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Published on 5 June 2009

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Was Shipman just the tip of the iceberg? Why pharmacy practice has to combat drugs diversion

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Few things are more likely to change the governance of pharmacy practice across the world than “The Shipman Enquiry”

John Lawson

Tri:M-V Inc
Montreal
Quebec
Canada

Member of Royal Pharmaceutical Society Dr John Lawson is a UKregistered pharmacist with a doctorate in business administration. He is currently working with a Quebec company with expertise in secure automation developing a narcotics dispensing solution for hospital use

Harold Shipman was convicted in 2000 of murdering 15 of his patients while he was a general practitioner in Hyde, near Manchester, UK.[1] He was dubbed “The Dr Jekyll of Hyde” and is now considered to be one of the most prolific serial killers in British history. He would have put Jack the Ripper and Sweeney Todd to shame.[2]

The story of Shipman
Shipman qualified as a doctor in 1970 and was known, even as a house officer, to have a drug habit. His first conviction for personal abuse of narcotics was in 1975 and yet he was still allowed to continue to practise. His deadly activities remained undetected until 1998 when a local GP reported concerns to the Coroner of an excessive number of deaths among Shipman’s patients. Following sentencing, he was sent to prison but, in 2004, he committed suicide. Subsequently it was discovered that Shipman had amassed extremely large quantities of the narcotic diamorphine (heroin), and a web of serial killings started to emerge. He was actually convicted of just 15 murders and forgery of a will, but an inquest suggested that there were a further 200 deaths attributable to him, and the final figure was probably nearer 265. These dated back to 1970 when he was actually working for the Police and Her Majesty’s Prison Service.[3]

Rather than being struck off by the BMA at that time, he was left to carry on his nefarious activities for 30 years – and the scapegoat appears to have been the practice of pharmacy.

General Pharmaceutical Council
Quite how surveillance of Shipman’s activities could have been achieved without modern database technologies is a moot point, but the outcome has been the emergence of the new General Pharmaceutical Council.

The Shipman case brought about two new guideline documents from the UK’s Department of Health and the Royal Pharmaceutical Society,and much effort  has been expended on filling the loopholes that are still present. [4,5] Controlled drugs legislation covers every facet of sale and supply from primary manufacture to destruction, including (in hospitals) final administration to patients, and the process requires strict compliance with the use of registers. Being in most cases completed manually, tracking is far from being in real time, and post-event examination of registers affords no more than a cursory examination of the supply chain.

The process often engenders “workarounds” or “shortcuts” aligned towards providing greater patient comfort or efficiency. Registers are often updated after the event, and this considerably increases the scope for diversion of drugs. Dr Allen Frankell, director of patient safety in Boston, USA, outlined various levels of potential noncompliance along a spectrum from strict legal obedience, through various manipulations of the regulations to satisfy different stakeholder needs, to performing cultural or learned practices that comply with neither the “spirit” nor the “letter” of the law.[6] From laziness to altruistic patient benefit, legal manipulation is rife. If such distortions are acceptable, then why are the rules on storage, prescribing, dispensing and destruction so strict? Why is there the need for alarmed, locked cabinets affixed to the wall or floor, with hinges on the inside and of a specified construction? Why, too, is authorisation of destruction obligatory?

One hospital in Washington, DC, admitted to having a “wall of shame”. The hospital pharmacy managed the process extremely strictly. If an anaesthetist had taken an ampoule of 20 mg and only 15mg had been given, 5mg had to be returned. If not, his name went on “the wall” until he could fully account for the loss. Think of the US legal implications had the patient died.

Use of narcotics in hospitals
Clearly narcotics are in continual use in hospitals. How else could they practically perform surgical and orthopaedic procedures or relieve pain during childbirth or cancer? Because most supplies are relatively cheap generic drugs (other than, that is, the sustained-release products and patches) the cost of the drug is much lower than either the cost of administration or the social consequences of misuse or abuse.

Analysis of the turnover of one typical Canadian hospital with 20 inpatient wards, emergency and surgery facilities confirmed that the cost of narcotics administration exceeded the cost of their controlled drugs purchases by at least 3:1. Is it surprising, therefore, that certain administrative corners are cut or that there is a lack of concern about “missing” doses? Perhaps familiarity breeds contempt.

Sadly, the regularity of use of narcotics has led to somewhat blasé attitudes towards behaviour on hospital wards, and this laxity has opened up the possibility of diversion. Diversion provides a handsome incentive for a lowly paid employee.

Indeed, there are many recorded cases of diversion by nursing and medical professionals, let alone lowerpaid staff. The problem is that, even with these safeguards in place, the social cost of narcotic abuse and misuse dwarfs even the administration costs. Clearly current security safeguards are not working. Neither traditional “lock-and-key” cabinets nor the newer “trays and drawers” systems (even with their stock control software) hold the answer to narcotics security. As long as access is given to multiple doses that have not been assigned to individual patients, the problem will continue.

Identifying the problem
One of the problems, it is claimed, is a shortage of pharmacists. In the USA in 2005 there were vacancies for 8,500 jobs when the universities were capable of producing just 8,000 new pharmacists per year,[7] and according to one report the USA will need 420,000 pharmacists by 2020 from the current 136,000.[8] This forecast takes into account the growth in the numbers of prescriptions (around 10%, fuelled by an ageing and a more demanding population), even when this is offset by productivity gains through automation. In Canada the shortfall is estimated at 2,000 with only 1,100 graduating from Canadian Universities over a sevenyear period.[9] The situation is dire and getting worse.

A study performed in 2006 on hospital pharmacy vacancies in British Columbia[10] suggested that even though their official vacancy rate had stood at 6–10% for the previous 5–6 years, some vacancies at individual hospitals were as high as 50%. Indeed, the average length of time that a vacancy existed was 32–33 weeks. The Quebec Ministry of Health, compounded by problems with bilingual requirements, commissioned a report to see whether a greater adoption of automation could ameliorate this shortage.[11] Amongst the revelations was that the cost of just administering narcotics on hospital wards cost around $41,900 for every care unit each year. This included all the handling and paperwork but excluded the costs of dealing with diversion.

Local regulations concerning narcotics control are remarkably similar between nations, perhaps because of two overriding UN treaties. These are the Single Convention on Narcotics Drugs (1961) and the Convention on Psychotropic Substances (1971). The World Health Organization, responsible for policing these treaties internationally through the Office on Drugs and Crime (UNODC), exercises local authority through bodies such as the Association of Chief Police Officers (ACPO) and Drug Enforcement Administration (DEA). While estimates vary, the UN believes that annual global sales of illicit drugs stack up to $750 billion per annum. This equates to 8% of all international trade.[12]

In Canada, the Government estimates the annual sales at up to $18 billion and it spends approximately $2.3 billion on enforcement (police, courts and corrections) with a further $1.1 billion on direct health costs annually dealing with illegal drugs.[13] Here, alone, there are 11 Federal departments that deal, in one way or another, with drug abuse, and they spend an additional $500 million annually to address the problem.[14]

According to the Canadian annual report to the United Nations International Drug Control Programme (2000), thefts accounted for 52% of all diverted controlled drugs: 27% of these came from hospitals and MD’s offices, 64% from pharmacies and 9% from factories and wholesalers. The sale of prescriptions to unauthorised persons was 18%, and diversion through medical and related professionals was 5%.

Since much of the data on diversion are still unknown or estimated, the proportion from medical and related professionals could be considerably understated. Data reported by Cincinnati Police Pharmaceutical Diversion Squad 1992–2002 showed opioids to be most commonly diverted drug by health workers, followed by benzodiazepines.[15] Nurses, nursing assistants and medical assistants were involved in almost three-quarters of all cases. Hospitals were the most common source of complaints to police, followed by pharmacies.

Facts and figures
In the USA, a 2001 National Household Survey on Drug Abuse showed 15% of 18–19-year-olds and 7.9% of 12–17-year-olds used prescription medications for nonmedical purposes during the past year.[16] The number of Americans who abuse controlled prescription drugs nearly doubled from 7.8 million to 15.1 million between 1992 and 2003. Abuse among teenagers has more than tripled during that time, according to a report by the National Center on Addiction and Substance Abuse at Columbia University (CASA).[17]

The estimated 15.1 million Americans abusing controlled prescription drugs exceeds the combined number of abusers of cocaine (5.9 million), hallucinogens (4.0 million), inhalants (2.1 million) and heroin (0.3 million).

CASA noted that between 1992 and 2002:

  • Prescriptions written for controlled drugs increased more than 150% – almost 12 times the rate of increase in population and almost three times the rate of increase in prescriptions written for all other drugs.
  • The number of people abusing controlled prescription drugs increased seven times faster than the increase in the US population.
  • Abuse of controlled prescription drugs grew at a rate twice that of marijuana, five times that of cocaine and 60 times that of heroin abuse.
  • New abuse of prescription opioids among 12–17- year-olds was up an astounding 542%, more than four times the rate of increase among adults. Between 1992 and 2000:
  • The number of new opioid abusers grew by 225%; new tranquiliser abusers by 150%; new sedative abusers by more than 125%; new stimulant abusers by more than 170%.
  • The increase in new abusers among 12–17-yearolds was far greater than among adults (four times greater for opioids; three times for tranquillisers and sedatives; 2.5 times for stimulants). Between 1991 and 2003:
  • Rates of lifetime steroid abuse among high-school students increased 126%, with abuse among girls up by nearly 350%, compared with 66% among boys.
  • Teens who abuse controlled prescription drugs were twice as likely to use alcohol, five times likelier to use marijuana, 12 times likelier to use heroin, 15 times likelier to use Ecstasy and 21 times likelier to use cocaine, compared with teens who do not abuse such drugs.

In 2003:

  • 2.3 million 12–17-year-olds (<10%) abused at least one controlled prescription drug; for 83% of them, the drug was an opioid.
  • Amongst 12–17-year-olds, girls were likelier than boys to abuse controlled prescription drugs (10.1% of girls vs 8.6% of boys).

The CSSA[18] emphasises that it is difficult to quantify the amount of drugs coming from individual sources but suggests that there are strong incentives for this traffic. They quoted, in a Vancouver study in 1998, that a 60mg MS-Contin® had a street value of $35 and a 4mg Dilaudid was $32. These equate to 2,059% and 7,800% markups on licit purchase prices respectively, but in most cases, clearly, diverted drugs would have cost the diverter nothing. They argue that diverted drugs are often easier to obtain than illicit supplies. Indeed, they also comment that it takes only a handful of corrupt, disgruntled, low-wage employees to supply quite a large area with drugs for nonmedical use. UNODC has also been quick to point out the coercive powers of organised crime to obtain supplies by using threats to the family and friends of medical professionals.

The CSSA attributed diversion of medicaments to the following methods.

  • “Double-doctoring” – obtaining multiple prescriptions from different physicians.
  • Prescription pad theft and tampering resulting in forged and altered prescriptions.
  • Physician fraud – fraudulent prescriptions written by doctors in return for money
  • Purchases from friends, relatives or dealers forwhom a drug has legitimately been prescribed.
  • Diversion of drugs from substance abuse treatment programmes (eg, methadone).
  • Diversion from supplies intended for patients in healthcare facilities.
  • Break-ins and theft from homes, doctors’ offices, pharmacies, hospitals, etc.
  • Purchases of drugs on the internet.

Conclusion
Diversion is, of course, not the only problem. A UK hospital pharmacy study[19] suggested that dispensing errors occurred in about 2% of all dispensed items. Nurses were the ones responsible for the majority of errors (59%), the intravenous route of administration was commonest (56%) and antibiotics were the most frequent drug (44%). Around 8% of the errors involved a 10-fold administration of the drug. Since narcotics have a narrow therapeutic window, this could potentially be fatal.

According to the FDA, medication errors in the USA cause at least one death every day and injure approximately 1.3 million people annually. Since most narcotics are issued on a “prn” basis, the scope for error and diversion is amplified. The pharmacy has generally lost control of the administration process on the wards and is merely able to “posthumously” (I hope not literally) check registers for compliance. There is a need, therefore, to implement a system on wards that only issues an individual dose to an approved nurse, for a named patient, on a prescription written by a named doctor that has been checked by a named pharmacist. Automation and real-time communication between ward physician and pharmacy will soon do this for us.

References
1. http://www.the-shipman-inquiry.org.uk/home.asp
2. Albeit some scholars claim he is fictional: http://en.wikipedia.org/wiki/Sweeney_Todd
3. http://en.wikipedia.org/wiki/Harold_Shipman.
4. A guide to good practice in the management of controlled drugs in primary care England. 2nd ed. 2007 Feb. http://www.npc.co.uk/controlled_drugs/CDGuide_ 2ndedition_February_2007.pdf
5. Safer management of controlled drugs: a guide to good practice in secondary care (England). 2007 Oct. http://www.dh.gov.uk/en/Publicationsandstatistics/ Publications/PublicationsPolicyAndGuidance/DH_079618
6. http://www.ehcca.com/presentations/ qualitycolloquium1/frankel.pdf.
7. USA Today 2005 Aug 18, Public Health News.
8. Pal S. Pharmacist shortage to worsen in 2020. US Pharmacist 2002;27:12.
9. http://findarticles.com/p/articles/mi_m3374/is_18_23/ ai_80933167.
10. Cheng P. BC Branch CSHP, Pharmacy Shortage Survey; 2006.
11. http://publications.msss.gouv.qc.ca/acrobat/f/ documentation/2005/05-719-01.
12. United Nations Office of Drug Control and Crime Prevention. Economic and social consequences of drug abuse and illicit trafficking. New York: UNODCCP; 1998. p. 3.
13. Rehm J, et al. The costs of substance abuse in Canada2002. Canadian Centre of Drug Abuse; 2006.
14. Illicit drugs: the Federal Government’s role. Office of the Auditor General of Canada; 2001.
15. Inciardi J, et al. The diversion of prescription drugs by health care workers in Cincinnati, Ohio. Substance Use Misuse 2006;41(2):255-64.
16. Substance Abuse and Mental Health Services Administration (SAMSHA); 2001. http://www.samhsa.gov
17. National Center on Addiction and Substance Abuse. Under the counter: the diversion and abuse of controlled prescription drugs in the US. CASA; 2005. http://www.casacolumbia.org/ViewProduct. aspx?PRODUCTID={43FFD58B-16FE-4185-A828- 717E67C63ADD}
18. Single E, et al. The costs of substance abuse in Canada. Canadian Centre on Substance Abuse; 1996. http://www.ccsa.ca/Eng/Priorities/Research/CostStudy/ Pages/default.aspx
19. Beso A, et al. The frequency and potential causes of dispensing errors in a hospital pharmacy. Pharm World Sci 2005;27(3):182-190.



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