Pharmacist jailed for illegal sale and supply of prescription medicines

 

A pharmacist was sentenced at Birmingham Crown Court today to twelve months imprisonment for selling hundreds of thousands of doses of addictive prescription drugs onto the black market. The medicines were sold at a huge profit during 2016 and 2017. The value of these medicines on the black market is estimated at over £1 million.

 

The pharmacist, 36, worked at his mother’s pharmacy in West Bromwich and made over £59,000 from the Class C drugs.

 

Following an investigation led by the Medicines and Healthcare products Regulatory Agency (MHRA), investigators and partners from West Midlands Police visited the pharmacy. Records found on the premises showed that of hundreds of thousands of doses of diazepam, nitrazepam, tramadol, zolpidem and zopiclone purchased from wholesalers, only a small percentage had been dispensed against prescription.

 

This left more than 800,000 pills unaccounted for that the pharmacist later admitted he had sold to drug dealers.

 

The investigation began following allegations that the pharmacy was selling large quantities of prescription-only medicine without a prescription. When contacted about the investigation by the General Pharmaceutical Council (GPhC), the pharmacist pretended to be his mother and said he was “shocked and blindsided” by the accusations. He then went on to provide falsified evidence intended to disprove the allegations.

 

While the pharmacist has admitted to the charges, he claims that after initially making a voluntary sale to drug dealers he was then forced to sell further medicines after he was threatened outside of his pharmacy. He has refused to provide any information on who these people were or who he sold to.

 

The pharmacist was suspended from the GPhC register under an interim order, meaning that he was unable to practice while waiting for the case to come to court.

 

His mother, whose pharmacy he worked at, was not involved in any of the criminal activity.

 

Grant Powell, the MHRA Enforcement officer leading the case, said:

 

“It is a serious criminal offence to sell controlled, unlicensed or prescription-only medicines in this way.

 

“Anyone who sells medicines illegally could be exploiting vulnerable people and clearly has no regard for their health or welfare. Prescription-only medicines are potent and should only be taken under medical supervision.

 

“We work closely with regulatory and law enforcement partners to identify and prosecute those involved.

 

“If you think you have been offered a medicine illegally, or have any information about suspected or known illegal trading in medicines, please contact the MHRA.”

 

The pharmacist pleaded guilty to five counts of supplying controlled class C drugs at Birmingham Crown Court on 09/02/2021.

 

Elements of this article are being shared under the Open Government Copyright licence.

 

 

MHRA appoint new Chief Executive

 

Dr June Raine has been appointed as the Medicines and Healthcare products Regulatory Agency’s (MHRA) new Chief Executive, having been the interim CEO since 2019.

 

Dr Raine played a crucial part in setting up rolling reviews during the pandemic to ensure the UK was the first in the world to authorise the Pfizer/BioNTech and Oxford University AstraZeneca Covid-19 vaccines.

 

Dr Raine’s work has helped improve patient safety and patient engagement and has helped establish the UK as a world-leading destination for life sciences and the development of new and cutting-edge innovation in medicines and medical devices.

 

Before becoming interim CEO, Dr Raine was Director of Vigilance and Risk Management of Medicines and has worked for MHRA and its predecessor organisations since 1985.

 

Dr Raine qualified in medicine at the University of Oxford and undertook postgraduate research leading to an MSc in pharmacology.

 

After several general medical posts, she joined the then Medicines Division of the Department of Health and has worked in several licensing and patient safety areas including widening the Yellow Card Scheme for patients and the public.

 

Health Minister Lord Bethell said:

 

“It is thanks to Dr Raine’s strong leadership during the pandemic that the UK was the first country in the world to authorise COVID-19 vaccines.

 

“The MHRA is widely regarded as one of the best regulators in the world with the highest standards of safety and I’m delighted to confirm Dr Raine’s appointment as CEO.

 

“I’m confident Dr Raine will build on MHRA’s success during the pandemic to make sure NHS patients are among the first to receive cutting-edge treatments in the future.”

 

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MHRA warn of online ‘miracle’ Covid-19 cures

 

Lynda Scammell, Senior Enforcement Advisor at the Medicines and Healthcare products Regulatory Agency (MHRA) today warned the public about medicines and other medical products being sold online claiming to treat or prevent COVID-19.

 

These include products being promoted as ‘miracle cures’, ‘divine cleansing oils’, ‘antiviral misting sprays’, herbal remedies, vitamins and unlicensed anti-viral medicines.

 

This advice is part of the ongoing MHRA #FakeMeds campaign which aims to encourage people who buy medical products online to make sure they are purchasing from legitimate sources.

 

To stay safe when buying medicines online, the MHRA advises that you purchase from a registered pharmacy – either from the premises or online.

 

Lynda Scammell, Senior Enforcement Advisor at the MHRA, said:

 

“You may have heard about products claiming to treat or cure COVID-19. At this time there is no medicine licensed specifically to treat or prevent COVID-19.

 

“We want to caution people that products claiming to do so are not authorised and have not undergone regulatory approvals required for sale on the UK market. We cannot guarantee the safety or quality of these products and this poses a risk to your health.

 

“We have been receiving reports of ‘miracle cures’, ‘antiviral misting sprays’, antiviral medicines being sold through websites. Offering to sell unauthorised medicines is against the law.

 

“Don’t be fooled by online offers for medical products to help prevent or treat COVID-19. One of the risks of buying medicines and medical devices from unregulated sources is that you just don’t know what you will receive. You could be risking your health, and this could further spread the virus and increase pressure on our NHS and social care systems.

 

“We are working alongside other law enforcement agencies to combat this type of criminal activity.”

 

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MHRA launch consultation on the reclassification of desogestrel

 

The MHRA has launched a public consultation on the reclassification of two progestogen-only contraceptive pills containing desogestrel. This is the first time such a change has been considered.

 

The consultation affects two products containing desogestrel; Lovima 75 microgram film-coated tablets and Hana 75 microgram film-coated tablets. Lovima and Hana are both oral contraceptives for continuous use to prevent pregnancy in those of childbearing age.

 

We are asking the public and stakeholders for their views on whether these two products should become a pharmacy medicine and available over the counter, without a medical prescription.

 

If these two products are reclassified, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.

The Commission on Human Medicines has advised that it is safe for these is products to be made available as a Pharmacy (P) medicines.

 

The consultations are open until 5 March. As these are 2 products, 2 separate consultation pages are required:

 

 

Dr Sarah Branch, Director of Vigilance and Risk Management of Medicines at the MHRA, said:

 

“Every response received will help us gain a better picture of whether people think the contraceptive pill with desogestrel should be available over the counter.

 

“We hope to hear from as many people and women’s groups as possible.”

 

Michelle Riddalls, CEO of the Proprietary Association or Great Britain, the consumer healthcare association, said:

 

“We fully support these reclassification applications. Switching products from prescription-only to make them available over the counter, once their safety and efficacy has been rigorously assessed and established, is a positive step.

 

“It enables people to self care where appropriate, minimising inconvenience for individuals and protecting NHS resources such as GP appointments for those who need them most. The applications by Maxwellia and HRA Pharma have particular significance as they are the first to seek over-the-counter licences for any form of daily contraceptive pill, 60 years after the pill in its original form was made available via prescription on the NHS for married women only.

 

“The MHRA consultation represents a landmark opportunity in women’s health and one which we hope will be viewed positively. Both Maxwellia and HRA Pharma have asked the MHRA to permit the sale of their progestogen-only pill products under the supervision of a qualified pharmacist.

 

“As expert healthcare professionals, pharmacists are fully equipped to offer advice to anyone seeking information about over-the-counter medicines. As part of any reclassification of desogestrel, they will be given specific training to enable them to identify whether the product is suitable for a particular individual and pinpoint any issues that might warrant further consultation with a GP or specialist.”

 

 

 

 

Benacort Hayfever Relief reclassified from POM to GSL

 

The Medicine Healthcare and Regulatory Authority (MHRA) has taken the decision to reclassify the legal status for Benacort Hayfever Relief for Adults 64 micrograms nasal spray from POM to GSL. The MHRA has made this decision with the following terms of reclassification:

 

  1. For use in the nose in the form of a nasal spray.
  2. For the treatment of seasonal allergic rhinitis (hayfever).
  3. Maximum strength: 64 micrograms per actuation (spray).
  4. Maximum dose: 132 micrograms per nostril (264 micrograms).
  5. Maximum daily dose: 132 micrograms per nostril (264 micrograms).
  6. Maximum duration of treatment: 1 month.
  7. Maximum pack size: 10 mls (60 actuations).

 

Commenting on their website the MHRA have said the following:

 

“The MHRA considers that there is no reason to believe that there is a higher risk of misuse for Benacort Hayfever Relief compared to other corticosteroid nasal sprays that are already classified as GSL. There is no evidence of abuse of these products since they were reclassified to GSL.

“GSL medicines for the treatment of hayfever have been available for decades. Therefore, a patient’s ability to self-diagnose hayfever has already been established.

 

“Instructions about who should not use the product, and warnings and precautions for when using it are on the label and PIL. The maximum duration of continuous use before seeking medical advice has been limited to one month, which has been emphasised clearly on the product information. Patients are advised to seek professional advice if symptoms are not controlled or persist for longer than 7 days. These limitations on use are considered safe enough for users to self-treat their condition without masking any underlying serious conditions or delaying the amount of time it takes for them to seek further advice from a healthcare professional. They are also consistent with the limitations on use for other GSL corticosteroid nasal sprays.

“The 60-actuation (spray) pack size provides a maximum of 30 days treatment (at the minimum daily dose), which is not greater than the maximum length of treatment of other GSL corticosteroid nasal sprays and aligns with the maximum recommended length of continuous treatment (at minimum dose) before seeking medical advice.

 

“No major issues have been identified in the assessment of this application for Benacort Hayfever Relief as a GSL medicine based on the following reasons:

 

  • The treatment of hayfever is very common with two other intranasal corticosteroids available to treat this condition in the GSL setting. Non-sedating antihistamine tablets and liquids are also available. Patients can self-diagnose hayfever when purchasing these products so it would be considered reasonable that patients who wish to purchase Benacort Hayfever Relief can correctly diagnose themselves with hayfever.
  • The proposed indication, route of administration, duration of treatment and maximum pack size are in line with the two GSL intranasal corticosteroids currently available.
  • Since the reclassification of other corticosteroid nasal sprays, no additional safety concerns have been raised as a result of their availability as GSL products.

 

“The treatment of hayfever is a well-established GSL indication within the UK environment. Consumers are used to buying hayfever treatments including nasal sprays on self-selection in a general retail outlet. The MHRA accepts that the wider availability of Benacort Hayfever Relief would be beneficial to patients as it would allow access to another corticosteroid nasal spray in the GSL setting.”

 

You can read about further details of this POM to GSL reclassification here.

 

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MHRA reviewing risks and benefits of isotretinoin

 

The Medicines and Healthcare products Regulatory Agency (MHRA) are reviewing the risks and benefits of acne medicine, isotretinoin. In particular, whether some of the possible psychiatric and sexual side effects continue after treatment has been stopped.

 

To support a review of evidence on the possible association between acne medicine, isotretinoin, and psychiatric and sexual disorders, a call for information has been launched by the MHRA.

 

Patients and their families, healthcare professionals, researchers and organisations are being invited to contribute to the review through the MHRA’s call for information.

 

An Expert Working Group is reviewing the available evidence relating to isotretinoin and will advise whether the MHRA should take additional regulatory action, for example, improving the information for patients to help minimise the risks of psychiatric and sexual side effects, suspected to be associated with isotretinoin.

 

Due to its suspected side effects, isotretinoin should only be prescribed under the supervision of consultant dermatologists, to treat severe forms of acne that have not responded to antibiotics and topical treatments (creams or gels). Isotretinoin capsules are also known by the brand names Roaccutane, Reticutan, and Rizuderm in the UK.

 

Anyone in the UK who suspects they may have experienced a side effect with isotretinoin, or any other medicine, can submit a report to the Yellow Card Scheme. This helps makes medicines safer for everyone.

 

Dr. Sarah Branch, Director of Vigilance and Risk Management of Medicines at the MHRA, said:

 

“We want patients taking isotretinoin to be informed of the risks and benefits and have recently issued a reminder to healthcare professionals.

 

“All medicines can cause side effects, and we need to ensure that the benefits of taking isotretinoin outweigh the potential risks associated with this medicine.

 

“That is why we need people’s help to gather information on psychiatric or sexual disorders, that they have suffered, and suspect to be associated with isotretinoin treatment.

 

“We are asking patients, family members and healthcare professionals to contribute to the review so that the Expert Working Group has-up-to-date information to consider. All information we receive will be treated confidentially.

 

“We know this is a personal issue for anyone who suspects they have suffered psychiatric or sexual disorders with isotretinoin treatment, therefore we would appreciate any help you may be able to give us.”

 

The MHRA has said that they will work with patients and their families, as well as healthcare professionals and organisations, to ensure everyone has an opportunity to contribute to the review. The agency is particularly interested to hear the experience of patients and families in the UK, but would also welcome contributions from those living outside the UK.

 

Details about the call for information, including what and how to submit, are available here.

 

This circular is being shared under the Open Government Copyright licence.