Virtual healthcare has to be understood and used for what it can offer

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.

Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual technology has also been in widespread use in areas like education and for monitoring remote workers in many organizations. Virtual healthcare can be seen as a natural extension of these uses of technology.


Understanding the dynamics of virtual healthcare

Healthcare analysts are quite upbeat about the growth prospects of virtual healthcare, making prognoses about its explosive potential growth, with estimates ranging from a size of well over $3 billion by 2022 to much rosier, nearly $14 billion for video consultation alone by 2018. While time will tell whether these forecasts will be fulfilled, we need to understand this tool and its prospects and pitfalls.

When adapting virtual healthcare, patients and healthcare providers are likely to use virtual healthcare in these ways:


This should rank as the most important element of virtual healthcare. Virtual healthcare itself would come to be of no use if it did not offer the patient the opportunity to interact with the patient remotely. Patients are likely to use technologies in the form of tablets, smartphones and other personal devices to consult physicians.

virtualHealthcareConsultation is a very important component of virtual healthcare and it goes beyond just obtaining billing and other information that is usually a part of an Electronic Health Record (EHR). Virtual healthcare aids in direct, non-physical contact between the patient and the healthcare provider, which is what this medium primarily seeks to facilitate.

This feature is all the more useful in situations where the patient may not be in a condition to travel to the healthcare provider or where patients with long-term ailments need to be monitored on a regular basis without having to visit the hospital.



EHR could be another major component of virtual healthcare. Following the passage and implementation of Obamacare; the EHR has become a very important document for people seeking healthcare. Virtual healthcare can bring in a new dimension to EHR by enabling documentation and recording of important events in the physician-patient relationship.

Drawbacks of virtual healthcare

While there is no doubting the fact that virtual healthcare is set for major growth; it is important to understand its inadequacies. The most important disadvantage of virtual healthcare is that it is best suited only for noncritical healthcare situations. It may help patients with long term ailments, as mentioned above, but can help only when the patient has reached a stage where all treatments are done and only resuscitation or convalescence is needed. For a patient requiring immediate attention in an emergency, virtual healthcare is not likely to be very effective. Thus, a patient seeking medical information or advice for a viral infection is far more suited for virtual healthcare than a patient in need of CPR.

The uses to which virtual healthcare can be put are limited, at least at this stage of its development. When this technology advances enough to be able to offer healthcare in all situations and for all kinds of ailments; it will become a more effective medium. Till then, virtual healthcare has to be understood and used for what it can offer.


Good Documentation Practices Relating to USP

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.

US Pharmacopeia (USP) has laid out a series of GDP’s. One of the major new updates is contained in the newly proposed USP-NF General Chapter <1029>.

Basis for GDP in USPGDP for USP is also formulated on the same principle and rationale on which any GDP is built: proper, accurate and comprehensive records are the backbone to proper documentation, which is the basis for all major and minor procedures and operation.

GDP for USP has guidelines in the General Chapter 1029. These guidelines are given with the intention of helping build a foundation for the Quality Systems, apart from also ensuring the integrity and control of documents.

These GDP’s are meant for use in the production and control of the following:

  • Active pharmaceutical ingredients (APIs)
  • Medical devices
  • Excipients
  • Pharmaceutical products
  • Dietary supplements
  • Food ingredients

The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.

In what areas are GDP’s listed out in Chapter 1029?GDP’s for USP are mentioned in relation to electronic and paper records, which include reports, raw data, protocol, and procedures concerning analytical data and manufacturing controls, and has recommendations on the kind of information that should be recorded for different kinds of documents that require GMP. A prominent amendment brought into the new chapter 1029 is that there is no longer a distinction between instructions and records, and all records and instructions are broadly merged into “records”.

Some broad requirements of GDP as set out in Chapter 1029USP Good Documentation Practices spell out a number of principles. Some of these include:

  • There should be clarity, accuracy, conciseness and legality of records
  • Every time an action is performed, there should be a documentation
  • Anyone dealing with documents should not backdate or postdate any action
  • The initial of the person who carried out a change should attest her initials and offer an explanation whenever an amendment is made

Electronic or manual records should go by the following GDP’s:

  • Any data entry should be traced back to the person who did the entry
  • Shorthand notations are not allowed
  • Controls should be put in place to ensure integrity of the record
  • When a thermal paper is used, a verified copy of its accuracy should be retained, and the user should initial it with the date

The EU’s Pharmacovigilance Directive

Pharmacovigilance is a major public health initiative of the EU. It is aimed at reducing the risk attendant in any part of the production, marketing and supply chain of medicinal products. Monitoring is done not only before the medicinal products enter the market; it is done at every stage after, too.

The aim of putting a strict vigilance regimen is to help detect any aspect of a medicinal product that could compromise on its safety. This whole system of monitoring is called pharmacovigilance.

The EU’s Pharmacovigilance Directive is the legal structure that spells out the objectives and implementation plans for the EU’s pharmacovigilance system. The Pharmacovigilance Directive is part of the EU’s efforts to enforce very stringent assessment of all medical products for their safety, quality and efficacy before they become authorized.

Regulation on all areas of medicineIn essence, the Pharmacovigilance Directive lays out the conditions and rules by which medicinal products have to be marketed within the EU and beyond. It prescribes the manner in which products have to be manufactured, labelled, marketed, recalled and destroyed. The Pharmacovigilance Directive, which applies to products for human use, bans any medicinal product that is not authorized by any member state of the EU from being marketed.

The review of 2010The Pharmacovigilance Directive underwent a major revision in 2010, by which a new legislation came into effect. The legislation passed that year further fortifies and streamlines the system relating to the safety of medicines that enter the European market.

The Pharmacovigilance Directive of 2010 strategizes areas relating to preventing, detecting and assessing of adverse reactions in patients to ensure improved patient safety and with it, public health. One of the major features of this amendment is that patients are empowered to directly report adverse drug reactions to the designated competent authorities. Another important aspect is that the definition of an adverse reaction has been widened to include issues like overdose and medication errors.

Important features of the Pharmacovigilance Directive of 2010The Pharmacovigilance Directive of 2010 seeks to take concrete steps to enhance its core objectives of patient safety and public health. It is built on these foundations:

  • It puts in place a robust, proportionate and proactive risk management regimen
  • It enhances safety data quality
  • It strengthens the link between safety evaluations and actions from regulatory authorities
  • The Pharmacovigilance Directive of 2010 has led to greater communication, transparency and patient involvement
  • It assigns clear-cut responsibilities and tasks for everyone concerned
  • It facilitates the decision-making apparatus within the EU
  • The Pharmacovigilance Directive of 2010 has established The Pharmacovigilance Risk Assessment Committee, a new scientific committee to be based at the European Medicines Agency (EMA).

Pharmaceutical Water Systems have to be Designed with a Lot of Common Sense

The effectiveness of a pharmaceutical water system depends on its design. The design is the soul of the system. Any pharmaceutical water system design should come equipped with the ability to serve its most basic purpose, which is to help the pharmaceutical organization meet the set quality.

The importance of water can never be overemphasized. Apart from the emotional, spiritual and cultural value it has; water also enjoys a position of complete primacy in the field of pharmaceuticals. In being used for anything from production to processing to cleaning to formulation to Quality Control water is the most widely used and critical substance in the pharmaceutical industry. Its varied grades are used in nearly all stages of the pharmaceutical manufacturing process.

Designing pharmaceutical water systems properly is of great importancePharmaceutical water systems thus acquire extreme importance for this reason, because inefficiency or ineffectiveness in the system could lead to faulty final products, which can affect the lives of individuals, apart from causing harm to the reputation of pharmaceuticals companies.


What are the principles of pharmaceutical water systems design?

  • Ensuring the pharmaceutical water system operates within its capacity is the first principle of pharmaceutical water systems, because any underutilization or overutilization of capacity can affect the quality of the water system
  • Working in tandem with Quality Assurance allows approval of use after installation and subsequent maintenance. A sound pharmaceutical water system has to enable this
  • The entry at any stage, be it production, storage or distribution, of unacceptable chemical, physical and microbial contamination should be prevented at all costs
  • An effective pharmaceutical water system should ensure consistency and reliability in the quality of water production
  • An effective pharmaceutical water system should help commission, install, qualify/validate, operate, perform and maintain itself. Making all these aspects of the water systems industry happen is a core characteristic of pharmaceutical water systems.
  • Pharmaceutical water systems must facilitate the easy and regular monitoring of chemical, microbiological and endotoxin levels in water sources.

Statement from FDA Commissioner Scott Gottlieb, M.D.,

Some of my most important time as Commissioner is spent speaking directly to patients and their families about significant health issues that affect their lives, from the devastating opioid crisis to the current flu season. Overseeing a wide array of medical products, the U.S. Food and Drug Administration plays a vital role in providing consumers with up-to-date, evidence-based information to help them make the most informed medical decisions. The products we regulate touch people’s lives in meaningful ways.con-con-1

Last month I had the opportunity to meet with consumers who have been affected by the medical device Essure to listen and learn about their concerns. This device is used as a method of permanent birth control. The product’s manufacturer, Bayer, estimates that more than 750,000 women worldwide have received the device implant since it was first approved by global regulatory authorities. Some of the women I spoke to went on to develop significant medical problems that they ascribe to their use of the product. As a physician, I know that patients are uniquely positioned to provide feedback to the FDA about their experiences with currently available medical products, and I appreciated the thoughtful discussion. Ensuring the safety and effectiveness of medical products is paramount to the FDA and a core part of our consumer protection role. The FDA takes concerns about Essure very seriously.

I would like to outline the steps we’ve taken, to date, regarding this product, and the additional steps that are underway. I also want to reiterate my commitment to regularly communicating with patients and physicians about this device as more information is made available and additional steps are taken.

Since Essure’s approval in 2002, the agency has continued to monitor the product’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. We convened a panel of medical experts in the fall of 2015 to provide us with advice on how we could better understand concerns about the device, such as patients who experienced abdominal pain, abnormal uterine bleeding and device migration.

In February 2016, we ordered the manufacturer of Essure, Bayer, to conduct a postmarketing (522) study to better evaluate the safety profile of this device when used in the real world. We also required a boxed warning to be added to the product labeling as well as a Patient Decision Checklist. The aim is to help make certain that a woman considering Essure receives and has full access to information about the benefits and risks of this type of device prior to undergoing treatment with this product.

As part of the FDA’s ongoing efforts to monitor Essure adverse events, we continue to review medical device reports submitted to our public database and provide updates about our ongoing analysis of the reports on our website. At the current time, the FDA is actively evaluating a significant collection of new medical device reports submitted to FDA on the Essure device. Of the nearly 12,000 reports received in 2017 for Essure, the majority were sent to the FDA in the last quarter of the year.

Detailed Statement enhanced here

ICH Q10 -the ICH’s Pharmaceutical Quality System

The purpose for which the International Conference on Harmonization (ICH) has issued wide-ranging in ICH Q 10 guidelines is that they help individuals and organizations in the pharmaceutical industry avoid duplication of their work, especially in pharmaceutical research and product registration.

ichQ10PharmaceuticalQualitySystemReduction of double work is the important purpose

Putting in place greater harmonization in the area of pharmaceutical product registration by interpreting and applying technical ICH guidelines was the aim with which the ICH was launched in 1990.

The harmonization the ICH Q 10 aims to bring about seeks to reduce and possibly eliminate repetition of testing and reduce double work of research and development of new human medicines. It uses extensive guidelines to achieve this. These guidelines are given for all areas of ICH Q 10.

Quality Guidelines:

Related to the Quality area; these guidelines include crucial milestones such as doing stability studies, defining appropriate limits for impurities testing, and evolving a malleable approach to GMP risk management based pharmaceutical quality.

Safety Guidelines:

Relates to the safety aspect of carrying out research in the carcinogenic, genotoxic and repro toxic areas, which carry a high risk of danger.

Efficacy Guidelines:

To ensure efficacy in research, ICH guidelines cover areas such as the conduct, design, safety and reporting of clinical trials. Efficacy guidelines also include biotechnological processes and pharmacogenetics or genomics techniques, which are aimed at producing medicines that target disease better.

Multidisciplinary Guidelines:

These are guidelines are for areas left out of the Quality, Safety and Efficacy Guidelines. Core elements of this area of ICH Q 10 guidelines include ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

When coliform bacteria are detected in drinking water

For over a hundred years, the western world has used coliform as a method of testing water contamination. A quick understanding of this method of testing the level of water contamination:

Coliforms belong to a broad class of bacteria. These bacteria are found freely in our environment. The feces of humans as well as other warm-blooded animals are a source of these bacteria. Coliforms are primarily used as a method for indicating water quality. When coliform bacteria are detected in drinking water; it may be indicative of the potential presence of other harmful, disease-causing organisms. The belief is that wherever coliform bacteria are present, there are chances that other more harmful bacteria could reside with them.


Used as a first step

Pathogens, or disease causing organisms -namely virus, bacteria and protozoa -have to be eliminated from water, or they could cause a range of waterborne diseases such as dysentery, hepatitis, and giardiasis and related ones.

Since it is difficult to physically test every sample of water for specific harm-causing bacteria, protozoa and viruses, testing water for coliform is considered. This makes sense, because it is easier to further test samples that have coliform than to test every sample.

Laboratories have been adapting this method because this is relatively much, much less expensive and less time consuming to implement this method rather than look for every specific pathogen.

Moreover, most laboratories are ill equipped to handle mass testing of huge samples of water. Coliform as a method of testing water contamination is thus a useful tool, because it prevents the incurrence of huge expenses.


Effectiveness of coliform as a method of testing water contaminationThe practical advantages of using coliform as a method of testing water contamination notwithstanding; its effectiveness is open to debate. Some scientists believe that this method is too antiquated. Later methods have been proven to be more effective methods. The Environmental Protection Agency (EPA) for instance, draws up plans for containing water contamination from time to time. Using coliform as a method of testing water contamination is just one small part of these. The agency looks more to methods such as addressing contaminants as groups, which is believed to be more effective. It encourages the development of new technologies that tackle contaminants better, faster and more economically.

However, it is too early to say if these developments will signal the discontinuation of using coliform as a method of testing water contamination in the near future.