Drug dissolution testing and establishing plasma drug levels in humans

Drug dissolution testing and establishing plasma drug levels in humans5

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

Drug dissolution testing and establishing plasma drug levels in humans

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

Drug dissolution testing and establishing plasma drug levels in humans1

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

Las Vegas hospitals must follow regular HIPAA privacy rule

Las Vegas hospita.jpg

After natural disasters, HHS sometimes waives certain HIPAA privacy rule requirements. That’s not usually the case after man-made disasters, such as Sunday night’s massacre in Las Vegas, where more than 50 were killed and hundreds were wounded after a gunman opened fire at a music festival.

Because the HIPAA privacy rule already allows information disclosure in certain cases, such as when public safety is threatened, and because there has been no declaration of a public health emergency, HIPAA waivers have not been necessary in this case.

Local hospitals will have to be careful, especially with so many requests for information from families, friends, and the media, said Mark Swearingen, a Hall Render attorney focused on health information privacy and security.

“Hospitals are going to have to be very careful about vetting and authenticating the individuals who might be calling in to make sure that they’re the type of person they can be sharing information with,” he said.

After Hurricane Harvey struck Texas in August, HHS Secretary Dr. Tom Price waived certain HIPAA penalties, which can range from $100 to $50,000 per violation. Providers would not be penalized for failing to giving out notices of privacy practices, for instance, nor would they be hit for not granting a patient the right to request privacy restrictions.

Meanwhile, other provisions of the HIPAA privacy rule were still in effect, including those that allow providers to disclose protected health information to patients’ families or others involved in their care. Other provisions allow providers to give out protected health information—including to law enforcement—if doing so would lessen a threat to those patients or to the public.

Given those rules, “when you have a shooting, the department has taken the position that a waiver isn’t necessary,” said Marcy Wilder, a privacy and cybersecurity lawyer with Hogan and Lovells, noting that no penalties were waived after the 2016 mass shooting that killed 49 people and injured 58 at Orlando’s Pulse nightclub. “The department wants to be careful here, because if you issue a waiver, that becomes a suggestion that without a waiver, these types of disclosures aren’t permitted,” she added.

Swearingen warns that Las Vegas hospitals therefore need to be cautious. “The hospital, I would hope, in this circumstance is going to be fairly guarded.”

Read More: http://snip.ly/8u7xj#http://www.modernhealthcare.com/article/20171002/NEWS/171009996/las-vegas-hospitals-must-follow-regular-hipaa-privacy-rule

 

What should Entities do to avoid HIPAA fines and penalties?

What should Entities do to avoid HIPAA fines and penalties.jpg

A look at the nature and numbers of HIPAA breaches over just the couple of years makes stark reading: On the one hand, in terms of numbers; 2016, with about 16 million records breached was a pretty good year compared to the previous year, in which about seven times that number, more than 113 million, were breached. But the bad news is that 2016 saw more Covered Entities reporting breaches than in any other year since the Office of Civil Rights (OCR) started publishing its data on healthcare record breaches.

These huge numbers show that not only is there a big demand for these records in the black market -they are in greater demand than even social security and credit cards -Covered Entities and Business Associates need to all that it takes to avoid HIPAA fines and penalties.

What should Entities do to avoid HIPAA fines and penalties4

The federal government has not been lax on this aspect. It is being extremely vigilant about protecting healthcare records. It has been consistently urging the HHS to take a serious view of the increased incidence of cyberattacks that has resulted in medical records theft and has suggested many measures towards ensuring this. The fact that there has been a steady increase in the global spending on cybersecurity-related hardware, software, and services and could reach $100 billion in 2020, according to estimates by the International Data Corporation (IDC), suggests the seriousness with which this issue is being viewed not just in the US, but all over the world.

One of the primary requirements that Business Associates need to comply with is adherence to HIPAA mandates regarding the handling and use of health information. This is spelt out in the HITECH Act, a recent update made to overall HIPAA regulations. It is mandatory for a Business Associate to comply with a wide range of regulatory obligations, which include certain privacy obligations, security standards, and breach notification requirements.

What should Entities do to avoid HIPAA fines and penalties2

However, there is a lot of confusion and misunderstanding among Business Associates about their roles and requirements. They must be completely knowledgeable about all the aspects of their roles, functions and requirements before they enter into agreements of contracts with subcontractors and vendors for their services

Learning about ways of avoiding HIPAA fines and penalties

Jay Hodes, who is President and Founder, Colington Security Consulting, LLC, will be providing thorough understanding of the roles and requirements of a Business Associate and Covered Entities in HIPAA enforcement at a webinar that is being organized by MentorHealth, a leading provider of professional trainings for the healthcare industry. Please visit What should Entities do to avoid HIPAA fines and penalties? to get complete clarity of the ways of avoiding HIPAA fines and penalties.

Clarity on how to avoid HIPAA fines and penalties

What should Entities do to avoid HIPAA fines and penalties1

The aim of this learning session is to help businesses understand what it means to be a Business Associate and know what required safeguards, policies and procedures must be in place or make sure that their current compliance program is adequate and can withstand government scrutiny.

Jay will highlight the importance of being compliant with the HIPAA requirements for an organization if it has to avoid HIPAA fines and penalties. The ways by which a Business Associate or Covered Entity can provide the appropriate patient rights and controls on its uses and disclosures of Protected Health Information (PHI) and what all it has to have in place for doing so, will all be explained.

He will cover the following areas at this session:

  • Why was HIPAA created?
  • Who Must Comply with HIPAA Requirements?
  • What are the HIPAA Security and Privacy Rules?
  • What are the Consequences of being a Business Associate
  • What is a HIPAA Compliance Program for a Business Associate?
  • What is a HIPAA Risk Management Plan?
  • What is a HIPAA Risk Assessment?
  • What is the Role of the HIPAA Security Official?
  • What are HIPAA training requirements?
  • What is a HIPAA data breach and what happens if it occurs?
  • What are the penalties and fines for non-compliance and how to avoid them
  • Case Examples of HIPAA Data Breaches
  • Creating a Culture of Compliance
  • Q&A.

 

 

Hurricane Harvey HIPAA Reminder

Disasters, which can ultimately lead to a data breach, come in various forms – natural, man-made and technical. HIPAA, the HITECH Act, the Federal Trade Commission and the Securities and Exchange Commission are just a handful of entities requiring that the confidentiality, integrity and availability of the sensitive information (e.g., protected health information (PHI) and personally identifiable information (PII)) remain intact. Although federal HIPAA has distinct categories (e.g., covered entity, business associate, and subcontractor), other state or federal government entities use “covered entity” to mean any person that creates, receives, maintains or transmits PHI or PII.

HIPAA sets forth three main categories of safeguards: administrative, physical, and technical safeguards. Often times, these categories overlap. For example, the administrative requirement of a sanction policy compliments the physical requirement of two-factor identification for building access.

Below are a couple of select sections from the Code of Federal Regulations (CFR), which organizations should be particularly vigilant about in relation to disasters.

•45 CFR §164.310 (Physical) – requires that policies and procedures for facility access in order to restore lost data under the disaster recovery and emergency access plan.

•45 CFR §164.308 (Administrative Safeguards) – multiple requirements are set forth under this particular section of the CFR. For example:

•Security management process

•Annual risk analysis

•Information activity review

•Workforce clearance procedure

•Security awareness training

•Contingency plan

 

Read More: http://snip.ly/duepz#http://www.diagnosticimaging.com/blog/hurricane-harvey-hipaa-reminder

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

The Value and Importance of Health Information Privacy

Ethical health research and privacy protections both provide valuable benefits to society. Health research is vital to improving human health and health care. Protecting patients involved in research from harm and preserving their rights is essential to ethical research. The primary justification for protecting personal privacy is to protect the interests of individuals. In contrast, the primary justification for collecting personally identifiable health information for health research is to benefit society. But it is important to stress that privacy also has value at the societal level, because it permits complex activities, including research and public health activities to be carried out in ways that protect individuals’ dignity. At the same time, health research can benefit individuals, for example, when it facilitates access to new therapies, improved diagnostics, and more effective ways to prevent illness and deliver care.

The intent of this chapter1 is to define privacy and to delineate its importance to individuals and society as a whole. The value and importance of health research will be addressed in Chapter 3.

CONCEPTS AND VALUE OF PRIVACY

Definitions

Privacy has deep historical roots (reviewed by Pritts, 2008Westin, 1967), but because of its complexity, privacy has proven difficult to define and has been the subject of extensive, and often heated, debate by philosophers, sociologists, and legal scholars. The term “privacy” is used frequently, yet there is no universally accepted definition of the term, and confusion persists over the meaning, value, and scope of the concept of privacy. At its core, privacy is experienced on a personal level and often means different things to different people (reviewed by Lowrance, 1997Pritts, 2008). In modern society, the term is used to denote different, but overlapping, concepts such as the right to bodily integrity or to be free from intrusive searches or surveillance. The concept of privacy is also context specific, and acquires a different meaning depending on the stated reasons for the information being gathered, the intentions of the parties involved, as well as the politics, convention and cultural expectations (Nissenbaum, 2004NRC, 2007b).

Our report, and the Privacy Rule itself, are concerned with health informational privacy. In the context of personal information, concepts of privacy are closely intertwined with those of confidentiality and security. However, although privacy is often used interchangeably with the terms “confidentiality” and “security,” they have distinct meanings.Privacy addresses the question of who has access to personal information and under what conditions. Privacy is concerned with the collection, storage, and use of personal information, and examines whether data can be collected in the first place, as well as the justifications, if any, under which data collected for one purpose can be used for another (secondary)2 purpose. An important issue in privacy analysis is whether the individual has authorized particular uses of his or her personal information (Westin, 1967).

Confidentiality safeguards information that is gathered in the context of an intimate relationship. It addresses the issue of how to keep information exchanged in that relationship from being disclosed to third parties (Westin, 1976). Confidentiality, for example, prevents physicians from disclosing information shared with them by a patient in the course of a physician–patient relationship. Unauthorized or inadvertent disclosures of data gained as part of an intimate relationship are breaches of confidentiality (Gostin and Hodge, 2002NBAC, 2001).

 

Read More: http://snip.ly/tlhw0#https://www.ncbi.nlm.nih.gov/books/NBK9579/

 

Hipaa—Should I Be Worried?

This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS, Inc.  a manager of medical professional liability insurance programs with services that include risk management consultation, education and onsite risk management audits, and other resources to healthcare providers to help improve patient outcomes and reduce professional liability risk. The answers published in this column represent those of only one risk management consulting company. Other risk management consulting companies or insurance carriers may provide different advice, and readers should take this into consideration. The information in this column does not constitute legal advice. For legal advice, contact your personal attorney. Note: The information and recommendations in this article are applicable to physicians and other healthcare professionals so “clinician” is used to indicate all treatment team members.

QUESTION

I have been hearing about the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for years, but I have not heard of very much enforcement by the government. Do I really need to be concerned about being found liable for HIPAA violations?

ANSWER

Yes. While it is true that the federal government’s enforcement of HIPAA’s Privacy and Security Rules has been limited in the past, this will no longer be true in the future.

OVERVIEW OF HIPAA ENFORCEMENT

Healthcare providers required to comply with HIPAA, a federal statute, are subject to enforcement actions for violations of the Privacy Rule1 and the Security Rule,2 federal regulations enacted under the HIPAA statute. The Office for Civil Rights (OCR), an agency within the Department of Health and Human Services, is responsible for civil enforcement of the Privacy Rule and the Security Rule. OCR can impose civil monetary penalties on covered entities up to $50,000 or more per violation, with an annual cap of $1.5 million for identical violations. The Department of Justice (DOJ) is responsible for the investigation and prosecution of criminal violations of the HIPAA regulations. Under HIPAA, the maximum criminal penalties are $250,000 and 10 years imprisonment.

 

Read More: http://snip.ly/ojh0m#https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552464/

Gauteng Health head office: Sheriff attaches furniture due to non-payment of negligence claim

Gauteng Health head office

Staff at the Gauteng Department of Health provincial head office are without equipment to do their work after the Sheriff of the Court attached two truckloads of furniture on Thursday following a failure by the department to pay court-ordered damages related to a hospital negligence case. By ORATENG LEPODISE.

If you walk into several offices at the provincial health department’s head office at the Bank of Lisbon building in downtown Johannesburg, you are likely to find administrative staff sitting on the floor.

On Thursday the sheriff arrived at the offices and removed two truckloads of furniture from four floors in the building in a bid to force the department to settle payment of a R6.2-million negligence claim awarded against it.

The negligence claim relates to a protracted legal battle between the department and the parents of a child who suffered brain damage during birth at the Pholosong Hospital in December 2009. The seven-year legal battle drew to a close on March 8 with a cost order being awarded against the department.

But it is yet to settle.

“It is a terrible injustice that this case has dragged on for more than seven years, with further suffering for the child and her family, and now the department delays further,” said Jack Bloom, the DA’s Gauteng Shadow MEC for Health.

On Thursday, according to the writ of attachment, the sheriff removed:

• 400 desks;

• 600 chairs
;

• 400 computers;

• 200 filing cabinets
;

• 50 printers
;

• 10 fridges;

• 10 microwaves; and

• three lounge suites

Asked by Daily Maverick to comment on the attachment of its furniture, its impact on the health department staff to do their work and on the department’s failure to pay the negligence claim, department spokesman Prince Hamnca said: “All I am willing to say is that we are concerned that the furniture has been taken from the offices, but that was a court order from the Sheriff.”

“I am appalled that the department has yet again disregarded a court-ordered payment,” said Bloom, while accusing the Gauteng Health MEC, Gwen Ramokgopa, of downplaying the effect of the removal of truckloads of furniture.

An employee at the department and branch secretary of the National Health, Education and Allied Workers Union, Charles Phasa, said the working conditions were “very bad” as everything with any value was taken.

“This is not something new. Every year the sheriff comes in and the department waits until the 11th hour to negotiate some sort of way to cover their payments, but this time around it is just too much,” Phasa said.

According to Phasa the department has urged its workers to be patient while it attempted to address the issue.

The health department finds itself in a pool of debt which includes outstanding payments to suppliers and medical negligence cases and in May this year faced a R10.9-billion funding gap as budgeted funds were all taken up by salaries, accumulated debt and payments for negligence.

Medical negligence claims have increased significantly in recent years. From just over R8-million paid out by the Gauteng Department of Health in 2010/11, almost R154-million was paid out by the same department in 2013/14. Contingent liabilities for medical malpractice (money that the department would have to pay should all medical negligence claimants be successful in their claims) in 2016 in Gauteng sat at over R13-billion.

Bloom said the Gauteng Provincial Government was being destabilised by the endless financial woes of the Health Department, which faces a potential medico-legal liability of more than R13-billion and owes large sums to suppliers as well.

“Delays in payment also add to the costs as a 10.5% penalty interest is charged – in this case, this amounts to more than R300,000,” Bloom said. DM

Photo: Gauteng premier David Makhura speaks at a Gauteng township economy revitalisation summit in Soweto, Tuesday, 7 October 2014. Picture: Werner Beukes/SAPA