procedure does not require an incisions, causes minimal pain, and there is virtually no recovery time for the patient. He/she can resume normal activities of daily living immediately following the procedure. The disadvantages are staining, allergic reactions, and the possible need to repeat the procedure. The only approved sclerosing agent is the United States is Sodium Tetradecly Sulphate (Sotradecol) 1% to 3% solution. Radio Frequency Ablation does not remove any veins. The catheter is threaded through the greater saphenous vein entering at a small incision below the knee or at the ankle. Ultrasound may be used to locate the vein. RF energy is delivered through the catheter, which heats the vein wall and causes it to shrink, collapse, and seal shut as the catheter is slowly removed. As with vein stripping, the body re-routes blood flow through remaining healthy veins. Symptoms will improve in 1-2 weeks. Endovenous laser treatment is a treatment alternative to surgical stripping of the greater saphenous vein. A small laser fiber is inserted, usually through a needle stick in the skin, into the damaged vein. Pulses of laser light are delivered inside the vein, which causes the vein to collapse and seal shut. The procedure is done in-office, under local anesthesia. Following the procedure a bandage or compression hose is placed on the treated leg. Endovenous laser treatment is FDA-approved for the treatment of the greater saphenous vein. Benefits: local anesthetic, often no incisions, quick recovery, very high (98%) early success rate Disadvantages: long-term results promising but unknown, very expensive cost of treatment per leg Phlebectomy is an invasive vein procedure in which a small incision is made into the leg, and a tiny hook is inserted to grasp the incompetent vein. The vein is hooked and then removed through the incision. Then the incision is sewn closed. Stripping & Ligation is an in-hospital procedure due to the required use of an anesthetic. It is quite traumatic for the patient and usually has longer recovery times and there is a high potential for healing complications causing cosmetic concerns. Fortunately, Stripping is not commonly done due to the advancements in treatments such as ELVT and ligation is the tying off of the vein with a suture that allows the vein to collapse with no blood able to get through. Containdications to this type of procedure is a thrombosis in recent months and lymphatic edema. Side Effects: Sensory disturbance of femoral and calf nerves, hematomas
  • COMPRESSION THERAPY (CT) is the cornerstone of treatment for venous and lymphatic disorders. Confusion reigns in the mind of most physicians between passive and active compression. Passive compression (“support”) is produced by inelastic bandages, which counteract the increase in muscle volume resulting from muscle contraction. At rest, the bandage delivers little or no pressure force. Therefore it is well tolerated for several days and may be applied in patients suffering from moderate arterial insufficiency. By muscle contraction, the inelastic bandage restrains the increasing muscle volume, creating a pressure force. Passive compression is therefore most active during muscle contraction, as in walking (“working pressure”), and almost totally inactive at rest (“resting pressure”). Active compression is delivered by an elastic orthosis both at rest and during exercise. The more or less powerful recoil forces of the elastic fibers exert an active pressure on the limb, which is enhanced by muscle contraction. Then both “working” and “resting” pressure are elevated. Active compression may be intolerable for bedridden or inactive patients. It is contraindicated in arterial insufficiency. Active and passive compression may be combined, as in multilayer bandages. Bandages Inelastic (i.e., unna boot) or short stretch bandages exert passive compression and are indicated in the treatment of edema, deep vein thrombosis, or trophic lesions of CVI. A properly trained staff must fit them. Long stretch elastic bandages high resting pressure effectively compresses superficial veins after surgery, sclerotherapy, or thrombophlebitis. However, working pressure may be less effective than with short stretch bandages. Superimposition of spirals enables an improvement in working pressure. These bandages are poorly tolerated when resting and have to be removed during the night. Intermittent Pneumatic Compression Devices Intermittent pneumatic compression devices compress the leg and/or foot and ankle and act as a pump to improve circulation in the lower extremities. Pneumatic compression devices consist of an inflatable garment for the leg and an electrical pneumatic pump that fills the garment with compressed air. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices. Intermittent pneumatic compression boots are generally accepted as a method for preventing deep venous thromboses (DVT) and complications of venous stasis in persons after trauma, orthopedic surgery, neurosurgery, or who for other reasons are unable to walk. Use of the intermittent pneumatic compression device has expanded to ambulatory persons who suffer from chronic venous insufficiency (CVI) of the legs and consequent edema, stasis dermatitis, ulcerations, and cellulitis. CVI of the legs is caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins. A systemic review of the literature concluded that the effectiveness of the addition of intermittent pneumatic compression in treatment of venous leg ulcers is unknown Pumps Each pump consists of an air compressor and an inflatable sleeve that envelops the arm or leg. The compressor pumps air into the sleeve. The first intermittent pump was developed for venous insufficiency in the 1960’s. The pump automatically inflates and deflates the sleeve intermittently. This action mimics the intermittent compression exerted by the body’s natural mechanisms. The pump is set to deliver a prescribed pressure at each inflation. Pressures generally range from 30-50 mmHg, frequently one to three times daily and duration from 1 hour to several. The compression classes vary from one country to another, while a European norm is awaited. We present here the classification proposed by the European Standardization Commission: ♦ Class I, 15–21 mmHg: minor varicose veins, functional venous insufficiency. ♦ Class II, 23–32 mmHg: slight CVI, or after surgery. ♦ Class III, 34–46 mmHg: more advanced CVI, leg ulcers, lymphoedema.
  • ( Ask question ) Do you know who has Compression Pumps in Your Area? ( Answer ) I recommend that you call your local hospitals nurses, etc., to become familiar with who offers this service in your area. Each pump consists of an air compressor and an inflatable sleeve that envelops the arm or leg. The compressor pumps air into the sleeve. The first intermittent pump was developed for venous insufficiency in the 1960’s. The pump automatically inflates and deflates the sleeve intermittently. This action mimics the intermittent compression exerted by the body’s natural mechanisms. The pump is set to deliver a prescribed pressure at each inflation. Pressures generally range from 30-50 mmHg, frequently one to three times daily and duration from 1 hour to several.
  • Short stretch bandages are used and long stretch bandages are contraindicated. The purpose of compression bandaging is to increase tissue pressure, which slows the flow of fluid into interstitial tissues and increases reabsorption into lymphatic circulation. Compression improves the efficiency of muscle pump action and prevents re-accumulation of evacuated lymph fluid. Bandaging also breaks up fibrosis and supports tissues while they return close to pre-edematous shape. Wraps can be difficult and time consuming to apply, but have a role in patient management and often are used to reduce excessive edema before fitting for compression garments. If the wrap is too tight, it will be painful and obstruct lymphatic and venous outflow. If the wrap is too loose it will not be effective. Unfortunately there is no mechanism to determine the pressure that is applied. In most cases a trained nurse must assist (increases cost), impeding the patient’s independence and reducing the patient’s willingness to comply with this therapy.
  • “ What are the goals of Compression Therapy?” To improve blood flow velocity To restore blood flow velocity to normal To reduce or prevent edema. 4. Prevent progression of venous or lymphatic?? disease Remember Virchow’s Triad and the possibility of dying from of pulmonary embolisms as a result of deep vein thrombosis (DVT)? According to Virchow’s Triad you only need 2 out of 3 specific factors to develop a DVT. One of those factors is a slowing of blood flow (venous stasis). Graduated Compression stockings and socks improves blood velocity and eliminates one of the potential factors for developing a DVT.
  • Discussion Points: Differentiate between the compression zones on a “graduated” compression stocking and an anti-embolism stocking. Point out that an antiembolism will graduate in pressure to the knee then is reverse gradient to the thigh vs. “graduated” compression stockings will continuously graduate in pressure from ankle to knee or thigh (style dependent).
  • Read slide. Discussion Points: Emphasize the patient population who should be wearing and receive a recommendation for “graduated” compression stockings vs. antiembolism stockings. Point out that as a pharmacist who receives an antiembolism prescription or request for an ambulatory patient, it is their role to educate and provide a proper recommendation. Also, to discuss the differences with the prescribing physician. Highlight
  • Discussion Points: Elaborate on each precaution. Diabetes is a precaution and not a contraindication, consider that most diabetics have some type of compromised blood flow and vascular damage occurring. Most diabetics should be able to tolerate wear a class I compression stocking. As Discuss progressive arterial insufficiency and why in theory it is a contraindication, but their not sufficient and consistent literature supporting this contraindication. Also, in practice, some physicians will still place a patient with PAD into compression stockings. Review that with intermittent claudication, arterial flow is impaired. So when a patient has pad—and wants to walk—an effort is placed on the muscles—they require more oxygen to function. The arterial blood flow is so impaired, the legs ache and “burn” the patient must rest—the requirement for oxygen is reduced—the legs feel better—the patient can walk more—until the pain starts again. So when evaluating a patient in the pharmacy, to distinguish between a patient with PAD and PVD, consider that a patient with PAD will experience relief of leg pain when walking vs. patient with PVD will not. Mention that arteries require oxygen supply, with narrowed arteries in a PAD patient, compression stockings may further compress the artery and lead to ischemia. This type of patient should be referred out. If medication can not control CHF—stockings should not be used or recommended.
  • Eighteen subjects (9 males, 9 females) average age of 61 years with diabetes, lower extremity edema, and a mean ABI of 1.10 completed the study. Subjects were fitted and dispensed 4-7 pair of stockings and instructed to wear them during all walking hours. Edema quantified through manual circumference measurements midfoot ankle calf Cutaneous edema measurements in the calf quantified via MoistureMeter handheld device that measures the difference in relative humidity between the ambient air and the measured skin
  • Eighteen subjects (9 males, 9 females) average age of 61 years with diabetes, lower extremity edema, and a mean ABI of 1.10 completed the study. Subjects were fitted and dispensed 4-7 pair of stockings and instructed to wear them during all walking hours.
  • Eighteen subjects (9 males, 9 females) average age of 61 years with diabetes, lower extremity edema, and a mean ABI of 1.10 completed the study. Subjects were fitted and dispensed 4-7 pair of stockings and instructed to wear them during all walking hours.
  • Eighteen subjects (9 males, 9 females) average age of 61 years with diabetes, lower extremity edema, and a mean ABI of 1.10 completed the study. Subjects were fitted and dispensed 4-7 pair of stockings and instructed to wear them during all walking hours.
  • Although mild weekly fluctuations are noted, there was an overall decrease in cutaneous edema in Week 0 to Week 4
  • SIGVARIS diabetic compression sock is ideal for: Pre-diabetic patients Newly diagnosed patients Diabetic patients with edema Expecting mothers diagnosed with gestational diabetes Because of the precaution of graduated compression therapy in diabetic patients, it is recommended to rule out neuropathy and determine the patients arterial sufficiency. Patients with an ABI>0.6 and no claudication could benefit from graduated compression therapy, but if the patient has cladication refer them to their physician for further evaluation. Most importantly for these patients, your recommendations of SIGVARIS diabetic compression graduated sock will help their legs to feel better because their circulation has improved…with improved ciruclation, your patients are more likely to be compliant with the need and your recommendation to exercise!
  • Thought type of slide!
  • The additional scripts can be SIGVARIS compression prescriptions or can be new medication prescriptions to your pharmacy…either way the business grows.
  • Reimbursement rates by insurance companies have fallen to the point where it is not profitable for a pharmacy to survive with just insurance as the primary payer!
  • There are many graduated compression stocking manufacturers for you and your patient to select amongst ranging from high quality premium brands listed on the left to low cost economical alternatives listed on the right. The most commonly known and utilized brands, listed here are Jobst, SIGVARIS, Futuro, and Activa. In the next couple of slides we will compare and contract these lines relative to our business needs as pharmacists and the care needs of your patients.
  • For safe numbers, if 10 pregnant patients entered your pharmacy per month. And ½ of these patients purchased 2 pair every 6 months: 10 x 12 months (assuming each month 5 new patients purchase) x 2 pair per visit (one to wash and one to wear) x 2 purchases per year = 480 480 pairs sold at $15 AWP = $7,200 in gross profit with 50% margins yields $14,400 in sales!
  • For safe numbers, if 40 diabetic patients entered your pharmacy per month. And ½ of these patients purchased 2 pair every 6 months: 20 x 12 months (assuming each month 5 new patients purchase) x 2 pair per visit (one to wash and one to wear) x 2 purchases per year = 960 960 pairs sold at $20 AWP = $19,200 in gross profit with 50% margins yields $38,400 in sales!
  • As we look at these compression manufacturers and as you evaluate other manufacturers products some points to keep in mind when selecting a line to carry in your store and recommend to your patients are the following: How will the company and sales representative support your pharmacy. Graduated compression stockings are medicine that your patient wears and consequently you want to have inventory in stock when requested by physicians and patients. However, graduated compression garments are an SKU intensive item, so when making the decision to allocate retail space to this product offering you want to ensure that it will turn. So, you want a company who will supply the manpower to promote and market your pharmacy location to healthcare professionals, prescribers, and consumers. The ideal type of manufacturer is one in which the sales representative is not overwhelmed with promoting too many products and/or services and can focus on one product. Furthermore, the ideal manufacturer offers a quality product that has been clinical studied and proven to fit your patient appropriately. An improperly fit graduated compression garment can cause a tourniquet effect and impose worsened circulation and irreversible complications…ultimately more harm than benefit. Think of graduated compression stockings like wearing glasses. Neither are an option and MUST be worn! They provide a significant medical benefit when worn and the patient has the appropriate strength. But the wrong strength in an eyeglass, like graduated compression, can worsen the patient’s vision and cause significant irreversible harm. So let’s look at the market leaders!
  • BSN Medical is a global medical device company with many subsidiaries that manufacturers casting, bracing, wound care products and compression stockings. Specific to graduated compression stockings, they own 2 subsidiaries: Jobst and FLA orthopedics which makes a low-cost compression line called Activa.
  • Jobst is a jack of all trades…they manufacturer products ranging from medical hosiery to bandages…which can be convenient one stop shopping for your pharmacy product needs and patient DME needs. This manufacturer does offer sales representative support; however, the sales representatives do not solely promote medical hosiery, but their entire line of products which can water down the quality of business support and products that you may receive. Jobst is #1 physician recommended brand in the US. They are like Coca-Cola and Kleenex. When you think of a soda or coke, people think or ask for a Coca-Cola or when wanting a tissue ask for Kleenex. While Jobst does make “ready-to-wear” garments which are garments that the patient can purchase readily available and made directly off of the shelf from your pharmacy, you can really see quality in their custom made garments. Those are the garments specially measured and made to fit patients with disproportionate body types which account for less than 5% of the patient population. They require numerous detailed measurements and can take anywhere from 3 days to 2 weeks to arrive for the patient.
  • SIGVARIS is the global leader of Ready to Wear graduated compression stockings, with a presence in 60 countries. They are known as the compression specialists because they only do graduated compression stockings and nothing else…like the majority of other compression manufacturers, SIGVARIS doesn’t fit the old saying “Jack of all trades master of none”. They are known for the precise fit garments that can fit 98% of the patient population with products available for sale right off of our pharmacy shelf by measuring the ankle circumference, calf circumference, and calf length. Their unique sizing system can fit an average or full sized calf in a person with a short or long leg. Fore example , SIGVARIS has garments that can fit a patient who is 5’2” and may have the same ankle and/or calf size as a patient who is 6’2”.
  • The starting inside materials of any regular sock is spandex. To keep cost low, most compression manufacturerer’s use bare spandex or will wrap the spandex one time to construct their garments. Cutting cost with bare or single wrapped spandex, compromises product quality because of the ability of the spandex to stretch and not recoil easily and easily break under stress or heat. Further, patient compliance is compromised…you will often times hear patients say that the garment is hard to put on. Part of the difficulty in putting on the garment will be due to the bare spandex rubbing against the skin…it alikened to the friction of a rubber band against the skin. SIGVARIS double wrapps their yarns in nylon or cotton so that the material that touches the skin is soft and more comfortable. This also increases the durability of the product to prevent the garment fibers from breaking under stress and heat. Lastly, SIGVARIS is the only company that has hired a pharmacist to who can relate to our business needs and address our concerns.
  • Futuro is your low cost alternative for compression. They do not offer business support services such as sales representatives, marketing materials and aids, or other value added services. This cost saving is passed on to you. Their products are made with bare spandex fibers. Products are available via all major wholesalers and can be purchased in most pharmacies nation-wide.
  • Venous insufficiency is a manageable condition. Once damage is done to the vein system, treatment goals are to restore the patients functionality and make them comfortable which can be achieved by [Read Next Slide].
  • Obama’s Healthcare Reform Legislation of March 23, 2010 Paradigm shift in pharmacist interactions with doctors More patients expected to consult their pharmacists through newly authorized MTM programs Emphasize pharmacist training to help patients coordinate medications, diet, lifestyle, & health history
  • Take home message/Summary slide “ Encourage your patient to visit you for measuring and fitting as early in their day as possible. For shift workers, this could be a mid-day or possibly early evening appointment. Using the SIGVARIS patient record card is a great way of tracking a patient’s measurements, as well as the compression garments that you have previously fit them in. ( Read point 3 from the slide) “Ask your patient…”
  • Discussion Points: As the pharmacist, the healthcare professional who sees and/or consults the patient, approximately every 30 days, more or less, you play a significant role in maintaining the patients healthcare. You have the ability to guide the patients healthcare in ensuring proper communication to the physician and the patient. Especially when the patient receives medical care from multiple physicians, you play a keep role in communicating duplication of therapy or substandard therapy. You essentially keep the loop going. In the compression business, you can not only provide a clinical service to your patients through venous disease consultations, but you have a key opportunity to grow your pharmacy revenues. With each recommendation to the physician for medical therapy, the physician will comfortably authorize the compression therapy prescription for you to fill because he or she will be confident in knowing that you are certified and trained to measure and fit for compression garments (which you will do this afternoon), have inventory on hard to meet the patients needs, and have a fitting room to maintain the patients privacy and measure them appropriately. Additionally, as your relationship grows with the physician he/she will continue to drive patients into your pharmacy.
  • Subjective complaints scored on an ordinal scale. Stocking measured and fit by an orthotist and worn during the working hours. After 3-months, significantly fewer complaints of tired legs (P<0.005; 21 of 30 vs. 8 of 30) and leg pain (P<0.05; 10 of 30 vs. 2 of 30) in compression wears vs. no difference in complaints in control group There was a statistical decrease in tired legs (P<0.01; 8 of 12 vs. 3 of 12) and no improvement in leg pain (7 of 12 vs. 6 of 12) in the rubber mat group
  • The physician was correct in that the patient needed to continue compression therapy; however, when the patient was discharged and is now ambulating, he needs to be in stockings. Stockings are for walking and TEDS are for BEDS!
  • Per CHEST guidelines, Mr. Little John should wear a 30-40mmHg graduated compression sock or stocking. However, in clinical practice, patients who have never worn a graduated compression sock or stocking would not either tolerate a 30-40mmHg compression garment or may not be compliant. In this type of situation, it is ideal to start the patient on a 15-20mmHg garment, not a 8-15mmHg garment, because again a 8-15mmHg garment has not been proven clinically effective. So to ensure that the patient is compliant, it is best to start the patient on an 15-20mmHg garment, then work him up to a 20-30mmHg garment and if the patient will tolerate a 30-40mmHg garment, then to this point.
  • Ask the audience about the appropriate way to measure Mr. Little John to arrive at these measurements.
  • Demonstrate each or ask an audience volunteer to come up. Ankle Circumference: Measure just above the ankle bone. Calf Circumference: Measure at the meatest part of the calf Calf Length: Measure from the 90 degree bend of the knee to the floor.
  • Thigh Circumference: Measure at the fatest part of the thigh. A trick is to ask the patient to spread their fingers as wide as possible and place the thumb at their coxic bone. Where the bird finger lies is typically the fatest part of the thigh and this is the point to measure. Leg Length: Measure from the gluteal fold down to the floor (patient should not be wearing shoes, if they are wearing shoes, then to the heal). Best way to measure is without shoes. To respect the patient’s privacy and maintain their level of comfort a good trick is to allow the patient to hold the measuring tape at the zero point at their gluteal fold (also, because in elderly patients their gluteal fold may sag and it can be difficult to identify their fold), then pull the measuring tape down to the floor.
  • Some brands do not take all three calf measurements which although may seem at first as a time saving benefit to you as the pharmacist, it is a huge disservice to the patient. Taking the three measurements – ankle circumference, calf circumference, and calf length – ensures that the patient will receive the stated graduated compression at the ankle and calf as well as ensures that the product will stay up on the leg so as not to fall down during the day. Compression garments should be considered as medicine to be worn, and therefore when the garment does not fit appropriately, slides down constantly the patients therapy is interrupted. In the instance of this brand, only a calf circumference and calf length measurements are required. Noting that the focal point of compression is at the ankle, the patient is likely not going to receive their full therapeutic effect. Nevertheless, to identify the size for our same patient in this particular brand, we have measurements of: 9 inch ankle circumference 16 inch calf circumference 16.5 inch calf length We note here that this brand does not accommodate for a patient with a short leg. With this brand the available garments will be too long on the leg and may cause pinching behind the knee so as to pinch the popliteal vein and cause a DVT opposed to prevent a DVT or manage the existing DVT or other vein problem that this patient may have. Alternatively we note on the right side (your left) the sizing chart for “support garments” which provide compression pressure below 20mmHg. These garments can easily be sized by the patients shoe size and recommended by you or the patient can simply determine their own size. in To ensure the precise fitting of your patient, you want to ensure that you read the sizing chart for the garment in which you aim to place the patient in. Using this sizing chart listed here, given that the first measurement that you always want to take for a patient is their ankle circumference, you would start at b and identify the column that falls within the patients measurements, next you would identify the patients calf circumference and would refer to c. So for example if you had a patient to present to your pharmacy counter and request a knee-high in this particular brand and upon taking their measurements, you have: 8 inch ankle circumference 13 ½ inch calf circumference 12 inch calf length What size garment would you place the patient in? were to use this brand of compression
  • To ensure the precise fitting of your patient, you want to ensure that you read the sizing chart for the garment in which you aim to place the patient in. Using this sizing chart listed here, given that the first measurement that you always want to take for a patient is their ankle circumference, you would start at b and identify the column that falls within the patients measurements, next you would identify the patients calf circumference and would refer to c. So for example if you had a patient to present to your pharmacy counter and request a knee-high in this particular brand and upon taking their measurements, you have: 9 inch ankle circumference 16 inch calf circumference 16.5 inch calf length What size garment would you place the patient in? were to use this brand of compression
  • Unique to this manufactures sizing chart and garments is their ability to fit a 14” ankle and 24” calf. Also, note the different lengths for Men and Women!
  • Discussion Points: How old is the patient? Consider hand strength in recommending compression strength or strength prescribed by the physician. If poor dexterity, patient may need to use a donning aid, have a caregiver to assist with application, or purchase two low compression garments that add up to higher desired compression pressure, What co-morbid conditions does the patient have? Consider precautions and contraindications. For example, diabetic patient typically have poor circulatory problems commonly attributed to PAD not PVD. Literature typically suggests no compression; however, the standard diabetic sock provides light compression ranging between 8-20mmHg, so a light compression sock with a flat toe seam and padded sole will not hard the patient. But the patient should likely be recommended a white sock so that any broken skin issues, fluid leaks can be visibly seen. What type of venous disorder does the patient have? Is it simply lower leg edema (calf length), spider veins in lower legs around calfs only (calf length), varicose veins in lower part of calf (calf length), varicose veins that run up the mid and upper part of calf (calf or thigh high, really consider that if the patient has varicose veins that extend up the upper part of the calf then there are likely some vein insufficiency issues behind the knee so a thigh high may be recommended), if recent vein surgery in upper leg (thigh high or panty hose). What area of the leg requires compression? A fashion preference? Any style suitable for the patient otherwise consider the area of the leg that is affected and aim to cover slightly above the area. Do the toes need to be monitored during treatment? If a major surgical procedure then the patient will likely need to be placed in an open toe garment for easy monitoring of peripheral blood flow to the toes. What type of lifestyle does the patient live? Active Sedentary What type of work does the patient perform on a daily basis? What type of shoe is commonly worn? Dress shoes Steel toe boot Tennis shoe How compliant will this patient be with the recommended level of compression? Special consideration and precaution should be given to diabetic patients who may have a deceptively elevated ankle/brachial index (ABI) secondary to disease related atherosclerotic changes and calcification of vessels.
  • As a pharmacist you may hear your patient give objections to your recommendation for compression therapy. Know that you have received proper training and knowledge about compression therapy and will be wearing it you can properly combat each objection. When patients give objections, they call in line with “I HATE U” I – I don’t need them, I don’t have a medical indication for them, I sit most of the day, I have tried them before and they slide down or are… H – too hot A – too hard to apply T – too tight E – too expensive U – too ugly You know have the tools to help them.
  • Too Hot Recommend cool and comfortable cotton as it wicks the moisture away Ask: If their legs are very swollen ask how they manage in the summer now? Can they do the things that are important to them now? Cooking Gardening Shopping Spend time with children/grandchildren Travel for any distance How long has it been since you were able to do these things comfortably – or at all? Would you like to do it again? Too Tight Explain graduated compression “yes, you need compression because your legs are swollen and the stockings “hug” them back to good health” They feel tighter because you have never worn them before - it takes time to adjust to them - but persist - your legs will respond and you will feel the difference in no time! Stockings should never hurt - if they do call me right away - you will know within a few hours If difficult to tolerate at first gradually increase the time you wear them Too Expensive Agree that if these were just tight socks then yes they are expensive However, please consider: These are your full course therapy to medicate your venous disease They cost less that $.60 cents a day No drug interaction required Comfortable, fashionable, functional This product help to heal your disease everyday Too Hard to Apply [DEMO various competitors stockings] – various competitors use different raw materials in making their stockings. Essentially all stockings start out with spandex and then are either left as bare spandex, single wrapped or double wrapped in cotton or nylon. The additional wrapping of the spandex in cotton or nylon decreases the tackiness of the product against the patients skin. This can be best explained with having a rubber band available and tell the patient to image the rubber band (the spandex) being the inside of the compression garment and the added effects of compression make the stocking hard to apply. Some manufacturers will remove the spandex barrier with a single or double wrapping. A good company will double wrap the spandex so that no matter which way the garment is stretched, 100% of the spandex is covered. Now this benefit may cost a bit more for your patient but it sure makes the stocking easier to apply and will result in a more compliant patient. Use the gloves to demonstrate how they work, then watch the consumer use them Demonstrate donning/doffing tools: Easy Slide Easy Off Easy Slide Caron Easy Lever Have consumer try these items and do not forget to COACH them Demonstrate the glove on the ground technique Too Ugly Show the patient some of the more fashionable products that manufacturers are making today. Find out what types of socks or stockings that the patient normally wears and recommend the similar products in compression therapy. If the patient has a really sick leg then recommend that the patient camouflage the compression sock or stocking under their ordinary socks and stockings.
  • Venous thromboembolism—DVT and pulmonary embolism (PE)—is costly because of the high rate of DVT recurrence (8%-17% within 2 years) and the costs associated with longterm sequelae, particularly post-thrombotic syndrome (see the article by Fanikos in this supplement). In a retrospective pharmacoeconomic analysis, extrapolation of data from patient and administrative records for managed care patients with acute proximal DVT suggests that the annual costs of treatment in 1997 amounted to $1.5 billion in the United States. A more comprehensive, controlled, retrospective observational study was conducted of administrative claims data for 26,958 managed care patients with DVT, PE, or both and patients with possible post-thrombotic syndrome. The mean annualized total health care costs for DVT, PE, or both were $33,200, $31,300, and $38,300, respectively, compared with $2,800 for matched control patients. The mean annualized total health care costs were $47,600 in patients with post-thrombotic syndrome and $35,900 in patients without the syndrome (i.e., the incremental cost of post-thrombotic syndrome was $11,700).
  • Discussion Points: Pharmacists roles extend beyond traditional dispensing and are looked to for comprehensive healthcare treatment and recommendations. Some patients who should receive recommendations for compression stockings identified easier than others. Particularly patients taking medications for a DVT, PE, pregnancy, or will soon be traveling can easily be identified and should at least receive a recommendation for a class I compression stocking.
  • Often times your patients will state: “ I don’t need graduated compression stockings, my doctor did not say that I need to wear them” “ I do not have a medical need to wear compression stockings.” “ Oh, I am not on my feet all day and do not need to wear compression stockings” All of these patients, including pharmacists – sitting or standing, male or female – need to be in compression stockings for healthy legs! Identify candidates for prophylactic graduated compression socks and stockings Consult patients on graduated compression socks and stockings Encourage appropriate use and compliance of graduated compression socks and stockings Implement safe and effective monitoring of venous disease patients. Pharmacists need to know how to identify candidates for graduated compression socks and stockings by evaluating each patient on a case by case basis or through physician referral.
  • You know about it, you wear it, you can recommend it, make it personal.

Transcript

  • 1. Presented by: Name, Credentials Title Place of EmploymentThis program has been sponsored by an educational grant from
  • 2. The faculty, planners, and manager who are in a positionto have control over content of this activity (including theirspouse and/or life partner) have disclosed the followingfinancial relationships or relationships to products ordevices they or their spouse/life partner have withcommercial interests relative to the content of this CEactivity.
  • 3. The Institute for Wellness and Education isaccredited by the Accreditation Council forPharmacy Education (ACPE) as a provider ofcontinuing pharmacy education. This programis approved for 2.0 contact hours (0.2 CEUs)under the ACPE universal program number0459-0000-11-038-L01-P&T.
  • 4.  Discuss the incidence and pathophysiology of venous disorders Identify patients at risk for the development of venous disorders Describe the effects and medical efficacy of medical compression stockings for venous disorders Evaluate the alternative revenue that graduated compression garments can generate Assess the role of the pharmacist in maximizing patient compliance and slowing disease progression Identify strategies to increase routine use of graduated compression garments for venous disease
  • 5. What percentage of Americans areaffected by venous disease?A.20%B.30%C.40%D.50%E.60%
  • 6.  60% of American suffer from venous disease and its sequelae  More than 80 million Americans suffer from vein problems, most common are › Varicose veins › Spider veins  Incidence increases with age and is more common in women  More people lose work time from venous disease than from arterial diseaseNational Heart Lung and Blood Institute (NHLBI). Available at: http://www.nhlbi.nih.gov/ Accessed 01/27/11.American College of Phlebology (ACP). Available at: http://www.phlebology.org/patientinfo/index.html Accessed01/27/11.Vascular Disease Foundation Newsletter. Spring 2005; Volume 5, N2
  • 7.  Family history Females › Pregnancy › Medications Travel (periods ≥8 hours)  DVT Lifestyle  Injury to vein walls and › Sedentary venous valves › Obese (women)  Immobilization post- › Smoking (men) surgery › Prolonged standing or sitting occupation  Increasing age (changes elasticity of veins) Bergan JJ. The Vein Book. 2007; p. 42 Geerts WH, et al. CHEST. 2008; 133: 381S-453S.
  • 8.  Prospective case-control study of 134 families (402 total subjects) › 67 controls and their parents › 67 patients and their parents  Varicose veins in legs  30-40 years old  No history of DVT Risk for development of varicose veins in › Both parents affected: 90% males and females › One parent affected: males 25%, females 62% › Neither parent affected: 20% males and females
  • 9. Study DataMark PE, et al.  Approx. 1.1-1.5 per 100,000 US and EU deliveries result in death from pulmonary embolismsThaler E, et al.  33% of primaparas and approx. 50% of multiparas have evidence of varicose veins after pregnancy  Emergent varicose veins occur in approximately 25% if pregnanciesRodger M.  Pregnant women have a 7- to 10-fold increased risk of VTE compared to nonpregnant women  VTE kills 1 in every 20,000 pregnant women annually  VTE occurs in up to 12 per 10,000 women from conception to delivery and up to 7 per 10,000 women after deliveryDresang LT, et al  VTE is the leading cause of maternal death in the US  78-90% of DVTs during pregnancy occur in left legMarik PE, et al. NEJM. 2008; 359(19):2025-2033Thaler E, et al. Swiss Med Wkly. 2001; 351:659-662Rodger M. Hematology. 2010: 173-180Dresang M. Hematology. 2010: 173-180
  • 10.  30% first time pregnancy; 55% two or more result in varicose veins › Increased blood volume (40-50%) › Hormonal changes › Pressure of the fetal head  Compression Stockings are beneficial during pregnancy and post partum periodSwiss Medical Weekly 2001; 659-662Physiology 1998; Issue 9: 1-3Br J. Obstec Gynecol. 1999; Jun; 106: 106(6): 563-9
  • 11.  Deep Vein System › High Pressure System › Handles up to 90% of venous blood volume › Include: Anterior and posterior tibial veins, peroneal veins, popliteal vein, superficial femoral vein, common femoral vein Superficial Vein System › Low Pressure System › Handles remaining 10% of venous blood volume › Include: Greater and lesser saphenous vein Perforating/Communicator Veins › Communicator veins connect “like” veins › Perforating veins connect deep to/from superficial veins
  • 12. Think of a Roadmap!  Deep  Superficial  Perforating/ Communicator
  • 13.  Primary function of venous system is blood return to the heart  Three mechanisms to achieve venous blood return to heart  Multiple muscle pumps  Competent valves  A pressure gradientLohr, J, et al. Curriculum Recommendations from American Venous Forum. 2006. Available at:http://veinforum.org/index.php?page=venous-curriculum Accessed 1/27/11
  • 14. Which muscle pump(s) is/arereferred to as the“peripheral heart” and is primarilyresponsible for venous return?A.Foot/ankle pumpB.Arterial pressureC.Calf pumpD.A and C onlyE.All of the above
  • 15.  The major peripheral pump consists of calf muscle Calf Muscle Contraction (Systole)  Increase in venous blood pressure forces valves open  Blood shunts towards heart to empty veins Calf Muscle Relaxation (Diastole)  Decrease in venous blood pressure allows valves to close  Prevents blood reflux
  • 16. Additional peripheral pumps include: Foot Ankle Arterial Pressure Abdominal Pressure
  • 17. Valve OpenPumps blood againstgravity towards heart Valve Closed Inhibits gravitational reflux of pumped blood
  • 18. Vein Wall Injury ↑ ↑Venous ↑Hypertension ↑ Damaged Valves
  • 19.  Dynamic Pressure › Energy imparted by pumping action of the heart  Hydrostatic Pressure › Pressure generated by the effects of gravity on the lower extremity › Venous blood is pumped out of the dependent limb against the force of gravity › Pressure determined by the distance (height) to the right atriumLohr, J, et al. Curriculum Recommendations from American Venous Forum. 2006. Available at:http://veinforum.org/index.php?page=venous-curriculum Accessed 1/27/11
  • 20. Pressure at the Ankle in Pressure at the Ankle inDefective Venous System Normal Venous SystemLying Down 10 mmHgStanding ≥100 mmHg 90 mmHg PressureWalking ≤70 mmHg 25-35 mmHg Difference 30-40mmHg 40-50mmHg The effect of the calf, ankle and foot pumps takes place after only 7 steps!
  • 21.  Disturbances within the veins which alter venous blood return to the heart  Due to local pathological changes:  Venous thrombosis  Valvular function  Changes in venous wall  Endothelial damageEklof B, et al. Controversies in the Management of Venous Disorders. London: Butterworths, 1989.
  • 22. DVT affects approx. 2 million Americans annually Pulmonary embolisms kill up to 300,000 Americans annually The Awareness… 74% of adults have little or no awareness of DVT 57% are unable to name any common risk factors or pre-existing conditions that could lead to the development of DVT 95% report that their physician had never discussed this medical condition with them September 15, 2008 “Call to Action” by acting Surgeon General – Steven Galson, Virchow’s Triad MD, MPHAPHA Deep-Vein Thrombosis Omnibus Survey. Conducted by Wirthlin Worldwide 2002.The Coalition to Prevent Deep-vein Thrombosis Web site. 2010. http://www.preventdvt.org/about/what-is-dvt.aspx. Accessed: 10/27/2010.
  • 23. Arch Intern Med. 2007; 167(14): 1471-1475 Observational study of 7222 subjects residing in Worchester, MA to evaluate VTE diagnosis (determined from ICD-9 codes) post- hospitalization from 1999, 2000, and 2003 1897 subjects experienced DVT (n=1348), PE (n=285), or both (n=264) within the 3-year period. Of the 1897 validated VTE cases, 73.7% (n=1399) presented in the outpatient setting with signs and symptoms or confirmed VTE diagnosis within 1 day of hospital admission.
  • 24. True or False. Venousinsufficiency is synonymous witharterial insufficiency.A.TrueB.False
  • 25. Peripheral Arterial Insufficiency (Disease) Peripheral Vein Insufficiency (Disease) Narrowing of the arteries, commonly the Inadequate return of venous blood from pelvis & legs the legs to the heart Clinical Symptoms: cramping, pain, tired Clinical Symptoms: tired/heavy, achy legs or hip muscles cramping in the legs Clinical Indication: pain worsens when Clinical Indication: pain that worsens standing and improves with leg during walking/activity and subsides with elevation and leg activity rest PAD=peripheral arterial disease; PVD=peripheral venous disease
  • 26. Telangiectasia Varicose Veins Lipodermatosclerosis(spider veins) Deep Vein Thrombosis Superficial Phlebitis
  • 27. Venous Ulcers Chronic VenousVenous Hypertension Insufficiency
  • 28. C=Clinical A=Anatomy E=Etiology P=Pathophysiology Grade Description C0 No evidence of venous disease C1 Superficial telangictasias (reticular veins) only (<4mm diameter) C2 Simple varicose veins only (>4mm diameter) C3 Ankle edema as a sequel of varicose veins C4 Skin changes (pigmentation, venous eczema, lipodermatosclerosis) C5 Skin changes with healed ulceration C6 Skin changes with active ulcerationEvans CJ, et al. J Vasc Surg. 2004: 40: 1248-1252
  • 29. Which medication classes mayindicate that a patient has or is atrisk for venous insufficiency?A.AnticoagulantsB.HRTC.Antineoplastic agentsD.Prenatal vitaminsE.All of the above
  • 30.  Medications that  Medications indicating increase additional thromboembolism risk: thromboembolism risk:  Hormone replacement  Antineoplastic or related therapy agents, i.e.,  Oral contraceptives  Etoposide  Raloxifene  Cyclophosphomide  Tyrosine Kinase inhibitors  Tamoifen (i.e., imatinib)  Thalidomide/lenalidomide  Anticoagulants
  • 31. True or False. Venousinsufficiency is a condition thatgoes away with treatment.A.TrueB.False
  • 32.  Treatment Goal: Restore patient to active lifestyle, minimize pain and/or disability Treatment Methods:  Pharmacologics (i.e., anticoagulants)  Herbal alternatives  Vein procedures  Non-Pharmacologics/ Compression Therapy
  • 33.  Reduces symptomatic and asymptomatic VTE by 50-65%  Oral vitamin K antagonist  Coumadin (warfarin)  Direct thrombin inhibitor  Pradaxa (dabigatran)  Anti-factor Xa inhibitor  Heparin  Lovenox (enoxaparin)  Fragmin (dalteparin)  Arixtra (fondaparinux)  Xarelto (rivaroxaban)  Oral investigational drugs*  Apixaban*Awaiting market approval.Vascular Disease Foundation Newsletter. Spring 2005; Volume 5, N2
  • 34. Main Constituen ts: Blueberry Sweet Clover Resveretro l Quericiten Red Wine Pycnogenol ElderberryGrape Seed Extract Butcher’s Broom Horse Chestnut Seed Extract
  • 35.  Sclerotherapy Radiofrequency Ablation (RFA) Endovenous Laser Treatments (EVLT) Phlebectomy Stripping & Ligation Before After In practice, it is recommended that graduated compression therapy be worn pre- and post- vein procedures
  • 36.  Bandages  Intermittent Pneumatic Compression Devices  Foot Pumps  Portable Devices (continuous enhanced circulation therapy)  Compression Therapy  Support stockings, Medical compression stockings, or Graduated compression stockings  Anti-embolism stockingsRamelet AA. Dermatol Surg. 2002;28:6-10.
  • 37.  Air compressor & inflatable sleeve  For ARMS or LEGS Gradient, segmental, intermittent compression
  • 38. SHORT STRETCH
  • 39. Photos Compliments of Circ Aid
  • 40.  Improve blood flow velocity To restore blood flow velocity to normal To reduce or prevent edema Prevent/treat venous diseases 44
  • 41. Graduated Compression  Therapeutic Compression Ranges: 15-20mmHg6 (class I) up 20 - 40% to 50-60mmHg (class IV)  Utilized in the community setting, including assisted living facilities, 50 - 80% long-term care facilities, and nursing homes 100%  Commonly available as:  Socks and stockings Graduated Compression  Calf-length, thigh-high, andIndicated for prevention and pantyhose stylesmanagement of venous  Cotton and/or nylon fabrics anddisorders in ambulating patients yarnsand wheel-chair bound patientsPicture obtained from http://www.newlook.com.sg/tedantiembolismstockings.asp. Accessed 09/02/10.
  • 42. Anti-embolism Stockings “TEDS are for BEDS” Therapeutic Compression Ranges: 18-8mmHg, 20- 10mmHg Utilized in the hospital or nursing home setting Anti-embolism Stockings Indicated for prevention of For bed-ridden patients thromboembolisms in recumbent patientsClass A (8-15mmHg) compression reflects the standard in some countries but there is insufficient clinical evidence tosupport it’s use in practice. (European Prestandard, 2001)TEDS=Thromboembolic Deterrent Stockings
  • 43. “OTC” Medical Therapy (Prescription Recommended) 15-20mmHg 18-25mmHg 20-30mmHg 30-40mmHg 40+mmHg• Tired, achy legs • Lower extremity • Heavy, fatigued, • Moderate • Severe• Occupational or edema in diabetic aching legs varicosities w/ varicosities evening edema patients without • Mild edema in mild-moderate • Severe edema• Leg discomfort from prolonged A simple change varicosities edema ± contraindications and ABI >0.6 lower extremities • Mild of socks!!! pregnancy • CEAP C4, C5, C6 standing/sitting w/ minimal • Post-procedure • Recurrent• Preventing edema of larger veins venous pregnancy • Mild varicosities • CEAP C3, C4, ulceration varicosities & pregnancy C5, C6 • Severe post &swelling edema • Recurrent or traumatic,• Predisposed risk • Post-procedure active venous fracture edema• Reduce travel of small veins ulceration • Severe PTS swelling • DVT prevention • DVT prevention• Prevention of or management or management traveler’s • DVT or PTS thrombosis treatmentThere is insufficient clinical evidence to support the clinical efficacy of compression pressures <15mmHg tosupport ambulatory patients. (European Prestandard, 2001)
  • 44. “OTC” Medical Therapy (Prescription Recommended) 15-20mmHg 18-25mmHg 20-30mmHg 30-40mmHg 40+mmHg• Tired, achy legs • Lower extremity • Heavy, fatigued, • Moderate • Severe• Occupational or edema in diabetic aching legs varicosities w/ varicosities evening edema patients without • Mild edema in mild-moderate • Severe edema• Leg discomfort simple change of socks!!! A contraindications lower extremities edema ± • CEAP C4, C5, from prolonged and ABI >0.6 • Mild varicosities pregnancy C6 standing/sitting w/ minimal • Post-procedure • Recurrent• Preventing edema of larger veins venous pregnancy • Mild varicosities • CEAP C3, C4, ulceration varicosities & pregnancy C5, C6 • Severe post &swelling edema • Recurrent or traumatic,• Predisposed risk • Post-procedure active venous fracture edema• Reduce travel of small veins ulceration • Severe PTS swelling • DVT prevention • DVT prevention• Prevention of or management or management traveler’s • DVT or PTS thrombosis treatment
  • 45. Signs of infection Extensive venous ulceration Skin sensitivities or allergies Neuropathy History of diabetes Confinement to bed or non-ambulatory use unless otherwise prescribed by the physician Progressive arterial insufficiency Uncontrolled congestive heart failure Acute dermatitis, weeping dermatosis, cutaneous sepsis
  • 46. True or False. Diabetic patientsshould not wear graduatedcompression socks.A.TrueB.False
  • 47.  Lower extremity edema is a common clinical finding in diabetic patients  Lack of reliable measures to objectively quantify edema makes it difficult to assess it’s prevalence in diabetic patients  Edema in diabetics is difficult to isolate and may have multiple etiologiesBrodovicz KG, et al. Clin Med Res. 2009;7(1-2):21-31.Fries R. MMW Fortschr Med. 2004;146(16):39-41.Powell AA, et al. Am Fam Physician. 1997;55(5):1721-6.
  • 48. What features should a diabeticcompression sock include?A.At least 18-25mmHgB.Is graduated in pressureabove the calfC.Flat-toe seamD.Cushioned soleE.Only C and EF.All of the above
  • 49.  4-week pilot study  N=18  Diabetes  Lower extremity edema of the leg, foot, and ankle  Ankle-brachial index (ABI) >0.6  Assess whether diabetic compression socks* can reduce LE edema in diabetic patients without compromising vascularity  Fitted for 4-7 pair of diabetic compression socks which were white, padded foot, and flat toe seamLE=lower extremityDiabetic compression socks provided 18-25mmHg
  • 50. Mean Foot Circumference 27.98 27.42 27.58 27.41 27.60
  • 51. Mean Ankle Circumference 25.28 24.42 24.32 24.36 24.14Statistically significant
  • 52. Mean Calf Circumference 41.59 40.32 41.12 41.10 41.08Statistically significant
  • 53. Cutaneous Edema 31.20 30.05 29.50 29.30 28.58
  • 54. Safety and Efficacy of Mild Compression (18-25mmHg) Therapy in Patients with Diabetes and Lower Extremity EdemaWu SC, Crews RT, Najafi B, et al. J Diabetes Sci Technol 2012 Vol 6 Issue 3 ABI 1.26 1.18 1.16 1.10 1.05
  • 55. Mild graduated compression socks decreasedswelling in diabetic patients with LE edemawithout compromising vascularity
  • 56.  Promotes circulation  Fiber blend of cotton, acrylic, nylon, and elastic  Regular 100% wool or cotton socks are too tight on the foot, reduce circulation, and are not cool and do not keep the foot dry  Cushioned  Regular socks do not provide comfort and protection  Flat seams  Coarse seams on regular socks rub the foot and . cause blisters and calluses to emergeFeldman CB, et al. Diabetes Spectrum.14(2), 59-613Herring KM, et al. J Amer Pod Med Assn. 80, 63-70.
  • 57.  Pre-diabetic  Newly diagnosed  Edema  Gestational diabetes  No neuropathy  ABI >0.6 without claudicationDiabetic patients a more likely toexercise when their legs feel good!
  • 58. Key Benefits:• Designed for oversized legs•Made with Nano Bamboo Charcoal Fiber which is anatural deodorizer that absorbs odor causing agents andreduces microbial growth• Helps regulate skin temperature•Releases Infrared Rays that may promote bloodcirculation.• Padded heel and forefoot for extra comfort.• Ventilated airflow mesh on top of forefoot and instep.Compression Level: 10-15mmHg up to 20-30mmHgStyle(s): Ankle, Crew, Merry Jane, Over the CalfColor(s): Black, Navy, Sand, White (Not all styles in allcolors) Sizing based on shoe size, availability varies byproductPrice: $9.95-$12.95
  • 59. Key Benefits:•Clinically proven to reduce swelling and improvecirculation•American Podiatric Medical Association (APMA)Seal of Approval•Non-binding calf band•Flat toe seam•Extra padding on foot•DriRelease fiber blend for moisture wicking, odorcontrol, and softness•Latex free•True graduated compressionCompression Level: 18-25mmHgStyle(s): Over the CalfColor(s): WhiteSizing ankle & calf measurementsPrice: $30-40
  • 60. SilverSoleKey Benefits:• Unisex. Sized by shoe size.• Silver knitted for antimicrobial benefits• Pillowed sole adds cushion to reduce blisteringand callous buildup• Mid-foot compression to prevent sockbunchingCompression Level: 12-16mmHgSize(s): S, M, L, XLStyle(s): Anklet, Low Cut, Crew Length, Knee-HighColor(s): Black, White, PinkPrice: $16-$17
  • 61. Key Benefits:•Non-irritating, smooth toe seam•Extra padding in the foot, heel and toe•Moisture-wicking acrylic multi-fiber yarns•Antibacterial, antifungal finishCompression Level: 8-15mmHgStyle(s): Knee Length, Crew Length, Mini-Crew LengthColor(s): White, Black, Navy, Brown/ Mini-Crew white onlyPrice: $9-$12.99 or 3/$34.50
  • 62. “Your labs show you have diabetes. I know your legs hurt but you need to exercise to improve your circulation, and start these medications!”
  • 63. Average Prescription Margins in 2009for an Independent Pharmacy were 6-12% (margins vary based upon brand vs. generic medication and cash vs. insurance reimbursement) How is the average independent pharmacy combating tight margins when 93% of their revenue is from Prescription Drugs? In addition to offering retail items on the front-end… SOME dramatically increase # of prescriptions filled/day! MINIMAL PROFIT INCREASE…PHARMACY CLOSES OTHERS find a Niche Service with wide margins! HUGE PROFIT INCREASE…PHARMACY SURVIVALGude S. Drug Topics. 2007 Oct 22. 70
  • 64.  School Supplies  Pens  Pencils  Paper  Book Bags Toys Greeting Cards Magazines Candy Hairbows Household Items  Paper Towels  Toilet Tissue  Laundry Detergent  All Purpose Cleaner  Trash Bags 71
  • 65. Premium Brands Economy Brands Jobst  Futuro SIGVARIS  Activa Mediven  Bellhorn Juzo  Bauerfeind  Loving Comfort  Therafirm  Truform  Many private label brands
  • 66.  How Many Pregnant Women Per Month? 10  120 Per Year 6 # pairs per year  720 pairs per year purchased $30 Retail Per Pair  $21,600 in Sales (Avg)  $10,800 in GP $$$ Margin 50%
  • 67.  How many pregnant patients enter your pharmacy monthly?  20 If, half purchased two pair every six months  480 pairs sold per year 50% margin $7,200 in GROSS PROFIT $14,400 in SALES
  • 68.  How many pregnant patients enter your pharmacy monthly?  40 If, half purchased two pair every six months  960 pairs sold per year 50% margin $19,200 in GROSS PROFIT $38,400 in SALES
  • 69. What type of products and serviceswould you want from a graduatedcompression manufacturer?A.Business supportB.Quality productC.AffordabilityD.Precise sizing to fit patientsE.All of the above
  • 70.  Business partnership with company and sales representative  Doctor detailing  Marketing support and literature  Health and wellness fairs  Education and training Clinically studied products, medically efficacious Product quality Safe and properly fit garments
  • 71.  Parent company to many subsidiaries supplying durable medical equipment items Manufacturer of orthopedic soft goods & bracing products including:  casting,  bracing,  wound care, and Premium Line  compression stockings Premium Line Economy Line Economy Line
  • 72.  Manufacture products ranging from medical hosiery to bandages. #1 physician recommended brand in the United States Specialize in custom made garments
  • 73.  World’s largest, physician founded, Ready to Wear graduated compression stocking company Global leader & “Compression Specialists” Precise fit sizing system (PFS2) accommodates patients with an average or full sized calf with a short or long leg
  • 74.  All medical hosiery is Covered Spandex/Lycra manufacturered with double- covered yarns NOT bare spandex 2nd covering Only company with an in- (S-twist) house pharmacist to manage the Pharmacy Relations 1st covering (Z-twist) Department to address pharmacy business support needs.
  • 75.  A subsidiary of 3M Widely recognized manufacturer of economical braces, supports, and compression stockings Available in most national & regional chain/franchise locations
  • 76. How can pharmacists help theirpatients to prevent and/or managechronic venous disease?A.Offer clinically-basedrecommendations to patientsregarding graduated compressiontherapyB.Measure patients and fit them into agraduated compression garment thatprecisely fitsC.Monitor patients compliance andcomfortability in wearing graduatedcompression therapyD.All of the above
  • 77. Webb JA. Drug Topics. June 2010; Vol 154(6): 25-28
  • 78.  Ask your patients about their medical history Ask your patients about their compression history Recommend compression therapy to your patients Counsel patients and physicians about the medical benefits of compression therapy Educate your patient Discuss and emphasize the need for compliance
  • 79.  1.4.3.1: Recommend that mechanical methods of thromboprophylaxis be used primarily in patients at high risk for bleeding, or possibly as an adjunct to anticoagulant-based thromboprophylaxis 2.1.4: For general surgery patients with multiple risk factors for VTE, a pharmacological method should be combined with a mechanical method 2.1.5: For general surgery patients with a high risk of bleeding, we recommend the optimal use of mechanical thromboprophylaxis with properly fitted GCS or IPC. When the high bleeding risk decreases, we recommend that pharmacologic thromboprophylaxis be substituted for or added to the mechanical thromboprophylaxis.Geerts WH CHEST 2008;133: 381S-453SKearon C, et al. CHEST 2008; 133;454S-545S
  • 80.  3.1.1: Patient with symptomaticproximal DVT, we recommend use of an elastic compression stocking with an ankle pressure gradient of 30-40 mmHg. Compression therapy, should be started after starting anticoagulant therapy and should be continued for a minimum of 2 years, and longer if patients have symptoms of PTS. 7.2.8: For all pregnant women with previous DVT, we suggest the use of GCS both antepartum and postpartum.Geerts WH CHEST 2008;133: 381S-453SKearon C, et al. CHEST 2008; 133;454S-545S
  • 81.  9.1: If there is a perceived high risk of VTE in long distance travelers (> 8 hours), we suggest the use of a properly fitted, below knee GCS, providing 15-30 mm Hg of pressure at the ankle, or a single dose of LMWH injected prior to departureGeerts WH CHEST 2008;133: 381S-453S
  • 82. Krijen R, et al. J Occu Environ Med. 1997;39(9):889-894 93 male workers with CVI from 14 meat factories randomized to the intervention (n=43; 20-30mmHg compression stockings or floor mats) or control (n=50) to assess the effect of compression stockings vs. floor mats on leg edema and pain Leg pain was measured via subjects subjective complaints of tired legs and leg pain Leg edema (volume) by Doppler ultrasound (standing) and light reflection rheography (sitting) Control Group Compression Rubber Mat Tired Legs No Difference P<0.005 P<0.01 Leg Pain No Difference P<0.05 No Difference Volume Change No Difference P<0.05 No Difference
  • 83. Mr. Little John is a 34 y.o. male and regular patient at yourpharmacy. Today he presents with a new prescription forCoumadin 3mg daily. During his ‘pick up’ consultation youlearn that he recently had a DVT and spent the past twoweeks in the local hospital and wore TEDS during hishospital stay. You notice that he is still wearing his TEDhose and he tells you that he has never had to wearcompression therapy but his doctor told him that he willneed to wear them daily while on Coumadin therapy. He isambulating, intends to resume his normal daily routine anddaily exercise schedule. Per CHEST guidelines andcompression indications, do you agree with the Mr. LittleJohn’s physician’s recommendations?
  • 84. Per CHEST guidelines andcompression indications, whatcompression level would yourecommend for Mr. Little John?A.8-15mmHgB.15-20mmHgC.20-30mmHgD.30-40mmHgE.Nothing, consult physician first
  • 85. Following an in-depth dialogue with Mr. LittleJohn, you both decide to switch his compressiontherapy from TEDs to graduated compressiontherapy. You now measure Mr. Little John anddetermine his measurements to be:Shoe Size: 9.5Ankle Circumference: 9 inchesCalf Circumference: 16 inchesCalf Length: 16.5 inches
  • 86. 1 2 3 Ankle Circumference Calf Circumference Calf Length
  • 87. 4 5 Thigh Circumference Leg Length
  • 88. You have three brands of graduatedcompression garments in stock –Futuro, Juzo, and SIGVARIS.Utilize Mr. Little John’smeasurements to determine whichsize of each brand you would placehim into.
  • 89. 1. Ankle circumference 2. Calf circumference 3. Calf length
  • 90. 9”9”16”16” 16.5” 16.5”
  • 91.  How old is the patient? What co-morbid conditions does the patient have? How compliant will this patient be with the recommended level of compression? What type of lifestyle does the patient live? What type of work does the patient perform on a daily basis? What type of shoe is commonly worn? What type of venous disorder(s) does the patient have? What area of the leg requires compression? Do the toes need to be monitored during treatment?
  • 92. For sure your patient will say – or be thinking…” I HATE U”!STOCKINGS ARE: Too Hot Too hard to Apply and remove Too Tight Too Expensive Too UglyHOW WILL YOU RESPOND? 101
  • 93. Too Hot Recommend cool and comfortable cotton or other breathable fabrics (i.e., microfibers)Too Hard to Apply Show patient how to use donning tools such as gloves, foot sleeves,& Remove and extensorsToo Tight Explain how compression works and that their legs will adjust Double compression garmentsToo Expensive Prove the value  On average they cost <$0.60 per day  “Medicine you Wear”  No drug interactions  Last 6-months or longer  Non compliance ± medications can cost thousands per year! Some raw materials provide easier donning, more durability, less shininess, and stay on better!Too Ugly Show the patient “NEW” fashion forward products Suggest camouflaging the sock or stocking under their everyday socks and stockings
  • 94.  Cost is dependent on the severity of venous disease, with indirect cost rising sharply as disease severity increases Estimated venous ulcer cost per-episode can exceed $40,000 Estimated 2 million workdays per calendar year are lost due to chronic venous ulcers Rudolph DM, et al. J Wound Ostomy Continence Nurs 1998; 25: 248-55.
  • 95. Seifert R. JMCP. 2008 Jul;14(6 S-a):S24-S27.
  • 96. Medication Intervention Medications Class OpportunityAnticoagulants DVT, PE, or Coumadin (warfarin), Lovenox PTS (enoxaparin), Arixtra (fondaparinux)Antiemetics Travelers- Bonine or Antivert (meclizine), related Phenergan (promethazine), Zofran thrombosis (ondansetron), Transderm Scop (scopalamine), Dramamine (dimenhydrinate)Prenatal Pregnancy- Prenatal DHA, Prenate Advance,Vitamins related leg NataChew, Prenate Elite, Nestabs FA edema Pregnancy- ANY PRENATAL VITAMIN related varicose veins
  • 97.  Identify candidates for prophylactic graduated compression socks and stockings Consult patients on graduated compression socks and stockings Encourage appropriate use and compliance of graduated compression socks and stockings Implement safe and effective monitoring of venous disease patients
  • 98. Dick Bradley, QS/1 Consulting Services
  • 99. Name, TitlePractice Site AddressCity, State Zip Code Phone Number Email Address