​Many times, people are unaware of the effects of drinking alcohol and fruit juices while on medications. 

Certain medications such as anti-depressants, anti-blood pressure, anti-diabetics should never be mixed or consumed along with alcohol (not even 1-2 social drinks). Similarly, certain anti-blood pressure medicines and antibiotics should never be consumed along with fruit juices especially grape-fruit juice. Why so? There are three main reasons: 

Firstly because many drugs inherently interact with alcohol and/ or fruit juices (including natural juices). In technical terms this is called as drug-food interaction. What this means is that, the drug’s behavior on a patient’s body changes and it may not show the desired beneficial effect or cure. This is called In other cases, it may also show single or multiple adverse effects including vomiting, head ache, flushing, paralysis or even death.

Secondly, if a patient takes multiple medications (including vitamins and supplements), consuming alcohol or fruit juice along with medications can lead to potential drug-drug interactions inside a patient’s body. This can aggravate effect of one drug while minimizing effect of other drugs, producing toxic effects of one drug while the other drugs show no effect at all !  

Thirdly, if a patient takes a ‘Time Release” medication, consuming alcohol along with such medications might prove to be fatal. 

A time-release medicament is a hi-tech product. It typically contains 2 or more doses of the drug (or medicament) in a single tablet or capsule, which is programmed to automatically release appropriate drug doses at programmed time intervals. Alcohol damages this programming and the patient gets all doses in one go, scientifically referred to as ‘dose dumping’. And the adversity of toxic effects as a result of dose-dumping, will directly be dependent upon the extent of dose-dumping and may include headache, vomiting, skin rashes, difficulty in breathing, loss of vision, memory loss, paralysis and death. Since, each person’s body reacts differently to alcohol initiated dose-dumping, it is absolutely impractical to predict severity of adverse effects. 

Synonymous time-release formulations include- Extended release (ER), Modified release (MR), Controlled release (CR), Sustained release (SR), Prolonged release (PR), Delayed release (DR) etc. 

Time-release medications are available both as Prescription (for example Sedatives, Marijuana, Antidepressants, Opiates, Anti-diabetic, Anti-blood pressure, Antibiotics etc.) as well as Over- the-counter (OTC) products (such as Cold, Flu, Anti-allergy, Aspirin, Pain remedies etc). 

Regardless of the medicament being regular or a time-release product, if you take prescription or over-the-counter medications, ask your health care provider for advice about alcohol, fruit juice intake. An important point to note is that even herbal medicines and supplements can have adverse interactions with alcohol and/or fruit juices.

Such information about a particular drug product's potential interaction with alcohol, fruit juices, or any other hot or cold beverage can be displayed on the pharma manufacturing company's website. This is an un-met opportunity in Continuous Improvement of patient engagement process. 

Disclaimer- Readers are advised to please note that, the information contained in this article is NOT a substitute for medical advice. It is intended to empower general public to understand the pharmaceutical world and consider ideas and alternatives while discussing their specific health scenario with medical and pharmaceutical professionals. Please discuss your specific scenario with a qualified Medical Doctor and ONLY follow health advice given by a qualified medical professional. Also, please note that each country has its own health care related regulation(s), readers are therefore expected to over-ride any information presented here to adhere to rules of their land.

These PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.  

The batch of 69 PSGs includes:  

• 26 new and 43 revised PSGs.
• PSGs for generic products for important treatments for diseases such as: Human Immunodeficiency Virus (HIV), Leukemia, Opioid Use Disorder, Post-Partum Depression. Read details about the guidances here.

​
This requires pharmaceuticals and allied organizations to keep pace and revisit their Kaizen strategies around the products impacted (if at all) by the above regulatory changes. 

​There are eighteen top business improvement techniques- Kaizen being the most propitious. 

Kaizen has its origins in Japan and is one of the most promising business improvement tool for pharmaceutical, medical device and biotech companies. It can be implemented in innovator as well as generic pharma set ups.

Moreover, Kaizen works equally well with at-site and remote operations. 

Kaizen involves making small improvements at all levels within a product’s lifecycle. These incremental changes then bring-on exponential benefits such as-  
​

1. Good quality affordable medicines.
2. Lower operational costs.
3. Error-free processes.
4. Increased safety, productivity.
5. High speed product development and
6. First-to-file.

Kaizen is based on cooperation and commitment (vis-à-vis radical or top-down changes) where employees at all levels of a company work together proactively to achieve regular, incremental improvements. Kaizen thus combines the collective talents within a company to create a powerful engine for continuous business growth. 

To learn more on how Kaizen can help your organization successfully drive thru the rough patch posed due to Covid-19 check here. 

To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp
​
​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
#ContinuousImprovement   #Innovation  #LeanSixSigma

A few years ago, I was approached by a CEO of a pharmaceutical contract research company to turnaround his sick unit into a profitable enterprise. This company was dealing with the development of solid oral dosage forms. To bring about the necessary change, we initiated several Kaizen campaigns companywide, with 360 degrees focus to overhaul all processes and operational systems. We addressed all key areas across the organization including accounts payable/ receivable, material procurement, order processing, suppliers, R&D, scale-up, production, logistics, product dossiers filings, project management, business development, sales & marketing and PR communication processes.
 
Another key area where Kaizen helped us in a big way was to integrate various client information data sets maintained within different databases on separate systems.​

​At the end of nine months, this company’s books started showing profits, and from there on, it kept going from ‘good to great’. It was an excellent example of a successful transformation.
 
Unfortunately, this contract research company is not alone in the challenges it has faced. Studies indicate that 88% of business owners in North America struggle to maintain consistent cash-flow. Key questions to consider are:

• Can your organization benefit from increased workplace productivity?
• Does your team face challenges with reduced R&D budget?
• Does your organization face challenges because of inconsistent or poor cash-flow?
• Do you need to cut corners as you are forced to do more with less?

 
If you answered ‘yes’ to any of the above questions, then Kaizen should be your mantra…​

​This book is a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device, and biotech companies.
 
It is an invaluable resource, an essential tool for all professionals within the pharmaceutical, medical device, biotech organizations i.e. all life sciences and health care companies, interested in employing Kaizen in their workplaces and their personal lives. This book will also facilitate running Kaizen in a manufacturing company and do it at a world-class level.

​This book doesn’t simply explain Kaizen process features, implementation, and application. The scope of this book is much wide.  

This book is meant for small to medium-size pharmaceutical, medical device and biotech research, manufacturing and contract services companies. This book is to-

• Demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech, and all life sciences organizations, irrespective of their size or workplace culture.
• Apply Kaizen to what really matters, that is, ‘to achieve business expansion along with increased productivity and profits’.  
• Provide practical and useful examples of Kaizen principles that can be executed at various levels: across the organization; within a specific department, business unit or team, as well as for yourself as an individual to further your personal career.
• Improve revenues and create a lasting change using Kaizen principles and techniques.​

Some salient features of this book

• It shows pharmaceutical & biotech scientists, design engineers, operators and everyone involved in product development, how to utilize Kaizen- to create innovations, shorten product development times, improve first-to-file rates, conduct successful scale-up and technology transfer to manufacturing sites.

 

• It shows everyone associated with manufacturing, how to use Kaizen to decrease cycle times, work-in-process & quarantine inventories, the cost of distribution & logistics, improve equipment efficiency, facility capacity utilization and shift output.

 

• It shows everyone in Human Resources how to use Kaizen to minimize employee turnover, hire and retain talent, and motivate employees to create a difference.

  

• It shows the company’s senior management, stakeholders, finance and other supporting business units, how to use Kaizen to increase ROI (return on investment) while complying with cGMP (current Good Manufacturing Practices) and other regulations, address rising competition and counteract fluctuating market economy.

 

• This book presents useful ideas that one can implement immediately, often at no additional cost.

 

• It shows how to transform a business from ‘good- to- great’. True benefits of Kaizen implementation are realized because, it adds value to your products, increases market share, and drives both top line and bottom line of your business.

 
Kaizen has mainly been used in Japan and many other SE Asian companies and in Europe. Up until now, it has not gained enough significance in North America, because of which it has not been utilized to its full potential. The root cause is the difference in work culture and corporate governance styles of companies in eastern and western countries; this book totally eliminates this gap.​

In addition, this book is an excellent resource for Kaizen beginners with a lot of real-life industry examples, case studies and provides several ‘do-it-yourself’ exercises, which is of tremendous value, in absence of a Kaizen coach.


Chapter 1:
 
Pharmaceutical industry growth unlike few other industries viz. retail, banking etc. is not completely determined by ‘value’ it brings to its customer. Frustrated customers can easily walk out of a shop and get their product from some other place. In contrast, pharmaceutical products are unique in the sense, the customer (i.e. patient) doesn’t usually have much say in its purchase. Patients usually buy medicines their doctors prescribe or pharmacist dispense (until such time they don’t experience any adverse effects). For the medicines where adverse effects are well-known or documented on the product label, patients really have no choice but to take bitter medicine (pun intended).
 
Also, a patient on a prescription drug may not always have the option to change medication or brand, because of lack of competing brands due to enforced Exclusivity and Patents laws. Even with the advent of generic medicines which offer price benefits, many patients don’t prefer to change the pill they have been taking over the years.

Moreover, Kano’s model may not strictly apply to Life science industries, because unlike other products, a drug product if not proved safe, efficacious and stable, will just not make it to the market. And this applies to all medicinal products- be it Rx (prescription), OTC (over the counter), medical devices etc.​

Pharmaceutical, medical device, and biotech companies are always under federal drug authorities radar for compliance to standards. The very existence of pharma business is based on meeting compliance- be it cGMP, safety, therapeutic efficacy, quality etc.
 
As federal drug regulations change, companies must upgrade to stay in business. Hence, there is an indirect continuous improvement happening all the time. This is probably one of the reasons why the majority of life science companies have not really attempted formal business process improvement methodologies.
 
However, Kaizen is not simply a business process improvement technique. Kaizen doesn’t just focus on cost-cutting or quality improvement. Kaizen is a way of life; of becoming ‘better’ every day; of becoming better than the best- consistently, and taking your business from being good to great with its products, market share, governance, and most importantly, Good to Great with PROFITS!
 
Let’s begin with what is Kaizen?
 
The name ‘Kaizen’ is an adaptation of the Japanese term that stands for continuous improvement. In Kaizen technique, it is believed that employees need to be empowered to enhance various processes of the company. Kaizen utilizes some of the Lean methodology philosophies to plan, implement and evaluate changes in a variety of roles. Kaizen must be integrated into a company’s daily operations to achieve maximum benefits.
 
Kaizen hails from the words, "Renew the heart and make it good." Therefore, an adaptation of Kaizen concept requires changes in the "heart of the business", corporate culture and structure; since Kaizen enables companies to translate the corporate vision in every aspect of its operational practice.​​

Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.
​

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
 

#DrShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #ProcessExcellence  #ContinuousImprovement #Kaizen  #QualityImprovement  #Innoworks  #Innovation  #Quality  #eLearning  #Business  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeScience  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #ShiftingParadigms #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  #Kanban  #FMEA  #RiskManagement  #Speaker  #KaizenTrainingAcademy

To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact ​Dr. Shruti Bhat via Form or WhatsApp

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
#ContinuousImprovement   #Innovation  #Audit  #USFDA 

​To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​#ContinuousImprovement   #Innovation  #Kaizen  #Kanban  #ProductDevelopment

To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​#ContinuousImprovement #Innovation #BusinessTurnaround #Kaizen #JustinTime #HoshinKanrii #QbD #DOE  #Lean