Saturday, April 29, 2006

A machine fills prescriptions in hospital lobby

Is this machine the future for our profession?

When a patient gets a prescription, the ER doctor asks if they want to use the dispenser. If so, the physician sends the prescription information to the machine. The patient, who gets a voucher, goes into the lobby and types a code into the machine.

The machine automatically looks up the person’s insurance information and labels and dispenses the drugs.

The cost is no more than a retail pharmacist and there is no added fee for using the machine.
There is a telephone on the machine that allows people to talk to a pharmacist from the company that operates the system.

The machine holds 80 different medications. Most are antibiotics and pain medicine, the most common prescriptions given in the ER. There are also some over-the-counter drugs in the machine, such as Tylenol. The machine not only dispenses pills, but also soluble medicine, such as the pink amoxicillin, an antibiotic commonly used for childhood ear infections. Those medicines come in pre-packaged amounts, with a powder in one packet and sterile water in another that can be mixed. So far, the machine has dispensed an average of nearly 20 prescriptions per day.

The machines had originally garnered some criticism from the pharmacy industry, which said a pharmacist is more likely to review a patient’s past prescription use, check for interactions or problems the patient may face and give other advice. But the criticism has mostly faded as the machines proliferate. Even some pharmacies in other states use a similar machine.

The InstyMeds was invented and developed in Minnesota by Ken Rosenblum, who started the Mendota Healthcare company. The Minnesota State Board of Pharmacy gave its approval of the machines in 2001. The machines are showing up in more hospitals, particularly in rural areas.

Recently, another company, Asteres, began producing self-dispensing prescription kiosks that are beginning to show up in pharmacies and grocery stores on the West and East coasts.


Tuesday, April 25, 2006

First biosimilar drug gets EU market authorisation

The EU has recently finalised its policy and legal framework for so-called biosimilars, opening the EU market for generic versions of biotechnology-derived drugs. The first such drug is about to enter the EU market.

All medicines enjoy a 20-year patent. After the expiry of the patent, other companies are allowed to develop and manufacture these medicines. Patent and data protection for the first bio-pharmaceuticals have just expired or are about to expire in Europe. This opens the market for new generic 'copies' of these products, referred to as biosimilars.

Until recently no legal framework existed for generic medicines derived from biotechnology. This issue was tackled in the review of EU pharmaceutical legislation ('Pharma Review 2001'), in which specific provisions establish the legal base for biogenerics, now called similar biological medicinal products. The general regulatory guideline for evaluating and approving similar biological medicinal products was to be transposed by member states before 30 October 2005.

The EU framework for biogenerics is, therefore, now in place. Once the patents and data exclusivity on the original bio-pharmaceutical product expire, selected biosimilar medicines can be launched on the European market after appropriate testing to confirm their safety, quality and efficacy. This will end big drugmakers' monopoly in bio-pharmaceuticals and could lower prices for biotech medicines due to market competition.

The European Medicines Agency (EMEA) adopted its first ever positive opinion for a similar biological medicinal product in January 2006. The product, Omnitrope, contains growth hormone and is intended for the treatment of growth disturbance in children and adults. It is manufactured by the Swiss drugmaker Novartis AG's generics unit Sandoz GmbH and, according to EMEA's studies, demonstrated comparable quality, safety and efficiency as the reference medicinal product Genotropin, which is manufactured by Pfizer.

Omnitrope was given market authorisation, by the Commission, on 20 April 2006.

The EU is the first in the world to have defined a policy and legal framework for biosimilars. Absence of such regulation and biosimilars approval process in other countries, in particular in the United States, can lead to a competitive advantage to the EU biosimilars industry.

According to Commissionner Günter Verheugen, biosimilar medicines offer new opportunities "for the control of national healthcare expenditure".

As more biotechnology-based products come off patent, biosimilars will play an increasingly important role by providing lowercost, safe and effective versions of patent-expired biological medicines,” said the CEO of Sandoz, Dr. Andreas Rummelt. With marketing authorisation granted in Europe, Sandoz now hopes that the US Food and Drug Administration (FDA) will act to approve Omnitrope in the US.

European Generic Medicines Agency (EGA) has welcomed the new legal framework and thinks that the EU is now set to become "the global centre for R&D and production of this new generation of affordable, biotech pharmaceuticals, giving the EU a huge competitive advantage over other countries like the United States and Japan".

"From the point of vew of innovation and stimulating R&D on the sector, having a legal framework for biosimilars is not necessarily a good thing, as it allows maket to 'copy' existing drugs," said the chairman of EuropaBio's biosimilar medicinal products working group, Tom Bols.

The current EU-framework does not address labelling of biosimilars. EuropaBio points to this as an outstanding issue and highlights the need for a unique name and label for a biosimilar: "Clear and distinct labelling is essential to avoid confusion between the innovator product and a biosimilar and to facilitate pharmacovigilance obligations."


Friday, April 14, 2006

APIMEDICA2006 - Ist International Forum on Apitherapy

The "APIMEDICA2006 - Ist International Forum on Apitherapy" under the patronage of APIMONDIA is being organised in Athens, the capital of ancient and modern Greece.

Several new developments have contributed to our knowledge and understanding of the basic principles of using products of the beehive in modern medicine.

Increased problems with disease causing agents that has become resistant to modern antibiotics have made doctors all over the world asking for high quality, efficient alternative methods and means to cure diseases. APITHERAPY gives answers to this problem.

The high cost of many pharmaceutical products mean that they are not available for the majority of people in the world today. APITHERAPY might in many cases give an answer to the problem.

The co-operation within APIMONDIA of strong bodies working with the therapeutic and dietetic values of APITHERAPY has meant a strong development and new knowledge since our last Symposium in 1998.

APIMONDIA is with its Standing Commission on APITHERAPY actively involved in the developments. Extensive studies and research have been carried out in hospitals. Strong efforts are put into involving international organisations in the implementation of the methods in the hospitals around the world.

Doctors, scientists, administrators and development workers meet in Athens for the "APIMEDICA2006 - Ist International Forum on Apitherapy" 12 - 15 October 2006 to discuss and learn under the following broad headlines:

Health: Nutrition, prevention of stress,
Well being: Illnesses, Infectious diseases, Autoimmune diseases, Cancer.
Research issues.

Asger Søgaard Jørgensen

The Greek Scientific Apitherapy Center, pursuing its efforts for the study, documentation and demonstration of the therapeutic qualities of bee products, organizes its 3rd annual conference.

This time, the scope of the event is considerably broadened; it has become international through the cooperation of Apimondia, the world organization for apiculture. Therefore, in October we host in our country "APIMEDICA 2006 - 1st International Forum on Apitherapy" which will be the worldwide event on the subject.

During the conference you will have the opportunity to learn the latest developments in the relevant field of research on a global scale as well as get informed by a number of specialists from various medical domains on the practical applications of apitherapy in health prevention, hygiene and treatment of various diseases.

We believe that the presence of the people involved in the health sector in this conference and the knowledge to be drawn from it will be most valuable for all and that through the dissemination of apitherapy we will contribute to the amelioration of health services and life quality.

D.A. Selianakis
President M.B. Greek Scientific Apitherapy Center


Sunday, April 02, 2006

European Commission warns about fake drugs on the internet

The European Commission ( has issued a warning that fakes of the medicine rimonabant are currently being sold via several websites. Rimonabant has been developed to treat obesity and related risk factors and smoking cessation[1].

The medicine is still under evaluation by the European Medicines Agency (EMEA). The product will only receive marketing authorisation by the European Commission once its quality, safety and efficacy have been satisfactorily established by the EMEA scientific committee, and this approval is still pending. Once approved, the company intends to market rimonabant under the name AcompliaTM.

Patients who buy unlicensed and counterfeit or illicit copies of rimonabant may be putting their health at risk. This latest example underlines European Commission concern that criminals are taking advantage of the anonymity of the internet to sell fake, adulterated and unlicensed medicines to an unsuspecting public, putting lives at risk as well as undermining the pharmaceutical industry.

Commission Vice-President Günter Verheugen responsible for enterprise and industry products said: “I am alarmed at the ever increasing number of counterfeit medicines sold via the internet. This represents a real danger to the health of patients. The Commission is working with European and international partners to do everything possible to ensure legal methods for marketing of medicines are respected and enforced.”

Counterfeiters try to bypass the foreseen regulatory pathways of licensing and supervision by competent authorities. According to a recent survey by the Member States, 170 medicines were identified to be counterfeit in the illegal distribution channels over the past 5 years. Such illegal trade often occurred through the internet. Among the cases identified, lifestyle, growth hormones for bodybuilding use and sleeping drugs played a particular role. Unauthorised copies and fakes of licensed medicines for the treatment of erectile dysfunction (e.g. ViagraR[2], CialisR[3]) and viral infections (e.g. TamifluR[4]) have also been on the sales lists of criminal counterfeiters. Counterfeits may include fakes which do not contain any of the medicine or the wrong medicine. At the same time, they may damage the image of a product and companies investing in the research and application of these products, while criminals try to make money without taking any responsibilities and risks.

To be marketed in the EU, all medicines must undergo a rigorous evaluation for authorisation to demonstrate that they are effective, adequately safe and of high quality. This is ensured by a robust regulatory system for the authorisation of new medicines. The EU also has a strong legal framework for the licensing, manufacturing and distribution of medicines. At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale over the Internet.

Member States enforcement services closely cooperate to combat fake medicines. To further protect patients and industry from criminal counterfeit activities, the Commission is currently analysing the situation and working together with Member States, the European Medicines Agency and international partners on what further actions may be necessary to safeguard public health.

[1] Developed by Sanofi Aventis
[2] market authorisation holder: Pfizer
[3] market authorisation holder: Lilly ICOS
[4] market authorisation holder: Hoffmann La Roche