SAMEDI 20 NOVEMBRE 2004

SESSION Nº 1. MODÉRATEUR : Dr Marie-Leila KHOURY

Le médicament à travers les commissions d'AMM et la commission de la transparence

Dr François MEYER, Secrétaire Général de la Commission de la Transparence. AFSSAPS

Abstract not available

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SESSION Nº 2. MODÉRATEUR: Dr Jean DIB

Erectile dysfunction and its new treatment options

Dr Rim IBRAHIM, MD. Associate Clinical Research Physician

Erectile dysfunction (ED), defined as consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance, is highly prevalent and under treated condition that can significantly impact quality of life. It has multifactorial etiology with predominating organic factors and early identification of ED can uncover multiple co-morbid conditions such as diabetes mellitus, hypertension, ischemic heart disease or depression.

Tadalafil is a new potent and highly selective reversible inhibitor of enzyme phosphodiesterase type 5 (PDE5). Mechanism of action (PDE5 inhibition in cavernous tissue smooth muscle cells) is identical with other PDE5 inhibitors (sildenafil, vardenafil), however its structure and pharmacodynamic characteristics are clearly different, providing tadalafil with absence of food interaction concerning to absorption and with up to 36 hours period of responsiveness.

In well-controlled phase III trials tadalafil in doses 10 and 20mg significantly improved erectile function in general population of men with ED (20mg dose improved erection in 81% of patients comp. 35% on placebo, 75% of all intercourse attempts on 20mg dose treatment was successful comp. 32% on placebo). The efficacy of tadalafil was evident without regard to erectile dysfunction etiology, severity or patient age.

Tadalafil is safe and well tolerated, reported treatment-related adverse events (mostly headache and dyspepsia) are usually transient and generally mild to moderate. Tadalafil is like other PDE5 inhibitors contraindicated with any nitrates or NO donors.

The freedom from interaction with food should allow tadalafil patients for uncomplicated dosing and consistent real life efficacy. Tadalafil extended period of responsiveness should allow couples the freedom to have intercourse, when the moment is right. Since current goal of ED therapy goes beyond simply achieving a sufficient erection and men's expectations of oral treatment seem to be evolving toward a desire for normality in sexual life, tadalafil seems to fulfill those goals and expectations more than short-acting PDE5 inhibitors.

This assumption is confirmed also by results of three different preference trials performed by Prof. Fred Govier, Prof. Alexander Von Keitz, Prof. Peter Stroberg. Provided that patients were offered the chance to try the PDE5 inhibitors, the overwhelming majority of the patients preferred the tadalafil being ahead due to its long duration of action.

Dual target in the treatment of atherosclerosis: hypertension and hyperlipidemia

Dr Atika ADHAMI, MD. Beirut Governmental University Hospital

Hypertension and dyslipidemia are the two major modifiable risk factors for atherosclerosis. They have a synergistic increase in cardiovascular risk and they are linked through their effects on endothelial dysfunction.

Arterial remodeling is a characteristic feature of hypertension and leads to an increased LDL cholesterol and monocytes retention within the arterial wall. Together inflammation and oxidation are involved in the progression of atherosclerosis and the development of new lesions.

Benefits of anti-hypertensive and lipid lowering drugs have been shown to have a synergistic decrease in cardio-vascular risk in many recent trials.Unfortunately there are barriers to an effective management; non adherence is a major problem especially when a second or third drug is prescribed. The future paradigm is to lower treatment target with combination therapy in a polypill.

Amlodipine/atorvastine a fixed dose combination offers a single pill once daily for the treatment of hypertension, angina and/or dyslipidemia, with a lower cost and improved drug's adherence. Amlodipine/atorvastine has been approved in the USA since January 2004 by the FDA and is indicated in patients in which both drugs amlodipine and atorvastine were taken.

Asthma management: the evolving role of the pharmacist

Dr Joudy BAHOUS, MD. St Georges Hospital

Asthma is a chronic inflammatory disease of the airway characterized by acute airflow limitation which is reversible spontaneously or with treatment, and airway hyper-responsiveness. Asthma is an important burden because it is one of the most common chronic diseases worldwide and its prevalence is increasing in many countries. Unfortunately, many asthmatic patients are undiagnosed or are not treated adequately. Many surveys in developed countries show that 45% of patients say asthma limit their ability to take part in sports or recreation, one in three asthma patients reported being awaked with breathing problems. Medications like ß 2 s hort acting are used to relieve symptoms but medications like inhaled corticosteroids able to control the disease, are essential in the treatment of asthma.

Knowing that the pharmacist is part of the team taking care of asthmatic patients, his role is very important in:

•  Advise the patients to seek a diagnosis for their symptoms.

•  Correct the false knowledge related to medications, specially inhaled corticosteroids.

•  Increase awareness that controlling disease is more important than relieving symptoms.

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SESSION Nº 3. MODÉRATEUR : Dr Angélique BARAKAT

Novel drug delivery systems

Dr Soula KYRIACOS BOUSTANI, PhD. Lebanese American University

The therapeutic efficacy and the therapeutic index of many drug products are not totally defined by the chemical constitution of the drug and its inherent pharmacokinetic profile. They are also greatly affected by the method of presentation of the drug to the patient. Hence, the objective of newly developed drug delivery systems aims to optimize drug therapy by incorporating in the product's design an advanced engineering systems control approach.

The drug delivery industry is currently enjoying a period of considerable growth and innovation to improve the safety and efficacy of existing drugs and those in the pipeline. Novel drug delivery systems are developing quickly and continuously to include e.g., needless injection techniques, oral controlled release, intra-nasal, polymer-based, liposomes, pulmonary and transdermal (ultrasound, iontophoretic, etc.) systems.

This presentation demonstrates the creativity of the science involved. It also explains the major healthcare benefits achieved, as illustrated with novel drug delivery systems that are currently marketed or that have successfully completed early clinical trials.

Pharmaceutical quality assurance: the GSK commitment

Dr Aly ZIWAR, Medical Director. GlaxoSmithKline GNE

GlaxoSmithKline mission statement mentions that GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK mission is fulfilled by producing medicines, pharmaceutical products and vaccines that are:

•  Innovative (NCE through R&D).

•  Of high quality by applying GMP and implementing quality control and quality assurance.

Quality Assurance is all systems which ensure that manufactured products are of required quality.

Quality assurance is the bridge that drives us safely through the production process, thus it is called the production bridge.

This bridge stands on a number of pillars that are going to be discussed in the presentation.

Status of intellectual property protection as relating to the pharmaceutical industry in Lebanon

Mr. Walid NASSER, attorney at law

Problems faced by the pharmaceutical industry in Lebanon

•  Registration of copies of pharmaceutical products using data derived not from the product being registered, but from the original product being copied

•  Counterfeiting

Brief History of the legal protection of pharmaceutical products in Lebanon

Legal protection afforded by the new patent law No 240/2000:

•  Patent protection on the basis of a Lebanese patent,

•  Conditions for such protection

•  Difficulties faced by the innovators to obtain a Lebanese patent

•  Drugs that were in the market before the passage of law No 240/2000

•  New drugs invented after the passage of law No 240/2000

•  Protection on the basis of the confidential data protection of article 47 of the new patent law:

•  Definition of confidential

•  Conditions required to obtain such protection

•  Difficulties faced by the industry to obtain such protection

Summary of the protection afforded by other laws

•  Trademark law

•  Designs and models law

•  Unfair competition law

The Latest FACTs in the management of postmenopausal osteoporosis

Dr Charles SAAB, MD. Sacré-Cœur Hospital

A one-year randomized, double-blind, controlled multi-center, trail was performed comparing the efficacy of once weekly (OW) alendronate (ALN) 70mg and OW risedronate (RIS) 35mg at 78 US sites. 1,053 postmenopausal women with low bone mineral density (BMD) (T-score <-2.0 at hip trochanter, total hip, femoral neck or spine) were randomly assigned to OW ALN 70mg and OW RIS placebo, or OW RIS 35mg and OW ALN placebo. Treatment was administered fasting, in the morning, and patients were instructed to remain fasting for 30 minutes post dosing. The primary endpoint was the hip trochanter BMD at 12 months. Secondary endpoints included total hip, femoral neck and spine BMD, markers of bone turnover (uNTx/Cr, serum CTxI, serum BSAP, and serum P1NP), and tolerability as assessed by adverse experience (AE) reporting.

The mean age of subjects was 64 years, with a mean time since menopause of 18.4 years. ALN produced significantly greater increases in BMD at all sites measured, than did RIS (P<0.001 for hip trochanter, total hip, lumbar spine, and P=0.005 for femoral neck). Significant differences were seen at all BMD sites as early as 6 months.

Significantly greater reduction in all markers of bone turnover was seen with ALN compared to RIS at 12 months; treatment differences were significant as early as 3 months.

76.5% of ALN patients and 76.1% of RIS patients reported any clinical AE during the study. There was no significant difference in the percent of patients reporting any upper GI AE (22.5% ALN, 20.1% RIS, p=0.364) or discontinuation due to an upper GI AE (2.5% ALN, 3% RIS, p=0.708).

In this one year head-to-head study, ALN produced significantly greater gains in BMD and greater reductions in markers of bone turnover than RIS, with no differences in overall and upper GI tolerability. The greater antiresorptive efficacy of ALN was seen as early as 3 months.

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DIMANCHE 21 NOVEMBRE 2004

SESSION Nº 4. MODÉRATEUR : Dr Waël ABI GHANEM

The hospital “dream team” of the future

Mme Jacqueline SURUGUE, Président de l'EAHP

A increasing number of papers in the health professions literature promote team work. In the USA , the Joint Commission of Accreditation of Health Organisations requires in its accreditation standards that health systems seeking accreditation show evidence of interdisciplinary team for the delivery of care. On the World level, three world health professional organisations, the World Medical Association, the Federation Internationale Pharmaceutique and the International Council of Nurses joined together to this aim in an Alliance , the World Health Professional Alliance, to help foster better teamwork between the three core members of the healthcare teams: the physician, the pharmacist, and the nurse.

But what about “dream team”? Almost no paper addresses the “dream team” at hospital. The health professionals who have most used the concept of “dream team” are the veterinarians.

The presentation features how the “dream team” could apply to the hospital world and what it should be. It leads to further reflexions on what our competencies will be in the future, the necessary human resources and their availability among countries in Europe and the foreseen changes in future health care provision.

Pharmaconomic Evaluation of an Antibiotic Streamlining Service: Role of the Hospital Pharmacist

Dr Oussayma MOUKHACHEN, PharmD BCPS. Lebanese American University

Presented by: Rania SLIKA, PharmD. Marielle FARES, PharmD. Nidale BECHARA, PharmD. Lebanese American University

Background: Anti-microbial streamlining involves simplifying routes of administration, decreasing the dose or frequency of antimicrobial administration or frequency of antimicrobial administration, or converting from broad spectrum agent or multiple-agent therapy to a single narrower spectrum agent.

Rationale: Anti-microbial streamlining service will benefit the patient and the hospital by providing the most cost-effective therapy to the patient and decreasing hospital care cost. It will reevaluate the clinical pharmacy services showing a beneficial effect on health care outcome and cost.

Significance: If the streamlining antibiotic service proved to be cost-beneficial, it will have a large impact on the hospital care cost & on the clinical outcome in individual patients and potentially it will justify having a clinical pharmacist routinely performing antibiotic streamlining among other tasks

Objective: The aim is to identify financial and outcome benefits of therapeutic intervention by a multidisciplinary antimicrobial treatment team composed of pharmacists and infectious disease specialists.

Methods: It is a prospective study conducted over a period of two months including patients above 18 years of age who have been maintained on a AUBMC-restricted broad spectrum antibiotics-therapy for more than 72 hours excluding patients with serious infections. Data collection included demographic patient information, infectious diagnosis, date, site of culture, pathogen responsible, sensitivity, clinical outcomes, antibiotic regimen used and length of stay. On those patients who fit the predefined streamlining criteria, the investigators communicated verbally to managing team the recommendations to change the antibiotic regimen. The final decision was left solely to the managing team.

The recommendations were divided into accepted or rejected and then, their respective antibiotic consumption (using defined daily total dose (DDD)), costs using a two-level analysis and cost per DDD and their outcomes were compared. Institution and provider's perspective to were used to assess the economic impact of antibiotic streamlining.

Results: Over 2 months period, 207 patients were evaluated. A total of 88 recommendations were given on 80 patients who were candidates for streamlining and 9% were accepted on 6. Overall in those 80 patients considered candidates for streamlining, there was a decrease in the DDD of the restricted antibiotics and parenteral form consumption and an increase in their counterparts. In addition, over the 2 months period, there was a net cost avoidance of 53,763,000 LL using the two level analysis and 73, 580,000 LL using the cost/DDD.

Conclusions: There is a role for an infectious disease pharmacist in the avoidance of cost and reduction of consumption of restricted broad spectrum antibiotics. These data demonstrate the urgent need for well-structured Antibiotic Management Program (AMP) with its goal being set to optimize antibiotic use.

Impact of pharmacists on cost reduction in a hospital setting

Dr Marwan TAHA, PharmD, Dr Oussayma MOUKHACHEN, PharmD BCPS, Dr Jean DIB, PharmD. Lebanese American University

Presented by: Riwa KFOURY, Rony ZEENNY

Background: In Lebanon , the role and impact of clinical pharmacists is still a debatable issue for many reasons such as financial considerations and lack of studies that support or deny this role.

Objective: To assess the impact of pharmacist-initiated interventions on cost saving. Methods: The study included all patients admitted to the intensive care unit and/or internal medicine ward in three teaching hospitals. Over a four-week period, the number and types of interventions and their impact on cost saving were collected by pharmacy students and reviewed by clinical pharmacists.

Results: One hundred eighty five interventions were recorded with potential cost saving of 11,311,902 LL. The most common type of interventions were duplicate/unnecessary drug (23%), modification of route of administration (20%), dosage errors (18%), drug information (15%), alternative therapy (11%), and missing information (6%). Interventions targeted mainly proton pump inhibitors (23%), antibiotics (20%), H2 antagonists (4%), and anticoagulants (4%).

Conclusion: Pharmacist-initiated interventions can lower costs of drug therapies.

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SESSION Nº 5. MODÉRATEUR: Dr Randa AOUN

Travelers' diarrhea from trouble to cure

Pr. Robert STEFFEN, MD. University of Zurich

Up to more than 60% of travelers originating in industrialized countries suffer of TD when they visit developing countries. The cause of TD is essentially fecal contamination of food and beverages, but also genetic factors play a role.

TD is only rarely life threatening and spontaneously cures after an average of 4.1 days; nevertheless it is important as incapacitation and the necessity to change travel plans have a great impact both in businessmen and tourists. Irritable bowel syndrome following TD has been described in up to 10 % of patients.

Options for prevention are limited since few travelers will systematically abstain from consumption of potentially contaminated food, few would continuously use prophylactic medication. There is no vaccine with broad efficacy on the horizon.

Self-therapy abroad is thus universally accepted. Probiotics, charcoal and oral rehydration solutions (ORS) have no significant effect on the duration or amount of diarrhea, but ORS are paramount in pediatric patients and senior travelers. Antimotility agents offer fast relief, but they are contraindicated in dysentery. Additionally they are often followed by a period of constipation. Antimicrobial agents, mainly quinolones, have been used. More recently, rifaximin – a non-absorbed rifamycin-derivative with a broad antimicrobial spectrum – has been demonstrated in patients with TD to be as effective as ciprofloxacine and possibly to be superior to co-trimoxazole. Obviously the adverse event profile is similar to placebo. These properties make rifaximin the number one candidate to be included in the travel kit for therapy of TD abroad.

Topiramate: new approval in migraine prevention

Dr Adnan AWADA, MD. Hôtel-Dieu de France Hospital

Preventive treatment is considered for migraine when the attacks are very frequent, or lengthy and disabling, or the patient has serious problems with acute medications.

None of the classical preventive treatment has an efficacy > 60% and many of them can have serious side effects.

Topiramate has been introduced in the market few years ago as a potent large spectrum anti-epileptic drug. It has been tried in migraine prevention since the year 2000, but the first retrospective large study showing its efficacy was published in 2002. At the same time, at least 3 prospective randomized studies were launched, the results of which were published in the first semester of 2004. All demonstrated a good efficacy of topiramate in migraine prevention, with very acceptable side effect profile at the doses that were used (50mg BID). Based on this, the FDA approved topiramate for migraine prevention in August 2004.

PDE5's: who, which and when

Dr Wassim WAZZAN, MD. American University of Beirut Medical Center

The talk covers physiologic and clinical basis of erectile dysfunction and its treatment modalities. Special emphasis on oral pharmacotherapy with the different phosphodiesterase inhibitors available in the market. Recent European and North American studies will be reviewed.

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SESSION Nº 6. MODÉRATEUR: Pr. Hayat AZOURI

Place des antifongiques en thérapeutique

Dr Rabab EL RASSI EL KHOURY, PharmD. Hôtel-Dieu de France Hospital

La recrudescence des mycoses est un sujet qui occupe une part des publications actuelles. Ceci pourrait être en rapport avec :

•  le déplacement des populations,

•  l'utilisation d'antibiotiques à large spectre,

•  l'utilisation de traitements immunosuppresseurs,

•  le développement de la greffe d'organes et de moelle osseuse...

Cet exposé se propose de présenter les nouveaux traitements antifongiques en insistant sur le bon usage des molécules appartenant à des classes différentes d'antifongiques systémiques

•  Allyamines et autres inhibiteurs non azolés de la biosynthèse de l'ergostérol

•  Antimétabolites

•  Imidazolés

•  Triazolés

•  Echinocandines

•  Polyènes

Seven-day gatifloxacin-rabeprazole-amoxicillin therapy in the treatment of helicobacter pylori infection

Pr. Ala SHARARA , MD. Head of Gastroenterology Division. American University of Beirut Medical Center

Although adequate therapeutic regimens are currently available for Helicobacter pylori, the large number of pills used (up to 10 per day), the duration and side effects of therapy limit compliance and hence efficacy. The most widely-used regimen consists of the combination of a proton pump inhibitor, clarithromycin, and amoxicillin or metronidazole, all given twice daily for 7-14 days with reported eradication rates of 70-90% on intent-to-treat analyses. Of importance, the development of resistant strains to metronidazole and clarithromycin contributes significantly to primary treatment failure.

We have recently shown in a well-designed clinical study that a seven-day regimen consisting of gatifloxacin (400mg once daily), amoxicillin (1g twice daily) and rabeprazole (20mg twice daily) is highly effective in the treatment of H. pylori with an eradication rate of 92%. Furthermore, in another study, the same regimen was also very effective in secondary eradication after failure of one or more conventional clarithromycin-based triple therapies (84.4% eradication rate). This new regimen is simple, well tolerated, and may lead to higher compliance and lower costs.

Diabetes mellitus: recent update

Dr Shawki ATALLAH, MD. Hôtel-Dieu de France Hospital

Diabetes mellitus (DM) consists of a group of metabolic diseases characterized by hyperglycemia resulting from a relative (type 2 DM) or absolute deficiency (type 1 DM) of the hormone insulin. A chronic hyperglycemic state is associated with long-term vascular complications, notably involving the eyes, kidneys, heart, nerves and blood vessels.

The current therapeutic approach to type 1 and type 2 DM commonly involves intensive blood glucose control (HbA1c ? 7%) aim of reducing the risk of long-term co mplications.

Treatment in type 1 DM, mainly consists in administering a traditional intermediate or long-acting insulin with a rapid acting insulin to cover meal times. In type 2 DM, there are several treatment options including oral antidiabetics (alone or in combination with insulin) or at some stages of the disease, insulin alone.

Traditional intermediate/long-acting insulins are associated with significant drawback that limits their use as basal insulins. The major drawback is the incidence of nocturnal hypoglycemia often related to the undesirable peak concentration characterizing these protracted-acting insulin suspensions.

Insulin glargin, a new basal insulin, is a recombinant human insulin analog. When injected subcutaneously, insulin glargine, which is a clear solution, forms a microprecipitate at the physiological, neutral PH of the subcutaneous space. Because of its stability, absorption of insulin glargine from the subcutaneous site of injection is delayed and last a long time, thus providing a fairly constant basal insulin supply, much like that of basal insulin secretion in non-diabetic people in the post absorptive state. The peakless and 24 hour pharmacokinetic profile of insulin glargin help in reducing the likelihood of nocturnal hypoglycemia and improve control of blood glucose as it was shown in clinical studies versus traditional basal insulin.

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SESSION Nº 7. MODÉRATEUR : Dr Rabab EL RASSI EL KHOURY

Prise en charge de la douleur à l'officine

Dr Patricia EL KHOURY, PharmD. Associate Product Manager.

Toute personne est susceptible d'être affectée par différents types de douleur.

Plusieurs facteurs peuvent contribuer à faciliter la prise en charge de la douleur du patient au comptoir :

•  du traitement médical avec les antalgiques (paracétamol, aspirine, AINS…)

•  au conseil et à la vente des antalgiques

•  à la prise en charge des objections du patient

Le rôle du pharmacien est primordial pour aider à soulager efficacement la douleur.

Thrombopénie induite par l'héparine

Dr Myrna GERMANOS, PhD. Hôtel-Dieu de France Hospital

Abstract not available

Place du pharmacien dans la réforme actuelle (officine, hôpital, inspection)

Pr. Isabelle DURAND-ZALESKI, Directrice de l'Aide à la Décision Publique et Professionnelle à l'ANAES

Abstract not available