Higher Drug Cost for Residents of Newfoundland and Labrador

New change in drug policy in one of the Canadian provinces is likely to cause trouble for both consumers and pharmacies. Prescription drug cost would increase for patients who rely on drug program by government. On the other hand pharmacies would earn less, according to proposed amendment in Pharmaceutical Services Act of Newfoundland.

Government is considering bringing changes in an act of drug price policy.

Former health minister of the province had assured, in a press note released by government in july of 2011, new changes would bring down the generic drug cost and no changes in drug price policy which eventually raise cost of medicines.

Patients who are on government's drug plan would have to pay the difference between the cost of brand drug and generic drug; if new the act is amended with proposed changes.

Consumers and Pharmacy Store Owners Concerned

Pharmacy and chemist shop owner are not happy with new amendment as it would significantly affect their revenue.

Policy makers argue that saving millions of dollars annually is the only intention of government. The act with changes would enable government to pay reasonable price for generic equivalent drugs.

Wade Locke, an economist at Memorial University, has been hired by independent pharmacists to study and figure out how exactly the amended act going to affect all the involved parties i.e. gov, pharmacies and patients.

Clinical Trial on Heart Risk Required for Obesity Drug

In a meeting on Thursday, drug review panel of FDA has announced that studies for heart safety would require for approval of obesity drug.

Regardless of whether an obesity drug pose heart risk, pharmaceutical companies would have to conduct trial to demonstrate effect of obesity drug on heart, said USA FDA advisory panel. Majority of the members voted in favor of this regulation.

Most of the obesity drugs have history of posing heart risk, according to Dr. Marvin Konstam - one of the member of advisory panel who voted in favor.

FDA is not bound to follow recommendations given by advisory panel, however, FDA does follow most of the time.

Several pharmaceutical giants have been bracing hard to acquire approval for first weight loss drug in a decade. Vivus and Arena are two companies ahead of other drug manufacturers. In past, FDA had sought clinical trial data on heart risk for the drug Contrave.
Demand for current weight loss drug (such as Xenical) is going to be high following this regulatory guidance as new weight loss drug would take several years to reach market.
Experts are eying on what companies would do next in order to pass the new obstacle; would they conduct entirely new trial on heart risk? or they would just submit analytical data of existing trial. Needless to say, conducting clinical trial is super expensive. Drug companies recover the trial cost from consumers by increasing drug cost. So, even if a company manages to acquire approval for obesity drug, price of the drug would be too high to purchase for obese patients.

This is the second time FDA asked for clinical trial on heart risk, first time it was for diabetes drugs of type two diabetes. Apart from proving efficacy of drug in treatment, manufacturers of obesity drug and diabetes drug have to prove that their drug do not pose risk of cardiovascular diseases.

What is (DIN) Drug Identification Number by Health Canada?

What is a DIN?

DIN or Drug Identification number is unique number given by Health Canada to any product with therapeutic effects, including vitamins and supplements. The DIN number is 8 digit number generated by computer system. The number is allotted only after health and safety assessment by Health Canada. It can be seen on drug label prescription.

A DIN of each product indentifies six properties of respective drug. Properties are Manufacturer Company, name of active ingredient, name of product, amount of active ingredient (strength), form (liquid or tablet or capsule) and method to take (such as oral or injection)

When is a DIN issued?

Assigning DIN is final step in order to allow product in market. A drug product receives, after authorization, DIN number from Health Canada which is like a license for the drug itself. Review is strict for a drug product which is completely new (i.e. it does not have any earlier market history). Such products require NOC (Notice of Compliance) along with DIN.

What is DIN intended to?

A DIN indicates to consumers that the product has been reviewed and its safety and effectiveness have been assessed by medical experts. Any drug in market without DIN is violation of Canadian law.

From administration point of view, DIN makes it easy to update particular drug or pull the drug from market or inspect.

Is that assigned to Prescription medicines only?

DIN is printed on both OTC (Over the Counter) and prescription medicines.

Does DIN have any secret mean?

No. DIN does not have any secret information or meaning. It is generated randomly by computer system.

Merck's New Anti-Platelet Drug Produce Mixed Result

A new antiplatelet drug has shown significant ability to prevent blood clots. However, the drug also caused abnormal bleeding in clinical trial. Merck & Co is testing the drug in a trial which is believed to be largest drug trial conducted for any heart medicine so far.

The manufacturer company is seeking approval for Vorapaxar drug since last year. But the approval is denied because of bleeding caused by the drug in patients with history of stroke. Submitted data of the study included 26,449 participants.

Merck has been asked to stop the trial on patients who had stroke in recent past and, allowed to continue trial on heart attack patients who are in stable condition at present. Vorapaxar is currently being tested on patients who have recently been diagnosed with clogged leg arteries.

Latest trial data published by drug maker last month showed significant reduction in forming of blood clots, while on the other hand, it caused excessive bleeding. Experts are inconclusive whether the company would apply for approval. A trial named TRACER for same drug had failed too. It is also not clear whether Merck would conduct another trial on heart attack patients only.

Despite drug maker is quite happy with trial result, experts see very less possibility for approval. Drug usage will be limited to small group even if Vorapaxar succeeds to get approval.

BEST FOR HEART ATTACK PATIENTS

Researchers involved in trial claimed that after 30 months administered Vorapaxar met goal when it's effects were compared with other popular antiplatelet drug such as Plavix and Aspirin. In fact Vorapaxar reduced the risk of stroke, heart attack and cardiovascular diseases by 13% when compared with its other counterparts in market.


In past several decades Vorapaxar is first new antiplatelet drug which provides long time protection for to patients with history of heart attack, says Dr. David Morrow - lead researcher of the trial.

Simple Way To Prevent Unintended Pregnancy

World Contraception day was on 22nd March. Many women in US is concerned on access to birth control contraception pills. Scientists have found feasible way to address the issue. They have found trivial change which would bring drastic change in unwanted pregnancy in USA.

Most of the health coverage in USA allow 3 months supply of contraceptive pills. Supply for more than 3 months won't be included in health coverage insurance plan. A study published on Obstetrics & Gynecology demonstrated that prescription of birth control pill for more than 3 months would significantly bring consistency in women to continue their birth control plan.

A research study conducted at New York family planning clinic proved that women are more likely to continue to take birth control pills if they are given long lasting supply of contraceptive pills. The research included 661 women of different ages. All the women were given option to go for 3 months supply or 7 months supply. 51% of women who opted 7 months supply had continued the pills after 6 months. And only 35% women of 3 months supply continued. This is not startling fact, in fact it is common sense. However, statistical data that back the claim is necessary to bring changes in insurance policy.

The reason of 3 months supply limit is that a pregnant women take visit to physician and that physician can know any sort of developing complications or side effects of the pill. However, the limit is seem to be problem as women stop taking pills when they run out of the pills.

Effective Generic Drug To Slow Down Bleeding, Used by UK USA Armies

A general generic version of drug has been saving lives of American soldiers. The generic drug is being given to severely injured soldiers to slow excess bleeding.

The drug is tranexamic acid. Cost of tranexamic acid is very low so much so that physicians were wary to use it. That why this drug took long time to fully recognized it’s potential in emergency units. Every year four thousand american people get into emergency care unit for the treatment of hemorrhage caused by various reasons such as vehicle accidents, shoot out and stabbings.

Because of its extremely low cost, manufacturer companies could not afford to market or advertise the drug.

Usefulness of the drug has sparked discussions amongst experts of many hospitals across the US on whether the drug should be included in pharmacies. The drug is OTC in UK to stop excess bleeding during menstrual cycle. A study, on more than twenty thousand patients who suffered bleeding for various reason, proved the drug as life saving drug treatment when it is about stop bleeding. Taking result of the study into consideration, UK and US military started to use the drug for their soldiers.

Along with military the drug is now being used in ambulances in UK. Around 400,000 patients die every year because of unstoppable bleeding. A research on usefulness of drug demonstrated that tranexamic acid can save 128,000 patients a year. The research has been available on March 1 publication of BMC Emergency Medicine.

Experts held pharmaceutical companies responsible as the companies did not marketed the drug despite its great potential in hemorrhage treatment.

Pfizer, a pharmaceutical giant, funded a study trial named as Crash-2. The trial was conducted by Dr. Ian Roberts in 2010. Dr Roberts is acting as director of clinical trial department of London School of Hygiene and Tropical Medicine.

Electroshock To Treat Depression Found Effective in Study

Experts demonstrated with the help of a study that electroshock therapy is so far effective and underestimated therapy for depression.

Brain images (MRI) of 9 adults who were suffering from chronic depression were examined by scientists. Scientists learned that that electroconvulsive therapy affected several connections between the parts of the brain in depressive people.

The study has confirmed presence of hyperconnectivity in brain of depressed people. And MRI scan showed that the hyperconnectivity can be eliminated by electroshock therapy. The study was conducted at University of Aberdeen in Scotland by Dr Christian Schwarzbauer and team.

It is widely believed that activities in brain of depression patient are too high to respond stimulation given from outside. But this therapy and its result has proved that even a overdriven brain can be treated from external therapy.

The study has opened the door for more improvment to increase efficacy of the treatment.

Electroshock treatment is usually preferred when patient with severe depression symptoms fails to respond antidepressants drug treatment and other available therapy.

The study has been published on Proceedings of the National Academy of Sciences.

Scan image of brain was taken for total nine patients of chronic depression. They then received therapy two times in a week. The therapy was continued till patients showed improvment such as decrease in sorrowness. Scan image of their brain was taken after therapy.

The scientists focused on prefrontal cortex. It is a part of brain located on left side. Brain images of the patients showed that the connections of prefrontal cortex with other part had become less intense after receiving shock therapy.

Studies in past has indicated link between dorsolateral prefrontal cortex and depression. That part of the brain is associated with emotions such as anger, mood such as sadness. Electroshock therapy stopped communication between prefrontal cortex and other part which studies showed association with depression.

New Drug Approval Option To Encourage New Antibiotics Development

The Congress and FDA are contemplating to new pathway for drug approval of antibiotics which are lifesaving and needed critically. The proposed new pathway has been suggested by IDSA. FDA is also in favor as the new approval option would make more drug accessible and control prescription drug abuse.
Purpose of this is to have another feasible approval option for antibiotics which treat serious infections. The need is being felt by FDA to treat infections for which no effective treatment is available in market. Current approval process is lengthy, expensive and time consuming which discourages pharma companies to develop drug which is required by few thousands patients. The new pathway will be based on Special Population Limited Medical Use (SPLMU) mechanism.

IDSA proposed this amendment during a hearing session held for reauthorization of USA FDA's Prescription Drug User Fee Act. PDUFA bill was enacted in 1992 and it requires reauthorization every 5 years from House of Senate. PDUFA has helped a lot in fast approval of drug, which made access to the drug for which no alternative is available in market. The senators are due to discuss the integration of the proposed amendment within another pending bill named as Generating Antibiotic Incentives Now (GAIN). The proposed provision of GAIN bill is to offer incentives to encourage development of new antibiotics for the treatment of diseases which are resistant to current antibiotics.

Antibiotics resistant infections are epidemic for countries across the world. Antimicrobial resistance is a condition where bacteria develop resistance to respond a drug. This means the drugs which were effective to treat infection are now not effective because of bacteria's resistance capability. The proposed mechanism would help to resolve the issue before the current condition worsens and pose serious threat to public health.
SPLMU mechanism would help improve feasibility of approval for the drug which are targeted to be used in few hundred patients.

Approved Rx Shampoo Treatment for Head Lice

A prescription only shampoo indicated to treat head lice has got approval from USA FDA. Shampoo named as Sklice has been developed by Sanofi. The lotion is approved to be used in people of age six months and greater.

Sanofi has received approval from FDA to be marketed in USA market. The shampoo has ivermectin as its active ingredient.

The approval come after evaluating clinical trial of the lotion submitted to FDA. Trial included 780 people who were infected with lice. Most of the participants of the trial did not need to comb hair to remove lice eggs.

Tablets of ivermectin are already being used to treat roundworm parasitic infections. Ivermectin belongs to anthelmintics drugs class. Ivermectin has successful history of preventing life threatening infection caused by worms in infested patients with weak immune system. Ivermectin lotion is prescription only. Lotion has some common side effects such as irritation in eyes, dry scalp or dandruff.

Lice are tiny insects found on scalp. They servive by sucking blood, blood is food for them. The saliva of these insects blocks blood clotting which helps them to keep sucking blood for long time. Saliva produced by lice also cause severe itching.

Hope for Female Infertility, Unlimited eggs Can be Produced with Stem Cells

A study conducted by scientists at Harvard Uni concluded that women with fertility issues might be able to produce countless eggs. Not only that but study also suggested that older women could also have baby.
Scientists have claimed to derive stem cells from female ovaries. This development would enable a woman to conceive even after menopause.

It is generally believed that women lose their capability of getting pregnant as they grow older. An arrangement could be made where eggs of a young girl could be store in an account (sort of bank account) and be used later when respective girl becomes woman.

Dr. Jonathan Tilly, Massachusetts General Hospital, has led the study. Dr Tilly has demonstrated his study on Nature Medicine. This can be a major breakthrough for female infertility problems.

At present there is no promising treatment for female infertility. But based on this finding, more research and development can lead to permanent solution of infertility. It is noticed that the stem cells which were kept outside the body could produce eggs on their own.

Most of the couples are confused about time of pregnancy as women have been found reluctant to have kid because of several reasons such as career ambitions and financial instability.

Research Highlights

Dr Tilly and his teammates extracted stem cells from woman ovaries and injected them into germ cells i.e. female eggs (medically known oocytes).
Scientists churned out these stem cells with the help of antibodies which are located on proteins found on peripheral of these cells. The cells were given different color (fluorescent green) for easy monitoring of process which involved those cells.
The cells, combined with ovarian tissues, were grafted below mice skin. After fourteen days the stem cells produced eggs. Some eggs were with fluorescent green color which showed that the eggs were produced by stem cells which were extracted from female ovaries.

Researches in future may reverse biological process.