An experimental treatment for multiple sclerosis (MS) has been withdrawn from clinical trials after it failed to delay progression of the condition in a late-stage trial.

Dirucotide, manufactured by Eli Lilly and Co and BioMS Medical Corp, had earlier failed to meet a main goal in a mid-stage study, which tested whether the drug prevented symptoms returning among patients with relapsing remitting MS.

The drugmakers, which have been collaborating since late 2008 on dirucotide, said the latest negative results were seen in a study of the drug that involved 612 patients with secondary progressive (MS).

Patients in the study were divided into groups that received either dirucotide or a placebo intravenously every six months for two years.

In addition to failing its primary goal of delaying the time it took for the condition to worsen in patients, the drug also failed a number of secondary goals.

“We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data,” BioMS Medical Chief Executive Kevin Giese said in a statement.

Source
Multiple Sclerosis Society

Over 50 pharmacists have been trained to provide seasonal flu vaccinations under a private Patient Group Direction that the NPA is facilitating. Training days were conducted in London and Birmingham with further training days scheduled at the start of September 2009 in Newport, Durham, St Albans and Haydock.

Raj Nutan, NPA Head of Business Development said: “Members were telling us that the burden of regulation was frustrating them if they wished to supply prescription medicines via private patient group directions. So we have embarked on developing a series of PGD opportunities that will provide them with a means of clearing the regulatory hurdle effortlessly. A bonus for NPA members is that they won’t need additional insurance - NPA Insurance already covers the pharmacist for providing this NPA service.

Nitin Shah, Fulham Pharmacy, London said: “There has always been a scope for a pharmacy based flu vaccination service especially when the NHS only provides for over 65 and at risk groups only. From business economics £370 is easily a worthwhile investment. The actual training was very much ‘hands on’ and I feel very comfortable at the prospect of commencing this soon. Overall the day covered all aspects of training well especially ‘trouble shooting’.”

Source
National Pharmacy Association

The Minister for Health and Children, Mary Harney TD, announced the commencement of the outstanding Sections of the Pharmacy Act 2007 to provide for the introduction of a Complaints, Inquires and Discipline regime for pharmacists and pharmacy businesses. Also included are Sections 63 and 64 of the Act, which relate to the prohibition of certain economic relationships between pharmacists or pharmacies and medical practitioners, or medical practices.

The Pharmacy Act 2007 is an essential piece of legislation that provides for the health, safety and welfare of patients and the public. The Act enables pharmacists to practise in a regulated, controlled and safe environment and in a manner which will ensure the provision of high-quality service, in the context of increasingly complex and evolving care and therapeutic regimens for patients. It also requires pharmacy owners to demonstrate responsible and accountable practices, whilst providing the highest level of patient care and service. The Act, now fully enacted, puts in place a modern fitness to practice structure aimed at safeguarding the public, and members of the profession in respect of their professional conduct.

The Act has been commenced on a staged basis. In May 2007, the Minister for Health and Children commenced the first stage when she dissolved the old Pharmaceutical Society of Ireland (established in 1875), established the new Pharmaceutical Society of Ireland and appointed its Council. In November 2008, the second stage of the Act commenced sections of the Act dealing with the registration of pharmacists and pharmacy businesses, the operation of such businesses (in respect of the sourcing, sale, supply, storage and keeping of records in respect of medicinal products), and inspection and investigation powers.

The two Commencement Orders, signed by the Minister, complete the third, and final, stage of implementation. This stage provides for the introduction of a Complaints, Inquires and Discipline regime for pharmacists and pharmacy businesses. This stage also includes Sections 63 and 64 of the Act, which relate to the prohibition of certain economic relationships between pharmacists, or pharmacies and medical practitioners, or medical practices.

The first Commencement Order (Pharmacy Act 2007 (Commencement) Order 2009) appoints the 1st of August 2009 as the day when the outstanding Sections of the Act will come into operation.

The second Commencement Order (Pharmacy Act 2007 (Section 64(9)) Order 2009) concerns the application of Sections 63 and 64 to registered retail pharmacy businesses, or medical practices, which were in existence immediately before the passing of the Act. The Minister has specified in the Order that the date from which the Section 64(9) of the Act will come into effect is 1st May 2010.

Source
Department of Health & Children

Foresight Biotherapeutics announced that the first patient has been dosed in a viral conjunctivitis clinical trial. Foresight’s proprietary lead compound, FST-100, will be tested in a placebo-controlled, masked, and randomized multicenter clinical study throughout the United States. The primary endpoint of the study is the resolution of clinical signs and symptoms of acute conjunctivitis. Secondary endpoints include a reduction in quantitative PCR (qPCR) viral titers, eradication of infectious virus determined by cell culture immunofluorescence assay (CC-IFA), and safety. The company anticipates enrolling up to 100 patients.

This controlled clinical trial follows a successful pilot trial in which the safety and efficacy of FST-100 were demonstrated. In addition, the company recently completed and announced a successful preclinical study in a rabbit model of adenoviral conjunctivitis.

Viral conjunctivitis or “pink eye” is the most common eye infection in the developed world. The highly contagious infection is a frequent cause of epidemics in the workplace, schools, medical centers and long term care facilities. Treatment is mostly supportive as there is currently no drug approved by the FDA for viral conjunctivitis. FST-100 is a novel formulation of dexamethasone that includes povidone-iodine. This novel formulation may be able to relieve the discomfort and shorten the course of the illness. Foresight Biotherapeutics looks forward to working with the investigators in conducting this clinical trial and advancing the development of the program.

Source
Foresight Biotherapeutics, Inc.

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly one year early due to safety concerns. In an interim review of safety data from 33 participants who completed 16 weeks of treatment, researchers found that, compared to participants on placebo (dummy pill), participants taking sildenafil (Revatio) were significantly more likely to have serious medical problems. The most common problem was episodes of severe pain called sickle cell crises, which resulted in hospitalization. No deaths have been associated with the drug in the clinical trial.

Known as walk-PHaSST, the study was the first multicenter, randomized clinical trial to test the safety and effectiveness of sildenafil for pulmonary hypertension in patients with sickle cell disease, one of the most common genetic blood disorders in the United States. Pulmonary hypertension is a debilitating condition of high blood pressure in the arteries that carry blood to the lungs, which can lead to heart failure and death. Approximately 30 percent of sickle cell disease patients develop pulmonary hypertension, and even mild levels of pulmonary hypertension have been associated with sudden death in people with sickle cell disease.

“The increase in sickle cell medical problems is concern enough for us to stop this clinical trial to protect the safety of our participants,” said NHLBI Director Elizabeth G. Nabel, M.D. “We will continue to look into the possible causes of these preliminary results. In the meantime, we encourage patients with sickle cell disease who are taking sildenafil for pulmonary hypertension to talk with their physicians about the potential risks and benefits of the medication and what actions they should consider, including whether to taper off this medication and how to best manage both sickle cell disease and pulmonary hypertension.”

Because the medical problems experienced in walk-PHaSST were complications specific to sickle cell disease, “The findings of the walk-PHaSST study should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective,” Nabel added.

Researchers are conducting extensive analyses of the study results, which could contribute to recommendations for treating pulmonary hypertension in patients with sickle cell disease. They will prepare reports of their research for publication in peer-reviewed journals.

The NHLBI stopped the study on July 7, 2009, based on the unanimous recommendations of the Pulmonary Complications of Sickle Cell Disease Data and Safety Monitoring Board (DSMB), an independent advisory group that has been monitoring the study since it began. This DSMB is composed of experts in sickle cell disease, lung disease, statistics, and bioethics.

Participants in walk-PHaSST have discussed the preliminary findings of the study with their study clinicians. They have been instructed to taper sildenafil treatment over a period of three to seven days to minimize problems associated with immediate withdrawal from the drug, such as worsening of symptoms of pulmonary hypertension. Researchers will continue to monitor participants and conduct further analyses to assess the findings.

Walk-PHaSST was designed to determine whether sildenafil lessens the symptoms of pulmonary hypertension, such as shortness of breath, by improving heart and lung function, in individuals with sickle cell disease who develop pulmonary hypertension. The primary outcome measure was the results of a six-minute walk test, a standard indicator of a person’s heart and lung function. Hence, the name walk-PHaSST reflects the primary test used to assess effectiveness of the treatment (”walk” test) for Pulmonary Hypertension and Sickle Cell Disease with Sildenafil Therapy. Researchers also evaluated the safety of the drug for sickle cell disease patients through reports of adverse effects and laboratory tests.

Sildenafil is approved by the Food and Drug Administration for use in patients with pulmonary hypertension. In general, the drug treats pulmonary hypertension by relaxing the blood vessels in the lungs to allow blood to flow more easily. Since sildenafil is not FDA-approved to treat pulmonary hypertension in patients with sickle cell disease, the walk-PHaSST study was conducted under an investigational new drug application. The FDA was notified of the termination of the study on July 14.

Walk-PHaSST began recruiting participants in July 2007 and enrolled 74 patients over the age of 19 (average age 45). Participants had sickle cell disease and mild to severe pulmonary hypertension. They were randomly assigned to receive sildenafil or placebo for 16 weeks. Participants could also receive other therapies as needed to manage sickle cell and related complications. After completing the study treatment (or placebo), participants could choose to be part of the open-label follow-up phase of the study and continue to be assessed for up to one year. In the open-label study, participants and clinicians knew that sildenafil was being taken. When the study was stopped, 33 participants had completed the clinical trial.

Researchers found that 38 percent of participants taking sildenafil had serious adverse effects — primarily sickle cell pain crises — compared to 8 percent of participants in the placebo group.

“Although these preliminary results are disappointing, we expect that the study’s results, once fully analyzed, will provide important insights into the role of pulmonary hypertension in sickle cell disease,” said Mark Gladwin, M.D., lead investigator of walk-PHaSST and director of the Vascular Medicine Institute at the University of Pittsburgh. Gladwin is also a special volunteer for the NHLBI and was formerly a senior investigator with the Critical Care Medicine Department at the NIH Clinical Center and chief of the NHLBI Pulmonary and Vascular Medicine Branch.

The design of the walk-PHaSST study was based on extensive evidence that sildenafil improves pulmonary hypertension regardless of its cause and on results of a small, open-label, nonrandomized pilot study led by Gladwin while he was at the NIH. The pilot study evaluated 12 sickle cell patients with mild or moderate pulmonary hypertension who were being treated with sildenafil and with hydroxyurea, a drug known to help reduce the numbers of episodes of sickle cell pain crises and acute chest syndrome, as well as hospitalizations and blood transfusions needed. In 2005, Gladwin and his colleagues reported that after about 6 months, sildenafil was well tolerated, decreased pulmonary blood pressure, and increased exercise capacity.

“Walk-PHaSST emphasizes the importance of multi-site, blinded, randomized clinical trials to increase our understanding of both the benefits and the potential risks of specific treatments,” noted Jonathan C. Goldsmith, M.D., NHLBI project officer of walk-PHaSST. “As with all clinical studies, patient safety is paramount.”

Walk PHaSST was conducted at the following locations:

• Children’s Hospital, Oakland, Calif.

• University of Colorado, Denver
• Howard University Hospital, Washington, D.C.
• University of Illinois at Chicago
• Johns Hopkins Medical Institutions, Baltimore
• NIH Clinical Center, Bethesda, Md.
• Albert Einstein College of Medicine, New York City
• Columbia University, New York City
• Children’s Hospital, Pittsburgh
• Imperial College London and Hammersmith Hospital, London, England

Rho Inc. of Chapel Hill, N.C., serves as the data coordinating center. Pfizer provided the treatment drug and placebo for the study.

Sickle cell anemia affects millions of people worldwide. An estimated 70,000 to 100,000 people in the United States have sickle cell disease, primarily African Americans and, to a lesser degree, people whose families come from South or Central America. Patients with this disease have abnormal hemoglobin molecules in their red blood cells. The abnormal molecules deform the red blood cells, causing them to clump together and block blood flow through blood vessels, leading to painful sickle cell crises, organ damage, and anemia. Life-threatening complications include infections, acute chest syndrome, stroke, and pulmonary hypertension. Painful crises are the leading cause of emergency room visits and hospitalizations of people who have sickle cell anemia.

There are currently no established guidelines for treating pulmonary hypertension in patients with sickle cell disease. Pulmonary hypertension can lead to heart failure and death as the heart must work harder to push blood into the lungs. In general, intensive management of sickle cell disease through hydroxyurea, blood transfusions, and/or bone marrow transplantation may be indicated. Other treatment options may include blood-thinning medicines, diuretics, and oxygen therapy.

“As new treatments have evolved over the past several years, sickle cell patients are living longer than in previous decades, presenting new challenges for managing chronic problems and complications such as pulmonary hypertension,” noted Susan Shurin, MD, NHLBI deputy director and a hematologist. “The NHLBI continues to maintain a strong commitment to supporting research in adults as well as in children to discover new and better ways to improve quality of life and survival for patients with sickle cell disease.”

Source:
NHLBI Communications Office

NIH/National Heart, Lung and Blood Institute

The Royal Pharmaceutical Society welcomed the decision by the Medicines and Healthcare Products Regulatory Agency that medicines containing ephedrine and pseudoephedrine should retain their status as pharmacy (P) medicines.

President Steve Churton said: “We are delighted at the MHRA’s decision to keep cold and flu remedies containing ephedrine and pseudoephedrine as pharmacy (P) medicines.

“The decision is a ringing endorsement of the vigilance pharmacists have shown in monitoring and controlling the sale of these products.

“Pharmacists are experts in medicines and experienced in dealing with medicines liable to misuse. The MHRA’s decision is great news for consumers and provides a clear signal of faith in the pharmacy profession.

“I urge pharmacists to continue to remain alert to the supply of these medicines so that they continue to keep their P status”.

Notes

The MHRA have taken this decision taken following the review by the Commission on Human Medicines (CHM) of the measures introduced from July 2007 to control the risk of misuse of OTC medicines containing pseudoephedrine and ephedrine, in the manufacture of the Class A controlled drug methylamphetamine http://www.mhra.gov.uk

Source
Royal Pharmaceutical Society

The Royal Pharmaceutical Society has called for clarification of the responsible pharmacist requirements but will not be asking the Department of Health to amend the commencement date of the regulations.

The Society’s Council debated the responsible pharmacist requirements in the light of concerns amongst community and hospital pharmacists about their implementation.

President Steve Churton said: “Some of the concerns relate to existing problems that have been brought into sharper focus as a result of the introduction of the regulations. These include concerns about the relationship with employers, and being properly supported to take professional decisions. Council agreed that these must be addressed regardless of when the responsible pharmacist requirements are implemented”.

There are a number of operational issues related to the responsible pharmacist requirements which need clarification for the profession. These include:

- The definition of operation of a pharmacy which seems to run counter to the government’s proposals around the greater use of skill mix in pharmacy

- Requirements to remain contactable during an absence from the pharmacy for a rest break

- Whether a responsible pharmacist should read all the standard operating procedures prior to commencement as a responsible pharmacist

“The Society will undertake urgent work, in conjunction with other bodies, to provide further clarification, guidance and support to members and pharmacy owners to enable them to fulfil their obligations under the new regulations. This clarification will be produced prior to the introduction of the responsible pharmacist requirements,” continued Mr Churton.

“The Society has also decided not to request a delay of the implementation date of the responsible pharmacist requirements. The regulations were published a year ago following a fairly lengthy period of consultation and discussion in the profession and a number of organisations and employers have produced support material or plan to deliver training in the lead up to that date.

“The responsibilities of the responsible pharmacist are not significantly different to the current responsibilities of the pharmacist in personal control. Indeed, the responsible pharmacist changes make explicit some of the implicit requirements of the Medicines Act.

“The views of a number of leading hospital pharmacists also informed our thinking and they stated the implementation of the responsible pharmacist requirements should not be delayed as clear guidance would be available for hospital pharmacy shortly.”

Source
Royal Pharmaceutical Society of Great Britain

The Council of the Royal Pharmaceutical Society of Great Britain has announced a fee
increase of 2.2% for 2010, following the outcome of the 2010 fees consultation and a review of
the Society’s financial position.

It is the second year in a row that fees have not been raised significantly. Last year’s fees only
rose by the annual inflationary rise and were between 3.9% - 4.5%.

This year’s fees were kept to a minimum and were set within the Retail Price Index (RPI) and
Consumer Price Index (CPI) measures of inflation. Council agreed to consult on a proposal to
set fees at 2.2% in April 2008. The consultation ran 24 April to 17 July 2009 and only 59
responses were received, including seven from organisations.

The Society’s Treasurer, John Gentle, said;
“I understand that Members may be disappointed that fees have increased this year but we
have tried to reflect the current economic climate in the fee setting process. It’s difficult to call
for any increase but 2.46 pence a day extra for a full time working pharmacist will help us to
ensure, as far as we can, a stable financial platform to launch the new professional body. “

“We are going through a time of significant organisational change and the fees revenue will
help to ensure financial stability when the Society separates in 2010. ”
In response to earlier feedback from members, a discounted fee for pharmacists on a lower
income will again be included. This fee was bought in last year to help lessen the financial
impact on pharmacists who work part-time.
The Council has also implemented staged payments as a result of the 2008 fee consultation
results. Practising pharmacists and pharmacy technicians will continue to have the option to
pay their retention fee in four quarterly instalments by direct debit.

The findings of the fees consultation and the Council’s response will be available on the
Society’s website and in The Pharmaceutical Journal in August 2009.

The majority of respondents to the fees consultation (76%) disagreed that a fee increase
should be implemented and 19% agreed to the fees proposal.

Source
Royal Pharmaceutical Society of Great Britain

The NPA is pleased by today’s decision from the MHRA to keep pseudoephedrine a P medicine and have no doubt that community pharmacies will continue to ensure pseudoephedrine is sold in line with MHRA guidance.

John Turk, NPA Chief Executive said: “We are absolutely delighted that our members were able to take up the mantle laid down by the MHRA 18 months ago. The decision demonstrates that the whole community pharmacy team is acting responsibly with regard to the sale and supply of pseudophedrine.”

“The NPA acted quickly and decisively to support members. Hard copies of the pseudoephedrine training pack produced at the end of 2007 were distributed to the majority of members while the pack is still available online to be downloaded through the NPA members’ website. We would still encourage all members to remain vigilant and to help train new staff by accessing the online training pack.”

The NPA’s pseudoephedrine training pack can be downloaded from http://www.npa.co.uk/members and includes the following:

- Digital audiovisual lecture available to be played on computers in the workplace or at home
- Presentation slides with speaker notes for the pharmacist to train all their staff in small groups
- Information booklet for pharmacy staff to read independently
- Digital audio lecture for download to MP3 players.
- Training record for use in the pharmacy
- Training assessment form.

Source
National Pharmacy Association

New research released by the Royal Pharmaceutical
Society of Great Britain (RPSGB) reveals how older people are taking a
cocktail of medicine without fully understanding what they are or the side
effects they are causing.

The RPSGB survey shows that nearly half (43%) of over 65’s are
currently taking over five medicines at any one time. However, one in five
admits to not always taking the medicine as prescribed. Sixty per cent also
believe that they either definitely or possibly have had a side effect from
medicine - yet one if five said they did not get it checked out.

In response to these findings, the RPSGB is launching a
campaign to urge older people to review the medicine they are taking by
visiting their local pharmacist for a Medicine Use Review (MUR).

MURs are undertaken by local pharmacies to help patients
manage their medicine more effectively and can be done on an annual basis. It
involves a consultation with a pharmacist and can be offered to anyone on one
or more medicines and/ or long term conditions.

Royal Pharmaceutical Society spokesman and pharmacist, Paul
Johnson says; “It’s not unusual for older people to get confused with the
medicine they are taking, particularly when they are on numerous types of
medication. As a result, they may also not realise the reactions they may be
causing when they are not used properly.

“Pharmacists are easily accessible and are ideally placed to
provide advice to a patient on their medicine which can really improve
someone’s health or even their quality of life. “

Other findings of the research revealed that almost one in 10
(9%) admit to not fully understanding what their medications do or how they
treat their condition, and one in seven (14%) say they sometimes forget to
take a pill at the recommended time.

Source
Royal Pharmaceutical Society of Great Britain

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