Simplifying the legal management of controlled drugs as medicines in the UK

Background: Paramedics working in advanced practice roles in the UK can now train to prescribe medicine. This is anticipated to benefit patient access to medicines and quality of care where there is a national shortage of doctors, particularly in primary care.Aim: To explore the experience of paramedics who are early adopters of independent prescribing in a range of healthcare settings in the UK.Design and setting: A qualitative study involving interviews between May and August 2019, with paramedics in the UK who had completed a prescribing programme.Methods: Individual interviews with a purposive sample of paramedics recruited via social media and regional paramedic networks. Interviews covered experiences, benefits and challenges of the prescribing role. A framework analysis approach was used to identify key themes.Results: Participants were 18 advanced paramedics working in primary care, emergency departments, urgent care centres and rapid response units. All participants reported being adequately prepared to prescribe. Key benefits of prescribing included improving service capacity, efficiency and safety, and facilitating advanced clinical roles. Challenges included technological problems, inability to prescribe controlled drugs and managing expectations about the prescribing role. Concerns were raised about support and role expectations, particularly in general practice.Conclusion: Paramedic prescribing is most successful in settings with a high volume of same-day presentations and urgent and emergency care. It facilitated advanced roles within multidisciplinary teams. Concerns indicate that greater consideration for support infrastructure and workforce planning is required within primary care to ensure paramedics meet the entry criteria for a prescribing role.

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Liability in Criminal Law

10.1093/oso/9780192847546.003.0009 ◽

2021 ◽

pp. 213-256

Keyword(s):

Criminal Law ◽

Regulatory Regime ◽

Law Enforcement Agencies ◽

Controlled Drugs ◽

Medicinal Use ◽

Financial Crimes ◽

Proceeds Of Crime ◽

Corporate Manslaughter ◽

The Uk

This chapter highlights the complexity of the interaction of the criminal law with the regulation of medicines and medical devices. It outlines the elements of the broader criminal law that include offences against the person and corporate and financial crimes that can be committed by individuals or corporate entities, such as corporate manslaughter, fraud, and bribery. It also elaborates on the criminal investigation in the UK that can be led by law enforcement agencies, including the Medicines and Healthcare products Regulatory Agency (MHRA). The chapter considers the relevance of the broader criminal law for individuals and corporates and the criminal law aspects of the regulatory regime. It refers to the criminal enforcement process and the role of the Proceeds of Crime Act 2002 (POCA), including the application of the controlled drugs licensing regime to cannabis-based products for medicinal use (CBPMs).

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Buprenorphine is now a controlled drug

Drug and Therapeutics Bulletin ◽

10.1136/dtb.27.21.84 ◽

1989 ◽

Vol 27 (21) ◽

pp. 84-84

Keyword(s):

Controlled Drugs ◽

The Uk ◽

Narcotic Drugs

Abuse of buprenorphine (Temgesic) in many countries including the UK has led the UN Commission on Narcotic Drugs to require signatories to the International Psychotropic Convention to impose stricter control. Accordingly in the UK buprenorphine has been made a Schedule 3 Controlled Drug. This means that it must be kept in a locked receptacle, prescriptions for it must be handwritten and the quantities stated in words and figures as for other controlled drugs (see BNF).

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Supplementary prescribers allowed to prescribed controlled drugs in the UK

PharmacoEconomics & Outcomes News ◽

10.2165/00151234-200504730-00031 ◽

2005 ◽

Vol 473 (1) ◽

pp. 11-11

Keyword(s):

Controlled Drugs ◽

The Uk

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A study of the reasons for prescribing and misuse of gabapentinoids in prison including their co-prescription with opioids and antidepressants

BJPsych Open ◽

10.1192/bjo.2021.774 ◽

2021 ◽

Vol 7 (S1) ◽

pp. S291-S292

Author(s):

Anju Soni ◽

Pamela Walters

Keyword(s):

Free Text ◽

Snomed Ct ◽

Case File ◽

Controlled Drugs ◽

Increased Risk ◽

Case Files ◽

Potential Risks ◽

Forensic Psychiatric ◽

The Uk ◽

Male Prisoners

AimsElectronic medical case files of male prisoners in a category B prison in London was studied to establish a prevalence during an 8-month period of the use of and the reasons for prescribing gabapentinoids in prison.In addition, the prevalence of co-prescription of gabapentinoids with opioids and antidepressants was also assessed in light of the increased risk of respiratory depression resulting in death when these drugs are used in combination.MethodA retrospective, SystmOne electronic case-file based survey was undertaken searching by SNOMED CT supplemented by examination of free text, in a category B prison for males (Capacity 1500 prisoners; Average turnover of prisoners up to 6000 per year), including to establish practice standards related to the prescription of Gabapentinoids in the prison and determine the compliance with these.ResultIn total, 109 cases were identified of prisoners having been prescribed gabapentinoids, pregabalin in 66 cases (61 per cent) and gabapentin in 43 cases (39 per cent). In 36 cases (33 per cent) prescriptions were for unlicensed indications. This in fact represented 50 per cent of the cases where the indications were documented. Half of the cases were co-prescribed gabapentinoids with an opioid substitute and 17% with antidepressants. Only in 22% of the cases there was documentation of discussion with the prisoner about the potential risks of co-prescribing with these medications. In 14 cases (13 per cent), prescribed gabapentinoids were diverted to other prisoners.ConclusionFor those prescribed gabapentinoids in prison, the indications for such use especially if off label should be reviewed and their use minimised where relevant.The initiation of gabapentinoids in prison should be avoided.For patients who are also receiving antidepressants and opioid substitutes or are abusing opiates, consideration should be given as to whether it is safe to continue on gabapentinoids, given the risks of misuse and death.Issues raised by this study are likely to apply to other prisons, secure forensic psychiatric facilities and indeed community mental health and primary care as well.From 1 April 2019, gabapentinoids have been classed as Class C controlled drugs in the UK.

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P16 Pharmacist prescribing in neonatal intensive care units in the uk: an update

Archives of Disease in Childhood ◽

10.1136/archdischild-2017-314584.27 ◽

2018 ◽

Vol 103 (2) ◽

pp. e1.20-e1

Author(s):

Mulholland Peter

Keyword(s):

Intensive Care ◽

Intensive Care Units ◽

Nurse Practitioners ◽

Medical Staff ◽

Neonatal Intensive Care ◽

Neonatal Intensive Care Units ◽

List Type ◽

Pharmacist Prescribing ◽

Controlled Drugs ◽

The Uk

AimFollowing the amendment of the Misuse of Drugs Act in 2012,1 pharmacists have the same prescribing rights as medical prescribers. A survey in 20122 looked at how far this had been implemented in Neonatal Intensive Care Units (NICU) in the UK. This follow up survey looked at how much progress has been made in the past five years.MethodNeonatal and Paediatric Pharmacist Group (NPPG) members working in NICU were invited to complete an electronic survey to determine the extent of prescribing being undertaken and what, if any, barriers were encountered for this service development.Results40 responses were received, with the majority (23) working in Level 3 units. Just over half (56%) were prescribers, with 53% being independent prescribers. This compares with 47% and 40% in 2012. Of those not currently qualified only 8% had no plans to undertake the course (27% in 2012).The areas where pharmacists were prescribing were similar to 2012 with 70% prescribing in NICU or Special Care Baby Units (SCBU). As in 2012, 19% of those qualified were not prescribing.The majority of respondents were sole pharmacists on their units (54%), with 34% having two pharmacists and one unit had 4 pharmacists (all prescribers)Main medicines being prescribed were nutritional supplements (86%), Parenteral Nutrition (76%), antibiotics (76%), caffeine (67%) and reflux medication (62%). More pharmacists were prescribing controlled drugs (50%) and clinical trials medicines (12%), up from 5% and 2.5% respectively in 2012.Improvement in safety was seen as a benefit of pharmacist prescribing, with quicker access to medicines for patients. Freeing up medical staff time, allowing teams to focus on diagnosis and stabilising sick babies, was also seen as a benefit. Pharmacist prescribers can demonstrate good prescribing practices and set an example for other prescribers, particularly junior medical staff and trainee Advanced Neonatal Nurse Practitioners (ANNP)Pharmacists were generally seen as the most consistent presence on the unit and so are more aware of medication histories of patients, facilitating better discharge planning and communication with families regarding items such as unlicensed specials and prescribable feeds. Pharmacist’s knowledge of medicine formulations meant that they were more likely to consider if doses are measurable when prescribingIt was also felt that being a prescriber helped the pharmacist to integrate more into the multidisciplinary team.Few barriers were reported, with medical and nursing staff supporting the process. The main barriers were pharmacy related: funding being prioritised to adult services and the need for a second pharmacist to clinically check the prescribing were reported.ConclusionPharmacist prescribing has developed since the previous survey in 2012 with the process now embedded as routine practice in many units. Further support is required from pharmacy management to support this development.ReferencesThe Misuse of Drugs (Amendment No.2) (England, Wales and Scotland) Regulations2012 SI No 973.Mulholland P. Pharmacist prescribing in neonatal intensive care units in the UK. Arch Dis Child2013;98:e1. http://adc.bmj.com/cgi/content/abstract/98/6/e1-an?etoc

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Misuse and Mortality Related to Gabapentin and Pregabalin are Being Under-Estimated: A Two-Year Post-Mortem Population Study

Journal of Analytical Toxicology ◽

10.1093/jat/bkz036 ◽

2019 ◽

Vol 43 (7) ◽

pp. 564-570 ◽

Cited By ~ 9

Author(s):

Limon Khatun Nahar ◽

Kevin G Murphy ◽

Sue Paterson

Keyword(s):

Drug Use ◽

Drug Group ◽

Post Mortem ◽

Toxicological Screening ◽

Heroin Users ◽

Controlled Drugs ◽

Common Drug ◽

Class C ◽

South East England ◽

The Uk

Abstract Due to the rise in their misuse and associated mortality, the UK government is reclassifying gabapentin (GBP) and pregabalin (PGL) to Class C controlled drugs from April 2019. However, it is impossible to gauge the extent of their use with current post-mortem toxicological screening, where GBP and PGL are only screened for if they are mentioned in the case documents. This study determines the prevalence of GBP and PGL, the potential extent of their under-reporting and poly-drug use in a post-mortem population. Between 1 January 2016 and 31 December 2017, 3,750 deceased from Coroners’ cases in London and South East England underwent a routine drugs screen and a specific screen for GBP and PGL. The prevalence of both drugs was determined in the cohort and the subcategories of heroin users and non-heroin-users. The prevalence of both drugs was compared to tramadol (Class C drug). Case documents were reviewed to investigate the under-reporting of GBP and PGL and poly-drug use. Of 3,750 samples analyzed, 118 (3.1%) were positive for GBP, 229 (6.1%) for PGL and 120 (3.2%) were positive for tramadol. If routine analysis without additional screening of GBP and PGL had been performed in this cohort, GBP would have been under-reported by 57.6% (P < 0.0001) and PGL by 53.7% (P < 0.0001) in deaths. The most common drug group observed with GBP and PGL was non-heroin-related opioids at 60.2% and 64.6%, respectively. In total 354 deceased (9.4%) were heroin users. GBP was positive in 23 (6.5%) of these cases and PGL was positive in 69 (19.5%). The prevalence of PGL in heroin users (19.5%) was 4.1 times greater than in non-heroin users (4.7%) (P < 0.0001). GBP and PGL are being significantly under reported in fatalities. Both drugs are extensively used with opioids. The prevalence of PGL in heroin users is highly significant.

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