NUCLEAR PHARMACY AN EMERGING CAREER

Nuclear pharmacy involves the preparation of radioactive materials that will be used to diagnose specific diseases. These materials are generally injected into a patient’s bloodstream or are swallowed, after which, gamma cameras scan the organs looking for the minute amounts of radioactive material. These scans provide the physician with a dynamic view of organ function. Other modalities, such as CT, MRI or X-ray, provide only structural information. It’s a growing field, with more than 1000 nuclear pharmacists in the World wide.

Profiling the job

In addition to preparing radiopharmaceutical agents, a nuclear pharmacist is responsible for quality control of these chemicals. Radiopharmaceuticals must meet certain IP or USP compendium standards for purity, particle size and pH. While this generally is the responsibility of the drug manufacturers, it is up to the nuclear pharmacist to make sure the standards are upheld. Because of the radioactive nature of the materials, disposing of waste materials properly is an important responsibility within the pharmacist’s realm. Uniform standards for this purpose have been set by the government and must be strictly adhered to in all institutions provided.

Meticulous record keeping matters, too. Nuclear pharmacists are responsible for reviewing patient charts prior to any testing. This procedure allows them to determine whether there are any other scheduled diagnostic tests for that time period which might use an incompatible agent. Sometimes medical conditions are present that might contraindicate the use of a radioactive drug, although, fewer than one in 300,000 patients develops an allergic reaction to radiopharmaceuticals.

The radiopharmaceuticals used in diagnostic imaging for 85 percent of the hospitals and clinics in Worldwide. Most of the drugs are bound with the radioactive isotope technetium 99 M. But the other ingredients are determined by the organ function the physicians are monitoring. Some drugs offer high-resolution bone scans to help doctors look for fractures; others provide the best imaging for heart blockages. 

Nuclear pharmacists earn about the same as those in all other specialties of pharmacy and the job market is wide open. There are perhaps 4,000 nuclear pharmacists in every country and job openings for many more. That demand intensified the need of training program for the pharmacy graduates studying for four to 6 years in handling, dispensing and compounding of radioactive materials.

From my words nuclear pharmacist’s terrain is considerably more relaxed than that of a retail or hospital pharmacist. Although the general routine and intense focus required is the same every day, no day is ever the same. Calls from hospital and lab staff keep the day busy and varied. The variants in compounds keep him constantly doing tabulations in his head. Although many of the prescriptions are standing orders, each day a nuclear medicine technologist from each hospital calls to amend the order for the next day.

TYPES OF NUCLEAR PHARMACY

There are essentially two different kinds of nuclear  pharmacy services called Institutional Nuclear Pharmacy and Commercial Centralized Nuclear Pharmacies:

1) Institutional Nuclear Pharmacy is most likely operated through large medical centers or hospitals.

2) Commercial Centralized Nuclear Pharmacies provide their services to subscriber hospitals. They prepare and dispense radiopharmaceuticals as unit doses that are then delivered to the subscriber hospital by nuclear pharmacy personnel.

PRACTICE OF NUCLEAR PHARMACY

The practice of nuclear pharmacy is composed of several domains related to the provision of nuclear pharmacy services. These domains, determined by formal task analyses, serve as the basic structure for the Nuclear Pharmacy Practice Guidelines. The nine general domains involved in nuclear pharmacy practice are

1. Procurement
2. Compounding
3. Quality assurance
4. Dispensing
5. Distribution
6. Health and safety
7. Provision of information and consultation
8. Monitoring patient outcome
9. Research and development

ROLE OF NUCLEAR PHARMACIST PHARMACY PRACTICE

When a particular radioactive material was needed, a trained nuclear pharmacist was available to prepare the product and dispense it to the end user. When you look at a nuclear pharmacy, its operation is not much different than that of a traditional pharmacy a "prescription" for a particular product is presented, and the nuclear pharmacist must prepare and dispense that "prescription". Where a traditional pharmacist will dispense doses in milligram weight units, a nuclear pharmacist will dispense in mill curie activity units.Where a traditional pharmacist dispenses tablets and capsules, a nuclear pharmacist dispenses the radioactive material in liquid or capsule form. Where a traditional pharmacist will generally dispense the prescription to the patient, the nuclear pharmacist will dispense to a hospital or clinic nuclear medicine department where the dose will be administered to the patient.

Nuclear pharmacists are available to provide drug information to other health professionals, to aid thenuclear medicine staff in the selection of products, and to assist in the interpretation of unusual studies. Nuclear pharmacists receive extensive training on the various radiopharmaceuticals that are used, as well as training on the safe handling of radioactive materials and the procedures that will minimize radiation exposure to themselves and to others.

Nuclear pharmacists serve as vital links in the provision of nuclear medicine services. By working closely with the nuclear medicine staff, nuclear pharmacists can contribute a tremendous amount to the provision of care for the patients who are undergoing nuclear medicine procedures. While similar to traditional pharmacy, nuclear pharmacy is also in many ways unique, and can be a challenging and rewarding carrier choice for pharmacists.

For complete course information.. Please utilize the link provided

http://www.nuclearonline.org/index.asp

by

Akshaya Srikanth

Pharm.D Internee

Hyderabad, India

Halting The Malaria Life Cycle

Scientists have discovered a new target in their fight against the devastating global disease 'malaria' thanks to the discovery of a new protein involved in the parasite's life cycle. 

The research has uncovered a vital player in the sexual phase of the malaria parasite's reproduction which could prove an effective target for new treatments to stop the disease in its tracks. 

The scientists from The University of Nottingham's School of Biology, with collaborators from the Universities of Leicester, Oxford, Imperial College London and Leiden in the Netherlands, have just published the results of their work in the journal PLoS Pathogens.

Biting back 

Malaria is a devastating global disease with several hundred million clinical cases and just under a million people die from it every year. The disease is caused by an infection of the red blood cells with a tiny parasite called a Plasmodium, of which there are four important species. These organisms are carried from person to person by the Anopheles mosquito. When it bites an infected person, the mosquito sucks up blood containing the parasite, which may then be passed on to the mosquito's next victim. 

Dr David Guttery, lead scientist of the paper and part of Dr Tewari's group from the University of Nottingham's Centre for Genetics and Genomics in the School of Biology said: 

"The malaria parasite is a complex organism and to understand how it multiplies is crucial to stopping its transmission. Our study has identified a cell-division cycle gene in the malaria parasite and its role in the development of male sex cells and is hence a good candidate for putting the brakes on its development. We have shown that by deleting this gene, male gametes cannot form and burst out of their host cell (a process called exflagellation). Blocking the formation of these cells can be an important strategy in the prevention of malaria transmission from mosquito to mammalian hosts". 

New Target 

The protein that has been identified is called CDC20 and plays a part in the cell division cycle of the malaria parasite Plasmodium berghei which infects mice and rats. This gene has been shown to have an important role in cell division in many organisms, but up to now nothing has been known about its function in the malaria parasite. The new study provides the first description of the role of CDC20 in Plasmodium cell division and in the development of the malaria parasite's male sex cells (microgametes), which are essential for parasite transmission between humans and the mosquito carrier. The scientists have discovered that the absence of this gene stops the male sex cell from bursting out of its host cell and fertilising a female cell as they are arrested in their cell division. 

The sexual stage of the malaria parasite's life-cycle occurs within the mosquito after it has fed on malaria-infected blood. This activates the parasite's sexual phase and during this period, the male sex cell precursor (microgametocyte) rapidly replicates it DNA and produces 8 male sex cells (gametes). These gametes then burst out of the microgametocyte in a process called exflagellation and seek out a female sex cell to fertilise. By blocking the process of exflagellation, the team have identified a way of slamming the brakes on malaria transmission. 

The team of researchers were from the Centre of Genetics and Genomics at The University of Nottingham, the University of Oxford, Imperial College London, Leiden University, the University of Leicester and the MRC National Institute for Medical Research funded by the MRC, Wellcome Trust, and EviMalar. 

The group at Nottingham has previously uncovered other major players in the life cycle of the malaria parasite. More details on these can be found in earlier media releases 'Stopping the spread of malaria' and 'Malaria research begins to bite'.

Complete article available at 

http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1002554

by

Akshaya Srikanth

Pharm.D Intern

Hyderabad, India

Some Thoughts on Expiration Dates

Have you ever looked at the label of an old medicine bottle before you deigned to take the pill? Of course you have. You were looking for the expiration date. And how many of you threw away the bottle of aspirin because it exceeded its allotted lifetime and expired? I am sure the majority among us have done it. Now, I am not a conspiracy theorist, but having had the privilege of an inside look at the working of drug companies I can’t escape the feeling that it’s time to critically examine the process behind those menacing word of “warning: do not take after…”. 

When a drug is in the process of development the company is obliged to conduct stability studies. From day 1, samples of the drug are kept at different temperatures (4-6°C, room temperature, 37°C) to simulate conditions in which the drug may be stored), and sometimes other environmental factors, like dark/ light,  relative humidity, etc. These stability studies continue throughout the development of the drug. Let’s take a typical development period of 12 years. At the end of this period the company submits an NDA or New Drug application to the FDA, and among the reams of data on what is known about the drug there is one critical page: THE LABEL. What you put in the label has to hew closely to what the data show, up to the date of submission. Everybody is involved in crafting the content of the label: the chemists who can attest to its structure, purity, and stability; the biochemists who are supposed to know about the drug’s metabolism and breakdown products in the body and in storage; the toxicologists who tested for any adverse effects on animals and humans; the clinicians who conducted the clinical trial and can attest to its efficacy.

But wait, that’s not the whole story: the marketing people weigh in as well. What does marketing have do with the label? Everything that is important to the bottom line, that’s what. Use the wrong language in the warnings section and physicians and patients will avoid you like the plague. Push the envelope a bit in your efficacy claims, and you’d gain market share worth billions of dollars over many years. Can one

blame them for trying? Of course, the FDA stands guard against such abuses, but as we all know –even they are not immune to the power of lobbying and political pressure.

So what about the stability data? If the drug had a 12-year development period, the company has only 12 years of data on stability. But that’s the maximum. The FDA encourages the company to take a conservative stance, and the company happily obliges. So they take a healthy “discount” to

the stability period from the 12 years which the data show to say, 6 years. The company can claim putting patient interest as their top concern. It will also help in product liability lawsuits. And –it will induce you to throw away a perfectly good drug, and buy a replacement. And this translates into moollah.

Now, before the chemists and pharmacologists among you get their dander up, let me say that there is always a slow process of breakdown in

any chemical, including drugs. But the emphasis is on ‘slow’. If it weren’t slow, it wouldn’t pass muster with the FDA. Now let’s say that in 12 years the company showed a 10% loss of efficacy. That would translate to taking 360mg of 12-year old aspirin instead of 400mg of newly synthesized aspirin. But wait: if you took that aspirin at 6 years, still within the approved period, your effective dose would be only 380mg. Now the important question: has anybody bothered to measure the differences in analgesic and anti-inflammatory activity between 360mg, 380mg, and 400mg. To my knowledge, nobody. Academic scientists wouldn’t because the difference would be so  minuscule as to be meaningless. Company scientists of course wouldn’t, because their company doesn’t want to know –it may cause a drop in sales.

The problem is that the consumer doesn’t have a way of knowing what is the real expiration date. And this is not a problem limited to consumers losing money and companies making it –it is a national problem, as a quick look at what the nation spends on medicating itself would reveal. Medicare Part D, which pays a large portion a patient’s drug bill, plays a major role in the precarious financial situation we are finding ourselves in. How much can be saved by simply keeping an effective drug a bit longer? The arithmetic is quite simple: a 10% reduction in drug consumption would translate to a 10% reduction in the national expenditure on medicines.

When we face a complex problem, like health care, we instinctively reach for complex solution. But sometimes solutions can be simple, and they hide in plain view. All we need is to “get in the weeds”, examine our assumptions, examine the data behind the assertions and separate fact from fiction.

by

Akshaya Srikanth

Pharm.D Intern

Hyderabad, India

All Prescribed Drugs Have Side Effects

Whenever a synthetic substance is introduced into the body there is a reaction. Prescribed drugs are synthetic substances -that is they are manmade and not naturally occurring. Sometimes the body’s reaction to such a substance is severe at the outset; at other times the initial reaction may be mild but the cumulative effect over time is significant. Most prescribed drugs fall into the latter category. 

A side effect is an unintended occurrence that results from taking a drug. The pharmaceutical companies who manufacture these drugs either deliberately downplay the side effects, or carefully manage the information pertaining to their concoctions so as not to alarm the public. They only usually get found out in their manipulation of the information when a significant number of patients make a complaint about a specific drug.

In 2004, Merck were forced to take their arthritis drug Vioxx from the market when it became obvious that a significant number of patients were likely to develop cardiovascular problems if they continued taking the drug. In 2011, GlaxoSmithKline took their Avandia drug for diabetes from the market when it was found to significantly increase the risk of heart attack. Both of these drugs at the time of removal were on general release have passed all clinical trials.

No matter how stringent the clinical trials insisted up by the regulatory authorities such as the FDA (Food and Drug Administration) in the USA, or MHRA (Medicines & Healthcare Regulatory Agency) in the UK, some drugs will make it onto the general market that are a danger to public health. There is therefore a need to be vigilant especially in relation to new drugs coming onto the market for the first time.

Some drugs do not get enough complaints to merit their removal from the market but nonetheless have serious side effects. Here is a list of the most serious of these as they have an impact on the body: affecting the blood causing dizziness, high blood pressure or heart attack; affecting the brain causing amnesia, speech disorder or stroke; affecting the bowels causing abdominal pain, constipation or diarrhea; affecting vital organs involving hepatitis, kidney or liver failure; affecting the lungs causing colds, flu or sore throat; affecting the mental state causing aggression, depression or confusion; affecting the senses causing tingling sensations, ringing in the ears or vision problems; affecting the skin causing itching, skin rash or sweating.

The possible consequences of taking prescribed drugs are such that every opportunity should be taken to avoid them if at all possible. Doctors should only use them in treating a patient for a complaint as a last resort instead of a first option.

by

Akshaya Srikanth

Pharm.D Intern

Hyderabad, India

ADRs in HIV patients using Antiretroviral therapy

A study recently published in the Journal of Infectious Diseases credited AIDS treatment for saving 3,000,000 years of life in the United States. While effective treatment of common AIDS-related opportunistic infections has indeed benefited AIDS patients, the study cites treatments that decrease the virulence of the HIV virus as having the greatest impact on mortality rates of AIDS patients. In the United States and countries that can afford it, the standard treatment for HIV is highly active antiretroviral treatment, HAART for short. HAART is composed of a combination of three or four drugs that fit into as many as three categories: reverse transcriptase inhibitors, protease inhibitors, and fusion inhibitors. Each of these categories of drugs attempts to interrupt the viral life cycle at a different point. Reverse transcriptase inhibitors block the activity of reverse transcriptase, an enzyme the virus uses to build new DNA from its RNA. Protease inhibitors inhibit the activity of viral enzymes used by HIV to cleave new proteins for final assembly into new HIV virons. Fusion inhibitors, the newest addition to the HAART treatment, block entry of HIV into the cell membrane, preventing infection of uninfected cells. The medications of HAART complement each other and are taken together to give an additive effect. 

While the HAART treatment has had a profound impact on the AIDS epidemic in America, it should be understood that the HAART treatment is not a cure for HIV and carries its own drawbacks. Until recently, the only HAART treatments available were complicated regimens that required patients to take a series of pills at varying times of the day. Atripla, a new once a day HAART treatment, has greatly simplified the HIV treatment regimen but it is not for everyone. Aside from its expense, it is likely that the HIV virus in some people will eventually evolve to become resistant to one or more drugs in Atripla, and those patients will have to revert to more complicated treatment regimens. 

While side effects of HAART treatment vary considerably between individuals and the particular medicines making up their therapy, the most common side effects include diarrhea, nausea, and vomiting ("Side effects"). Lipodystrophy is another common side effect of HAART treatment in which fat is redistributed to other parts of the body. Often in this condition, face and limbs become thin while one's breasts, stomach and/or neck enlarge. Hyperglycemia and onset of diabetes have also occurred in a significant number of HAART patients. Liver toxicity including liver failure, pancreatitis and neuropathy are other unpleasant and potentially life threatening side effects experienced by some patients. These side effects can amount to such a physical and psychological burden that patients skip doses or stop taking their medications all together which increases the likelihood of drug resistance developing. In fact, about 25 % of patients stop therapy within the first year on HAART because of side effects (akshaya srikanth et.al 2012). Reconstitution of the immune system, a major goal of HAART treatment, may even carry risks in some patients. A debilitating inflammatory syndrome has recently been linked to HAART treatment. 

This podcast was not meant to scare anyone away from seeking HAART therapy; indeed as I stated earlier, it is very effective in combating infection and allows many HIV positive patients to live longer healthier lives. My goal was to simply alert people to the fact that there are frequently side effects and complications associated with HAART treatment. Prevention is still the best treatment for HIV that carries no side effects. 

Read complete article at

Incidence of adverse drug reactions in HIV-positive patients using antiretroviral therapy http://t.co/AkIB1rf4

by

Akshaya Srikanth

Pharm.D Intern

RIMS, Kadapa

India

MAKING TRIALS FAIR

Regulating clinical research continues to be an area of serious concern for the health authorities in India with increasing number of violations taking place in various parts of the country. The most recent one is reported from the state of Andhra Pradesh last week. In this case, 20 persons were subjected to clinical trials in Warangal district of the state by an unknown contract research company. The matter came to light after the death of one of the subjects due to serious adverse effects of the drug. It seems that the district health officials were unaware of any such trials in the area. In another instance,7 girls died during a trial of HPV vaccine conducted during 2010 by an NGO in the states of Gujarat and Andhra Pradesh. Nearly 25000 girls were subjected to the trials in which both the state governments were collaborating partners. The trial got suspended later in April 2010 and a committee was appointed to inquire into the irregularities of the trial. Now even after several months of submission of the inquiry report, the health authorities do not seem to be acting on the findings. Several other cases of violations of clinical trial guidelines were reported in the country for the last 10 years.

India has detailed guidelines under Schedule Y of the Drugs & Cosmetics Act to streamline the clinical research in the country. But, many of these guidelines are weak, need to be modified, notified and made into a part of the Act. It is the absence of the stringent provisions of the Act that emboldens the pharmaceutical companies and CROs to break the rules during clinical research. Take the case of formation of ethics committees. Although D&C Act stipulates establishment of an ethics committee at the trial site before conducting the research, many trials are being conducted either without them or with ineffective committees. Because of this, most of the protocol violations, negligence of researchers, failure of investigational products, adverse events due to concomitant medication, etc. go unreported. The health ministry needs to develop a suitable mechanism to regularly inspect operations of ethics committees  to curb deaths and serious injuries. The compensation to the victims of trials is another critical area that is being neglected by the pharma companies and the CROs. It is important that the government should stipulate adequate compensation to relatives of  subjects who die during a trial or get seriously injured.

by

Akshaya Srikanth

Pharm.D Internee

Hyderabad, India

Centre yet to disburse funds for state's 18 pharmacovigilance at govt medical college hospitals

The Union government is yet to provide the funding, staff and infrastructure to commission the 18 Centres for Pharmacovigilance at government medical college hospitals in Karnataka.

Pharmacovigilance prevents adverse drug reactions. The Centres will monitor and evaluate the information from hospitals on Adverse Drug Reactions (ADRs) besides identifying information on drug hazards to ensure the safety of patients.

In early 2010, following the need to open up pharmacovigilance across the country, the erstwhile Drugs Control General of India (DCGI) Dr Surinder Singh was working to approve the Centre for Pharmacovigilance at  government hospitals attached to the medical colleges.

This led the Karnataka health and family welfare department to identify 16 locations which covers 12 government medical colleges hospitals  and six   government independent hospitals to establish the Centre for Pharmacovigilance. The state had also sent a letter of intent to these institutions.

The 12 colleges from the 10 districts are Bangalore Medical College and Research Institute, Government Dental College and Hospital, Bangalore,  Mysore Medical College and Research Institute (MMC&RI), Bellary Medical College now renamed as Vijayanagara Institute of Medical Sciences, Government Dental College and Research Institute, Bellary, Mandya Institute of Medical Sciences, Karnataka Institute of Medical Sciences, Hubli  which is attached to the Kempegowda Institute of Medical Sciences, Belgaum Institute of Medical Sciences (BIMS), Shimoga Institute of Medical Sciences(SIMS), Bidar Institute of Medical Sciences(BRIMS), Raichur Institute of Medical Sciences(RIMS), Hassan Institute of Medical Sciences (HIMS). The four hospitals are Jayadeva Institute of Cardiology, Indira Gandhi Institute of Child Health, Kidwai Memorial Institute of Oncology, Rajiv Gandhi Institute of Chest Diseases and SDS Sanatorium, Karnataka Institute of Diabetology, Karnataka Institute of Nephrology.

In fact in 2004, the  Director General Health Services (DGHS), Ministry of Health and Family Welfare received grant from the World Bank to start a  National Pharmacovigilance Programme for which Central Drugs Standard Control Organization (CDSCO) was the coordinator. Under the programme, 21 pharmacovigilance centres were opened with two zonal centres While  All India Institute of Medical Sciences, New Delhi covered North and East, the  KEM Hospital at Mumbai monitored southern and western regions in the country. There were five regional pharmacovigilance centres at Kolkata, Pondicherry (JIPMER), Nagpur and Mumbai with two centres. There were several periphery centres including Bangalore at the Victoria Hospital, Goa, and Mysore within JSS College of Pharmacy.

There are already a couple of similar centres run by pharmacy colleges in Karnataka which include the Drug Information Centre at Victoria Hospital supported by the Al Ameen College of Pharmacy.

“Since pharmacovigilance is now viewed as a critical component in patient care, we had  proposed to the DCGI on the need to set-up centres across healthcare providers in the state,” stated Dr BR Jagashetty, Karnataka drugs controller.

With India now recognized as a hub for human drug studies, an efficient pharmacovigilance programme is a must as stringent safety pharmacology  studies also help to prevent fatality and serious injuries of volunteers and patients who are part of the clinical trials, he added.

Source:PB

by

Akshaya Srikanth

Pharm.D Intern

Hyderabad, India

Pharmaceutical Legislation Changes In Europe

Preparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995. The Agency is finalizing their preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), which is scheduled for 19 July 2012. 

Stakeholders are kept up-to-date on the ongoing implementation process through The Agency's website and stakeholder meetings, including information on transitional arrangements for the pharmaceutical industry, consultations and guidance on new or revised processes, and information on ways in which patients and healthcare professionals can get involved in identifying and managing safety issues in European Member States. This information will be supplementary to the finalization of the implementing measures by the European Commission. 

Adjunct to the establishment of PRAC, the mandate of the existing Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has also been revised to reinforce its role in pharmacovigilance, with meetings commencing as of September 2012 that will focus on its newly assigned responsibilities. 

According to The Agency, the new urgent Union procedure for safety issues with regard to nationally and centrally authorized medicines in 2012 will be starting to operate, and it will implement the procedure for protocol approval of post-marketing safety studies and results management, however, at first these will apply only for centrally authorized medicines. Furthermore, The Agency will develop a revised process for the coordination of pharmacovigilance inspections during the year starting from July 2012 with the revised process for signal detection for centrally authorized medicines with support from The European Member States for nationally authorized products providing additional data. 

Any patient in European Member States will be able to report suspected adverse drug reactions to his or her national medicines authority under the new legislation, a right that already exists in some Member States. Both, The Agency and Member States will cooperate to provide patients with information on direct reporting during 2012. 

The Agency's and European Member States' transparency of all their pharmacovigilance activities will be raised substantially under the new pharmacovivgilance legislation, with the Agency increasing transparency of its processes and procedures through the publication of its agendas, recommendations, opinions and minutes from its scientific committees, which include the PRAC, the CMDh and the Committee for Medicinal Products for Human Use (CHMP). The Agency will also organize public hearings on request of the PRAC that will enable the public to openly discuss safety issues with the Agency. This will reinforce the Agency's current responsibility in ensuring the exchange of coherent and consistent messages on safety issues across Europe. 

The Agency had a consultation with European industry associates in a workshop held on the 30 January 2012, and will subsequently publish details on the revised implementation of the electronic submission of information on all medicines for human use authorized or registered in the European Union (also known as Article 57 requirements) in February 2012. 

The Agency will also publish its concept paper on the structure of good pharmacovigilance practice (GVP) in February, releasing the first wave of GVP modules for public consultation, and has just published a new implementation plan that provides detailed activities of the new pharmacovigilance legislation scheduled to be implemented in 2012 together with those activities that will be a key issue beyond 2012. 

The highest priority will be assigned to activities that contribute to public health, followed by activities that increase transparency and improve communication, after which come those that simplify processes. 

Starting in February, the Agency and its stakeholders will be communicating closely on development issues regarding the implementation of the new legislation. 

by

Akshaya Srikanth

Pharm.D*