Difference between revisions of "Drugs Medicines and Supplements"

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(Medical oxygen and oxygen concentrators)
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==Equipment==
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==Medical equipment==
 
There is no restriction, to our knowledge, in offering or requesting items of medical equipment.
 
There is no restriction, to our knowledge, in offering or requesting items of medical equipment.
  
See https://discourse.ilovefreegle.org/t/would-you-allow-this-there-are-different-types-of-oxygen-generators-for-the-home/2499 for discussion on whether to allow oxygen generators.See https://www.blf.org.uk/support-for-you/oxygen/delivery#:~:text=All%20oxygen%20equipment%20is%20supplied,oxygen%20consent%20form%20(HOCF) for confirmation that medical oxygen has to be prescribed.
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[https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety Medical devices regulation and safety: detailed information]
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==Medical gases, including oxygen==
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'''Requesting or offering medical gases including oxygen is prohibited'''
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Justification:
 +
* [https://bnf.nice.org.uk/treatment-summary/oxygen.html medical oxygen has to be prescribed] using a [http://www.hscbusiness.hscni.net/pdf/Home_Oxygen_Order_Form_HOOF_Part_A_non_speciaist.pdf Home Oxygen Order Form (HOOF)]
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* medical gases are classified as a medicine and are always managed and controlled by a Pharmacist
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* [https://www.nhs.uk/conditions/home-oxygen-treatment/ expert medical assessment is required before oxygen is prescribed and supplied]
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* [http://www.bcga.co.uk/pages/index.cfm?page_id=29&title=medical_gases medical gases are not to be used for non-medical purposes]
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* the following controls apply to medicines sold or supplied by retail [http://www.bcga.co.uk/pages/index.cfm?page_id=106  whether they are sold or supplied via internet transactions, by mail order, or any other form of supply:]
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Regulation:
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All medical gases and some of the associated equipment used to administer [http://www.bcga.co.uk/pages/index.cfm?page_id=29&title=medical_gases medical gases] are highly regulated by European Directives and UK legislation. The gases are classified as medicinal products for administration to a patient and the associated equipment is classified as a medical device when used to administer the gas. Within in the UK there are several legal controls on the retail sale or supply of medicines which are set out in the [https://www.legislation.gov.uk/ukpga/1968/67/contents Medicines Act 1968] as amended by the [https://www.legislation.gov.uk/uksi/2012/1916/regulation/182 Human Medicines Regulations 2012].
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'''Non-medical gases are not covered by these restrictions and are therefore permitted for non-medical use
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'''
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==Oxygen concentrators for medical use==
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See [https://discourse.ilovefreegle.org/t/would-you-allow-this-there-are-different-types-of-oxygen-generators-for-the-home/2499 discussion on whether to allow oxygen generators / concentrators / compressors]
 +
 
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Oxygen concentrators need to be considered in the same way as medical gases because:
 +
* they are medical devices for generating oxygen for medicinal use
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* [https://healthoxygen.com/product-category/o2-concentrators/ medical approval is needed to purchase these products privately]
 +
 
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'''Therefore requesting or offering oxygen concentrators for medical use is also prohibited
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'''
  
 
==Message for Members==
 
==Message for Members==

Revision as of 21:15, 2 December 2020

Human Medicines

The Medicines Act (1968) governs the manufacture and supply of medicine for human consumption. There are three categories:

Prescription Only drugs (POM) can be sold by a pharmacist if prescribed by a doctor.
Pharmacy medicines (P) may be sold by a pharmacist without prescription.
General sales list medicines (GLS) may be sold without a prescription in any shop.

Possession of Prescription Only medicines without a prescription is a serious offence. Link to the Act: [1]

The electronic medicine compendium [2] has a database of medicines and includes which category each medicine falls into.

Should we allow drugs or medicines for human consumption to be offered on our groups?

The answer to that is 'no'. A message to this effect was posted on Central on 14.2.14 [3] and a bulk mailing sent to all group owner addresses.

Background:

A member asked for clarification on this from the MHRA (Medicines & Healthcare products Regulatory Agency) in January 2014 and got the following reply, which he forwarded to the central mailbox:


From: Case Referrals <CaseReferrals@mhra.gsi.gov.uk>
Date: 02/01/2014 16:16 (GMT+00:00)
To: xxxxxx
Cc: Case Referrals <CaseReferrals@mhra.gsi.gov.uk>
Subject: FW: Freegle

Many thanks for your e-mail .

Your concerns are well founded, and I would urge to bring the following to the attention of the www.ilovefreegle.org and Freecycle membership.

In order to protect the public’s health, the sale or supply of any medicinal product in the UK is strictly regulated under the Human Medicines Regulations 2012.

To summarise;

- The sale or supply of a prescription only medicine (POM) other than by a registered pharmacist on receipt of a prescription issued by a qualified heath practitioner, is a criminal offence

- The sale or supply of a pharmacy only medicine (P) other than by a registered pharmacist, is a criminal offence.

- The sale or supply of general sales ledger (GSL) ledger medicine (the sort you would normally find on sale in a non-pharmacy retail outlet) other than from a lockable premises, is in the MHRA’s view, a criminal offence.

The supply of any medicinal product outside the regulated supply chain, poses a serious risk to the public’s health.

Medicines of any kind should not be supplied to the public, other than in the circumstances I have described above.

The MHRA will seek to prosecute those who sell medicinal products outside the regulated supply chain.

Further information about purchasing medicines on-line can be found on the web-link below.

http://www.mhra.gov.uk/Patientsandpublic/Buyingcounterfeitmedicinesandmedicinesonline/index.htm

Let me know if you have any further queries.


With best wishes,

Eanna O'Lochlainn
Deputy Team Leader
Case Referral Centre
Inspection, Enforcement & Standards Division
Medicines & Healthcare products Regulatory Agency (MHRA)


Following discussion of this email on Central, the Reps sent an email to MHRA asking for clarification:

From: Freegle Reps [4]
Sent: 02 February 2014 10:12
To: Case Referrals
Subject: Re: FW: Freegle

We have received the email below, forwarded by a Freegle group member. We are writing to ask for further clarification on the legality of passing on to others of unused medicines

Freegle is a network of independent groups. Each of the groups runs an online message list so that people can give away items they don't want to other people in their community. Freegle groups don't supply anyone with anything other than the ability to post a message; like eBay, items are never in our physical possession - they pass directly from one member to another. No money is exchanged, there is no selling involved, it is purely an act of kindness from one member of a community to another, which also has the added bonus of keeping usable items out of landfill. Each group is locally run by volunteers.

We have had a look at eBay's rules on medicines at http://sellercentre.ebay.co.uk/medicine-and-healthcare-products-policy and would like to know if Freegle groups had a set of rules equivalent to those, would that be legal?

We are aware of the facility for local pharmacies to take in unwanted medicines and then dispose of them, but we are keen to encourage waste prevention in the community. The government policy https://www.gov.uk/government/publications/waste-prevention-programme-for-england has recently been introduced. It is a framework for all organisations to rethink their policy, guidelines and actions so that less stuff enters the waste stream. If it is illegal at present for a private individual to pass on an unwanted GSL item to someone else, then we hope the MHRA will take active steps to set up a safe and legal system for medications (or the packaging) to be recycled or reused instead of being disposed of as waste, or to give people no other choice than to throw them in the bin to end up in landfill.

We look forward to hearing from you.

Best regards

Jacky
On behalf of the Freegle Reps
Alison, Cat, Edward, Jacky, Jane, Richard, Saira, Sheila and Tina


The MHRA replied:


From: Case Referrals <CaseReferrals@mhra.gsi.gov.uk>
Date: 10 February 2014 15:59
Subject: [FreegleReps] RE: FW: Freegle
To: Freegle Reps <reps@ilovefreegle.org>
Cc: "Scammell, Lynda" <Lynda.Scammell@mhra.gsi.gov.uk>, Case Referrals <CaseReferrals@mhra.gsi.gov.uk>

Dear Jacky,

I have nothing further to add to my e-mail to Mr xxxxx, other than to state that the act of kindness to which you refer in your email, has the potential to place the lives and health of your members at risk, and expose your network to criminal prosecution.

E-bay’s rules have no basis in law. The MHRA advises that any unused medicines should be returned to your pharmacist for safe disposal.

The sale or supply of medicinal products, including the facilitation you describe, is strictly controlled in the UK in order to protect the public’s health.

For this reason I would ask that you and your colleagues desist from any attempt to supply any medicinal products via your network.

With best wishes,

Eanna O'Lochlainn
Deputy Team Leader
Case Referral Centre
Inspection, Enforcement & Standards Division
Medicines & Healthcare products Regulatory Agency (MHRA)

UPDATE JUNE 2015: EU Directive 2011/62/EU amending Directive 2001/83/EC has now put a stop to any medicines being donated, as it has been implemented to ensure there is no break in the licensed audit trial from manufacturer to end user.

The charity InterCare has therefore had to stop taking unused/returned medicines to send to clinics in Africa. http://www.intercare.org.uk/ but they are still hoping to distribute medical dressings, devices, clothing etc.

Veterinary Medicines

The Reps wrote to the Veterinary Medicines Directorate (VMD) in January 2014 to ask for guidance on messages offering or requesting veterinary medicines:

From: Freegle Reps [5]
Sent: 24 January 2014 11:36
To: post master
Subject: Unused Medicines

Hello

We are writing to ask advice on the legality of the passing on to others of unused over the counter or prescription veterinary medicines.

Freegle is a network of independent groups. Each of the groups runs an online message list so that people can give away items they don't want to other people in their community. Freegle groups don't supply anyone with anything other than the ability to post a message; like eBay, items are never in our physical possession - they pass directly from one member to another. No money is exchanged, there is no selling involved, it is purely an act of kindness from one member of a community to another, which also has the added bonus of keeping usable items out of landfill. Each group is locally run by volunteers and the responsibility of the Yahoo group owner/s.

We have recently received guidance from MHRA on the offering of drugs and medicines. As a result, our advice to group owners now is that they should not allow drugs or medicines to be offered on groups. We are unclear, however, as to whether this advice should be extended to veterinary medicines and would be most grateful for your advice on this.

We look forward to hearing from you.

Alison Redway
On behalf of Freegle Reps
www.ilovefreegle.org
http://wiki.ilovefreegle.org/Freegle_Reps



The VMD replied as follows:

From: Burge, Denise <d.burge@vmd.defra.gsi.gov.uk> r><b Date: 5 February 2014 15:37
Subject: [FreegleReps] RE: Postmaster Enquiry: Unused Medicines
To: "reps@ilovefreegle.org" <reps@ilovefreegle.org>
Cc: post master <postmaster@vmd.defra.gsi.gov.uk>, "Shelley, Lorna" <l.shelley@vmd.defra.gsi.gov.uk>

Dear Alison,

Thank you for your email that has been passed to me to respond to.

Authorise veterinary medicines carry one of the following distribution categories:

POM-V – these are prescription only medicines and may only be supplied by a veterinary surgeon or pharmacist in accordance with a prescription from a veterinary surgeon.

POM-VPS – these are prescription only medicines and may only be supplied by a veterinary surgeon, pharmacist or suitably qualified person (SQP) in accordance with a prescription from one of these persons.

NFA-VPS – these are medicines that may only be supplied by a veterinary surgeon, pharmacist of SQP

Medicines carrying any of the above distribution categories cannot be offered via Freegle.

There is another distribution category called AVM-GSL. There are no legal restrictions in the Veterinary Medicines Regulations for the retail supply of veterinary medicines classified as AVM-GSL (“over the counter” medicine) but a responsible approach to the supply of these medicines is still expected. Medicines carrying this distribution category could be offered via Freegle.

I hope you find this information useful. Please contact me if you have any further questions.

Kind regards,
Denise.

Denise Burge |Legislation Development Advisor |UK Legislation Team
Veterinary Medicines Directorate
d.burge@vmd.defra.gsi.gov.uk | 01932 338316
Woodham Lane | New Haw | Addlestone | Surrey | KT15 3LS

Supplements

Supplements (eg. vitamins and minerals) are the responsibility of the Food Standards Agency (FSA) in England, and by FSA Devolved Administrations of Scotland, Wales and Northern Ireland for national legislation in their own administrations, where separate but similar regulations apply. The FSA guidance can be found here [6]

There are some substances which are 'borderline' and the MHRA or FSA make judgements on which legislative body is responsible for them. The MHRA website [7] gives an explanation on these.


Medical equipment

There is no restriction, to our knowledge, in offering or requesting items of medical equipment.

Medical devices regulation and safety: detailed information

Medical gases, including oxygen

Requesting or offering medical gases including oxygen is prohibited

Justification:

Regulation:

All medical gases and some of the associated equipment used to administer medical gases are highly regulated by European Directives and UK legislation. The gases are classified as medicinal products for administration to a patient and the associated equipment is classified as a medical device when used to administer the gas. Within in the UK there are several legal controls on the retail sale or supply of medicines which are set out in the Medicines Act 1968 as amended by the Human Medicines Regulations 2012.

Non-medical gases are not covered by these restrictions and are therefore permitted for non-medical use

Oxygen concentrators for medical use

See discussion on whether to allow oxygen generators / concentrators / compressors

Oxygen concentrators need to be considered in the same way as medical gases because:

Therefore requesting or offering oxygen concentrators for medical use is also prohibited

Message for Members

Here is a sample message you could use if a member offers drugs or medicines on your group - Medicine, Drugs


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