Pharmacy News Online: Downtrend Call Realized As KV Pharmaceutical Stock Falls 43.5% (KV.A)

Downtrend Call Realized As KV Pharmaceutical Stock Falls 43.5% (KV.A)

SmarTrend identified a Downtrend for KV Pharmaceutical (NYSE:KV.A) on March 18, 2011 at $8.82. In approximately 2 weeks, KV Pharmaceutical has returned 43.5% as of today’s recent price of $4.99.

In the past 52 weeks, shares of KV Pharmaceutical have traded between a low of $0.60 and a high of $13.55 and are now at $4.99, which is 725% above that low price.

KV Pharmaceutical is currently below its 50-day moving average of $6.87 and should find support at its 200-day moving average of $3.17. Look for these moving averages to decline to confirm the company’s downward momentum.

In the last five trading sessions, the 50-day MA has climbed 7.46% while the 200-day MA has risen 4.36%.

SmarTrend will continue to scan these moving averages and a number of other proprietary indicators for any changes in momentum for shares of KV Pharmaceutical.

NCPDP Releases New Industry Standard and Enhancements to ePrescribing SCRIPT Standard

The National Council for Prescription Drug Programs (NCPDP), the leading not-for-profit pharmacy standards development organization, announced today the release of a new Specialized Standard and enhancements to its SCRIPT Standard, a requirement of Meaningful Use of electronic health records (EHRs), enabling eligible providers (EPs) to transmit prescriptions electronically (ePrescribing) to pharmacies. The Specialized Standard and the SCRIPT Standard enhancement leverage NCPDP’s model-driven architecture — developed in 2010 based on a proposal initiated by the Veteran’s Health Administration — to create XML schemas to enable rapid implementation of its ANSI-approved industry standards.

Specialized Standard
Developed for transmitting information electronically between prescribers, providers, payers, pharmacies and other entities, the Specialized Standard Implementation Guide addresses:
Electronic transmission of census information about a patient between a facility and a pharmacy; and
Medication therapy management (MTM) transactions between providers, payers, pharmacies, and other entities.

The Standard will include other transactions for electronic exchanges between these entities in the future.

SCRIPT Standard
The SCRIPT Standard is in widespread use by the industry for ePrescribing. This is the first model-driven version of the SCRIPT standard that creates XML schemas. The SCRIPT Standard Implementation Guide Version 2Ø1Ø121:
Meets requirements for Brand Medically Necessary electronic prescriptions per CMS;
Supports one common syntax for SCRIPT transactions; and
Moves the Census transaction to the Specialized Standard Implementation Guide to support an implementation guide for general exchanges.

The framework on which the Specialized Standard and SCRIPT Standard enhancement were developed emanated from a Veteran’s Health Administration proposal to develop model-driven XML schemas to accelerate developers’ ability to implement standards. NCPDP assigned a task group for the initiative, facilitated by NCPDP Vice President, Lynne Gilbertson. “Through this work, the foundation has been laid for the development of new functionality, as well as the movement of existing NCPDP standards into the new model framework,” explained Gilbertson. “This represents both a seamless and effective methodology for marrying the best practices of using a model environment to NCPDP’s culture and standards.”

China’s new rules on Good Manufacturing Practice is likely to drive consolidation among the country’s 5,000-plus pharmaceutical companies, according to legal company Bird & Bird.

China’s new rules on Good Manufacturing Practice is likely to drive consolidation among the country’s 5,000-plus pharmaceutical companies, according to legal company Bird & Bird.

The new GMP rules came into effect on 1 March 2011 and “significantly elevates GMP standards in China”, according to Bird & Bird’s Grace Chen and Weishi Li.

As elevated standards under the new GMP mean higher manufacturing costs for drug companies, it will benefit big drug companies with resources, particularly those who have already adopted higher GMP standards, whereas many smaller companies will likely be eliminated, they note.

The new rules place greater emphasis on the use of effective quality control system by pharmaceutical companies, through the strengthening of drug manufacturing quality management systems.

The new GMP also introduces the concept of quality risk management, and includes a number of significant changes including an increase in employee quality requirements and refinement of China’s document management rules to encourage the use of standard operating procedures (SOPs) and manufacturing records.

The updated rules also include new processes and measures for supplier audits, change control, more secure approaches for procurement of excipients and other raw materials, and other measures designed to help prevent and correct quality failures.

Newly established drug manufacturing units, and renovations or expansions of manufacturing facilities by existing drug manufacturing sites will have to comply with the new GMP immediately. However, existing manufacturing facilities have a transition period to come into compliance.

Those manufacturing sterile drug products such as blood products, vaccines and other injectable drug products will be required to comply by 31 December, 2013, while all other facilities will have until 31 December, 2015.

Companies that fail to bring manufacturing sites into compliance within the deadlines will no longer be permitted to continue making their drug products at the facilities.

“These developments will significantly boost the overall quality of China’s pharmaceutical industry which will improve the competitiveness of Chinese pharmaceutical companies on the global market”, note Chen and Li.