Analyisis | Pharmacy Consulting Supporting Primary Healthcare Tue, 13 Mar 2018 10:57:39 +0000 en-GB hourly 1 FDA crackdown on illegal meds Sun, 19 Jul 2015 12:56:51 +0000 In May, the FDA in conjunction with international law enforcements agencies enforced a major crackdown on illegal and crackdown medications with action taken against 1,050 websites.

Seized products were found to have originated in India, China, Hong Kong and Singapore.  Medicines seized included antidepressants, hormone replacement therapies, sleep aids, erectile dysfunction medications and anti-cholesterol medications.  Devices included colon-care products and dermal filers.

Coming from this, the FDA is also providing information on how to identify illegal medication and pharmacy websites via an initiative entitled “BeSafeRx: Know Your Online Pharmacy.”

On the back of this investigation, the MHRA inspected more than 150,000 packages and announced a haul of 15.8 million pounds worth of illegal medications and devices.

Would your pharmacy and/or wholesale staff know how to identify counterfeit/illegal medications?

Are you at ris? And how can you mitigate?

]]> 0
The revamp of the TGA Sun, 19 Jul 2015 12:55:52 +0000 The Therapeutic Goods Administration (TGA) are aiming to remove unnecessary duplication in assessing therapeutic goods in Australia where they have been approved elsewhere in the world.  New assessment protocols will allow changes to streamline the process and use global examples as a precedent.

The move is expected to streamline access in Australia to new medicines and devices after research showed that many Australian patients waited up to 15 months compared to Europe and the USA as many drug companies delayed bringing their business to Australia.

The move makes sense to the industry and with patient care at the heart of the decision it comes as a win for many Australian patients.

]]> 0
Boots and global pharmacy Sun, 19 Jul 2015 12:55:03 +0000 News made it here to Australia over the 700 job cuts imposed within the Boots head office and support network noting that the job cuts will not be coming from within any retail locations.  This news follows the Boots merger with US chain Walgreens and whilst not affecting retail locations one must be sceptical as to how long retail jobs will be safe.

While the merger is a first step towards a global pharmacy-led chain ongoing pressure of on continued profitability will most surely squeeze the labour markets and pay rates within Boots retail locations.

Is this a reality?

Will the knowledge of the 700 redundancies be picked up within the industry? Is the industry keeping its best people?

How will the merger play out? Is it a step in the right direction for pharmacy?

Or a further corporatisation of what was once a health advisor led profession?

]]> 0
Regulations in Australia and real life examples Sun, 19 Jul 2015 12:52:29 +0000 The community pharmacy industry remains heavily regulated in Australia as most of us in the industry believe it should be.  In every case, rules are there for a reason and though we know the rules sometimes some of us simply ignore them.

Here in Australia, the Victoria Pharmacy Authority (VPA) recently released the following details from recent cases.

  1. A pharmacist was cautioned for failure to comply to good pharmaceutical practice; the dispensary was not maintained as a private area with medicine privacy not being maintained. The dispensary was in fact being used to store staff belongings (near to medicines) and a staff meals area.
  2. A pharmacist was reprimanded and ordered to submit quarterly audit for poor record keeping in relation to Schedule 8 drugs and incorrect procedures in use for the disposal of unwanted medicines.

Whilst both cases seem minor in nature the outcomes remind us why a pharmacy needs to follows regulations and have suitable procedures in place.  Both cases could easily have been avoided with better management and strict coherence with the regulations.

No matter where you are in the world in the pharmacy industry the regulations are in place to maintain patient safety and to ensure the effective delivery of health solutions. Be diligent, vigilant and committed to best practice so we don’t need to hear cases such as the above!

]]> 0
Before you REACH for your CHIPS get the SDS Wed, 01 Jul 2015 11:57:39 +0000 In a recent case a supplier of biologically active products for clinical trials was reported to the HSE for not supplying Safety Data Sheets (SDS) to their client.

Under the CHIP or Chemicals (Hazard Information and Packaging for Supply) Regulations 2002, suppliers are responsible for identifying the dangers of the chemicals they supply to enable users to take the necessary measures to protect human health and the environment.

In addition to providing hazard information on the label, suppliers have to supply more detailed documentation in the form of a Safety Data Sheets which lists key information including how to handle the product in case of damage / spillage.

The CHIP regulations were replaced by REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) the system for controlling chemicals in Europe. This became law in the UK on the 1st June 2007.

REACH has retained the old system regarding the issue of Safety Data Sheets.

In the UK, suppliers are EXEMPT from providing Safety Data Sheets if:

  1. If the substances/mixtures are supplied in the UK and not classified as hazardous or considered to be substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) (e.g., endocrine disruptors).
  2. For certain products intended for the final user, e.g. medicinal products or cosmetics.

As well as receiving chemicals you may supply them to others.

If you are dealing with hazardous products you should ensure your internal processes do not allow you to book in the products on to your system until you have received the Safety Data Sheets.

Your supplier need only supply you this document initially. If sell the products on, you must pass on information (as Safety Data Sheets) to those whom you supply including your logistics provider who will be handling the goods.

]]> 0
Internet Pharmacy: Display the Logo or Face a Jail Sentence Thu, 18 Jun 2015 15:33:41 +0000  

EU Logo

Mandatory Logo of Internet Pharmacies in the EU









As more and more of us are going online to purchase medicines there has been a worldwide growth in the number of internet pharmacies selling counterfeit (falsified) medicines. Oftensuch medicines are harmful as they may be substandard, not contain the correct active medicine or worse contain harmful ingredients.

In an attempt to stop the trade in falsified (counterfeit) medicines within the EU, all online pharmacies will be required to display the new EU logo from the 1st of July 2015.

The logo incorporates the flag of the member state in which the pharmacy is registered and is linked to the national competent authority so that the buyer can click on the logo and ensure they are dealing with a certified pharmacy. In the UK the logo will be hyperlinked to the MHRA.

Internet pharmacies are required to display this logo on every page of their website

It should be noted that the EU common logo is a legal requirement, unlike the GPhC logo which is voluntary.

The penalty for selling medicines online without being registered and not displaying the logo is up to 2 years in prison or a fine or both.

You can register your internet pharmacy on the MHRA portal

]]> 0
Free Online Course to Disaster Fri, 12 Jun 2015 14:21:05 +0000 Yesterday I had a call from a distraught pharmacist who desperately wanted to know how to go about growing his new pharmaceutical wholesaling venture which he had set up with a friend.  Our conversation went as follows:


Caller: “We have applied for a MHRA wholesale licence to distribute pharmaceutical medicines but I are not clear on who we can supply or how and whom to procure product from”

Me: “Have you taken a course outlining the principles of good distribution practice and the legislation which was introduced not long ago”

Caller:“No, I haven’t but my friend has completed a free on-line course”


It wasn’t long into our conversation by which time the caller realised the vast gap the duos knowledge.

After our conversation, I decided to check out what free GDP courses were available on the web and I was surprised to find several.

These free on-line courses have a common theme. They are all similar in content with the current legislation presented on a series of slides. And, of course as with all things free, nNo guidance, no feedback and no interaction is offered.

The Latin phrase ‘Caveat Emptor’ meaning ‘Let the buyer beware’ comes to mind, although technically such courses are free.

There is no substitute for face to face training . It is a powerful dynamic process if facilitated correctly, as students interact with fellow students and the trainer.

It also provides a medium through which experiences can be shared, questions asked and knowledge gained. In addition recall and retention rates are higher.


At Pharmacy Consulting we offer a  number of flexible training courses facilitated by experienced trainers, including:

  • Good Distribution Practice
  • Responsible Person Training
  • Audit Training
  • Distance Selling Pharmacy

Up to date availability and dates can be found in the Training Calendar on our website.

]]> 0
The ongoing role of pharmacy Tue, 26 May 2015 16:59:31 +0000 As the government and community pharmacy industry now have a “letter of intent” in regards to the Sixth Community Pharmacy Agreement it is time for the other health professions to take their shot.  Whilst we are continually hearing the pressure that doctors, nurses and health care providers are under surely then the move to move some services to a pharmacy level would be welcomed.

Not the case.

The Australian Medical Association have noted that pharmacists “… are not doctors. And they shouldn’t try to be.”

The nurses’ union are also upset that pharmacists are undertaking additional training to take on roles of other health professionals.  i.e. nursing and wound care

The Pharmaceutical Society of Australia have since responded noting that pharmacies are highly regarded worldwide as a cost-effective source of care within the health-care system.  They also note that using pharmacist skills will allow them to target any gaps within health care especially in rural and remote areas.

Again, personally, I’m not sure why health professionals can’t work together and provide a broader level of care.  I guess sometimes the professions forget about the most important group in the equation; the patients.

Will they ever get along? Or is this just protecting the patch?

]]> 0
Pharma Reputation Tue, 26 May 2015 16:56:44 +0000 Bayer is the most recent winner of the reputation stakes according to a survey conducted by The Reputation Institute.  The German company has maintained its position at the top for the fourth year in a row.

Roche, Abbot, Lilly and GSK in that order followed Bayer.

Data was collated across 15 countries and 61,000 general public members over February and March of this year.  Companies were ranked on reputation, products & services, innovation, workplace governance, citizenship, leadership and financial performance.

Of the companies in the study, Novo Nordisk and Novartis were those shown to have declined in reputation.

Interestingly enough and found in the conclusion of the study, the reputation of global pharma is mixed with 34% perceiving the industry as having an excellent reputation.  Also, it seems those in Russia, Australia and the US remain positive and have scored the industry as strong/robust compared to other countries who scored the industry lower.

]]> 0
24/7 Pharmacies Tue, 26 May 2015 16:54:12 +0000 The Victorian State Government in Australia has committed $28.7m over the next four years to fund the establishment and running of 20 super pharmacies.  The pharmacies will operate 7 days a week 24 hours a day and will employ a nurse to be on hand from 6pm to 10pm for advice and services.  There are 20 funded sites with 15 located within Melbourne and 5 in rural areas.

The move aims to reduce the pressure by providing an alternative to emergency care services.

The Pharmaceutical Society of Australia has welcomed the move whilst the Australian Medical Association has provided significant critique.

Personally, I feel this is a step in the right direction from both the Victorian government and the pharmacy sector.  With pharmacies being located in prominent retail areas such super pharmacies may in fact become central to healthcare in the community.   Obviously the results will be reviewed in time with expansion of the program to more sites being a long-term goal.  The allocation of an evening nurse also adds an element of care that, whilst seemingly suitable, has been trialled only lightly.

Would you attend a 24-7 pharmacy instead of Emergency Care?  Do you trust a nurse and pharmacist to deliver health advice out of hours?

]]> 0