FDA Watching 19 Drugs for Safety Risks

This is an article that very important for everyone to know, especially medical personels.

PLEASE READ THIS !

From Medscape Pharmacists

Susan J. Bliss, RPh, MBA

Published: 10/08/2009

Although prescription drugs undergo clinical trials before they hit the market, unexpected adverse events may still occur in the general patient population. As a result, the Food and Drug Administration (FDA) collects adverse event reports and looks for potential trends. In its latest surveillance report, the agency has identified 19 drugs that are associated with adverse events and, therefore, are undergoing close evaluation.

A centerpiece of the FDA's safety surveillance efforts is the Adverse Drug Event Reporting System. This computerized database is used to collect and analyze safety reports on all approved drug and therapeutic biological products. If a potential safety concern occurs, further epidemiologic studies may be performed, and, eventually, regulatory actions may be taken such as changing a drug's labeling, restricting its use, warning the public, or even removing the drug from the market.^[1]

The most recent FDA report based on Adverse Drug Event Reporting System data collected in the fourth quarter of 2008 provides a list of drugs that represents "potential signals of serious risks" or that has new safety information (Table).^[2] These potential safety issues were identified in reports filed by clinicians and patients via the agency's MedWatch program.

Table. Drugs With Potentially Serious Risks or New Safety Information

Active Ingredient (Trade Name) or Product Class	Potential Safety Risk or New Safety Information
Apomorphine (APOKYN®)	Psychiatric events
Choriogonadotropin alfa (Ovidrel®)	Anaphylactic reactions
Clomiphene citrate (Clomid®)	Visual disorders
Clozapine orally disintegrating tablet (FazaClo®)	Deaths
Darifenacin (ENABLEX®) and solifenacin (VESIcare®)	Angioedema and other allergic reactions
Drospirenone/ethinyl estradiol (Yasmin®)	Pancreatitis
Efavirenz (Sustiva®)	Birth defects involving the eye and face
Fibrin sealant, human (Evicel™)	Air embolism
Hydrochlorothiazide in combination products	Skin reactions
Imiquimod cream (Aldara™)	Dysuria due to severe local reactions during use in the genital area
Modafinil (Provigil®) and armodafinil (Nuvigil®)	Serious skin reactions
Orlistat (XENICAL®, alli-®)	Hepatotoxicity
Polyethylene glycol oral laxative (various trade names)	Neuropsychiatric events
Raltegravir (ISENTRESS®)	Psychiatric events
Selegiline (EMSAM®)	Hypertension
Sumatriptan/naproxen (TREXIMET®)	Myocardial infarction
Testosterone gel (AndroGel®, Testim®)	Adverse events from accidental exposure
Tolterodine tartrate (Detrol®)	Stevens-Johnson syndrome
Varenicline (CHANTIX®)	Angioedema, serious skin reactions, visual impairment, accidental injury

From US Department of Health & Human Services, US Food and Drug Administration. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/
ucm161063.htm Accessed October 1, 2009.^[2]

FDA evaluation of these drugs continues, and officials stress that until a potential relationship between the drug and the risk is fully evaluated, it is not clear what causes the association.^[2] The adverse event(s) may be precipitated by concurrent disease states, coadministration of other drugs, change in patient health status, previous drug therapy, or other causes. Clinicians do not need to stop using these drugs, but they should be aware of the potential risks.

Already, the FDA has taken action on several of the drugs on the list. For example:

• Sumatriptan/naproxen. The FDA reviewed the existing boxed warning on the product label addressing myocardial infarction and concluded it was adequate^[2];
• Testosterone gel. A May 2009 news release announced the addition of a new boxed warning that addresses potential adverse events in children and women who are accidentally exposed to testosterone gel^[3]; and
• Varenicline, bupropion. The FDA distributed a Safety Alert and Public Health Advisory concerning these smoking cessation agents. The FDA now requires that medication guides highlighting the risk of neuropsychiatric symptoms be provided to patients receiving these medications. Information for healthcare professionals, patients, family members, and caregivers is included.^[4]

The FDA recently redesigned its Website (www.fda.gov) to make drug safety information more accessible for patients and providers. There are 3 ways to search for topics on this site: an A-to-Z index, a topic index, and a search box.

In addition, the federal agency provides several other tools that are useful for clinicians:

• MedWatch Website. MedWatch is the agency's reporting program, and the site provides the latest updates on adverse drug event reports. You can use the 1-page MedWatch form to report your own adverse drug events.
• Drug Safety Newsletter. Designed to complement FDA product labeling, Public Health Advisories, and Alerts for Healthcare Professionals, the Newsletter is available by electronic subscription and is posted on the FDA Website.
• MedWatch E-list. This free email subscription service allows for rapid dissemination of new safety information regarding drugs and devices. Subscribe here.
• FDA Transparency Blog. This is a place where you can have a "conversation" with the FDA -- ask questions, respond to their questions, and provide general feedback on the agency's efforts. Regular updates are scheduled to appear through November 2009.

Much of the drug safety information available on the FDA Website can be distributed via RSS feed and text messages sent directly to cell phones. Podcasts, videos, and other newsletters are also available on the Website.

Seasonal Flu Vaccine May Help Protect Against H1N1

Laurie Barclay, MD

October 7, 2009 — Seasonal influenza vaccine may help protect against novel pandemic influenza A (H1N1), according to the results of a frequency-matched, case-control study in Mexico City reported online October 6 in the British Medical Journal. However, the investigators and authors of an accompanying editorial urge that a specific vaccine against H1N1 flu is still needed.

"The viral genomic sequence for several of the novel A/H1N1 strains, including a Mexican isolate, has been made publicly available," write Lourdes Garcia-Garcia, from Instituto Nacional de Salud Pública in Cuernavaca, Mor, Mexico, and colleagues. "Given the new reassortant nature of this virus — that is, unusual mixing of swine, avian, and human influenza genetic sequences — the available evidence, although incomplete, suggests that seasonal vaccines will confer little or no protection against influenza A/H1N1. Mexican guidelines recommend vaccination with trivalent inactivated influenza vaccine (virus strains A/Brisbane/59/2007 (H1N1)-like, A/Brisbane/10/2007 (H3N2)-like, and B/Florida/4/2006-like antigen) for children aged 6-35 months, all adults aged more than 60, and individuals older than 35 months with conditions conferring a higher risk of influenza related complications."

The goal of this study was to examine the association of 2008–2009 seasonal trivalent inactivated vaccine with cases of influenza A/H1N1 during the epidemic in Mexico. From March to May 2009 at a specialty hospital in Mexico City, 60 patients with laboratory-confirmed influenza A/H1N1 were compared with 180 control patients matched for age and socioeconomic status. Control subjects had diseases other than influenza-like illness or pneumonia and were living in Mexico City or the state of Mexico. The primary study endpoints were odds ratio (OR) and effectiveness of trivalent inactivated vaccine against influenza A/H1N1.

Compared with control patients, patients with laboratory-confirmed influenza A (H1N1) had higher rates of hospitalization, invasive mechanical ventilation, and death. However, control patients were more likely than patients with laboratory-confirmed influenza A (H1N1) to have chronic conditions associated with a higher risk for influenza-related complications. H1N1 influenza was independently associated with receipt of trivalent inactivated vaccine (OR, 0.27; 95% confidence interval [CI], 0.11 – 0.66) and with underlying conditions (OR, 0.15; 95% CI, 0.08 – 0.30), based on the multivariate model. Trivalent inactivated vaccine effectiveness against H1N1 influenza was 73% (95% CI, 34% – 89%), and none of the 8 vaccinated patients with laboratory-confirmed influenza A (H1N1) died.

"Preliminary evidence suggests some protection from the 2008-9 trivalent inactivated vaccine against pandemic influenza A/H1N1 2009, particularly severe forms of the disease, diagnosed in a specialty hospital during the influenza epidemic in Mexico City," the study authors write. "These results are to be considered cautiously and in no way indicate that seasonal vaccine should replace vaccination against pandemic influenza A/H1N1 2009. Our data support the hypothesis that partial protection provided by the seasonal vaccine may be explained by the boosting of existing antibodies that were elicited by previous exposure, through either infection or vaccination, to an influenza A/H1N1 virus genetically and antigenically more closely related to the novel influenza virus than contemporary seasonal H1N1 strains."

Limitations of this study include its retrospective design, small sample size, self-reported vaccine status, and lack of blinding of interviewers to the status of patients with laboratory-confirmed influenza A (H1N1) and control patients.

"The estimates for vaccine effectiveness could be inflated owing to a high prevalence of chronic conditions and vaccination in our control population," the study authors conclude. "Similar studies in other settings are needed to confirm or refute our results."

In an accompanying editorial, Menno D. de Jong, from the Academic Medical Centre of the University of Amsterdam, the Netherlands, and Rogier W. Sanders, from Weill Medical College of Cornell University, New York City, also warn that a specific vaccine against influenza A (H1N1) is still needed. Even in countries that have arranged for vaccine production in sufficient quantities, vaccines may not be available in time.

"Antibodies that recognise multiple influenza strains are rare, which explains the frequent lack of cross protection between vaccines and natural infection," Dr. De Jong and Dr. Sanders write. "However, antibodies have been identified that may open possibilities of developing a 'universal flu vaccine.' Traditional flu vaccines have a good track record in terms of efficacy and safety, so it will take years to replace them, but the new techniques and vaccines at various stages of testing are both necessary and promising."

The Mexican Ministry of Health supported this study. Two of the study authors are employed by Laboratorios de Biológicos y Reactivos de México. Dr. De Jong and Dr. Sanders have disclosed no relevant financial relationships.

BMJ. Published online October 6, 2009.

HOW SHOULD WE MANAGE DRUG INTERACTIONS BETWEEN CLOPIDOGREL AND PROTON-PUMP INHIBITORS?

AN ARTICLE FROM MEDSCAPE

Question

What is the best practice intervention for patients on both clopidogrel and proton-pump inhibitors (PPIs)?

Response from Jenny A. Van Amburgh, PharmD, CDE Associate Clinical Professor, School of Pharmacy, Northeastern University, Boston, Massachusetts; Director of the Clinical Pharmacy Team and Residency Director, Harbor Health Services, Inc., Boston, Massachusetts

According to a 2007 survey, clopidogrel is the sixth most commonly dispensed medication in the United States. Indicated to reduce the rates of antithrombotic events in patients with a recent cardiovascular event, clopidogrel plays an integral role in the care of patients after myocardial infarction, stroke, or acute coronary syndrome. To reduce the risk for gastrointestinal bleeding, which can be associated with this drug, clinicians often prescribe a concomitant proton-pump inhibitor (PPI) for high-risk patients. Because of its generic availability and over-the-counter (OTC) status, omeprazole (Prilosec^®, Prilosec OTC^®) is one of the most widely used and accessible PPIs today.

Recent evidence suggests that certain PPIs reduce the antiplatelet effects of clopidogrel. Clopidogrel, a prodrug, requires metabolism in the liver via cytochrome P450 (CYP) enzymes. Once activated, clopidogrel blocks platelet aggregation by inhibiting adenosine diphosphate at the P2Y12 receptor. PPIs, such as omeprazole and its S-enantiomer esomeprazole (Nexium^®), are thought to inhibit the CYP2C19 enzyme, thus negating the antithrombotic effects of clopidogrel. CYP2C19 also acts as the primary enzyme responsible for determining a patient’s pharmacodynamic response to clopidogrel. The question of how to best care for patients taking both PPIs and clopidogrel remains unanswered.

Gilard and colleagues conducted a randomized, double-blind, placebo-controlled study to assess the influence of omeprazole on clopidogrel efficacy. They randomly assigned 145 patients who were undergoing coronary artery stent implantation and receiving aspirin, 75 mg daily, and clopidogrel, 75 mg daily (after a 300-mg loading dose), into 2 groups. The treatment group received omeprazole, 20 mg daily for 7 days, and the control group received placebo for 7 days. Assessment of the platelet reactivity index (PRI) was the primary endpoint. A PRI less than 50% indicated a favorable response to clopidogrel.

The data from 124 patients were reviewed after the 7-day course of therapy. Before treatment, the PRI was 83.2% in the control group and 83.9% in the treatment group. At study end, the PRI was 39.8% in the control group and 51.4% in the treatment group (P < .001). Patients who received gastroprotection with omeprazole were 4.31 times more likely to respond poorly to clopidogrel. The long-term implications of this interaction are uncertain but may suggest reduced cardioprotective benefits of clopidogrel.

Although recent evidence indicates an interaction between PPIs and clopidogrel, further emphasis should be placed on the pharmacogenetic properties that influence clopidogrel metabolism. An estimated 30% of whites, 40% of blacks, and over 55% of East Asians have a CYP2C19 gene polymorphism that reduces the pharmacodynamic and pharmacokinetic response of clopidogrel. With clopidogrel metabolism reduced in these patients, concomitant PPI therapy can further reduce its metabolism, predisposing patients to such adverse events as cardiovascular events and death.

At the 2009 Society for Cardiovascular Angiography and Interventions meeting, investigators reported results of a retrospective cohort of over 16,700 patients who received clopidogrel (with or without PPI) after stenting. Patients who received PPIs had a more than 50% higher risk for 1-year cardiovascular events compared with patients who did not receive PPIs. The findings suggest that the increased risk for cardiovascular events may be a class effect of PPIs and may not just be the result of specific agents as once perceived.

For now, healthcare providers should exercise clinical judgment and recommend that only high risk-patients (those receiving dual antiplatelet therapy, those with a history of gastrointestinal bleeding or ulcers, or those receiving concomitant anticoagulant therapy) receive PPIs in conjunction with clopidogrel. The manufacturer of clopidogrel discourages its use with omeprazole on the basis of the new evidence.

If gastroprotection is deemed appropriate, consider using histamine-2 blockers such as ranitidine (Zantac^®) or famotidine (Pepcid^®) as first-line therapy. Clinicians should note that histamine-2 blockers may be less efficacious than PPIs for gastroprotection, but they have similar efficacy for heartburn and symptoms similar to those of gastroesophageal reflux disease.

APPROVAL OF NEW DIPLOMA TITLE

Good day to all Malaysian Assistant Pharmacist. Today another history was created in our profession. The long awaited to get recognised of our Diploma is finally succeeded. The Education Bureau from Health Ministry Training Division finally approved our diploma title change from "Diploma Pembantu Farmasi" to "DIPLOMA FARMASI". (Diploma in Assistant Pharmacist to Diploma in Pharmacy).

This is the most sweetest news after the change of our job title. At the meeting this morning, the bureau also approved our very first "POST BASIC" course since 50yrs of our profession in the Pharmacy Industry.

All the credit should be given to Pharmacy Services Division, National Pharmacy Assistant Association, our Union, staffs from Health Ministry training division, staffs from pharmacy college (KSKB Sg.Buloh)and those involved make this dream come true. GOD BLESS ALL.

Most thankfull to our new Pharmacy Services Division Director, Puan Eisah bt Abd Rahman who always supported our struggle, understand and who really care as a mother to fulfill the needs of a child.

GOD BLESS MOTHER EISAH AND EVERYONE INVOLVED.

THANK YOU

Pharmacist-Doctor Teams Help Keep Heart-Failure Patients Out of the Hospital

ARTICLE FROM MEDSCAPE, AUGUST 18TH

August 18, 2009 (Adelaide, Australia) — Collaboration between doctors and pharmacists can reduce medication-related problems and hospitalizations and improve health outcomes in patients with heart failure, Australian researchers report in a study published online before print August 18, 2009 in Circulation: Heart Failure [1].

A service wherein pharmacists visited heart-failure patients in their homes to review their medications and then reported the findings to the patients' doctors cut the rate of hospitalization for heart failure by 45% in its first year of operation, Dr Elizabeth E Roughead (University of South Australia, Adelaide) and colleagues write.

"Medication-related problems contribute to the problem of hospitalization for heart-failure patients, so educating these patients about drug use is important," Roughead told heartwire . "The home visit part of this program enables time for more thorough education. Clinicians should work with pharmacists to help their heart-failure patients."

A Synergistic Relationship

Dr Mauro Moscucci (University of Miami Miller School of Medicine, FL) agreed that the partnership between pharmacists and clinicians has important and positive implications for improving outcomes for heart-failure patients.

"It's the synergy that is impressive. Improved outcome is due not to pharmacists' visits alone but to the partnership between the two healthcare providers," Moscucci told heartwire .

Roughead and her colleagues sought to determine whether collaborative medication reviews, which have been shown to be successful in improving outcomes for patients with heart failure in randomized controlled trials, would also be successful in a "real-world" setting. Such reviews are nationally funded in Australia.

They retrospectively reviewed administrative claims data on veterans and war widows aged 65 years and older who were prescribed bisoprolol, carvedilol, or metoprolol succinate for heart failure and compared 273 patients who received general practitioner-pharmacist collaborative home medication review with 5444 controls who did not.

The average age of the patients in both groups was 81.6 years. The median number of comorbidities was eight in the group who received the collaborative reviews compared with seven in the group who did not (p<0.0001).>

"We chose to study a veteran population because they are elderly and an appropriate target population for home medicines review services," Roughead explained.

Review Delayed Hospitalization for Heart Failure

The time to hospitalization for heart failure was significantly delayed in the group that received a home medicines review, the investigators found. After adjustment for a variety of confounding variables, only 5.5% of the patients in the review group were hospitalized within a year, compared with 12% of the control group (hazard ratio [HR] 0.55, 95% CI 0.39–0.77; p<0.0001).

Pharmacist Dr Amy Seybert (University of Pittsburgh Medical Center, PA) told heartwire that pharmacists are particularly well-suited for counseling patients. "Definitely. It's what we are trained to do. We explain to patients why they should take their medications and stress the importance of compliance. We tell them how the drugs work. I really think that if patients understand why they are taking something and for what purpose, they are much more apt to be compliant."

Her colleague, Dr Joon Sun Lee (University of Pittsburgh Medical Center), agrees.

"The Australian study confirms much that is known. As treatment regimens, especially medication regimens for heart-failure patients, become more and more complex, the potential for patients to get confused becomes greater. So measures that confirm medication regimens and also check up on patients are effective at decreasing readmissions," he said.

It Works Well Down Under, But Will It Work in the US?

More and more institutions in the US are using pharmacists to help educate patients, usually as part of hospital discharge programs. But Sun Lee questions whether a partnership between pharmacist and clinician as the Australians have would be feasible in the US.

"One of the vulnerabilities and inefficiencies of the US healthcare system is that the collaborative medication review part of healthcare is not rewarded financially. It is an extra cost without reimbursement, whether you are talking about the hospital incurring the cost or the doctor's office. Right now, this is one of the cracks that exist in the delivery care system," he said

Diabetes May Soon Be Diagnosed by MRI

by, DIABETES PHARMACIST.COM
August 6, 2009 by Joel Shpigel R.Ph.

Using noninvasive imaging (Magnetic Resonance Imaging (MRI) ) for the first time in diabetes research, physicians at Massachusetts General Hospital and Harvard Medical School have discovered how it may aid in the early diagnosis, staging, and treatment of diabetes.

"With noninvasive MRI we have the ability to evaluate beta cell mass, a major factor of insulin secretion that is significantly reduced in type two diabetes and almost gone in type one,” said Anna Moore, MD, lead author of the study. “Knowing the number of functional beta cells left would allow physicians to develop the most appropriate treatment plans for their patients. It would also allow them to respond, change or manipulate those treatment plans at any time,” she said.

- Diabetes Pharmacist has been named one of the 100 Best Blogs for Pharmacy Students by Jill Gordon on Nursing Schools.Net., a nursing school network and directory.

Medication Reconciliation Performed by Pharmacy Technicians at the Time of Preoperative Screening

Abstract

Background: Medication errors occur regularly in surgical patients, especially due to transfer problems at the time of hospital admission. A method for decreasing the error rate is medication reconciliation by hospital pharmacists as part of a preoperative clinic. The role of pharmacy technicians in this process has not been studied.
Objective: To study the use of pharmacy technicians in medication reconciliation by measuring the effect of early reconciliation in the preoperative clinic on medication and allergy discrepancies and on inadvertent continuation of antithrombotics. A secondary objective was to study the effect of community pharmacist follow-up on recommendations to discontinue antithrombotic therapy.
Methods: During the preintervention measurement period, patients received usual care by anesthesiologists, who recorded the medication and documented allergies of the patient. The intervention consisted of the addition of a pharmacy technician to the preoperative screening clinic to perform the same tasks as anesthesiologists as related to medication reconciliation. If necessary, the patient was advised on stopping the antithrombotic. On the day that the patient was supposed to stop the antithrombotic, that person's community pharmacist contacted the patient to determine whether this had been done. The main outcome measures were the proportions of patients with one or more medication discrepancy, one or more allergy discrepancy, and one or more antithrombotic error.
Results: In the preintervention period, 204 patients were evaluated; 93 were included in the postintervention analysis. The proportion of patients with one or more medication discrepancy (RR 0.29; 95% CI 0.12 to 0.71) was statistically significantly reduced in the postintervention group. The proportions of patients with one or more allergy discrepancy (RR 0.76; 95% CI 0.35 to 1.64) and one or more antithrombotic errors (RR 0.18; 95% CI 0.02 to 1.33) were reduced, but not significantly. Follow-up by the community pharmacist did not identify any patients who had not followed the preoperative clinic's advice on temporarily withholding their antithrombotics.
Conclusions: The results of this study show that pharmacy technicians can be successfully assigned to a preoperative clinic, resulting in a statistically significant decrease in medication discrepancies.

INNOVATION AWARDS FOR PHARMACIST & PHARMACY TECHNICIAN

See how a good team work between Pharmacist and Pharmacy Technicians on a innovation project in USA which gives more room to Pharmacist to practice in clinical works.

We should follow this steps too in Malaysia. Read more belows from MEDSCAPE.

New York (MedscapeWire) Dec 13 — Five teams of pharmacists and certified pharmacy technicians were declared the winners of this year's Innovations in Pharmaceutical Care Award on December 4th at the American Society of Health-System Pharmacists (ASHP) Midyear Conference in Las Vegas, Nevada.

Winners included a team at Duke University Medical Center that reengineered pharmacy work functions to allow pharmacists more time to focus on patient care. Another winning team, from North Mississippi Medical Center - Department of Pharmacy Services, uses a certified pharmacy technician in the medication error tracking and reporting process, giving pharmacists and other health professionals more time to implement new patient care programs.

The award, founded in 1998 by the Pharmacy Technician Certification Board (PTCB), recognizes innovations in pharmaceutical care by teams of pharmacists and certified pharmacy technicians in any practice setting. Each of the five winning teams received a cash award of $1,000 to be shared equally by the pharmacist and certified pharmacy technician and a framed certificate to be displayed in their respective practice settings.

"We take great pride in the Innovations Award Program," said Melissa M. Murer, RPh, PTCB Executive Director. "Efforts to enhance patient care, reduce medication errors and manage patient's chronic diseases serve as best practices for the over 70,800 certified pharmacy technicians nationwide."

ARTICLE FROM MEDSCAPE

New CDC Recommendation: All Children Should Receive Annual Seasonal Flu Vaccines

July 27, 2009 — The US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, is changing its recommendation for annual seasonal influenza vaccination for children aged 6 months to 18 years to a "full recommendation," Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, announced.

In addition, the CDC is advising a seasonal flu vaccine for anyone who feels they need one.

"While we are focusing a lot of attention on the 2009 H1N1 influenza virus, we do expect seasonal strains to emerge, and we are issuing updates of which strains to expect," Dr. Schuchat said. These include the A-H1N1, A-H3N2, and B strains, "which are available in this year's vaccine," she noted. "This past year's recommendations encouraged annual vaccination [of children].... This year, [the CDC] is no longer just advising vaccination whenever feasible but is [issuing] a full-out recommendation" of the seasonal flu vaccine.

Only about 40% of the US population received a flu vaccine last year. The CDC is recommending and emphasizing "an intensification of use" of the vaccine.

The CDC has specifically recommended that healthcare workers be immunized, as well as that campers at sleepover summer camps and attendees of military academies where there have been notable outbreaks of influenza receive the flu vaccine and antiviral agents, but only if appropriate.

"I don't think antiviral prophylaxis is a good idea," Dr. Schuchat said, noting that oseltamivir-resistant influenza strains have been reported.

Dr. Schuchat said that the latest laboratory-confirmed case count for the H1N1 influenza virus is 43,771 cases and 302 deaths, "but this is the last time we will be reporting cases in this way." Instead, the CDC will have a FluView Weekly Surveillance Report, updated every Friday, on its Web site.

The National Institutes of Health announced yesterday that clinical trials will begin as early as next week of 2 H1N1 influenza vaccine candidates in adults, either alone or in conjunction with the seasonal flu vaccine and, if safe, in children.

Sanofi Aventis and CSL Biotherapies, manufacturers of the 2 candidate vaccines, told a US Food and Drug Administration (FDA) advisory committee yesterday that they expect to have a vaccine available by October. Dr. Schuchat said that she is concerned that the flu season could be well underway by that time, because the school year begins within weeks in many areas.

The virus is unpredictable, she said, "skipping entire communities, while hitting others really hard." In addition, the virus can cause a wide spectrum of illness, from mild symptoms to respiratory arrest and neurological problems, including seizures. "That is why we are taking the virus so seriously." H1N1 often affects young, apparently healthy individuals, as well as those at high risk, and it could affect more than 40% of the population.

"We are preparing for the worst-case scenario of 60% of the population being affected," Dr. Schuchat said. "The value of worst-case scenario planning is that it allows for continuity planning."

The FDA's Advisory Committee on Immunization Practices is set to meet July 29 to propose H1N1 vaccine recommendations. Children aged 0 to 4 years will likely be the top priority, followed by school-age children, healthcare workers, pregnant women, and adults with chronic diseases.

Today, the FDA announced it had issued an emergency use authorization for a third diagnostic test for the 2009 H1N1 influenza virus because a public health emergency involving H1N1 was declared on April 26, 2009. It is the Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction diagnostic test.

The emergency use authorization allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments to perform high-complexity tests. This test is intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.

The test does not indicate the stage of infection, nor does a negative result preclude influenza virus infection, FDA officials emphasize.

MMWR Morb Mortal Wkly Rep. Posted online July 24, 2009

From MedscapeCME Cardiology

Raising Awareness of Resistant Hypertension: Burden, Diagnosis, and Emerging Therapies

Michael A. Weber, MD

Published: 07/31/2009

Introduction

Resistant hypertension is defined as blood pressure that remains above target goals despite concurrent use of 3 antihypertensive medications of different classes, including a diuretic, all at optimal doses.[1-3] The exact prevalence of resistant hypertension is not well defined, and there is no current standard of care for its management. Overall, resistant hypertension remains understudied and additional knowledge is needed to better identify and treat patients with the condition. Clinical data on novel therapeutic options for the management of treatment-resistant hypertension were highlighted at this year's meeting of the European of Society of Hypertension (ESH), held June 12-16, 2009 in Milan, Italy. To provide a context for these results, Linda Brookes, MSc, on behalf of MedscapeCME Cardiology, spoke with Michael A. Weber, MD, Professor of Medicine, SUNY Downstate College of Medicine, Brooklyn, New York. In the following interview, Dr. Weber discusses the global burden of the condition, diagnosis, and current and emerging treatment options.
Burden of Resistant Hypertension

MedscapeCME: Hypertension management guidelines are consistent about the definition of resistant hypertension as failure to achieve blood pressure goal (<>

Michael A. Weber, MD: Resistant hypertension may occur in only about 10% to 15% of all cases of hypertension, but bearing in mind that there are over 70 million people with hypertension in the United States, this means that there are several million people with resistant hypertension.[4] So if this were a disease all by itself, it would be regarded as a relatively common condition.

MedscapeCME: Is this why resistant hypertension seems to have been the subject of so much attention recently?

Dr. Weber: In many places around the world, physicians are pressured to do a better job in treating common chronic conditions and to demonstrate that they are doing everything they possibly can to treat them. In hypertension, they must show either that they have the patient's blood pressure well controlled or at least that they have gone through all the steps to try and get it well controlled. Yet there will be a proportion of patients who will be difficult to treat, and I believe experts are focused on that problem now.
Challenges in Diagnosing and Managing Resistant Hypertension

MedscapeCME: What about the diagnosis of resistant hypertension? This seems to involve 3 questions: What makes hypertension truly "resistant?" How early can it be recognized? And is there a genotype or a typical phenotype associated with resistant hypertension?

Dr. Weber: For a start, there isn't a recognized genotype. And there really isn't an obvious predictive finding that tells you in advance that a particular patient is going to have treatment-resistant hypertension. Many people with treatment-resistant hypertension emerge with that classification only after several weeks or months of disappointments for the physician trying to manage the hypertension.

MedscapeCME: So how does a physician confirm that a patient has resistant hypertension?

Dr. Weber: First, it is important to ensure, as best you can, that the patients are actually taking their medications. This may involve a lot of detailed discussion with patients to satisfy doctors that the patients really are following their treatment. If they are, the next question is whether the treatment regimen is a logical one. For instance, does it include drugs that ought to be part of any hypertension treatment plan, such as a diuretic and a blocker of the renin-angiotensin system, and are the drugs being given at appropriate doses?

In terms of diuretics, I believe that our efforts in the past few years have sometimes been inadequate in that we have tended to often rely on low-dose hydrochlorothiazide (HCTZ). This works well in most hypertensive patients when it is paired with a drug such as an angiotensin-receptor blocker (ARB), an angiotensin-converting enzyme (ACE) inhibitor, or a calcium-channel blocker. However, in people with resistant hypertension, who often have diminished renal function, HCTZ at a dose of 12.5 or 25 mg may not be effective and chlorthalidone should be considered instead. Also, much of the clinical trial experience demonstrating prevention of major outcomes, such as stroke, has been with chlorthalidone rather than HCTZ.[5-9]

So if the right drugs are being prescribed in the right doses and the patient is taking their medications, is something happening to prevent these drugs from working effectively? One explanation may be that the patient has an underlying so-called "secondary cause'" for hypertension that does not respond to drugs -- for example, an adrenal cortex tumor, a pheochromocytoma, renal artery stenosis, or advanced kidney disease.[2] The other main cause of not responding adequately despite a good treatment regimen is that the patient is taking a medication that is raising blood pressure and interfering with the actions of the antihypertensive drugs.[2] Culprits include nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives, and some common cold remedies.

MedscapeCME: Wouldn't patients usually be warned about taking other medications at the start of their treatment?

Dr. Weber: Not necessarily. Some physicians overlook the fact that drugs such as NSAIDs might be a problem, and second, they may not always know that a patient is taking drugs like ibuprofen or naproxen because they are usually acquired over the counter and not reported to the doctor. So it is necessary to think proactively about drugs that could be interfering with blood pressure-lowering medications.

MedscapeCME: Presumably it is fairly straightforward to deal with those sorts of problems, but identifying or ruling out secondary causes is more complicated and time-consuming?

Dr. Weber: That is correct. The modern approach to looking for secondary causes typically involves some sort of imaging -- for example, an angiogram, computerized tomography scan, or magnetic resonance imaging. So it can be a fairly major commitment to consider a secondary cause of hypertension. It has to be on the list of possible causes to check, however. You have to decide that these conditions are unlikely before you can conclude that a patient truly has treatment-resistant hypertension.

MedscapeCME: At that point should a patient have been referred to a clinical hypertension specialist?

Dr. Weber: Yes. If you are really pursuing secondary hypertension, the patient is probably served best in the hands of a specialist who has experience in working up these kinds of conditions. In reality, these conditions are relatively uncommon and most physicians have probably not had much experience in the latest diagnostic methods for identifying underlying causes of hypertension. So the patient should be referred to a hypertension specialist, or if there isn't one readily available, then a nephrologist or other specialist who has experience with secondary hypertension.

MedscapeCME: What about primary aldosteronism -- is that a common secondary cause?

Dr. Weber: A fair number of people with resistant hypertension have high aldosterone levels, so the simplest, most effective approach might be to try an aldosterone-receptor blocker, such as spironolactone or eplerenone, for a few weeks and see whether it works. Experience suggests that this should produce a good result quite often,[10-14] especially in African American patients, although there have not been comprehensive studies to confirm this.

MedscapeCME: Even after trying an aldosterone-receptor blocker, there are a number of other classes of drugs that might be tried, such as beta-blockers and centrally acting alpha-agonists. How does a physician decide which one to add?

Dr. Weber: A beta-blocker, preferably one that does not carry the metabolic and symptomatic side effects of the more traditional beta-blockers, may be effective (ie, nebivolol or carvedilol). Then you can consider the centrally acting drugs, such as clonidine, which can be quite efficacious even though they may cause drowsiness in some patients.[1] It is possible to consider even older drugs like reserpine, although it has been shown that some patients experience negative emotional disturbances with the drug.[1] Hydralazine can be effective; it is a vasodilator, but it causes fluid retention, so you should ensure that the patient is getting a good diuretic. It can also accelerate the heart rate, so you usually need to give a beta-blocker as well. If you want to be more aggressive than hydralazine, you can give a stronger vasodilator, minoxidil, which can be effective in patients with complicated cases of refractory hypertension and concomitant kidney disease.[1] In short, some of these older drugs work, but they can be difficult to use.
Emerging Therapeutic Options

MedscapeCME: So it appears that even after exercising all of these options, there are some patients whose blood pressure remains uncontrolled. What is the future, as far as new drugs are concerned, with different mechanisms of action?

Dr. Weber: There are a number of investigational drugs and interventions in development for the management of resistant hypertension. The effects of endothelin antagonism, for example, were discussed at this year's ESH meeting.

We presented the results of the phase 3 clinical trial, DAR-311 (also known as DORADO), which evaluated the use of darusentan (Gilead Sciences; Foster City, California), an investigational oral, once-daily endothelin- receptor antagonist for the treatment of resistant hypertension.[15] As reported at the American Society of Hypertension (ASH) meeting in San Francisco[16] and at the ESH meeting,[17] the findings showed that compared with placebo, darusentan was associated with significant reductions in blood pressure in patients with resistant hypertension.

All patients enrolled in the DAR-311 trial were already taking at least 3 well-selected and well-dosed drugs -- in fact, 60% were taking 4 or more drugs -- so they were getting good treatment. With the addition of darusentan they achieved close to an additional 10-mm Hg decrease in systolic blood pressure compared with placebo. Previously in a phase 2 study, darusentan was seen to decrease mean systolic and diastolic blood pressure and was well tolerated compared with placebo in over 100 patients with resistant hypertension.[18]

MedscapeCME: Darusentan is a selective endothelin type A-receptor antagonist. Do these phase 3 data tell us more about the role of endogenous endothelin in hypertension?

Dr. Weber: We know theoretically that endothelin could have adverse vascular effects that might be associated with the major cardiovascular outcomes of hypertension. However, there are many endogenous factors that potentially could have adverse vascular effects, so we must be careful that we don't overinterpret our results. Although the findings with endothelin blockade are interesting, we should be cautious about using these data to speculate about underlying causes of resistant hypertension.

MedscapeCME: Can you comment on the cardiac side effects associated with darusentan that occurred in the phase 3 trial?

Dr. Weber: We reported a number of cardiac side effects, but it is important to understand that the treatment-resistant patients we studied were a high-risk group: 40% of them had diabetes, about one third had kidney disease, and about one third had a history of coronary disease. This group was at high cardiovascular risk and it shouldn't be a surprise that 2 patients taking darusentan had nonfatal myocardial infarctions and 1 patient on placebo had sudden cardiac death. There were also some patients who had the clinical findings of heart failure. One case was a patient known to have heart failure before the study began and should not have been enrolled in the trial. The other heart failure cases in patients receiving darusentan appeared to be related to fluid retention and manifested as pulmonary congestion. In fact, the patients with heart failure all had preserved left ventricular systolic function with normal ejection fractions. My personal belief is that these patients, who responded rapidly to appropriate diuretic therapy, most likely represented an unmasking of underlying left ventricular diastolic dysfunction in patients with long-standing severe hypertension. Bearing in mind that these events, with concomitant fluid retention, became apparent in the first few weeks of therapy, it seems unlikely that the drug affected heart function independently of its volume effects. This phenomenon has also been observed with other vasodilatory drugs used in hypertension.

We did learn a lesson, though, which was that in using vasodilatory drugs like darusentan, we cannot assume that the low doses of HCTZ typically prescribed in hypertension will be adequate. In patients who have diabetes or kidney disease or a history of coronary events, this type of diuretic therapy is not sufficient. I believe that we either need to use higher doses of HCTZ or, even better, work with a drug like chlorthalidone or consider a long-acting loop diuretic like torsemide (rather than furosemide, which is difficult to work with long-term in hypertensive patients).

MedscapeCME: Is there another phase 3 trial ongoing with darusentan?

Dr. Weber: A long-term extension of the recently completed trial and an additional phase 3 study (DAR-312 [also known as DORADO-AC]) comparing darusentan with active treatment rather than with placebo are being done.[19] I believe that the latter trial will be finished before the end of the year.

We have shown that darusentan is an effective strategy in treatment-resistant hypertension. Our next task is to devise clear information for physicians on its use -- in other words, how to choose the correct dose and how to optimize the other drugs that are taken with it. These are areas that we have an obligation to study.

MedscapeCME: What about the other investigational drugs in clinical development for resistant hypertension?

Dr. Weber: LCI699 (Novartis AG; Basel, Switzerland) is an aldosterone-synthase inhibitor in clinical trials for resistant hypertension.[20] This is an interesting drug, as it provides an alternative to aldosterone-receptor blockers but may be better tolerated than spironolactone. Another promising strategy for the future may be LCZ696 (Novartis Pharmaceuticals; East Hanover, New Jersey), a novel vasopeptidase inhibitor that acts as a dual ARB inhibitor plus neutral endopeptidase (NEP) inhibitor. Unlike omapatrilat, a dual ACE inhibitor plus NEP inhibitor that was effective but associated with severe angioedema, LCZ696 has been shown to be effective but apparently without major adverse effects.[21,22] I have also heard about a nicotinic-channel blocker, TC-5214 (Targacept, Inc; Winston-Salem, North Carolina), that is being looked at as a possible augmentation therapy for resistant hypertension.[23,24]

MedscapeCME: There are 2 interventional approaches that are being developed for patients with resistant hypertension: the Rheos® Hypertension Therapy system (CVRx, Inc; Minneapolis, Minnesota), an implantable device that has been shown in clinical trials to lower blood pressure through activation of carotid baroreceptors[25]; and renal sympathetic denervation, a catheter-based interventional procedure, which has been shown to be effective in a proof-of-concept study.[26]

Dr. Weber: These approaches have shown encouraging results, although they both involve significant interventions. They should be studied further because there are so many patients who are very hard to treat.

Perspective

MedscapeCME: Are you hopeful for the future treatment of resistant hypertension in general?

Dr. Weber: One of the good things about these recent developments is that they have drawn a lot of physicians' attention to resistant hypertension. These cases can draw nihilism after 3 or 4 drugs have been tried without success. This new focus on resistant hypertension will, I believe, energize many physicians to try a little longer and a little harder with their patients to find an answer to their hypertension problems.

This activity is supported by an independent educational grant from Gilead Sciences, Inc.

Pharmacy medication errors may be ruled criminal???

Aug 8, 2009
By: Kenneth R. Baker, BS Pharm, JD
Health-System Edition

Every pharmacist makes mistakes, and all too often they are medication errors. Sometimes the system does not catch a medication error and it reaches a patient. Sometimes, thankfully not often, an error injures a patient.

In such an instance, we can be held liable in a civil suit for money damages as compensation for the injury. We carry malpractice insurance because we know that no matter how good we are, we will never eliminate the possibility of a negligent act that may result in human error and injury to a patient.

What if, however, our medication error resulted in a criminal charge? In May, an Ohio pharmacist pleaded "No contest" (essentially equivalent to a guilty plea without admission of guilt) to a charge of involuntary manslaughter. He faces up to five years in prison and a fine of up to $10,000.

We commonly think that a person charged with a crime is a "bad person." The pharmacist in the Ohio case was not a bad person, but a mistake occurred under his supervision that resulted in the death of a two-year-old girl.

There seems little question that negligence was involved. According to newspaper accounts and Board of Pharmacy minutes, a hospital pharmacy technician mistakenly mixed chemotherapy solution with 23.4 percent instead of 0.9 percent sodium chloride. The parents' civil suit charging negligence against the hospital was settled out of court.

Negligence charges are common in civil cases involving professional malpractice. In civil cases, negligence means deviation from professional standards of practice or failure to exercise due care. In criminal cases, negligence means something more. An earlier Ohio court explained:

A person is [criminally] negligent when, because of a substantial slip from the standard of care [the person] fails to take steps to evade a risk that his conduct may cause a certain result. ... It defines a higher degree of negligence than ordinary negligence. For one to be [criminally] negligent ... he must be guilty of a substantial departure from due care, whereas ordinary negligence merely requires a failure to exercise due care.

It does not happen often that a pharmacist is charged with a crime for a medication error. Whether the pharmacist in this case would have been found guilty had the case continued through a trial, we cannot know.

How can a pharmacist "take steps to evade a risk that his conduct may cause a certain result?" Every time we fill a prescription or drug order, there is a chance that we might make a mistake. When we dispense or compound dangerous drugs, i.e., ones that are designated Rx only, any selection of wrong drug or wrong strength could be a "substantial slip" if the only thing we judge by is the result. The only way to actually "evade a risk" of making a mistake that will result in a predictable (certain) outcome is to refuse to fill the prescription or drug order.

Mike Cohen, president of the Institute for Safe Medical Practices, said about this case, "Focusing on the individual is unlikely to have a positive effect in the long run. I have not read anywhere that he purposefully tried to hurt the patient." I agree; nothing I have read about this case indicates that the pharmacist's conduct rose to the level of a criminal violation. A criminal conviction here serves no purpose. It may also have a dangerous, unintended consequence and may result in injury to a future patient.

The Institute of Medicine (IOM) report "To Err Is Human" found that medical errors are among the leading causes of death in the United States; it estimated that each year 40,000 to 98,000 patients die in hospitals from preventable adverse events — medical errors. The IOM, as part of its report, cited studies estimating that there are 7,000 deaths each year just from medication errors. How many of the professionals involved in these cases should be put in jail?

Prosecutors and grand juries, the ones who make such decisions, are as much subject to pressure to "do something" as the rest of us. They need to think hard about this type of case in the future and resist easy, "feel good" decisions. I was taught in law school that a person should be able to conform his or her actions to avoid being charged with a crime. In this case, to conform your actions, you'd have to avoid being a fallible human being — or refuse to fill the drug order.

There is a reason we teach that when a medication error occurs, we fix the system and do not punish the person. This is the basis of risk management and avoidance of medication errors. Systems are in place because people make mistakes. If people never made mistakes, we wouldn't need systems. If systems never failed, none of our mistakes would ever reach a patient.

Routinely punishing the person who made the mistake may make it less likely that we will learn of every mistake. If we do not learn of an error, we will not have a chance to fix the system. The result will be that some day, some patient will be injured when we could have modified the system to prevent the error from reaching the patient. In the present case, it is the prosecutors who need to fix their system.

This article is not intended as legal advice; it is intended to promote thought about ways to reduce medication errors. For legal advice, consult your own attorney.

Ken Baker is a pharmacist, attorney, and consultant on risk management. Contact him at ken@kenbakerconsulting.com

CPE ONLINE

Prograf
from: http://www.thepharmacytechnician.com/

Generic Name: tacrolimus (oral) (ta CRAL ih mus)
Brand Names: Prograf

What is Prograf?

Prograf lowers your body’s immune system. The immune system helps your body fight infections. The immune system can also fight or “reject” a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Prograf is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

Prograf may also be used for other purposes not listed in this medication guide.
Important information about Prograf

Taking Prograf may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

There are many other medicines that can interact with Prograf. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Do not consume grapefruit or grapefruit juice during treatment with Prograf unless your doctor has told you do. Prograf can have a dangerous interaction with grapefruit or grapefruit juice.

Prograf can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Some people receiving Prograf after a kidney transplant have developed diabetes, most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes.

ANNUAL GENERAL MEETING MALAYSIAN PHARMACY ASSISTANT ASSOCIATION 2009

MALAYSIAN PHARMACY ASSISTANT ASSOCIATION ANNUAL GENERAL MEETING 2009

Malaysian Pharmacy Assistant Annual General Meeting was over yesterday 26th July 2009 at Langkawi Island (Hotel Langkasuka)

I would like to convey my million thanks to all members who gave me the opportunity and put trust on me to be the new National Exco. I was also appointed as Chairman Of the Education & Research Bureau. I know this is a heavy task for anyone carryout this duty and not that easy as we all know our profession facing the most critical condition and having a long gap between other paramedics in developments.

I will do my very best and make sure a steady progress and developments for all Assistant Pharmacist in Malaysia.

Thank you very much.

COCA COLA - INVENTED BY A PHARMACIST !

JOHN S.PEMBERTON -THE INVENTOR

The world's most recognized trademark in the World!
It is recognized by 94% of the world's population.

The world has changed in many ways since pharmacist, John Styth Pemberton first introduced the refreshing taste of Coca-Cola in Atlanta, Georgia. However, the and simple magic of one thing remains the same - Coca-Cola. The name and the product mean so many things to hundreds of millions of consumers around the globe. Coca-Cola products are served more than 705 million times every day, quenching the thirsts of consumers in more than 195 countries in every climate. That's a long way to come after such a modest beginning...
May 1886 - Pemberton concocted a caramel-colored syrup in a three-legged brass kettle in his backyard. He first "distributed" the new product by carrying Coca-Cola in a jug down the street to Jacobs Pharmacy. For five cents, consumers could enjoy a glass of Coca-Cola at the soda fountain. Whether by design or accident, carbonated water was teamed with the new syrup, producing a drink that was proclaimed "Delicious and Refreshing." Dr. Pemberton's partner and bookkeeper, Frank M. Robinson, suggested the name and penned, in the unique flowing script that is famous worldwide today, " ".

1886 - Sales of Coca-Cola averaged nine drinks per day. That first year, Dr. Pemberton sold 25 gallons of syrup, shipped in bright red wooden kegs. Red has been a distinctive color associated with the No. 1 soft drink brand ever since.
1891 - Atlanta entrepreneur Asa G. Candler had acquired complete ownership of the Coca-Cola business. Pemberton was forced to sell because he was in a state of poor health and was in debt. He had paid $76.96 for advertising, but he only made $50.00 in profits. Candler acquired the whole company for $2,300. Within four years, Candler's merchandising flair helped expand consumption of Coca-Cola to every state and territory.
1893 - In January "Coca-Cola" was registered in the U.S. Patent office.
1894 - The first syrup plant outside of Atlanta was opened in Dallas.
1899 - Chandler's great achievement -- large scale bottling of Coca-Cola
1906 - The first two countries outside the United States to bottle Coca-Cola were Cuba and Panama
1915 - The Root Glass company created the Coca-Cola contour glass bottle.
1917 - 3 Million Coke's sold per day. " " is the worlds most recognized trademark.
1919 - The Coca-Cola Company was sold to a group of investors for $25 million.
1923 - The Coca-Cola Company was sold after the Prohibition Era to Ernest Woodruff for 25 million dollars. He gave Coca-Cola to his son, Robert Woodruff, who would be president for six decades.

Woodruff's leadership took the business to unrivaled heights of commercial success, making Coca-Cola an institution the world over. Woodruff was an influential man in Atlanta because of his contributions to area colleges, universities, businesses and organizations. When he made a contribution, he would never leave his name, this is how he became to be known as "Mr. Anonymous."

During the Woodruff era, Mr. Woodruff made a promise to the armed forces of the United States to supply Coca-Cola to every serviceperson. He said that costs and location did not matter, he supplied 5 billion bottles to the service.
Robert Woodruff did have one dubious distinction, he raised the syrup prices for distributors. But he improved efficiency at every step of the manufacturing process. Woodruff also increased productivity by improving the sales department, emphasizing quality control, and beginning large-scale advertising and promotional campaigns. Woodruff made Coke available in every state of the Union through the soda fountain. For all of these achievements he earned the name, "The Boss"

1923 - Woodruff introduced the six bottle carton
1925 - 6 Million Coke's sold per day.
1927 - The first Coca-Cola radio advertisement.
1928 - Sales of bottled Coca-Cola surpassed fountain sales for the first time.
1929 -
- Coca-Cola was made available through vending machine
The Coca-Cola bell glass was made available
1931 - The Coke Santa was introduced as a Christmas promotion
1934 Johnny Weissmuller, and Olympic champion swimmer, and Maureen O'Sullivan, a motion-picture star, appeared on a metal serving tray for Coca-Cola.
1940 - Coke is bottled in over 40 countries.
1943 On June 29, an urgent cablegram arrived from General Dwight Eisenhower's Allied Headquarters in North Africa, requesting 10 Coca-Cola bottling plants to serve American servicemen overseas. Eventually, 64 plants were set up during WWII.
1950 - Advertising on on the television began. Currently Coca-Cola is advertised on over five hundred TV channels around the world.
1952 - "The Big Beverage", the first novel about Coca-Cola, was written by William T. Campbell.
1960 - The twelve ounce Coke can was introduced.
1961 - Sprite was introduced.
1971 - The song "I'd like to Buy the World a Coke" was released.
1977 - The Coca-Cola contour bottle was patented
1978 - The two liter bottle was introduced, and during that same year the company also introduced plastic bottles
1979 - Fifteen hundred employees moved to the new corporate headquarters in Atlanta located on North Avenue. The new corporate headquarters came to be known as "The Tower."
1982 - Diet Coke was introduced in July.
1985 - The Coca-Cola Company made what has been known as one of the biggest marketing blunder. They stumbled onto a new formula in efforts to produce diet Coke.

They put forth 4 million dollars of research to come up with the new formula.
The decision to change their formula and pull the old Coke off the market came about because taste tests showed a distinct preference for the new formula. The new formula was a sweeter variation with less tang, it was also slightly smoother. Robert Woodruff's death was a large contributor to the change because he stated that he would never change Coca-Cola's formula. Another factor that influenced the change was that Coke's market share fell 2.5 percent in four years. Each percentage point lost or gain meant 200 million dollars. This was the first flavor change since the existence of the Coca-Cola company. The change was announced April 23, 1985 at the Vivian Beaumont Theater at the Lincoln Center. Some two hundred TV and newspaper reporters attended this very glitzy announcement. It included a question and answer session, and a history of Coca-Cola. The debut was accompanied by an advertising campaign that revived the Coca-Cola theme song of the early 1970s, "I'd Like to Buy the World a Coke"

The change to the world's best selling soft drink was heard by 81 percent of the United States population within twenty-four hours of the announcement. Within a week of the change, one thousand calls a day were flooding the company's eight hundred number. Most of the callers were shocked and/or outraged, many said that they were considering switching to Pepsi. Within six weeks, the eight hundred number was being jammed by six thousand calls a day. The company also fielded over forty thousand letters, which were all answered and each person got a coupon for the new Coke. Many American consumers of Coca-Cola asked if they would have the final say. When Pepsi heard that the Coca-Cola company was changing its secret formula they said that it was a decision that Pepsi tastes better. Roger Enrico, the president and CEO of Pepsi-Cola wrote a letter to every major newspaper in the U.S. to declare the victory.
Coca-Cola management had to decide: Do nothing or "buy the world a new Coke". They decided to develop the new formula.

1985 - July 10, eighty-seven days after the new Coke was introduced, the old Coke was brought back in addition to the new one. This was greatly due to dropping market share and consumer protest. The market share fell from a high of 15 percent to a low of 1.4 percent. This was said to be a classic marketing retreat. Coca-Cola executives admitted that they had goofed by taking the old Coke off the market. The Coca-Cola company's eight hundred number received eighteen thousand calls of gratitude. One caller said they felt like a lost friend had returned home. The comeback of old Coke drove stock prices to the highest level in twelve years. This was said to be the only way to regain the lead on the cola wars.

1988 - Coca-Cola was the first independent operator in the Soviet Union.
1993 - Coca-Cola exceeds 10 Billion cases sold worldwide.
1993 - Advertising slogan -"Always Coca-Cola".
1995 - Coke was consumed aboard the Space Shuttle Discovery -- marking the third trip into space for Coca-Cola and the first for Diet Coke.
1996 - The Summer Olympics will be held in Atlanta, Georgia, the home of Coca-Cola.
For more than 65 years, Coca-Cola has been a sponsor of the Olympics.

One great earmark that the Coca-Cola Company has is helping the people of Atlanta. They accomplish this through scholarships, hotlines, donations and contributions. Another large accomplishment that the Coca-Cola has, is being the first company to make and use recycled plastic bottles. One way to see all of the achievements of the Coca-Cola company is to visit the World of Coke in Atlanta. It houses a collection of memorabilia, samples of the products, exhibits, and many other exciting items. All of what has been said is the basis of what Coca-Cola was built on. Without societies help, Coca-Cola could not have become over a 50 billion dollar business. Keep on consuming the world's favorite soft drink, Coca-Cola.
Until the 1960s, both small town and big city dwellers enjoyed carbonated beverages at the local soda fountain or ice cream saloon. Often housed in the drug store, the soda fountain counter served as a meeting place for people of all ages. Often combined with lunch counters, the soda fountain declined in popularity as commercial ice cream, bottled soft drinks, and fast food restaurants came to the fore.

• The term "soda water" was first coined in 1798.
• In 1810, the first U.S. patent was issued for the manufacture of imitation mineral waters.
• The first soda fountain patent was granted to Samuel Fahnestock in 1819.
• In 1858, G.D. Dows invented and operated the first marble soda fountain, which he patented in 1863.
• In 1883, James W. Tufts patented a soda fountain, which he called the Arctic. Tufts went on to become a huge soda fountain manufacturer.
• On January 25, 1870, Gustavus Dows patented a modern form of the soda fountain.
• In October of 1874, Robert M. Green created the first ice cream soda.
• In 1903, a revolution in soda fountain design took place with the front service fountain patented by Dr. Heisinger.
________________________________________

More fun facts and trivia
• Coca-Cola can be used to bake a ham. Pour one can into the baking pan, rap the ham in aluminum foil, and bake. Thirty minutes before the ham has finished cooking, remove the foil, allowing the drippings to mix with the Coca-Cola to make a delicious brown gravy.
• Mexico and Iceland have the highest per capita consumption of Coca-Cola.
• Coca-Cola translated to Chinese means, "To make mouth happy".
• Every second over 7,000 Coca-Cola products are consumed.
• The tallest Coca-Cola bottling plants are in Hong Kong. The plant in Quarry Bay is 17 floors, and the plant in Shatin is 25 floors.
• The bottling plant at the highest elevation in the world is located in Bolivia, at 12,000 feet.
• The world's longest Coca-Cola truck is in Sweden. It is 79 feet long with a four-azle trailer.
• The best selling non-carbonated soft drink in Japan is a product of The Coca-Cola Company named "Georgia", a coffee flavored beverage.
• Coca-Cola first crossed the Atlantic on board the Graf Zeppelin, the German dirigible.
• The Varsity Restaurant in Atlanta, Georgia, has earned the distinction of serving the highest volume of Coca-Cola anywhere. It dispenses nearly 3 million servings of Coca-Cola annually.
• If the Coca-Cola company constructed a sign like the ones McDonald's uses to count their millions of customers, by 1983 it would have read "over 1 trillion served."
• If all the Coca-Cola ...
o ever produced were in 6 1/2 oz. bottles and placed end to end they would wrap around the earth more than 11,863 times.
o sold in 1994 were in 8-ounce bottles laid end-to-end, those bottles would reach to the moon and back 76 times.
o vending machines in the U.S. were stacked one on top of each other, the pile would be over 450 miles high.
o ever produced were to erupt from "Old Faithful" at its normal rate of 14,000 gallons per hour, the geyser would flow continually for 1,577 years.
o products sold in 1994 were flowing over Niagara Falls at its normal rate of 1.5 billion gallons per second, the falls would flow for three hours.

The Coca-Cola Company began bottling operations in ...
... 1907 in Hawaii.
... 1912 in the Philippines.
... 1920 in France.
... 1927 in Belgium, Bermuda, Colombia, Honduras, Italy, Mexico, Haiti and Burma.
... 1928 in Antigua, China, Guatemala, Holland, Spain, Venezuela, and the Dominican Republic.
... 1929 in Germany and Spanish Morocco.
... 1938 Australia, Austria, Gutana, Surinam, Jamaica, Curacao, Luxembourg, Norway, Scotland, South Africa, The Virgin Islands, and Trinidad.
... 1940 in Ecuador, and El Salvador.
... 1942 in Nicaragua, Argentina, Brazil, Costa Rica, Iceland, and Uruguay.
... 1945 in Egypt, and Martinique
... 1946 in Barbados, Japan, and Okinawa
... 1947 in Morocco and Tangier
... 1948 in Liberia, Rhodesia, and Guadeloupe

What's in a Coke???
• Carbonated Water
• High Fructose Corn Syrup
• Caramel Color
• Phosphoric Acid
• Natural Flavors
• Caffeine

RESEARCH ON JOB SATISFACTION AMONG ASSISTANT PHARMACIST

Hi everyone,

Currently I'm very busy conducting a research on our profession with the title :

" A STUDY ON JOB SATISFACTION AMONG GOVERNMENT ASSISTANT PHARMACIST WORKING AT INSTITUTIONS UNDER MINISTRY OF HEALTH MALAYSIA "

Job satisfaction has been defined as a pleasurable emotional state resulting from the appraisal of one’s job;an affective reaction to one’s job; and an attitude towards one’s job.Weiss (2002) has argued that job satisfaction is an attitude but points out that researchers should clearly distinguish the objects of cognitive evaluation which are affect (emotion), beliefs and behaviours. This definition suggests that we form attitudes towards our jobs by taking into account our feelings, our beliefs, and our behaviors.

One of the biggest preludes to the study of job satisfaction was the Hawthorne studies. These studies (1924-1933), primarily credited to Elton Mayo of the Harvard Business School, sought to find the effects of various conditions (most notably illumination) on workers’ productivity. These studies ultimately showed that novel changes in work conditions temporarily increase productivity (called the Hawthorne Effect). It was later found that this increase resulted, not from the new conditions, but from the knowledge of being observed. This finding provided strong evidence that people work for purposes other than pay, which paved the way for researchers to investigate other factors in job satisfaction.

Teamwork was believed to be an important factor in job satisfaction. Whetten & Cameron (2007) pointed that teamwork has been found dramatically affect the organizational performance. Effective teams have interdependent members, like geese, the productivity efficiency of an entire unit is determine by the coordinated, interactive effort of all its members. According to Whetten et.al, in an effective teams, members care for and nuture one another. No member is devalued or unappreciated. All are treated as an integral part of a team. Whetten also pointed out that effective leaders have the respect and commitment of the team members. That is they develop credibility (Kouzes & Posner, 1987). Establishing credibility and the capacity to influence team members are the first key challenges faced by leaders of the teams. Giving direction, articulating goals, or trying to motivate team members are all wasted effort if they have not established credibility and respect.

My research will be focusing on current developments in pharmacy setting in one of the hospital. The purpose of study is to findout the level of satisfaction, teamwork in the department and the morale of Assistant Pharmacist relates to current developments at pharmacy outpatient department and reveal all the problem that cause the stress and recommendation to employer how to overcome the problem findings.
The study may be beneficial both for the department and the employees. Department can benefit by knowing the employees level of satisfaction. And the employees got the chance to convey their dissatisfaction through this research for the benefits of the Pharmacy Department and Health Ministry Organization in general.

Design : cross sectional descriptive
Respondent : Assistant Pharmacist from selected institution(not disclosed yet)

See you again all friends.

Ganesan

WILL BE AWAY FOR POST BASIC MANAGEMENT COURSE

Dear Friends,

I'm very sorry for not updating this blog. Its due to my busy work at my clinic which have to prepare all kinds of reports and task as u all know at the end of year.

And now, currently I'm attending a 6 month Post Basic course at Medical Assistant College, Ulu Kinta, Perak (HBUK) starting 15th January 2009. I will update very soon with latest news and article.

Thank you for visiting.

ASSISTANT PHARMACIST REGULATION & REGISTRATION

Dear fellow Assistant Pharmacist of Malaysia,

I would like to highlight some of the important points for the developments of our profesion in Malaysia. To get some idea, I paste some infomations from a website which was in a powerpoint presentation taken from Canada Pharmacist Council regarding Regulations and Registrations of Pharmacy Technician.

Key Points (Powerpoint presentations):

SLIDE 1 :Considering Regulation

Benefits:
1. Enhanced safety overall
* More qualified personnel
* More focus on areas of expertise (Pharmacists and Pharmacy Technicians)

2. More time for pharmacists to provide comprehensive and cognitive patient care services.

SLIDE 2 : Benefits to Registered Pharmacy Technicians

* Role would be strengthened and raised to that of a regulated profession
* Clearly set professional standards of practice and scope of practice equals greater job satisfaction
* Increased professional status and recognition by the public
* Would participate in the self-governance of a profession already established

SLIDE 3 : Health System Improvement Act (Bill 171 introduced Dec. 2006)

Expanding Health Care Services

- Regulating pharmacy technicians would allow them to independently compound and dispense drugs, enabling pharmacists to turn their attention to providing more comprehensive patient-centred health care services with regards to drug therapy/care.

SLIDE 4 : Proposed Legislation

* New class of registration
* Title protection for pharmacy Technicians
* Council to include pharmacy technicians (phased-in process)
* Access to Controlled Act (dispensing/compounding) subject to terms, conditions and imitations

SLIDE 5 : Proposed R.Ph.T. Role Will Include:

* Confirm accuracy and completeness of prepared pharmaceutical products
* Check and sign off on technical accuracy of filled prescriptions
* Functions defined through College Standards and policies and procedures in the individual workplace

SLIDE 6 : REGISTERED PHARMACY TECHNICIAN will:

* Have standards of practice
* Have accountability and responsibility for their actions
* Be subject to complaints and discipline processes
* Be expected to keep current and participate in a Quality Assurance program

SLIDE 7 : Registration requirements

* Entry-to-practice requirements including:
education (expanded curriculum, accredited education programs)
* fluency
* practical training
* exams (knowledge, performance, jurisprudence)

SLIDE 8 : Accreditation for Pharmacy Technician Education Programs

* National educational outcomes approved (CPTEA)
* Canadian Council for Accreditation of Pharmacy Programs (CCAPP) to accredit
pharmacy technician education programs
* Preliminary Program accreditation possible for spring 2008

SLIDE 9 : Bridging Programs

* Some new learning for everyone (becoming a regulated professional)
* Needs will be varied (tech-check-tech)
* Demonstration of competency needed
* Flexibility of programs is important

SLIDE 10 : Moving Forward

* Maintain dialogue with primary stakeholders (pharmacy technicians, pharmacists, employers, educators, professional associations and organizations, government)

* Educate and update all stakeholders of ongoing progress (transition process, bridging programs, examination)

SLIDE 11 : Integration of Pharmacy Technicians in A COUNCIL

* Strategic plan includes “regulation and integration of pharmacy technicians”
* Two pharmacy technician observers at Council during transition phase
* Pharmacy Technician Working Group will plan transition planning process

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*
The duration of basic course for Pharmacy Technician in Canada is just two years, but for us in Malaysia, it is 3 years Diploma course with 98 credit hours. With a comprehensive studies and curricullum, we deserve a better recognitions and respect from all parties.
**
In the slide no 10, i had bold the sentences, as I find it is very important for us in Malaysia. This is another reason for the formation of "MAJLIS PERUNDINGAN PEN.PEGAWAI FARMASI" which was supported by all parties. (10 organisations)

A CHANGE IS KNOCKING THE DOOR ....