Turacoz's Insight: Influenza vaccination Week, 7-13 Dec 2014

Influenza Vaccination Week was from December 7-­13, 2014, with a primary aim to remind everyone that 6 months and older should be vaccinated with the flu vaccine. National Influenza Vaccination Week (NIVW) was established in 2005 by the Centers for Disease Control and Prevention (CDC) to draw attention to the importance of continuing influenza vaccination after the holiday season into January and beyond.

The influenza is an infectious respiratory illness which can cause mild to severe illness, and at times lead to death.  According to recent estimates influenza attacks 5-10% of adults and 20-30% of children globally, thus leading to considerable levels of illness, hospitalization and deaths. Children <5 years of age, and particularly those <2 years of age, have a high burden of influenza. In India, influenza virus has been reported to cause 1.5% to 14.5% of all acute respiratory infections (ARIs) episodes. The two major mechanisms by which these viruses undergo rapid changes in their genetic constituents are “antigenic drift and antigenic shift” and are a challenge in the field of vaccination.

Globally, trivalent inactivated vaccines (TIV) and live attenuated influenza vaccines (LAIV) are the most common vaccines available for influenza whereas in India, LAIV is not available and a monovalent vaccine containing single pandemic strain, A (H1N1) pdm09 is available. Current trivalent influenza vaccines are not approved for children <6 months of age. Children (previously immunized with seasonal influenza vaccine) and adults should receive one dose of influenza vaccine each year. Children 6 months to < 9 years of age receiving seasonal influenza vaccine for the first time should be given two doses, with a minimum interval of four weeks between doses. For intramuscular (IM) TIV, the dose is 0.5 ml for all age groups.⁴

The "Influenza Vaccination Week" focused on the following activities:

• Increase awareness by interactive programs and blogs to get vaccinated in December, January and beyond for better protection.
• Remind parents and providers of the need for high risk children receive a second dose of flu vaccine for optimal protection.
• Provide an opportunity for interaction with people ask questions about the flu and flu vaccination.
• Provide an update on local influenza activities.
• CDC launched a Google keyword search and display to raise awareness that everyone 6 months of age and older should get vaccinated.

Recommendations of Advisory Committee on Immunization Practices (ACIP) for influenza vaccination 2014-2015

• The flu shots are recommended for children as ≥6 months of age and in pregnant women and people with chronic health conditions and for children < 6 months are not recommended for a flu shot. Factors like an egg allergy and presence or clinical history of Guillain-Barré Syndrome (GBS) require a consultation from doctor before getting a flu shot. 
• The nasal spray vaccine is approved for people 2 -49 years of age. Asthmatic patients, patients with chronic condition like lung disease, heart disease, kidney or liver disorders, neurologic/neuromuscular, or metabolic disorders and the presence or clinical history of Guillain-Barré Syndrome (GBS) require a consultation from doctor before getting a nasal spray.

Read more at:

Key Facts about Influenza (Flu) & Flu Vaccine. www.cdc.gov/flu/keyfacts.htm (Accessed on December12, 2014).

WHO. Vaccines against influenza. WHO position paper – November 2012 Weekly Epidemiol Record 2012.87(47):461–76. 

Medical Device Price Control in India

With the growing middle class and increasing world class healthcare facilities, India has emerged as one of the largest medical device markets in Asia and is rallying ahead in this field with striking rate. The medical device market in India is expected to grow with a rate 15% per year for the coming years. Selling of medical devices in India requires compliance with Indian Medical Device regulations. Foreign companies cover 70% of the medical device market in India.

For the first time after 2005, medical devices have been regulated under Drugs and Cosmetics Rule in India, which is under the control of Central Drugs Standard Control Organization (CDSCO) headed by Drug Controller General of India (DCGI). The manufacturers of medical devices either from India or from International market require their prior market authorization in US, Canada, Europe, Australia, Japan or any other international market as well as proof of approval in their home market, in order to register the device in India.

National Pharmaceutical Pricing Authority (NPPA) of India controls the prices of drugs and other products in India. The essential drugs are regulated under a Drug Price Control Order (DPCO) in India, to make them affordable to poor patients. In recent past, the Maharashtra Food and Drugs Administration (FDA) has recommended to the DCGI and NPPA to bring the medical devices in India under DPCO. This recommendation came in the wake of some studies conducted by the Maharashtra FDA in which it was found that manufacturers in collusion with importers, distributors and hospitals which ultimately provide the devices to the patients and fixes maximum retails price (MRP) of medical devices randomly which is finally passed on to credulous patients. Specially, in the case of drug eluting stents (DES), MRP was found to be exorbitantly high and patients have no option but buy it without any bargain. MRP of the devices are fixed in India by the importers and not the manufacturers. There is one more startling fact associated with the costing that, the cost of devices is recovered immediately from patients (sometimes even before implantation in patients), but the payment to distributors are made after a period of 60-120 days, and applicable taxes to the state government are made only within 51 days by the distributors.

In one case of overpricing it was found that a DES imported in India at around Rs. 31,000 has an MRP of Rs. 1,62,000, it was sold to distributor for Rs. 67,000 and in turn the DES is provided to hospital at a price of Rs. 1,06,650 by the distributor which was in turn sold to patients.

In yet another case of profit making practice by the importer, A DES imported from Europe for Rs. 40,710  has an MRP of Rs. 1,50,000, a mark-up of more than 250%, was sold to a distributor at Rs. 73,440 and in turn sold to the hospital at Rs. 1,13, 400 and the patient paid a price of Rs. 1,19,070.

These devices are generally not available freely in the market and patients get the supply from hospitals at their quoted price through distributor and are forced to pay double or triple the price at which it has been imported. It has also been reported that distributor bribe doctors and hospitals from the extra money through selling at higher prices.

NPPA has taken steps recently in response to the recommendation from Maharashtra FDA about the price violation of these devices; especially FDA demanded a price cap on DES and orthopaedic implants. It is recommended that most effective way to regulate the price of these devices is to bring them in National List of Essential Medicines (NLEM), which can bring relief to millions of patients. In India two medical devices – intra uterine device and condoms are already covered under NLEM and their prices are under control.

Role of NPPA in this regard can be effective in this scenario to bring relief to the common middle class population of this country.

References:

http://www.pharmabiz.com/NewsDetails.aspx?aid=83063&sid=1

http://epaperbeta.timesofindia.com/Article.aspx?eid=31808&articlexml=RevealmedicaldeviceMRPcompaniestold10122014017011#