HeartWare issues voluntary medical device correction for HeartWare batteries

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HeartWare International, a global medical device company, has issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE.  In letters to clinicians and patients, the company reports an observed increase in complaints related to earlier-than-expected battery depletion and routine battery handling.

HeartWare is providing information to assist patients and clinicians in monitoring battery performance, recognising abnormal behaviours and reinforcing proper power management.  Premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death.  If a battery shows abnormal behaviour, patients are instructed to stop using that battery and contact their VAD Coordinator for a replacement.

Similar to the battery in a mobile cell phone, HeartWare batteries will begin to lose charge over time.  If a fully-charged battery lasts less than two hours or if the controller switches back-and-forth between batteries, patients are asked to take the affected battery out of service and replace it with a new one.

No deaths have been reported to HeartWare that were directly related to a faulty battery.  However, between January 1, 2011 and March 31, 2014, three deaths were reported that were potentially related to power source management.  Of those, two patient deaths occurred after both sources of power were simultaneously disconnected; the third patient had batteries that far exceeded their expected useful life.  A fourth death was originally reported as possibly related to power management, but was later determined to be more likely related to an accidental disconnection of the driveline.

Clinicians and patients are encouraged to review the correction letters and the Patient Manual to ensure proper power management.

Patients with questions about this announcement should contact their physician or VAD Coordinator at their hospital centre.  Clinicians with questions related to the correction should contact their HeartWare representative or HeartWare’s 24-hour Clinical Support line at (888) 494-6365 or via email at FSCA@heartware.com.

Source: PharmaBiz


Kerala pharmacy council introduces health insurance coverage for registered pharmacists

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Committed to helping the pharmacist community to curtail their escalating healthcare costs, the Kerala state pharmacy council has started a scheme of health insurance cover for its registered pharmacists. The plan will benefit the family members of the pharmacists as well.

‘Apart from the pharmacists, the plan would also benefit the members of pharmacy council forums and non-pharmacist proprietors and owners of pharmacies on account of their long experience and association with pharmacy profession”; said B Rajan, president of KSPC.

According to him, this is the first health insurance scheme for registered pharmacists introduced by a state pharmacy council. The scheme has come into effect on April 1 this year and it is implemented through United India Insurance Company which signed an MoU with the pharmacy council in this regard.

While briefing Pharmabiz, Rajan said the premium starts with Rs 2300 for an insured amount of Rs.1 lakh, Rs.2875 for two lakh, Rs.3450 for three lakh, Rs.4025 for four lakh and Rs.4425 for five lakh. The policy has to be renewed every year. The medical stores and the wholesale premises can also be brought under the coverage.

“The enrollment of pharmacists to the scheme had commenced in September last year and we hope that about 50,000 registered pharmacists in the state can avail of the benefit. Within one month’s time, 1500 registered pharmacists have been enrolled into the scheme. Though there are 50,000 pharmacists registered with the Council so far, those renew their registration every year and practice the profession is only 25000. The pharmacists and their family members will come under the scheme”, he said.

He further said the premium for the scheme is very low compared to other health insurance plans available at present. In the scheme, all the diseases including chronic illness will be covered. Maximum age limit for taking policy is 70 years and it is a lifelong scheme. The council proposes to bring all the registered pharmacists under the insurance scheme shortly.

Apart from the insured amount, the benefits include ambulance charge of Rs.2000 in case of emergency and free accessibility of IP rooms, ICU and reimbursement of claims for treatment in non-net work hospitals. Maternity benefit is covered upto Rs.15000 for normal delivery and Rs.25000 for caesarian. Expenses incurred for 30 days before hospitalisation and for 60 days after it are also eligible to be availed through the scheme, said the Council president.

Source: PharmaBiz

Physicians to soon get new revised model prescription format

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While Maharashtra Food and Drug Administration (FDA) efforts to implement uniform and good prescription practices by launching a model prescription format is on since February, a new revised model prescription format is currently being drafted by Medical Council of India (MCI) in consultation with Maharashtra Medical Council (MMC), State Pharmacy Council and FDA.

Scheduled to be out in coming two weeks time, the revised model prescription format would be an answer to the practical difficulties faced by physicians in implementing FDA’s model prescription format like writing the names of the medicines in Capital Letters, patient’s address, specifying doctor’s qualification and registration number in addition to giving generic drug names.

MCI will hold a meeting of all the stakeholders comprising of state council presidents and MMC on May 4, 2014 in Delhi to contemplate on issues faced by physicians in implementing FDA’s model prescription format which was issued on February 28, 2014 by the hands of Chief Minister to discourage irrational use of drugs and combat multi-drug resistance.

According to Dr Kishor Taori, president, MMC,”We will be consulting Maharashtra FDA based on the recommendations of the meeting with the stakeholders to come out with a new model prescription format within 15 days. Maharashtra FDA has done an excellent job in coming out with the format as it will stall quackery but it needs to be made simpler and physician friendly.”

As per the contentious FDA format, it is statutory requirement to mention name of the prescriber on cash or credit memo of the drugs under Rule 65(3) and authenticate prescription. Therefore, the prescription shall bear doctor’s full name as mentioned in her or his registration certificate. To know competency and genuineness of prescriber, the prescription shall bear doctor’s primary qualification such as MBBS or BAMS followed by subsequent qualifications. Prescription shall bear the registration number of doctor’s registration with their respective council. The registration number should be prefixed with letters indicating the council in which doctor has registered her or his name.

“MMC plans to have simpler and more practical prescription format in the near future. It is tough for doctors who have to write prescriptions every five minutes to follow the FDA model,” an MMC official said.

The FDA format also states that it is statutory requirement to mention the address of the prescriber on the cash or credit memo of the drugs under Rule 65 (3) and the patient and pharmacist should know where the prescriber is practicing and, therefore, prescription shall bear complete address of clinic or hospital where the prescriber is practicing. The prescription shall have telephone number and e-mail address of prescriber.

As per the Rule 65 (10) prescription shall be dated and prescription shall specify the name and address of the person for whose treatment it is given or name and address of the owner of the animal if the drug is meant for veterinary use.

The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 under Indian Medical Council Act 1956 under Code of Medical Ethics at 1.5 prescribes as “Every physician should as far as possible prescribe drugs with Generic names and he or she shall ensure that there is a rational prescription and rational use of drugs”. Therefore, prescription shall bear the name of medicine as Generic name. The name of medicine should be in Capital letters in legible manner. If the prescriber is not sure about generic name he shall add following instructions on the prescription above her or his signature. “Or any other cheaper generic medicine as per choice of patient.”

Prescription shall invariably bear strength of the medicine. Eg. paracetamol tablets 500 mg., amoxycillin capsules 250 mg and shall also bear a proper dosage form of medicine prescribed. eg. tablets, capsules, syrups, creams etc.

Source: PharmaBiz

India an example of how IPR to be followed, not criticised: MSF

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The international medical humanitarian organization Médecins Sans Frontières (MSF) has asked the United States (US) to desist from painting India as a rogue government on the intellectual property rights (IPR) issues as India is an example on IPR that should be followed and should not be criticised.

Responding to the US Trade Representative (USTR) 2014 “Special 301 Report” released on May 1 in which India remains on the Priority Watch List, as in previous years, for what the USTR considers to be inadequate protection of intellectual property, MSF said that the USTR is throwing every single intimidation and pressure tactic it has at its disposal at India.  This is just the latest example of how USTR is attempting to penalise India for not bowing to the endless efforts of the multinational pharmaceutical industry to severely restrict generic competition in India and world-wide.

“The USTR is painting India as a rogue government, when in fact every action in India’s efforts to secure access to affordable, lifesaving medicines is fully consistent with global trade rules. India is playing by the rules, and USTR knows it. India’s policies have saved lives.  It’s an example that should be followed, not criticised,” said Judit Rius Sanjuan, US manager, MSF Access Campaign.

The MSF is enraged over the fact that this year the USTR has gone a step further by announcing a more in-depth investigation into Indian patent law (called an Out-of-Cycle Review), through which it will maintain ongoing and increased pressure on India.

India — the world’s principal producer and supplier of quality generic medicines — has in recent years repeatedly been singled out by the US government and the multinational pharmaceutical industry on the grounds of insufficient enforcement of intellectual property.

Yet what India is doing when it seeks to limit patent evergreening (where companies file multiple patents in a bid to ever-extend monopolies), or when it authorises the sale of a generic version of an expensive patented medicine through the use of compulsory licenses, is entirely within global trade rules, and these actions save lives.

Other countries are now considering similar legislation replicating the Indian model. The US pharmaceutical industry and USTR are clearly worried and are now seeking to curb India’s influence on global patent reform efforts that have the potential to increase access to medicines for millions in need in developing countries.

Source: PharmaBiz

Coffee Tied to Lower Diabetes Risk

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Drinking more coffee may decrease your risk of Type 2 diabetes, while cutting down may increase your risk, a new study has found.

Over a 20-year period, researchers periodically collected detailed information on diet, lifestyle and medical conditions in more than 120,000 participants. They found 7,269 cases of Type 2 diabetes.

After controlling for smoking, age, weight, physical activity, alcohol consumption and a family history of diabetes, they found that people who increased their coffee intake by more than an eight-ounce cup a day in a four-year period had an 11 percent lower risk of diabetes than those whose consumption remained steady. People who decreased their consumption by the same amount had a 17 percent higher risk. The report appears online in Diabetologia.

“It’s not the caffeine,” said the lead author, Shilpa N. Bhupathiraju, a research fellow at Harvard. “We know that. But coffee has a lot of antioxidants and other bioactive compounds” important in glucose metabolism. The effect has been found in previous studies with decaffeinated coffee, she said.

Dr. Bhupathiraju warned that coffee is not a cure-all, and that a healthy diet and lifestyle are still the best protection against diabetes. “If you’re going to eat a doughnut and smoke while having coffee,” she said, “it won’t help.”