Preventing Adverse Drug Reactions

Adverse Drug Reactions are problematic in that they cause significant morbidity and mortality. Almost 95% of ADRs are Type A (predictable) reactions, and thus with quality improvement measures, ADRs can be avoided and prevented. [a]

Knowledge of causative factors and an increase in patient education may help prevent ADRs. Improvements in the documentation of allergic reactions (e.g., via computer tracking), development of tools to enhance compliance, and application of tools to improve prescribing and administration of drugs are other preventative approaches to ADRs.

In 1994, the ASHP, the American Medical Association (AMA), and the American Nurses Association (ANA) generated the following system of recommendations to prevent ADRs in health care systems:

1. Health care systems should establish processes in which prescribers enter medication orders directly into computer systems.

2. Health care systems should evaluate the use of machine-readable coding (e.g., bar coding) in their medication use processes.

3. Health care systems should develop better systems for monitoring and reporting adverse drug events.

4. Health care systems should use unit dose medication distribution and pharmacy-based intravenous medication admixture systems.

5. Health care systems should assign pharmacists to work in patient care areas in direct collaboration with prescribers and those administering medications.

6. Health care systems should approach medication errors as system failures and seek system solutions in preventing them.

7. Health care systems should ensure that medication orders are routinely reviewed by the pharmacist before first doses and should ensure that prescribers, pharmacists, nurses, and other workers seek resolution whenever there is any question of safety with respect to medication use. [b]

References:

[a]. Rawlins, M.D. Adverse reactions to drugs. Br. Med. J. 1981, 82, 974–976.
[b]. American society of health system pharmacists. Top-priority actions for preventing adverse drug events in hospitals: ‘‘Recommendations of an expert panel.’’ Am. J. Health-Syst. Pharm.1996, 53, 747–751.

The Emerging Role of Biosimilars

Countries around the world face a growing, aging population and an increase in chronic disease. With expanding demand for good-quality healthcare comes the challenge of controlling healthcare expenditure.
The safe and regulated introduction of biosimilars into the market has been forecasted to increase access to much needed biologic medicines and reduce costs.

Over the next few years, a new generation of complex biosimilars will be developed as numerous leading biologic medicines, worth an estimated $81 billion in global annual sales, will lose their patents by 2020. Fusion proteins and monoclonal antibodies used in cancer and autoimmune diseases are expected to form a substantial proportion of this new line of biosimilars.

What is Six Sigma?

Six Sigma is a performance improve-ment methodology that seeks to identify the key sources of variation in a process(critical factors) that cause defects to occur. By mapping processes, measuring their output, and analyzing its many input variables, Six Sigma determines how to optimize the output from a process by controlling the inputs. Six Sigma projects move through a disciplined framework (known as 'DMAIC')

Define the problem – in terms of performance, consequences and gaps from what is desired 

Measure the process – first to ensure the data is reliable, then to decide how well the process performs 

Analyze the variables – using statistical tests of significance, to find those variables that have the greatest impact on process yield

Improve the process – through small scale experiments and hypothesis tests to compare the impact, before and after

Control the process – to sustain gains and ensure process does not regress to previous levels

Modified Release Drug Product

The term modified-release drug product is used to describe products that alter the timing and/or the rate of release of the drug substance. A modified-release dosage form is defined

as one for which the drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as solutions, ointments, or promptly dissolving dosage forms as presently recognized.

Several types of modified-release drug products are recognized:


1. Extended-release drug products. A dosage form that allows at least a twofold reduction in dosage frequency as compared to that drug presented as an immediate-release (conventional) dosage form. Examples of extended-release dosage forms include controlled-release, sustained-release, and long-acting drug products.

How Are Drugs Designed?

Drug design is the process of finding new drugs based on the understanding of the disease and the structure and function of a biological target molecule involved in the disease. Once these are known, chemical compounds  are  synthesized  with  structures that allow them to bind to and alter the behavior of the target. The structures of  these  compounds  are  progressively refined,  often  using  computer-modeling, to fit even better with the target. In addition to being able to bind to the target, a drug must be able to pass through barriers our body puts in its path. It must be able to adequately withstand the body’s protective mechanisms that reject or decompose it. Ultimately, the body should be able to eliminate and remove the drug. This systematic approach to new drug discovery is called rational drug design.

In  the  past,  most  drugs  were  discovered through a search of natural sources such as plants and microorganisms, or by the synthesis of an extensive number of compounds of varying structures. These synthetic  or  natural  compounds  were then tested for various kinds of biological activities  in  the laboratory.  This  type  of trial-and-error  approach,  called random screening, resulted in the discovery and development  of  many  important  drugs. It still has a place in drug discovery and is  often  used  by pharmaceutical  companies  to  identify lead  compounds.  These lead  compounds  are  then  synthetically modified  to  give  new  compounds  with improved properties.

Most drugs are small organic molecules produced through chemical synthesis, but biopharmaceutical drugs (also known as biologics)  produced  through  biological processes are becoming increasingly more common. [Source: Introduction to Pharmaceutical Sciences]

Pharmaceutical Cartoon: Reason behind pharma pricing!

BioPharma Mexico - Top 9 Innovators | Terrapinn Blogs

One of the most important things to look for when establishing a new pharmaceutical or biotech company is scientific talent in the region.

Terapinn has compiled a list of the top innovations that will be presented at BioPharma Mexico 2013. Each of these projects were selected because of their originality and relevance to the pharmaceutical and biotech industries. But most importantly, these projects show that there is scientific talent in Mexico, which makes it ideal to conduct clinical development of any type.

This ranking was built based on the novelty of each project and its relevance to the pharmaceutical and health industries. The selection criteria are based on the following:

• Originality of research
• Relevance to industry
• Technology
• Clinical stage of project
• Projected impact

 The innovators are listed in alphabetical order by project and are not ranked within the 9.

## Production of Vaccines Fused to Genetically Encoded Nanocrystals

Innovator Scientist: Luis Vaca, CaramelTech

Innovation:

Baculovirus expression system for insect cells (BEVS) is a novel procedure used to make stable proteins that can be used in vaccines. It takes advantage of the polyhedrin production system in insect cultures to manufacture effective recombinant proteins. This process requires the fusion of a recombinant sequence with a polyhedrin sequence which is then inserted into a BEVS factor, resulting in production of high amounts of encapsulated proteins that are resistant to heat and dehydration.

## MedicalHub: Health maps of Mexico

Innovator Scientist: Ivan Pech, CaramelTech

Innovation:

Medical Hub is a big data project that makes health statistics available to the private sector in Mexico and Latin America. One of its components is Medical Metrics, which creates health maps with health graphics and indicators for each city, state, and country. Medical Manik complements it by allowing doctors to control their patients records on the go. Medical Hub will benefit pharma by facilitating the application of big data to the developing and monitoring of novel therapies and the generation of new health initiatives.