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Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident (2004)

Chapter: 6 Existing Distribution Plans for Potassium Iodide

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Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

6
EXISTING DISTRIBUTION PLANS FOR POTASSIUM IODIDE

Various governments have decided to distribute KI to protect populations against exposures to radioactive iodine in connection with nuclear facilities; others have decided not to distribute it. This chapter reviews US and international experiences in deciding to distribute KI and implementing those decisions. It emphasizes factors important to consider when contemplating whether and how to distribute KI. First, the international experience is discussed, beginning with international guidelines and recommendations for countermeasures. The development of countermeasures to mitigate radioiodine exposures in the event of a release by various countries is then outlined, followed by details on how various countries have made KI available. The US experience is then discussed, starting with recommendations made by public-health institutions regarding KI distribution and the roles and guidance of the involved federal

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

agencies. Before the September 11, 2001, attacks, few states were prepared to distribute KI to the general population. After the attacks and the offering of KI by the Nuclear Regulatory Commission, several states began KI distribution programs. The decisions of states regarding whether to distribute are discussed with the experiences of the states that decided to distribute KI. The chapter then discusses the elements of state distribution programs, highlighting options and limitations to consider in planning such programs. Finally, some obstacles to and limitations of distribution efforts are summarized with observations regarding improvements to overcome them.

International Experience with Potassium Iodide and Other Countermeasures in Nuclear Emergency

Guidelines and Database

The International Atomic Energy Agency (IAEA) and the World Health Organization (WHO) have published general recommendations for countermeasures in the case of a nuclear emergency: the International Basic Safety Standards for Protection Against Ionising Radiation and for the Safety of Radiation Sources (IAEA, 1996) and the Guidelines for Stable Iodine Prophylaxis Following Nuclear Accidents (WHO 1989, Update 1999). However, radiological emergency preparedness and rules for countermeasures differ from country to country. The Nuclear Energy Agency (NEA) of the Organisation for Economic Co-operation and Development (OECD) initiated a questionnaire-based evaluation of short-term countermeasures in March 2001. The results of this evaluation have recently been published under the title Short-term Countermeasures in the Case of Nuclear or Radiological Emergency (NEA/OECD, 2003)1. The NEA distributed questionnaires to its 22 European and 6 non-European member countries. It received 15 completed questionnaires—from Australia, Canada, the Czech Republic, Finland, Germany, Hungary, Ireland, Japan, Luxembourg, the

1  

The report is available at the OECD/NEA publication services (email: neapub@nea.fr).

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Netherlands, Norway, Sweden, Switzerland, the United Kingdom, and the United States. Results of the NEA/OECD evaluation, which included general approaches for short-term countermeasures and more specific information on evacuation, sheltering, and iodine blockade will be the primary basis for the discussion of the international experience in KI distribution in this chapter. This is supplemented with data from other reports from Germany, France, and other countries.

General Approach to Countermeasures

All countries responding to the NEA/OECD questionnaire consider evacuation, sheltering, and administration of stable iodine the preferred short-term countermeasures in areas close to an emergency site. The planning zone for evacuation is generally an area some 10 km (6.2 miles) in radius around the NPP, whereas the planning zones for sheltering and stable iodine are generally larger—a radius of 10-20 km (6.2-12.4 miles). This indicates that sheltering and use of stable iodine administration may be implemented together.

The decision to implement the different countermeasures is based on non-uniform criteria, such as the safety status at NPP, results of radiation monitoring on site and in the vicinity, the meteorological situation, the actual release of radioactivity, and, most important, the dose expected or the dose likely to be averted by the protective measures.

Interestingly, the timing of countermeasures is handled differently in different countries: some countries do not expect to implement them consecutively, but other countries plan to implement them first for the nearby areas and for specific populations (such as pregnant women and schoolchildren) and then address the remaining populations and areas further out.

In developing emergency-plan guidelines and procedures, the responsible organizations have considered various factors. Table 6.1 shows that the most important factor in all countries is the time necessary to implement countermeasures, followed by public-health risk, the shielding qualities of average houses, and the public trauma induced by emergency measures.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.1 Considerations for Emergency Plan Guidelines

Factors

Countries

Australia

Canada

Czech Republic

Finland

Germany

Hungary

Ireland

Japan

Luxemburg

Netherlands

Norway

Sweden

Switzerl and

United Kingdom

United States

Public health risk

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Time necessary for the implementation

X

X

X

Xb

X

X

X

X

X

X

X

X

X

X

X

Shielding qualities of average houses

X

X

X

 

X

X

 

X

X

X

X

X

X

X

X

Availability of basement and shelters

 

 

X

 

X

 

 

X

X

X

X

 

X

 

 

Transportation availability

 

 

X

 

X

 

 

X

X

X

X

X

X

X

 

Public trauma

 

X

X

 

 

X

X

X

X

X

X

X

X

X

X

Night or day

 

 

X

 

X

 

 

X

X

X

X

 

X

 

 

Nuclear power plant near a border

 

 

X

 

X

X

 

 

X

 

X

X

X

 

 

Costs

 

X

X

 

 

X

 

X

X

 

X

-

-

X

X

Countermeasur e applied to entire population

 

X

X

 

X

X

X

X

X

Xc

X

X

X

 

 

Other:

 

 

 

 

Xa

 

 

 

 

Xd

 

-

-

 

 

aOnly for evacuation.

bStable iodine and sheltering could be only for children. In the case of evacuation, if there is not enough time or transport facilities, pregnant women and children first.

cWeather conditions.

dWeather conditions and number of people involved.

Source: NEA/OECD, 2003.

For most European countries, the IAEA International Basic Safety Standards is the basis for radiation-emergency planning. Recently, the WHO Guidelines for Stable Iodine Prophylaxis Following Nuclear Accidents, which were updated in 1999, were implemented by many countries.

In Germany, a country with a federal constitution comparable with that of the United States, general guidelines are laid down in the Basic Recommendations for Disaster Preparedness in Areas Surrounding Nuclear Facilities (The German Minister for the

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Environment, Nature Conservation and Nuclear Safety 1999). These guidelines were approved by the Conference of Ministers of the Interior of the Federal States, and the responsible organizations of the states (county district magistrates or district authorities) developed procedures for the implementation of short-term countermeasures.

Evacuation

According to the IAEA International Basic Safety Standards a generic optimized intervention level of 50 mGy (5 rad) of avertable effective dose in a period of no more than 1 week is recommended for temporary evacuation, that is, evacuation is indicated when the action averts a dose greater than this level. The national intervention levels for evacuation differ considerably, with intervention levels for most countries falling within a wide range of anticipated effective dose: 30-500 mGy (3-50 rad), typically with an integration time of 7 days.

Timely evacuation offers the highest degree of protection against external and internal exposure. If evacuation cannot be finished in the pre-release phase, sheltering may be more effective. Evacuation, compared with sheltering or iodine blockage, however, can have more severe psychological, social, and economic consequences.

Sheltering

According to the IAEA International Basic Safety Standards, for sheltering the generic optimized intervention level is 10 mGy (1 rad) of avertable effective dose2 in a period of no more than 2 days.

Staying indoors is a relatively simple way to reduce external or internal radiation exposure in the event of an emergency. Protection against external radiation depends strongly on the shielding capabilities of the building and the building material used. People should use cellars or protection rooms of solid construction.

2  

The committee discussed and decided to use the term "avertable dose" for its recommendation (averted dose addresses the same issue). This decision follows the recommendations of the International Committee on Radiological Protection given e.g. in publication No. 60.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Windows and outer doors have to be closed, and ventilation systems must be shut down. For a sheltering period of 24 h or longer, food, water, and medical care should be provided. Long-term sheltering may cause social, medical, and hygiene problems.

The variation in intervention levels used for sheltering is smaller than that in other countermeasures (evacuation and iodine blockage). Generally, the recommendations of the IAEA International Basic Safety Standards are followed. For almost all countries, sheltering is implemented as the initial countermeasure because it is easy to organise and the compliance of the population is expected to be relatively high. During sheltering, people are easy to find if it is decided to use iodine blockage. In fact, sheltering is usually combined with the administration of KI. In some countries, the recommendation that children stay indoors is used as a “lighter” countermeasure.

Iodine Blockade

Iodine blockade will rarely be used as a stand-alone protective action. It normally is combined with sheltering or evacuation. All countries recommend the additional use of stable iodine when inhalation of radioiodine is the major exposure pathway. In the case of ingestion of contaminated food (such as milk and leafy vegetables), however, restricting the production and consumption of foodstuffs will be more effective (WHO, 1999).

Dose criteria used to initiate iodine blockade in the 14 countries that completed the NEA questionnaire are summarized in Table 6.2.

In nearly all countries, KI is the preferred chemical form for administration of stable iodine, but three countries use potassium iodate (KIO3). The dosages, administration mode, and duration of iodine blockade used by different countries are shown in Table 6.3.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.2 Criteria for Stable Iodine Intervention

Country

Intervention level

Dose type at intervention level

Dose integration time

Operational intervention criteria

Australia

100 mGy

Averteda dose

 

Under review at present

Canada

100 mSvb

Thyroid organ dose (averted dose)

 

c

Czech Republic

5–50 mSv

50–500 mSv

Effective dose Organ dose (averted)

 

0.1 mSv/hd

Finland

10 mGy

(for children under 18)

100 mGy

(for adults)

Averted dose to the thyroid

 

10 μSv/h

(for children under 18)

100μSv/h

(for adults)

Germany

50 mSv

(for children up to 18 and pregnant women)

250 mSv

(for adults up to age of 45)

Thyroid organ dose

(anticipated)

Radioactive iodine inhaled over a period of 7 days including dose equivalent commitment

Criteria are given for

  • released activity of iodine at the source and

  • time integrated air concentration (see Annex A)

Hungary

100 mGy

Thyroid organ dose

(averted)

 

0.1 mSv/h; 4 h plume transitione

Ireland

100 mSv

Anticipated averted thyroid dose

 

Thyroid dose from radioiodines

Japan

 

 

 

Where a high thyroid dose is anticipated, stable iodine prophylaxis taken according to judgement of experts.

Luxembourg

30–250 mSv

(children)

Anticipated organ dose

 

 

Netherlands

250 mSv

(for children < 17 and pregnant women)

1000 mSv (for adults)

Projected thyroid dose

 

 

Norway

100 mGy

Averted dose

 

 

Sweden

10–100 mGy

(for children)

Averted dose to the thyroid

 

 

Switzerland

30–300 mSv

Organ dose

(anticipated dose)

Inhalation dose integrated over time of plume passage

Source term estimation

United Kingdom

30–300 mSv

Committed thyroid dose, averted by countermeasure

 

Varies with site/operator

United States

5 Gy

(for adults over 40 yrs)

100 mGy

(for adults 18-40 yrs)

50 mGy

(for pregnant/lactating women and those under 18 yrs)

Committed dose equivalent to thyroid

 

 

a The averted (or avertable) dose is the dose to be prevented by the particular protective action (i.e., the difference between the dose to be expected without stable iodine blockade and that to be expected with it).

b Health Canada’s Federal Recommendation. The province of Quebec has other intervention levels: 50 mSv. (0–20years), 100 mSv (20–40 years).

c To be developed.

d The default value of several ten mSv/h will be used, depending on real course and conditions of radionuclides release; for calculation the averted dose of 100 mSv from inhalation was used as basis assumption, and various accident sequences for WWER-213 reactor were calculated to assess the possible consequences for country specific conditions.

e To be included into the National Nuclear Emergency Plan being revised, not yet accepted.

Source: NEA/OECD, 2003. The table shows that different countries use different dose units.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.3 Dosages of Stable Iodine Recommended for Radioiodine Prophylaxis

Country

Populationa

Dosage (mg)

Frequency

Duration

Mass of KI

Mass of iodine

Australia

Infants

 

25–50

Single dosage

 

Children

50

Single dosage

Adults

100

Single dosage

Pregnant women

100

Single dosage

Emergency Workers

100

1 per day

10 days

Canada

Neonates

 

12.5b

c

c

Infants

25b

 

Children

50b

Adults

100b

Czech Republic

Infants

32

 

24 h 16 mg

48 h

Children

65

24 h 3.5 mg

48 h

Adults

130

24 h 65 mg

48 h

Pregnant women

130

24 h

max. 2x

Others

130

 

Finland

Neonates

16

 

d

24 h

Infants

32.5

 

Children

65

Adults

130

Pregnant women

130

Germany

Neonates

12.5

 

Normally single dosage. In exceptional cases taking an additional tablet may be recommended

The intake for neonates should be confined to one day.

Infants

25

Children

50

Adults

100

Pregnant women

50

Hungary

Infantse

65

 

Twice daily

10 days

Childrene

 

 

 

Adultsf

Pregnant womene

Ireland

Neonates

 

12.5 (1/4 tablet)

 

One day

Infants

25 (1/2 tablet)

 

Children

50 (1 tablet)

Adults

100 (2 tablets)

Pregnant women

100 (2 tablets)

Japan

Infants

50

 

50 mg/day

Max. 10 days;

Children

100

100 mg/day

Adults

100

100 mg/day

Less than 1 g (total)

Pregnant women

100

100 mg/day

Luxemburg

Neonates

 

12.5

1

Only 1 dosage

Infants

25

 

2 days

Children

50

2 days

Adults

100

2 days

Pregnant women

100

Only 1 dosage

Netherlands

0-4 year

KIO3

25

Normally single dosage. In exceptional cases taking an additional tablet may be recommended

Only during the passage of the plume. Normally, ‘clean’ food can be supplied

5-16 year

 

50

> 16 year

100

Pregnant women

100

Norway

Neonates

16

 

d

24 h

Infants

32.5

 

Children

65

Adults

130

Pregnant women

130

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Country

Populationa

Dosage (mg)

Frequency

Duration

Mass of KI

Mass of iodine

Sweden

0-1 month

16

 

Normally single dosage. In the case of prolonged release, an additional dosage may be recommended

 

Infants < 3yrs

32.5

Children < 12 yrs

65

Adults < 40 yrs

130

Pregnant women

130

Switzerland

Neonates

16.2

 

Single dosage

Only one time

Infants

32.5

Single dosage

Only one time

Children

65

Per day

g

Adults

130

Per day

a

Pregnant women

130

Per day

Max. 2 days

United Kingdom

Neonates

 

12.5

Single administration only, preferred

Single administra tion provides protection for 24 hours

Infants

25

Children

50

Adults (including pregnant and lactating women)

100

United Statesh,i

Birth through 1 mo

16

 

Until risk of significant exposure to radioiodin e by either inhalation or ingestion no longer exists

1 mo through 3 yrs

32

Children 3-12 yrs

Adults 12-18 yrs

65

Adults over 18 yrs

Pregnant/lactating women

130

a Neonates: birth–1 month old

Infants: 1 month–3 years old

Children: 3–12 years old

Adults: include adolescents aged 13–16 years old

b Federal recommendation follows the 1989 WHO Guidelines. Varies by province.

c Varies by province. In New Brunswick, the frequency is 1 dosage per 24 hr (except for newborns, where a single dosage is advised), until instructed to stop. At the federal level, a protracted dosage is generally not advised

d If needed, authorities give an order for another dosage after 24 h

e ½ or ¼ may be administered depending on age or in case of iodine sensitivity

f Adults under 40 years old

g The duration depends on the actual situation

hIn the United States, the plume phase exposure lasts 24 hours or less due to evacuation being the primary protective action. KI is provided to address plume exposure and one dose should be taken to address the first 24 hour period during which time evacuation is occurring.

iIt is assumed throughout this report that the need for administration of KI is necessary only once and to protect the thyroid gland against inhalation of radioiodine from a passing plume (cloud) and that further protection from radioiodine will be accomplished by evacuation and control of contaminated milk and other foods.

Source: NEA/OECD, 2003.

For practical use of iodine the pharmacological shelf life of predistributed tablets is of interest. Table 6.4 summarizes how the shelf life for stable iodine tablets is taken into account by different countries.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.4 Assumed Stable Iodine Tablets Shelf-Life

Country

Assumed Shelf-Life for Stable Iodine Tablets in years

KI

KIO3

Australia

5a

 

Canada

5

 

Czech Republic

5

 

Finland

5

 

Germany

10–15

 

Hungary

5

 

Ireland

 

5

Japan

 

 

Luxemburg

10

 

Netherlands

 

Check every 5 years

Norway

5

 

Sweden

5

 

Switzerland

8

 

United Kingdom

 

3

aAfter 5 years, the tablets are tested; depending on result, shelf-life might be extended.

Source: NEA/OECD, 2003.

Information about possible side effects of iodine tablets is presented in leaflets that are distributed by most of the countries to households in EPZs before an emergency. In Luxembourg, people who may suffer severe side effects from a large dosage of stable iodine or who have thyroid disease are invited to consult their doctors in advance. In Germany, two types of leaflets are distributed: one to households and the other to family doctors. The German information about possible side effects and countermeasures for family doctors reads as follows:

Persons with a known hypersensitivity to iodine (very rare disorders, such as genuine iodine allergy, dermatitis herpetiformis Duhring, iododerma

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

tuberosum, hypocomplementaemic vasculitis, myotonia congenita) must not take iodine tablets. In rare cases, iodine tablets may also lead to skin rashes, edema, sore throat, watering eyes, nasal catarrh, swelling of the salivary glands and elevated temperature.

In very rare cases, signs of hypersensitivity to iodine (genuine iodine allergy), e.g. iodic rhinorrhea or iodic rash, may be observed. However, the possibility of intolerance to iodine should not be overrated. Absorption of iodine by the body can be inhibited by gastric irrigation with starch solution (30 g to 1 litre until blue colour disappears) or with a 1-3% solution of sodium thiosulphate. Administration of Glauber’s salt and forced diuresis are recommended to speed up excretion. Any shock and any water and electrolyte disorders are to be treated according to guidelines well known by physicians.

In cases of a previous history of thyroid disorders, even if its course has been so far asymptomatic (especially in case of nodular goiter with functional autonomy) hyperthyroidism may be triggered within weeks or months after administration of iodine.

If stable iodine is contraindicated because of the reasons mentioned, the most suitable medication apart from iodine is perchlorate, which competitively inhibits the uptake of iodine. The following dosage is recommended for adults: Sodium perchlorate (as Irenat®): on first day 60 drops, thereafter 15 drops every 6 hours for seven days (15 drops = 345 mg).

Contra-indications such as hypersensitive reactions (agranulocytosis) and serious liver damage must be watched for.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

In Germany, it is recommended that people over 45 years old not take iodine tablets because, owing to the still prevailing general iodine deficiency in Germany, early forms of thyroid overactivity (so-called functional autonomy or hot nodules) are relatively common in this age group (up to 50% of the population). The risk posed by taking iodine tablets—possible induction of hyperthyroidism—outweighs the risk posed by exposure to radioactive iodine, which is negligible in this age group.

The distribution logistics and availability of stable iodine have not been evaluated in depth by the NEA/OECD questionnaire. However, interesting details about this issue have been collected by NEA/OECD and reported as follows:

With the exception of Austria, Canada, and the United Kingdom, stable iodine tablets are commercially available at pharmacies. In Luxembourg, tablets are only available for children not older than four years.

In Australia, the tablets will be distributed in an emergency situation only. The tablets are not commercially available, e.g. at pharmacies, but are stockpiled by the police and local and national authorities. In case of an emergency, they will be distributed to the residences of the population and to pre-designated locations.

In Canada, the provinces are responsible for the decision to distribute stable iodine. There are various policies, some provinces decided to predistribute the iodine tablets to residences, other provinces make them available at pre-designated locations. Within a radius of about 8 km around Gentilly 2 nuclear power plant, for example, iodine tablets will be predistributed to some 12,500 persons (inhabitants and workers). In New Brunswick, 3500 people living within 20 km radius around Pt. Lepreau NPP received stable iodine tablets. Pills are also

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

provided in quantity to police departments, public health offices, schools and local facilities. Additional supplies are stockpiled at the generating station and at the offsite emergency centre in Lepreau, New Brunswick. In Canada, iodine tablets are not commercially available at pharmacies.

The Czech Republic has the most widespread predistribution of stable iodine tablets to residences, businesses, pharmacies, schools and other locations. Around the nuclear power plant Dukovany, about 110,000 people living in the emergency planning zone have already received the tablets. Around the Temelin nuclear power plant, about 40,000 people living in the emergency planning zone received the tablets. People may also buy stable iodine tablets in designated pharmacies.

In Finland, tablets are predistributed to residences surrounding (5 km) nuclear power plants. The tablets are also predistributed to companies near the nuclear power plant. Stable iodine tablets are predistributed to about 1,150 people living around Loviisa NPP (50 permanent inhabitants and about 400 holiday homes with a maximum of 1,100 inhabitants) and 1,370 people surrounding Olkiluoto NPP (70 permanent inhabitants and about 450 holiday homes with a maximum of 1,300 inhabitants). In case of an emergency, tablets will also be distributed by emergency services at pre-designated locations and at public shelters.

In other parts of Finland, iodine tablets are also made widely available, e.g. in schools and nurseries. In addition, tablets are commercially available at pharmacies.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

In Germany, stable iodine tablets are currently stockpiled in schools, public shelters, pharmacies and at local authorities. In case of an emergency they will be distributed at pre-designated locations or, with the help of emergency services, directly to the residences of the population.

In Hungary, tablets are stored at pharmacies and will be distributed at pre-designated locations during an emergency.

Tablets will be distributed to every household in Ireland.

In Japan, the tablets are stockpiled by local authorities and distributed at public shelters during an emergency.

In Luxembourg, stable iodine tablets will be commercially available in pharmacies for children of up to five years only. For other population groups, the tablets are stockpiled at schools and other pre-designated locations (e.g. local and national authorities).

In The Netherlands, stable iodine tablets are stockpiled in a central depository. They are also available around Borssele in Health Service Centres.

In Norway, stable iodine will be distributed by the emergency services at designated locations. The distribution system is being revised. In Northern Norway, tablets will be available for all relevant groups and distributed through local authorities (from schools, hospitals etc). For the rest of the country, national authorities keep a central storage (few tablets). Around the research reactors, the operator has supplied some tablets (stored at the plant and by the police).

In Sweden, iodine tablets are predistributed to all households within the inner emergency zone around the

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

four NPPs. This procedure is repeated every 5 years. There is also central storage of tablets for additional distribution. Larger workplaces, schools and hospitals have also received tablets.

In Switzerland, iodine tablets are predistributed about 4 km (zone 1) around the nuclear power plants. Depending on the location of the NPP, between 3,000 and 30,000 tablets are predistributed to residences of the population, to places of business, local authorities and pharmacies. Up to a distance of 20 km (zone 2) around nuclear power plants, tablets need not be distributed if the population can get them within the first two hours of an emergency. In this case, the public in general must go and fetch their tablets at specially designated locations. The solution chosen depends on the decision taken by the local authority. Currently, discussions are underway to change the legal basis to allow for a predistribution in zone 2 as well. In addition, a national central stockpile is available from which tablets can quickly be transported by helicopters to any location in Switzerland. Stable iodine tablets are also available commercially from pharmacies.

In general, there is no predistribution of potassium iodate tablets in the United Kingdom. However, the local health authority together with the operator, the police and the local government makes the decision for a predistribution in certain areas. Around Sellafield and Hinkley Point, the population density is low and residences are widespread around the sites. The local authorities therefore decided to predistribute tablets in an area of 1–3 km around the sites. Apart from that, tablets are stockpiled in schools, places of business, public shelter, and local authorities. Potassium iodate tablets are not accessible by the general public, e.g. cannot be purchased at pharmacies. They will only be distributed as part of the agreed upon emergency response

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

arrangements after decision of the relevant Directors of Public Health.

In the United States, the distribution of KI for the general public is the responsibility of State and local officials. Because the Federal policy addressing the use of KI by the general public was only recently changed, there is not much experience with the logistics associated with the distribution and storage of KI on a large scale. However, each State that desires to stockpile KI for the population living in the vicinity of a nuclear power plant will have to develop a distribution plan that will be reviewed by the Federal government. In the United States, KI is available over the counter. But, most pharmacies do not keep it in stock and thus it is not readily available to the general public in large quantities.

Recently, the German government started to implement the recommendations of the Radiological Protection Commission (SSK, 1997) to predistribute KI tablets to households within a radius of up to 5 km around a NPP. In the zone between 5–10 km, it is being recommended that stocks of iodine tablets at several locations in the communities (town halls, schools, hospitals, workplaces, and so on) should be made available or predistribution should be considered. For people living at a distance of 10–25 km, stocks of iodine tablets in communities or in suitable establishments are being recommended; predistribution to households is considered only for exceptional cases. Generally, in the zone with a radius of 25 km around a NPP, it recommended that stocks of iodine tablets should be made available for all persons up to 45 years old. For areas outside a radius of 25 km around a NPP in the entire territory of the Federal Republic of Germany, central stocks (at several places, if appropriate) of iodine tablets should be made available for children and adolescents up to 18 years old and for pregnant women. Blister packs with 20 tablets provided by the federal government will contain 65 mg of KI per tablet and will be exempted from usual regulations concerning shelf-

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
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life; 130-mg KI tablets are also commercially available at pharmacies without prescription.

In France, the Central Military Pharmacy has manufactured 350,000 packages of 10 tablets, each containing 130 mg of KI. These were distributed in a conventional manner to pharmacies all over the country. Every person living within 10 km of a NPP received an informational letter signed by the governor of the county and a coupon to be exchanged for the tablets at a pharmacy. Schools, local industry, and public buildings were also supplied with tablets. In comparison, two other distribution protocols have been tested in France: home delivery by firemen or civil defense representatives and postal delivery. The French experience revealed that home delivery allowed successful distribution to over 90% of the population involved, compared to 60-70% for pickup from pharmacies (Le Guen et al., 2002).

In the UK, experience 2 years after the predistribution of iodine tablets to households, almost 60% of the tablets were still available for the target population. The authors of the English study (Astbury et al., 1999) recommended arrangements be made for redistribution of tablets earlier than the shelf-life of stable iodine would indicate.

The Polish Experience

Two days following the explosion of the Chornobyl No. 4 Reactor (April 27 and 28, 1986) considerable activity of 131I in air was measured by Polish authorities. So, the government decided to implement countermeasures on April 29, taking into consideration that although some thyroid uptake had already occurred, stable Iodine would be still useful to protect the gland against continuing contamination resulting from the accident (Nauman and Wolff 1993). On April 29, 1986, the Minister of Health gave orders to prepare KI-solution in the centralized pharmacy for distribution to the 11 provinces most affected. This was to be made available to all hospitals, public health centers, school, kindergartens etc. The following KI-dosage protocol was used: 15 mg for newborns, 50 mg for children 5 years or under and 70 mg for all others. Because the

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

cancer risk for adults was believed to be low and some side-effects in persons with nodular goiter were anticipated, iodine prophylaxis was not recommended for adults; pregnant and lactating women, however, were included in the program. Distribution of KI-solution was accompanied by additional protective measures: fresh-milk with radioactivity above 1,000 Bq/l was banned for consumption by children and pregnant and lactating women, all children below age of 4 were provided with powdered milk, and children and pregnant or lactating women were advised to minimize their ingestion of fresh leafy vegetables until May 16. A total of 10.5 million dosages of KI-solution were given to children and 7 million dosages to adults. So, from the fourth day to the seventh day after the beginning of the release of radioactivity from the Chornobyl nuclear power plant, KI-solution was distributed to more than 90% of the children younger than 16 and about a quarter of the adults.

Three years later, questionnaires were sent to 52,000 people and 35,000 responded (response rate of 62%). Children up to the age of 16 accounted for 37% of the group. Measurements of thyroid radioactivity and reconstruction of thyroid doses revealed that the projected mean maximum burden would have exceeded 50 mGy (5 rad) in children below the age of 1 year in 12 provinces with a range of 53 to 88 mGy (5.3 to 8.8 rad) with minimal burdens ranging between 3 and 15 mGy (0.3 to 1.5 rad). The average total reduction in thyroid burden in three fourths of the children (age 1 to 4) in the 11 provinces treated between April 29 and May 2 was 62%, whereas the remaining fourth of the children received an average of 40% reduction. No thyroid cancers have been found in the study population; comparison of total and nodular goiter prevalence before and after the accident showed no significant difference.

In addition, the survey probed quite intensively for possible adverse reactions to Iodide. No permanent effects on thyroid function could be detected by TSH-measurements in children of the study group. Only 0.4% of newborns who received KI-prophylaxis on the second day of life showed transient increases of serum TSH levels accompanied by decreases of free T4. Among extrathyroidal side-effects after KI-prophylaxis, vomiting and skin-rashes in 2.4% and 1.1% of the children and 0.9% and 1.2% of the adults, respectively,

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
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were the only side-reactions considered to be statistically significant. Nauman and Wolff concluded that the present program involved the largest population ever studied after a single pharmacological (high) dosage of KI. The administration proved to be effective and safe since no increase of the incidence of thyroid cancer was registered after Chornobyl in Poland and adverse reactions to KI were very rare.

US Experience in the Distribution of Potassium Iodide

Until recently, there has been limited experience in the United States in distributing KI to the general population. A few states with commercial nuclear facilities distributed KI, and one state experimented with different methods of distribution. After the Chornobyl experience and the increased concern over a possible terrorist attack that would lead to radioiodine exposure, several states and the federal government reassessed their policies and initiated KI distribution programs to cover emergencies at NPPs. Guiding some of the policies are recommendations from public-health institutions regarding the KI distribution and protective dosages. All state distribution plans are subject to federal review.

This section describes guidance from various federal agencies and public-health institutions in KI distribution, the application of this guidance in the US. It also outlines experience of the states in planning and implementing KI distribution programs. The discussion of states’ experience is based on responses to a request for information sent by the committee to each of the 50 states, presentations heard by the committee, reports and other data retrieved from the Internet, and a few publications in scientific journals.

Recommendations from Public-Health Institutions

Since 1984, the American Thyroid Association (ATA) has recommended the stockpiling of KI, and it currently recommends the predistribution of KI to households within a 50 mile radius of a NPP and stockpiling of KI at distribution centers 50-200 miles from

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
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nuclear plants (see the American Thyroid Association Web site http://www.thyroid.org/professionals/publications/statements/ki/02_04_09_ki_endrse.html; the site was accessed on September 23, 2003). The American Academy of Pediatrics (AAP, 2003) notes the high risk of thyroid cancer from fetal and childhood exposure to radioiodine and its effective prevention with KI near the time of exposure. AAP therefore recommends the development of strategies that permit the rapid administration of KI to large numbers of children potentially at risk. It also recommends that communities near a NPP have access to KI as an adjunct to evacuation and sheltering and that schools and child-care centers within a 10-mile radius of a reactor have immediate access to KI. AAP notes that it is prudent for parents living within a 10-mile radius of a reactor to keep KI in their homes. Noting that KI distribution to all US families remains controversial, the AAP nonetheless asks that universal access to KI be considered. Because rapid and complete evacuation of a region depends on population density, APP suggests distribution of KI within a 50-mile radius of a NPP in densely populated regions and within a 10-mile radius in less densely populated region. AAP recommends preparatory training exercises and recommends that FDA facilitate the development of a pediatric preparation of KI. With regard to the dosage administered, ATA and AAP defer to FDA’s 2001 guidelines for KI administration (Table 6.5). One caveat is that, contrary to FDA (2001a), the AAP recommends that women exposed to radioiodine cease breastfeeding unless there are no alternatives. The FDA advice suggests breastfeeding can continue if the mother has received KI.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.5 FDA (2001a) Guidance for KI Administration: Threshold Thyroid Radioactive Exposures and Recommended Dosages of KI for Different Risk Groups1,2

Patient

Predicted thyroid exposure (cGy)

KI dosage (mg)

No. of 130 mg tablets

No. of 65 mg tablets

Adults: > 40 years old

> 500

130

1

2

Adults: 18–40 years old

≥ 10

130

1

2

Pregnant or lactating women

≥ 5

130

1

2

Adolescents3: 12–17 years old

≥ 5

65

½

1

Children: 4–11 years old

≥ 5

65

½

1

Infants and children: 1 month–3 years old4

≥ 5

32

¼

½

Neonates: Birth–1 month old

≥ 5

16

1/8

¼

1Footnote 2 to this table was given in the FDA (2001a) guidance. The remaining table footnotes were provided in the AAP (2003) presentation of FDA guidance. AAP presented the predicted thyroid dose in units of Gy and rad (1 cGy is equivalent to 1 rad).

2KI is useful only in a severe emergency situation when there is a risk of exposure to radioiodine. KI is given once only to pregnant women and neonates unless other protective measures (evacuation, sheltering, and control of the food supply) are unavailable. Repeat dosing should be on the advice of public health authorities.

3Adolescents weighing more than 70 kg should receive the adult dosage (130 mg).

4KI from tablets or as a freshly saturated solution may be diluted in water and mixed with milk, formula, juice, soda, or syrup. Raspberry syrup disguises the taste of KI the best. KI mixed with low-fat chocolate milk, orange juice, or flat soda (for example, cola) has an acceptable taste. Low-fat white milk and water did not hide the salty taste of KI.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Federal Agencies

The FDA (2001a) guidance modifies earlier recommendations (FDA, 1982) on KI intervention with respect to KI dosages and the radiation levels that trigger prophylaxis. The update came after a federal interagency working group examined the data on radioiodine and post-Chornobyl thyroid cancer. The working group found that thyroid-cancer risk may accrue in children and adolescents from “very low doses of radiation exposure” and that KI administration in Poland after the Chornobyl accident was safe and effective. The main changes from the earlier guidance were the establishment of lower radiation levels that should prompt KI administration and the recommendation of relatively low minimum effective dosages of KI for the very young. FDA has also issued the guidance Home Preparation Procedure for Emergency Administration of Potassium Iodide Tablets to Infants and Children when using 65- and 130-mg tablets (FDA, 2003b; 2003c).

The earlier FDA guidance (FDA, 1982), recommended dosages of 130 mg/day for those over 1 year old, and 65 mg/ day for those under 1 year old. FDA (2001a) now recommends effective dosages of 32 mg/day for very young children (1 month–3 years old) and 16 mg/day for neonates (less than 1 month old) (Table 6.5). It indicates that the lowering of effective dosages was based on bodyweight considerations. The 2001 guidance emphasizes the importance of avoiding overdosing of the fetus and very young child. Of special concern is transient hypothyroidism, which can lead to intellectual developmental deficits. Although deficits have not been reported in neonates treated with KI in Poland after Chornobyl, transient hypothyroidism was reported, and the potential for deficits remains a concern. FDA therefore advises that neonates and pregnant and lactating women be given priority with regard to other countermeasures to reduce radioiodine exposure and thereby obviate repeat dosing with KI. FDA further recommends that those under 1 month old treated with KI be monitored for hypothyroidism and hormone therapy be instituted in the event it develops.

Because the graded dosing recommended by FDA (2001a) may be logistically difficult, FDA has issued further guidance and fact

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

sheets (FDA, 2001b, 2002, 2003d) indicating that the benefits of KI far exceed the risks posed by overdosing. According to FDA (2002), “the overall benefits of taking up to 130 mg instead of the lower dosages recommended for certain age groups far exceed the small risks of overdosing. However, where feasible, adherence to FDA guidance should be attempted when dosing infants.” In discussing overdosaging, FDA (2001b) had provided the caveat that “particular attention should be paid to dosage and duration of treatment in infants and in pregnant women.” The FDA (2001a) recommendation for monitoring neonates for hypothyroidism is not repeated in these materials. Indeed, the most recent informational release (FDA, 2003d) does not mention adhering to dosage levels for neonates but stresses “the risks posed by KI are far outweighed by the benefits with regard to prevention of thyroid cancer in susceptible individuals.”

In 2001, FDA (2001a) reduced the radiation dose levels that would trigger intervention by about a factor of 5 from the earlier (1982) guidance for neonates, children, and pregnant and lactating women and increased the level for adults over 40 years old. The 1982 FDA guidance recommended thyroid blocking for anyone likely to receive a dose of at least 250 m Gy (25 rad for radioiodine). The 2001 update recommends KI intervention for those under 18 years old and pregnant and lactating women receiving 50 mGy (5 rad) or more and recommends no prophylaxis for those over 40 years old unless they receive 5000 mGy (500 rad) or more.

With regard to KI dosage administration, the 2001 FDA guidance (2001a) differs from the WHO guidance (1999) (see above section on iodine blockade) in two ways. First, FDA recommends a dosage of 65-mg for children 12-18 years old, the same as for younger schoolchildren, so all school-age children would receive the same dosage. WHO recommends 130 mg for children 12-18 years old. FDA indicates, though, that two 65-mg tablets should be given to children approaching adult size. Thus, the guidelines are fairly similar with respect to administered dosage. Second, with regard to the level of radioiodine exposure that would trigger KI intervention, the guidelines differ substantially. WHO (1999) recommends KI intervention for children and pregnant and lactating women exposed to 10 mGy (1 rad) in contrast with the FDA recommendation of 50

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

mGy (5 rad). That is because FDA found the most reliable human evidence of an effect in the Chornobyl data at child exposures of 50 mGy (5 rad) or more (FDA, 2001a), presumably owing to the absence of population data on doses less than 50 mGy (5 rad) (Leissa, 2003). WHO performed a modeling exercise to estimate risk. Given the WHO (1999) lifetime cancer risk of 1% per Gy for exposed children cited earlier in this chapter, the risk to children at the FDA intervention threshold would be 0.05%, or 5 cancers per 10,000 exposed.

The updated FDA guidance states that KI is optimally effective when taken in advance or coincidentally with the passage of the radioactive cloud but has a substantial protective effect even if taken 3–4 hours after exposure. The guidelines call for continued dosing until the risk no longer exists. The guidelines (FDA, 2001a) go on to say that because timing is of the essence, state and local governments that choose to incorporate KI into their emergency-response plans may consider the option of predistribution of KI to people who do not have a medical condition that would contraindicate its use.

In 2003, FDA issued draft guidance to advise stockpilers on how to extend the shelf-life of KI maintained in controlled conditions (FDA, 2003a).

The Federal Emergency Management Agency (FEMA), now housed in the Department of Homeland Security, is responsible for assessing the adequacy of offsite emergency planning for nuclear-reactor accidents. In January 2002, FEMA issued its revised federal policy regarding the use of KI. The guidance was issued for use by state and local agencies involved in emergency planning and preparedness for accidents at NPPs (FEMA, 2002). The policy states the federal position that KI should be stockpiled and distributed to emergency workers and institutionalized persons, and that its use should be considered for the general public within the 10-mile EPZ. It notes that the decision on whether to use KI for the general public is left to the discretion of the states and in some cases local governments. FEMA questions the need for distribution of KI beyond a 10-mile radius of a facility, and further finds that an interim 20-mile

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

standard is not needed, and finds the need for a large distribution to respond to a terrorist event questionable.

The Nuclear Regulatory Commission is ultimately responsible for the safety of commercial nuclear facilities in the United States, and it regulates the facilities and the development of on-site emergency plans. For emergency-planning purposes, the commission defines two planning zones around NPPs. The first covers the area roughly up to 10 miles from the facility, called the plume exposure emergency planning zone (EPZ). The second, larger planning zone, the ingestion pathway zone, is larger than the first zone—roughly up to 50 miles from the facility (see Chapter 5 for a more complete description of emergency planning procedures). The commission relies on FEMA determinations that adequate protective measures will be taken offsite in the event of an emergency. On April 19, 2001, the commission amended 10 CFR 50.47(b)(10) to state that a range of protective actions has been developed for the plume (10-mile) EPZ for a commercial NPP, including the consideration of prophylactic KI use as a supplement to evacuation and sheltering. In January 2001, the commission offered states affected by the 10-mile radius criterion an initial supply of KI amounting to two free tablets per resident living within 10 miles of a NPP (Federal Register, 66(13):5427, 2001). On December 20, 2001, the commission sent letters discussing its program to the 31 states that have NPPs (see Table 6.6), to the two states that did not have NPPs but had NPPs within 10 miles of their borders (Delaware and West Virginia), and to one tribe (Prairie Island Indian Community in Minnesota). The commission did not commit to replenishing states’ supplies.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.6 Commercial Nuclear Power Plants in United Statesa

State

Plants

Alabama

Brown’s Ferry, Joseph Farley (Dotham)

Arizona

Palo Verde (near Wintersburg)

Arkansas

Arkansas Nuclear (Pope County)

California

Diablo Canyon (San Luis Obispo Co.), San Onofre (San Clemente)

Connecticut

Millstone (Waterford)

Florida

Crystal River (Citrus County), St Lucie (Ft. Pierce), Turkey Point (Miami)

Georgia

Edwin Hatch (Baxley), Vogtle (near Augusta)

Illinois

Braidwood (Will Co.), Byron (Ogle Co.), Clinton (Clinton), Dresden (Grundy Co.), LaSalle County, Quad Cities (Davenport, Rock Is., Moline, E. Moline)

Iowa

Duane Arnold (Palo)

Kansas

Wolf Creek (Coffee County)

Louisiana

River Bend (W. Feliciana), Waterford (Taft)

Maryland

Calvert Cliffs

Massachusetts

Pilgrim (Plymouth)

Michigan

Donald C. Cook (Berrion Co.), Enrico Fermi (Detroit), Palisades (South Haven)

Minnesota

Monticello, Prairie Island (Red Wing)

Mississippi

Grand Gulf (Vicksburg)

Missouri

Callaway

Nebraska

Cooper Station (Brownsville), Fort Calhoun (Omaha)

New Hampshire

Seabrook (Portsmouth)

New Jersey

Hope Creek (Lower Alloways Creek), Oyster Creek (Forked River), Salem

New York

Fitzpatrick (Oswego), Indian Point (Buchanan), Nine Mile Point (Oswego) Robert E. Ginna (Rochester)

North Carolina

Brunswick, McGuire (near Charlotte), Shearon-Harris (Raleigh)

Ohio

Davis-Besse (Oak Harbor), Perry (near Cleveland)

Pennsylvania

Beaver Valley (Shippingport), Limerick (near Philidelphia), Peach Bottom, Susquehanna (Luzerne Co.), Three Mile Island (near Harrisburg)

South Carolina

Catawba, Oconee (Greenville), H.B. Robinson (Hartsville), Virgil C. Summer (Jenkinsville)

Tennessee

Sequoyah (Chattanooga), Watts Bar (Chattanooga/Knoxsville)

Texas

Comanche Peak (Somervell Co.), South Texas Project

Vermont

Vermont Yankee (Vernon)

Virginia

North Anna (Louisa Co.), Surry (near Williamsburg)

Washington

Columbia (Benton Co.)

Wisconsin

Kewaunee (Carlton), Point Beach (near Two Rivers)

aSource: Energy Information Agency, Nuclear Regulatory Commission, Nuclear Power Plants Operating in the United States, 2001 and request for information responses.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

FEMA is available to assist states that decide to predistribute or stockpile KI as a method of preparedness for an accident at a NPP. If a state incorporates KI administration to the general public, FEMA evaluates a state’s ability to disseminate KI as embodied in documented plans and procedures, public-information materials, and emergency instructions that must be submitted to FEMA within a year of receipt of KI from the Nuclear Regulatory Commission (Conklin, 2002). The capability to distribute KI tablets to the general public is to be demonstrated by state and local governments that incorporate KI administration to the general public in their plan during the first required exercise “emergency drill” after the submission of plans and procedures. Issues regarding distribution of KI to the general public if incorporated into the plan are to be addressed in the annual letter of certification for the radiological emergency response plan (RERP). The letter is to discuss the number of KI tablets issued or reissued during the previous year.

KI distributed to the states was taken from the Strategic National Stockpile (formerly called the National Pharmaceutical Stockpile), a stockpile of pharmaceuticals and other medical supplies maintained by the Centers for Disease Control and Prevention for rapid deployment in the event of a public-health emergency.

US Postal Service Distribution of KI

After the September 11 terrorist attack and the anthrax mailings, the US Postal Service (USPS) formed the Mail Security Task Force consisting of representatives of postal unions and management associations and of USPS management. A USPS decision to offer KI to all its 750,000 employees (USPS, 2002a, 2003b; APWU, 2002) grew out of meetings of the task force. One consideration in the decision was the Nuclear Regulatory Commission’s offering of KI to the states with populations in the vicinity of commercial NPPs. The offering came on the heels of the anthrax mailings and generated much fear and anxiety among postal workers (Reid, 2003). USPS decided to fund a KI distribution program for all its employees and purchased 1.6 million tablets at a cost of 18.3 cents per tablet, or about 37 cents per employee.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

The basic USPS KI distribution program (APWU, 2002) involves the distribution and storing of KI tablets at all postal facilities. A safety talk is given to inform employees about the program, to provide information needed “to make an educated decision about whether to take the tablets in the event of a radiation emergency”, and to distribute informed-consent forms ("Potassium Iodide Distribution Employee Acceptance Form"). A signature on the form is required to receive KI in a facility distribution conducted in response to a nuclear emergency. The form confirms that the signatory understands that the taking of KI is voluntary and that KI is for his or her own use; it lists the side effects, and contraindicating medical conditions. It also confirms that the tablets are to be held at their work location and distributed when the appropriate notifications have been received in a nuclear emergency.

Purchase of KI by Individual Members of the Public

In late 1978, 3 months before the Three Mile Island accident, FDA announced its conclusion that KI is an effective and safe prophylactic for radioiodine exposures resulting from nuclear emergencies. It also encouraged manufacturers to submit new drug applications for oral forms of KI. These would be used to approve over-the-counter formulations of KI. Since that notice, FDA has approved four KI drugs, two of which are currently marketed and available through the Internet at relatively low cost: one as 130-mg tablets (IOSTAT by Anbex), and the second as 65-mg tablets (ThyroSafe by Recip AB) (FDA, 2003a, 2003d; The Medical Letter, 2002). An oral solution (KI oral solution by Roxane) and an oral tablet product (ThyroBlock by Wallace Laboratories) were approved by FDA but are no longer marketed. FDA and some states (such as Maine and Maryland) make information known to the public on how to purchase FDA-approved KI through their Web sites (see Appendix E). Non-FDA-approved KI is also available through the Internet. The committee did not have information on the extent of KI purchases over the Internet.

Dosaging directions available from the manufacturer on the Internet for the 130-mg tablet formulation follow the 1982 FDA

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

guidance, and dosaging for the 65-mg formulation follows the 2001 guidance of graded dosing for children of different body size. The 65-mg formulation has cross scoring to enable quartering. One quarter of a 65-mg tablet is the recommended dosage for those under 1 month old.

States

As the responsible party for protecting the public in the event of a nuclear incident, a state must decide whether to obtain KI for distribution, the means of distribution, and other policies regarding KI distribution. Until recently, Alabama, Arizona, and Tennessee were the only states that stockpiled and predistributed KI in the event of an emergency. Maine had had a program that was discontinued with the decommissioning and dismantling of the Maine Yankee power plant. After the September 11, 2001, attack and the Nuclear Regulatory Commission’s provision of KI to requesting states, several states began KI distribution programs.

Appendix C summarizes material made available to the committee regarding the distribution programs in different states and information on states that had decided not to distribute KI.

States Without KI Distribution Programs

Several states do not distribute KI, because commercial nuclear plants are believed to be too distant to cause concern or do not perceive KI as an effective supplement to evacuation or sheltering for their jurisdiction (see Table 6.7). In the highly unlikely event of exposure to radioiodine, they would rely on the Strategic National Stockpile (formerly called the National Pharmaceutical Stockpile). Some states that have nuclear facilities within their borders decided not to request KI from the Nuclear Regulatory Commission. The committee heard from some of those states about their plans to protect the public in the event of a radioiodine release.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.7 States Without KI Distribution Programs for the General Population

No NPPs within or near borders

Alaska

Kentucky

Oklahoma

Colorado

Maine

Oregon

District of Columbia

Montana

Rhode Island

Hawaii

Nevada

South Dakota

Idaho

New Mexico

Utah

Indiana

North Dakota

Wyoming

NPPs within borders

Arkansasa

Louisiana

Nebraska

Georgia

Michigan

Texas

Iowa

Minnesota

Washington

Kansas

Missouri

Wisconsin

aIn process of changing policy to distribute to general population.

Several states (such as Texas, Michigan, Kansas) note that prompt evacuation is the only sure means of comprehensive protection from radioiodine and other radionuclide exposures. A resolution recently adopted by the Texas Radiation Advisory Board on the use of KI in NPP emergencies (Texas Department of Health, 2002-2003) articulates issues discussed by other states that have chosen not to distribute KI to the general population:

  • Providing KI to the general public is a complex enterprise that involves the timing of administration, the logistics of stockpiling and distribution, and potential adverse reactions.

  • KI protects only against radioiodine

  • KI provides only partial protection at best. The public is therefore given an unwarranted sense of protection by KI.

  • Prompt evacuation gives sure and effective protection.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

The practicality with safe and effective distribution of KI on a mass scale, and uncertainty with regard to the benefits were emphasized by Michigan. Georgia noted that the federal program for KI distribution does not cover the substantial administrative costs associated with distribution.

Several states that chose not to distribute KI to the general population have made provisions for protecting of special populations that would be difficult to evacuate. For example, Louisiana, Michigan, and Missouri have plans to distribute KI to institutionalized people or those who would shelter in place. Michigan has made special provisions for providing KI to the homebound public. Some states stockpile KI at facilities that would shelter in place; others rely on postincident distribution to special populations. Rather than develop plans to distribute KI, Nebraska has made provisions for early evacuation of nonambulatory persons.

Several states (Georgia, Missouri, and Nebraska) indicate that KI is available for emergency workers, some through local emergency-operations centers. Some require signature on forms that indicate receipt and briefing on exposure issues; others require that forms be completed when emergency workers ingest KI. Various states reported that during an emergency, the consumption of KI by emergency workers would be voluntary. Some states routinely provide training that include instruction on distribution of KI to special populations and emergency workers and assess the effectiveness of the distribution plan in such training.

Few statistics were available to the committee with regard to total amounts of KI required for emergency workers and special populations. Missouri has distributed 4,000 packets (14 tablets, 130-mg per tablet), and Michigan maintains a stockpile of 3,200 bottles (14 tablets, 130-mg per tablet) distributed among eight local entities for such purposes.

Arkansas provides KI only to emergency workers but is changing its policy. It is considering stockpiling KI at the evacuation centers and making it available to the general population for pickup at local pharmacies, county health units, and other locations on “county KI days”.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Idaho has a test reactor and an associated Fixed Nuclear Facility Emergency Plan but notes that there are no residents within 10 miles of the facility. Emergency workers would use KI; the state is still considering the best means of supplying KI to them. New Mexico also noted that although it had no commercial facilities, it did have some small experimental reactors, but none that operates continuously and none capable of releasing substantial radiation in any conceivable scenario. The state noted the availability of KI through the Strategic National Stockpile in the event of a nuclear incident.

Some states that do not have commercial nuclear plants (Alaska, Colorado, Maine, and Wyoming) noted the possibility of dirty bombs used by terrorists but stated that radioiodine risk from such bombs is extremely unlikely, implying that stockpiling of KI was unnecessary for protection of their residents.

States With KI Distribution Programs

Table 6.8 lists the states with KI distribution programs. Three basic approaches have been adopted thus far for distributing KI to the general public: stockpiling KI for postincident distribution; predistributing KI to the general population via the mail; and a combination of the two. Stockpiling involves collecting and retaining KI at one or more fixed locations from which it is dispensed directly to the potentially affected population in an emergency, or moved to evacuation centers for distribution. Predistribution involves providing KI to the potentially affected population as part of the preparation to respond to an incident. KI can be predistributed to individuals and groups via the mail, voluntary pick-up or door-to-door; making KI available on a voluntary basis to those interested in obtaining it; or a combination of both. All states with predistribution programs, on which the committee had detailed information, also had postincident distribution programs, many of them extensive. KI is supplemental to the primary policy of evacuation in the event of a nuclear emergency, and several states noted the importance of establishing KI programs that did not interfere with evacuation.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.8 States with KI Distribution Programs for General Population

Stockpile KI for postincident distribution:

Alabama

Florida

Mississippi

Arizona

 

 

Predistribution (includes stockpiling for postincident distribution):

California

New Hampshire

South Carolina

Connecticut

New Jerseya

Tennessee

Delawarea

New York

Vermont

Illinois

North Carolina

Virginia

Maryland

Ohio

West Virginiaa

Massachusetts

Pennsylvaniaa

 

aState border within 10 miles of nuclear facility (Delaware, Salem/Hope facility in New Jersey; West Virginia, Shippingport facility in Pennsylvania).

Four states have decided to stockpile KI for postincident distribution (Table 6.9). Each plans full coverage of the population within the 10-mile radius of the NPP. Florida notes that the flexibility of its plan enables coverage of populations beyond the 10-mile radius. All four states plan to distribute KI to the evacuated population at the reception centers. The Alabama plan includes administration of KI under the supervision of physicians and registered nurses; Arizona will provide information sheets to recipients, and public-health nurses and educators will be available to answer questions. Two states with postincident distribution plans, Arizona and Mississippi, have relatively small populations living in the 10-mile EPZ. Mississippi notes that the estimated evacuation time for the entire EPZ is 2.5 h. Effectiveness of postdistribution is evaluated in drills required by

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

federal oversight procedures, but data on such drills were not available to the committee.

Table 6.9 Tablets for States with Only Postincident-Distribution Programs

State

Where Stockpiled

No. of 130-mg KI Tablets Available

Alabama

County health departments in vicinity of plants

270,410 on hand; does not cover all people within 10-mile radius of facilities

Arizona

Data not available

7000 for general public,

2800 for emergency workers,

800 for schools

Florida

Near power plants

780,000 for general population

 

9 facilities named in FDEM

28,000 for emergency workers, special populations

Mississippi

Data not available

For a population of 10,000

To provide some background on issues that arise with predistribution, the experiences of Connecticut, Tennessee, and Maryland are presented in more detail below. Connecticut predistributed tablets by mass mailing, Tennessee distributed initially by door-to-door delivery and then by a voluntary pickup program, and Maryland by pickup. The various other state predistribution programs are described in Appendix C.

Connecticut

Connecticut completed its application to the Nuclear Regulatory Commission for KI tablets on February 6, 2002, and on March 15 received 450,000 130-mg tablets packaged in individual

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

foil strips of 14 tablets each. Numerous groups participated in the development of the state distribution plan, including the state’s Department of Public Heath, Department of Environmental Protection, Department of Consumer Protection, Department of Education, Office of Policy and Management, Office of Emergency Management, Nuclear Energy Advisory Council, chief elected officials, local health departments, school officials, the state pharmacists association, state legislators, and NPP representatives.

Distribution was conducted in phases. Targets of the distribution included the general population, host communities where KI would be stockpiled, and special populations, such as schools, day-care facilities, nursing homes, businesses, hospitals, prisons, and colleges (see Table 6.10). As a major means of making KI available and accessible in an emergency, the state decided to predistribute by mass mailing in the initial phase. The mailing was also seen as another avenue to inform the public and encourage emergency preparedness. The mass mailing to 68,000 households occurred on October 16 and 17, 2002. The first phase also included predistribution to towns to cover nonresident workers, seasonal and part-time residents, and large households. During the first phase, the state engaged in a mass-media campaign of education that involved newspaper ads and a press conference. Postings were placed on the Department of Public Health’s Web site. The physician and pharmacist communities were also involved in this phase, and local emergency-management training was given.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.10 Distribution of KI Tablets in Connecticut

Route

No. Tablets

Mass mailing

268,800

Town surplus

50,000 (5,000 distributed)

Schools

29,000

Colleges

10,000

Hospital

7,800

Prisons

11,116

Nursing homes

12,816

Large businesses

24,358

Local emergency workers

27,300

Military facilities

6,600

Day care facilities

5,600

Host communities

183,176

The second phase targeted schools—public, private, parochial, and charter schools—with outreach to school superintendents and principals and training of school officials. Kits were developed with parental-consent forms, establishment of school procedures, and development of other information material. The third phase targeted identified special-needs populations noted above. Also during phase 3, the state developed procedures for distributing KI to stockpiles in the host communities. An additional 235,000 tablets were purchased by the state for distribution to host communities.

A series of public-information materials were developed to provide basic information about use and side effects, to warn of allergy, and to reinforce the idea that KI protects only the thyroid and that it is to be taken only at the direction of state officials. The information was disseminated in a variety of educational materials: letters to physicians and residents, newspaper ads, press releases and a press conference, a cable television program, and the Millstone Emergency Planning Guidebook. The Nuclear Regulatory

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Commission issued the tablets with the label “IOSTATTM”—not “potassium iodide” or “KI”—that required additional packaging so that the identity of the tablet was easily recognizable. The state developed a fact sheet, a small envelop to hold and label the medication, and a letter to residents and packaged the mailing in consultation with the US Postal Service. The state decided to provide emergency dosage-administration instructions based on the 1982 FDA dosage guidance: one tablet, or 130 mg, for everyone 1 year old and older and 1/2 tablet, or 65 mg, for children less than 1 year old.

In discussing FDA (2001a), the state (Connecticut DPH, 2003) indicated that “FDA recently provided additional guidance on what is the smallest amount of KI you can take and still protect the thyroid. The smaller amounts may reduce the risk of side effects such as a minor upset stomach or rash. It may not be practical to administer very small dosages during an emergency. If you want to use smaller dosages, the FDA recommends taking the following minimum amount of KI…” In answer to the question “Are there any other concerns regarding taking KI”, the fact sheet does not mention FDA’s recommendations regarding neonates or repeat exposures of young infants and nursing and pregnant women. Connecticut developed its advice after making inquiries of FDA. The state was informed that the FDA (2001a) guidance gave minimum effective dosages and that the higher FDA dosages (1982) were safe.

The Connecticut fact sheet (Connecticut DPH, 2003) suggested that parents check with their pediatricians for appropriate KI dosages for their children. There do not appear to be any specific precautions given regarding exposure to young infants in the materials distributed by Connecticut.

The cost of the distribution was upwards of $172,000, or roughly $0.50 per tablet distributed, in addition to staff time. The supply will expire in March 2007. The state is planning to conduct public-education campaigns annually. It has heard various criticisms regarding its distribution program, for example, objection to mass mailing medication, the delay in distribution (KI was received in March and mailed in October), the idea that one tablet will not be enough in some circumstances, and the idea that coverage of only the towns in the EPZ will not be sufficient in some emergencies.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×
Tennessee

Tennessee began its program to distribute KI to populations near nuclear facilities in 1981 with a pilot project to assess door-to-door predistribution of KI to households within 5-mile radius of the Sequoyah NPP near Chattanooga operated by the Tennessee Valley Authority (TVA) (Fowinke et al., 1983). The decision to predistribute KI was made after emergency drills that simulated distribution after an emergency had been declared; distribution was found to be too slow to protect the public effectively. Because the pilot door-to-door distribution was expensive, it was replaced with a system of community stockpiles that would be moved to mass shelters for administration to the evacuating population. In addition, since the early 1980s, the Tennessee Department of Health has publicized KI and made it available to those who wished to pick it up and store it at home. That continues, although only about 5% of the population near the facility takes advantage of the offering.

The pilot door-to-door distribution of KI is well described in Fowinkle et al. (1982). It took place from November 16 to December 11, 1981. Thirty-eight employees of county health departments, after a 1-day training session, attempted to distribute KI to the 5,591 households within 5 miles of the power plant. The households were identified from addresses on TVA meter-reader sheets. Those distributing were local health professionals with experience in communicating with the public. They were prepared to answer general questions about the response plan for a nuclear accident. Some 3,022 households accepted the KI at the door. A letter left if residents were not at home indicated that they could pickup KI at two local health centers at specific times on three designated Saturdays; an additional 682 residents availed themselves of this opportunity. A few more residents arranged to pickup KI later. In total, 66% of the targeted households received KI. KI was packaged in a dark clear glass vial wrapped in the manufacturer’s package insert. To discourage indiscriminate use, this was placed in a childproof brown plastic vial. The glass vial contained 14 130-mg tablets. Before the distribution, a letter from the commissioner of public health was mailed to the targeted households. News media also attended the training sessions given to those distributing KI. In the expectation

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

that people would consult their physicians regarding the distribution, a program to inform local physicians through the local medical society was conducted before the distribution. As a partial indication of cost, it took 166 person-days to visit the 5,591 households.

Because of the costliness of the pilot program, a program of stockpiling, supplemented with voluntary pickup, was established in 1983, and it remains in place. The program has been described by Hagstrom (2003). KI is stored at central community stockpiles that are to be distributed to mass shelters in the event of an emergency. At the shelters, it would be administered to the evacuated public by public-health nurses. The Tennessee Department of Health decided not to make KI available to schools or day-care centers, because the facilities would not have health-care professionals available at the time of an emergency to oversee the administration of KI. The plan is to relocate schoolchildren by bus to schools outside the 10-mile radius around a nuclear facility immediately on declaration of an on-site emergency at the power plant.

The amount of KI in the stockpile is sufficient to cover all those living within 2-mile radius of the power plant and 20% of the population living within 2–10 miles. KI is packaged in blister packs of 14 130-mg tablets. Dosages recommended in the 2001 FDA guidelines are to be administered. As part of the communication strategy for the stockpiling program, calendars are mailed yearly to all living within 10-mile radius of the power plant. The calendars contain instructions for parents of schoolchildren, information on evacuation routes and sectors and on a location of shelters, and other information related to NPP emergencies.

Anyone living within 10 miles of a nuclear facility can pickup KI from the few health-department offices near the power plants. The Tennessee Department of Health states that it continues to publish availability of KI for home storage. In the early 1990s about 20% of those affected picked up KI. That proportion has declined, and now only about 5% of those affected pickup KI for their household. Besides information made available in packaging, through calendars, and in publicizing KI availability for pickup, it is planned to have the mass media play a role in advising the public on dosing and possible side effects during an emergency.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×
Maryland

Information on Maryland’s program comes in response to the committee’s request for information and presentations by Sharon (2003) and Rogers (2003). In response to the committee’s request for information, Maryland emphasized evacuation as the principal means of protecting the public in a NPP emergency. KI is relied on as a supplemental measure when evacuation is infeasible because of weather conditions or an extremely rapid accident.

The state requested KI from the Nuclear Regulatory Commission in January 2002 and began distributing it in the following spring. Maryland opted for a multipronged distribution strategy—predistribution enabling people to pickup dosages at clinics, providing for stockpiles at reception centers in the event of a disaster, and preplacing KI at schools and other facilities, such as senior centers and scout camps. Five counties fall within the 10-mile EPZ, with a total affected population of 85,000. In planning the distribution, the mixed results of past distribution efforts were acknowledged with an understanding that full coverage was unlikely. Distribution of KI is limited to those living and working within 10 miles of the nuclear facility.

To plan the distribution, an ad hoc KI working group was established; it was made up of local health officers, emergency-management directors, and staff in the involved state health, environment, and emergency-management departments. The group considered various distribution options, such as predistribution door to door, voluntary pickup, and mail and post-distribution through reception centers at the time of event. The group decided on voluntary distribution through pickup at scheduled clinics. In addition, a decision was made to place KI at schools and scout camps and other facilities for distribution to students, staff, and others at the facility at the time of the event and also to make KI continually available through local health departments. The decision to take KI would be reached through consensus of local governments and the state health, environment, and emergency-management departments. The public would be notified and instructed through the Emergency Alert System and the mass media.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

One of the most effective predistribution programs with respect to reaching residents that came to the committee’s attention was that of Calvert County, Maryland. This county, the fastest-growing county in Maryland, has a population of 75,000, with 35,000 residents within the 10-mile vicinity of the NPP. The county relied heavily on the public schools and other facilities for distribution, using school mails to disseminate information to families, health-department mails to inform designated facilities for KI placement, and the local print and television media to alert residents. From April to June, 2002, KI was placed in 97 schools and other facilities for distribution to the public. Five Saturday clinics were held at two high schools to inform and distribute to families that had been identified through the elementary-school network, and two additional clinics were held at the high school and four at the health department for the general public. The public was also encouraged to visit the county health department. Home visits were made to the homebound. KI reached about 24,400 of 35,000 residents living within 10 miles of the Calvert Cliffs NPP: 2,421 households covering some 11,450 people reached by the school framework and about 12,955 people reached via other facilities (a large LNG plant, 65 small workplaces, senior facilities and nursing homes, and day-care centers). Those reached by the school framework received two tablets per person, and those reached through other facilities received one tablet per person. The cost of the Calvert County predistribution program was fairly low, totaling $13,126 for county health-department staff and printing and mailing. That corresponds to $0.55 per person reached.

In response to the committee’s request for information, limitations in the plan were noted. The major limitations have to do with resources, which were characterized as “sorely limited”. That affects the evaluation and monitoring of the distribution program, the degree of public education and outreach, the general management of the distribution and related programs, and access to people who may not be aware of the program but might wish to obtain KI. It was noted that federal resources, if made available, would best be applied to fund staff to support the plan, assist in distribution, carry out public education and outreach, and evaluate the program. It was felt that additional federal guidance was unnecessary and that local

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

jurisdictions and states were the best equipped to plan and execute KI distribution because of their familiarity with the affected communities.

Elements of State Distribution Programs

The differing experiences and implementation plans of Connecticut, Maryland, Tennessee and other states (see Appendix C) highlight options and limitations to consider in planning distribution programs, as discussed below.

Predistribution with Postincident Stockpiling. All states on which the committee had detailed information about predistribution programs also had extensive plans for stockpiling and postincident distribution.

Target Population. All states target predistribution efforts to those living in the 10-mile EPZ. The Nuclear Regulatory Commission decision to offer KI dosages to the general public in the 10-mile EPZ no doubt was a dominant factor in producing this uniformity. Some states are evaluating populations beyond the 10-mile radius. States with predistribution programs currently distribute or offer KI to the entire population; age has not been a factor in predistribution of KI, despite the fact that children and pregnant women with fetuses in the second and third trimester of pregnancy are at most risk. States’ stockpiling programs also target the general and special populations in the 10-mile EPZ. Some states attempt complete coverage of the entire population that may be present in the EPZ during an emergency, others a specified fraction of those residing in the EPZ (such as Tennessee), while others decided to use the residual KI not distributed in predistribution programs for stockpiling and distribution in the event of an emergency.

Advice on Dosages. The complexity of the public health message that must be given to mitigate overdosages and ensure adequate dosages appears to have contributed to the oversimplified dosages information given by some state programs. Different dosages

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

messages and advice are used by the states. Some states (such as California, Massachusetts, and South Carolina) recommend dosages at the recent FDA (2001a) guidance levels for minimum effective dosage (see Table 6.11). Others (such as Ohio and New York) found that a scheme of graded dosages would be difficult to implement during a radiologic emergency. Some noted that adherence to the FDA minimum effective-dosage guidance should be followed where feasible, but compliance would be more likely if the simple instruction for two dosages (Dosage Message 2 in table 6.11) were given. Vermont recommended the administration of one tablet to children above 3 years old in such settings as schools, and ½ tablet to those under 3.

Several states appear to be unaware of the important precautions regarding overdosing neonates given in the FDA 2001 guidance (see section above Recommendations from Public Health Institutions in the U.S.). This may result from the interpretative guidance and fact sheets issued by the FDA (2001b, 2002, 2003c); they all emphasize the benefits of KI compared to the risks of overdosage, and none discuss TSH monitoring of neonates after KI dosage, as recommended in FDA (2001a). An example of the confusion in the FDA guidance on dosing is provided above in discussion of Connecticut’s distribution program.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.11 Dosages recommended by States

Dosage Message 1

1 tablet = 130 mg

Adults 18 years and older

1 tablet

Pregnant or nursing women

1 tablet

Adolescents 12-18 years old

½-1 tablet

Children 3-12 years old

½ tablet

Children 1 month-3 years old

¼ tablet

Infants—birth-1 month old

1/8 tablet

Dosage Message 2

1 tablet = 130 mg

Children over 1 year old and adults

1 tablet

Children under 1 year old

½ tablet

Number of Tablets to Predistribute. Some states provided two dosages per person, others (such as New York) provided one dosage. One state provided two tablets per individual residing in households identified and reached via schools and one tablet per individual in households reached by other facilities. In this case, a greater proportion of children compared to adults would be expected to have multiple tablets available to them. States stockpile and reserve for post-accident distribution the tablets not predistributed. Inefficient predistribution programs (ones who do not manage to predistribute most of the KI they plan to) following this strategy could be expected to have an adequate supply for a single day of post-distribution. Connecticut, with its efficacious predistribution program, purchased additional KI tablets to ensure adequate supply for stockpile and postdistribution.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Method of Predistribution. The efficacy of the voluntary-pickup predistribution program appears to depend heavily on the methods used, the intensity of community and stakeholder involvement in planning and distributing KI, public-education materials and messages, and mass-media involvement (Table 6.12). The general methods used have included door-to-door distribution (as was done in 1981 in Tennessee), mass mailing of tablets and information on use (Connecticut), request by mail after mass mailing (California), formal application for KI via a mailed application (some involving an informed-consent form), and pickup at identified locations in the community on particular “KI days.” Some states routinely provide residents information on the predistribution and make KI available to persons moving into the EPZ after the initial distribution.

States’ programs of voluntary pickup by residents at specified locations generally resulted in distribution to no more than 5% of residents. In addition to the door-to-door distributions of Tennessee in the early 1980s, other means appear to have been effective. KI reached 2/3 of the effective population in a program involving mass mailing accompanied by publication and public education effort, and a well-orchestrated distribution through schools and local facilities (Calvert County, Maryland).

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Table 6.12 Coverage of Some Predistribution Programs

State

Predistribution Method

Coverage Statistics

California

Mass mailing of brochures including postcard to request KI; mass-media campaign

KI distributed to 31.7% residents ordering

Connecticut

450,000 tabletsa

Mass mailing of tablets

High

Illinois

360,000 tablets

KI made available for residents to pickup at distribution stations

6% of eligible population requested KI

Maryland

Other counties

Predistributed to local residents through clinics; continuing distribution through local health-department offices

State estimates that 25% of eligible population obtained KI

Calvert County

Voluntary pickup; distributed to general population through schools, workplaces, other facilities

70%

New Hampshire

350,000 tabletesa

Requires submitting application available at town halls, and health-department offices, over Internet

3.5%

New Jersey

722,000 tabletsa

KI made available at designated locations via “public education and distribution” sessions

About 10%

New York

1.2 million tablets

Distribution varied by county; provided locations for pickup, pickup via mail

15% of population in EPZ

North Carolina

750,000 tabletsa

Voluntary pickup

35% of public

picked up tablets

Ohio

Mass mailing of information letter with coupon for KI pick-up; mass-media campaign

40% of amount received was distributed

Pennsylvania

for 640,000 people

Voluntary pickup

About 34%

Tennessee

Voluntary pickup

<5%

Vermont

Application required for distribution

<5%

aTablets requested.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Predistribution to Schools and Workplaces. States have varied in their approach to predistribution and requirements of consent forms for postincident administration of KI at day-care facilities, schools, and workplaces. Some leave it to school districts and workplaces to design programs for distribution. Others have standardized education materials, methods for distribution, and consent materials.

Education and Communication Strategies. Distribution programs with extensive public education and use of mass media appeared to be much more effective than those without. Structuring, implementing, and sustaining a public-awareness campaign appear to be necessary elements of a predistribution program.

Provisions for Special Populations Difficult to Evacuate. One state has plans for early evacuation of nonambulatory residents. Several states have plans to administer KI and to shelter in place at prisons, hospitals, and nursing homes. One state routinely identifies the homebound and has plans for distributing KI to them. Morbidity and mortality associated with evacuating segments of special populations were important considerations in state decisions on strategies for their protection.

Packaging and Labeling of KI Tablets. Because the tablets are issued by the Nuclear Regulatory Commission in blister packages of 14 tablets each, repackaging for distribution is necessary. Information with the packages can include the identity of the drug, the dosage, and precautionary messages. The Commission makes tablets available to the states in amounts of 130 mg, which may in an emergency make it more difficult to achieve accurate dosage of small children. An FDA-approved 65-mg KI tablet with cross scoring is available. This enables the tablet to be quartered. One-quarter tablet is the dosage required for a young infant.

It has been a challenge to provide with sufficient clarity the rather complex notion that the very young are very sensitive to the radioiodine exposure, that it is essential that they receive a sufficient dosage, and that it is important not to overdosage, because of risks to

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

normal growth and development. The additional message for full disclosure is that although taking KI will reduce the risk of thyroid disease, it will not protect against the radiation effects of other radioactive materials released with the radioactive iodine. States would clearly benefit from research to ensure that such messages are given in a manner that would lead to the desired outcome.

Number of Tablets to Stockpile for Postdistribution. Some states merely stockpiled tablets that were not retrieved by the public in the predistribution. Other states set aside a specified number per person, and at least one purchased for post distribution tablets beyond those given by the Nuclear Regulatory Commission.

Means and Circumstances of Advising the Public to Take KI. All states on which such information was available refer to the triggering dosage levels given in the FDA guidance. Some that have predistributed KI will advise the public to take KI at the same time that emergency workers in the EPZ are given word to ingest the tablets. If KI is to be provided at evacuation or reception centers, several states have information sheets for advising the public of adverse reactions and dosages. Some states will administer KI under the supervision of physicians and registered nurses. Others will have other public-health professionals available to answer questions.

Distribution Postincident from Stockpiles to Reception Centers and Shelter in Place Locations. Issues to be considered include the number and placement of stockpiles with respect to where they will be needed in a nuclear incident.

Restocking and Resupply. Few states have in place plans for resupply when official or actual shelf-life expires. The Nuclear Regulatory Commission has made no commitment to resupply states. If needed in the days after a major incident, resupply is dependent on the Strategic National Stockpile.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

Conclusions

In the United States and internationally, iodine blockade is supplemental to evacuation and sheltering in place, and this is appropriate. Because KI is most effective when taken within a few hours of exposure to radioiodine, predistribution programs are used extensively. Some states do not have distribution programs and rely on evacuation for protection. The committee did not review the relevant information to conclude whether, in the event of a serious incident, rapid and complete evacuation could be accomplished for sites without rapid access to KI, but it notes the need for such an evaluation.

Local, rapid access to KI is accomplished through stockpiling and predistribution. Predistribution to residences alone is not sufficient to protect the public, and local stockpiling appears to be a part of all local KI distribution programs. Because of low coverage and inadequate education, some predistribution programs offer little more protection than a stockpiling program, although these ineffective programs do provide a “right to have” KI even though few decide to obtain it. Several states had predistribution programs that reached less than 10% of the affected population. Voluntary pickup programs reach more than 50% of the general population only if there is active community involvement. Door-to-door delivery appears more effective, but can be costly. With mass mailing, greater coverage can be obtained, especially when it does not involve completion of request forms. It may be, though, that fewer recipients of mass mailings will be able to retrieve stored KI in an emergency. The fraction of residents recalling where they have stored KI, say, 2-3 years after obtaining it and how this might be related to the method of distribution and public-information campaigns have not been adequately studied. Even with the most efficacious predistribution programs, well-developed programs for local stockpiling and postdistribution are required to ensure protection.

The Nuclear Regulatory Commission offered KI coverage for those working and living within the 10-mile EPZ, and all local distribution programs in the United States are designed for this coverage. Geographic features and weather conditions vary

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

substantially among NPPs and alternative coverage areas might be preferable. These could be based on analyses to evaluate the populations that may be at significant risk from radiation exposures under different release scenarios and on the related contours to circumscribe the area associated with that risk. It would also aid in consideration of whether more-detailed planning of KI distribution to populations beyond the 10-mile EPZ is warranted. Furthermore, such analyses would provide the states and communities a framework for considering alternative intervention and significant risk levels. FDA recommends intervention with KI administration at 50 mGy (5 rad) exposure to children; at this level, FDA determined that radiation-induced cancers were not observed to be increased in the Chornobyl population. Using the WHO dose-response analysis, 50 mGy (5 rad) corresponds to a risk of five thyroid cancers per 10,000 children exposed. Some states may wish to afford a different level of risk protection to potentially exposed populations.

FDA’s messages regarding advice on dosages are not uniform. The current guidelines, interpretive guidance, and approved labeling of KI differ, and considerably different messages have been developed by states to provide advice and procedures for KI administration. Precautions regarding overexposure of neonates and follow-up monitoring of the very young for hypothyroidism once KI is administered are not given by some states. Different messages are also given for populations that may be sensitive to iodine. A consistent set of advice from FDA regarding adequacy of messages to protect the public from the risks of overexposure but to encourage adequate dosage is needed. The difficulty of providing complicated messages to effect optimal behavior under emergency conditions is recognized. In this regard, research would benefit the states in the development of effective education and mass-media strategies and benefit FDA and the states in developing packaging and labeling messages.

Several states’ distribution efforts were hampered by the limited support given for distribution programs by the Nuclear Regulatory Commission. Many states noted that they did not have sufficient funds for resupply and stockpile, which the commission has

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
×

not committed to support. For some states, decisions on whether to use KI and how to use it also appear to depend on federal funding.

Suggested Citation:"6 Existing Distribution Plans for Potassium Iodide." National Research Council. 2004. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident. Washington, DC: The National Academies Press. doi: 10.17226/10868.
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Radioactive iodines are produced during the operation of nuclear power plants and during the detonation of nuclear weapons. In the event of a radiation incident, radioiodine is one of the contaminants that could be released into the environment. Exposure to radioiodine can lead to radiation injury to the thyroid, including thyroid cancer. Radiation to the thyroid from radioiodine can be limited by taking a nonradioactive iodine (stable iodine) such as potassium iodide. This book assesses strategies for the distribution and administration of potassium iodide (KI) in the event of a nuclear incident. The report says that potassium iodide pills should be available to everyone age 40 or younger—especially children and pregnant and lactating women—living near a nuclear power plant. States and municipalities should decide how to stockpile, distribute, and administer potassium iodide tablets, and federal agencies should keep a backup supply of tablets and be prepared to distribute them to affected areas.

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