Health products policy and standards
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Impact of Impaired Access to Controlled Medications

Impact of Impaired Access to Controlled Medications

Severe undertreatment is reported in more than 150 countries, both developing and industrialized. They count for about 80% of the world's population. Annually, at least 6 million people suffer from lack of access to controlled medications. Most of them are pain patients, but also other conditions are involved. The impact of impaired access to these medications is huge.

Use of controlled medications in pain treatment

According to the WHO Guideline Cancer Pain Relief (2nd Ed) pain treatment should go in three steps:

  • step 1: (mild pain) non-opioid analgesics (e.g. paracetamol), to which if necessary an adjuvant can be added

when a non-opioid no longer adequately controls the pain, an opioid analgesic should be added:

  • step 2: (mild to moderate pain) weak acting opioid analgesics, to which if necessary non-opioid analgesics and adjuvants can be added

if the pain is still persisting or increasing:

  • step 3: (moderate to severe pain) strong acting opioids, to which if necessary non-opioid analgesics and adjuvants can be added.

If the pain is increasing, the dosage of the opioid should be increased in steps until the patient is free of pain. The effective analgesic dose of morphine varies considerably and ranges from as little as 5 mg to more than 1000 mg every four hours. The effective dose varies partly because of individual variations in systemic bioavailability. The correct dose is the dose that works.

Five principles on managing pain

According to the WHO Guideline Cancer Pain Relief (2nd Ed) pain treatment should go in three steps:

  • step 1: (mild pain) non-opioid analgesics (e.g. paracetamol), to which if necessary an adjuvant can be added

when a non-opioid no longer adequately controls the pain, an opioid analgesic should be added:

  • step 2: (mild to moderate pain) weak acting opioid analgesics, to which if necessary non-opioid analgesics and adjuvants can be added

if the pain is still persisting or increasing:

  • step 3: (moderate to severe pain) strong acting opioids, to which if necessary non-opioid analgesics and adjuvants can be added.

 

Number of untreated pain patients

Every year 6 million people die from cancer without sufficient analgesia or even often without any treatment of their pain. About half of all end stage AIDS patients suffer from severe pain. Then there are many people with acute severe pain from injuries (e.g. car accidents, victims of war), myocardial infarction and also many chronic pain patients. Together up to another several million.

 

Health effects of treatment on people with opioid dependence

About 13.1 million people are injecting drug users (IDUs) globally. A number of them suffer from opioid dependence. Mortality rate for opioid dependence is 2-3%, which is 15-16 times as high as in the general population.

Opioid substitution treatment of opioid dependence is a therapy with very strong evidence for its efficacy, as well as with regard to the health and life expectancy of the patient and for delaying the transmission of HIV. The experience from France and other countries with treatment programmes is that the mortality rate almost normalizes once such programmes are introduced. Also the public nuisance caused by opioid dependence is largely reduced.

 

HIV prevention by dependence treatment programmes

25 – 90% (30% average) of all new HIV/AIDS cases in countries outside sub-Saharan Africa are injecting drug users (IDUs) and 5% of all people living with HIV/AIDS are IDUs.

Once the HIV virus is introduced among injecting drug users in a city, the prevalence will reach over 50% in the population of IDUs within two years time and will also spread from here to the general population.

Opioid substitution treatment of these patients is shown to be an effective means of HIV-preventions. Therefore, from the viewpoint of public health it is also important to treat IDUs with opioid agonist pharmacotherapy, like methadone maintenance treatment (MMT) or buprenorphine maintenance treatment (BMT).

Availability of essential medicines in obstetrics

Ephedrine and ergometrine are essential medicines used in delivery that can be life saving. Although they are not abused as drugs, they can be used to synthesize certain drugs and for that reason they are controlled substances under the 1988 Convention.

Unfortunately it is reported that in some countries these medicines are not available for this reason, thus contributing to the 250,000 maternal deaths annually


Availability of essential medicines in obstetrics

Ephedrine and ergometrine are essential medicines used in delivery that can be life saving. Although they are not abused as drugs, they can be used to synthesize certain drugs and for that reason they are controlled substances under the 1988 Convention.

Unfortunately it is reported that in some countries these medicines are not available for this reason, thus contributing to the 250,000 maternal deaths annually

Other controlled medications

Other controlled medications are benzodiazepines, used as hypnotics and anxyolitics. Also phenobarbital, an anti-epileptic is controlled. Not much is known about a possible impaired access to these medicines. In some countries the benzodiazepines are rather over-prescribed than under-used. Nevertheless, both benzodiazepines and phenobarbital are necessary for medical practice and should be available.